Microbiology - Wadsworth Center

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New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and GuidanceProposed Standard and GuidanceThe following Microbiology standards are applicable to thesubspecialty testing categories as follows: Bacteriology (MBS1-S11); Mycobacteriology (MB S1-S9); Mycology (MB S1S11); Parasitology (MB S6, MB S8-S9); Virology (MB S1, MBS6, MB S8-S11).DeletedThe following specialty sustaining standards of practice andapplicable general system standards shall be incorporated intothe laboratory’s quality management system, where applicableto the scope of services provided.DeletedEffective May 1, 2011.Mycobacteriology Sustaining Standard of Practice 1 (TBS1): Biological Safety Cabinet (BSC)Microbiology Standard of Practice 1 (MB S1): BiologicalSafety CabinetA class II or higher biological safety cabinet (BSC) shall beused when:A class II or higher biological safety cabinet (BSC) must beused when:a) processing specimens submitted for mycobacteriologicaltesting, including slide preparation;b) handling or processing unsealed mycobacteriology cultures;c) performing any other procedures that have the potential tocreate aerosols.Guidance – Operational guidelines for biological safetycabinets can be found in the Safety Standards of the GeneralSystems Standards Part 1.Public Comment – 2020a) processing specimens submitted formycobacteriological testing, including slide preparationor handling unsealed mycobacteriology cultures;b) processing patient specimens submitted for isolation ofpathogenic fungi or handling cultures of pathogenicfungi;c) inoculating cell cultures with clinical specimens and forall procedures involving the maintenance andprocessing of inoculated cell cultures and culture-1

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and GuidanceMycology Sustaining Standard of Practice 1 (MY S1):Biological Safety Cabinet (BSC)A class II or higher biological safety cabinet (BSC) shall beused whenever:a) processing patient specimens submitted for isolation ofpathogenic fungi;b) handling or processing cultures of pathogenic fungi.Guidance – Additional required use of the BSC should beestablished by the laboratory director based on an infectiousagent risk assessment (refer to Safety Standards).Proposed Standard and Guidanceamplified materials; ord) performing any other procedures that have the potentialto create infectious aerosols.Guidance –Additional required use of the BSC should be established bythe laboratory director based on an infectious agent riskassessment (refer to Laboratory Safety Standard of Practice 7(LS S7): Biohazard Risk Assessment.Mycobacteriology Sustaining Standard of Practice 2 (TBS2): Centrifugation SafetyMicrobiology Standard of Practice 2 (MB S2):Centrifugation SafetyFor all mycobacteriology procedures that use centrifuges:For all mycobacteriology, mycology and virology proceduresinvolving centrifugation of potentially infectious materials:a) aerosol-free centrifuge cups shall be used;b) centrifuge cups shall be opened in a class II or higherBSC.Mycology Sustaining Standard of Practice 2 (MY S2):CentrifugationFor all mycology procedures that use centrifuges:a) aerosol-free centrifuge cups shall be used;a) aerosol-free centrifuge cups must be used; andb) centrifuge cups must be opened in a class II or higherbiological safety cabinet (BSC).Guidance –Proper safety practices are important for centrifugation of shellvial cultures.b) centrifuge cups shall be opened in a class II or higherBSC.Public Comment – 20202

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and GuidanceProposed Standard and GuidanceMicrobiology Sustaining Standard of Practice 1 (MB S1):Quality Control Stock CulturesMicrobiology Standard of Practice 3 (MB S3): QualityControl Stock CulturesThe laboratory shall maintain stock cultures for all qualitycontrol procedures.The laboratory must have quality control procedures for allstocks cultures to minimize contamination or alteration ofrelevant characteristics.Guidance – Maintenance of stock cultures should bestandardized in a manner that minimizes the opportunity forcontamination or alteration of relevant characteristics. Stockcultures should consist of low-passage material rather thanlaboratory-adapted high passage material.Validated patient isolates, proficiency testing specimens, orcommercially prepared controls may be used unless otherwiserequired by manufacturer. American Type Culture Collection(ATCC) controls are not required, except for use insusceptibility testing.Guidance –Maintenance of stock cultures should be standardized in amanner that minimizes the opportunity for contamination oralteration of relevant characteristics. Stock cultures shouldconsist of low-passage material rather than laboratory-adaptedhigh passage material.Validated patient isolates, proficiency testing specimens, orcommercially prepared controls may be used unless otherwiserequired by manufacturer.Microbiology Sustaining Standard of Practice 2 (MB S2):Commercial MediumMicrobiology Standard of Practice 4 (MB S4): MicrobialGrowth MediumEach lot or shipment of commercially prepared media shall betested:Each lot or shipment of commercially prepared or in-houseprepared media must be tested:a) on-site for growth, selectivity, and/or inhibition andbiochemical responses; or,a) on-site for growth, selectivity, and/or inhibition andbiochemical responses; orb) by the manufacturer in accordance with established criteria.Quality control checks for sterility, growth, selectivity and/orinhibition and biochemical responses need not be retestedby the user provided that:b) by criteria established by the manufacturer or thelaboratory in absence of manufacturer instructions.Quality control (QC) checks for sterility, growth,selectivity and/or inhibition and biochemical responsesneed not be retested by the laboratory provided that:i.for each shipment or lot of media, the laboratory hasPublic Comment – 20203

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and Guidancedocumentation on the media label, package insert,technical manual, or other document, that themanufacturer’s quality control practices conform tospecifications; and,ii.the laboratory documents receipt and condition ofeach shipment or lot of media, and notifies themedia manufacturer of:Proposed Standard and Guidancei.for each shipment or lot of media, the laboratoryhas documentation on the media label, packageinsert, technical manual, or other document, thatthe manufacturer’s or in-house QC practicesconform to specifications; andii.the laboratory documents receipt and conditionof each shipment or lot of media, and notifies themedia manufacturer or in-house preparer of:- cracked Petri dishes;- cracked Petri dishes;- unequal filling of plates;- unequal filling of plates;- cracked media in plates;- cracked media in plates;- hemolysis;- hemolysis;- freezing;- freezing;- excessive number of bubbles; or- excessive number of bubbles; or- contamination.Guidance – Media may be tested concurrent with initial useprovided results are reviewed prior to release of patient results.- contamination.Guidance –Media may be tested concurrent with initial use provided QCresults are reviewed prior to release of patient results.Public Comment – 20204

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and GuidanceProposed Standard and GuidanceMicrobiology Sustaining Standard of Practice 4 (MB S4):Expiration Date Prepared In-HouseMicrobiology Standard of Practice 5 (MB S5): ExpirationDate Prepared In-HouseThe expiration date for each batch of in-house preparedmicrobiological media shall not exceed 8 weeks from thepreparation date for plated and non-screw cap tubed mediaand six months from the preparation date for screw cap tubedmedia provided the laboratory:The expiration date for each batch of in-house preparedmicrobiological media must not exceed eight (8) weeks fromthe preparation date for plated and non-screw cap tubed mediaand six (6) months from the preparation date for screw captubed mediaa) has taken into account the inclusion of labile componentssuch as antibiotics;b) stores the media under required conditions (e.g.temperature, shielded from light, proper humidity); and,c) has previously tested at least one batch of each mediumtype and shown it to perform as expected at the end of thedesignated shelf life.Guidance – This testing should be repeated when changingvendors.Microbiology Sustaining Standard of Practice 9 (MB S9):ReportsReports shall include:Microbiology Standard of Practice 6 (MB S6): ReportsIn addition to the requirements in Reporting Standard ofPractice 2, test reports must include:a) the test methodology;a) the test method;b) an interpretation, when necessary, to explain thesignificance of the test result;b) qualifiers for viral cultures that are incomplete oruninterpretable or when isolate identification isconsidered presumptive, i.e., an isolate is not confirmedby a specific viral identification system; andc) a qualifier identifying an assay limitation, if appropriate;and,Public Comment – 20205

