Integrated Dermatology Of Tidewater-Norfolk

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Integrated Dermatology of Tidewater on November 18, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 11/6/2020 and virtual record review conducted on 11/9/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. 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 the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), proficiency testing (PT) records, procedures, lack of documentation, and interviews, the laboratory failed to verify the accuracy of Mycology Potassium Hydroxide (KOH) microscopy testing twice annually during the twenty-six (26) months reviewed. Findings include: 1. Review of the laboratory's CMS 209 personnel form, during the virtual record review on 11/9/20, revealed that one (1) testing personnel performed patient mycology KOH microscopy examinations. 2. Review of the laboratory's available PT documentation from August 2018 to 11/9/20 revealed no accuracy verification for mycology KOH microscopy examinations. The inspector requested to review documentation for twice annual accuracy checks. No records were available for review. 3. Review of the laboratory procedures revealed a Proficiency Testing protocol that stated: "Peer review for accuracy checks are requested twice annually". 4. In an interview with the office manager on 11/18/20, 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 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Integrated Dermatology of Tidewater on July 25, 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: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of policies, temperature logs, patient logs, and interview, the laboratory failed to document the cryostat equipment temperature on three (3) dates of patient testing in the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's policy manual revealed a "Thermometer and Temperature" policy that stated: "record the cryostat temperature and lab area for each day of operation". 2. Review of the laboratory's Cryostat Temperature charts from August 2016 to the date of the survey on July 25, 2018, revealed that the laboratory failed to document temperatures on: 2/20/17, 8/19/18, and 9/16/18. 3. Review of the patient MOHS test logs revealed that the laboratory reported the following number of cases on the dates outlined above: 2/20/17- Case numbers 007, 008, 009, 010, 011, 012, 013, 014, 015; 8 /19/18- Case numbers 056, 057, 058, 059, 060, 061, 062; 9/16/18- Case numbers 063, 064, 065, 066, 067, 068, 069, 070, 071; a total of twenty-five (25) MOHS patient cases. 4. In an interview with the nurse manager at approximately 3:30 PM, it was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- confirmed that the laboratory failed to document the crytostat temperature, according to their policy, as outlined above in calendar year 2017 and 2018. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of policies, instrument maintenance logs, patient logs, and an interview, the laboratory failed to perform and document equipment maintenance on three (3) dates of patient testing in the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's policy manual revealed a "Cryostat Maintenance" policy that stated: "all required maintenance procedures will be documented on the cryostat maintenance record chart". 2. Review of the laboratory's Tanner Cryostat instrument maintenance charts from August 2016 to the date of the survey on July 25, 2018, revealed the following required daily maintenance procedures: clean debris, insert clean blade in blade holder, return clean check holders to cryostat cup, oil cryostat, manually defrost and/or decontaminate cryostat, clean work areas with 10 percent bleach, and complete biohazard clean procedures. The charts indicated that MOHS patient testing was performed once monthly. The chart review revealed that the laboratory failed to document performance of the maintenance listed above on: 2/20/17, 8/19/18, and 9/16/18. 3. Review of the patient MOHS test logs revealed that the laboratory reported the following number of cases on the dates outlined above: 2/20/17- Case numbers 007, 008, 009, 010, 011, 012, 013, 014, 015; 8/19/18- Case numbers 056, 057, 058, 059, 060, 061, 062; 9/16/18- Case numbers 063, 064, 065, 066, 067, 068, 069, 070, 071; a total of twenty-five (25) MOHS patient cases. 4. In an interview with the nurse manager at approximately 3:30 PM, it was confirmed that the laboratory failed to document required cryostat equipment maintenance, according to their policy, as outlined above in calendar year 2017 and 2018. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of temperature logs, instrument maintenance logs, quality assurance (QA) records, patient logs, and an interviews, the laboratory failed to identify and document problems in cryostat equipment maintenance and temperature documentation for three (3) days and twenty five (25) patients in calendar years 2017 -- 2 of 3 -- and 2018. Findings include: 1. Review of the laboratory's Cryostat Temperature and Maintenance charts from August 2016 to the date of the survey on July 25, 2018, revealed that the laboratory failed to document temperatures and maintenance on: 2/20 /17, 8/19/18, and 9/16/18 (Cross Reference D 5413 and D 5433). 2. Review of the patient MOHS test logs revealed that the laboratory reported the following number of cases on the dates outlined above: 2/20/17- Case numbers 007, 008, 009, 010, 011, 012, 013, 014, 015; 8/19/18- Case numbers 056, 057, 058, 059, 060, 061, 062; 9/16 /18- Case numbers 063, 064, 065, 066, 067, 068, 069, 070, 071; a total of twenty-five (25) MOHS patient cases. 3. Review of the laboratory's QA log revealed no documentation of