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Clinical Laboratory Evaluation Program - In the News

Electronic Health Records and Access to Laboratory Test Results: Ensuring compliance with 10 NYCRR § 58-1.8 (February 2014)

UPDATE: On January 17, 2014, the New York State Department of Health (the Department) posted frequently asked questions (FAQs) regarding patients' access to laboratory test results using electronic health records (EHRs) and steps that could be taken to ensure compliance with New York State (NYS) regulation 10 NYCRR § 58-1.8. This regulation states that laboratory test results cannot be reported directly to the patient "except with the written consent of the physician or other authorized person." On February 6, 2014, the Federal Department of Health and Human Services published amendments to 42 CFR Part 493 and 45 CFR Part 164 which give patients a right to access medical records directly from clinical laboratories, including completed laboratory test reports. To provide additional information on how this Federal rule affects NYS requirements related to patients' access to laboratory results, the Department is providing guidance that is available at http://www.wadsworth.org/labcert/regaffairs/clinical/ElectronicHealthRecordsFAQ.pdf.

Off-Label Use of Glucose Meters

The Food and Drug Administration has recently issued draft guidance regarding the off-label use of glucose meters. Laboratories that use glucose meters for purposes or in populations beyond the Intended Use in the package insert or device manual are considered to be engaging in off-label use. If a laboratory performs glucose meter testing for an off-label purpose, the glucose meter defaults to high complexity and the laboratory must meet the CLIA and NYS requirements for high complexity testing. A letter explaining the implications on laboratories permitted in New York State as well as reference documents can be found here. To provide additional information on this topic, the Department has prepared guidance in the form of frequently asked questions. This FAQ document can be found here. Any questions can be directed to the Clinical Laboratory Evaluation program at CLEP@health.state.ny.us. Please use "Glucose Meter Off-Label Use" and your laboratory's PFI in the subject line.

Electronic Health Records and Access to Laboratory Test Results: Ensuring compliance with 10 NYCRR § 58-1.8 (January 2014)

Electronic Health Records and Access to Laboratory Test Results: Ensuring compliance with 10 NYCRR § 58-1.8 Many facilities are establishing Electronic Health Records (EHRs) so that patients can directly access their medical records, including laboratory test results. New York State (NYS) regulations require that laboratory test results cannot be reported directly to the patient unless authorization is first provided by the physician or authorized person. Since EHRs will allow access of laboratory results directly to the patient, steps need to be taken to ensure this requirement is met when using EHRs. The New York State Department of Health (NYS DOH) recommends that all laboratories review the new NYS guidance on these regulatory requirements and the steps that can be taken to meet these requirements. The NYS DOH guidance is formalized into a Frequently Asked Question (FAQ) that is available at http://www.wadsworth.org/labcert/regaffairs/clinical/Authorized_Ordering_Source.pdf. Any questions can be directed to the Division of Laboratory Quality Certification at dlqcinfo@health.state.ny.us.

Interim Guidelines for Laboratories on the use of a new Diagnostic Testing Algorithm for Human Immunodeficiency Virus Infection

On May 17, 2013, the Interim Guidelines for Laboratories on the use of a new Diagnostic Testing Algorithm for Human Immunodeficiency Virus Infection were sent to all laboratories holding Virology or Diagnostic Immunology categories. If you have any questions regarding the new HIV diagnostic testing algorithm, please send an email to hivtesting@health.state.ny.us
For questions related to ECLRS reporting of HIV-related results, please contact the Bureau of HIV/AIDS Epidemiology by telephone at 518-474-4284 or by email at BHAELab@health.state.ny.us
(Posted 6/10/13)

Proposed Mycology Standards have been posted for comment.

The proposed Mycology Standards have been posted for comment. Comments can be sent to clep@health.state.ny.us by July 5, 2013.
(Posted 5/20/13)

New FAX number for Non-Permitted Laboratory Test Requests

Please update your records accordingly: (518) 449-6917

eCLEP available for year-round notification of changes in laboratory operations

(Posted 5/13/13)

Beginning immediately after all the laboratory's permit reapplication material has been reviewed and accepted by the Program, our web-based clinical laboratory information management tool, eCLEP, will be available year-round to accept changes to laboratory information electronically. This will be the preferred method of reporting such changes as indicated below. Current features of eCLEP will allow staff to: make changes to laboratory information such as contact information and hours of operation; make changes to laboratory owner information such as contact information; make changes to management contract information; make changes to laboratory directors and assistant directors, their assigned permit categories of responsibility and their on-site hours; add tests to the laboratory’s test menu; add or delete permit categories; and make changes to point-of-care testing location information for laboratories located in New York State.

Please note that after changes have been submitted (by clicking the submit button) the laboratory must print the summary page, the laboratory director must sign the attestation, and the laboratory must email or fax the signed summary to CLEP as indicated of the summary. While submitted changes are pending review by the Program, no additional changes can be made in eCLEP. If you must make changes during the review period, please complete and submit changes via the traditional paper-based method using forms available on our website under Applications and Forms (links found on right side of page), Changes to Laboratory Operations.

Access to eCLEP is provided through the Health Commerce System (HCS). You can access eCLEP from the HCS home page by finding "eCLEP" under 'My Applications' in the blue field on the left side of the page. Laboratory directors and assistant directors with active HCS accounts are granted data entry and data submission privileges for eCLEP without further action by the laboratory. Additional personnel may be designated to submit changes by the laboratory director; this individual(s) is known as a Designated Submitter. If your laboratory has already submitted a Delegated Submitter form for the eCLEP, it is not necessary to send a duplicate.

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* The document is available as Adobe Portable Document Format (PDF) files. The Adobe Acrobat Reader software is required to view and print these forms. [ HELP with PDF files.]

Requests for the document in an alternate format can be requested by sending an e-mail note to CLEP@health.state.ny.us