Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology and Skin Care Specialists on June 27, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the laboratory's policy manual, quality assurance (QA) records, patient logs, and an interview, the laboratory failed to enroll in proficiency testing (PT) for Dermatophyte test medium (DTM) fungal cultures in calendar years 2016, 2017, and year to date 2018. Findings include: 1. Review of the laboratory's Dermatology Practice Administration CLIA Manual revealed a QA policy for proficiency testing. The policy states that the laboratory will participate in PT or perform split sample for the DTM testing performed. 2. Review of the available QA records revealed no PT or split sample study documentation in calendar years 2016, 2017, or 2018. The inspector requested to review documentation of split sample or proficiency testing for DTM cultures. The documentation was not available for review. 3. Review of the DTM patient log books from 6/14/16 to 6/27/18 revealed that the laboratory performed and reported thirty-six (36) patient cultures. 4. In an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- interview with the primary testing personnel at approximately 2:30 PM on 6/27/18, it was confirmed that the laboratory failed to participate in PT for DTM cultures in calendar years 2016, 2017, and 2018. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of patient test culture logs, temperature monitoring records, available quality control (QC) records, and interviews, the laboratory failed to document monitoring and