Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from Wisconsin State Laboratory of Hygiene (WSLH) and an interview with the laboratory lead on 1/17 /2024, the laboratory failed to sign PT attestations for 2023. The findings include: 1. A review of PT records from WSLH for the two events in 2023 identified that the laboratory director and testing personnel failed to sign the attestation statements for potassium hydroxide (KOH) slide examination testing for all 2023 events. 2. An interview with the laboratory lead on 1/17/2024 at 8:29 am confirmed that the laboratory director and testing personnel failed to sign attestation statements for all KOH PT 2023 events. 3. The laboratory reports performing 1,000 KOH slide examination tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Academy of Family Physicians (AAFP) and Wisconsin State Laboratory of Hygiene (WSLH) and an interview with the laboratory lead on 1/17/2024, the laboratory director failed to 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 -- review PT results for 2022 and 2023. The findings include: 1. A review of PT records from AAFP for the three events in 2022 identified that the laboratory director failed to review and evaluate graded results for potassium hydroxide (KOH) slide examination testing for all 2022 events. 2. A review of PT records from WSLH for the two events in 2023 identified that the laboratory director failed to review and evaluate graded results for KOH testing for all 2023 events. 3. An interview with the laboratory lead on 1/17/2024 at 8:29 am confirmed that the laboratory director failed to review and evaluate the graded KOH PT results for all events in 2022 and 2023. 4. The laboratory reports performing 1,000 KOH slide examination tests annually. 5. This is a repeat deficiency from the 2/17/2022 survey. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a lack of documentation of verification of performance specifications for digital pathology and an interview with the laboratory lead on 1/17/2024, the laboratory failed to ensure test performance specifications were established and verified before patient testing began in October 2022. The findings include: 1. A lack of documentation for the verification of performance specifications for digital pathology identified that the laboratory failed to establish diagnostic concordance between digital images and glass slides before converting to digital pathology in October 2022. 2. A lack of documentation for the verification of performance specifications for digital pathology identified that the laboratory failed to confirm that digital images and patient information transmitted by the reference laboratory were received in their entirety and accurate. 3. An interview with the laboratory lead on 1/17 /2024 at 8:27 am confirmed the above findings. 4. The laboratory reports performing 648 dermatopathology cases annually. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of patient reports and an interview with the laboratory lead on 1/17 -- 2 of 6 -- /2024, the laboratory failed to have documentation of Hematoxylin and Eosin (H&E) stain quality control (QC) since October 2022. The findings include: 1. A review of patient reports identified that the laboratory failed to document QC of H&E stained slides after converting to digital pathology in October 2022. 2. An interview with the laboratory lead on 1/17/2024 at 9:08 am confirmed that the laboratory failed to have documentation of H&E stain QC since October 2022. 3. The laboratory reports performing 648 dermatopathology cases annually. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a review of proficiency testing (PT) documents from American Academy of Family Physicians (AAFP) and Wisconsin State Laboratory of Hygiene (WSLH), the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, training and competency assessment records, laboratory policies and procedures, a lack of documentation and interviews with the laboratory lead on 1/17/2024, the laboratory director failed to ensure that digital pathology verifications were performed, that PT graded results were reviewed, that testing personnel had appropriate training and were competent to perform testing, to ensure policies and procedures were available for testing personnel to follow, that quality controls were documented for patient result reporting and that the laboratory had a quality assurance plan. See D6082, D6091, D6093, D6094, D6103 and D6106. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on a lack of documentation for the verification of performance specifications for digital pathology and an interview with the laboratory lead on 1/17/2024, the laboratory director failed to ensure test performance specifications were established and verified before beginning patient testing in October 2022. The findings include: 1. A lack of documentation for the verification of performance specifications for digital pathology identified that the laboratory failed to establish diagnostic concordance between digital images and glass slides and verify that digital images and patient information transmitted by the reference laboratory was accurate before converting to digital pathology in October 2022. See D5423 2. An interview with the laboratory lead on 1/17/2024 at 8:27 am confirmed the above findings. 3. The laboratory reports performing 648 dermatopathology cases annually. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) -- 3 of 6 -- The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require