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Laboratory Proficiency Testing Program

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Newsletter

NOVEMBER 12, 1996

No. 191

Bethesda Terminology System for Cervical-Vaginal Cytology

by Patricia Ann Shaw, MD, FRCP(C), Chair, Quality Assurance in Cytology Subcommittee of Ontario Cervical Screening Collaborative Group, and William R. Geddie, MD, FRCP(C), Chair, LPTP Cytology Committee

With the goal of reducing the incidence and mortality of cervical cancer in Ontario by the year 2005, the Ontario Cervical Screening Collaborative Group, which is chaired by Dr. Aileen Clarke of the Ontario Cancer Treatment and Research Foundation and includes representation from LPTP, has developed a number of important initiatives, building on the present system to establish a more comprehensive approach to cervical screening in Ontario. A key component of the success of the screening program, which will include a cytology registry to facilitate recruitment and recall of patients, is the adoption of a standardized reporting system for cervicovaginal cytology. After consultation with all Ontario laboratories licensed to perform cytology, and with several professional organizations, the Quality Assurance in Cytology Subcommittee of the Ontario Cervical Screening Collaborative Group, together with LPTP, endorses and encourages the adoption of the Bethesda System (TBS) for use in the reporting of all cervicovaginal cytology. The Bethesda System offers the advantage of a precise terminology better reflecting current knowledge of preinvasive cervical disease. To assist pathologists and cytotechnologists in further understanding the application of TBS in their laboratories, LPTP is pleased to present Dr. Diane Solomon as the keynote speaker at this years annual symposium on November 15, Future Directions in Cervicovaginal Cytology in Ontario. While some Ontario laboratories are already using TBS, LPTP recognizes that many laboratories, pathologists and practitioners will require a transition period. It is anticipated that most laboratories will initiate the adoption of the new terminology in early 1997. A summary of the Bethesda System terminology, including categories for both the Statement of Adequacy and Diagnostic Categories, follow. An important reference highly recommended for pathologists and cytotechnologists using TBS is The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses by Dr. Robert Kurman and Dr. Diane Solomon, published by Springer-Verlag, New York, 1994. Continued on page 2

Ontario Hospital Association Convention Session for Medical Technologists

by Linda Crawford

The Ontario Hospital Association Convention & Exhibition 96 was held on November 4-6, 1996 at the Metro Toronto Convention Centre. The timely theme of the convention was Moving Ahead Meeting the Challenge. On Monday, November 4, a session for medical technologists was cosponsored by the Ontario Society of Medical Technologists (OSMT) and chaired by Alexandra Clegg, OSMT president. Three speakers were included on the program: Dawn Ogram, Director, Laboratory Services Restructuring Secretariat; Sheila Woodcock, Registrar, College of Medical Continued on page 4

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IN THIS ISSUE

Bethesda Terminology System for Cervical-vaginal Cytology ................... 1 Correction Coagulation K-9609 Survey Report .................................... 6 Ontario Hospital Association Convention Session for Medical Technologists ..................................... 1 Ontario Society of Medical Technologists Names New President ............................................. 6 LPTP Mailings sent this Week .......... 2

LPTP Newsletter

No. 191 November 12, 1996

Bethesda Terminology System (continued)

Recommendations for Terminology for Reporting of Cervical/Vaginal Cytology

Ontario Cervical Screening Collaborative Group Quality Assurance in Cytology Subcommittee 1. STATEMENT OF ADEQUACY 1. Satisfactory for evaluation Transformation zone component is present 2. Satisfactory for evaluation but limited by: i) Transformation zone component is not present. ii) 50-75% of the epithelial cells are obscured by: blood, inflammation, thick areas, poor fixation, air drying artifact or contaminant. 3. Unsatisfactory for evaluation i) Squamous cells cover <10% of slide surface ii) >75% of the epithelial cells are obscured by: blood, inflammation, thick areas, poor fixation, air drying artifact or contaminant. II. DIAGNOSTIC CATEGORIES 1. Within Normal Limits 2. Benign Cellular Changes This category may be further clarified with: Trichomonas vaginalis identified Yeast identified Cellular changes associated with herpes simplex virus identified Bacteria morphologically consistent with actinomyces species identified Reactive changes associated with: inflammation, repair, atrophy with inflammation, radiation, intrauterine contraceptive device or other Continued on page 3

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C-9610 C-9610BG D-9610 G-9608 H-9609-Y H-9611 M-9609 V-9607 V-9610

