Summary:
Summary Statement of Deficiencies D0000 An initial survey was performed on April 15, 2025. The facility was found to be NOT in compliance with the following CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1230 - General Laboratory Systems D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor review of Histopathology records and staff interviews, the laboratory failed to ensure positive identification and optimum integrity of 7 out of 9 dermatopathology specimens from the time of collection through completion of testing and reporting of test results (refer to D5203); and failed to monitor, identify and correct errors found with positive identification and optimum integrity of dermatopathology specimens (refer to D5291). The number and severity of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- results. This STANDARD is not met as evidenced by: Based on review of 7 out of 9 Mohs test records on April 15, 2025, lack of established policies and procedures and interview with the facility personnel, the laboratory failed to ensure positive identification and optimum integrity of dermatopathology specimens from the time of collection through completion of testing and reporting of test results. Findings include: 1. The laboratory performs testing in conjunction with the Mohs procedure under the subspecialty of histopathology, with a reported annual test volume of 456. It is the practice of the laboratory to assign a unique accession number to each Mohs specimen which is documented on the laboratory's Mohs log, Mohs map and patient's slides. The final pathology report is maintained in the patient's EHR (Electronic Health Record). 2. The laboratory failed to ensure positive identification and optimum integrity of 7 out of 9 patient's specimens from the time of collection or receipt of the specimen through completion of testing and reporting of results, as evidenced below: - One of one Mohs map reviewed from 1/20/25 failed to include the accession number of the Mohs specimen. - One of one Mohs map reviewed from 2/03/25 failed to include the accession number of the Mohs specimen. - Mohs case# P017-2025 (as documented in the log book) failed to include the accession number of the Mohs map. - Mohs case# P004-2025 (as documented in the log book) failed to include the accession number of the Mohs map. - Mohs case# P139-2023 failed to include an accurate test result in the EHR. The Mohs map stated, "Stage 1: Positive in Deep Margin." The test result documented in the patient's EHR stated, "Stage 1: Frozen section analysis showed: No residual tumor seen. Histology: There were no malignant cells seen in the sections examined." - The Mohs map for case# P010-2025 (as documented on the laboratory's Mohs log and patient's slides) contained an incorrect accession number (P004-2025). - Two out of four slides for Mohs case# P255-2024 were labeled with an incorrect testing date (4-14-24). The correct testing date for case# P255-2024 was 4-15-24 as verified by laboratory personnel. 3. No documentation was presented for review to indicate the laboratory established written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. 4. The facility personnel interviewed on 4/15/25 at 12:22 PM acknowledged the errors indicated above and confirmed that no policies and procedures were established by the laboratory that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of established quality assessment (QA) policies and procedures on April 15, 2025, review of the laboratory's Mohs log and interview with the facility personnel, the laboratory failed to monitor, assess and correct problems identified in -- 2 of 6 -- the general laboratory systems requirements specified at 493.1231 through 493.1236, including but not limited to, problems identified with specimen identification and integrity. Findings include: 1. It is the practice of the laboratory to perform a monthly audit of one patient's Mohs record to ensure the case was performed and documented correctly throughout the preanalytic, analytic and postanalytic systems. 2. The laboratory's Mohs log reviewed from January 2025 revealed the laboratory staff wrote over and assigned different accession numbers to cases P007-2025 through P017- 2025. 3. Review of the monthly QA audit from 1-31-2025 indicated only one case was reviewed (P006-2025). 4. The laboratory failed to take action to identify errors or potential errors with the reassigned accession numbers for cases P007-2025 through P017-2025. 5. The laboratory's established QA procedures were not effective at monitoring, assessing and correcting errors found in the general laboratory systems, including but not limited to, ensuring the positive identification and optimum integrity of patient's specimens throughout the entire test process. 6. The facility personnel interviewed on 4/15/25 at 12:50 PM acknowledged that the laboratory failed to investigate errors or potential errors with the reassigned accession numbers from January 2025, and acknowledged that the laboratory's QA processes at the time of the survey were not effective at monitoring, assessing and correcting problems identified in the general laboratory system. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)