Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Forefront Dermatology SC (DBA: Ridgeview Dermatology) on March 24, 2022 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. The laboratory was not in compliance with: D6168 -42 C.F.R. 493. 1487 Condition: Testing Personnel. 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: A. Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), procedure manual, proficiency testing (PT) records, and an interview, the laboratory failed to verify Mohs Micrographic examination accuracy twice annually per their policy in the twenty-five (25) months reviewed for Testing Personnel A (TP A). *See Testing Personnel Code Sheet. Findings include: 1. Review of the laboratory's CMS 209 form revealed "TP A" was identified as performing patient Mohs Micrographic Surgery and slide examination /reading during the review timeframe of January 2020 to the date of the inspection on 3/24/22. 2. Review of the procedure manual revealed a written QA policy that outlined twice annual Mohs PT for accuracy documentation. The policy stated: "3 cases Mohs peer review will be verified semi-annually. 3 cases Frozen Section peer review will be verified semi-annually." 3. Review of the available PT records for 2020, 2021, and year to date 2022 revealed 1 record of Mohs peer review (3 cases: 20- 006, 20-132, 20-0283 on 12/8/21). The inspector requested additional documentation of Mohs PT for TP A. No additional documentation was available for review. 4. An interview with the clinic manager and lead tech on 3/24/22 at approximately 12:30 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 -- PM confirmed the above findings. B. Based on a review of the CMS 209 personnel form, procedure manual, PT records, and an interview, the laboratory failed to verify twice annual accuracy of Potassium Hydroxide (KOH) and Ectoparasite microscopy examination testing in the twenty-five (25) months reviewed for TP B. *See Testing Personnel Code Sheet. Findings include: 1. Review of the laboratory's CMS 209 form revealed that "TP B" was identified as responsible for performing patient KOH /Ectoparasite microscopy examination testing during the review timeframe of January 2020 to the date of the inspection on 3/24/22. 2. Review of the procedure manual revealed a written quality assurance (QA) policy that outlined twice annual proficiency testing (PT) for accuracy documentation. 3. Review of the available PT records for 2020, 2021, and year to date 2022 revealed one record of KOH /Ectoparasite PT (signed/dated by TP B on 12/21/21). The inspector requested additional documentation of microscopy PT. No additional documentation was available for review. 4. An interview with the clinic manager and lead tech at approximately 12:30 PM confirmed the above findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of equipment maintenance logs, manufacturer's operations manual, lack of documentation, and interviews, the laboratory failed to document performance of required fume hood filter replacement maintenance according to manufacturer's instructions in the twenty-five (25) months reviewed (January 2020 to March 24, 2022). Findings include: 1. Review of the laboratory's equipment maintenance logs revealed no fume hood maintenance in calendar years 2020, 2021 and up to the date of the inspection on 3/24/22. The inspector noted that no filter replacement was documented. Documentation of filter replacement was requested. No records were available. 2. Review of the LabConCo Fume Adsorber Operations Manual revealed instruction statements: "It is important to include filter replacement in routine preventative maintenance schedule. Monthly routine maintenance requires monitoring and/or replacement of carbon filter. Time can be used to anticipate saturation or TWA (recommended Exposure Limits expressed as a Time Weighted Average) levels. However, this does not replace the need for sampling. Consult LabConCo technical specialist for an estimate of carbon filter lifebased on chemical usage. The carbon filters must be checked at intervals of 20% of the total estimated filter life. The exception to the 20% recommendation is formaldehyde and any carcinogen or suspected carcinogen. These more hazardous chemicals must be checked at least every 10% of the total estimated time". 3. The inspector inquired regarding the protocol for changing the fume hood charcoal filter. The lead histotech stated at approximately 11:30 AM: "We have Marston Technical Services provide maintenance for all of our lab equipment. I do not recall that they checked or replaced the filters but I can contact them regarding the LabConCo Fume hood." The inspector requested to review the Marston Technical Services field service maintenance reports for calendar year 2020 and 2021. No records were available for the LabConCo Fume Adsorber hood. 4. An interview with the clinic manager and lead tech at approximately 12:30 PM confirmed the above findings. -- 2 of 5 -- D5785