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SECTION 800: SCOPE OF SERVICES INFUSION NURSING SERVICES

The provision of nursing care and services involving the assessment, planning, implementation, and evaluation of the infusion client. Standard 801. Infusion nursing services will be provided by qualified nurses in accordance with state laws, regulations and recognized professional practice standards. Standard 801, Criterion A: Infusion nursing services will be provided by a qualified RN or LPN/LVN in accordance with the state's Nursing Practice Act, the Board of Pharmacy, and the organization's policies/job descriptions. Interpretation: Registered nurses and Licensed Practical/Licensed Vocational nurses will function in accordance with professional standards, the state's practice act, and according to the organization's job description. Organizations can also look to the standards of the American Nurses Association for guidance in determining appropriate professional standards for infusion nursing care. Infusion therapy services can look to American Society for Parenteral and Enteral Nutrition (ASPEN), Intravenous Nursing Society (INS), Oncology Nursing Society (ONS), and various specialty nursing organizations' standards for guidance. Current copies of applicable rules/regulations, the state's nursing practice act, and professional practice standards are available to nursing staff. Evidence: Copies of current license Job descriptions/policies State's Nursing Practice Act Professional Practice Standards Personnel records

Standard 802. There are written policies and procedures related to infusion nursing services. Standard 802, Criterion A: There are written policies and procedures describing the scope of services offered by the infusion nursing service program. Interpretation: The infusion nursing program has written and implemented policies and procedures addressing the scope of infusion nursing services offered by the organization. These services should include, but not be limited to, types of services/treatments provided, target client populations, and the goals of the program. Evidence: Written nursing policies and procedures

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Standard 802, Criterion B: Infusion nursing services are provided according to the client's plan of care with access to a nurse available 24 hours a day, 7 days per week. Interpretation: The organization provides nursing services 24 hours a day, 7 days a week when necessary to meet client needs. An on-call coverage system may be used to provide this coverage during evenings, nights, weekends and holidays. Written policies and procedures will describe the levels of nursing services made available to the client on a 24-hour daily basis. Evidence: Written service policies Response to interviews

Standard 803. Qualified personnel supervise the infusion nursing services. Standard 803, Criterion A: There is a qualified professional responsible for supervision of all infusion nursing services. Interpretation: All infusion nursing services must be provided under the direction of a registered nurse with infusion nursing services training and education or an experienced registered pharmacist with access to infusion nursing practice consultation, as appropriate. A registered pharmacist oversees the pharmaceutical care services provided and consults with the RNs administering the medications. It is preferred that the registered nurse in charge of the infusion nursing program have a minimum of two years previous supervisory experience or the equivalent. State regulations may dictate nursing requirements. Evidence: Personnel file State regulations for minimum qualifications

Standard 803, Criterion B: Licensed Practical/Vocational nurses are supervised by a Registered Nurse in accordance to organization policy and the state board of nursing. Interpretation: The organization follows their state board of nursing regulations and policy and procedures that demonstrate supervision of care provided by licensed practical nurses (LPNs). The policy and procedure identify the method and frequency for assessing LPN practice to ensure that client care needs are met. Supervision activities may include, but are not limited to, a visit to the client's home by the RN, with or without the LPN present, every 60 ­ 62 days as well as client record reviews and conferences. Evidence: Client record Policy and procedure Response to interviews

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Standard 804. Clients will have an assessment of need and participate in the development of the plan of care. Standard 804, Criterion A: All clients referred for nursing services will have an evaluation/assessment of need. Interpretation: A nursing services eligibility assessment will be performed on clients referred for infusion nursing services and documented in the client's record. The comprehensive assessment should be based on client need or perceived need and address physical and behavioral status. The evaluation assessment will be documented whether services continue or not. Evidence: Client Record

Standard 804, Criterion B: There is a written plan of care for each client accepted for services, ordered by the physician, and based upon assessment data which includes at a minimum, the types of services to be provided, the frequency and duration of services, specific treatments, prescribed medications, and client goals. Interpretation: The plan of care is ordered by a physician and specifies: (1) types of services to be provided; (2) the frequency and duration of services; (3) specific treatments; (4) prescription and over-the-counter medications; and (5) expected client outcomes/goals. Where applicable, the plan of care may also include: equipment required, functional limitations, rehabilitation potential, diet and nutritional needs, pain management, care related to dying and end-of-life needs, and any safety measures. Evidence: Client record

Standard 804, Criterion C: The organization will show evidence of the client/caregiver participation in the plan of care. Interpretation: The client/responsible party has a right to be involved in the development of the plan of care and any changes in that plan. However, the degree of involvement may vary depending on the ability of the client. At a minimum, the client or responsible party must agree to the plan of care prior to the beginning of services and as subsequent changes occur. The client record must show involvement of the client/family/caregiver in the development or at least agreement to the plan of care and any revisions made to the plan. The following are suggestions as to how organizations may document this information: (1) the plan of care may be signed by the client/responsible party; (2) a notation may be made in the client record that the client/responsible party participated in the development of the plan of care; or (3) there may be documentation in the client record that the plan of care was reviewed and accepted by the client/responsible party. Evidence: Client record Responses to interview

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Standard 805. The plan of care and services provided will be appropriate for the client's level of service/care needs. Standard 805, Criterion A: Nursing care is delivered in accordance with the written plan of care and directed at achievement of established infusion nursing and client treatment goals. Interpretation: The client record reflects nursing care delivered in accordance with the plan of care and directed at achievement of established nursing and client treatment goals Evidence: Client records

Standard 805, Criterion B: There is demonstrated consistency between service/tasks performed by the organization personnel, the written plan of care, and the services billed. Interpretation: The client record verifies consistency between the services performed by the nursing staff, the written plan of care, and the services billed. Evidence: Client records Billing records Responses to interviews

Standard 805, Criterion C: There is evidence that the plan of care is reviewed. Interpretation: Policy and procedure describe the frequency and the process for the plan of care review. There is documentation in the client record that reflects the plan of care is reviewed for: (1) appropriateness (services being provided are still needed); (2) effectiveness (client outcomes/response to care); and (3) to determine if all needed services are being provided. Included in this review is discussion with the client/responsible party to determine the level of satisfaction with the types of services being provided. Notation of a review may be made in the client record, in minutes of meetings such as team meetings or case conferences. The organization follows program regulations and policies for the frequency of review activities. The plan of care review would occur more frequently based on the client's need for changes. Evidence: Written policies Client records Case conference minutes of meetings Responses to interviews

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Standard 805, Criterion D: There is evidence of changes in the plan of care based on reassessment data. Interpretation: Changes should be noted on the plan of care and in the progress notes based on client requests, client's condition, client's response to therapy, and when physician orders indicate changes. There should be evidence of communication to the physician regarding the client's condition and changes to the plan of care. If new or revised client or treatment goals are indicated, they should be reflected in the plan of care. Note: Supplemental physician orders may serve as part of the client's plan of care. Evidence: Client records

Standard 805, Criteria E: If physician orders are needed for services, there is evidence of initial physician involvement and physician notification when changes in the plan of care are needed. Interpretation: Physician orders are needed to provide any services requiring the administration of medication, prescribed treatment(s), or other activities governed by state law. Physician orders may also be required under certain program requirements (i.e., Medicare, Medicaid, Managed Care, and other third party payers). In these situations, the organization has a responsibility to obtain physician orders prior to initiation of the services and to notify the physician of any changes in the client's condition. Verbal orders will be documented by the staff receiving the order, indicated by staff signature and credential, and cosigned by the physician within a reasonable time frame established in the organization's policy and/or state licensure requirement. Evidence: Client records

Standard 805, Criterion F: Client and/or caregiver education should focus on goal and outcome achievement as established in the plan of care. Interpretation: Client education is an integral part of home infusion services. Assessment of the client and/or caregiver's knowledge deficits and learning abilities are evaluated during the initiation of services. Client education/instruction will proceed in accordance with the client's willingness and condition to learn.

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Education should be coordinated with the client/caregivers and the health care team and should focus on goal and outcome achievement as established in the plan of care. Elements of client education may include, but not be limited to: (1) ongoing assessment of client and caregiver's learning needs; (2) communication of needs to other health care team members; and (3) incorporating client needs into the plan of care. The client records will include documentation of all teaching, client's response to teaching, and the client's level of progress/achievement of goals/outcomes. Written instructions will be provided to the client when appropriate. Evidence: Client records Client and staff interviews

Standard 806. Infusion nursing services transfer and discharge clients as appropriate and in accordance with established policies and procedures. Standard 806, Criterion A: Infusion nursing services follow transfer policies and procedures. Interpretation: A client is transferred if the client's needs can no longer be met adequately by the organization. The transfer policy will define activities that represent a client transfer. Large organizations may include inter-organization transfers between branch offices in this definition. A transfer summary will be completed and a copy will be maintained in the client record and a copy will be forwarded to the receiving program service entity A transfer summary will include: (1) date of transfer; (2) client identifying information and emergency contact; (3) receiving facility; (4) client's physician and phone number; (5) diagnosis related to the transfer; (6) significant health history; (7) transfer orders and instructions; (8) a brief description of services provided and ongoing needs that cannot be met; (9) status of client at the time of transfer. Evidence: Client Record Policy and procedure

Standard 806, Criterion B: Infusion nursing services follow discharge policies and procedures. Interpretation: The organization has a process which assesses the client's ongoing appropriateness for therapy/services. The discharge policy will define activities that represent client discharge. The client record should reflect discharge planning activities, coordination with other care providers, the client's response and understanding to these activities, client care instructions and a reasonable notice prior to discharge, whenever possible.

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A discharge summary is written which includes: (1) a summary of services provided; (2) the date and reason for discharge; (3) a brief description of ongoing needs that cannot be met: and (4) any instructions or referral information given to the client or responsible party. A copy of the discharge summary is made available to the primary physician and a copy is included in the client record. Evidence: Client records Policy and procedure

Standard 807. All pharmaceuticals and medical treatments are administered in accordance with applicable laws/regulations and organization policies and procedures. Standard 807, Criterion A: The service/program has written policies and procedures that identify the drugs or drug classifications and routes of administration that staff may administer. Interpretation: There must be a list of drugs or drug classifications, approved by the governing board that may be administered by nursing service staff. The list must include any exceptions as well as the routes of administration that are allowed (i.e., oral, intramuscular, subcutaneous, intravenous, intrathecal, epidural, etc.), and any special criteria for the acceptance of clients for this service. The organization may have a policy that addresses drugs and drug classifications that are not allowed rather than listing all that are allowed. These policies and procedures must also address any blood or blood products that may be administered. Evidence: Written policies and procedures Client records

Standard 807, Criterion B: A licensed nurse reviews all client medications both prescription and non-prescription on an ongoing basis as part of the services to a client. Interpretation: When nursing services are provided, a licensed nurse must review all prescription and non-prescription medications a client is taking. The licensed nurse is specifically accountable for recognizing the following: (1) side effects; (2) toxic effects; (3) allergic reactions; (4) immediate desired effects; (5) unusual and unexpected effects; and (6) changes in the client's condition that contraindicates continued administration of the medication. In addition, the nurse must be able to anticipate those effects that may rapidly endanger a client's life or well being, and instruct the client, family members and/or caregiver, as necessary, in following the prescribed regimen.

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A medication log or profile that lists, at a minimum, all current client medications, date prescribed or taken, name of medication, dose, frequency, drug classification and date discontinued should be included in the clients record. Evidence: Client records

Standard 807, Criterion C: There are written guidelines relating to special education, experience or certification requirements for nursing staff to administer pharmaceuticals and/or special treatments. Interpretation: The organization must have written guidelines defining any special education, experience or licensure/certification requirements necessary for nursing staff to administer pharmaceuticals and/or special treatments. Qualifications may vary based upon state board of nursing requirements for licensed practical nurses and registered nurses. Example: If the organization provides pediatric infusion services the organization will assign staff with pediatric training and experience. The organization must verify competence of performance for high-risk care skills in the home. Evidence: Written policies or guidelines Client records Personnel records

Standard 807, Criterion D: There are written policies and procedures that address response to adverse drug reactions. Interpretation: The organization has written policies and procedures that identify potential drugs and drug classifications that may cause adverse reactions when administered concomitantly. Policies and procedures should address the standard protocol for managing and reporting Adverse Drug Reactions (ADR) internally and to outside state agencies as required by law. This may include standing orders to treat anaphylaxis and recommended dosages of drug per age group. Evidence: Written policies and procedures Response to interviews ADR record book MedWatch records

Standard 807, Criterion E: The organization has policies and procedures for participating in clinical research/experimental therapies and/or administering investigational drugs. Note: This standard is not applicable to organizations that are not participating in clinical research/experimental therapies, or administering investigational drugs. Interpretation: Policies include both when staff is administering investigational medications and when staff is monitoring a client's response to investigational medications or treatments or participation in research or a clinical study.

