Laboratory Testing Surgical Pathology

 

Health Testing Services – Florida Statutes Chapter 483

Clinical Laboratories – Florida Administrative Code Chapter 59A-7 

Florida Cancer Data System – Florida Administrative Code Chapter 64D-3.034 

 

Laboratory Tests

Some surgical centers elect to perform minimal lab tests such as hemoglobin or urinalysis. For this, the center must apply for a CLIA waiver. A call to the Agency for Health Care Administration will provide the application materials.

No laboratory tests are required for a patient to have surgery at a surgery center. The need for medical testing information is the decision of the anesthetist and surgeon.

Surgical Pathology Reporting And On Site Frozen Section Services

Laboratory reports must be provided by a state licensed laboratory. If the surgical center is sending specimens to a pathology lab, an agreement and a copy of that pathology laboratory license will be the only items necessary for regulatory compliance.

If the surgical center also has on site frozen section services, where a pathologist comes to the surgery center to provide interpretation of findings on frozen sections of specimens, the surgical center must have a license for the pathology laboratory site located at the surgical center. The surgical pathology service you select will handle this laboratory licensure.

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 ā€‘ 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 ā€‘ 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 10Dā€‘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.