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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550 CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual

Microbiology Laboratory Specimen Collection and Transport

Doc. No. BMP ­ 0 Date: 3/25/2010

Rev: 0 Page 1 of 36

CLINICAL MICROBIOLOGY SPECIMEN COLLECTION AND TRANSPORT

Title Laboratory Director Quality Systems Manager Supervisor

Name Rodger Silletti, Ph.D. Maria SuarezAlcivar MD Connie Iannucci

Telephone # 516-5721202 516-5721208 516-5721231

Signature of Approval

Date

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 2 of 36

Microbiology Laboratory Specimen Collection and Transport

REVISION RECORD

Date

Revision (indicate page #)

Name of Responsible Person

Description of Change (specify topic)

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 3 of 36

Microbiology Laboratory Specimen Collection and Transport

ANNUAL REVIEW

PROCEDURE

UNIVERSAL ACCESSION INFORMATION POSTMORTEM SPECIMENS LOWER RESPIRATORY SPECIMENS SPINAL & BODY FLUID SPECIMENS STOOL & GASTROINTESTINAL SPECIMENS WOUND & SKIN SPECIMENS EYE SPECIMENS THROAT & NASOPHARYNGEAL SPECIMENS SPECIMENS FOR NEISSERIA GONORRHOEAE BLOOD SPECIMENS FOR CULTURE URINE SPECIMENS BLOOD SPECIMENS FOR IMMUNOLOGY URINE FOR GC/CT NAAT FOOD FOR MICROBIOLOGY TB BLOOD TEST (QUANTIFERON) ORASURE (HIV)

WRITTEN REV

3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010 3/31/2010

REV

REV

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 4 of 36

Microbiology Laboratory Specimen Collection and Transport

Table of Contents

UNIVERSAL ACCESSION INFORMATION POSTMORTEM SPECIMENS LOWER RESPIRATORY SPECIMENS CEREBROSPINAL AND BODY FLUID SPECIMENS STOOL AND GASTROINTESTINAL SPECIMENS WOUND AND SKIN SPECIMENS EYE SPECIMENS THROAT AND NASOPHARYNGEAL SPECIMENS SPECIMENS FOR NEISSERIA GONORRHOEAE BLOOD SPECIMENS FOR CULTURE URINE SPECIMENS FOR CULTURE BLOOD SPECIMENS FOR IMMUNOLOGICAL TESTING URINE SPECIMENS FOR GC/CT NAAT TESTING FOOD SAMPLES FOR MICROBIOLOGY TB BLOOD TEST SPECIMENS (QUANTIFERON) ORASURE SPECIMENS FOR HIV TESTING DISTRIBUTION LIST 5 7 9 11 13 15 17 19 21 22 25 26 29 30 32 34 36

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 5 of 36

Microbiology Laboratory Specimen Collection and Transport

Universal Accession Information Requisition forms: 1) The NC PHL Clinical Requisition Form can be found at the following URL: http://www.nassaucountyny.gov/agencies/Health/labs.html. 2) Each specimen must be accompanied by a printed requisition form containing all patient and submitter information including; a) full patient name b) unique patient identification number (may be birth date) c) address d) date of birth e) sex f) ethnicity (Hispanic/Latino) g) race h) physician name, address and phone number i) specimen type (swab, fluid, tissue, etc) j) source (specific body site) h) date and time of collection NOTE: For HIV testing, the disclaimer on the bottom left of the form must be signed indicating that informed consent has been obtained. NOTE: If an HIV test is ordered, you must indicate on the bottom right of the form if a rapid HIV test device was used and if the result was positive or negative.

A separate requisition form must accompany each specimen except as follows; Immunology: 1) All hepatitis tests can be ordered on a single, separate requisition form and can be performed with one 10cc speckled red top tube of blood (serum separator tube). 2) All viral serology tests (rubella, measles, mumps, varicella) can be ordered on a single, separate requisition form and can be performed with one 10cc speckled red top tube of blood.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 6 of 36

Microbiology Laboratory Specimen Collection and Transport

3) FOR HIV TESTING a) HIV tests can be ordered on a single, separate requisition form and can be performed with one 7cc or 10cc speckled red top tube of blood or Orasure. b) For OraSure specimens submitted in conjunction with the NYS DOH Bureau of Direct Program Operations, see ORASURE SPECIMENS FOR HIV TESTING. 5) TB Blood Testing: The questions (reason for test, PPD status, and therapeutic status) must be answered. See TB BLOOD TEST SPECIMENS for collection and transport of specimens for the Quantiferon test. 6) STD Testing: a) Chlamydia/GC tests (urine) must be ordered on a single, separate requisition form and can be performed on urine. b) Syphilis tests (blood) must be ordered on a single, separate requisition form and can be performed on a 10cc or 7cc speckled top tube or 5cc of CSF (VDRL only performed on CSF).