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Policies describe the process and identify the responsibility for obtaining informed consent whenever a client is being treated with investigations or experimental drugs or is participating in research or a clinical study. Written policies include client responsibilities, the client's right to refuse acceptance of investigational drugs or experimental therapies, and the client's right to refuse participation in research and clinical studies. Evidence: Policies and procedures

Standard 808. The organization will have access to a reference library appropriate to the level of services provided. Standard 808 Criterion A: The organization will have access to a reference library appropriate to the level of services provided. Interpretation: The nursing program has available reference books, journals, Internet access, etc. appropriate for the client population served and the medications administered. At a minimum, the library will address: (1) general clinical references; (2) drug reference books; (3) infusion clinical practice guidelines; and (4) State Board of Nursing practice acts for any state into which the staff practice. Evidence: Review of reference library Staff interviews

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PHARMACY SERVICES

The provision of pharmaceutical care and services involving the preparation and dispensing of infusion medications and infusion medication-related devices and supplies by a licensed pharmacy. This includes but is not limited to home pharmacy services, infusion pharmacy services, and hospice pharmacy services. Standard 809. All pharmacy services will be provided by qualified pharmacists in accordance with state laws, regulations and recognized professional practice standards. Standard 809, Criterion A: All Pharmacy Services will be provided by qualified personnel and administered in accordance with the organization's policies and job descriptions, federal, state, and local laws, and established regulatory guidelines as dictated by the Board(s) of Pharmacy of the state(s) into which medications are dispensed. Interpretation: Pharmacist and pharmacy technicians will function in accordance with the organization's job description, accepted ethical and professional practice standards and in accordance with all applicable federal, state and local laws and guidelines set by the state appropriate Board of Pharmacy. If pharmacy services are dispensing in other states, a pharmacy license or permit for states serviced will be obtained if required by that state. Current copies of applicable rules and regulations are maintained in the organization office at all times and are readily available to appropriate organization staff. Evidence: State Board of Pharmacy Regulations Resident State Pharmacy License Resident State Board of Pharmacy Permit/License Additional State Board of Pharmacy Permit/License DEA Registration State Controlled Substance License (when required) Licenses of Practicing Technicians, where applicable Job descriptions/policies Out of State Pharmacy Permit(s) (where required) Personnel record reviews

Standard 809, Criterion B: All required licenses and/or permits for the physical facility are current and conspicuously placed on display in an appropriate area of public view. Interpretation: The organization will display in an area of public view all licenses and/or permits required in the operation of the pharmacy services. Evidence: License displayed in an appropriate place for public view (if required) Device Dispensing Permit (if required) State Board of Pharmacy License or contract with a locally licensed pharmacy (contract available for review)

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Standard 810. There are written policies and procedures relating to pharmacy services. Standard 810, Criterion A: There are written policies and procedures describing the scope of services offered by the infusion pharmacy program. Interpretation: The infusion pharmacy program has written and implemented policies and procedures addressing the scope of pharmacy services offered by the organization. These services should include, but not be limited to, types of services provided, target client populations, and goals of the program. Evidence: Written pharmacy policies and procedures

Standard 810, Criterion B: Pharmacy services are provided according to the client's plan of care with access to a Registered Pharmacist available 24 hours a day, 7 days per week. Interpretation: The organization provides pharmacy services 24 hours a day, 7 days a week when necessary to meet client needs. An on-call coverage system may be used to provide this coverage during evenings, nights, weekends and holidays. Evidence: Written service policies On-call schedule/log

Standard 811. Qualified personnel supervise the pharmacy services. Standard 811, Criterion A: There is a qualified professional responsible for supervision of all services. Interpretation: All pharmacy services must be provided under the direction of a registered pharmacist with sufficient education and experience in the scope of services offered. It is preferred that the registered pharmacist in charge of the pharmacy program has a minimum of two years previous supervisory experience or the equivalent. State regulations may dictate pharmacist requirements. Evidence: Personnel file of the supervising pharmacist

Standard 811, Criterion B: Pharmacy technicians are supervised by a registered pharmacist in accordance to organizational policy and the state board of pharmacy. Interpretation: The organization follows their state board of pharmacy regulations and organizational policies and procedures that demonstrate supervision of services provided by pharmacy technicians. The policies and procedures identify the method and frequency for assessing pharmacy technician practice to ensure that services are provided appropriately. Evidence: Policy and Procedure Documentation of supervision activities ­ client record or personnel record Response to Interviews

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Standard 812. Clients will have an assessment of need and participate in the development of the plan of care. Standard 812, Criterion A: All clients referred for pharmacy services will have an assessment of appropriate therapy. Interpretation: An assessment will be performed and information documented in the client's record for clients referred for pharmacy services. The assessment shall focus on appropriateness for therapy in the home, safety in the home, and method of drug delivery. Evidence: Client Record

Standard 812, Criterion B: There is a written plan of care for each client accepted for services, ordered by the physician, and based upon assessment data which includes at a minimum, specific treatments, prescribed medications, and client goals. Interpretation: The plan of care is ordered by a physician and specifies: (1) treatments; (2) prescription and over-the-counter medications; (3) problems; (4) interventions; (5) monitoring expectations; (6) expected client outcomes/goals; and (7) resolutions. The physician, or other professional authorized to prescribe, will provide adequate medical management for the client receiving pharmacy services. Evidence: Client record

Standard 812, Criterion C: The organization will show evidence of the client/caregiver participation in the plan of care. Interpretation: The client/responsible party has a right to be involved in the development of the plan of care and any changes in that plan. However, the degree of involvement may vary depending on the ability of the client. At a minimum, the client or responsible party must agree to the plan of care prior to the beginning of services and as subsequent changes occur. The client record must show involvement of the client/family/caregiver in the development or at least agreement to the plan of care and any revisions made to the plan. The following are suggestions as to how organizations may document this information: (1) the plan of care may be signed by the client/responsible party; (2) a notation may be made in the client record that the client/responsible party participated in the development of the plan of care; or (3) there may be documentation in the client record that the plan of care was reviewed and accepted by the client/responsible party. Evidence: Client record Responses to interview

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Standard 813. The plan of care and services provided will be appropriate for the client's level of service/care needs. Standard 813, Criterion A: Pharmacy services are delivered in accordance with the written plan of care and directed at achievement of established pharmacy and client goals. Interpretation: The client record reflects pharmacy care delivered in accordance with the plan of care and directed at achievement of established pharmacy and client goals. Evidence: Client records

Standard 813, Criterion B: There is demonstrated consistency between service/tasks performed by the organization personnel, the written plan of care, and the services billed. Interpretation: The client record verifies consistency between the services performed by the pharmacy staff, the written plan of care, and the services billed. Evidence: Client records Billing records Responses to interviews

Standard 813, Criterion C: There is evidence that the plan of care is reviewed. Interpretation: Policy and procedure describe the frequency and the process for the plan of care review. There is documentation in the client record that reflects the plan of care is reviewed for: (1) appropriateness (services being provided are still needed); (2) effectiveness (client outcomes/response to care); and (3) to determine if all needed services are being provided. Included in this review is discussion with the client/responsible party to determine the level of satisfaction with the types of services being provided. Notation of a review may be made in the client record, in minutes of meetings such as team meetings or case conferences. The organization follows program regulations and policies for the frequency of review activities. The plan of care review would occur more frequently based on the client's need for changes. Evidence: Written policies Client records Case conference minutes of meetings Responses to on-site interview questions

Standard 813, Criterion D: There is evidence of changes in the plan of care based on reassessment data. Interpretation: Changes should be noted on the plan of care and/or in the progress notes based on client requests, client's condition, client's response to therapy, and when physician orders indicate changes.

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There should be evidence of communication to the physician regarding the patient's condition and changes to the plan of care. If new or revised client or treatment goals are indicated, they should be reflected in the plan of care. Note: Supplemental physician orders may serve as part of the patient's plan of care. Evidence: Client records Responses to on-site interview questions

Standard 813, Criteria E: If physician orders are needed for services, there is evidence of initial physician involvement and physician notification when changes in the plan of care are needed. Interpretation: Physician orders are needed to provide any services requiring the administration of medication, prescribed treatment(s), or other activities governed by state law. Physician orders may also be required under certain program requirements (i.e., Medicare, Medicaid, Managed Care, and other third party payers). In these situations, the organization has a responsibility to obtain physician orders prior to initiation of the services and to notify the physician of any changes in the client's condition. Verbal orders will be documented by the pharmacist receiving the order and indicated by pharmacist signature and credential. Evidence: Client records

Standard 813, Criterion F: Client and/or caregiver education should focus on goal and outcome achievement as established in the plan of care. Interpretation: Client education is an integral part of home infusion services. Assessment of the client and/or caregiver's knowledge deficits and learning abilities are evaluated during the initiation of services. Client education/instruction will proceed in accordance with the client's willingness and condition to learn. Education should be coordinated with the client/caregivers and the health care team and should focus on goal and outcome achievement as established in the plan of care. Elements of client education may include, but not be limited to: (1) ongoing assessment of client and caregiver's learning needs; (2) communication of needs to other health care team members; and (3) incorporating client needs into the plan of care. The client records will include documentation of all teaching, client's response to teaching, and the client's level of progress/achievement of goals/outcomes. Written instructions will be provided to the client when appropriate. Evidence: Client records Client and staff interviews

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Standard 814. Pharmacy services discharge clients as appropriate and in accordance with established policies and procedures. Standard 814, Criterion A: Pharmacy services follow discharge policies and procedures. Interpretation: The organization has a process which assesses the client's ongoing appropriateness for therapy/services. The discharge policy will define activities that represent client discharge. The client record should reflect discharge planning activities, the client's response and understanding to these activities, client care instructions and a reasonable notice prior to discharge, whenever possible. A discharge summary or notation made in the client's progress notes which includes: (1) a summary of services provided; (2) the date and reason for discharge; (3) a brief description of ongoing needs that cannot be met; and (4) any instructions or referral information given to the client or responsible party. A copy of the discharge summary is made available to the primary physician and a copy is included in the client record. Evidence: Client records Policy and procedure

Standard 815. All pharmaceuticals are administered in accordance with applicable laws/regulations and organization policies and procedures. Standard 815, Criterion A: A registered pharmacist must review all client medications and consult with other health care professionals caring for the client, including the physician. Interpretation: A licensed pharmacist must review all prescription and non-prescription medications a client is currently taking prior to dispensing. A medication profile is established at the start of therapy. The medication profile is updated and kept current through ongoing review and revision of client data. A licensed pharmacist is specifically accountable for recognizing the following: (1) side effects; (2) toxic effects; (3) allergic reactions; (4) immediate desired effects; (5) unusual and unexpected effects; (6) drug interactions; (7) appropriateness of drug for diagnosis; (8) appropriateness of dose; and (9) changes in the client's condition that contraindicates continued administration of the medication. In addition, the pharmacist, in conjunction with other health care professionals caring for the client, must be able to anticipate those effects which may rapidly endanger a client's life or well being, and instruct the client, family members and/or caregiver, as necessary, in following the prescribed regimen. Evidence: Written policies and procedures Client records (care conference, progress notes) Responses to on-site staff interview questions

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Standard 815, Criterion B: Medications and supplies are accurately labeled and dispensed to the patient for whom they are ordered. Interpretation: Medications dispensed to clients are appropriately labeled according to applicable law and regulation and standards of practice. There is a process to verify that the correct medication(s) and supplies, if applicable, were dispensed and delivered to the correct client. Evidence: Pharmacy Logs Delivery tickets or logs

Standard 815, Criterion C: There are written guidelines relating to special education, experience or certification requirements for pharmacy staff to prepare pharmaceuticals and administrative devices. Interpretation: The organization must have written guidelines defining any special education, experience or certificates necessary for pharmacy staff to prepare pharmaceuticals and administrative devices. Qualifications may vary based upon classifications of drugs as well as State Board of Pharmacy requirements. Evidence: Written policies or guidelines Personnel Files

Standard 815, Criterion D: There are written policies and procedures that address response to adverse drug reactions. Interpretation: The organization has written policies and procedures that address the steps taken should an adverse drug reaction occur. Policies and procedures should address the standard protocol for managing and reporting Adverse Drug Reactions (ADR) internally and to outside state agencies as required by law. This may include standing orders to treat anaphylaxis and recommended dosages of drug per age group. Evidence: Written policies and procedures Response to interviews ADR record book MedWatch records

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Standard 816. The pharmacy has a system for the recall of medications. Standard 816, Criterion A: Records are maintained to identify each client who is receiving or has received recalled medications. Interpretation: There are written policies and procedures for tracking medications or products dispensed to patients. Documentation will include, but not be limited to, the manufacturer of each client's medication, lot numbers and expiration dates. Evidence: Policies and procedures Dispensing records Client record Response to staff interviews

Standard 816, Criterion B: Processes are maintained for the safe disposition of recalled medications or products stocked and dispensed to clients. Interpretation: There are written procedures for external reporting of medication product defects. Client's physicians are notified when medications are discontinued, expire, or are recalled. Evidence: Policies and procedures Dispensing records Client record Response to staff interviews

Standard 817. All parenteral medications are prepared and compounded by qualified personnel in a suitable environment using appropriate aseptic technique. Standard 817, Criterion A: Qualified personnel comply with aseptic technique when compounding sterile admixtures. Interpretation: Personnel demonstrate understanding of aseptic techniques in accordance with established, recommended guidelines and state specific Board of Pharmacy regulations. Personnel qualifications include initial and follow-up training for periodic evaluation of performance. Evidence: Personnel files Observation of staff State BOP regulations Response to staff interviews

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Standard 817, Criterion B: Sterile products are compounded in a Class 100 environment, using the appropriate compounding equipment. Interpretation: Laminar flow hoods are certified annually or in accordance with state Board of Pharmacy regulations. A qualified independent contractor performs certification according to accepted standards for operational efficiency. Procedures are maintained for monitoring the proper operating conditions for all equipment used in sterile compounding in accordance with manufacturer guidelines. Evidence: Facility inspection Quality control records State BOP regulations Response to staff interviews

Standard 817, Criterion C: The organization has a written plan for drug compounding. Interpretation: The written plan for drug compounding defines quality control procedures for monitoring aseptic technique and the compounding environment to comply with established standards and/or state Board of Pharmacy regulations. The written plan defines processes for preparing/compounding sterile products and includes: · · · · · · · · Aseptic technique Validation of aseptic processing procedures (media fills or end product testing), when indicated Appropriate attire for personnel who compound (gown, mask, gloves) Hand washing procedures Environmental considerations (security, temperature, ventilation) Preparation of parenteral drugs Preparation of cytotoxic drugs Preparation of sterile drugs form non-sterile products Policies and procedures Facility Inspection State BOP regulations Quality control records Response to staff interviews

Evidence:

