High Valley Dermatology And

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 10/28/2025, the laboratory failed to follow written procedures to assess testing personnel's training and competency for potassium hydroxide (KOH) examinations in 2024 and 2025. The findings include: 1. A lack of training records identified one testing personnel (TP) listed on the CMS 209 hired on 1/18/2024 that failed to have documentation of initial training for KOH examinations. 2. A lack of competency assessment records identified one of two TP listed on the CMS 209 hired since the last inspection on 10/27/2023 that failed to have documentation of a six month competency assessment for KOH examinations. 3. A lack of competency assessment records identified one of two TP listed on the CMS 209 that failed to have an annual competency assessment for KOH examinations in 2024 and two of two TP listed on the CMS 209 that failed to have competency assessments for KOH examinations in 2025. 4. An interview with the laboratory lead on 10/28/2025 at 10:32 am confirmed the above findings. 5. The laboratory reports performing 40 KOH examinations 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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the American Association of Bioanalysts (AAB) and an interview with the laboratory supervisor on 10/27/2023, the laboratory failed to have testing personnel and the laboratory director attest to the integration of PT samples with routine testing of patient samples in 2023. The findings include: 1. A review of PT results for serum human chorionic gonadotropin (hCG) and potassium hydroxide (KOH) slide examination from AAB identified that the laboratory failed to have the performing testing personnel and the laboratory director attest that the PT samples were tested in the same manner and with patient samples for events one (1), two (2) and three (3) in 2023. 2. An interview with the laboratory supervisor on 10/27/23 at 10:18 am confirmed that the laboratory failed to sign PT attestations in 2023. 3. The laboratory reports performing 730 moderate and high complexity tests annually. 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 a review of polices and procedures and an interview with 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 -- supervisor on 10/27/2023, the laboratory director failed to approve, sign and date the laboratory policies and procedures. The findings include: 1. A record review of laboratory policies and procedures identified that the laboratory director failed to approve, sign and date laboratory policies and procedures after becoming the laboratory director on 4/5/2023. 2. An interview with the laboratory supervisor on 10 /27/2023 at 9:29 am, confirmed that the laboratory director had not approved, signed or dated the laboratory policies and procedures. 3. The laboratory reports performing 730 moderate and high complexity tests annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a record review and interviews with the laboratory supervisor on 10/27 /2023, the laboratory failed to document humidity and room temperature as required by manufacturers. The findings include: 1. A review of the manual for the Avantik QS12 cryostat identified that the operational humidity is less than 60%. 2. A review of the laboratory microtome maintenance log identified that the laboratory failed to document humidity in 2022 and 2023. 3. A review of the instructions for use for the One Step Human chorionic gonadotropin test identified a storage temperature of 2-30 C. 4. A review of the upstairs temperature log identified that the laboratory failed to document room temperature in May, June, July, August, September and October of 2023. 5. An interviews with the laboratory supervisor on 10/27/2023 at 10:39 am and 11:02 am respectively confirmed the above findings. 6. The laboratory reports performing 730 moderate and high complexity tests annually. 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: Based on a direct observation and an interview with the laboratory supervisor on 10/27 /2023, the laboratory failed to discontinue the use of expired potassium hydroxide (KOH) with DMSO. The findings include: 1. During the laboratory tour on 10/27 /2023 a direct observation identified that the laboratory failed to discontinue the use of expired 20% KOH with DMSO used in KOH slide examinations. Delasco 20% KOH with DMSO lot K20354 expiration 3-31-2023 2. An interview with the laboratory supervisor on 10/27/2023 at 11:40 am confirmed the above finding. 3. The laboratory reports performing 40 KOH slide examinations annually -- 2 of 2 --