Bacteriology, Mycobacteriology, Parasitology: 1) Each different specimen requires a separate requisition form Specimen Labeling: Each specimen received in the laboratory must be satisfactorily labeled. The information must be written on, or the electronic label must be affixed to, the container and not the lid of any specimen. If agar plates are received, the label or information must be on the half that contains the agar. The specimen container must be labeled with the patient's name, ID number, and date of collection as it appears on the requisition form. Do not wrap the requisition form around the specimen container/blood tube or allow the form to come in contact with the specimen. The requisition form must be physically separated from the specimen container and its contents.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 7 of 36

Microbiology Laboratory Specimen Collection and Transport

Postmortem Specimens

Specimen: Autopsy specimens may consist of swabs, agar plates and broths inoculated at the site, blocks of tissue received in sterile sputum containers, or microscope slides on which the specimen has been applied with a swab or on which impression smears have been made. Specimens may include heart blood in blood culture bottles, heart tissue, spleen tissue, liver tissue, both lungs, and may include any muscle involved in a local abscess or inflammation.

Requisition: The appropriate requisition must accompany any specimen. Collection: Appropriately collected specimens include the following: 1) Tissue in a sterile sputum container without a liquid preservative or growth media, and without gauze or other material surrounding the specimen. 2) Chocolate agar, Blood agar, MacConkey agar, a thioglycollate broth, Bactec bottles, which have been inoculated at the site of the autopsy. 3) Microscope slides for Gram or AFB stain. 4) Culture swab When tissue is submitted, the prosector should obtain at least a 6 cm3 portion of tissue with one serosal or capsular surface intact. The tissue should then be placed in a sterile, sealed plastic container and sent to the laboratory for immediate processing (within 2 hours) or storage at 5C up to 48 hours. The body of the container, not the lid, should bear the name, the date, and the type of specimen. Transport: All specimens from autopsy must be received in the laboratory within two hours or held at 5C for up to 24 hours until processing can be accomplished. Swabs should be maintained at room temperature (25C) until processing can be accomplished

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 8 of 36

Microbiology Laboratory Specimen Collection and Transport

(within 48 hours). Agar plates and broths should received within 2 hours or incubated appropriately until transport (Chocolate agar in carbon dioxide, the rest in ambient air, both at 35C).

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) 2) 3) 4) 5) 6) 7) 8) 9) Wrong requisition accompanies specimen Requisition not completed properly No date and/or time of specimen collection Required demographic information absent or illegible Specimen source incorrect or not marked Specimen QNS for tests requested No specimen accompanies requisition No name on specimen Media received are outdated or damaged

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 9 of 36

Microbiology Laboratory Specimen Collection and Transport

Lower Respiratory Specimens

Specimen: Lower respiratory specimens include expectorated or induced sputum collected in a sterile sputum container, broncial washings collected in a sterile trap, a bronchial brush submitted in thioglycollate broth, bronchial lavage, and a transtracheal aspirate. Microscope slides may accompany any of the above specimens.

Requisition: Each specimen must be accompanied by a Clinical Microbiology requisition form.

Collection: Appropriately collected specimens include the following: 1) Expectorated or Induced sputum in a sterile sputum container without alcohol or other preservative or gauze. 2) Bronchial brush received in Thioglycollate broth. 3) Bronchial wash or lavage received in a sterile trap. 4) Transtracheal aspirate in a sterile trap.

Transport: All specimens should be transported to the laboratory within three hours or kept at 2C to 10C for up to 18 hours prior to receipt in the laboratory.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 10 of 36

Microbiology Laboratory Specimen Collection and Transport

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) Wrong requisition accompanies specimen Requisition not completed properly No date and/or time of specimen collection Required demographic information absent or illegible Specimen source incorrect or not marked Specimen QNS for tests requested No specimen accompanies requisition No name on specimen Media received are outdated or damaged Expectorated sputum > 3 hours old when received in the laboratory and not refrigerated Specimen > 18 hours old when received in the laboratory

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 11 of 36

Microbiology Laboratory Specimen Collection and Transport

Spinal and Body Fluids

Specimen: Cerebrospinal fluid specimens will be received in sterile containers. There is usually between 0.5 ml and 3.0 ml of specimen per tube. Synovial fluid specimens, peritoneal fluid specimens, and pleural fluid specimens may also be received in these tubes, but may also be received in a sterile sputum container. Peritoneal fluid specimens and pleural fluid specimens for anaerobic investigation should be received in Blood bottles.

Requisition: CSF specimens, joint fluid specimens, peritoneal fluid specimens, and pleural fluid specimens must be submitted with a Microbiology form. Collection: Because CSF, pleural fluid, and synovial fluid are obtained by skin puncture, the same collection methods used for blood cultures apply. Prior to skin puncture, an iodophor or 2% tincture of iodine should be used to prepare the site of needle insertion. It should be recognized that iodophores are slow-acting agents and when used should be allowed to dry, as activation of the disinfectant is through the drying process. Two percent tincture of iodine produces its effect within 1 to 2 minutes after application. The probability of detecting an organism in a specimen by culture is generally related to the amount of specimen cultured , and the administration of antimicrobial agents previous to collection . Generally 1 - 2 ml of specimen is sufficient to detect bacteria. When fungal or mycobacterial etiology is suspected, at least 3 ml of specimen should be cultured for EACH of these entities, as these organisms are usually present in smaller numbers than bacteria. The success of culturing tubercle bacilli from one specimen is approximately 50%, with two specimens it increases to 83% if three ml are used for culture. Transport: Specimens should be transported to the laboratory immediately and must not be refrigerated or frozen.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 12 of 36