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and Guidanced) a recommendation for follow-up testing, if appropriate.Guidance – These requirements are in addition to thoserequired by Reporting Sustaining Standard 1 (Reporting S1).a) Examples of assay methodology include culture, EIA, PCR,etc. Specific test systems are not required to be listed on atest report.b) Report qualifiers are used to convey information that wouldaffect the significance and/or clinical interpretation of thetest result.c,d) Rapid antigen tests for influenza virus are particularlyvulnerable to assay sensitivity issues because of antigenicvariations among circulating influenza sub-types/strainsand/or the emergence of novel sub-types/strains. Thelaboratory should be alert to these performance issues andinclude qualifiers and recommendations for follow-up testingas appropriate.Proposed Standard and Guidancec) a recommendation for follow-up testing, if appropriate.Guidance –a) Examples of assay methodology include culture, EIA, PCR,etc. Specific test systems are not required to be listed on atest report.Microbiology Sustaining Standard of Practice 10 (MB S10):Laboratory Response Network (LRN)Microbiology Standard of Practice 7 (MB S7): LaboratoryResponse NetworkThe laboratory shall have a section in the SOPM describingpolicies and practices related to their activities as a LaboratoryResponse Network (LRN) sentinel (formerly level A) laboratory,if applicable, including:In addition to the requirements for Test Procedure ContentStandard of Practice 1, the laboratory must have a section inthe standard operating procedure describing policies andpractices related to their activities as a Laboratory ResponseNetwork (LRN) sentinel laboratory, if applicable, including:a) maintaining updated LRN guidelines and protocols relatedto the testing, identification and reporting of select andemergent agents including information regarding specialhandling and safety practices to be employed;Public Comment – 2020a) maintaining updated guidelines and protocols related tothe testing, identification and reporting of select andemerging infectious agents including information6

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and Guidanceb) providing staff with information regarding the biosafetylevel(s) (BSL) recommended for the microbiological testingbeing performed and identifying the highest BSL availablefor each category of microbiological testing;c) identifying the LRN reference laboratory for their facility andcontact information for individual(s) to be contacted if aselect agent is suspected; and,d) distribution of information to health care providers regardingspecimen collection and submission instructions that shouldbe followed when infection with a select agent or otherinfectious agent requiring special handling is suspected.Guidance – Laboratories holding a clinical laboratory permit ineither Bacteriology –Comprehensive or Virology are currentlyconsidered LRN sentinel (formerly Level A) laboratories, unlessdesignated as a LRN reference laboratory.Information regarding laboratory testing for critical andemergent agents is available to all laboratories on the CDCwebsite. LRN sentinel laboratories holding NYS clinicallaboratory permits are advised to regularly access theNYSDOH Health Commerce System (HCS) for updatedinformation related to testing, identification and reporting ofthese agents. Information regarding NYS HCS accounts canbe obtained at 1-(866) 529-1890, option 1. Laboratoriesserving NYC should also access the NYC Department ofHealth and Mental Hygiene’s Health Alert Network (HAN); forinformation, contact 1-888-NYCMED-9 ornycmed@health.nyc.gov.The Wadsworth Center may define the levels of testing (e.g.Public Comment – 2020Proposed Standard and Guidanceregarding special handling and safety practices to beemployed;b) providing staff with information regarding the biosafetylevel(s) (BSL) recommended for the microbiologicaltesting being performed and identifying the highest BSLavailable for each category of microbiological testing;c) identifying the LRN reference laboratory for their facilityand contact information for individual(s) to be contactedif a select agent is suspected; andd) distribution of information to health care providersregarding specimen collection and submissioninstructions that should be followed when infection witha select agent or other infectious agent requiring specialhandling is suspected.Guidance –Laboratories holding a New York State clinical laboratorypermit in either Bacteriology or Virology are currentlyconsidered LRN sentinel laboratories, unless designated as anLRN reference laboratory.Information regarding laboratory testing for select andemerging infectious agents is available to all laboratories on theAmerican Society of Microbiology website.The Wadsworth Center may define the levels of testing (e.g.,rule out only) and identification (e.g., presumptive only) and thereporting pathway for a particular agent. The WadsworthCenter’s LRN distributes this information as needed to sentinellaboratories by e-mail or e-fax to the laboratory director and7

