1. On Site Laboratory Licensure
The area for providing frozen section services must be licensed as a separate testing site of the laboratory. It is the responsibility of the laboratory to notify AHCA of the request for licensure in histology at a new site. A state inspection team will be dispatched to inspect the testing site. The laboratory must send the appropriate licensed personnel to meet the inspectors. After the initial survey, inspections are conducted unannounced every two years.
2. Licensure Requirements
The inspector will determine if the space and equipment are suitable and will inspect the laboratory under the CLIA histology checklist.
Technical Documentation ‑ The inspector will require: (1) a written procedure manual signed by the laboratory medical director and (2) quality assurance data including temperature charts, machine maintenance records and specimen receipt logs.
Safety Policies ‑ The inspector will survey for compliance with safety rules pertaining to: (1) Occupational Exposure to Bloodborne Pathogens (29CFR 1910.1030), (2) Occupational Exposure To Formaldehyde (29CFR Part 1910), (3) Florida Health and Rehabilitative Services (HRS) Bio Waste Removal (Chapter 10D‑104 Florida Administrative Code), and (4) Occupational Exposure To Hazardous Chemicals found in Laboratories (29CFR 1910.1450). The laboratory will provide safety training and equipment pertaining to frozen section coverage. There must also be documentation that the laboratory employees servicing the surgery centers are trained under the ASC general safety program. The ASC is required to have a formaldehyde training and monitoring program for all employees.
3. Facility Space Requirement
The histology laboratory space should be no less than 100 square feet and must include a sink, floor space for stand up cryostat (approximately 24″ W x 32″ D x 48″ H) storage cabinet for supplies and counter space for staining, cutting and microscopic interpretation. Proper lighting over counter is required. Normally, the laboratory dispatches a histotechnologist and a pathologist to complete the frozen section. Therefore space for two people to work comfortably is required.
4. Notices
The name of the laboratory, laboratory licenses and personnel licenses must be posted. Also safety signs (including biohazard warnings and formaldehyde warning) must be visible in the workplace. Employees of the laboratory must wear name tags to identify them as employees of a separate entity.
5. Pathologist Credentialing
It will be required that the pathologist performing frozen sections on site be credentialed by the ASC. Participation in various ASC committees such as tissue committee may be required by the surgery center.
6. Conclusion
The best way to assure compliance with necessary rules and regulations is to contract with a laboratory experienced in providing services to ambulatory surgery centers. In choosing a laboratory to provide services the following parameters should be considered:
a. Accreditation by the College of American Pathologists (CAP) in anatomic pathology;
b. Licensure in histology under Florida Agency for Health Care Administration (AHCA) and the Clinical Laboratory Improvement Act (CLIA);
c. Personnel duly licensed by the Florida Department of Business and Professional Regulation (DBPR) as pathologists and histotechnologists;
d. Service capabilities including courier pick up and delivery, provision of supplies, on site printing of reports, rapid turn around time and timely cost effective billing;
e. Capacity to provide frozen section coverage within 48 hour notice.