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Standard 817, Criterion D: The organization has policies and procedures for cleaning and disinfection. Interpretation: Procedures for cleaning of the work surfaces, equipment, and compounding/anteroom areas to reduce the risk of particulate matter in the work area and contamination of the compounding environment include: · · · Process and frequency for cleaning work surfaces, equipment, and work areas using dedicated cleaning tools specific to each area. Appropriate disinfectant solutions, rotated regularly with another sanitizing solution of a different action. Documentation of the cleaning process. Policies and procedures Staff observation and response to interviews Quality control records

Evidence:

Standard 818. The pharmacy assures medications are stored under appropriate conditions of security, sanitation, light and temperature in the facility, during deliveries, and in the client's home. Standard 818, Criterion A: The pharmacy stores pharmaceuticals under appropriate conditions of security, sanitation, light and temperature. Interpretation: Pharmaceuticals are stored in accordance with manufacturer or USP requirements. Temperatures are monitored wherever pharmaceuticals are stored to assure the requirements are met. Prescription and legend drugs are stored in the licensed pharmacy, which is accessible only under the supervision of licensed pharmacists(s). Evidence: Inspection of facilities Quality Control Records

Standard 818, Criterion B: The pharmacy uses delivery containers that assure pharmaceuticals are maintained under appropriate conditions of sanitation, light and temperature in the course of deliveries. Interpretation: Where appropriate, the pharmacy uses suitable delivery containers such as coolers and ice packs to maintain the storage conditions in accordance with manufacturer or USP requirements. There are written policies and procedures for the cleaning and disinfecting of any reusable containers. The policies and procedures are implemented. Evidence: Staff interviews Inspection of facility Home visits Policy and Procedure

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Standard 818, Criterion C: The pharmacy assures that pharmaceuticals are stored under appropriate conditions of sanitation, light and temperature in the client's home. Interpretation: The pharmacy has and acts upon information affecting the maintenance of appropriate conditions of sanitation, light and temperature in the client's home. Where necessary, the pharmacist intervenes appropriately to assure that appropriate conditions are achieved or maintained. Pharmaceuticals dispensed to the patient are clearly labeled as to the appropriate storage. Evidence: Client telephone interviews Home visits Staff interviews Prescription labeling from the pharmacy

Standard 819. All equipment services are provided in accordance with federal, state, local laws/regulations, manufacturer guidelines, and organization policies and procedures. Standard 819, Criterion A: The organization implements its policies and procedures for client ready equipment. Interpretation: Client ready equipment is defined as equipment that is durable in nature, disinfected, and operating within manufacture guidelines. The organization has clearly defined guidelines for the cleaning, storage, and transportation of client ready equipment. These guidelines should include but are not limited to: (1) separation of dirty and clean equipment; (2) appropriate warehousing and tagging of equipment; (3) use of appropriate cleaning and disinfecting agents; (4) maintenance of equipment; and (5) separation of inoperative equipment. Maintenance of the equipment will be, at a minimum, in accordance with the manufactures written guidelines. The organization practices their client ready equipment policies and procedures. Evidence: Policies and Procedures Manufacturer's service manuals Maintenance Logs Staff interviews Inspection of warehouse and delivery vehicles

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Standard 819, Criterion B: Staff implement written policies and procedures concerning the set-up, delivery, environmental requirements, and electrical safety of the equipment. Interpretation: Company personnel perform environmental assessments, set-up, and demonstrate safe and proper use of all infusion equipment according to manufacturer's guidelines. At the time of delivery, organization personnel will address at a minimum the following: (1) safety and adequacy of electrical outlets; (2) safe use of extension cords and outlet adapters; (3) location and function of all equipment controls and equipment circuit breakers; and (4) expected results/outcomes of proper use. Training provided to the client at set-up will be documented in the client record according to established policy. Evidence: Policies and Procedures Client records Copies of Manufacture Instruction/Set up Guidelines Staff interviews Client interviews Client education materials

Standard 819, Criterion C: There are written policies and procedures relating to the maintenance and repair of infusion equipment. Interpretation: Company policy will clearly define training, qualifications, and skill validation required by personnel to perform routine maintenance and repair of all infusion equipment. Routine maintenance, preventative maintenance, and repairs will be performed according to manufacturer's guidelines. Provider personnel will only perform repair services within their respective areas of training and expertise. Policies and procedures also clearly define the appropriate use of outside repair sources. Evidence: Policies and Procedures Maintenance logs Personnel records Staff interviews Manufacturer's service manuals Client records (for routine maintenance performed in home)

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Standard 819, Criterion D: There are written policies and procedures relating to tracking and manufacturer recalls of equipment. Interpretation: There will be written guidelines for the accurate tracking of equipment. It is preferred that the organization be able to track all equipment in use by active clients. There are guidelines that facilitate any recall notices and address the immediate removal of recalled equipment or supplies from client ready inventory, notification of all clients having recalled items, and the exchange of recalled equipment supplies in the field. Disposition of recalled inventory will be handled according to the manufacturer's directions. Evidence: Policies and Procedures Tracking logs Inventory records Staff interviews

Standard 819, Criterion E: Policies and procedures relating to the processing of contaminated or soiled infusion equipment are implemented. Interpretation: Providers guidelines specify that only durable medical equipment will be returned to the company for processing. Policy and procedures will specify the separation of dirty equipment from client ready equipment in the warehouse and delivery vehicles. Cleaning and disinfection of equipment will be performed in compliance with universal precautions and company policies. Guidelines will also clearly define curbside disinfection. Evidence: Policies and procedures Staff interviews Inspection of delivery vehicles and warehouses

Standard 819, Criterion F: There are written policies and procedures relating to back up systems for equipment or power failure in the home. Interpretation: The provider has clearly defined policy and procedures to determine the back-up requirements for equipment failure in the home. Evidence: Policies and procedures Staff interviews Client interviews/home visits Client records

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Standard 820. The pharmacy will have access to a reference library appropriate to the level of services provided. Standard 820 Criterion A: The pharmacy will have access to a reference library appropriate to the level of services provided. Interpretation: The pharmacy has available reference books, journals, Internet access, etc. appropriate for the client population served. At a minimum, the library will address: (1) drug compatibility and stability; (2) drug interactions; (3) general clinical references; and (4) current pharmacy regulations for any state into which medications are dispensed. Evidence: Review of reference library Staff interviews

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CLINICAL RESPIRATORY CARE SERVICES

Clinical Respiratory Care Services pertains strictly to "hands-on" assessment and treatment of a client in need of respiratory care. This section does not preclude home medical equipment companies from utilizing non-clinical delivery staff to provide delivery, set-up, instruction, or maintenance of home medical equipment.

Standard 821: Clinical Respiratory Care Services will be provided by qualified Respiratory Care Practitioners in accordance with state laws, regulations and recognized professional practice standards. Standard 821, Criterion A: All Clinical Respiratory Care services will be provided by qualified personnel and administered in accordance with the organization's policies and job descriptions, federal, state, and local laws, and established regulatory guidelines as dictated by the State Respiratory Care Board. Interpretation: Clinical Respiratory Care Services will be conducted in accordance with accepted ethical and professional practice standards and in accordance with all applicable federal, state and local laws and guidelines set by the American Association of Respiratory Care (AARC). Current copies of applicable rules and regulations are maintained in the organization office at all times and are readily available to appropriate organization staff. All organization staff and independent contractors practicing as clinical respiratory therapist will maintain an active state respiratory therapist license or be a health care professional who is trained in respiratory therapy, i.e. a licensed registered or practical nurse. Respiratory Care staff in states without licensure must be a Registered Respiratory Therapist (RRT) or a Certified Respiratory Therapist (CRT) as registered/certified by the National Board of Respiratory Care. Individuals providing clinical respiratory home care services will be a qualified health care professional in both education and experience.

Evidence:

AARC Clinical Guidelines Job descriptions/policies State Respiratory Care Board Practice Act and Rules Licenses of Respiratory Care Practitioners, where applicable

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Standard 822. There are written policies and procedures relating to Clinical Respiratory Care Services. Standard 822, Criterion A: There are written policies and procedures covering the scope of services offered by the clinical respiratory care program. Interpretation: The Clinical Respiratory Care program has written policies and procedures addressing the scope of clinical respiratory care services offered by the organization. These services should include, but not be limited to, types of services/treatments provided, target client populations, and goals of the program. Evidence: Written Policies and Procedures

Standard 822, Criterion B: Clinical respiratory care services are available 24 hours a day, 7 days per week. Interpretation: The organization provides clinical respiratory care services 24 hours a day, 7 days a week when necessary to meet client needs. There is availability of a Licensed Respiratory Care Practitioner. An on-call coverage system may be used to provide this coverage during evenings, nights, weekends and holidays. Evidence: Written policies and procedures On-call schedule

Standard 823: Qualified personnel supervise the Clinical Respiratory Care services. Standard 823, Criterion A: There is a qualified professional responsible for supervision of all clinical respiratory care services. Interpretation: All clinical respiratory care services must be provided under the direction of a Licensed RCP. The Respiratory Care supervisor in states without licensure must be a Registered Respiratory Therapist (RRT) or a Certified Respiratory Therapist (CRT) as registered/certified by the National Board of Respiratory Care. It is preferred that the Respiratory Care Practitioner in charge of the program has a minimum of two years previous supervisory experience or the equivalent. State regulations may dictate Respiratory Care Practitioner requirements. If providing perinatal/pediatric home respiratory care, it is preferred that the Respiratory Care Practitioner in charge of the program have at least one (1) year experience providing perinatal/pediatric respiratory care. Evidence: Personnel Files of the supervising RCP

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Standard 824. Clients will have an assessment of need and participate in the development of the plan of care. Standard 824 Criterion A: All clients referred for clinical respiratory care services will have an assessment of appropriate therapy. Interpretation: An assessment will be performed and information documented in the client's record for clients referred for respiratory care services. The assessment shall focus on appropriateness for therapy in the home, safety in the home, and services needed. The organization may perform an initial assessment for clients referred for HME services as appropriate to determine the need for clinical respiratory care services and request approval for these services from the client's physician. Evidence: Client Records

Standard 824, Criterion B: There is a written plan of care for each client accepted for services, approved by the physician, and based upon assessment data which includes at a minimum, specific treatments, prescribed medications, and client goals. Interpretation: The plan of care is approved by a physician and specifies: (1) problems; (2) needs; (3) interventions; (4) treatments; (5) monitoring; and (6) expected client outcomes/goals. The physician, or other professional authorized to prescribe, will provide adequate medical management for the client receiving respiratory care services. Evidence: Client Records

Standard 824, Criterion C: The organization will show evidence of the client/caregiver participation in the plan of care. Interpretation: The client/responsible party has a right to be involved in the development of the plan of care and any changes in that plan. However, the degree of involvement may vary depending on the ability of the client. At a minimum, the client or responsible party must agree to the plan of care prior to the beginning of services and as subsequent changes occur. The client record must show involvement of the client/family/caregiver in the development or at least agreement to the plan of care and any revisions made to the plan. The following are suggestions as to how organizations may document this information: (1) the plan of care may be signed by the client/responsible party; (2) a notation may be made in the client record that the client/responsible party participated in the development of the plan of care; or (3) there may be documentation in the client record that the plan of care was reviewed and accepted by the client/responsible party. Evidence: Client record Client interviews

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Standard 825. The plan of care and services provided will be appropriate for the client's level of service/care needs. Standard 825, Criterion A: Clinical respiratory care services are delivered in accordance with the written plan of care and directed at achievement of established goals. Interpretation: The client record reflects clinical respiratory care services delivered in accordance with the plan of care and directed at achievement of established goals. Evidence: Client records

Standard 825, Criterion B: There is demonstrated consistency between service/tasks performed by the organization personnel, the written plan of care, and the services billed. Interpretation: The client record verifies consistency between the services performed by the respiratory care staff, the written plan of care, and the services billed. Evidence: Client records Billing records Responses to interviews

Standard 825, Criterion C: There is evidence that the plan of care is reviewed. Interpretation: Policy and procedure describe the frequency and the process for the plan of care review. There is documentation in the client record that reflects the plan of care is reviewed for: (1) appropriateness (services being provided are still needed); (2) effectiveness (client outcomes/response to care); and (3) to determine if all needed services are being provided. Included in this review is discussion with the client/responsible party to determine the level of satisfaction with the types of services being provided. Notation of a review may be made in the client record, in minutes of meetings such as team meetings or case conferences. The organization follows program regulations and policies for the frequency of review activities. The plan of care review would occur more frequently based on the client's need for changes. Evidence: Written policies Client records Case conference minutes of meetings Responses to interviews

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Standard 825, Criterion D: There is evidence of changes in the plan of care based on reassessment data. Interpretation: Changes should be noted on the plan of care and/or in the progress notes based on client requests, client's condition, client's response to therapy, and when physician orders indicate changes. There should be evidence of communication to the physician regarding the client's condition and changes to the plan of care. If new or revised client or treatment goals are indicated, they should be reflected in the plan of care. Evidence: Client records

Standard 825, Criteria E: If physician orders are needed for services, there is evidence of initial physician involvement and physician notification when changes in the plan of care are needed. Interpretation: Physician orders are needed to provide any services requiring the administration of medication, treatment(s), ongoing assessments, pulse oximetry or other activities governed by state law. Physician orders may also be required under certain program requirements (i.e., Medicare, Medicaid, Managed Care, and other third party payers). In these situations, the organization has a responsibility to obtain physician orders prior to initiation of the services and to notify the physician of any changes in the client's condition. Verbal orders will be documented by the respiratory care practitioner receiving the order and indicated by respiratory care practitioner signature and credential. Evidence: Client records

Standard 825, Criterion F: Client and/or caregiver education should focus on goal and outcome achievement as established in the plan of care. Interpretation: Client education is an integral part of clinical respiratory care services. Assessment of the client and/or caregiver's knowledge deficits and learning abilities are evaluated during the initiation of services. Client education/instruction will proceed in accordance with the client's willingness and condition to learn. Education should be coordinated with the client/caregivers and the health care team and should focus on goal and outcome achievement as established in the plan of care. Elements of client education may include, but not be limited to: (1) ongoing assessment of client and caregiver's learning needs; (2) communication of needs to other health care team members; and (3) incorporating client needs into the plan of care. The client records will include documentation of all teaching, client's response to teaching, and the client's level of progress/achievement of goals/outcomes. Written instructions will be provided to the client when appropriate. Evidence: Client records Client and staff interviews

