Western Wyoming Dermatology

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on review of the CMS-116 form, procedure manual review, and staff interview, the current laboratory director failed to sign, and date as approved, the laboratory's standard operating procedure and histopathology manuals. The findings were: 1. Review of the CMS-116 form showed a change of the laboratory director, effective 10/25/21, was approved on 10/27/21. 2. Review of the histopathology and standard operating manuals failed to include the current director's signature and date of approval. 3. Interview with the office manager and medical assistant on 4/26/22 at 8:27 AM confirmed the laboratory director had not reviewed and approved the procedure manuals. 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 D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on patient test records review, lack of documentation and interview with staff, the laboratory failed to retain 1 of 1 reference laboratory report for Mohs case #M19- 139. The laboratory performed approximately 200 Mohs frozen section cases per year. Findings include: 1. Mohs map for case M19-139 included the diagnosis for the original biopsy from the right lateral upper lip, specimen number C19-11193 for basal cell carcinoma. 2. In an interview with staff on 08/27/2020 at approximately 11:30 A. M., staff confirmed the laboratory failed to retain the test report for at least 10 years from the date of reporting. 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 lack of documentation and interview with staff, the laboratory failed to verify histopathology frozen section analysis to determine the persistance or absence of tumor cells for 1 of 2 years of testing reviewed from August 27, 2018 to August 27, 2020. The laboratory performed approximately 200 frozen section tests per year. 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 -- Findings include: 1. The laboratory failed to document histopathology of Mohs frozen section histopathology test accuracy twice in 2019. 2. In an interview conducted on 08 /27/2020 at approximately 1:30 P.M., staff confirmed the laboratory failed to verify histopathology testing at least twice annually in 2019. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review and interview with staff, the current laboratory director failed to sign and date as approved the current laboratory procedure manual. Findings include: 1. The laboratory procedure manual failed to include the current director's signature and date of approval. 2. In an interview conducted on 08/27/2020 at approximately 12:45 P.M., office staff confirmed the procedure manual failed to include the current director's signature and date of approval. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on procedure manual review and confirmation by staff the laboratory failed to document the dates mycology testing potassium hydroxide (KOH) and dermatophyte cultures were discontinued. Findings include: 1. The procedure manual included procedures for KOH and dermatophyte cultures. 2. The laboratory no longer performed KOH and dermatophyte culture testing. 3. In an interview conducted on 08 /27/2020 at approximately 12:30 P.M., laboratory staff confirmed the procedure manual failed to document the date the testing was discontinued. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on patient test record review, lack of documentation, electronic mail confirmation, and interview with staff, the laboratory failed to retain 1 of 11 Mohs micrographic surgery frozen section map for at least 2 years. The laboratory tested approximately 250 specimens per year; (approximately 3 to 5 cases 3 days per week). Findings include: 1. Patient test records review for Mohs frozen section specimen M18-002, collected on 01/08/2018, failed to include the specimen map used to record, spatially, each stage of removal for sections of affected skin to identify the persistence of presence or absence of tumor cells. 2. Electronic mail received on 05/08/2018 confirmed the map was not retrievable as scanned into the laboratory information system. 3. In an interview conducted on 05/04/2018 at approximately 5:30 P.M. the laboratory director stated the surgery map for specimen M18-002 was not readily available from the previous information system in use in January 2018. The final surgical report for the surgical specimen was located. 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 --