Physician Office Laboratory Evaluation Program (POLEP) - In the News
Notification of Incorrect Labeling -
Roche CoaguChek XS Plus System
(August 2010)
Roche Diagnostics recently notified the Department of incorrect labeling for the Coaguchek XS Plus system for professional use. The system was announced by Roche as being a waived device; however, this labeling only applies to the home use of the device and use in a professional setting (such as a physician office laboratory) is considered by the FDA as moderate complexity. Roche Diagnostics has released an Analyzer Bulletin notifying users that laboratories using the Coaguchek XS Plus system must follow CLIA Moderate Complexity guidelines. This affects all laboratories, including physician office laboratories (POLs), in New York State. If you are a POL with a Certificate of Waiver currently using the device, you may apply for a Certificate of Compliance to continue use or stop testing with the Roche instrument until the labeling issue is resolved. For future information on certificate requirements, please contact POLEP by phone or email using the information on the right hand side of this page.
COLA Ceases Accreditation for Physician Office Laboratories Performing Pathology (July 2010)
CMS has recently informed the New York State agency that COLA, an accrediting agency for physician office laboratories (POLs), has ceased CLIA certification in the specialties of histopathology and cytopathology. This affects all POLs in New York performing the technical or professional components of pathology specimen examinations that are currently accredited by COLA.
Although COLA's letter to laboratories outlined several options, POLs operating in New York State have only one option: CMS/CLIA certification with the NYS Physician Office Laboratory Evaluation Program for all testing performed in the laboratory. Laboratories are unable to retain COLA accreditation for other testing performed in the same laboratory that performs pathology testing. A completed CMS-116 application must be submitted to POLEP within sixty days of July 1, 2010 or risk termination.
POLEP will be working to make this transition to CLIA certification as seamless as possible. If you have any questions please contact us by phone or email (see contact information on the right side of this page).
Lead Poisoning Prevention Awareness Stressed by Health Commissioner Daines (June 2009)
The Health Department is committed to advancing Governor Paterson's new initiatives to eliminate childhood lead poisoning. The Department has updated lead poisoning prevention regulations and issued good laboratory practice guidelines for health care providers using point-of-care waived lead screening devices in physician office laboratories (POLs). A pamphlet explaining the meaning of blood lead test results to practitioner´s patients is also available for copying and use within your practice. More information about lead poisoning and prevention can be found Department´s Lead website.
Access to blood lead testing has potential to expand greatly with the availability to health care providers of point-of-care devices for use in POLs. The Department has issued a standards of practice document outlining good laboratory practices for blood lead screening using waived devices and strongly recommends that all POLs performing lead screenings review and implement these guidelines to ensure accurate and reliable lead screening results.
Medicaid reimbursement for blood lead screenings performed in POLs will commence on September 1, 2009. At that time, POLs seeking reimbursement from Medicaid for in-office lead screening tests will be required to implement the practices outlined in the guidance document as a condition for reimbursement. Further information on reimbursement from Medicaid is available on the NYS Department of Health´s Medicaid Update webpage.