Microbiology Laboratory Specimen Collection and Transport

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows:

1) 2) 3) 4) 5) 6) 7)

Wrong requisition accompanies specimen Requisition not completed properly No date and/or time of specimen collection Required demographic information absent or illegible Specimen source incorrect or not marked Specimen QNS for tests requested No specimen accompanies requisition

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 13 of 36

Microbiology Laboratory Specimen Collection and Transport

Stool and Gastrointestinal Specimens

Specimen: A 1 to 2 gm sample of feces is more than sufficient for culture. On patients, particularly neonates, who cannot provide a stool sample, a swab passed 3 to 5 cm beyond the anal sphincter can be submitted in Cary-Blair transport medium. Generally, three specimens collected on different days are necessary to detect or rule out the presence of an intestinal pathogen. Under certain circumstances, vomitus and duodenal contents may be submitted for isolation of bacteria causing diarrhea. Requisition: All stool samples submitted for bacterial pathogens must be accompanied by a Microbiology requisition. Collection: Specimens for bacterial agents of infectious diarrhea may be submitted in a clean, waxed cardboard container tightly capped. Feces can be collected in a sterile bedpan; however, the specimen is unsatisfactory if there is any residual soap, detergent, or disinfectant left in the pan or if there is contamination by urine. Specimens can be collected from the toilet if paper toweling has been placed on the surface of the water and the specimen retrieved from the paper toweling without urine contamination. NOTE: Toilet paper should not be used for collection of stool specimens because it has usually been impregnated with bismuth salts in the manufacturing process and a number of pathogens in feces are inhibited or killed by these salts. Swabs are satisfactory if submitted in Cary-Blair transport medium with a phenol red pH indicator. Most Salmonella or Shigella infections are detected in two or three specimens. To rule out the carrier state, three negative specimens in a row are necessary. Transport: Specimens must be received in transport media in the laboratory within 48 hours. After this, the change in temperature causes a drop in pH which is detrimental to the survival of shigellae and an appreciable number of salmonellae. If there will be a delay of more than three hours the specimen must be received in Cary-Blair transport medium with phenol red. One gram of feces should be mixed well with 10 ml Cary-Blair medium, and if the indicator is yellow when received, the pH is too low and the specimen is

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 14 of 36

Microbiology Laboratory Specimen Collection and Transport

unsatisfactory. Though a phosphate buffer with glycerol is suitable for shigellae and salmonellae, it is not sufficient to preserve Campylobacter sp. Specimens received in transport medium can be accepted by the laboratory up to 48 hours after collection as long as the indicator is not yellow. NOTE: Specimens for parasitology or AFB must not be received in specimen transport medium. Specimens for parasitology must be received well-mixed in Formalin and PVA collection/transport tubes and specimens for AFB must be received in a clean, waxed cardboard container within 3 hours or refrigerated at 2-8C for up to 48 hours.. No method exists for properly holding specimens prior to processing if not received in transport medium; therefore, such specimens must be processed immediately upon receipt or mixed with transport medium and held at room temperature (25C) until processing can be accomplished. It must be remembered that the three hour limit for satisfactory specimens includes the time it takes to get the specimen to the laboratory. Under no circumstances can these specimens be incubated.

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) Wrong requisition accompanies specimen 2) Requisition not completed properly 3) No date and/or time of specimen collection 4) Required demographic information absent or illegible 5) Specimen source incorrect or not marked 6) Specimen QNS for tests requested 7) No specimen accompanies requisition 8) Specimen not in transport medium over 3 hours old 9) Specimen in transport medium over 48 hours old 10) AFB sputa not refrigerated over 3 hours old 11) AFB sputa over 48 hours old 12) Parasitology stool specimen not received in formalin/PVA

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 15 of 36

Microbiology Laboratory Specimen Collection and Transport

Wound and Skin Specimens

Specimen: Wound specimens are most frequently received as culture swabs in transport medium; however, tissue, fluid or pus aspirated with a syringe (or dialysis fluid), and inert objects that have been in contact with the vascular system or other internal cavities (e.g. CVP catheter tips) may also be received. Fluid specimens may be received, in anaerobic transport vials, in tubes of thioglycollate broth, in sterile screw cap containers, or in blood culture bottle sets. Inert objects may be received in sterile sputum containers or in thioglycollate broth. Tissue is usually received in sterile sputum containers without gauze or other wrapping material. Specimens may be derived from the skin and subcutaneous tissue, muscle tissue, intra-abdominal and thoracic areas, head and neck areas, mouth, and external ear. Eye specimens are discussed in a separate section (see Eye Specimens), as are Throat specimens (see Throat Specimens).

