Summary:
Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on the lack of policies and procedures, review of randomly chosen patient test records, and interview with the surgical technician (ST), it was determined that the laboratory failed to provide an approved and signed policy and procedure for retention and storage requirements. Findings include: 1. In reference to the retention requirements in 42 CFR Part 493.1105a, the laboratory is herein cited for the deficient practice of lacking an approved and signed retention and storage requirements policy and procedure. 2. The ST stated during an interview at 11:45 a.m. on December 9, 2024, that the laboratory does not have an official policy and procedure for record retention and storage but kept records for a minimum of seven years. 3. Based on the laboratory's testing declaration submitted at the time of the survey, the laboratory performed 300 Mohs patient samples during the time that no retention and storage policy and procedure was implemented. 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. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies and procedures, peer review records, five (5) randomly selected patient records, and an interview with the surgical technician (ST); it was determined that the laboratory failed to verify the accuracy of dermatopathology testing at least twice annually for the years 2022, 2023, and 2024. The findings include: 1. Based on the surveyor's review of the laboratory's policies and procedures and 5 randomly selected patient records, no peer review records could be retrieved for the years 2022, 2023, and 2024. Therefore, the accuracy of patient results could not be assured. 2. The ST affirmed by interview on December 9, 2024, at approximately 12:05 p.m., that the laboratory missed performing peer review as mentioned in statement #1. 3. Based on the laboratory's testing declaration form submitted at the time of the survey, the laboratory performed 300 tests in dermatopathology annually during the time that no peer review was performed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, equipment function check documentation, five (5) randomly selected Mohs patient test records, and an interview with the surgical technician (ST), it was determined that the laboratory failed to ensure function checks performed were monitored and documented properly prior to patient testing. The findings include: 1. Based on the review of equipment function check documentation on December 9, 2024, at approximately 12:30 p.m., the cryostat temperature was out of range on 3/18/2024 prior to patient testing. The acceptable temperature range was between -18C and -30C, and the temperature recorded for the day of the procedure performed was -16C. 2. Based on the review of 5 randomly selected Mohs patient test records, one out of five records, case number M24-071, was performed on 3/18/2024 when the cryostat temperature recorded was out of range (-16C). Upon further review of the log sheet, the temperature on 3/11 /2024 was also out of range (-17C). 3. The ST affirmed by interview at approximately 12:30 p.m. on December 9, 2024, that the laboratory had recorded an out-of-range temperature on the dates mentioned in statement #2 prior to patient testing. 4. Based on the annual testing declaration form submitted at the time of the survey, the laboratory performed and reported approximately 300 patient tests for Mohs, including the time the cryostat temperature was out of range. Thus, the quality and accuracy of patient reports cannot be assured. D5779