Summary Statement of Deficiencies D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on record review of proficiency testing (PT) for KOH from American College of Physicians (ACP) and an interview with the Laboratory Director on November 5, 2020, the laboratory failed to not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample(s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Findings: 1. 2020 event 1 KOH from ACP, both medical testing personnel performed testing on samples K-1 and K-2 on February 12, 2020 and both medical testing personnel signed the attestation as testing personnel. 2. 2020 event 2 KOH from ACP, both providers performed testing on samples K-3 and K-4 on May 28, 2020 and neither medical testing personnel signed the attestation as testing personnel. 3. 2020 event 3 KOH from ACP, both medical testing personnel performed testing on samples K-5 an K-6 on October 1, 2020 and both medical testing personnel signed the attestation as testing personnel. 4. An interview with the laboratory director on November 5, 2020, at 10:30 am, revealed that both medical testing personnel were performing the PT test on the same slides prior to the submission deadline for training purposes. 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 -- 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 review of procedures and an interview with the laboratory director on November 5, 2020, the laboratory failed to have written procedure for proficiency testing (PT) that was available to, and followed by, laboratory personnel. Findings: 1. A record review of the laboratory procedures manual revealed the laboratory did not have a PT procedure for their laboratory personnel to follow. 2. An interview with the laboratory director on November 5, 2020, at 10:55 am, confirmed that the laboratory did not have a PT procedure for their laboratory personnel to follow. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) log review and an interview with the laboratory director on November 5, 2020, the laboratory, at least once a day when patient specimens are assayed, failed to perform two control materials that correlate with the specimen matrix that is being tested. Findings: 1. A record review of the QC log revealed that the laboratory was only performing urine QC on the hCG combo test. The laboratory uses hCG combo test for both serum and urine samples. They perform approximately 175 serum hCG tests per year using the hCG combo. 2. An interview with the laboratory director on November 5, 2020, at 11:55 am, confirmed that the laboratory did not perform serum QC on the hCG combo test, that they only perform urine QC on the hCG combo test. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager and proficiency testing (PT) record review, the laboratory director failed to sign the attestation statements from the College of American Pathologists (CAP) for the human chorionic gonadotropin (hCG) analyte for 2017. Findings: 1. A CAP PT document review revealed the laboratory director failed to sign the attestation statements for the hCG analyte for 2017. 2. An interview on March 12, 2018 at 9:15 AM, with the laboratory manager, confirmed the laboratory director failed to sign the PT attestation statements for hCG testing for 2017. 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. 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 -- This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager and a record review of personnel documents, the laboratory failed to follow the written procedure for assessing employee competency for the Consult Diagnostics human chorionic gonadotropin (hCG) and potassium hydroxide (KOH) tests since the last survey on April 12, 2016. Findings: 1. A record review of personnel documents for the 14 testing personnel listed on the CMS-209 Personnel Report form, revealed the laboratory failed to perform competency assessments on 14 testing personnel. 2. An interview on March 12, 2018 at 9:30 AM, with the laboratory manager, confirmed the laboratory failed to perform competency assessment on the 14 testing personnel. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager and a record review, the laboratory failed to monitor and record the room temperature where the Consult Diagnostics human chorionic gonadotropin (hCG) patient samples are tested as required by the manufacturer's instructions since the last survey on April 12, 2016. Findings: 1. A record review revealed the laboratory failed to monitor and record the room temperature of the laboratory where hCG tests are performed. 2. An interview on March 12, 2018 at 10:00 AM, with the laboratory manager, confirmed the laboratory failed to monitor and record the laboratory room temperature. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager and a record review, the laboratory failed to establish the quality control plan (QCP) and the quality assurance plan (QAP) for the Consult Diagnostics human chorionic gonadotropin (hCG) Individualized Quality Control Plan (IQCP) since the last survey on April 12, 2016. -- 2 of 3 -- Findings: 1. A review of the IQCP for the Consult Diagnostics hCG test revealed the laboratory failed to establish the QCP and the QAP. 2. An interview on March 12, 2018 at 10:00 AM, with the laboratory manager, confirmed the laboratory failed to write the QCP and the QAP for the Consult Diagnostics hCG test. 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 an interview with the laboratory technician and a record review of personnel documents, the laboratory failed to establish and follow a written procedure for assessing employee competency at least semiannually during the first year of patient testing on the Consult Diagnostics human chorionic gonadotropin (hCG) since the last survey on April 12, 2016. Findings: 1. A record review of personnel documents revealed 8 out of 14 testing personnel listed on the CMS-209 Personnel Report form, failed to have competency assessments performed at least semiannually during the first year of patient testing. 2. An interview on March 12, 2018 at 9:30 AM, with the laboratory manager, confirmed the laboratory failed to perform semiannual competency assessments on the testing personnel. -- 3 of 3 --