Requisition: All wound specimens must be received with an appropriate requisition. The specific source of the wound should be indicated. Collection: Topical wound specimens should be collected with a moist swab because, when moistened in sterile water or saline, the swab picks up a large number of organisms. Specimens from deep closed wounds or abscesses are best collected by aspiration with a needle and syringe. It is important that the skin or wound surface be treated with alcohol and an iodophor in order to reduce the number of surface microorganisms before aspiration of the wound. The best procedure is to transport the syringe with the needle in place and corked directly to the laboratory after expelling all the air pockets which may be in the syringe. If transport of the syringe is not practical, the contents can be expelled into an anaerobic transport vial or a blood culture bottle set. Tissue and inert materials may be submitted in sterile sputum containers without gauze or other wrapping material or in thioglycollate broth if there is a chance of drying.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 16 of 36

Microbiology Laboratory Specimen Collection and Transport

Transport: Culture swabs must be submitted in transport media. These can be maintained at room temperature (25C) for up to 48 hours prior to processing. Swabs in transport media must not be refrigerated or incubated. Tissue in sterile sputum containers must be received within two hours, or refrigerated for up to 18 hours prior to processing. Fluid submitted in a syringe should be received within two hours. If processing cannot be accomplished immediately, the contents of the syringe should be inoculated to a blood culture bottle. Inert materials submitted in broth need only be incubated at 35C in ambient air, but these materials submitted in sterile sputum containers must be received and placed in a thioglycollate broth within 30 minutes. Specimens already inoculated to agar media or broths when received should be promptly incubated in the appropriate environment until processing can be accomplished. Prior to storage, make sure the media is appropriately labeled.

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) 2) 3) 4) 5) 6) 7) 8) 9) Wrong requisition accompanies specimen Requisition not completed properly No date and/or time of specimen collection Required demographic information absent or illegible Specimen source incorrect or not marked Specimen QNS for tests requested No specimen accompanies requisition Specimen not in transport medium over 3 hours old Specimen in transport medium over 48 hours old

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 17 of 36

Microbiology Laboratory Specimen Collection and Transport

Eye Specimens

Specimen: Eye specimens are usually submitted on culture swabs. Occasionally a corneal scraping will be directly applied to agar and the laboratory will receive a Chocolate agar plate and/or a Blood agar plate. Requisition: Requests for bacterial culture are made on a Microbiology requisition slip. Collection: Swab specimens should be collected with a moist culture swab. Calcium alginate and cotton swabs have inhibitory activity to certain bacteria and Chlamydia, and have been shown to inactivate herpes simplex type 2 virus and should not be used. All swab specimens should be submitted in transport medium. Corneal scrapings can be inoculated to Blood agar or Chocolate agar plates at the collection site, and submitted to the laboratory. Rarely, LJ slants will be inoculated at the site with eye scrapings and submitted with a Microbiology requisition slip. Certain topical anesthetics may have a deleterious effect on microorganisms. A study by Badenoch and Coster compared the inhibitory and cidal activity of eight topical anesthetics in vitro. Their studies suggest that topical anesthetics with preservatives are more inhibitory to bacteria than those without preservatives. Therefore, it is important that only topical anesthetics without preservatives be used prior to specimen collection. Transport: Culture swabs in transport media are satisfactory up to 48 hours after collection. They may be maintained at room temperature but should not be refrigerated or incubated. Many pathogens such as Neisseria sp. and Haemophilus are susceptible to cold. Specimens submitted on media must be placed in the respective incubator (ambient air or CO2) immediately upon receipt, whether accessioning can take place at that time or not.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 18 of 36

Microbiology Laboratory Specimen Collection and Transport

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) 2) 3) 4) 5) 6) 7) 8) 9) Wrong requisition accompanies specimen Requisition not completed properly No date and/or time of specimen collection Required demographic information absent or illegible Specimen source incorrect or not marked Specimen QNS for tests requested No specimen accompanies requisition Specimen not in transport medium over 3 hours old Specimen in transport medium over 48 hours old

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 19 of 36

Microbiology Laboratory Specimen Collection and Transport

Throat and Nasopharyngeal Specimens

Specimen: Generally swabs which have been vigorously rubbed against the tonsillar areas and the posterior pharynx are submitted, either in transport media or dry in the original swab wrapper. If the isolation of specific organisms is requested, media may be inoculated at the collection site. In these cases Thayer-Martin plates (for N. gonorrhoeae) may be received. Requisition: All throat or nasopharyngeal specimens will be received with a Microbiology requisition. Requests for traditional "Throat" culture (Group A strep only) or for specific investigations such as S. aureus may be made.

Collection: For pharyngitis caused by Group A streptococci, a dacron swab vigorously rubbed against the posterior pharynx and tonsillar areas may be submitted dry or in transport media. Requests for Neisseria (GC) should be received on the appropriate media (Thayer-Martin plates), and other bacteria should be received on appropriate media or in transport media. Nasopharyngeal swabs can be received in transport media or can be used to inoculate appropriate media at the site of collection. Gram stains for streptococcal pharyngitis are not done, and microscope slides received for this purpose are rejected.

