Cheyenne Skin Clinic

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) (2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). This STANDARD is not met as evidenced by: Based on review of proficiency testing records, staff interview, and policy and procedure review, the laboratory failed to ensure the microscopic evaluation of dermatological histopathology slides was performed twice annually for 1 of 2 Mohs surgeons (MD #1) and 1 of 2 dermatologists (MD #2) for 2 of 2 years (2023, 2024) reviewed: The findings were: 1. Review of the proficiency testing records showed the following concerns: a. The laboratory's records for MD #1 showed a peer review of a Mohs case was performed on 3/10/23; however, there was no evidence a second case had been assessed for accuracy. b. The laboratory's records for MD #2 showed an independent offsite evaluation was completed on 10/17/23; however; there was no evidence a second case had been assessed for accuracy. The laboratory was unable to locate any documentation for 2024. 2. Interview with MD #3 on 4/29/25 at 12:29 PM confirmed there was no documentation of a second accuracy assessment in 2023 for MD #1. 3. Interview with MD #2 on 4/29/25 at 12:35 PM confirmed an independent offsite evaluation had not been completed. 4. Review of the "MOHS Surgery and Proficiency Testing" policy, effective 10/7/21, showed "...2. Proficiency testing will be assessed at least semiannually. 3...Semiannually MOHS surgeons shall randomly select a minimum of 1 cases (sic) 2 times per year per MOHS surgeon..." 5. Review of the "PROFICIENCY TESTING" policy, revised on 10/26/21" showed "1. Slides shall be sent to another laboratory for evaluation and interpretation. At least twice per year reports shall be reviewed and evaluated for proficiency." D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 -- 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 review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel and laboratory records, policy and procedure review, and staff interview, the laboratory failed to ensure initial, 6-month, and annual competency assessments were completed for 9 of 9 testing personnel (MD #1, MD #2, MD #3, MD #4, NP #1, NP #2, PA #1, PA #2, PA #3) as required for 2 of 2 years reviewed (2023, 2024). In addition, the laboratory failed to develop a procedure for assessing the competency of the clinical consultant, technical consultant, and general supervisor. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed MD #1, MD #2, MD #3, MD #4, NP #1, NP #2, PA #1, PA #2, and PA #3 were listed as testing personnel. Review of the laboratory's records showed fungal testing was performed using KOH (potassium hydroxide) and DTM (dermatophyte test media) by each of the testing personnel listed. The following concerns were identified: a. Review of the personnel file for MD #1 showed a proficiency testing event had been completed on 3/14/23 and 12/9/24. There was no evidence a competency assessment had been conducted which included the direct observation of routine test performance, problem solving, and quality control. b. Review of the personnel file for MD #2 showed a proficiency testing event had been completed on 3/14/23 and 10/29/24. There was no evidence a competency assessment had been conducted which included the direct observation of routine test performance, problem solving, and quality control. c. Review of the personnel file for MD #3 and MD #4 showed a proficiency testing event had been completed on 3/13/23 and 10/28 /24. There was no evidence a competency assessment had been conducted which included the direct observation of routine test performance, problem solving, and quality control. d. Review of the personnel file for NP #1 showed a proficiency testing event had been completed on 3/13/23 and 10/30/24. There was no evidence a competency assessment had been conducted which included the direct observation of routine test performance, problem solving, and quality control. e. Review of the personnel file for NP #2 showed no evidence competency assessments had been conducted which included the direct observation of routine test performance, problem solving, quality control, and proficiency testing (or other blind specimens) in 2023 or 2024. f. Review of the personnel file for PA #1 showed a proficiency testing event had been completed on 3/14/23 and 10/25/24. There was no evidence a competency assessment had been conducted which included the direct observation of routine test performance, problem solving, and quality control. g. Review of the personnel file for PA #2 showed she was hired on 1/1/24. There was no evidence an initial, 6-month, or annual competency assessment had been completed. Review of the patient testing logbook showed PA #2 performed approximately 38 fungal tests in 2024. h. Review of the personnel file for PA #3 showed she was hired on 3/1/24 and a proficiency testing event had been completed on 10/24/24. There was no evidence an initial, 6- month, or annual competency assessment had been completed. Review of the patient testing logbook showed PA #3 performed approximately 86 fungal tests in 2024. 2. There was no evidence a procedure and been developed to assess the duties of the clinical consultant, technical supervisor, and general supervisor. 3. Interview with the practice administrator on 4/29/25 at 10:44 AM confirmed no further documentation was available. 4. Review of the "DTM/Dermatophyte Test Medium Fungal Cultures" -- 2 of 3 -- and "KOH" policies, effective 10/7/21, showed "...Physicians and mid-level providers will be trained on preparation and reading of [DTMs and KOHs] and follow the Laboratory's established policy for the evaluation of testing personnel for moderate complexity testing. Upon hire, testing shall be conducted at least semi-annually for the first year and annually following the first year of employment. 5. Review of the "NON-WAIVED TEST COMPETENCY" policy showed "1. During the first year of an individual's duties, or a new method/test, competency will be assessed at least semi- annually. 2. Annual Competency Assessment shall include six elements for each lab employee, on each test system, unless an element is not applicable to the test system. 3. The Lab Director shall review Laboratory Personnel Competency Assessments for efficiency. 4. Technical consultant shall evaluate and document of the performance of individuals responsible for moderate complexity testing annually after the first year. 5. Mid-level practitioner performing mycology testing shall be reviewed annually for their competency to read, report and troubleshoot KOH skin scraping preparations and DTM cultures." -- 3 of 3 --

