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Program Landing Page

Exanthemous Viruses

An exanthem is a widespread rash and usually refers to those occurring in children. Historically, six "classical" infectious childhood exanthems have been recognized; numbers were coined around 1905, from First to Sixth Diseases. Four of…
https://www.wadsworth.org/programs/id/virology/services/exanthemous-viruses
Program Landing Page

Respiratory Viruses

The General Virology Laboratory (GVL) is the largest laboratory in the Laboratory of Viral Diseases. A combination of classical and molecular virology techniques are used to detect, type, subtype, and sequence for strain analysis, viruses…
https://www.wadsworth.org/programs/id/virology/services/respiratory-viruses
Program Landing Page

Sexually Transmitted Diseases

Herpes Simplex Virus (HSV) infections typically cause characteristic oral and/or genital vesicular lesions.  The General Virology Laboratory (GVL) provides testing for the detection and typing of HSV 1 and 2, as part of the STD testing…
https://www.wadsworth.org/programs/id/virology/services/std
Program Landing Page

Vaccine Preventable Disease Reference Center

The Wadsworth Center Virology Laboratory is one of four public health laboratories in the United States contracted through a competitive process to perform diagnostic testing for viral VPDs using standardized methods developed by the Centers for…
https://www.wadsworth.org/programs/id/virology/vaccine-preventable-diseases
Event

Spinal Cord Injury Research Board Business Meeting

Videoconferencing site: Wadsworth Center, Biggs Laboratory, Sturman Conference Room, Empire State Plaza, Albany, NY.The Spinal Cord Injury Research Board held a regular business meeting from 1:00pm-5:00pm. It made award recommendations for the 2015…
https://www.wadsworth.org/events/spinal-cord-injury-research-board-business-meeting-3
Program Landing Page

Clinical Laboratories

Detailed information about the Clinical Laboratory Evaluation Program can be found in the CLEP Program Guide.Which facilities are required to obtain a clinical laboratory permit?All clinical and forensic laboratories and blood banks located in or…
https://www.wadsworth.org/regulatory/clep/clinical-labs
Program Landing Page

Limited Service Laboratories

Limited Service Laboratories include hospital extension clinics, hospital owned physician practices, nursing homes, home health care agencies, school/student health services, dialysis facilities, ambulatory surgery centers, county health departments…
https://www.wadsworth.org/regulatory/clep/limited-service-lab-certs
Program Landing Page

Certificate of Qualification & Laboratory Director Requirements

New York State Public Health Law requires that all individuals designated as laboratory directors or assistant directors at a clinical laboratory or blood bank holding or applying for a New York State clinical laboratory permit to hold a Certificate…
https://www.wadsworth.org/regulatory/clep/certificate-requirements
Program Landing Page

Cytopathology Requirements

New York State Public Health Law was amended effective December 13, 2024 such that cytotechnologists are no longer required to register with the Department. Compliance with the workload standard is still required.  Cytotechnologists:New York…
https://www.wadsworth.org/regulatory/clep/cytotechnologist-registration
Program Landing Page

Clinical Laboratory Evaluation Program - Laws & Regulations

Clinical Laboratory Statute and RegulationsStatute - Public Health LawArticle 5, Title V: Clinical Laboratory and Blood Banking ServicesFollow the link, click "PBH" from the list, click "Title 5" under "Article 5"Article 31: Human Blood and…
https://www.wadsworth.org/regulatory/clep/laws
Program Landing Page

Obtain a Permit

Apply for a Clinical Laboratory Permit[collapse collapsed]Information for new laboratoriesAll clinical and forensic laboratories and blood banks located in or accepting specimens from New York State must hold a New York State Department of Health…
https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit
Program Landing Page

Change a Permit

eCLEP Permit Materials Manual[collapse collapsed]Changes in Laboratory Director, Owner or LocationArticle 5, Title V of the New York State Public Health Law specifies that a laboratory permit is void upon a change in laboratory director, owner…
https://www.wadsworth.org/regulatory/clep/clinical-labs/change-permit
Program Landing Page

Re-Apply for a Permit

Laboratories holding a permit or applying for a permit must complete a reapplication annually.Successful reapplication includes the following, at a minimum:Submission of the web-based re-application on eCLEP, accessible from the Health Commerce…
https://www.wadsworth.org/regulatory/clep/clinical-labs/re-apply-for-permit
Program Landing Page

Search Approved Clinical Laboratories

https://www.wadsworth.org/regulatory/clep/approved-labs
Program Landing Page

Health Commerce System

Health Commerce SystemThe Health Commerce System (HCS) is the secure website for web-based interactions with the New York State Department of Health which includes eCLEP, the application tool for clinical laboratories to submit…
https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit/health-commerce
Program Landing Page

On-Site Survey Process

Laboratories seeking a permit must have an initial on-site survey before a permit is issued and before patient testing can be performed. A surveyor from the Department will contact the laboratory to schedule an initial on-site survey. Out-of-state…
https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit/on-site-survey
Program Landing Page

Clinical Laboratory Evaluation Program Proficiency Testing

Proficiency Testing GuidePT Designation Tutorial*The NYS Department of Health no longer provides proficiency testing samples, effective January 1, 2017. Notification of this change was sent to Laboratory Directors on July 22, 2016.* Proficiency…
https://www.wadsworth.org/regulatory/clep/pt
Program Landing Page

Test Approval

Only laboratories that hold a New York State clinical laboratory permit are authorized to perform testing on specimens originating from New York.  Review of laboratory-developed tests (LDT) begins after the clinical laboratory permit…
https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit/test-approval
Program Landing Page

Patient Service Centers & Health Fairs

[collapse collapsed]Patient Service Centers (PSC)A laboratory holding clinical laboratory permit may operate patient service centers (also known as collecting stations) which are defined as a facility, fixed or mobile, for the collection, drawing…
https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit/patient-service-centers-health-fairs
Program Landing Page

Laboratory Standards

[collapse collapsed]Standards Open for CommentProposed revisions to the New York State Clinical Laboratory Standards of Practice, General Systems Standards, are available for review and comment.  Please send comments regarding these…
https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards

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