Transport: Dry swabs for streptococcal pharyngitis and swabs in transport media can be received in the laboratory up to 48 hours after collection. Specimens should not be refrigerated or incubated, but should be maintained at room temperature (25C) during transport and until processing can be accomplished. Agar media must be received in the laboratory within three hours of collection and must be appropriately incubated within that time frame. Agar media should never be refrigerated.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 20 of 36

Microbiology Laboratory Specimen Collection and Transport

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) 2) 3) 4) 5) 6) 7) 8) 9) Wrong requisition accompanies specimen Requisition not completed properly No date and/or time of specimen collection Required demographic information absent or illegible Specimen source incorrect or not marked Specimen QNS for tests requested No specimen accompanies requisition Specimen not in transport medium over 3 hours old Specimen in transport medium over 48 hours old

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 21 of 36

Microbiology Laboratory Specimen Collection and Transport

Specimens for Neisseria Gonorrhoeae

Specimen: Transgrow bottles, JEMBEC plates and sometimes, NYC Media or ThayerMartin plates inoculated at the site of collection will be submitted. Infrequently a swab in transport medium is received by the laboratory. Dry swabs without transport medium are unsatisfactory. Specimens received include cervical, vaginal, urethral, throat, rectal, and, occasionally, prostatic fluid. Requisition: A Microbiology requisition should accompany all requests for GC (gonococcal) investigation. The GC source is usually indicated on the requisition, but other sources such as Throat or Wound may be checked with GC specified. Collection: Specimens are collected and inoculated to Transgrow bottles or JEMBEC plates at the site of collection. Swabs in transport media or inoculated Thayer-Martin, Martin-Lewis, or NYS Media, while not ideal, are satisfactory. Transport: Swabs in transport media for GC culture (containing CO2) can be received in the laboratory up to 48 hours after collection. Specimens should not be refrigerated or incubated, but should be maintained at room temperature (25C) during transport and until processing can be accomplished. Agar media, must be received in the laboratory within three hours of collection and must be appropriately incubated within that time frame. Agar media should never be refrigerated. Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) Wrong requisition accompanies specimen 2) Requisition not completed properly 3) No date and/or time of specimen collection 4) Required demographic information absent or illegible 5) Specimen source incorrect or not marked 6) No specimen accompanies requisition 7) Specimen not in transport medium over 3 hours old 8) Specimen in transport medium over 48 hours old 9) Specimen refrigerate

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 22 of 36

Microbiology Laboratory Specimen Collection and Transport

Blood Specimens

Specimen: Blood specimens for bacteria will be received already inoculated to blood culture bottles; one for anaerobic investigation and one for aerobic investigation or one Oxoid signal bottle for aerobic and anaerobic investigation. Blood specimens for AFB should be received in a yellow top signal tube. Requisition: Blood specimens are submitted with a Microbiology requisition with "BLOOD" indicated as the source. Requests for MYCOBACTERIA require special handling; please call the laboratory prior to specimen collection. Collection: To reduce the contamination of blood cultures by skin flora and environmental contaminants, prior to skin puncture the site should be cleaned with 70% alcohol and disinfected with an iodophor or 2% tincture of iodine. This should be used to prepare the site of needle insertion, the tips of any fingers used for palpation unless new gloves are used, and the rubber septum on each blood culture bottle. It should be recognized that iodophores are slow-acting agents and when used should be allowed to dry, as activation of the disinfectant is through the drying process. Two percent tincture of iodine produces its effect within 1 to 2 minutes after application.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 23 of 36

Microbiology Laboratory Specimen Collection and Transport

When to draw blood for culture is often dictated by the clinical circumstances; in acute infections therapy should not be withheld for specimen collection. In this situation, two blood samples each from two venipuncture sites should be taken immediately. In less urgent situations it has been recommended that the blood be drawn before the patient undergoes a chill or when the patient is undergoing a rise in fever, but this is rarely practicable. Washington reported that three sets of blood cultures over a 24 hour period will detect the etiologic agent in 99% of cases. He suggested an arbitrary one hour interval between cultures. Others have recommended intervals of 30 minutes and simultaneously drawn paired blood samples from the left and right arms. The "paired" blood culture recommendation has generated some confusion because it is though to mean two bottles from the same site in some hospitals whereas in other hospitals it is thought to mean two separate blood culture sets (four bottles) from the same site. The correct interpretation is that a "paired" culture is a pair of bottles, one for aerobic investigation and one for anaerobic investigation. Blood drawn from a single venipuncture site at one time constitutes a single blood culture whether two, four, six, or more bottles are inoculated. For bacteria, three blood cultures should be drawn on each patient suspected of having septicemia. Whether these are drawn one hour apart, or whether two are drawn simultaneously from separate venipuncture sites, depends upon the clinical condition. The volume of blood collected depends upon the age of the patient and the volume of broth in the bottle. To achieve a 1:10 dilution of blood for bacterial and fungal culture, at least 5ml of blood should be inoculated to each 50 ml bottle (10ml venipuncture) for adults and 2ml to 3ml of blood should be inoculated to each blood culture bottle (4ml to 6ml venipuncture) for pediatric patients. If less than 4ml to 6ml of blood is obtained from pediatric patients, the entire amount should be inoculated for aerobic investigation only. For recovery of mycobacteria, 5ml of blood should be inoculated to each yellow top tube. Transport: Inoculated blood culture bottles should be transported to the laboratory within three hours, though overnight incubation at room temperature (25C) is not harmful. Blood culture bottles should never be refrigerated or subjected to temperatures below 22C during transport.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 24 of 36