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Standard 826. Respiratory Care services transfer and discharge clients as appropriate and in accordance with established policies and procedures. Standard 826, Criterion A: Clinical respiratory services follow transfer policies and procedures. Interpretation: A client is transferred if the client's needs can no longer be met adequately by the organization. The transfer policy will define activities that represent a client transfer. A transfer summary will be completed and a copy will be maintained in the client record and a copy will be forwarded to the receiving program service entity. A transfer summary will include: (1) date of transfer; (2) client identifying information and emergency contact; (3) receiving facility; (4) client's physician and phone number; (5) diagnosis related to the transfer; (6) significant health history; (7) transfer orders and instructions; (8) a brief description of services provided and ongoing needs that cannot be met; and (9) status of client at the time of transfer. Evidence: Client record Written policies and procedures

Standard 826, Criterion B: Clinical respiratory services follow discharge policies and procedures. Interpretation: The organization has a process, which assesses the client's ongoing appropriateness for therapy/services. The discharge policy will define activities that represent client discharge. The client record should reflect discharge planning activities, coordination with other care providers, the client's response and understanding to these activities, client care instructions and a reasonable notice prior to discharge, whenever possible. A discharge summary is written which includes a summary of services provided, the date and reason for discharge, and any instructions given to the client or responsible party. A copy of the discharge summary is made available to the primary physician and a copy is included in the client record. Evidence: Client records Policy and procedure

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Standard 827. All pharmaceuticals and medical treatments are administered in accordance with state laws/regulations and organization policies and procedures. Standard 827, Criterion A: The program has written policies and procedures that identify the drugs or drug classifications and routes of administration that staff can administer. Interpretation: There must be a list of drugs or drug classifications, approved by the governing board that may be administered by the Respiratory Care staff. The list must include any exceptions as well as the routes of administration that are allowed (i.e., inhalation), and any special criteria for the acceptance of clients for this service. Evidence: Written policies and procedures Client records

Standard 827, Criterion B: A respiratory care practitioner reviews all client medications on an ongoing basis as part of the services to a client. Interpretation: When clinical respiratory therapy services are provided, a respiratory care practitioner must review all prescription and non-prescription medications a client is taking. The respiratory care practitioner is specifically accountable for recognizing the following on all cardiopulmonary medications: (1) side effects; (2) toxic effects; (3) allergic reactions; (4) immediate desired effects; (5) unusual and unexpected effects; and (6) changes in the client's condition that contraindicate continued administration of the medication. In addition, the respiratory care practitioner must be able to anticipate effects from cardiopulmonary medications, which may rapidly endanger a client's life or well being, and instruct the client, family members and/or caregiver, as necessary, in following the prescribed regimen. It is preferred that a medication log or profile that lists all current client medications, dose, frequency, and other comments be included in the clients record. Evidence: Client records

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Standard 827, Criterion C: There are written policies and procedures that address response to adverse drug reactions. Interpretation: The organization has written policies and procedures that identify potential drugs and drug classifications that may cause adverse reactions when administered concomitantly by respiratory care practitioner staff. The organization has written policies and procedures that address appropriate actions the respiratory care practitioner should take in the event of an adverse drug reaction. The client record should indicate education to the client and caregiver about appropriate actions to take if a reaction occurs when the respiratory care practitioner is not present. Evidence: Written policies and procedures Response to interviews ADR record book

Standard 828. The Clinical Respiratory Care staff will have access to a reference library appropriate to the level of services provided. Standard 828, Criterion A: The Clinical Respiratory Care staff will have access to a reference library appropriate to the level of services provided. Interpretation: The clinical respiratory care staff has available reference books, journals, Internet access, etc. appropriate for the client population served. At a minimum, the library will contain: (1) general respiratory care journals; (2) general clinical references; (3) drug reference books; (4) AARC clinical guidelines; and (5) current medical dictionary; (6) and current respiratory care regulations for any state into which the staff practice. Evidence: Review of reference library Staff interviews

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HOME MEDICAL EQUIPMENT SERVICES

HME services include the provision of medical equipment and/or medical gases to individuals in their place of residence, along with ongoing monitoring of its use. It does not include the sale of medical equipment unless ongoing monitoring and maintenance is provided. Examples of HME include but are not limited to beds, ambulatory aids (walkers, canes, crutches), wheelchairs, bathroom aids, oxygen delivery systems, CPAP, BiPAP, suction machines, and ventilators. Standard 829. Home Medical Equipment (HME) services will be provided by qualified personnel and administered in accordance with legal and regulatory guidelines as dictated by state laws and regulations. Standard 829, Criterion A: All HME services will be provided by qualified personnel and administered in accordance with all applicable state and federal laws, the organization's policies, and job descriptions. Interpretation: Home medical equipment services will be conducted in accordance with accepted ethical and industry standards and in accordance with all applicable federal, state and local laws. Current copies of applicable rules and regulations are maintained in the home medical equipment services office at all times for staff consultation. Personnel will function in accordance with ethical and industry standards, organization policies and their job descriptions. Evidence: Written policies and procedures Industry standards All applicable rules and regulations Job descriptions Personnel record review

Standard 830. There are written policies and procedures related to the home medical equipment program. Standard 830, Criterion A: There are written policies and procedures describing the scope of services offered by the HME service program. Interpretation: The home medical equipment program has written policies and procedures addressing the scope of services offered by the organization. These services should include but not be limited to, types of services/equipment provided, target client populations, geographical service area, and goals of the program. Evidence: Policies and procedures

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Standard 830, Criterion B: HME services are available 24 hours a day, 7 days per week. Interpretation: The organization provides home medical equipment services 24 hours a day, 7 days a week as necessary to meet client needs. There is availability of appropriate personnel. A supervisor will be accessible via paging system, answering service, portable telephone or other means. This criterion applies to those organizations that supply life sustaining and/or monitoring equipment such as continuous oxygen, apnea monitors and ventilators. Evidence: Written policies and procedures On-call schedule Response to interviews

Standard 831. Qualified personnel supervise the HME services. Standard 831, Criterion A: There is a qualified person responsible for supervision of HME services. Interpretation: All HME services must be provided under the direction of a person with sufficient education and experience in the scope of services offered. It is preferred that the person in charge of the program has a minimum of two years' previous supervisory experience or the equivalent. Evidence: Personnel File

Standard 832. Clients will have an assessment of need and participate in the development of the plan of service. Standard 832, Criterion A: All clients referred for HME services will have an evaluation/assessment of need. Interpretation: There will be an initial assessment of client. The assessment will be used to determine the client's problems/needs and goals. The assessment must include but not be limited to the following: (A) determination of client knowledge and skills in managing the equipment; (B) home safety; and (C) ability to assume responsibility for the home medical equipment. Evidence: Client records

Standard 832, Criterion B: There is a written plan of service for each client accepted for service. Interpretation: The plan of service specifies: (1) problems; (2) needs; (3) interventions; and (4) expected client outcomes/goals. A formal plan of service is not required for clients receiving simple HME not requiring ongoing maintenance. Examples of simple HME include canes, crutches, walkers, and bathroom safety equipment. Evidence: Client records

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Standard 832, Criterion C: The organization will show evidence of the client/caregiver participation in the plan of service. Interpretation: The client/responsible party has a right to be involved in the development of the plan of service and any changes in that plan. However, the degree of involvement may vary depending on the ability of the client. At a minimum, the client or responsible party must agree to the plan of service prior to the beginning of services and as subsequent changes occur. The client record must show involvement of the client/family/caregiver in the development or at least agreement to the plan of service and any revisions made to the plan. The following are suggestions as to how organizations may document this information: (1) the plan of service may be signed by the client/responsible party; (2) a notation may be made in the client record that the client/responsible party participated in the development of the plan of service; or (3) there may be documentation in the client record that the plan of service was reviewed and accepted by the client/responsible party. Evidence: Client record Response to interviews

Standard 833. The plan of services will be appropriate for the client's level of needs. Standard 833, Criterion A: HME services are delivered in accordance with a physician's prescription, if required and directed at achievement of established goals. Interpretation: The client record reflects HME delivered in accordance with the physician's prescription and directed at achievement of established goals. Evidence: Client records

Standard 833, Criterion B: There is demonstrated consistency between service/tasks performed by the organization personnel, the plan of service, and the services billed. Interpretation: The client record verifies consistency between the services performed by the HME staff, the plan of service, and the services billed. Evidence: Client records Billing records Responses to interviews

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Standard 833, Criterion C: There is evidence that the plan of service is reviewed. Interpretation: Policy and procedure describe the frequency and the process for the plan of service review. There is documentation in the client record that reflects the plan of service is reviewed for: (1) appropriateness (services being provided are still needed); (2) effectiveness (client outcomes); and (3) to determine if all needed services are being provided. Included in this review is discussion with the client/responsible party to determine the level of satisfaction with the types of services being provided. Notation of a review should be made in the client record. The organization follows program policies for the frequency of review activities. The plan of service review would occur based on the client's need for changes. Evidence: Written policies Client records Responses to interviews

Standard 833, Criterion D: There is evidence of changes in the plan of service based on reassessment data. Interpretation: Changes should be noted in the plan of service and/or in the progress notes based on client needs, and when physician orders indicate changes. There should be evidence of communication to the physician regarding client's equipment changes. If new or revised client goals are indicated, they should be reflected in the plan of service. Evidence: Client records

Standard 833, Criterion E: Client and/or caregiver education should focus on goal and outcome achievement as established in the plan of service. Interpretation: Client education is an integral part of HME services. Assessment of the client and/or caregiver's knowledge deficits and learning abilities are evaluated during the initiation of services. Client education/instruction will proceed in accordance with the client's willingness and condition to learn. Education should be coordinated with the client/caregivers and the health care team and should focus on goal and outcome achievement as established in the plan of service. Elements of client education may include, but not be limited to: (1) ongoing assessment of client and caregiver's learning needs; (2) communication of needs to other health care team members; and (3) incorporating client needs into the plan of service. The client records will include documentation of all teaching, client's response to teaching, and the client's level of progress/achievement of goals/outcomes. Written instructions will be provided to the client when appropriate. Evidence: Client records Client and staff interviews

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Standard 834. HME services transfer and discharge clients as appropriate and in accordance with established policies and procedures. Standard 834, Criterion A: HME services follow transfer policies and procedures. Interpretation: A client is transferred if the client's needs can no longer be met adequately by the organization. The transfer policy will define activities that represent a client transfer. Reasons for client transfer may include the client moves outside of the organization's geographic service area, the client requires equipment not provided by the organization, or the organization is not a preferred provider by the client's insurance company. All transfers should be noted in the client record. The transfer summary should include: (1) the date of the transfer; (2) the company receiving the transfer; and (3) the reason for the transfer. Original Certificates of Medical Necessity and/or Prior approval authorizations should be transferred to the receiving facility. Evidence: Client Record Written policies and procedures

Standard 834, Criterion B: Home Medical Equipment services follow discharge policies and procedures. Interpretation: The organization has a process, which assesses the client's ongoing appropriateness for services. The discharge policy will define activities that represent client discharge. Reasons for client discharge may include the client expires, the client's condition improves therefore the client no longer needs the home medical equipment, the physician discontinues the order for the home medical equipment, or the client refuses the home medical equipment and requests discontinuation of services. The client record should reflect discharge planning activities, coordination with other care providers, the client's response and understanding to these activities, client care instructions and a reasonable notice prior to discharge, whenever possible. The discharge must be noted in the client record and include the date, reason for discharge, and any instructions given to the client or responsible party. Evidence: Client record Written policies and procedures

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Standard 835. All HME services are provided in accordance with federal, state, local laws/regulations and organization policies and procedures. Standard 835, Criterion A: The organization implements its policies and procedures for client-ready equipment. Interpretation: Client-ready equipment is defined as equipment that is durable in nature, disinfected, and operating within manufacturer guidelines. The organization has clearly defined guidelines for the cleaning, storage, and transportation of client-ready equipment. These guidelines should include but are not limited to: (1) separation of dirty and clean equipment; (2) appropriate warehousing and tagging of equipment; (3) use of appropriate cleaning and disinfecting agents; (4) maintenance of equipment; and (5) separation of inoperative equipment. Maintenance of the equipment will be, at a minimum, in accordance with the manufacture's written guidelines. The organization practices their client-ready equipment policies and procedures. Evidence: Policies and Procedures Manufacturer's service manuals Maintenance Logs Staff interviews Inspection of warehouse and delivery vehicles

Standard 835, Criterion B: HME staff implement written policies and procedures concerning the set-up, delivery, environmental requirements, and electrical safety of the equipment. Interpretation: Company personnel perform environmental assessments, set-up, and demonstrate safe and proper use of all home medical equipment according to manufacturer's guidelines. At time of delivery, organization personnel will address at a minimum the following: (1) safety and adequacy of electrical outlets; (2) safe use of extension cords and outlet adapters; (3) location and function of all equipment controls and equipment circuit breakers; and (4) expected results/outcomes of proper use. Training provided to the client at set-up will be documented in the client record according to established policy. Evidence: Policies and Procedures Client records Copies of Manufacturer Instructions/Set-up Guidelines Staff interviews Client interviews Client education materials

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Standard 835, Criterion C: There are written policies and procedures relating to the maintenance and repair of medical equipment. Interpretation: Company policy will clearly define training, qualifications, and skill validation required by personnel to perform routine maintenance and repair of all home medical equipment. Routine maintenance, preventative maintenance, and repairs will be performed according to manufacturer's guidelines. Provider personnel will only perform repair services within their respective areas of training and expertise. Policies and procedures also clearly define the appropriate use of outside repair sources. Evidence: Policies and Procedures Maintenance logs Personnel records Staff interviews Manufacturer's service manuals Client records (for routine maintenance performed in home)