LPTP MAILINGS SENT THIS WEEK

Chemistry-General Survey Report Chemistry-General Blood Gas Survey Report Drug Monitoring Survey Report Cytogenetics Committee Comments and Survey Report Hematology-General Committee Comments Hematology-General Analysis Worksheet Hematology-Morphology Committee Comments Virology Committee Comments Virology Preliminary Reference Results

Endocrinology: Committee Comments, Quality Assurance (Update) Parasitology: Bulletin Revised Analysis Worksheet and Survey Reporting Codes

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Each laboratory will receive only selected items. If you consider you should have received an item and have not done so within 7 days, please contact LPTP.

2 NEXT DISPATCH DATES: November 26 and December 10, 1996

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LPTP Newsletter

No. 191 November 12, 1996

Bethesda Terminology System (continued)

Recommendations for Terminology for Reporting of Cervical/Vaginal Cytology (Continued)

3. 3.1 Epithelial Cell Abnormalities Squamous cells

3.1.1 Atypical squamous cells of undetermined significance (ASCUS) This category should be used for cellular abnormalities that are more marked than those attributable to those of reactive changes, but that quantitatively or qualitatively fall short of a definitive of squamous epithelial lesion (SIL). When used as a diagnosis, the atypical cells should be further qualified, if possible, as to whether a reactive or neoplastic condition is favoured. 3.1.1.1 ASCUS, favour reactive changes 3.1.1.2 ASCUS, favour SIL 3.1.1.3 ASCUS, see comment 3.1.2 Low-grade squamous intraepithelial lesion (LSIL) Low-grade lesions encompass the cellular changes associated with HPV cytologic effect and mild dysplasia (CIN I). 3.1.3 High-grade squamous intraepithelial lesion (HSIL) High-grade lesions encompass CIN II and CIN III. 3.1.4 Squamous Cell Carcinoma 3.2 Glandular Cells

3.2.1 Endometrial cells, cytologically benign in a post-menopausal woman 3.2.2 Atypical glandular cells of undetermined significance (AGUS) 3.2.2.1 3.2.2.2 3.2.2.3 3.2.2.4 Favour endometrial origin Favour reactive endocervical cells Favour neoplastic endocervical cells Not otherwise specified

3.2.3 Atypical glandular cells present consistent with adenocarcinoma in situ 3.2.4 Malignant cells present consistent with adenocarcinoma 3.2.4.1 3.2.4.2 3.2.4.3 3.2.4.4 Endocervical Endometrial Extra-uterine Other

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LPTP Newsletter

No. 191 November 12, 1996

Ontario Hospital Association Convention Session for Medical Technologists

Laboratory Technologists of Ontario (CMLTO) ; and David More, Manager, Clinical Laboratories of Eastern Ontario (CLEO). Laboratory Services Review Moving Ahead Dawn Ogram, Director, Laboratory Services Restructuring Secretariat Dawn began by sharing the planning objectives for laboratory services restructuring, outlining the key principles and elaborating on each. She then discussed future directions for laboratory services and the process envisioned to achieve these goals. Dawn identified the Ministry of Healths (MOH) proposed geographical planning areas and explained the consultative process conducted in each area to date, sharing some of the major issues. She concluded by putting into perspective the challenge of restructuring laboratory services in the context of the concurrent changes occurring in the broader health-care sector. Ontarios laboratory community is charged with the task of defining a planning process to be carried out at the grass roots level. Dawn emphasized that restructuring is not just about saving money, but doing things better. The ultimate challenge is to integrate shortrun strategies with long-run directions. In the short run, hospitals are pressured to find immediate savings; in the midterm, planning with local and regional partners is required; and in long-term, vertical integration with other aspects of the health-care system is essential. This requires that highlevel planning be cautious in its approach. This process involves an external advisory council and external working groups, a MOH implementation secretariat and key planning partners (consisting of major stakeholders, district health councils and professional associations). The MOHs roles are: · to develop policies, identify standards and criteria to ensure consistent services; · to establish an appropriate funding model to support systems and facilitate change; and · to ensure appropriate planning of involved partners. The key principles of its planning objectives are: · Consistent policy and direction, regional coordination · Emphasis on quality improvement · Consistent standards · Equitable funding system that accounts for population needs; incentives for cooperation · Province-wide information systems. Objectives include: · Continuity of Care The benefit is improved patient care and involves acknowledging changing patient care needs and a move to community-based care. Linkages are required between different levels of care and to achieve effective follow-up. Tools of information technology will be integral to this concept. · Partnerships and Regional Coordination A variety of partnerships among providers will ensure that professional expertise is available everywhere in Ontario. · Building on Technological Advances The benefits of point-of-care and centralized testing will be assessed to promote economies of scale while maximizing the effectiveness of patient encounters within the system. Research and training are vital. · Maximizing Quality of Care Standards and benchmarks must be identified to foster improved surveillance and evaluation of the system. Information sharing will be introduced, and quality managementincluding accreditation and proficiency testingwill be enhanced. Directions mapped for the provinces laboratory services include identification of planning areas, the planning process itself, a reformed funding system, a quality management program that will be external to the MO H, and a common reporting and information system. An external working group chaired by Dr. Murray Treloar is investigating the development of a common coding system for laboratory tests (LOINC), which is HL7-compatible and will be integrated with other MOH information systems. This will allow the electronic transfer of data from laboratory service providers for planning, managerial initiatives, utilization studies and improvements. It will also allow patient-care information exchange and facilitate continuity of care. For the purpose of consultation, the MOH proposed nine planning areas, balancing geographic area and population. While Dawn acknowledged that some of these areas need redefining and that planning will likely occur in smaller communities within these areas, the original proposal was for nine areas: North West North East East Central East Central West South West 1 1 2 3 or more 1 1 Continued on page 5