Microbiology Laboratory Specimen Collection and Transport

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) 2) 3) 4) 5) 6) 7) Wrong requisition accompanies specimen Requisition not completed properly No date and/or time of specimen collection Required demographic information absent or illegible Specimen source incorrect or not marked Specimen QNS for tests requested No specimen accompanies requisition

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 25 of 36

Microbiology Laboratory Specimen Collection and Transport

Urine Specimens

Specimen: Urine specimens may be obtained by midstream collection of voided urine, aspiration by suprapubic tap (needle aspiration of bladder urine), cystoscopy (catheterization of the ureters), or aspiration from a Foley (or urethral) catheter. Requisition: Each specimen must be accompanied by a Microbiology requisition.

Collection: Appropriately collected specimens include the following: 1) 2) 3) Liquid urine received in a sterile container. Liquid urine received in a boric acid collection tube. Liquid urine received in special collection tubes for cystoscopic specimens. Liquid urine received in a sterile tube or syringe from suprapubic aspirates.

4)

Transport: All liquid specimens should be transported to the laboratory within two hours, or refrigerated on collection and transported on ice within 6 hours. Uricults should be incubated in ambient air at 35oC immediately upon receipt. Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) Wrong requisition accompanies specimen 2) Requisition not completed properly 3) No date and/or time of specimen collection 4) Required demographic information absent or illegible 5) Specimen source incorrect or not marked 6) Specimen QNS for tests requested 7) No specimen accompanies requisition 8) Liquid urine > 2 hours old not received on ice 9) Uricult received filled with urine or media separated from the paddle

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 26 of 36

Microbiology Laboratory Specimen Collection and Transport

Blood Specimens for Immunology

Hepatitis, Measles, Mumps, Rubella, Varicella, Quantiferon, Syphilis, HIV Specimen: Blood must be collected in a 7 or 10cc speckled top tube (serum separator) using the same technique as for Blood Specimens. Oral Fluid must be collected using the Orasure collection device. Requisition: Each specimen must be accompanied by a Microbiology requisition. See the section on Requisition Forms under Universal Accession Information. Collection: Appropriately collected specimens include a 7cc or 10cc speckled top (serum separator) vacutainer tube. Transport: Blood tubes must be transported to the laboratory promptly after collection or centrifuged to separate serum and stored at 2C to 8C prior to testing (see chart below for holding times). If testing cannot be completed within the holding time, serum specimens must be frozen at -20C. A frost-free freezer must not be used because it may allow the specimen to undergo repeated freeze-thaw cycles which may cause unreliable results.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 27 of 36

Microbiology Laboratory Specimen Collection and Transport

Holding times for various tests Test must be performed within the holding time to avoid rejection of the specimen. Please consider the testing schedule when scheduling specimen collection and transport. HOLDING TIME (TIME WITHIN WHICH THE TEST MUST BE PERFORMED) 7 days 2 days 2 days 2 days 2 days 2 days 7 days 7 days 21 days 2 days 2 days 2 days 2 days 2 days 5 days

TEST HBsAg HBsAb HB core Total HB core IgM HA IgM HA Total HCV HIV (blood) HIV (oral fluid)

TEST SCHEDULE Wednesday Wednesday Wednesday Wednesday Wednesday Wednesday Wednesday Wednesday Wednesday

SPECIMEN Blood Blood Blood Blood Blood Blood Blood Blood Oral Fluid in Orasure Collection Device Blood Blood Blood Blood Blood Blood

Varicella IgG Measles IgG Mumps IgG Rubella IgG Rubella IgM Syphilis

Tuesday Tuesday Tuesday Tuesday Tuesday Daily (Mon-Fri)

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 28 of 36

Microbiology Laboratory Specimen Collection and Transport

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) Wrong requisition accompanies specimen 2) Requisition not completed properly 3) No date and/or time of specimen collection 4) Non-serum specimen received after 3 hours 5) Specimen received after the holding time or not in time to perform the test within the holding time. 6) Hemolyzed blood specimens 7) Required demographic information absent or illegible 8) Specimen source incorrect or not marked 9) Specimen QNS for tests requested 10) No specimen accompanies requisition

