Utah Valley Dermatology

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: A review of American Proficiency Institute (API) Proficiency Testing (PT) attestation statements and an interview with the clinical manager revealed that the laboratory failed to test PT samples in the Microbiology PT events for Potassium Hydroxide (KOH ) testing the same number of times that it routinely tests patient samples. Approximately 125 KOH tests are performed annually. Findings include: 1. A review of the attestation statements for the API 2021 Microbiology 1st Event, 2022 Microbiology 2nd Event, and 2022 Microbiology 3rd event, at approximately 4:00 PM on 4/17/23, revealed that multiple providers attested to performing the testing on the KOH sample slides. 2. The API Microbiology events contain 2 slides per event. In the 2021 Microbiology 1st Event the attestation statement lists 5 Testing Personnel (TP) that each read both slides. The attestation statement for the 2022 Microbiology 2nd Event lists 4 TP that each read both slides. The 2022 Microbiology 3rd event attestation statement lists 6 TP that each read both slides. 3. In an interview with the clinical manager at approximately 4:30 PM on 4/17/23, it was stated that all the providers that participate in the PT event will each read the slides and come to a consensus before submitting the results for the PT testing. 4. In an interview with the clinical manager at approximately 4:30 PM on 4/17/23, it was confirmed that the laboratory PT testing was not performed the same number of times that it routinely tests patient samples. 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 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 lack of documentation and confirmation by staff the laboratory failed to evaluate 1 of 1 new testing persons twice the first year of potassium hydroxide testing. Findings include: 1. Moderate complexity test person B lacked documentation of semiannual competency the first year of KOH testing. 2. In an interview conducted on 01/14/2021 at approximately 12:00 P.M., staff confirmed they did not have semi annual documentation of competency evaluations for testing person B. 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 lack of documentation and interview with staff, the laboratory failed to evaluate 1 of 1 moderate complexity test person annually after the first year of testing in 2019 and 2020. Findings include: 1. Test person C lacked documentation of competency evaluations in 2019 and 2020 for potassium hydroxide testing. 2. In an interview conducted on 01/14/2021 at approximately 12:00 P.M. staff confirmed test person C did not have a competency evaluation in 2019 or 2020. 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 -- D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to evaluate 2 of 2 testing personnel semiannually for the first year of histopathology testing. Findings include: 1. The laboratory lacked documentation 2 of 2 new dermatologists were evaluated twice the first year of histopathology testing in 2019 and 2020. 2. In an interview with staff on 01/14/2021 staff confirmed high complexity testing personnel were not evaluated for competency semiannually the first year they performed testing. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on lack of dermatology board certification documentation and lack of training documentation for Mohs Micrographic surgical specimen frozen section histopathology testing, two of three histopathology testing personnel failed to qualify as high complexity histopathology testing personnel. (See D6171) D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 -- 2 of 3 -- semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, two of two new histopathology testing personnel failed to have documentation to perform histopathology frozen section testing, (testing personnel B and C). Findings include: 1. Testing person B lacked a copy of dermatology board certification and Mohs micrographic frozen section training and testing person C lacked documentation they received training for micrographic frozen section histopathology specimen testing received during their dermatology residency. 2. In an interview conducted on 01/14 /2021 testing person C stated the syllabus contained Mohs survey frozen section histopathology diagnosis and resolution training. Such documentation was not received for testing persons B or C. -- 3 of 3 --

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 patient test record review, patient specimen slide review, and interview with staff, the laboratory failed to establish and follow a procedure that ensures positive identification of patients specimens from the time of collection through completion of testing and reporting of results. Findings include: 1. Patient test records review failed to include the case number or a unique identification for Mohs surgical specimens to connect the specimen to the map to the test report for patient's with record numbers: 258997 collected on 06/09/2016, 324100 collected on 10/27/2016, 333206 collected on 03/29/2017, 251214 collected on 11/13/2017, 282856 collected on 02/15/2018, and 283676 collected on 03/29/2018, 2. Mohs specimen slide review included documentation the slides were labeled with the patient name, date of birth, date of service, stage, cut and Mohs surgical case number. 3. Mohs map review are labeled with the Mohs case number, patient's name and date of surgery. 4. Patient test reports failed to include the case number for patients: 333206, 251214, 282856, and 283676 . 4. In an interview conducted on 04/19/2018 at approximately 1:30 P.M., staff confirmed the laboratory failed to ensure the Mohs testing process uniquely linked the patient identity to the Mohs specimen, with the Mohs map with the patient specimen slide with the patient test report. D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) 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 -- The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on patient test reports review, lack of documentation, and interview with staff, the laboratory failed to ensure the laboratory performing gross analyses was CLIA certified for 2 of 8 histopathology formalin fixed, paraffin embedded biopsy specimen reports reviewed. The laboratory reported approximately 600 to 800 biopsies per year. Findings include: 1. Patient test report review included the statement that gross analyses were performed at Independent Histology for patient 10426 for specimen M18-0250 and patient 322258 for specimen M18-0538. 2. Independent Histology lacks a CLIA certificate for histopathology testing. 3, In an interview conducted on 04 /19/2018 at approximately 1:00 P.M., laboratory staff stated they were not aware a CLIA certificate is required for performing gross analysis. testing 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 lack of documentation and interview with staff, the technical consultant failed to ensure competency evaluations for 1 of 1 testing person was performed annually for 1 of 2 years of testing reviewed (2017) for potassium hydroxide (KOH) preparation testing. The laboratory performed approximately 25 to 30 KOH tests per year. Findings include: 1. The laboratory failed to document they evaluated moderate complexity testing person annually in 2016 for KOH testing competency. 2. In an interview conducted on 04/19/2018 at approximately 12:45 P.M. staff confirmed the laboratory technical consultant failed to evaluate KOH testing personnel competency in 2016. -- 2 of 2 --