Jordan Valley Dermatology Center

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 record review and interview with the Medical Manager, the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination for TP1 and TP2 (testing Personnel). The laboratory performs approximately 3,600 histopathology slide examinations annually. Findings include: 1. Record review revealed that the laboratory failed to verify the accuracy, at least twice annually, of their test system for histopathology slide examination for TP1 and TP2 since the last survey which was performed on 2/27/2024. 2. In an interview on 9/18/2025 at approximately 11:55 am, the Medical Manager confirmed the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination. D5805 TEST REPORT CFR(s): 493.1291(c) (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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Medical Manager, the laboratory failed to list the correct address of the laboratory's location on the test report.The laboratory performs approximately 3600 histopathology tests annually. Findings include: 1. Record review of the test report on 9/18/2025 at approximately 11:45 AM, revealed the incorrect address of 10654 South River Heights, Suite 210, South Jordan UT 84095 on the test report, rather than 630 Medical Drive, Bountiful UT, 84010 where slide examinations occurr. 2. Interview with the Medical Manager on 9/18/2025 at approximately 11:45 AM, confirmed the test report listed the incorrect address of 10654 South River Heights, Suite 210, South Jordan UT 84095 on the test report, rather than 630 Medical Drive, Bountiful UT, 84010 where slide examinations occurr. -- 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 Record review and interview with the office manager and TP2 (testing personnel), the laboratory failed to evaluate, at least twice annually, the accuracy of their test system for histopathology slide examination for TP2. The laboratory performs approximately 3600 histopathology slide examinations annually. Findings include: 1. Record review revealed that the laboratory failed to verify the accuracy, at least twice annually, of their test system for histopathology slide examination for TP2 in the year 2020, and once in 2021. 2. In an interview on 2/28/2022 at approximately 5:15pm, the office manager and TP2 failed to produce evidence to verify the accuracy of their test system for TP2. 3. The lab failed to verify the accuracy of the lab's test system for TP2 for 0 of 2 instances in 2020 and 1 of 2 instances in 2021. 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 record review and interview with the office manager, the laboratory failed to 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 -- follow their procedure manual for performing Qualtiy Control (QC) on the Potassium Hydroxide (KOH) Reagent. The laboratory performs approximately 80 KOH tests annually. Findings include: 1. The approved KOH procedure states that Quality Control of the KOH reagent is to be completed monthly. 2. At the time of survey on 2 /28/2022 at approximately 1:51pm, the laboratory was unable to produce documentation of monthly completion of the KOH QC, as defined by the laboratory's policy. 3. The laboratory was unable to produce documentation for monthly KOH QC for 0 of 24 months requested. 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 direct observation and interview with the office manager, the laboratory failed to ensure that reagents and other supplies must not be used when they have exceeded their expiration date. Findings include: 1. Direct observation conducted on 2 /28/2022 at approximately 4:06pm, found that the Potassium Hydroxied (KOH) reagent bottle stated "Discard after 12/14/21." 2. In an interview on 2/28/2022 at approximately 5:00pm, the office manager confirmed that the KOH reagent was in use beyond the expiration date. 3. The laboratory performs approximately 80 KOH tests annually. 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 record review and interview with the office manager, the laboratory failed to document the Potassium Hydroxide (KOH) test result for 1 of 2 patient records that were reviewed. The laboratory performs approximately 80 microscopic KOH tests annually. Findings include: 1. Record review revealed that the laboratory failed to include the microscopic KOH test result on 1 of 2 final patient reports. 2. In an interview on 2/28/2022 at approximately 3:54pm, the office manager confirmed that the laboratory failed to record the microscopic KOH test result on 1 of 2 final patient reports. -- 2 of 2 --

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on lack of documentation and confirmation by staff, the laboratory failed to retain histopathology slides for at least 10 years for 1 of 10 biopsies reviewed. The laboratory performed approximately 3600 skin biopsies per year. Findings include: 1. The laboratory was unable to locate slide number PS17-06994 collected on 08/08 /2017 for a right distal pretibial specimen for patient 23363251. 2. In an interview conducted on 03/29/2019 at approximately 1:15 P.M. staff confirmed they could not locate the slide. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. 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 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to check immunohistochemical stains for positive and negative reactivity each time of use for 1 of 4 immunohistochemical stain specimens reviewed. The laboratory performed approximately 3600 histopathology biopsies per year. Findings include: 1. The laboratory failed to locate control slides for histopathology case PS17-10214 collected on 11/30/2017 for patient #23577272 for melanine A, and S100. 2. In an interview with staff on 03/29/2019 at approximately 1:15 P.M. staff stated they could not locate the control slides for same test run as patient PS17-10214. -- 2 of 2 --