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The document establishes that permitted facilities must follow the General Systems Standards and any specialty requirements by laboratory category. It provides defined expectations across the laboratory lifecycle, including quality management, director responsibilities, human resources, facility design, safety, laboratory information systems, resource management, and key pre-analytic, analytic, and post-analytic 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","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-31","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",11,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"Which laboratories must comply with the General Systems Standards?","Question",{"text":113,"@type":114},"Laboratories located in New York State and laboratories conducting clinical or forensic testing on specimens originating in New York State must hold a New York State clinical laboratory permit and adhere to the standards.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"What standards are required in addition to the General Systems Standards?",{"text":118,"@type":114},"Permitted laboratories and blood banks must follow applicable Clinical Laboratory Standards of Practice, including the General Systems Standards and any Specialty Requirements by Category.",{"name":120,"@type":111,"acceptedAnswer":121},"Are there category-specific standards for every permit category?",{"text":122,"@type":114},"No. The document states there are no category specific standards for Clinical Chemistry, Endocrinology, Therapeutic Substance Monitoring/Quantitative Toxicology, Transplant Monitoring, and Wet Mounts.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},434734,1790979734,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":146,"preview_page_count":4},2336478951081,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","New York State Department of Health Wadsworth Center  \nClinical Laboratory Evaluation Program  \nClinical Laboratory Standards of Practice General Systems Standards  \nEffective August 1st, 2020  \nNew York State Department of Health Clinical Laboratory Standards of Practice General Systems Standards  \nLaboratories located in New York State, and laboratories conducting clinical or forensic testing on specimens originating in New York State regardless of location, must hold a New York State Department of Health clinical laboratory permit pursuant to Article 5, Title V, Section 574 of the New York State Public Health Law.  \nAll laboratories and blood banks holding a New York State clinical laboratory permit must adhere to applicable Clinical Laboratory Standards of Practice, including:  \n• General Systems Standards; and  \n• Specialty Requirements by Category.  \nThere are no category specific standards for the following permit categories:  \n• Clinical Chemistry  \n• Endocrinology  \n• Therapeutic Substance Monitoring/Quantitative Toxicology  \n• Transplant Monitoring  \n• Wet Mounts  \nGeneral Systems Standards  \nNew York State Department of Health Clinical Laboratory Standards of Practice General Systems Standards  \nTABLE OF CONTENTS  \nDefinitions …………………………………………………………………………………………………………….….…................…..…..i  \nQuality Management System (QMS)………………………….…………………………………………………...…………………………..……......…1  \nDirector Responsibilities (DR) .………………………………………………………………………………………….……………………...….…….….8  \nHuman Resources (HR)………………………………………………………………………………………………….…………….………....…....….14  \nFacility Design (FD)……………………………………………………………………………………………………….……………………..….….…..24  \nLaboratory Safety (LS)…………………………………………………………………………………………………….………………………..…...…27  \nLaboratory Information Systems (LIS)………………………………………………………………………………………………….………..……….38  \nResource Management (RM)……………………………………………………………………………………...………………….………….….…....42  \nGeneral Resource Management (GRM)………………………………………………………………………………..….………..…..…..…42  \nLaboratory Equipment and Instrumentation (LEI)……………………………………………………………………..………...….......….…46  \nReagents and Media (RGM)……………………………………………………………………………………………………............…..…..51  \nDocument Control (DC)…………………………………………………………………………………………………………………………..…….….55  \nPre-Analytic Systems (PRS)………………………………………………………………………………………………………….….…………....….59  \nTest Request (TR)…………………………………………………………………………………………………………...….….…..……......59  \nSpecimen Processing (SP)………………………………………………………………………………………………...………….......…....62  \nReference and Contract Laboratories (RCL)…………………………………………………………………………………...……....……..68  \nAnalytic Systems (AS)…………………………………………………………………………………………………………………..…....………..….70  \nTest Procedure Content (TPC)……………………………………………………………………………………………………......….........70  \nTest Performance Specifications (TPS)…………………………………………………………………………………….……..…….....….74  \nCalibration and Calibration Verification (CAL)………………………………………………………………………...……….…….…....….77  \nQuality Control (QC)……………………………………………………………………………………………………….....………….…...….79  \nPost-Analytic Systems (PAS)…………………………………………………………………………………………………………….…...…..…..….90  \nResult Review (RR)………………………………………………………………………………………………………..…….…...…..…..….90  \nReporting (REP)……………………………………………………………………………………………………………..……...…....….......93  \nPublic Health Reporting (PHR)………………………………………………….………………………………………..……..…....….....….97  \nConfidentiality (CON)……………………………………………………………………………………………………..………….....…...…..99  \nDocument and Specimen Retention (DSR)……………………………………………………………………………………..…...……..….......…101  \nProficiency Testing (PT)…………………………………………………………………………………………………………….………....…...…...111  \nInvestigations and Corrective Actions (ICA)…………………………………….………………………………………………………...…..….…...121  \nAppendix …………………………………………………………………………………………………………………………………………………..126  \nNew York State Department of Health Clinical Laboratory Standards of Practice General Systems Standards  \nDEFINITIONS  \nAcceptability criteria: Laboratory or manufacturer-defined performance re","cbCaibHHKSBRmzVl","https://ap.wps.com/l/cbCaibHHKSBRmzVl","pdf",643344,135,"English","# Quality Management System (QMS)\n# Director Responsibilities (DR)\n# Human Resources (HR)\n# Facility Design (FD)\n# Laboratory Safety (LS)\n# Laboratory Information Systems (LIS)\n# Resource Management (RM)\n## General Resource Management (GRM)\n# Laboratory Equipment and Instrumentation (LEI)\n# Reagents and Media (RGM)\n# Document Control (DC)\n# Pre-Analytic Systems (PRS)\n## Test Request (TR)\n## Specimen Processing (SP)\n# Reference and Contract Laboratories (RCL)\n# Analytic Systems (AS)\n## Test Procedure Content (TPC)\n## Test Performance Specifications (TPS)\n# Calibration and Calibration Verification (CAL)\n# Quality Control (QC)\n# Post-Analytic Systems (PAS)\n## Result Review (RR)\n## Reporting (REP)\n# Public Health Reporting (PHR)\n# Confidentiality (CON)\n# Document and Specimen Retention (DSR)\n# Proficiency Testing (PT)\n# Investigations and Corrective Actions (ICA)\n# Appendix","[{\"question\":\"Which laboratories must comply with the General Systems Standards?\",\"answer\":\"Laboratories located in New York State and laboratories conducting clinical or forensic testing on specimens originating in New York State must hold a New York State clinical laboratory permit and adhere to the standards.\"},{\"question\":\"What standards are required in addition to the General Systems Standards?\",\"answer\":\"Permitted laboratories and blood banks must follow applicable Clinical Laboratory Standards of Practice, including the General Systems Standards and any Specialty Requirements by Category.\"},{\"question\":\"Are there category-specific standards for every permit category?\",\"answer\":\"No. The document states there are no category specific standards for Clinical Chemistry, Endocrinology, Therapeutic Substance Monitoring/Quantitative Toxicology, Transplant Monitoring, and Wet Mounts.\"}]","Clinical Laboratory Standards of Practice General Systems Standards - Effective August 1st, 2020 | PDF",1790670366,340]