Skip to main content
New York State Home

Pre Header Navigation

  • Services
  • News
  • Government
New York State Department of Health, Wadsworth Center
  • Public Health Programs
    • Environmental Health
      • Emergency Response
      • Environmental Biology
      • Environmental Organic Chemical Analysis
      • Inorganic Analytical Chemistry
      • Nuclear Chemistry
      • Proficiency Testing
    • Infectious Diseases
      • Laboratory Response Network
      • Online Test Request/Reporting
      • Antimicrobial Resistance Laboratory Network
      • Arbovirology
      • Bacteriology
      • Biodefense
      • Bloodborne Viruses
      • Cellular Immunology
      • Diagnostic Immunology
      • Mycobacteriology
      • Mycology
      • Parasitology
      • Rabies
      • Virology
      • Infectious Diseases Requisition Form
    • Newborn Screening and Genetics
      • Newborn Screening Program
      • Cancer Referrals
      • Pediatric Referrals
      • Prenatal Genetics Referrals
  • Research
    • Research by Area of Study
    • Featured Laboratories
    • Cores
    • Office of Research & Technology
    • Scientific Resources
    • Research Summaries for all Investigators and Senior Staff
  • Regulatory Programs
    • Clinical Laboratory Evaluation Program
    • Environmental Laboratory Approval Program
    • Physician Office Laboratory Evaluation Program
    • Breath & Blood Alcohol Testing
    • Blood Resources Program
    • Source Plasma Donation Center
    • Tissue Resources Program
    • Regulated Medical Waste Program
    • Laboratory Animal Welfare Program
    • Laboratory Investigations Unit
  • Education
    • Postdoctoral & Visiting Scientists
    • Postgraduate Fellowship Opportunities
      • APHL/CDC Fellowships
    • Undergraduate
      • Public Health Lab Academy
      • Volunteers
    • Graduate Programs at UAlbany
  • Extramural Funding
    • NYSTEM
    • Breast Cancer Research & Education
    • Multiple Sclerosis
    • Spinal Cord Injury Research
  • About Us
    • Affiliations
    • Contact Us
    • Director's Office
    • Employment Opportunities
    • History
    • Landmark Achievements
    • News and Events
    • Privacy Policy
    • Senior Staff
Laboratory Standards

Breadcrumb

  1. Home
  2. Regulatory Programs
  3. Clinical Laboratory Evaluation Program
  4. Clinical Laboratories
  5. Laboratory Standards

Laboratory Standards

Standards Open for Comment

Proposed revisions to the New York State Clinical Laboratory Standards of Practice, Specialty Requirements by Category (Pathology), are available for review and comment. 

Please send comments regarding these proposed changes to clep@health.ny.gov no later than January 11, 2025.

Please include the words Standard Revisions in the subject line of any emails related to this announcement.

  • Pathology - Proposed Revisions
Comments, Responses, and Revisions to General Standards-Proficiency Testing - December 2024

Responses to comments received during the General Systems Standards Proficiency Testing open comment period

  • General Systems Standards Proficiency Testing Comment Responses

     

Summary showing revisions to the General Systems Standards Proficiency Testing. Changes are effective December 6, 2024.

  • General Systems Standards Proficiency Testing Revision Summary December 2024

 

Current Standards

Clinical Laboratory Standards of Practice

  • General Systems Standards - Effective December 2024

     

Specialty Requirements by Category

  • Andrology - Effective August 2020
  • Blood Lead - Effective August 2020
  • Blood pH and Gases - Effective August 2020
  • Laboratory Blood Services and Immunohematology - Effective August 2020
  • Cellular Immunology and Cytokines - Effective August 2020
  • Clinical Toxicology - Effective August 2020
  • Cytogenetics - Effective August 2020
  • Diagnostic Immunology - Effective August 2020
  • Fetal Defect Markers - Effective August 2020
  • Forensic Identity - Effective August 2020
  • Forensic Toxicology - Effective August 2020
  • Genetic Testing - Effective August 2020
  • Hematology - Effective August 2020
  • Histocompatibility - Effective August 2020
  • Microbiology Categories - Effective May 2021
  • Oncology - Effective August 2020
  • Parentage/Identity Testing - Effective August 2020
  • Pathology Categories - Effective May 2021
  • Trace Elements - Effective August 2020
Additional Materials and Policies

NYS Cytogenetics Quality Assurance Program Chromosome Microarray Analysis policy

IQCP Requirements CLIA To NYS - May 2021

Print

Clinical Laboratories

  • Obtain a Permit
  • Change a Permit
  • Re-Apply for a Permit
  • Laboratory Standards
  • Laboratory Fees

Clinical Laboratory Evaluation Program

Phone Number
(518) 485-5378
Fax Number
(518) 485-5414
Email Address
clep@health.ny.gov

US Postal Service

Clinical Laboratory Evaluation Program
Biggs Laboratory
Wadsworth Center
NYS Department of Health
Empire State Plaza
Albany, NY 12237

UPS, FedEx, Courier

Clinical Lab Eval Program
Biggs Lab – Wadsworth Center
NYS Department of Health
Dock J – P1, Empire State Plaza
Albany, NY 12237

New York State Department of Health, Wadsworth Center

Footer

  • PUBLIC HEALTH PROGRAMS

    • Emergency Response
    • Environmental Biology
    • Environmental Organic Chemical Analysis
    • Inorganic Analytical Chemistry
    • Nuclear Chemistry
    • Proficiency Testing
    • Laboratory Response Network
    • Online Test Request/Reporting
    • Arbovirology
    • Bacteriology
    • Antimicrobial Resistance Laboratory Network
    • Biodefense
    • Bloodborne Viruses
    • Cellular Immunology
    • Diagnostic Immunology
    • Mycobacteriology
    • Mycology
    • Parasitology
    • Rabies
    • Virology
    • Newborn Screening Program
    • New York Mid-Atlantic Consortium
  • RESEARCH

    • Research Areas
    • Featured Laboratories
    • Core Facilities
    • Office of Research & Technology
    • Scientific Resources
  • REGULATORY PROGRAMS

    • Clinical Laboratory Evaluation Program
    • Environmental Laboratory Approval Program
    • Physician Office Laboratory Evaluation Program
    • Breath & Blood Alcohol Testing
    • Blood Resources Program
    • Tissue Resources Program
    • Regulated Medical Waste Program
    • Laboratory Investigations Unit
  • EDUCATION

    • APHL/CDC Fellowships
    • Postdoctoral & Visiting Scientists
    • Graduate
    • Research Experience for Undergraduates
    • Student Volunteers
  • EXTRAMURAL FUNDING

    • Breast Cancer Research & Education
    • Multiple Sclerosis
    • New York State Stem Cell Science
    • Spinal Cord Injury Research
  • ABOUT US

    • Affiliations
    • Director's Office
    • Employment Opportunities
    • History
    • Landmark Achievements
    • News and Events
    • Contact
    • Senior Staff
    • Privacy Policy
    • Site Map
    • NYS Department of Health
New York State Home

Footer Bottom

  • Agencies
  • App Directory
  • Counties
  • Events
  • Programs
  • Services