Clinical Laboratory Evaluation Program - In the News
National Medical Laboratory Professionals Week in New York State, April 20-26, 2008
Governor Paterson proclaims National Medical Laboratory Professionals Week, recognizing the contributions of clinical laboratories to the well-being of New Yorkers.
Article5 Title V Updated
Public Health Law (PDF 34k) has been amended by Chapter 317 of the Laws of 2007 to require electronic reporting and provide clear authority for the Commissioner of Health and local health officials to require clinical laboratories to submit specimens (e.g., sera) or their derivatives (e.g., culture isolates) whenever supplemental testing is necessary to confirm evidence of a disease or health condition otherwise required to be reported. The new provisions became effective July 18, 2007.
Part 70 Regulated Medical Waste
Good Laboratory Practices for Waived Testing Sites - MMWR Publication
Good Laboratory Practices for Waived Testing Sites - Survey Findings from Testing Sites Holding a Certificate of Waiver Under the Clinical Laboratory Improvement Amendments of 1988 and Recommendations for Promoting Quality Testing
Criminal History Record Checks for Phlebotomists
Department regulations that took effect April 1, 2005 mandate the use of criminal history record checks of employed persons involved in direct patient care by operators of residential health care facilities, AIDS home care programs, home care agencies, and other users of clinical laboratory services. The Department's Division of Legal Affairs has recently clarified that these amendments do NOT apply to phlebotomists and laboratory technical personnel sent into a nursing home or home care setting by a clinical laboratory. Such laboratory employees need not be fingerprinted since they are not persons used by the covered provider (i.e, the nursing home) to provide direct care or supervision to patients within the meaning of the regulation.
Amended Part 63
Impact On Laboratories
The recent case of multiple drug resistant HIV with apparent rapid progression to AIDS highlighted the need for better ways to track HIV drug resistance in the population. Laboratory reporting of HIV-related testing is necessary to monitor the suppression of HIV by antiretroviral therapy and, thus, the risk of drug resistance. With amendments to Part 63 regulations, effective June 1, 2005, laboratories conducting tests on specimens from New York State residents are required to report HIV resistance test results, non-detectable viral load test results and CD4 test results.
Part 63, as amended effective June 1, 2005, no longer includes two forms (i.e., Informed Consent to Perform an HIV Test; Authorization for the Release of Confidential HIV Related Information), but the forms will continue to be posted on the Department's web site. The new Informed Consent form documents patient authorization for HIV antibody testing and, if HIV-positive, for viral load testing and resistance testing; it also allows pregnant women to consent to more than one test during the same pregnancy.
Laboratories are reminded that the practitioner retains the patient-signed consent form and the practitioner is required by law to certify to the laboratory that informed consent had been obtained. The Department does not require laboratories to demand, or to be in possession of certification prior to performing the ordered HIV tests or releasing results. However, many laboratories have adopted policies that require practitioners to certify on each and every test requisition that they have obtained patients' informed consent. While the Department continues to encourage use of requisitions with dedicated space for practitioner certification, amended Part 63 gives laboratories flexibility to control costs and paperwork attributable to obtaining repetitive certifications. The new consent forms, available for use June 1, 2005 and after, and ensuing certifications are applicable to series of tests, meaning that a one-time certification covers not only antibody screening and confirmatory tests, but also any viral load and resistance testing ordered by the certifying practitioner for that patient. Laboratories may refer to one-time certifications on file rather than solicit repeat certifications, e.g., for a series of viral load analyses.
Education Law Article 165
Clinical Laboratory Technology Practice Act
On January 30, 2005 Governor Pataki signed a bill adding Article 165 to the Education Law, creating the Clinical Laboratory Technology Practice Act. This act establishes licensing requirements through the State Education Department Office of the Professions, for persons who perform clinical testing and related activities in clinical laboratory settings. The act defines the practice of clinical laboratory technology; establishes licensure requirements for clinical laboratory technologists and cytotechnologists; and establishes certification requirements for clinical laboratory technicians. These requirements are now in effect for all individuals practicing in permitted laboratories located in New York State, subject to certain exceptions.
Cytopathology changes
Effective December 29, 2004, 10 NYCRR Subpart 58-1 was amended to establish a mechanism for cytotechnologists using devices approved by the FDA to perform instrumented examinations of gynecologic slides to obtain approval to exceed the current work standard of 80 slides. Cytotechnologists previously approved to examine 96-100 slides may perform instrumented examinations up to the maximum designated in their existing approval; however, in order to exceed a number previously approved when conducting instrumented examinations, a new filing and approval is required. The amendment did not affect the requirement that workload limits be set by the laboratory director for each cytotechnologist on an individual basis.
This amendment to the regulation does not itself establish a new work standard; it provides the Department with the authority to establish a new work standard and it identifies the information that must be submitted to obtain approval. New cytopathology standards have been developed that establish instrument-specific workloads (i.e., the limitation on the actual number of slides that may be examined in a work day).
A form has been developed using the workload figures proposed in these draft technical standards to allow laboratories using instrumented cytology examinations to submit requests for approval for one or more cytotechnologists at this time; however, approvals will not be issued until the draft Technical Standards and specific workload figures are finalized.
If you have any questions concerning the new regulation, you may contact Betty Kusel, Director for Regulatory Affairs, at kusel@wadsworth.org, or by telephone at 518- 485-5357. Questions related to filing an application to exceed the work standard may be directed to Louise Newton at 518-474-6343.
December 2004 - Submission Guidelines
The Submission Guidelines have been updated and this Adobe Reader compatible form can now be completed online. The completed form should then ideally be forwarded as an attachment to CLEP@health.state.ny.us with the rest of the validation package. CLEP has set up a paperless review/archiving process, with a quicker turnaround time for laboratories that send their validation packages as email attachments. Electronic submissions are not mandatory, but the processing time will also be shortened if all mailed submissions contain only one sided and letter sized (8 x 11 inches) pages.
October 2001
October 15, 2001 - For questions on the identification and handling of suspicious mail, please see the U.S. Postal Service website www.usps.com/news/2001/press/pr01_1010tips.htm
October 12, 2001 - Guidance for handling clinical specimens for Bacillus anthracis in the clinical microbiology laboratory (PDF format *).
* 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