Standard 835, Criterion D: There are written policies and procedures relating to tracking and manufacturer recalls. Interpretation: There will be written guidelines for the accurate tracking of equipment. The organization must comply with the FDA's Medical Device Tracking program and other regulatory bodies. It is preferred that the organization be able to track all rented equipment in use by active clients. There are guidelines that facilitate any recall notices and address the immediate removal of recalled equipment or supplies from client-ready inventory, notification of all clients having recalled items, and the exchange of recalled equipment supplies in the field. Disposition of recalled inventory will be handled according to the manufacturer's directions. In addition, there are guidelines for the tracking of lot numbers of compressed gas, nutritional formula and other appropriate products. Evidence: Policies and Procedures Tracking logs Inventory records Staff interviews

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Standard 835, Criterion E: Policies and procedures relating to the processing of contaminated or soiled home medical equipment are implemented. Interpretation: Providers guidelines specify that only durable medical equipment will be returned to the company for processing. Policy and procedures will specify the separation of dirty equipment from client-ready equipment in the warehouse and delivery vehicles. Cleaning and disinfecting of equipment will be performed in compliance with universal precautions and company policies. Guidelines will also clearly define curbside disinfection. States with bedding laws will disinfect bedding in accordance with state regulations. Evidence: Policies and procedures Staff interviews Inspection of delivery vehicles and warehouses

Standard 835, Criterion F: There are written policies and procedures relating to back-up systems for equipment or power failure. Interpretation: The provider has clearly defined policy and procedures to determine the back-up requirements for general equipment failure and life sustaining/monitoring equipment failure. Evidence: Policies and procedures Staff interviews Client interviews/home visits Client records

Standard 836. The HME staff will have access to a reference library appropriate to the level of services provided. Standard 836, Criterion A: The HME staff will have access to a reference library appropriate to the level of services provided. Interpretation: The HME staff has available reference books, journals, Internet access, etc. appropriate for the client population served. At a minimum, the library will contain: (1) general HME journals; (2) manufacturer literature for all equipment and products provided; (3) American Association for Home Care guidelines; (4) current medical dictionary; (5) third party billing guidelines; and (6) HME regulations for any state into which the staff deliver equipment. Evidence: Review of reference library Staff interviews

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REHABILITATION TECHNOLOGY SUPPLIER SERVICES

Rehabilitation Technology services are defined as the application of enabling technology systems designed to meet the needs of a specific person experiencing any permanent or longterm loss or abnormality of physical or anatomical structure or function. These services, prescribed by a physician, primarily address wheeled mobility, seating and alternative positioning, ambulation support and equipment, environmental control, augmented communication and other equipment and services that assist the person in performing their activities of daily living. Rehabilitation technology services facilitate and/or enhance access and independence thereby improving the person's quality of life. Standard 837. Rehabilitation Technology Supplier services will be provided by qualified personnel and administered in accordance with legal and regulatory guidelines as dictated by state laws and regulations. Standard 837, Criterion A: Rehabilitation Technology services will be provided by qualified personnel and administered in accordance with all applicable state and federal laws, the organization's policies, and job descriptions. Interpretation: Rehabilitation technology services will be provided in accordance with accepted ethical and industry standards as well as all applicable local, state and federal statutes. Copies of all applicable rules and regulations are maintained in the RTS office at all times for staff consultation. Rehab Technology Companies should employ at least one certified Rehab professional per location. Rehab professionals include Certified Rehab Technology Supplier (CRTS), Assistive Technology Supplier (ATS), Assistive Technology Practitioner (ATP) and/or Rehabilitation Engineering Technologist (RET). Rehab Technology Companies should employ at least one trained technician per service center that has attended an industry-wide techniciantraining program. Customer Service/Billing staff should attend an industry-wide customer service/billing training course(s). Personnel will function in accordance with ethical and industry standards, organization policies, and their job description. The RTS actively pursues communication and interaction with other rehabilitation suppliers in order to: Maintain the standards of professionalism, Increase awareness of services and products, improve overall product quality, and enhance product and service development within the field. Rehabilitation technology companies should maintain adequate levels of general liability insurance for products and services provided. Evidence: Policies and procedures Industry Practice Standards All applicable rules and regulations Job Description Personnel record reviews

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Standard 838. There are written policies and procedures related to Rehabilitation Technology Supplier services (RTS). Standard 838, Criterion A: There are written policies and procedures describing the scope of services offered by the RTS services program. Interpretation: There are written policies and procedures addressing the scope of on-site and alternate-site programs for provision of rehabilitation technology services offered by the organization. These services should include, but not be limited to, types of services/equipment provided, target client populations, and goals of the program. Evidence: Policies and procedures

Standard 839. services.

Qualified personnel supervise the Rehabilitation Technology Supplier

Standard 839, Criterion A: There is a qualified professional responsible for supervision of RTS services. Interpretation: All RTS services must be provided under the direction of a person with sufficient education and experience in the scope of services offered. It is preferred that the person in charge of Rehabilitation Technology Services have at least 2 years experience in Rehabilitation Technology and one year of supervisory experience. It is preferred that the supervisor be certified by the National Registry for Rehabilitation Technology Suppliers (NRRTS) as a Certified Rehabilitation Technology Supplier (CRTS). Evidence: Personnel File.

Standard 840. Clients will have an assessment of need and participate in the development of the plan of service. Standard 840, Criterion A: All clients referred for RTS services will have an evaluation/assessment of need. Interpretation: There will be an initial assessment of client. The assessment will be used to determine the client's problems/needs and goals. The assessment must include but not be limited to the following: (a) relevant health history; (b) determination of client knowledge and skills in managing the equipment; (c) home safety and appropriateness for equipment and (d) ability to assume responsibility for the equipment provided. The evaluation should be conducted in an appropriate setting (client home and work environment) and should include input from other health professionals (PT/ OT/ Physician, etc.). Evidence: Client records

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Standard 840, Criterion B: There is a written plan of service for each client accepted for services, and based upon assessment data which includes at a minimum, prescribed equipment, and client goals. Interpretation: The plan of service is based on the client assessment and specifies the following: (1) problems; (2) needs; (3) interventions and (4) expected client outcomes/goals. A formal plan of service is not required for clients receiving simple RTS products not requiring ongoing maintenance. Examples of simple RTS products include non-customized seating cushions and pads. Evidence: Client records

Standard 840, Criterion C: The organization will show evidence of the client/caregiver participation in the plan of service. Interpretation: The client/responsible party has a right to be involved in the development of the plan of service and any changes in that plan. However, the degree of involvement may vary depending on the ability of the client. At a minimum, the client or responsible party must agree to the plan of service prior to the beginning of services and as subsequent changes occur. The client record must show involvement of the client/family/caregiver in the development or at least agreement to the plan of service and any revisions made to the plan. The following are suggestions as to how organizations may document this information: (1) the plan of service may be signed by the client/responsible party; (2) a notation may be made in the client record that the client/responsible party participated in the development of the plan of service or (3) there may be documentation in the client record that the plan of service was reviewed and accepted by the client/responsible party. Evidence: Client record Client interviews

Standard 841. The plan of service will be appropriate for the client's level of service needs. Standard 841, Criterion A: RTS services are delivered in accordance with a physician's prescription, if required and directed at achievement of established goals. Interpretation: The client record reflects RTS delivered in accordance with the physician's prescription and directed at achievement of established goals. Rehabilitation technology companies should provide cost-effective options and choices to meet the goals and objectives set by and for, the consumer. Recommendations for specific commercially available products or fabricated components are based on consumer goals, objectives, and desires, as well as input from other professionals as appropriate. A qualified individual (CRTS, ATS, ATP or RET) should have overall responsibility for delivery, checkout, and follow-up. Evidence: Client records

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Standard 841, Criterion B: There is demonstrated consistency between service/tasks performed by the organization personnel, the plan of service, and the services billed. Interpretation: The client record verifies consistency between the services performed by the RTS staff, the plan of service, and the services billed. Evidence: Client records Billing records Responses to interviews

Standard 841, Criterion C: There is evidence that the plan of service is reviewed. Interpretation: Policy and procedure describe the frequency and the process for the plan of service review. There is documentation in the client record that reflects the plan of service is reviewed for: (1) appropriateness (services being provided are still needed); (2) effectiveness (client outcomes) and (3) to determine if all needed services are being provided. Included in this review is discussion with the client/responsible party to determine the level of satisfaction with the types of services being provided. Notation of a review should be made in the client record. The organization follows program regulations and policies for the frequency of review activities. The plan of service review would occur based on the client's need for changes. Evidence: Written policies Client records Responses to interviews

Standard 841, Criterion D: There is evidence of changes in the plan of service based on reassessment data. Interpretation: Changes should be noted on the plan of service and/or in the progress notes based on client needs, and when physician orders indicate changes. There should be evidence of communication to the physician regarding the client's changes to the plan of service. If new or revised client goals are indicated, they should be reflected in the plan of service. Evidence: Client records

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Standard 841, Criterion E: Client and/or caregiver education should focus on goal and outcome achievement as established in the plan of service. Interpretation: Client education is an integral part of RTS services. Assessment of the client and/or caregiver's knowledge deficits and learning abilities are evaluated during the initiation of services. Client education/instruction will proceed in accordance with the client's willingness and condition to learn. It is imperative that clients who need Rehab Technology be properly evaluated and their equipment individually fit. They should also be educated thoroughly in the use and function of their equipment, including how to operate it safely and effectively. Education should be coordinated with the client/caregivers and the health care team and should focus on goal and outcome achievement as established in the plan of service. Elements of client education may include, but not be limited to: (1) ongoing assessment of client and caregiver's learning needs; (2) communication of needs to other health care team members and (3) incorporating client needs into the plan of service. The client records will include documentation of all teaching, client's response to teaching, and the client's level of progress/achievement of goals/outcomes. Written instructions will be provided to the client when appropriate. Evidence: Client records Client and staff interviews

Standard 842. RTS services transfer and discharge clients as appropriate and in accordance with established policies and procedures. Standard 842, Criterion A: RTS services follow transfer policies and procedures. Interpretation: A client is transferred if the client's needs can no longer be met adequately by the organization. The transfer policy will define activities that represent a client transfer. Reasons for client transfer may include the client moves outside of the organization's geographic service area, the client requires equipment not provided by the organization, or the organization is not a preferred provider by the client's insurance company. All transfers should be noted in the client record. The transfer summary should include: (1) the date of the transfer; (2) the company receiving the transfer and (3) the reason for the transfer. Original Certificates of Medical Necessity and/or Prior approval authorizations should be transferred to the receiving facility. Evidence: Client Record Policy and procedure

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Standard 842, Criterion B: RTS follow discharge policies and procedures. Interpretation: The organization has a process, which assesses the client's ongoing appropriateness for services. The discharge policy will define activities that represent client discharge. Reasons for client discharge may include the client expires, the client's condition improves therefore the client no longer needs the RTS services, the physician discontinues the order for RTS services or equipment, or the client refuses RTS services or equipment and requests discontinuation of services. The client record should reflect discharge planning activities, coordination with other providers, the client's response and understanding to these activities, client instructions and a reasonable notice prior to discharge, whenever possible. The discharge must be noted in the client record and include the date, reason for discharge, and any instructions given to the client or responsible party. The organization has a process, which assesses the client's ongoing appropriateness for services. The discharge policy will define activities that represent client discharge. Evidence: Client records Policy and procedure

Standard 843. All Rehabilitation Technology equipment is provided in accordance with federal, state, local laws / regulations and organization policies and procedures. Standard 843, Criterion A: The organization implements its policies and procedures for client ready equipment. Interpretation: Client ready equipment is defined as equipment that is durable in nature, disinfected, and operating within manufacture guidelines. The organization has clearly defined guidelines for the cleaning, storage, and transportation of client ready equipment. These guidelines should include but are not limited to: (1) separation of dirty and clean equipment; (2) appropriate warehousing and tagging of equipment; (3) use of appropriate cleaning and disinfecting agents; (4) maintenance of equipment and 5) separation of inoperative equipment. Maintenance of the equipment will be, at a minimum, in accordance with the manufactures written guidelines. The organization practices their client ready equipment policies and procedures. Evidence: Policies and Procedures Manufacturer's service manuals Maintenance Logs Staff interviews Inspection of warehouse and delivery vehicles

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Standard 843, Criterion B: RTS staff implement written policies and procedures concerning the set-up, delivery, environmental requirements, and electrical safety of the equipment. Interpretation: Company personnel perform environmental assessments, set-up, and demonstrate safe and proper use of all RTS equipment according to manufacturer's guidelines. At the time of delivery, organization personnel will address at a minimum the following: (1) safety and adequacy of electrical outlets, if applicable; (2) safe use of extension cords and outlet adapters, if applicable; (3) location and function of all equipment controls and equipment circuit breakers; (4) use and function of their equipment, including how to operate it safely and effectively; (5) expected results/outcomes of proper use and (6) service policy for the equipment provided. Since each Rehabilitation Technology equipment solution is specific to the client's needs, the responsibility of the Rehab Technology Company does not end upon delivery of the equipment. Training provided to the client at set-up will be documented in the client record according to established policy. Evidence: Policies and Procedures Client records Copies of Manufacture Instruction/Set up Guidelines Staff interviews Client interviews Client education materials

Standard 843, Criterion C: There are written policies and procedures relating to the maintenance and repair of RTS equipment. Interpretation: There should be a repair shop on-site, as well as an area designated for assembly and modification of products. Repair services should also be available in the consumer's home and work environment. Company policy will clearly define training, qualifications, and skill validation required by personnel to perform routine maintenance and repair of all RTS equipment. Routine maintenance, preventative maintenance, and repairs will be performed according to manufacturer's guidelines. The organization should maintain parts inventory that is appropriate to the products they provide and adequate to meet their client's needs. Provider personnel will only perform repair services within their respective areas of training and expertise. Policies and procedures also clearly define the appropriate use of outside repair sources. Evidence: Policies and Procedures Maintenance logs Personnel records Staff interviews Manufacturer's service manuals Client records (for routine maintenance performed in home)