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, review of laboratory documentation, and staff interview the laboratory failed to check each new lot number or shipment of potassium hydroxide (KOH) for positive and negative reactivity prior to patient testing for 2 of 2 years (2021, 2022) reviewed. The laboratory performed approximately 45 KOH preparations per year. The findings were: 1. Review of the laboratory's documentation showed no evidence the KOH solution used to detect fungal elements had been checked for positive and negative reactivity prior to patient testing. 2. Observation on 3/15/23 at 10:54 AM showed the KOH solution was stored in a small amber-colored glass bottle and was labeled 1/2023. There was no expiration date on the bottle. 3. Interview with the nurse manager on 3/15/23 at 10:54 AM revealed the KOH solution was transferred from the original bottle into the smaller bottle because the KOH was corrosive. The nurse manager was not aware if the reagent had an expiration date and confirmed quality control had not been performed. 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 potassium hydroxide (KOH) skin scraping preparations and dermatophyte test media culture (DTM) test record review, lack of documentation, and staff interview, the laboratory failed to verify the accuracy of KOH and DTM testing at least twice annually for 2 of 2 years (2019, 2020) of testing reviewed. The laboratory performed approximately 30 KOH skin scraping preparations and 285 DTM cultures per year. The findings were: 1. Review of the laboratory's test records showed no evidence KOH preparations or DTM cultures had been verified for accuracy in 2019 and 2020. 2. Interview with the laboratory director on 6/23/21 at 4:20 PM revealed the laboratory had reviewed DTM culture and KOH skin scraping preparation testing for accuracy verification through peer review, however the laboratory had not documented the results. This is a repeat deficiency. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation, procedure manual review, and staff interview, 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 4 -- failed to revise the procedure manual to include the current procedure for grossing (a macroscopic examination of tissue biopsies). The laboratory performed approximately 19,872 tissue biopsies per year. The findings were: 1. Observation on 6/23/21 at 12:20 PM showed HT (histotechnologist) #1 was preparing tissue biopsies for processing by documenting the number of pieces of tissue, the shape, length, width, and the thickness. The HT recorded the results in a log book and initialed his findings. Interview with the HT at that time revealed he was the only HT to perform the grossing procedure and his findings were used for quality assurance purposes, and were not part of the pathology report. 2. Review of the 2017 Dermatopathology Procedure manual showed...."4. No gross description is made in the lab..." 3. Interview with the laboratory director on 6/23/21 at 4:20 PM confirmed the HT performed tissue grossing in the lab and she reviewed and initialed the HT's results daily. The laboratory director stated the physician who performed the biopsy grossed the sample before placing the tissue in formalin, and those findings were used on the final report. The laboratory director confirmed the procedure manual was incorrect. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on medical record review, review of laboratory testing logs, lack of documentation, and staff interview, the laboratory failed to ensure the patients' medical record included the results of testing for dermatophyte test media cultures (DTM), potassium hydroxide (KOH) preparations, and tissue biopsies for 3 of 30 patient charts reviewed (#1, #2, #3). The laboratory performed approximately 30 KOH preparations, 285 DTM cultures, and 19,872 tissue biopsies per year. The findings were: 1. Review of the laboratory's fungus testing log showed a DTM culture had been ordered for patient #1 on 5/4/20 and was resulted on 5/18/20. Review of the patient's chart showed no documentation of the DTM culture test result. 2. Review of the laboratory's KOH testing log showed a KOH preparation had been performed for patient #2 on 12/17/19. Review of the patient's medical record showed no documentation of the result of the KOH preparation. 3. Review of the laboratory's histopathology log showed a tissue biopsy was performed on 9/3/19 for patient #3. Review of the patient's medical record showed no documentation of the biopsy results. 4. Interview with the nurse manager on 6/23/21 at 1:17 PM confirmed the test results were missing from the patient's medical record. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on patient test report review, review of testing logs, review of the laboratory's quality assurance procedure, and staff interview, the laboratory failed to monitor test results in the patient's medical record for errors related to completeness and accuracy for 4 of 30 patient records reviewed (#1, #2, #3, #4). The findings were: 1. Review of the laboratory's fungus testing log showed a dermatophyte test media (DTM) culture had been ordered for patient #1 on 5/4/20 and was resulted on 5/18/20. Review of the patient's chart showed no documentation of the DTM culture results. 2. Review of the laboratory's potassium hydroxide (KOH) testing log showed a KOH preparation had been performed for patient #2 on 12/17/19. Review of the patient's medical record showed no documentation of the result of the KOH preparation. 