Centracare Clinic- Plaza Dermatology

Summary Statement of Deficiencies D0000 The CentraCare Clinic Dermatology laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on February 22,2024. The following standard-level deficiencies were cited: 493.1236 Evaluation of proficiency testing performance 493.1273 Histopathology 493.1407 Laboratory director responsibilities . 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 document review and interview with laboratory personnel, the laboratory failed to perform and document testing accuracy verification activities for 2 of 3 microscopic examinations at least twice annually in 2022 and 2023. Findings are as follows: 1. The laboratory performed parasite and virus microscopic examinations under the specialty of Microbiology as confirmed by the Dermatology Manager (DM) during a tour of the laboratory at 10:05 a.m. on 02/22/24. 2. Twice annual verification of testing accuracy requirements for Scabies parasite preparations (S), and Tzanck virus preparations (T) were established in the Lab Quality Assurance Program policy and procedure found in the CLIA Quality Control manual. 3. Parasite and virus microscopic examination verification of testing accuracy documentation was not found during review of 2022 laboratory records. One parasite microscopic examination verification and zero virus microscopic examination verifications were found during review of laboratory records from 2023. The laboratory was unable to provide the missing documentation upon request. 4. The laboratory's KOH Logbook patient testing log found in the KOH Logbook manual indicated patient samples received microscopic examinations for parasites in 2022 and 2023. See below. 2022 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 -- Test Number of patients S 4 T 0 2023 Test Number of patients S 7 T 0 5. In an interview at 11:50 a.m. on 02/22/24, the DM confirmed the above finding. *This is a repeat deficiency from the 03/28/22 recertification survey.* D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to retain lot number and expiration date records for two of two stains used for Histopathology testing in 2022, 2023, and 2024. Findings include: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Mohs technician (MT) during a tour of the laboratory at 10:05 a.m. on 02/22/24. 2. A Thermo Scientific Linistat automated linear slide stainer loaded with Hematoxylin and Eosin stains was observed in use during the tour. 3. Documentation of reagent lot numbers and expiration dates was required as established in the Lab Quality Assurance Program policy and procedure found in the CLIA Quality Control manual. 4. Documentation of Hematoxylin and Eosin stain lot numbers and expiration dates was not found from 03 /29/22 through date of survey during review of 2022, 2023, and 2024 laboratory records. The laboratory was unable to provide the missing documentation upon request. 5. In an interview at 11:55 a.m. on 02/22/24, the MT confirmed the above finding. . D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director failed to ensure established quality assurance procedures were followed in 2022 and 2023. Findings are as follows: 1. The laboratory performed microscopic examinations for parasites and viruses under the specialty of Microbiology as confirmed by the Dermatology Manager (DM) during a tour of the laboratory at 10:05 a.m. on 02/22/24. 2. Twice annual verification of testing accuracy requirements for Scabies parasite preparations (S), and Tzanck virus preparations (T) were established in the Lab Quality Assurance Program policy and procedure found in the CLIA Quality Control manual. 3. The twice annual verification of parasite and virus testing accuracy policy was not followed in 2022 and 2023. See D5217. 4. This finding is a repeat deficiency from the 03/28/22 recertification survey. 5. In an interview at 11:50 a.m. on 02/22/24, the DM confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the laboratory failed to perform and document testing accuracy verification activities for 3 of 3 microscopic examinations at least twice annually in 2021. Findings are as follows: 1. The laboratory performed microscopic examinations for fungus, parasites, and viruses under the specialty of Microbiology as confirmed by the Dermatology Manager (DM) during a tour of the laboratory at 10:00 a.m. on 03/28/22. 2. Requirements for twice annual verification of accuracy testing for KOH fungal preparations (KOH), Scabies parasite preparations (S), and Tzanck virus preparations (T) were established in the laboratory's Dermatology Quality Assurance Plan found in the CLIA Quality Control manual. 3. Verification of testing accuracy documentation for the three microscopic examinations was not found during review of laboratory records from 2021. The laboratory was unable to provide the missing documentation upon request. 4. The laboratory's KOH, Tzanks (sic) and Scabies log indicated patient samples received microscopic examinations for fungus and parasites in 2021. See below. 2021 Test Number of patients KOH 66 S 5 T 0 5. In an interview at 11:30 a.m. on 03/28/22, the DM confirmed the above finding. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of a Histopathology test procedure at least twice annually. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery (MMS) testing under the subspecialty of Histopathology as confirmed by the Nurse Manager (NM) during a tour of the laboratory on 05/04/18 at 10:05 a.m. 2. Verification of accuracy requirements for the MMS testing were established in the Dermatology Quality Assurance Program policy provided by the laboratory. The laboratory required annual assessment of 1 case per Mohs physician. 3. Documentation of one 2017 MMS case verification was found in laboratory records. The laboratory was unable to provide additional MMS case verification records from 2017 upon request. A minimum of 2 cases must be verified annually. 4. In an interview on 05/04/18 at 12:15 p.m., the NM confirmed MMS accuracy had not been verified twice in 2017. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: 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 -- . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure Histopathology and Mycology testing materials were not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the subspecialty Histopathology and microscopic examinations for fungus under the subspecialty of Mycology as confirmed by the Nurse Manager (NM) during a tour of the laboratory on 05/04/18 at 10:05 a.m. 2. Expired tissue marking materials were observed as present and available for use during the tour of the laboratory. See below. -Cancer Diagnostics Tissue Marking Dye, Black Lot 15240 Expiration 07/2017 -Cancer Diagnostics Tissue Marking Dye, Violet Lot 15169 Expiration 12/2016 -Cancer Diagnostics Tissue Marking Dye, Orange Lot 15169 Expiration 12/2016 -Cancer Diagnostics Tissue Marking Dye Lot 16161 Expiration 12/2017 3. Expired fungal stain was observed as present and available for use during the tour of the laboratory. See below. -Chlorazol Black E Lot 5315 Expiration 11/11/2017 4. In an interview on 05/04/18 at 10:30 a.m., the NM confirmed the above materials were used after the expiration date had been exceeded. -- 2 of 2 --