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Standard 843, Criterion D: There are written policies and procedures relating to tracking and manufacturer recalls of equipment. Interpretation: There will be written guidelines for the accurate tracking of equipment. It is preferred that the organization be able to track all equipment in use by active clients. There are guidelines that facilitate any recall notices and address the immediate removal of recalled equipment or supplies from client ready inventory, notification of all clients having recalled items, and the exchange of recalled equipment supplies in the field. Disposition of recalled inventory will be handled according to the manufacturer's directions. Evidence: Policies and Procedures Tracking logs Inventory records Staff interviews

Standard 843, Criterion E: Policies and procedures relating to the processing of contaminated or soiled RTS equipment are implemented. Interpretation: Providers guidelines specify that only durable medical equipment will be returned to the company for processing. Policy and procedures will specify the separation of dirty equipment from client ready equipment in the warehouse and delivery vehicles. Cleaning and disinfection of equipment will be performed in compliance with universal precautions and company policies. Guidelines will also clearly define curbside disinfection. Evidence: Policies and procedures Staff interviews Inspection of delivery vehicles and warehouses

Standard 844. Rehabilitation Technology Services provides quality products and services. Standard 844, Criterion A: Rehabilitation Technology Service provides on-site services for clients. Interpretation: The facility will have room(s) designated for fitting and evaluation that are private, clean and safe for the client. The site must comply with the accessibility standards of the Americans with Disabilities Act. Policies and procedures describe aspects of RTS on-site services which will include but not be limited to: (1) Obtaining information during the assessment phase about the client's needs and the environment in which he/she will be utilizing adaptive equipment and services during the Rehabilitation Technician on-site client evaluation/assessment; (2) The final fitting of rehabilitation technology products should take place in the client's home or work environment to assure that the product is suitable and that it fulfills the client needs; (3) Instruction for the client and caregivers on the proper usage of equipment for optimum safety and effectiveness. Evidence: Delivery Records Client Records

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Standard 844, Criterion B: The Rehabilitation Technology Service offers a variety of equipment and options. Interpretation: The RTS offers the client an assortment of products to improve the selection process in determining the item(s) that best serve the client's needs, goals and objectives. The client is made aware of options and components commercially available and those, which can be custom fabricated. The RTS provides the consumer; family and funding source with costeffective options for meeting specified goals and objectives. Evidence: Inventory Records Client Records Client Interviews

Standard 844, Criterion C: The Rehabilitation Technology Service provides products for demonstration, simulation and trial. Interpretation: In order to determine product suitability, to appropriately meet the needs of the client, the RTS provides either the exact item to be purchased or a close facsimile to properly demonstrate its effectiveness. It is recommended that products be made available to loan to for clients to use in the event that the actual item needed has to be ordered from a manufacturer. Evidence: Client Records Client Interviews

Standard 844, Criterion D: The RTS provides products for loan to clients in case of equipment failure. Interpretation: To meet the needs of the client without back up RTS equipment, the RTS provides either an exact item or a close facsimile to clients who experience failure of their RTS equipment while the client's equipment is being repaired. Evidence: Client record Response to interviews

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Standard 844, Criterion E: A written warranty is provided on all products and services. Interpretation: Policy and procedure describe the organization's written warranty practice and should include the following: (1) A product warranty should given to the client/caregiver on all rehabilitation products and/or services provided by the RTS; (2) The warranty may be the one offered by the product manufacturer or one by the RTS or a combination of both; (3) Items that are custom-fabricated by the RTS are to be covered by a written warranty; (4) The client/caregiver should also be made aware of the particulars of the warranty including the duration, what is covered, owner responsibilities for maintenance and care and for expenses involved in repair/replacement such as labor, shipping or delivery and (5) The client/caregiver should also be made aware of the actions that may void a warranty, particularly if the product needs to be modified for any reason. The organization should also develop and maintain a system for tracking warranty repairs and use this collected information to assist clients in making informed decisions about the products recommended. Evidence: New Inventory Item Inspection Client Interviews Product Warranty Policies and Procedures

Standard 845. The RTS staff will have access to a reference library appropriate to the level of services provided. Standard 845, Criterion A: The RTS staff will have access to a reference library appropriate to the level of services provided. Interpretation: The RTS staff has available reference books, journals, Internet access, etc. appropriate for the client population served. At a minimum, the library will contain: (1) general RTS journals; (2) manufacturer literature for all equipment and products provided; (3) NRRTS and RESNA guidelines; (4) current medical dictionary; (5) third party billing guidelines and (6) current HME and/or RTS regulations for any state into which the staff perform evaluations and deliver equipment. Evidence: Review of reference library and Staff interviews

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FITTER SERVICES

Standard 846: The organization has written policies and procedures that ensure the competency of all fitters. Standard 846, Criterion A: The organization has written policies and procedures that ensure all fitters receive adequate education and training. Interpretation: The organization's policies and procedures must define the minimum education and training required before a fitter can perform fittings without supervision. Adequate education and training must be established in the following: (1) surgical site assessment; (2) accurate measuring; (3) selection of appropriate product(s); (4) actual fitting technique; (5) identify fitting problems that may require adjustment or customization; and (6) techniques to check fit to ensure comfort, balance, symmetry and customer satisfaction. All fitters must be able to demonstrate proficiency in the fitting skills they are expected to provide. Evidence of competency will be performed by direct observation by a certified fitter or post-breast surgery consultant. Knowledge can be acquired through a variety of methods such as manufacturers' training seminars/schools, in-service programs presented by qualified post-breast surgery consultant and on-the-job training and observation. The organization must provide an accessible on-site fitting manual. Evidence: Written policies and procedures Personnel files Document of industry certification In-Service education/training programs Certificate of course completion/proof of attendance Responses to on-site interviews

Standard 846, Criterion B: The organization ensures that all fitters have received basic education related to breast cancer and breast cancer surgery related products and services. Interpretation: Approved schools/courses must be a minimum of one full day and include instruction and training by qualified, experienced professionals on all of the following: (1) anatomy and physiology of the breast and surrounding area; (2) breast cancer surgeries and treatment; (3) emotional and psychological aspects of breast cancer; (4) fitting techniques and skills; (5) product introduction and application; (6) common problems and solutions; (7) modifications; and (8) general business practices that support the assumption that all products and services are presented in a professional and caring manner by qualified professionals. Evidence: Signed personalized certificate of course completion

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Standard 846, Criterion C: All fitters can identify the major breast cancer surgeries, and understand the fitting challenges or possible complications resulting from each surgery. Interpretation: All fitters have been educated regarding breast cancer surgical techniques, have viewed the surgical sites, and know basic terminology. Knowledge can be acquired through a variety of methods such as manufacturers' training seminars/schools, educational seminars presented by qualified healthcare professionals directly related to breast cancer and on-the-job observation. Evidence: Personnel files Document of industry certification Certificate of course completion/proof of attendance Responses to on-site interviews

Standard 846, Criterion D: All fitters have a basic understanding of adjuvant therapy following breast cancer surgery. Interpretation: All fitters have received education regarding adjuvant therapy (i.e. chemotherapy and radiation) and understand the fitting challenges or possible complications they may present, such as the presence of drain port, catheter or skin sensitivity. Knowledge can be acquired through a variety of methods such as manufacturers' training seminars/schools, educational seminars presented by qualified healthcare professionals directly related to breast cancer and on-the-job observation. Evidence: Personnel files Document of industry certification Certificate of course completion/proof of attendance Responses to on-site interviews

Standard 846, Criterion E: All fitters are trained to recognize the need for emotional and psychological support. Interpretation: Fitters receive education and/or information on handling the sensitive issue of breast cancer surgery, and how it affects women emotionally and psychologically, not just physically. Fitters should be aware of national and local support groups which can be recommended should the need arise. Knowledge can be acquired through a variety of methods such as manufacturers' training seminars/schools, educational seminars presented by qualified healthcare professionals directly related to breast cancer, sensitivity training, and self-education utilizing information from cancer support organizations (American Cancer Society, Y-ME, etc.). Evidence: Personnel files Document of industry certification Certificate of course completion/proof of attendance Responses to on-site interviews

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Standard 846, Criterion F: All fitters demonstrate basic upper torso anatomy knowledge. Interpretation: All fitters know the basic internal and external anatomy of the breast and surrounding area, can identify landmarks (i.e. sternal notch, axilla), and understand the basic function/purpose of the breast and lymph system. The organization must provide on-site access to a medical dictionary or glossary of medical terminology. Knowledge can be acquired through a variety of methods such as manufacturer's training seminars/schools, anatomy courses, educational seminars presented by qualified healthcare professionals directly related to breast cancer. Evidence: Personnel files Document of industry certification Self-education Certificate of course completion/proof of attendance Responses to on-site interviews

Standard 847: The organization has written policies and procedures that ensure all fitters can competently identify and correct fitting problems. Standard 847, Criterion A: The organization's policies and procedures ensure that fitters demonstrate their ability to recognize and correct fitting problems. Interpretation: Corrections may require adjustment or customization and fitters must be able to perform the necessary modifications to ensure an accurate and comfortable fit. Written policies and procedures must specify a reasonable time frame for the completion of modifications. A certified fitter will assess competency through direct observation. Fitters must have available (or have access to) the raw materials needed to perform modifications. It is preferred that a sewing machine is available on-site and that all fitters have the basic sewing skills necessary to make adjustments. If modifications cannot be performed at the time of the fitting, or are performed off-site by qualified personnel, a reasonable time frame must be set within which the modifications should be completed.

Knowledge can be acquired through a variety of methods such as manufacturers' training seminars/schools, in-service programs presented by a qualified post-breast surgery consultant and on-the-job training and observation. Evidence: Written policies and procedures Competency checklists Personnel files Job descriptions Certificate of course completion/proof of attendance Industry certification documentation Responses to on-site interviews

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Standard 847, Criterion B: All fitters can competently identify other anatomical anomalies that are not breast cancer related, but can affect the fitting and choice of product. Interpretation: All fitters should be trained to address situations that involve multiple/complicating diagnoses or conditions that require special attention, products and/or modifications (i.e. osteoarthritis, osteoporosis, transplant surgeries, hiatal hernias, congenital breast anomalies), perform necessary modifications, and/or order specialty product(s) that will meet the unique demands of the client's condition. Knowledge can be acquired through anatomy courses and on-the-job training and observation. Evidence: Personnel files In-service education/training programs Self-education Certificate of course completion/proof of attendance Responses to on-site interviews

Standard 848: The organization ensures that all fitters have received industry certification. Standard 848, Criterion A: Fitters must attend at a minimum, one school/seminar approved for industry certification. Interpretation: To ensure competency and quality of care, all fitters must have Industry Certification within 12 months of being employed as a fitter. At least one fitter must be certified as specified under Fitter Services before the facility can be accredited. The certificate must be displayed in a conspicuous location accessible to public view within the fitting area. "Industry Certification" is to be interpreted as the certification received following the completion of a school or seminar presented by one of the major manufacturers of post-breast surgery products or an independent institution directly related to post-breast surgery services. Fitters are encouraged to attend two (2) school/seminars, but only one is required. Evidence: Signed personalized certificate displayed in the fitting area

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Standard 849: The organization should have written policies and procedures defining the number of programs of in-service and/or continuing education required for fitters. Standard 849, Criterion A: The organization must allow time and resources to support the fitter in obtaining additional knowledge and ability through in-service training and/or continuing education programs. Interpretation: It is to be understood that before and after certification, a fitter participates in self-education, in-services, and other appropriate instructions regularly to enhance and reenforce awareness, knowledge and ability. Fitters must attend continuing education programs annually. A minimum of one of the following must be attended: (1) training seminar presented by a manufacturer; (2) educational in-service programs presented by qualified professional (i.e. a manufacturer's representative/consultant); (3) educational seminar/workshop presented by qualified healthcare professional(s) pertinent to post-breast surgery for breast cancer related topics, such as the Women's Healthcare Educational Network. Evidence: Written policies and procedures Personnel files In-service records Responses to on-site interview questions

Standard 850. The organization ensures that all fitters have knowledge/awareness of a variety of products and manufacturers. Standard 850, Criterion A: The organization promotes product knowledge/awareness for all fitters. Interpretation: The organization provides on-going in-service education opportunities that allow fitters to familiarize themselves with and recognize the need for the products. Fitters should be exposed to a variety of products available from a variety of manufacturers. It is imperative that all fitters are aware of new product development, and/or new styles of breast forms and specialty bras as they become available. The organization must provide on-site access to a current product catalog. Evidence: Personnel files Current product catalog Document of industry certification Certificate of course completion/proof of attendance Responses to on-site interviews In-service training records

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Standard 850, Criterion B: The organization ensures that all fitters are knowledgeable and understand the differences between similar products and styles and know their indications for use. Interpretation: The organization provides on-going in-service education opportunities to ensure that fitters are knowledgeable and understand the differences between products and styles. The organization also ensures that fitters are knowledgeable about the indications for use of each product (i.e. the type and extent of surgery will determine the anatomical shape of the breast form, the size and contour of the remaining breast will determine the size, shape and consistency of the breast form, the type of surgery and size of the woman will determine the size and style of bra). Knowledge can be acquired through a variety of methods such as manufacturers' training seminars/schools, in-service programs presented by a qualified post-breast surgery consultant and on-the-job training and observation. Evidence: Personnel files Document of industry certification Certificate of course completion/proof of attendance Responses to on-site interviews

Standard 850, Criterion C: The organization ensures that the fitter is knowledgeable in policy and procedure related to the notification of defective product to the manufacturers and vendors of that product. Interpretation: Fitters notify the manufacturers and vendors of defective products and document the incident with reporting to the supervisor/manager/owner for use in the overall quality improvement plan. Evidence: Written policies and procedures Incident report summary

