#06-5558 Accrd Manual V7 - COLA

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CRITERIA FOR QUALITY LABORATORY PERFORMANCE>ORG 12 RDoes the procedure manual include all the tests offered by the laboratory?Don’t forget to include those tests performed by manual methods (e.g., urine sediment examination).ORG 13 RIs the procedure manual easily accessible to your personnel?It is important for laboratory personnel to have easy access to the procedure manual. Staff should not relyon memory as this may lead to erroneous results if the procedure isn’t remembered correctly.ORG 14 RDo personnel follow all procedures as written in the procedure manual?If you have someone from outside your practice prepare your procedure manual, make sure that the proceduresreflect the way your personnel actually perform the tests in your laboratory.> NOTE: A copy of the manufacturer’s package insert or operator’s manual, or a copy of a textbook descriptionof the test procedure may be used in the manual if it provides the information required under SectionAPM. Any components of the test procedure that are not addressed by the manufacturer, such as thesteps to be taken when a test system is malfunctioning, must be written into the individual procedure.You can also maintain a general policy statement in the laboratory for these procedures.ORG 15 RAre all test procedures reviewed, approved, and signed annually by the laboratory director?Does the laboratory director sign and date (ORG 16 to ORG 18):ORG 16 REach new procedure?ORG 17 RAny changes in a procedure?ORG 18 REntire manual if he/she is a new director?ORG 19 RAre procedures dated when they are initially put into use and when they are discontinued?This will be helpful to you in determining when a procedure can be discarded.ORG 20 RAre discontinued procedures kept for at least two years beyond the discontinued date?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org3
CRITERIA FOR QUALITY LABORATORY PERFORMANCEFacilityFAC 1 RDoes your laboratory have adequate space, ventilation, and utilities necessary for conducting all phases of thetesting process in order that patient care is not compromised?The laboratory should be located in a convenient, yet out of the way place in the facility. It should not be aheavy traffic area and it should not be an area where patients must pass through on a routine basis.You must ensure access to the necessary utilities, (power, environment, water, drainage and disposal systems)are sufficient for the work and equipment used in the laboratory.If your lab handles biological or caustic chemicals, a proper ventilation system is essential for employee andpatient safety. The type of caustic or biological materials handled will determine the requirements necessaryfor adequate protection of patients and safety. The laboratory may consult MSDS sheets, OSHA requirements,and other laboratory texts to determine the type of precautions required.FAC 2 RIs the laboratory constructed, arranged, and maintained to minimize contamination of patient specimens,equipment, instruments, reagents, materials and supplies?Based on the volume and type of testing performed, the laboratory should evaluate the workspaces availableto perform various laboratory functions. To the extent possible, designate specific areas for varioustasks to minimize accidental spills, mix-ups or contamination.FAC 3 RIs the laboratory organized to ensure uni-directional workflow if molecular amplification procedures are performed.Uni-directional workflow refers to the manner in which testing personnel and patient specimens movethrough the molecular testing process. The purpose of moving in a single direction is to prevent cross-contamination.This must include separate areas for specimen preparation, reagent preparation, amplification,and product detection.Molecular procedures based on nucleic acid testing are growing in popularity for the detection of infectiousdiseases (HIV, HBV, HCV, CMV, Chlamydia trachomatis, Neisserria gonorrhoeae, and Mycobacterium tuberculosis).Common procedures that involve amplification processes include polymerase chain reaction (PCR),strand displacement amplification (SDA), transcription mediated amplification (TMA) and ligase chain reaction(LCR). This list is by no means complete. Laboratories performing testing based on any of these principleswill need to evaluate workflow processes in accordance with their test system and manufacturersrequirements.FAC 4 RHave steps been taken to prevent sporadic power fluctuations?Many newer laboratory instruments have internal surge protectors; check your operator’s manual to see ifthis is the case. If it does not contain an internal surge protector, a surge protector can be obtained from yourlocal hardware or electronics store. Also, check your operator’s manual to see whether your instrumentrequires a dedicated line. If this is the case, nothing else should be plugged into the circuit where your instrumentis attached to the power source. Any other instruments or even a light or radio could cause enoughpower fluctuation to affect the calibration of the instrument.FAC 5 RIs there a proper type fire extinguisher in working condition and/or a fire blanket in the laboratory or within 50feet of the lab?Make sure the extinguisher’s gauge shows that it is properly charged and/or is inspected on an annual basis.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
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CYTOLOGY706. EThe cytotechnologists
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CYTOLOGYLaboratory Safety and Envir
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CYTOLOGY726. EAre the proper method
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CYTOLOGY740. EAre non-gynecologic s
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CYTOLOGYEnsuring Quality of Examina
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CYTOLOGYAre there documented evalua
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CYTOLOGY795. EAre unsatisfactory sp
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HISTOPATHOLOGY816. EResponsibilitie
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HISTOPATHOLOGY830. EHIV and AIDS831
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HISTOPATHOLOGYThe laboratory shall
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HISTOPATHOLOGY859. EAre the stained
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HISTOPATHOLOGY873. EAre unsatisfact
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#06-5558 Accrd Manual V7 - COLA

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