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 29 of 36

Microbiology Laboratory Specimen Collection and Transport

Urine Specimens for GC/CT NAAT

Using BD ProbeTec Urine Preservative Transport Kit (UPT) Collection The patient should not have urinated for at least 1 h prior to specimen collection. Collect the specimen in a sterile, preservative-free specimen collection cup. The patient should collect the first 15-60 mL of voided urine (the first part of the streamnot midstream) into a urine collection cup. Cap and label the urine collection cup with patient identification and date/time collected. Urine Transfer to UPT NOTES: Urine should be transferred from collection cup to the UPT within 8 h of collection provided the urine has been stored at 2-30ºC. Urine can be held for up to 24 h prior to transfer to the UPT provided that the urine has been stored at 2-8ºC. Wear clean gloves when handling the UPT and the urine specimen. If gloves come in contact with the specimen, immediately change gloves to prevent contamination of other specimens. After the patient has collected the urine sample, label the urine collection cup. Open the Urine Preservative Transport Kit and remove the UPT and the transfer pipette. Label the UPT with the patient identification and date/time collected. Hold the UPT upright and firmly tap the bottom of the tube on a flat surface to dislodge any large drops from inside the cap. Repeat if necessary. Uncap the UPT and use the transfer pipette to transfer urine into the tube. The correct volume of urine has been added when the fluid level is between the black lines on the fill window on the UPT label. This volume corresponds to approximately 2.5 - 3.45 mL of urine. DO NOT overfill or under fill the tube. Discard the transfer pipette. NOTE: The transfer pipette is intended for use with a single specimen. Tighten the cap securely on the UPT. Invert the UPT 34 times to ensure that the specimen and reagent are well mixed. UPT Storage and Transport Store and transport urine specimens in UPT at 2-30ºC and transport to the laboratory within 30 days of collection. Specimens may be stored at -20°C for up to two months.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 30 of 36

Microbiology Laboratory Specimen Collection and Transport

Food Samples for Microbiology

Requisition Form: 1) The NC PHL Food Microbiology Requisition Form (NCPHL109) can be found at the following URL http://www.nassaucountyny.gov/agencies/Health/labs.html. 2) Print the Requisition Form and complete it in ink. 3) Each sample must be accompanied by a separate requisition form containing all required information including; sample description, date and time of collection, and the name and address of the sample location. 4) For the sample matrix, check all that apply. Indicate the reason for submission by checking one entry for Outbreak (include number if available), Routine Screening, or specify Other. 5) Complete the Submitter information. If NCDOH Environmental Protection, check the appropriate box and include the Contact Name, phone and fax number, and email address so that we can readily contact you if there is a problem. 6) Do not wrap the requisition form around the specimen container or allow the form to come in contact with the specimen. Specimen Collection and Transport: 1) Collect specimens in clean, dry, leak proof, wide mouth, sterile containers of sufficient size to safely transport the sample. Avoid glass containers. Whirl-pack bags can be used for solid samples but not for liquid samples. Collect samples using aseptic technique and make sure the primary container is sealed properly. 2) Place each container in a zip lock plastic bag and seal properly; protect the sample from contamination by water or ice. 3) Be sure to collect adequate amounts of the sample. At least 25 grams per test requested; 8 ounces (~ 225gm) for all tests). 4) If multiple samples are obtained, pack each separately and include a separate requisition form for each sample. Do not combine individual samples. 5) Deliver each sample to the laboratory as soon as possible. Maintain the sample at the temperature at which it was collected except that perishable food should be refrigerated and kept cold during transport if collected at room temperature. 6) Deliver specimens to the Nassau County Department of Health Public Health Laboratory at 209 Main Street, Hempstead. Call 516-572-1202 prior to collecting the specimen(s) to assure that the lab is ready to receive them. Tests: 1) Tests are performed on the day of receipt if received prior to 10am. 2) Screening (Presumptive) Test Results for Salmonella, Listeria, and Camplyobacter are generally complete 3 days after receipt in the laboratory and Confirmatory Test Results are generally complete 5 days after receipt.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 31 of 36

Microbiology Laboratory Specimen Collection and Transport

3) Screening and Confirmatory Test Results for E. coli O157:H7 are generally complete 2 days after receipt of the sample in the laboratory. 4) Test Results for Staphylococcal Enterotoxin are generally complete 2 days after receipt of the specimen in the laboratory.

Each sample must be accompanied by a Food Microbiology Requisition Form (NCPHL109). http://www.nassaucountyny.gov/agencies/Health/documents/MicrosoftWordFoodMicrobiologyRequisitionFormNCPHL109.pdf

Criteria for Rejection: Specimens are rejected on the basis of incomplete, absent, or incorrect requisitions or for inappropriate, inadequate, or unsatisfactory specimens, as follows: 1) 2) 3) 4) 5) 6) Wrong requisition accompanies specimen Requisition not completed properly No date and/or time of specimen collection Specimen source incorrect or not marked Specimen QNS for tests requested No specimen accompanies requisition

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 32 of 36

Microbiology Laboratory Specimen Collection and Transport

TB BLOOD TEST (QUANTIFERON)