Standard 851. The organization ensures that all fitters have access to a variety of products and manufacturers. Standard 851, Criterion A: The organization ensures a comprehensive inventory of a variety of products. Interpretation: The organization maintains an on-site inventory of a variety of products. The scope of products offered must include, at a minimum, the following: (1) temporary forms and products used immediately after surgery but prior to fitting weighted breast forms; (2) silicone breast forms, post-mastectomy bras; (3) supplies and raw materials necessary for alterations; (4) supplies for the care and maintenance of products offered; and (5) access to ancillary products women need following surgery or treatment such as swimwear, turbans, wigs/bangs, lingerie, etc. Evidence: Inventory lists On-site interviews

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Standard 851, Criterion B: The organization has a written policy and procedure for supplying a client with a product that is not normally stocked. Interpretation: The organization has established policies and procedures for the ordering of products not normally carried in inventory. The organization will whenever possible, special order a needed product from the manufacturer or from a competitor, or when appropriate, refer the client to another organization. The organization must set a reasonable time frame within which the necessary product(s) is ordered. Evidence: Written policy and procedures

Standard 851, Criterion C: The organization ensures that clients will receive manufacturer's information at the time of sale. Interpretation: At the time of sale, clients should receive the following written information whenever appropriate: (1) warranty information; (2) indications/contraindications for use; (3) general product information; (4) maintenance; and (5) instructions. Evidence: Manufacturers' advisory pamphlets Client interviews

Standard 852. The organization ensures that the facility environment is conducive to comfort, privacy and professionalism. Standard 852, Criterion A: The fitting room(s) are private, appropriately decorated, comfortable and functional. Interpretation: The organization ensures that the fitting room(s) are quiet, private, comfortable and secure. They should be warm and receptive in appearance. Inventory should not be kept in the fitting room(s). At a minimum, an enclosed, private room should contain the following items: (1) door; (2) covered or painted walls; (3) finished ceiling; (4) carpeting; (5) table; (6) full length mirror; (7) adequate lighting; (8) coat hook; (9) comfortable chairs/sofa; (10) a soft gown to check the symmetry or fit; (11) tape measure; (12) paper; (13) pencil/pen; (14) tissues; (15) disinfectant spray; (16) hand sanitizer solution; (17) paper towels; (18) disposable examination gloves. Evidence: On-site observation

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Standard 852, Criterion B: The facility is professional in appearance. Interpretation: The organization ensures the professional appearance of the facility by presenting the merchandise in a tasteful, professional manner. Retail showroom(s), fitting room(s) and stockroom(s) should all be kept separate. Hours of operation should be convenient and posted for view. The facility must be handicapped accessible. There must be someone available during store hours to greet clients and answer the telephone. After hours, some type of answering service/voice mail system must be used. Calls should be returned by the end of the next business day. Evidence: On-site observations

Standard 852, Criterion C: The stockroom is well maintained. Interpretation: The organization ensures that the stockroom is well lit and organized in an efficient manner. All merchandise is kept clean, preferably in containers, and not directly touching the floor. Merchandise is rotated regularly and inspected annually. Evidence: On-site observations Responses to on-site interviews

Standard 852, Criterion D: There are adequate resources available to the client. Interpretation: The organization ensures that educational, informational and inspirational literature, books and videotapes are available to the client where they can be viewed in comfort and privacy. To promote the continuity of care, there should be information regarding local and national support groups, and other community resources available whenever possible. The organization and product literature should also be readily available. Evidence: Responses to on-site interviews On-site observations

Standard 853. The Fitter Services staff will have access to a reference library appropriate to the level of services provided. Standard 853, Criterion A: The Fitter Services staff will have access to a reference library appropriate to the level of services provided. Interpretation: The Fitter Services staff has available reference books, journals, Internet access, etc. appropriate for the client population served. At a minimum, the library will contain: (1) general Fitter Services journals; (2) Manufacturer literature for all products provided; (3) current medical dictionary; (4) third party billing guidelines and (5) current regulations for any state in which the staff perform evaluations and provide products. Evidence: Review of reference library Staff Interviews

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SPECIALTY PHARMACY SERVICES

Standard 854. All pharmacy services will be provided by qualified pharmacists in accordance with state laws, regulations and recognized professional practice standards. Standard 854, Criterion A: All pharmacy services will be provided by qualified personnel and administered in accordance with the organization's policies and job descriptions, state laws and regulations and recognized practice standards. Interpretation: Pharmacist and pharmacy technicians will function in accordance with the organization's job description, accepted ethical and professional practice standards and in accordance with all applicable laws and guidelines set by the state Board of Pharmacy. If pharmacy services are dispensing in other states, a pharmacy license or permit for states serviced will be obtained if required by that state. Current copies of applicable rules and regulations are maintained in the organization at all times and are readily available to appropriate agency staff. Evidence: Policy and Procedure State Board of Pharmacy Regulations Resident State Pharmacy License Resident State Board of Pharmacy Permit/License Additional State Board of Pharmacy Permit/License DEA Registration State Controlled Substance License (when required) Licenses of Practicing Technicians, where applicable Job descriptions / policies Out of State Pharmacy Permit(s) (where required)

Standard 855. There are written policies and procedures relating to pharmacy services. Standard 855, Criterion A: There are written policies and procedures covering the scope of services offered by the Specialty Pharmacy program. Interpretation: The service program has written and implemented policies and procedures addressing the scope of pharmacy services offered by the organization. These policies should identify types of services provided. These services must be appropriate for the home setting, physician office or medical clinic. Evidence: Written pharmacy policies and procedures

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Standard 855, Criterion B: Pharmacy services are provided according to the client's prescription with access to a Registered Pharmacist available 24 hours a day, 7 days per week. Interpretation: The organization provides pharmacy services 24 hours a day, seven days a week when necessary to meet client needs. An on-call coverage system may be used to provide this coverage during evenings, nights, weekends and holidays. Policy and procedure describes the process for accessing an on-call pharmacist and includes a reasonable agency response time. Evidence: Written service policies On-call schedule / log Staff interviews

Standard 856. Pharmaceutical care is ordered by a physician, appropriate, and delivered in accordance with the prescription. Standard 856, Criterion A: All clients will have a valid prescription ordered by the physician. Interpretation: All clients will have a valid prescription that delineates the drug, dosage, and frequency. Physician verbal orders will be received by a pharmacist, unless otherwise allowed by state law. Evidence: Client record

Standard 856, Criterion B: All clients referred for pharmacy services will have an assessment of appropriate therapy by the pharmacist. Interpretation: All prescriptions will be reviewed by a pharmacist, prior to dispensing to assure appropriateness of the drug and dose to the client's diagnosis. This review must be documented in the client record or on the prescription. (i.e. The RPh. signs the script after review verifying it's appropriateness.) The physician, or other professional authorized to prescribe, should provide adequate medical management for the client during pharmacy services. Results of appropriate lab work will be maintained in the client record. Evidence: Client record Response to interviews

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Standard 856, Criterion C: The organization will show evidence of the client/caregiver understanding and participation in the prescribed therapy. Interpretation: The client record must show understanding and participation of the client / caregiver in the prescribed therapy. Examples may include a progress note client counseling regarding education materials, administration regimen, drug actions, potential side effects, proper storage and disposal of the medication and / supplies. Evidence: Client record Client interviews

Standard 856, Criterion D: Pharmacy services follow discharge policies and procedures. Interpretation: All clients will be discharged upon completion of their therapy. The discharge summary documentation should include: (1) a summary of services provided; (2) the date and reason for discharge, i.e. therapy completed or interruption due to adverse events; (3) date of last prescription fill; and (4) any instructions or referral information given to the client or responsible party. Evidence: Client records

Standard 857. All pharmaceuticals are administered in accordance with applicable laws / regulations and organization policies and procedures. Standard 857, Criterion A: A licensed pharmacist must review all client medications and consult with other health care professionals caring for the client, including the physician, if potential medication interactions are noted. Interpretation: Policy and procedure describe the licensed pharmacist's role in reviewing all prescription and non-prescription medications a client is currently taking prior to dispensing. The purpose of the review is to assess for known / potential drug interactions with the prescribed therapy. A medication profile is established and should be updated and kept current through ongoing review and revision of client data. A Registered Pharmacist is specifically accountable for recognizing the following on the medication profile: (1) side effects; (2) toxic effects; (3) allergic reactions; (4) immediate desired effects; (5) unusual and unexpected effects; (6) drug interactions; and (7) changes in the client's condition that contraindicates continued administration of the medication.

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In addition, the pharmacist, in conjunction with other health care professionals caring for the client, must be able to anticipate those effects which may rapidly endanger a client's life or wellbeing, and instruct the client, family members and/or caregiver, as necessary, in following the prescribed regimen. Evidence: Written policies and procedures Medication profile in client records Responses to on-site staff interview questions

Standard 857, Criterion B: There are written policies and procedures that address response to adverse drug reactions. Interpretation: The organization has written policies and procedures that address probable and potential adverse reactions to the classifications of drugs being dispensed. There is a procedure for documenting any reported adverse drug reaction, which may include informing the physician and / or initiating a MedWatch form. Evidence: Written policies and procedures Response to interviews ADR record book MedWatch records

Standard 857, Criterion C: There are written guidelines relating to special education, experience or certification requirements for pharmacy staff to prepare pharmaceuticals and administrative devices. Interpretation: The organization must have written guidelines defining any special education, experience or certificates necessary for pharmacy staff to prepare pharmaceuticals and administrative devices. Qualifications may vary based upon classifications of drugs as well as Board of Pharmacy requirements. Evidence: Written policies Personnel Files

Standard 857, Criterion D: There is demonstrated consistency between service provided by the organization, the physician order / prescription, and the services billed. Interpretation: Client record reviews prior to billing verify that the services ordered / prescribed by the physician are being provided by the organization. Evidence: Client records Billing records Responses to interview

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Standard 858. The pharmacy has a process for verifying the lot number and expiration date of all compounded pharmaceuticals. Standard 858, Criterion A: Records of product formulation are prepared for all compounded pharmaceuticals. Note: This criterion is not applicable to pharmacy organizations that do not compound medications. Interpretation: There are written policies and procedures pertaining to the use of product formulation records in the preparation of parenteral medications. Signatures or initials of person(s) preparing the medication as well as the pharmacist checking the medication must be recorded on the product formulation record. Evidence: Review of Product Formulation Records Dispensing Logs Staff interviews Policy and procedure

Standard 858, Criterion B: The lot numbers and expiration dates of all pharmaceuticals dispensed are recorded. Interpretation: The organization has written procedures for the recording of lot numbers and expiration dates of all pharmaceuticals dispensed. These procedures include how, when, and where this information is to be recorded. Evidence: Policies and procedures Dispensing Logs Staff interviews

Standard 859. All parenteral medications are prepared using appropriate techniques and in a suitable environment. Note: This standard is not applicable to pharmacy organizations that do not compound medications. Standard 859, Criterion A: Qualified personnel use appropriate aseptic techniques to compound sterile pharmaceuticals. Interpretation: Personnel demonstrate understanding of USP General Chapter 1206 Sterile Drug Products for home use or the ASHP Guidelines on Quality Assurance for pharmacy prepared sterile products. The personnel are properly attired, display good handwashing technique, and operate in such a way as to minimize the potential for contamination. Evidence: Observation of Compounding Interviews of staff

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Standard 859, Criterion B: Sterile pharmaceuticals are compounded in an appropriate environment. Interpretation: Policies and procedures address and implement the process by which pharmaceuticals are compounded in a class 100 environment. The pharmacy has written policies and procedures for process validation testing through observation of sterile technique and end product testing of products compounded with non-sterile products. The frequency of testing is statistically significant and appropriate based upon the level of services provided. Evidence: Inspection of facilities Observation of process Written policies and procedures Equipment used for compounding is aseptic and tested

Standard 859, Criterion C: regularly.

