Summary:
Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the clinical administrator, the laboratory did not ensure that PT was performed at least twice annually. Findings: 1. The laboratory sends 4 already completed/reported slides twice a year to Aurora Diagnostics in Sterling, VA to be reviewed. The results of this review by the outside laboratory are to be compared to the original report and evaluated for accuracy. 2. A review of PT records from 2020 showed that the laboratory had sent slides to Aurora Diagnostics on 5/18/2020 and 11/6/2020. At the time of the survey, the outside laboratory had not returned the slides or their interpretation of the slides to the laboratory. 3. During an interview on 11/13/2020 at 10:15 AM the clinical administrator stated that they had called the outside laboratory "repeatedly" requesting the return of the slides and interpretations, but that the outside laboratory stated that they had not reviewed the slides yet due to reduced staffing due to the COVID-19 pandemic. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (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 procedure manual and temperature and humidity log record review and interview with the clinical administrator, the laboratory failed to define, monitor, and document the laboratory's acceptable range for room humidity to ensure reliable test system operation. Findings: 1. The laboratory operates approximately once a month, when Mohs surgery is performed at the dermatology office it serves. The laboratory's room and cryostat temperatures and ambient humidity are documented on a log, each day of patient testing. 2. Procedure manual review showed that the acceptable range for ambient humidity in the laboratory was not defined. 3. A review of temperature and humidity logs showed that room and cryostat temperatures and ambient humidity were documented 3 times in 2019 and 12 times in 2020. The acceptable range for humidity was not included on the temperature and humidity log. 4. During an interview on 11/13/2020 at 10:30 AM, the clinical administrator confirmed that the acceptable criteria for the laboratory's ambient humidity had not been defined and monitored to ensure reliable test system operation. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on procedure manual and quality assurance (QA) record review and interview with the clinical administrator, the laboratory failed to follow written policies and procedures for performing post-analytic assessments of test report accuracy as stated in the laboratory's QA plan. Findings: 1. Once a month, as part of the laboratory's QA activities the laboratory randomly selects a patient to review and follow through the pre-analytic, analytic, and post-analytic phases of testing. The results of this review are documented on the "Monthly Quality Assurance Checklist." 2. The procedure, "Section 8: PROFICIENCY TESTING & QUALITY ASSURANCE", "Monthly Quality Assurance" states that "Monthly the nurse or tech will check off the Monthly Quality Assurance Checklist" and that "The lab director will also review and sign off the checklist monthly." 3. A review of "Monthly Quality Assurance Checklists" for 2020 showed that the doctor who performs the laboratory testing, viewing and interpreting histological slides was the one who signed the checklists, not the laboratory director. 4. During an interview on 11/13/2020 at 10:30 AM, the clinical administrator confirmed that QA reviews were not performed as instructed in the laboratory's procedure manual. -- 2 of 2 --