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and GuidanceProposed Standard and Guidancerule out only) and identification (e.g. presumptive only) and thereporting pathway for a particular agent. The WadsworthCenter’s LRN distributes this information as needed to sentinellaboratories by fax and/or electronic copy to the laboratorydirector and posts these announcements on the HCS.posts these announcements on the HCS.NYS and NYC LRN reference laboratory contacts and otherLRN information is available on the NYSDOH LRN websitewhich is accessed through the HCS. The Wadsworth CenterLRN program staff can be contacted at26TLRNexec@health.state.ny.us26T.Biosafety levels and associated recommendations andpractices are described in the CDC publication “Biosafety inMicrobiological and Biomedical Laboratories” (BMBL) and onthe CDC website at 26Twww.cdc.gov26T.New York State and New York City LRN reference laboratorycontacts and other LRN information is available on theWadsworth Center LRN website. The Wadsworth Center LRNprogram staff can be contacted at:LRNexec@health.state.ny.us.Biosafety levels and associated recommendations andpractices are described in the CDC publication “Biosafety inMicrobiological and Biomedical Laboratories” (BMBL) and onthe CDC website at: https://www.cdc.gov/labs/BMBL.html.Laboratories must comply with infectious disease reportingrequirements as outlined in the Public Health ReportingStandards of Practice 1 and 2.Laboratories must comply with infectious disease reportingrequirements as outlined in the Public Health SustainingStandard of Practice 1 (Public Health S1): Reporting.Laboratories must comply with pertinent items of USA PatriotAct and the Select Agent Rule (e.g. disposal/transfer of selectrule—see Microbiology Sustaining Standard 11 (MB S11)).Microbiology Sustaining Standard of Practice 11 (MB S11):Inventory and Track of Select AgentsMicrobiology Standard of Practice 8 (MB S8): Select AgentInventoryThe laboratory shall establish and implement an inventory andtracking system that ensures that all samples and theirderivatives suspected or confirmed to contain select agents areaccounted for until laboratory findings establish the absence ofa select agent. If a select agent is confirmed thenThe laboratory must ensure that all samples and theirderivatives suspected or confirmed to contain select agents areaccounted for until laboratory findings establish the absence ofa select agent. If a select agent is confirmed, documentation ofPublic Comment – 20208

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and GuidanceProposed Standard and Guidancedocumentation of its transfer including record of appropriatepacking and shipping or destruction within seven days must becompleted.its transfer including record of appropriate packing and shippingor destruction within seven days must be completed.Guidance – A list of select agents (Biological Diseases/AgentsList) can be found at the federal Centers for Disease Controland Prevention website at http://www.selectagents.gov.Inventory and tracking documentation shall include the identityof all individuals accessing such materials, as well ascompletion of APHIS/CDC forms 3 (Report of Theft, Loss orRelease of Select Agents or Toxins) and 4 (Report ofIdentification of a Select Agent or Toxin) for organisms andtoxins isolated from clinical specimens. This tracking systemincludes select agents used as control material and for thosespecimens that are suspected to be positive for a select agent.Tracking will begin at the time it is suspected that a specimencontains a select agent.Microbiology Sustaining Standard of Practice 3 (MB S3):Media Prepared In-HouseA sample of each batch of microbiological media prepared inhouse shall be tested, prior to or concurrent with initial use, forsterility, ability to support growth, selectivity and/or inhibition,and biochemical responses.Guidance –A list of select agents (Biological Diseases/Agents List) can befound at the federal Centers for Disease Control andPrevention website at: http://www.selectagents.gov.Laboratories must comply with pertinent items of the SelectAgent Rule (e.g., disposal/transfer of select agents)Inventory and tracking documentation should include theidentity of all individuals accessing such materials, as well ascompletion of APHIS/CDC forms 3 (Report of Theft, Loss orRelease of Select Agents or Toxins) and 4 (Report ofIdentification of a Select Agent or Toxin) for organisms andtoxins isolated from clinical specimen. Additional information isavailable at: http://www.selectagents.gov.Standard deletedRequired under Reagents and Media Standard of Practice2 (RGM S2): Verification of Reagents and Media – ControlProceduresGuidance – Media may be tested concurrent with initial useprovided results are reviewed prior to release of patient results.Microbiology Sustaining Standard of Practice 5 (MB S5):Media for Satellite LocationsPublic Comment – 2020Standard deleted9