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LPTP Newsletter

No. 191 November 12, 1996

Ontario Hospital Association Convention Session for Medical Technologists

In each area, the proposal suggested a role for the District Health Councils. Recognizing that each area of the province has different needs or unique issues, the Laboratory Services Implementation Secretariat conducted consultations (ten in total) in September 1996 in all areas. The purpose was to present the above planning objectives, and to elicit feedback. A total of 222 hospitals, 34 private laboratory companies, 13 public health laboratories, 36 District Health Councils and 42 public health units were invited to participate. A questionnaire was provided for participant feedback. As of October 22, 1996, 150 responses have been received. Major issues identified in the responses include difficulties with the planning process itself, existing regional programs that cross planning area boundaries, geographic areas not matching current service associations, social issues regarding patient versus care delivery flow, spectrum support of academic health science centres, and funding. Dawn concluded by presenting a list of considerations that must be addressed (e.g., integrated delivery and funding, specimen collection and transport, coordinated testing services, standardization, shared materials management, quality improvement and strategic management) for the planning process to stand the test of time and fit with models under development in other health care sectors. CMLTO Competency Assurance Program The Requirements and How MLTs Will Meet This Challenge Sheila Woodcock, Registrar Sheila began her presentation by stressing the role of the medical laboratory technologist (MLT) in ensuring the quality of laboratory services. She then provided some historical background and reviewed the complaints process. After outling the roles and requirements of both the employer and MLT, she provided a simple working definition of competence and described the competence assurance program. In her conclusion, she emphasized the importance of continual improvement. With the advent of the Regulated Health Professions Act (1991), the responsibility for quality of laboratory practice is shared by the MLT. According to Sheila, MLTs are individually accountable for their actions and thus responsible for acquiring necessary skills, improving performance and taking the initiative in becoming multiskilled. The CMLTOs activities encompass competence assessment. On its inception, the CMLTO established registration standards (minimum requirements) for education, clinical experience and initial examination. This was the first step in the process of establishing competence assessment. Next, the complaints and disciplinary committees were formed to direct punitive measures as necessaryin other words, dealing with the bad apple. Complaints can originate from the public or the profession. In all cases, the complaint must be recorded (usually in writing). At this time, the member is notified that a complaint is being investigated. The CMLTO must investigate all complaints and present them to the Complaints Committee. This may involve hiring a private investigator who works in concert with a member appointed to the investigation. Although some Colleges employ their own investigators, the CMLTO hires investigators on an ad hoc basis. Two cases requiring investigation have been handled so far. It is the responsibility of the Complaints Committee to ascertain whether a case goes to the Discipline Committee. In the past year and a half, the Complaints Committee has received complaints from the public regarding collection centre incidents (although these did not involve MLTs), alleged incompetence and alleged misconduct. The Act requires an employer to report dismissals for reasons of professional misconduct or incompetence, and employers appear to be aware of this requirement. In December 1996, the Discipline Committee will hear its first case. To comply with the requirements relating to competence, an employer must meet generally accepted operational standards and provide a supportive environment. An MLT must meet the required standards of practice and upgrade as needed. The CMLTO defines competence as the demonstration of current and relevant knowledge, skill and judgment in the practice of medical laboratory technology. All members are assumed to be competent unless proven otherwise. By January 1997, the CMLTO (and all other Colleges) must have a quality assurance program in place. This will shift the responsibility for demonstrating competence from an accuser to the individual. The program reflects the standards of practice that encompass knowledge, skill and judgment. Each member must complete the process once every two years. Piloted in the summer of 1996, the CMLTOs program consists of a professional portfolio that includes a career summary, documents activities in the past two years and allows the individual to determine his/her own needs for future development. Alternatively, the bench technologist may opt for a technical competence assessment, conducted in his/her workplace. Portfolios will be subject to random audit, and subsequently returned to the members. Any Continued on page 6

