High Valley Dermatology

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, a lack of documentation and an interview with the laboratory lead on 8/25/2025, the laboratory failed to follow written procedures to assess testing personnel's training and competency for potassium hydroxide (KOH) examinations and the laboratory director failed to assess the competency of the technical supervisor (TS) in 2024 and 2025. The findings include: 1. A lack of training records identified two testing personnel listed on the CMS 209 hired since the last inspection on 5/31 /2023 that failed to have documentation of initial training for KOH examinations. 2. A lack of competency assessment records identified two testing personnel listed on the CMS 209 hired since the last inspection on 5/31/2023 that failed to have documentation of a six month competency assessment for KOH examinations. 3. A lack of competency assessment records for the TS identified one of two TS listed on the CMS 209 failed to have an annual TS competency assessment for 2024 and 2025. 4. An interview with the laboratory lead on 8/25/2025 at 2:12 pm confirmed the above findings. 5. The laboratory reports performing 950 tests annually. 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 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 results. This STANDARD is not met as evidenced by: Based on record review, policy and procedure review, and interview with the office manager, the laboratory failed to establish policies and procedures to ensure positive identification of histopathology tests. Findings include: 1. Record review of one of three Mohs test records, revealed that the laboratory failed to correct the specimen accession identification on the original Micrographic Surgery "EMF" report. The Mohs patient test log identified the slide as M23-048 performed on 05/11/2023. On 05 /17/2023 the slide was relabeled as M23-288. 2. Record review of pathology notes (EMF) indicates that the pathologist reevaluated the patient specimen size and determined that the tissue sample was adequate to be prepared for a histopathology slide (E23-048). 3. Record review of the "EMF" report revealed the laboratory failed to generate a corrected "EMF" report to reflect the changed identification numbers in the final report. 4. Policy and procedure review revealed that the laboratory failed to have policies and procedures to ensure that patient specimens reflect the identification through all the phases of testing. 5. Interview with the office manager confirmed on 05 /31/2023 at 03:22 PM that the laboratory does not have a policy or procedure that includes corrected reporting. 6. The laboratory reports performing 900 histopathology tests annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review of competency assessments and interview with the office manager, the laboratory failed to have policies and procedures to assess competency. Findings include: 1. Record review of histopathology competency assessment log "Mohs Log," revealed that the competency assessment log "Mohs log" does not indicate who was being assessed or who was the assessor. 2. Record review revealed that the laboratory failed to have policies and procedures to assess 2 of 2 testing personnel competencies. 3. Interview with office manager confirmed on 05/31/2023 at 04:20 PM confirmed that the laboratory failed to have policies and procedures to assess competency. 4. The laboratory performs approximately 900 histopathology and 50 KOH test annually. 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 record review and interview with the office manager, the laboratory failed to verify the accuracy of histopathology testing twice annually. Findings include: 1. Record review of twice annual verification for 2 of 2 testing personnel (TP), revealed that verification of accuracy for histopathology testing was performed when TP "needed assistance" for identification. 2. Interview with the office manager on 05/31 /2023 at 004:40 PM confirmed that twice annual verification done on histopathology was not performed in accordance with CLIA regulations. 3. The laboratory reports performing approximately 900 histopathology tests annually. 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 patient record review, lack of policy and procedure, and interview with the office manager the laboratory failed to have an ongoing mechanisms to monitor, assess, and correct problems. Findings include: 1. Record review of patient report #17123 collection date "05/11/2023 09:11" revealed 2 of 2 corrections reported on 05 /11/2023 at 05:16 PM MDT and on 05/17/2023 at 05:13 AM MDT. 2. Record review revealed no assessment performed for 2 of 2 corrections on patient report #17123. 3. Policy and procedure review revealed no mechanism was in place to monitor, assess and correct problems. 4. Interview with the office manager on 05/31/2023 at 03:22:00 PM confirmed that the laboratory does not have a policy or procedure to monitor, -- 2 of 4 -- assess, and correct problems. 5. The laboratory performs approximately 950 tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a record review of personnel competency assessments and an interview with the laboratory director, the laboratory failed to establish and follow procedures to assess the competency of 2 out of 2 testing personnel performing microscopic fungal examinations using potassium hydroxide (KOH) since the last survey on December 7, 2017. Findings: 1. A review of personnel documents and laboratory procedures and policies, revealed the laboratory failed to establish a policy to assess and document the competency of 2 out of 2 providers performing microscopic KOH exams since the last survey. 2. The laboratory performed approximately 90 KOH examinations in 2018. 3. An interview with the laboratory director on July 15, 2019, at 11:45 AM, confirmed the laboratory failed to establish in writing and document competency assessments for the testing personnel performing KOH examinations. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory director, the laboratory 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 -- director failed to ensure the laboratory established a policy or procedure for quality assessment activities in the laboratory in order to identify errors and correct problems since the last survey on December 7, 2017. Findings: 1. A review of the laboratory procedure manual revealed the laboratory failed to establish a quality assessment policy or procedure to identify and correct problems in laboratory testing. 2. An interview with the laboratory director on July 15, 2019, at 11:55 AM, confirmed the laboratory failed to establish in writing a policy or procedure for the quality assessment activities for the laboratory. -- 2 of 2 --