Westlake Dermatology And Cosmetic Surgery

Summary Statement of Deficiencies D0000 The Westlake Dermatology and Cosmetic Surgery laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey on 05/13/2026 and recertification is recommended. Standard level deficiencies were cited. 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 review of the laboratory's policy and procedure, accuracy assessments, pre- survey paperwork, and interview, the laboratory failed to verify the accuracy of grossing dermatopathology specimens at least twice annually for 2 of 2 years reviewed in 2024 and 2025. Findings follow. A. Review of the laboratory's policy and procedure titled Pathology Peer Review Protocol, effective 05/2022, did not include peer reviews for grossing. B. Accuracy assessments from 2024 and 2025 for grossing dermatopathology specimens were requested on May 13, 2026 at 1210 hours but not provided. C. Review of the CMS Form 116 showed an estimated annual volume of 47,085 cases, special stains, and IHCs (Immunohistochemical stains). D. Interview with the Laboratory Director on May 13, 2026 at 1210 hours in the breakroom confirmed they did not have peer reviews for grossing. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for 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 -- high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, competency evaluations, pre-survey paperwork, and interview, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing in diagnostic interpretations of dermatopathology specimens and individuals responsible for grossing dermatopathology specimens at least semiannually during the first year for 2 of 2 new employees. Findings follow. A. Review of the laboratory's policy and procedure titled Personnel Assessment Policy under Procedure at Personnel Competency Assessment stated, "Observed assessment of all personnel to include specimen handling, instrument use, proficiency testing, test reporting, worksheets and printouts, laboratory records, and communication skills. Performed at hire, 6 months, and annually thereafter. Technical Supervisor or Laboratory Manager, if qualified, is responsible to ensure testing personnel competency evaluations are performed in the required timeframes." B. 1. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #2 (as listed on the CMS form 209) responsible for diagnostic interpretations of dermatopathology specimens, was hired in July 2023 and completed training 07/05/2023. 2. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #5 responsible for grossing dermatopathology specimens, was hired in August 2024 and completed training 08/05 /2024. C. 1. Review of the laboratory records for testing personnel #2 showed one semi-annual competency evaluation performed 01/04/2024. A second semi-annual competency evaluation was requested on May 13, 2026 at 1110 hours but not provided. 2. Review of the laboratory records for testing personnel #5 showed one semi-annual competency evaluation performed 02/04/2025 and another performed 10 /09/2025 (elapsed time 1 year 2 months). D. Review of the CMS 116 showed approximately 47,085 cases, special stains, and IHCs (Immunohistochemical stains) were performed per year. E. Interview with the Laboratory Manager on May 13, 2026 at 1110 hours and 1120 hours in the breakroom confirmed the findings. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, competency evaluations, pre-survey paperwork, and interview, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing in diagnostic interpretations of dermatopathology specimens at least annually for one of three testing personnel in 2024. Findings follow. A. Review of the laboratory's policy and procedure titled Personnel Assessment Policy under Procedure at Personnel Competency Assessment stated, "Observed assessment of all personnel to include specimen handling, instrument use, proficiency testing, test reporting, worksheets and printouts, laboratory records, and communication skills. Performed at hire, 6 months, and annually thereafter. Technical Supervisor or Laboratory Manager, if qualified, is -- 2 of 3 -- responsible to ensure testing personnel competency evaluations are performed in the required timeframes." B. Review of annual competency evaluations from 2024 and 2025 for diagnostic interpretations in dermatopathology specimens for testing personnel #1 (as listed on the CMS form 209) showed none for 2024. Additional competency evaluations were requested but not provided on May 13, 2026 at 1110 hours. C. Review of the CMS 116 showed approximately 47,085 cases, special stains, and IHCs (Immunohistochemical stains) were performed per year. D. Interview with the Laboratory Manager on May 13, 2026 at 1110 hours in the breakroom confirmed they were missing a competency evaluation in 2024. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, test reports, and interview the laboratory failed to identify that the removal of the date on the slides made it impossible to determine when the quality control was prepared for one of 10 cases reviewed. Findings follow. A. Review of the laboratory policy and procedure titled Quality Assessment Plan under Purpose stated, "a quality assessment plan [was] designed to monitor and evaluate the ongoing and overall quality of pre-analytical, analytical, and post-analytical testing as a total process. The process begins with the test order and continues through collection, handling, testing of samples, and transmitting a report back to the person authorized to receive the results." B. Review of patient reports showed for case number PDP23-00123 was received on 07/21/2023 and reported on 07/24/2023. Review of the quality control slides for PAS showed quality control slides for the following dates: 07/21/2023 and 07/25/2023. Without dates on the slides, it was difficult to determine what date the patient/control slides were made. C. Interview with the Laboratory Manager on July 16, 2024 at 1725 hours acknowledged it was laboratory practice that on Day 1 the slide was processed, Day 2 the slides were interpreted and additional stains requested if needed, Day 3 additional slides prepared, and Day 4 slides interpreted. He confirmed it was impossible 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 2 -- determine when the slides were prepared without the date on the slide and acknowledged the slide may have been misfiled. And on July 16, 2024 at 1800 hours acknowledged they used to put the date prepared on the slides, but stopped including the date around July 2023 (elapsed time one year). D. Review of pre-survey paperwork showed the estimated annual test volume for dermatopathology was 36090. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of test reports, laboratory records and interview, the laboratory director failed to specify in writing the responsibilities and duties for two of three technical supervisors performing diagnostic interpretations in dermatopathology. Findings follow. A. Review of dermatopathology test reports (DP24-13254, DP24- 13448, DP23-19730) showed three personnel performing diagnostic interpretations: technical supervisor position required, per 42 CFR 493.1273 (b). B. Review of laboratory records found no written delegation of responsibilities and duties for technical supervisors #2 and 3 (as listed on the CMS form 209). C. Interview with the Laboratory Manager on July 16, 2024 at 1030 hours confirmed they currently had three dermatopathologists that performed diagnostic interpretations and written delegation of duties were not available for technical supervisors #2 and 3. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and certification is recommended. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, formaldehyde badge test, and interview, the laboratory failed to repeat the formaldehyde exposure monitoring test after a failed test occurred for one of two random employees tested in the last year. Findings follow. A. Review of the laboratory's policy and procedure titled Westlake Dermatopathology and Cosmetic Surgery Chemical Hygiene Plan, approved 10/10/2022, stated under "XII. Xylene and Formaldehyde Monitoring: ... 2. Formaldehyde is a common chemical used as a tissue preservative in laboratories. Formaldehyde is a common sensitizing agent found in laboratories that can trigger an allergic reaction in normal tissue after single or repeated exposures. It is also classified as a known to be a human carcinogen. Small formaldehyde specimen containers are used in the clinic. Samples are sent to a reference lab for processing. Monitoring is not required." The procedure does not recognize the laboratory is a grossing laboratory and does cut and stain specimens preserved in formaldehyde. B. Review of the Formaldehyde Personal Monitoring Badge test performed on December 21, 2021, showed a badge test failed for testing personnel #3, as listed on the CMS form 209. The Monitoring Compliance Information stated, for "OSHA: 0.75 ppm 8- 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 -- hour TWA; 2.0 ppm 15-minute STEL; 0.5 ppm 8-hour Action Level". And at requirements stated, "If the last monitoring results reveal employee exposure at or above the action level, the employer shall repeat the monitoring of the employees." The results for Badge SFM21714 reported on January 6, 2022, was 8-hour TWA: 0.54 ppm. C. Interview with the grossing lab manager on October 12, 2022, at 1325 in the conference room acknowledged that he missed that and will repeat it. -- 2 of 2 --