Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Oyster Point Dermatology, INC. on February 6, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of procedures and policies, proficiency testing (PT) logs, and an interview, the laboratory failed to perform accuracy evaluations twice a year for MOHS testing in calendar year 2017. Findings include: 1. Review of the laboratory's procedure manual revealed a PT policy that stated, "twice yearly slides from at least 2 MOHS cases are sent to and evaluated for accuracy by a qualified MOHS surgeon, dermatologist, and/or the American Society of MOHS Surgery Peer Review Program". 2. Review of the laboratory's 2017 and 2018 Proficiency Testing Logs revealed that one (1) peer review PT evaluation was documented during calendar year 2017 (dated 11/8/17). The inspector requested to review additional documentation of MOHS accuracy evaluations in calendar year 2017. No other records were available for review. 3. In an exit interview with the lab director, histotechnologist, and office manager at approximately 12:00 PM, the above findings were confirmed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --