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Patient Service Centers & Health Fairs

Laboratories holding permits may operate patient service centers or collecting stations, which are defined as a facility, fixed or mobile, operated by a clinical laboratory under permit, for the collection, drawing and/or temporary storage of materials derived from the human body, until forwarded to the clinical laboratory for testing.

A Health Fair or a temporary collecting station is a “one-time, one-site facility, operated by a clinical laboratory under permit, with the prior approval of the department, which collects, draws and/or temporarily stores materials derived from the human body, as part of a health fair, health assessment or health risk reduction program, for the purpose of screening for health risks under a general order (Part 58-1.7 Title 10 NYCRR).

Patient Service Centers (PSC)

Initial application

To apply for approval of a new Patient Service Center (PSC), the parent laboratory must complete and submit a PSC Application (instructions provided) / Location Change Form (instructions provided) including the self-assessment documenting that the PSC will be operated in compliance with Department requirements. Please allow at least two weeks to process these applications.

If the application is complete and the responses to the self-assessment questions are satisfactory, a letter will be issued granting approval to operate the new or relocated PSC for three months. An on-site survey will be conducted during this three-month period and if the PSC is found to be in compliance, the PSC approval certificate will be issued. Continuing on-site surveys of approved PSC sites will occur periodically. A PSC may not operate prior to the effective date indicated on the Interim Approval Letter.

All applicants are required to provide a floor plan of the PSC that illustrates the relationship between the PSC and any other health services purveyor(s).

Laboratories responding “yes” to question 5 must include a copy of the lease/rental agreement for the space occupied by the proposed PSC.

The following definitions are applicable:

  1. A patient service center is a facility, fixed or mobile, operated by a clinical laboratory under permit, for the collection, drawing and/or temporary storage of materials derived from the human body, until forwarded to the clinical laboratory for testing.
  2. The "parent laboratory" is the clinical laboratory under permit that operates or proposes to operate the PSC named on the application form.
  3. "Adjacent to" means within 100 feet of.
  4. Health services purveyor (HSP) means any person, firm, partnership, group, association, business corporation, not-for-profit corporation, professional corporation, limited liability company, or any agent, employee, fiduciary, employer or representative thereof, including, but not limited to, any entity that provides health related services, a physician, dentist, podiatrist, chiropractor, either in individual practice, group practice or employed in a facility owned by any person, group, association, firm, partnership, business corporation, not-for-profit corporation, professional corporation, limited liability company, hiring any one of the aforementioned practitioners who provides health or health related services.

 

Changes to Existing Patient Service Centers 

Location change: The parent laboratory must complete and submit a PSC Application (instructions provided) / Location Change Form (instructions provided) including the self-assessment documenting that the PSC will be operated in compliance with Department requirements.

Change in Owner

  1. Complete the appropriate sections of the PSC Change Form (instructions provided). Both the current parent laboratory and the new parent laboratory must submit letters acknowledging this change along with the change form.
  2. The new parent laboratory must submit the PSC Application (instructions provided) / Location Change Form (instructions provided).

Change in Parent Laboratory (same owner)

  • Intended for instances where an affiliated laboratory under common ownership assumes the PSC from another laboratory.
  • Complete the appropriate section of the PSC Change Form (instructions provided) and submit the form.

PSC Closure

  1. Complete the appropriate section of the PSC Change Form (instructions provided) and submit the form.
  2. Please return the current operating certificate for the closed PSC.

Health Fairs

To qualify for approval to operate a Health Fair, a laboratory must hold a New York State Clinical Laboratory permit, and must submit a Health Fair (Community Screening) Application (CLEP-HF) (instructions provided) at least two weeks prior to the Health Fair.

Tests performed should be those appropriate for a health screen setting, meeting criteria as set forth in Subsection 58-1.7 Title 10 NYCRR.

The laboratory must either hold a permit in the appropriate category for tests performed on site and/or for tests performed on specimens collected and transported back to the laboratory for analysis or refer the specimens to a laboratory that holds the appropriate New York State permit.

A laboratory procedure manual must be developed for such fairs and must be available for review by the department upon request. This manual must include the name of the authorizing physician who will request the tests for fair participants; who will give permission for results to be given directly to fair participants (if applicable); and who will be responsible for the referral of any abnormal results.

Accession and report records for all fair participants are considered patient records and must be retained as required by Subsection 58-1.11 Title 10 NYCRR.

Alternatively, facilities holding a Limited Service Laboratory registration may request the addition of Community Screening to the registration.