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and GuidanceProposed Standard and GuidanceLaboratories that supply media to satellite locations areresponsible for either sending or maintaining quality controldocumentation and for notification of each satellite location of arecall.Guidance – In compliance with Reagents Sustaining Standard4 (REAG S4), satellite laboratories are responsible formaintaining inventory control documentation which includes thename of the central laboratory provider.Microbiology Sustaining Standard of Practice 6 (MB S6):Specimen CriteriaThe SOPM shall define specimen types acceptable for eachassay and shall include collection, storage and transportcriteria, and rejection criteria.Microbiology Sustaining Standard of Practice 7 (MB S7):Automated Identification SystemsThe laboratory shall check each new lot number or shipmentreceived of reagents with positive and negative reactivityquality control organisms for automated identification systems(QC). A streamlined quality control may be instituted whenusing microbial automated identification systems (MIS)provided that they follow a written protocol that ensures thatthey:Standard deletedRequired under Test Procedure Content Standard ofPractice 1 (TPC S1): Test Procedure ContentStandard deletedRequired under Reagents and Media Standard of Practice2 (RGM S2): Verification of Reagents and Media – ControlProceduresa) performed a verification study;b) maintain documentation that the manufacturer hasperformed adequate QC to ensure that the systemPublic Comment – 202010

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and Guidancec)d)e)f)g)h)Proposed Standard and Guidanceperforms appropriately;maintain documentation that states that the distributor hasfollowed all the manufacturer’s requirements for shippingand storage;store and maintain the system according to themanufacturer’s requirements;perform streamlined QC as directed by the manufacturerthat integrates the manufacturer’s risk mitigationinformation ;maintain records of all QC performed;remediate all QC failures and repeat QC in triplicate beforeresuming patient testing; andnotify the manufacturer and distributor of the unresolvedQC failure.Guidance – The streamlined quality control protocol is subjectto the requirements of Quality Control Sustaining Standard ofPractice (QC Design S1): Design of Individualized QualityControl Plan.Automated systems used exclusively to screen for bacterialcontamination of blood components must also follow thisstandard.Non-automated screening tests for bacterial contamination ofblood components, such as pH or glucose, are covered underthe permit category of Blood Services – Transfusion or BloodServices – Collection. Identification of the organism requires aBacteriology –Comprehensive permit.Public Comment – 202011

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology CategoriesFormer Standard and GuidanceProposed Standard and Guidancea) A review of historical data may be used for the verificationstudy.Refer to Reagents Sustaining Standard of Practice 2 (REAGS2): Verification- General Requirement and ReagentsSustaining Standard of Practice 3 (REAG S3): Verification ofReagents and Media for quality control requirements for allother reagents.Microbiology Sustaining Standard of Practice 8 (MB S8):Laboratory WorksheetsLaboratory records shall include worksheets and/or electronicrecords that include all tests and test results that led to theidentification of microorganisms.Standard deletedRequired under Document and Specimen RetentionStandard of Practice 8 (DSR S8): Analytic System RecordsRetentionGuidance – Worksheets and/or electronic records shouldinclude identification of the media or host systems used and thecorresponding observations for each medium as well asbiochemical test reactions where appropriate.Public Comment – 202012

