Patient Service Centers & Health Fairs

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 and/or temporary storage of materials derived from the human body until forwarded to the clinical laboratory for testing. Newly applied laboratories should wait until a New York State clinical laboratory permit is issued before applying for a patient service center.

Subpart 58-1 of Title 10 of the New York State Codes Rules and Regulations govern the operation of patient service centers.

 

Initial application

To apply for approval of a new Patient Service Center (PSC), the laboratory must request a New PSC in our web-based portal, eCLEP. Please see our Health Commerce System website for further information about eCLEP.  Please review the eCLEP Permit Materials Manual for information on navigating in eCLEP.   

Users will be required to have the following information on hand when entering the eCLEP request:

• Floorplan of the proposed PSC that illustrates the relationship between the PSC and any other health services purveyor(s) on the same floor of the building.
• Responses to the Self Assessment Questions.
• Copy of the lease, if applicable.
• The expected opening date of the PSC. 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, an Interim Approval 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.

The following definitions are applicable:

1. The "parent laboratory" is the clinical laboratory under permit that operates or proposes to operate the PSC named on the application form.
2. "Adjacent to" means within 100 feet of.
3. 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 

The laboratory must report any changes to the PSC; such as location, hours, contact person, closures, etc.) in our web-portal, eCLEP. Please see our Health Commerce System website for further information about eCLEP.  Please review the eCLEP Permit Materials Manual for information on navigating in eCLEP.   

Note that a change in location is treated like a new PSC application and the laboratory must provide a floorplan and respond to all the self assessment questions.

 

Policy for Revoking an Approval to Operate a Patient Service Center

Approval to operate a Patient Service Center (PSC) or to receive interim approvals may be rescinded when one of the following conditions occurs:

• When on-site survey identifies that the responses to questions answered on the PSC application and self-assessment were inaccurate or misrepresented and deficiencies are cited as a result,
• When there is a repeated pattern of deficiencies that indicates the parent laboratory is not routinely monitoring the PSCs to demonstrate compliance with Department requirements,
• When more than five (5) deficiencies have been cited for any one PSC during a survey event, and
• When a physical and/or structural change has been made to the PSC without notification to the Department such that the original application is no longer reflective of the actual circumstances of the PSC.

 

A laboratory holding clinical laboratory permit may also operate a Health Fair (or temporary collecting station) which is defined as a one-time, one-site facility 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 medical order.

Tests offered at the health fair must be appropriate for a health screen setting (i.e., testing for treatable diseases or of public health significance and preventable by early detection).

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.  Alternatively, the laboratory may refer the specimen to another laboratory that holds the appropriate New York State permit.

A laboratory procedure manual must be developed for health 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 for seven years.

Alternatively, laboratories holding a Limited Service Laboratory registration may request the addition of Community Screening to the registration.  Please call CLEP at 518-485-5378 if you have any questions.

 

Initial application

To apply for approval of a Health Fair (HF), the laboratory must make the request in our web-based portal, eCLEP. Please see our Health Commerce System website for further information about eCLEP.  Please review the eCLEP Permit Materials Manual for information on navigating in eCLEP.

 

Changes to a Health Fair

The laboratory must report any changes to the HF (such as contact person, or addition/removal of specific tests) in our web-portal, eCLEP. Please see our Health Commerce System website for further information about eCLEP.  Please review the eCLEP Permit Materials Manual for information on navigating in eCLEP.