Interpretation: Equipment used for compounding such as high speed compounders is aseptic and tested regularly. Laminar flow hoods are certified at least annually or as prescribed by State Board of Pharmacy regulation. Evidence: Inspection of facilities Staff interviews Test logs Laminar Flow Hood certification current

Standard 859, Criterion D: The organization has a written plan for reducing the risk of bacterial contamination of the compounding environment. Interpretation: There is a written and implemented plan for reducing the risk of bacterial contamination of the compounding environment. The plan includes periodic environmental monitoring, personnel monitoring, and endproduct evaluation testing. The frequency of monitoring is appropriate to the level of service provided. ACHC encourages pharmacies to follow both ASHP and USP guidelines on the quality assurance and quality control activities needed for the preparation of sterile products. Evidence: Record review Staff interviews Observation of testing Written Plan

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Standard 860. The pharmacy assures medications are stored under appropriate conditions of security, sanitation, light and temperature in the facility, during deliveries, and in the client's home. Standard 860, Criterion A: The pharmacy stores pharmaceuticals under appropriate conditions of security, sanitation, light and temperature. Interpretation: Pharmaceuticals are stored in accordance with manufacturer or USP requirements. Temperatures are monitored daily wherever pharmaceuticals are stored to assure the requirements are met. Legend drugs are stored in the licensed pharmacy, which is accessible only by under the supervision of a licensed pharmacist(s). Evidence: Inspection of facilities Review of documentation

Standard 860, Criterion B: The pharmacy uses delivery containers that assure pharmaceuticals are maintained under appropriate conditions of sanitation, light and temperature in the course of deliveries. Interpretation: Where appropriate the pharmacy uses suitable delivery containers such as coolers and ice packs to maintain the storage conditions in accordance with manufacturer or USP requirements. There are written policies and procedures for the cleaning and disinfecting of any reusable containers. The policies and procedures are implemented. Evidence: Staff and client interviews Inspection of facility Policy and procedure

Standard 860, Criterion C: The pharmacy assures that pharmaceuticals are stored under appropriate conditions of sanitation, light and temperature in the client's home. Interpretation: The pharmacy has and acts upon information effecting the maintenance of appropriate conditions of sanitation, light and temperature in the client's home. Where necessary, the pharmacist intervenes appropriately to assure the conditions are achieved or maintained. Pharmaceuticals dispensed to the patient are clearly labeled as to the appropriate requirements for storage. Evidence: Client telephone interviews Staff interviews

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Standard 861. The pharmacy will have access to a reference library appropriate to the level of services provided. Standard 861, Criterion A: The pharmacy will have access to a reference library appropriate to the level of services provided. Interpretation: The pharmacy has available reference books, journals, internet access, etc. appropriate for the client population served. At a minimum, the library will address: (1) drug compatibility and stability; (2) drug interactions; (3) general clinical references; and (4) current pharmacy regulations for any state into which medications are dispensed. Evidence: Review of reference library Staff interviews

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FIRST DOSE PHARMACY SERVICES

Standard 1901. All pharmacy services will be provided by qualified pharmacists in accordance with state laws, regulations and recognized professional practice standards. Standard 1901, Criterion A: All Pharmacy Services will be provided by qualified personnel and administered in accordance with the organization's policies and job descriptions, federal, state, and local laws, and established regulatory guidelines as dictated by the Board(s) of Pharmacy of the state(s) into which medications are dispensed. Interpretation: Pharmacist and pharmacy technicians will function in accordance with the organization's job description, accepted ethical and professional practice standards and in accordance with all applicable federal, state and local laws and guidelines set by the state appropriate Board of Pharmacy. If pharmacy services are dispensing in other states, a pharmacy license or permit for states serviced will be obtained if required by that state. Current copies of applicable rules and regulations are maintained in the organization office at all times and are readily available to appropriate organization staff. Evidence: State Board of Pharmacy Regulations Resident State Pharmacy License Resident State Board of Pharmacy Permit/License Additional State Board of Pharmacy Permit/License DEA Registration State Controlled Substance License (when required) Licenses of Practicing Technicians, where applicable Job descriptions/policies Out of State Pharmacy Permit(s) (where required) Personnel record reviews

Standard 1901, Criterion B: All required licenses and/or permits for the physical facility are current and conspicuously placed on display in an appropriate area of public view. Interpretation: The organization will display in an area of public view all licenses and/or permits required in the operation of the pharmacy services. Evidence: License displayed in an appropriate place for public view (if required) Device Dispensing Permit (if required) State Board of Pharmacy License or contract with a locally licensed pharmacy (contract available for review)

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Standard 1902. There are written policies and procedures relating to pharmacy services. Standard 1902, Criterion A: There are written policies and procedures describing the scope of services offered by the infusion pharmacy program. Interpretation: The infusion pharmacy program has written and implemented policies and procedures addressing the scope of pharmacy services offered by the organization. These services should include, but not be limited to, types of services provided, target client populations, and goals of the program. Evidence: Written pharmacy policies and procedures

Standard 1902, Criterion B: Pharmacy services are provided according to the client's plan of care with access to a Registered Pharmacist available 24 hours a day, 7 days per week. Interpretation: The organization provides pharmacy services 24 hours a day, 7 days a week when necessary to meet client needs. An on-call coverage system may be used to provide this coverage during evenings, nights, weekends and holidays. Evidence: Written service policies On-call schedule/log

Standard 1903. Qualified personnel supervise the pharmacy services. Standard 1903, Criterion A: There is a qualified professional responsible for supervision of all services. Interpretation: All pharmacy services must be provided under the direction of a registered pharmacist with sufficient education and experience in the scope of services offered. It is preferred that the registered pharmacist in charge of the pharmacy program has a minimum of two years previous supervisory experience or the equivalent. State regulations may dictate pharmacist requirements. Evidence: Personnel file of the supervising pharmacist

Standard 1903, Criterion B: Pharmacy technicians are supervised by a registered pharmacist in accordance to organizational policy and the state board of pharmacy. Interpretation: The organization follows their state board of pharmacy regulations and organizational policies and procedures that demonstrate supervision of services provided by pharmacy technicians. The policies and procedures identify the method and frequency for assessing pharmacy technician practice to ensure that services are provided appropriately. Evidence: Policy and Procedure Documentation of supervision activities ­ client record or personnel record Response to Interviews

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Standard 1904. All pharmaceuticals are administered in accordance with applicable laws/regulations and organization policies and procedures. Standard 1904, Criterion A: Medications and supplies are accurately labeled and dispensed to the patient for whom they are ordered. Interpretation: Medications dispensed to clients are appropriately labeled according to applicable law and regulation and standards of practice. There is a process to verify that the correct medication(s) and supplies, if applicable, were dispensed and delivered to the correct client. Evidence: Pharmacy Logs Delivery tickets or logs

Standard 1904, Criterion B: There are written guidelines relating to special education, experience or certification requirements for pharmacy staff to prepare pharmaceuticals and administrative devices. Interpretation: The organization must have written guidelines defining any special education, experience or certificates necessary for pharmacy staff to prepare pharmaceuticals and administrative devices. Qualifications may vary based upon classifications of drugs as well as State Board of Pharmacy requirements. Evidence: Written policies or guidelines Personnel Files

Standard 1905. The pharmacy has a system for the recall of medications. Standard 1905, Criterion A: Records are maintained to identify each client who is receiving or has received recalled medications. Interpretation: There are written policies and procedures for tracking medications or products dispensed to patients. Documentation will include, but not be limited to, the manufacturer of each client's medication, lot numbers and expiration dates. Evidence: Policies and procedures Dispensing records Client record Response to staff interviews

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Standard 1905, Criterion B: Processes are maintained for the safe disposition of recalled medications or products stocked and dispensed to clients. Interpretation: There are written procedures for external reporting of medication product defects. Client's physicians are notified when medications are discontinued, expire, or are recalled. Evidence: Policies and procedures Dispensing records Client record Response to staff interviews

Standard 1906. All parenteral medications are prepared and compounded by qualified personnel in a suitable environment using appropriate aseptic technique. Standard 1906, Criterion A: Qualified personnel comply with aseptic technique when compounding sterile admixtures. Interpretation: Personnel demonstrate understanding of aseptic techniques in accordance with established, recommended guidelines and state specific Board of Pharmacy regulations. Personnel qualifications include initial and follow-up training for periodic evaluation of performance. Evidence: Personnel files Observation of staff State BOP regulations Response to staff interviews

Standard 1906, Criterion B: Sterile products are compounded in a Class 100 environment, using the appropriate compounding equipment. Interpretation: Laminar flow hoods are certified annually or in accordance with state Board of Pharmacy regulations. A qualified independent contractor performs certification according to accepted standards for operational efficiency. Procedures are maintained for monitoring the proper operating conditions for all equipment used in sterile compounding in accordance with manufacturer guidelines. Evidence: Facility inspection Quality control records State BOP regulations Response to staff interviews

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Standard 1906, Criterion C: The organization has a written plan for drug compounding. Interpretation: The written plan for drug compounding defines quality control procedures for monitoring aseptic technique and the compounding environment to comply with established standards and/or state Board of Pharmacy regulations. The written plan defines processes for preparing/compounding sterile products and includes: · · · · · · · · Aseptic technique Validation of aseptic processing procedures (media fills or end product testing), when indicated Appropriate attire for personnel who compound (gown, mask, gloves) Hand washing procedures Environmental considerations (security, temperature, ventilation) Preparation of parenteral drugs Preparation of cytotoxic drugs Preparation of sterile drugs form non-sterile products Policies and procedures Facility Inspection State BOP regulations Quality control records Response to staff interviews

Evidence:

Standard 1906, Criterion D: The organization has policies and procedures for cleaning and disinfection. Interpretation: Procedures for cleaning of the work surfaces, equipment, and compounding/anteroom areas to reduce the risk of particulate matter in the work area and contamination of the compounding environment include: · · · Process and frequency for cleaning work surfaces, equipment, and work areas using dedicated cleaning tools specific to each area. Appropriate disinfectant solutions, rotated regularly with another sanitizing solution of a different action. Documentation of the cleaning process. Policies and procedures Staff observation and response to interviews Quality control records

Evidence:

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Standard 1907. The pharmacy assures medications are stored under appropriate conditions of security, sanitation, light and temperature in the facility, during deliveries, and in the client's home. Standard 1907, Criterion A: The pharmacy stores pharmaceuticals under appropriate conditions of security, sanitation, light and temperature. Interpretation: Pharmaceuticals are stored in accordance with manufacturer or USP requirements. Temperatures are monitored wherever pharmaceuticals are stored to assure the requirements are met. Prescription and legend drugs are stored in the licensed pharmacy, which is accessible only under the supervision of licensed pharmacists(s). Evidence: Inspection of facilities Quality Control Records

Standard 1907, Criterion B: The pharmacy uses delivery containers that assure pharmaceuticals are maintained under appropriate conditions of sanitation, light and temperature in the course of deliveries. Interpretation: Where appropriate, the pharmacy uses suitable delivery containers such as coolers and ice packs to maintain the storage conditions in accordance with manufacturer or USP requirements. There are written policies and procedures for the cleaning and disinfecting of any reusable containers. The policies and procedures are implemented. Evidence: Staff interviews Inspection of facility Home visits Policy and Procedure

Standard 1907, Criterion C: The pharmacy assures that pharmaceuticals are stored under appropriate conditions of sanitation, light and temperature in the client's home. Interpretation: The pharmacy has and acts upon information affecting the maintenance of appropriate conditions of sanitation, light and temperature in the client's home. Where necessary, the pharmacist intervenes appropriately to assure that appropriate conditions are achieved or maintained. Pharmaceuticals dispensed to the patient are clearly labeled as to the appropriate storage. Evidence: Client telephone interviews Home visits Staff interviews Prescription labeling from the pharmacy

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Standard 1908. All equipment services are provided in accordance with federal, state, local laws/regulations, manufacturer guidelines, and organization policies and procedures. Standard 1908, Criterion A: The organization implements its policies and procedures for client ready equipment. Interpretation: Client ready equipment is defined as equipment that is durable in nature, disinfected, and operating within manufacture guidelines. The organization has clearly defined guidelines for the cleaning, storage, and transportation of client ready equipment. These guidelines should include but are not limited to: (1) separation of dirty and clean equipment; (2) appropriate warehousing and tagging of equipment; (3) use of appropriate cleaning and disinfecting agents; (4) maintenance of equipment; and (5) separation of inoperative equipment. Maintenance of the equipment will be, at a minimum, in accordance with the manufactures written guidelines. The organization practices their client ready equipment policies and procedures. Evidence: Policies and Procedures Manufacturer's service manuals Maintenance Logs Staff interviews Inspection of warehouse and delivery vehicles

Standard 1908, Criterion B: Staff implement written policies and procedures concerning the set-up, delivery, environmental requirements, and electrical safety of the equipment. Interpretation: Company personnel perform environmental assessments, set-up, and demonstrate safe and proper use of all infusion equipment according to manufacturer's guidelines. At the time of delivery, organization personnel will address at a minimum the following: (1) safety and adequacy of electrical outlets; (2) safe use of extension cords and outlet adapters; (3) location and function of all equipment controls and equipment circuit breakers; and (4) expected results/outcomes of proper use. Training provided to the client at set-up will be documented in the client record according to established policy. Evidence: Policies and Procedures Client records Copies of Manufacture Instruction/Set up Guidelines Staff interviews Client interviews Client education materials

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Standard 1908, Criterion C: There are written policies and procedures relating to the maintenance and repair of infusion equipment. Interpretation: Company policy will clearly define training, qualifications, and skill validation required by personnel to perform routine maintenance and repair of all infusion equipment. Routine maintenance, preventative maintenance, and repairs will be performed according to manufacturer's guidelines. Provider personnel will only perform repair services within their respective areas of training and expertise. Policies and procedures also clearly define the appropriate use of outside repair sources. Evidence: Policies and Procedures Maintenance logs Personnel records Staff interviews Manufacturer's service manuals Client records (for routine maintenance performed in home)

Standard 1908, Criterion D: There are written policies and procedures relating to tracking and manufacturer recalls of equipment. Interpretation: There will be written guidelines for the accurate tracking of equipment. It is preferred that the organization be able to track all equipment in use by active clients. There are guidelines that facilitate any recall notices and address the immediate removal of recalled equipment or supplies from client ready inventory, notification of all clients having recalled items, and the exchange of recalled equipment supplies in the field. Disposition of recalled inventory will be handled according to the manufacturer's directions. Evidence: Policies and Procedures Tracking logs Inventory records Staff interviews

Standard 1908, Criterion E: Policies and procedures relating to the processing of contaminated or soiled infusion equipment are implemented. Interpretation: Providers guidelines specify that only durable medical equipment will be returned to the company for processing. Policy and procedures will specify the separation of dirty equipment from client ready equipment in the warehouse and delivery vehicles. Cleaning and disinfection of equipment will be performed in compliance with universal precautions and company policies. Guidelines will also clearly define curbside disinfection. Evidence: Policies and procedures Staff interviews Inspection of delivery vehicles and warehouses

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Standard 1908, Criterion F: There are written policies and procedures relating to back up systems for equipment or power failure in the home. Interpretation: The provider has clearly defined policy and procedures to determine the back-up requirements for equipment failure in the home. Evidence: Policies and procedures Staff interviews Client interviews/home visits Client records

Standard 1909. The pharmacy will have access to a reference library appropriate to the level of services provided. Standard 1909 Criterion A: The pharmacy will have access to a reference library appropriate to the level of services provided. Interpretation: The pharmacy has available reference books, journals, Internet access, etc. appropriate for the client population served. At a minimum, the library will address: (1) drug compatibility and stability; (2) drug interactions; (3) general clinical references; and (4) current pharmacy regulations for any state into which medications are dispensed. Evidence: Review of reference library Staff interviews

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