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology Nucleic Acid (MNA) Amplification AssayFormer Standard and GuidanceProposed Standard and GuidanceUnless otherwise stated these standards apply to FDAapproved assays, modified FDA-approved assays andlaboratory-developed nucleic acid amplification assays andsequencing assays used for thedetection/identification/characterization of infectious agents.Laboratories may not report results obtained using laboratorydeveloped assays or modified FDA-approved assays withoutprior approval of the assay protocol by the Clinical LaboratoryEvaluation Program as per Validation Sustaining Standard ofPractice 5 (Validation S5). Application and submissionguidelines are available l-labs/obtainpermit/test-approval. These standards apply to all microbialagents including HIV and supplement the general systemsstandards that pertain to molecular test methods.DeletedThe following specialty sustaining standards of practices shallbe incorporated into the laboratory’s quality managementsystem, where applicable to the scope of services provided.DeletedEffective May 1, 2011.Microbiology Nucleic Acid Amplification AssaysSustaining Standard of Practice 2 (MNA S2): Preventionand Remediation of Nucleic Acid ContaminationThe SOPM shall include a description of practices andprocedures intended to prevent nucleic acid contaminationincluding:Standard move to General Systems StandardsRequired under Test Procedure Content Standard ofPractice 2 (TPC S2): Test Procedures for UnidirectionalWorkflowa) a workflow pattern that utilizes separate areas and movesPublic Comment – 202013

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology Nucleic Acid (MNA) Amplification AssayFormer Standard and GuidanceProposed Standard and Guidanceunidirectionally from pre- to post-amplification processes;b) dedicated pre-amplification equipment, reagents, supplies,and PPE that have been neither stored nor used in postamplification areas or other areas that may result inexposure to amplicon, plasmids, and culture-amplifiedmaterials;c) the handling, processing and storing of clinical specimensand pre-amplification reagents and supplies (e.g. extractionreagents, mastermix, probes) in a manner that preventsexposure to amplicon;d) a decontamination and remediation plan to be implementedin the event that amplicon contamination is identified.Guidance – Item a of this standard does not apply to FDAapproved Closed System Amplification Tests (CSATs).Pre-amplification activities include the storage, processing andextraction of clinical specimens and preparation of assayreagents.Post-amplification activities include those processes that occurafter molecular amplification has been performed and result inan exponential increase in the amount of nucleic acid product(amplicon).a) The unidirectional workflow pattern is intended to ensurethat pre-amplification procedures are performed in a workarea that excludes amplification products (amplicon). Thehigh level of concern is based on the significant risk ofgenerating false-positive test results due to ampliconcontamination of patient specimens and/or pre-amplificationPublic Comment – 202014

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology Nucleic Acid (MNA) Amplification AssayFormer Standard and GuidanceProposed Standard and Guidancesupplies and reagents. Failure to adhere to the establishedunidirectional workflow pattern requires implementation anddocumentation of additional measures for monitoring andpreventing amplicon contamination. These measures mayinclude the use of UNG in PCR assays, use of ampliconcontamination monitoring programs such as swipe testingof molecular areas, and the use of decontaminationproducts designed to eliminate nucleic acid contaminants.a) The practices and space designation policies should betailored to the laboratory’s test menu and design. Ideally, alaboratory should have 3 separate rooms for performingnucleic acid amplification assays: a pre-amplificationreagent preparation room; a room used for specimenpreparation/nucleic acid extraction and for templateaddition; and, a room dedicated to post-amplificationprocesses. An alternative arrangement may be developedwithin a room where reagent preparation (e.g. mastermixset-up and template addition) are performed in distinctareas provided that strictly dedicated and delineatedareas, PCR workstations, supplies, reagents, etc. areutilized for separating the two pre-amplification phases ofwork. However, it remains a high priority that postamplification procedures be performed in a separate room.a) It is suggested that negative controls in addition to thoserequired when performing FDA approved assays beincluded when “open amplicon” systems are utilized in alaboratory that does not have at least two separate roomsfor pre- and post-amplification activities.Public Comment – 202015

New York State Department of HealthClinical Laboratory Standards of PracticeSpecialty Requirements by CategoryMicrobiologyMicrobiology Nucleic Acid (MNA) Amplification AssayFormer Standard and GuidanceProposed Standard and Guidancea) Individuals performing CSATs may return to preamplification areas since the closed systems do not releaseamplicon into the environment provided that assay anddiscard procedures are followed.b) This refers to all equipment, furniture, instruments, supplies,reagents and PPE, including, but

Additional required use of the BSC should be established by the laboratory director based on an infectious agent risk assessment (refer to Safety Standards). amplified materials; or d) performing any other procedur

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