(PLEASE CALL 516-572-1202 FOR MORE INFORMATION) Requisition forms: 7) The Requisition Form can be found at the following URL http://www.nassaucountyny.gov/agencies/Health/labs.html. If you are unable to use the on-line form, print out and complete the manual entry Requisition Form NCPHL408-3A being sure to include all requested information. 8) Follow the instructions on the NC PHL Clinical Specimen Submission Requirements document (available at the above URL) to complete the requisition form. Check the "Quantiferon" box and indicate Reason for Test, PPD Status (and year of test if positive), and check the appropriate box for Antituberculous drugs. This information is required to perform the test. Specimen: 1) Blood for the Quantiferon test must be collected in the special In-Tube 3-tube system supplied by the Nassau County Public Health Laboratory (PHL). Please call 516-572-1202 for collection tubes. a. In-Tube: collect 1ml of blood by venipuncture directly into each of the three collection tubes (grey cap, red cap, and purple cap). i. As the tubes fill slowly, keep the tube on the needle for 2 to 3 seconds once it appears to have completed filling to ensure the correct volume has been drawn. ii. The black mark on the side of the tube indicates the fill level, and the level of blood must be close to this indicator line. iii. If a butterfly needle is used, a "purge" tube must be used to ensure that the tube is filled with blood before attaching Quantiferon TB Gold tubes. iv. Once filled, tubes must be vigorously shaken up and down 10 times to ensure that the entire inner surface of the tube has been coated with blood. b. The tubes should be held at room temperature (17C ­ 27C) and transported to the laboratory within 16 hours of collection. 2) The Nassau County PHL does not have phlebotomy services. Please call the laboratory at 516-572-1202 when the patient has arrived at your facility for venipuncture so that the laboratory can schedule the specimen pick-up as soon as possible.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 33 of 36

Microbiology Laboratory Specimen Collection and Transport

3)

4)

Specimens must be picked-up by the Nassau County PHL by 2:00pm at the latest or delivered to 209 Main Street by 2:30pm on Monday, Tuesday, Wednesday, or Thursday, except for Nassau County Holidays and weekdays prior to Nassau County Holidays. The test result will be reported the day after pick-up.

Quantiferon Test Uses and Limitations: For proper use and interpretation of the Quantiferon TB Blood test please see the "Guidelines for Using the Quantiferon®-TB Gold Test for Detecting Mycobacterium tuberculosis Infection, United States" and the "Quantiferon-TB Gold Fact Sheet" available on the laboratory website and at the following URL http://www.cdc.gov/search.do?queryText=Quantiferon&action=search or call 516-572-1202.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 34 of 36

Microbiology Laboratory Specimen Collection and Transport

ORASURE SPECIMENS FOR HIV TESTING

(PLEASE CALL 516-572-1202 FOR MORE INFORMATION) Specimen Collection: Follow the directions on the OraSure HIV-1 Oral Specimen Collection Device package insert. Requisition Form Completion: The Clinical Microbiology Requisition Form can be printed from the internet at: http://www.nassaucountyny.gov/agencies/Health/labs.html Enter the requested information on the Requisition form. **For a confidential test enter client/patient's full name and complete address. **For an approved anonymous test enter client/patient's ID number and no address information. Test Request Section: Select the box for the type of testing to be performed: · Check HIV for conventional testing (EIA and, if necessary, WB) when no rapid test has been performed on client during this visit. · Check HIV-1 WB only when the rapid test was reactive and this specimen is for western blot confirmation. Please indicate in the COMMENT section of the requisition form if a rapid test was not used or, if used, whether the result was positive or negative. A signature must be provided where indicated to certify that informed consent was obtained for this test. A completed requisition form must accompany each specimen so that processing can occur and to avoid delays in reporting results. Specimen Vial Label: The client's name and/or ID number and the specimen collection date must be written on the specimen vial label exactly as it was written on the requisition form. NOTE: If a label containing an ID number is used, take care to not cover the expiration date printed on the specimen vial. As a quality assurance check; ask the client to verify the name and/or subject ID on the oral fluid tube and match the information to the laboratory requisition form.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 35 of 36

Microbiology Laboratory Specimen Collection and Transport

Packaging Specimen for Shipment: Place labeled specimen vial in a plastic zip close bag, fold the completed requisition form around the bag and place in a 6" x 9" padded mailer. More than one specimen can be sent in the same envelope. Address mailer to: Nassau County Department of Health Division of Public Health Laboratories 209 Main Street Hempstead, NY 11550 Ensure a return address is included on the mailer. Mark the mailer "CONFIDENTIAL" when submitting specimens for confidential testing. Mailing Specimen: Send specimens via first class mail using the United States Postal Service. Do not put specimens in an outside drop box because lengthy exposure to extreme temperatures can compromise the integrity of the specimen. Reporting of Results: NCPHL will send test results to the provider at the address indicated on the requisition form via USPS first class mail.

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Nassau Co. DOH PHL 209 Main Street Hempstead, NY 11550

CLEP Laboratory ID#: 2117

Laboratory Standard Operating Procedure Manual Doc. No. BMP ­ 0 Date: 3/25/2010 Rev: 0 Page 36 of 36

Microbiology Laboratory Specimen Collection and Transport

DISTRIBUTION LIST

Department Quality Systems Microbiology Laboratory Laboratory Location 20 33 Web Site Name of Responsible Individual Maria Suarez-Alcivar, MD Connie Iannucci Rodger Silletti, Ph.D.

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