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LPTP Newsletter

No. 191 November 12, 1996

Ontario Hospital Association Convention Session for Medical Technologists

information submitted for quality assurance may not be used for any other purpose by the College (e.g., complaints or discipline). Sheila stated that the program will be available to all members soon. In summary, Sheila offered the following statement: Those who stop being better, stop being good. The Kingston Hospitals Laboratory Outreach Program An Example of Meeting the Restructuring Challenge David More, Manager, Clinical Laboratories of Eastern Ontario (CLEO) David described the Laboratory Outreach Program, Clinical Laboratories of Eastern Ontario (CLEO), operating out of Kingston and serving the communities of Trenton, Belleville, Picton, Napanee, Perth, Smiths Falls, Brockville and Winchester. He cited it as an example of an established network of services that meets many of the planning objectives of the Ministry of Healths Laboratory Services Restructuring, while demonstrating problems in the acceptance of the proposed planning areas in this region. CLEO is the name of the Laboratory Outreach Program operated by the diagnostic clinical laboratories at Kingston General Hospital and Hotel Dieu Hospital, in conjunction with the Department of Pathology at Queens University. It was formed in 1987 for the original purpose of organizing pickup and delivery of specimens and completed reports to contractual and noncontractual partners and clients. Since its inception, continuous quality improvement has been incorporated through the use of client satisfaction surveys, regular interactions with clients, and the provision of continuing education services. The client base for which reference laboratory services are provided includes community hospital laboratories in Trenton, Belleville, Picton, Napanee, Kingston, Perth, Smiths Falls and Brockville. Laboratory services are provided to the Canadian Forces Base in Kingston, Queens Student Health Services, MDS Laboratories, regional Correctional Services Canada institutions, Canadian Medical Laboratories, HospitalIn-Common Laboratories, Inc., and a large number of individual practising physicians in Kingston and Napanee. Medical consultation is offered to community hospital laboratories in Perth, smiths Falls, Napanee, Picton, Belleville and Kingston. Technical and laboratory management expertise are available to clients on request. In 1991, remote printing and on-line inquiry were instituted, with electronic reporting currently available at nine client sites. This offers the potential for same-day test reporting of referred tests. STAT testing is available. Virtually all referred tests are performed at the Kingston Hospitals, with a few referred to Hospitals-In-Common Laboratory, Inc., Toronto, and the Public Health Laboratories. The total population served is approximately 500,000. David stressed that this program supports local testing and strengthens scientific, technical and managerial expertise for clients. He noted some of the unique features it offers, such as a regional anticoagulant monitoring system (RAMS). He also pointed out that this program has identified some of the perceived problems associated with the proposed restructuring initiative namely, their limited success in obtaining group purchasing integration and joint ventures between public and private providers. He did, however, state that this program has achieved integration of consultative services, academic support, an information network and specimen collection, and some positive working relationships with private sector, proving that such endeavours can be successful. David concluded by stating that there is a demonstrated opportunity for laboratory services to provide innovative initiatives for Ontarios broader health-care sector.

Ontario Society of Medical Technologists names new president

Alexandra Clegg was recently elected president of the Ontario Society of Medical Techologists (OSMT). Alex is currently the Education Coordinator, Hamilton Civic Hospitals. Congratulations Alex!

CORRECTION Coagulation K-9609 Survey Report

A typographical error occurred on the Survey Report for Coagulation Survey K-9609. PT/INR NOTE #9, last sentence should read: K-9609-C and K-9607-E were also from a single lot number. LPTP regrets this error.

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