3. Review of the laboratory's histopathology log showed a tissue biopsy was performed on 9/3/19 for patient #3. Review of the patient's medical record showed no documentation of the biopsy results. 4. Review of the laboratory's fungus testing log showed a KOH preparation was performed on 4/7/21 for patient #4. Review of the log book showed the result was negative. Review of the patient's medical record showed the KOH was reported as positive for yeast. 5. Review of the 2017 Quality Assurance (QA) Plan stated "at least twice a year the lab manager shall evaluate QA logs and review programs for quality patient care and assurance...Patient Test Management Procedures for specimen submission and dermatopathology handling, test requisitions, test reports, timeliness of reporting accuracy shall be reviewed and documented in the Patient Test Management Log." 6. Interview with the office manager on 6/23/21 at 5 PM revealed the laboratory had not been following the QA plan and laboratory did not have a Patient Test Management Log. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on medical record review, lack of documentation, and staff interview, the technical consultant for mycology testing failed to ensure 2 of 2 testing personnel (MD (medical doctor) #4, MD #5) were evaluated semi-annually for competency in reading and reporting potassium hydroxide (KOH) preparations and dermatophyte test media agar (DTM) cultures. The findings were: 1. Review of patient test records and review of the laboratory's testing log showed the initials of the testing personnel reporting KOH and DTM test results included MD #4 and MD #5. 2. Interview with the office manager on 6/23/21 at 3:30 PM revealed MD #4 and MD #5 began practicing at the facility on 8/1/20. 2. Review of the laboratory's documentation showed no evidence MD #4 and MD #5 had been evaluated for competency prior to testing patient samples or at any time thereafter. 3. Interview with the office manager on 6/23/21 at 3:30 PM revealed she was unaware competency evaluations were required for physicians performing moderate complexity testing and confirmed the evaluations had not been completed. Interview with the laboratory director on 6/23/21 at 4:20 PM revealed the competency evaluations were completed through peer review, however it was not documented. -- 3 of 4 -- D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on medical record review, lack of documentation, and staff interview, the technical consultant for mycology testing failed to ensure 4 of 7 testing personnel (MD (medical doctor) #1, MD #2, MD #3, TP (testing personnel) #1) were evaluated annually for competency in reading and reporting potassium hydroxide (KOH) preparations and dermatophyte test media agar (DTM) cultures in 2019 and 2020. The findings were: 1. Review of patient test records and review of the laboratory's testing log showed the initials of the testing personnel reporting KOH and DTM test results included MD #1, MD #2, MD #3, and TP #1. 2. Review of the laboratory's documentation showed no evidence MD #1, MD #2, and MD #3 had been evaluated for competency in 2019 or 2020. Review of the competency evaluations for TP #1 showed no evidence a competency evaluation had been completed in 2020. 3. Interview with the office manager on 6/23/21 at 3:30 PM revealed she was unaware annual competency evaluations were required for physicians performing moderate complexity testing and confirmed the evaluations had not been completed. Interview with the laboratory director on 6/23/21 at 4:20 PM revealed the laboratory had reviewed DTM culture and KOH preparation testing for competency through peer review, however the laboratory had not documented the results. This is a repeat deficiency. -- 4 of 4 --

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 Potassium Hydroxide (KOH) and Dermatophyte Test Media Agar (DTM) test records review, quality assurance records review, lack of documentation and interview with the office manager and testing personnel, the laboratory failed to verify test accuracy for 2 of 3 test systems for 2 years of testing reviewed, (2017 and 2018). The laboratory performed approximately 350 DTM tests and 55 KOH tests per year. Findings include: 1. Test and quality assessment records review failed to include documentation the laboratory verified they could accurately identity the presence or absence of fungal elements in KOH or the presence or absence of dermatophytes using dermatophyte tests agar in 2017 and 2018, using, for example, proficiency testing, split sample analysis or duplicate testing. 2. In an interview conducted on 04 /08/2019 at approximately 2:20 P.M. the office manager and testing personnel who manages the culture process confirmed they did not document verification twice annually in 2017 and 2018. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 patient chart records review, lack of documentation, and interview with the office manager, the technical consultant for mycology testing failed to ensure 3 of 3 testing personnel were evaluated annually for competency in reading and reporting Potassium Hydroxide (KOH) and Dermatophyte Test Media Agar (DTM) in 2017 and 2018. Findings include: 1. Patient test records review included the initials of the test person reporting KOH and DTM. 2. The initials of testing personnel included those of 3 midlevel providers and 3 physicians. 3. The laboratory lacked documentation the technical consultant evaluated mid-level practitioners (Licensed Nurse Practitioners and Physician's Assistants) performing mycology testing annually for their competency to read, report, and trouble shoot KOH skin scraping preparations and DTM cultures in 2018 and 2019. 4. In an interview conducted on 04/08/2019 at approximately 2:20 P.M., the office manager confirmed the technical consultant for Mycology testing had not evaluated mid level providers annually in 2017 and 2018 for KOH and DTM competency. -- 2 of 2 --