Intermountain Park City Specialty Mohs Surgery

Summary Statement of Deficiencies 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 personnel record review and interview with the technical consultant, the laboratory failed to employ qualified testing personnel that met the educational requirements for high complexity grossing examination in histopathology testing. (refer to 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 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 -- 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 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 an interview with the technical consultant and review of education records, the laboratory failed to employ qualified personnel to perform gross examinations for high complexity histopathology testing since the last survey performed on June 24, 2021. The laboratory performed approximately 859 tests per year. Findings include: 1. Review of education records for one of one testing personnel revealed educational requirements were not met for high complexity grossing examination in histopathology testing. 2. During an interview with the technical consultant on September 28, 2023 at approximately 1:35 p.m. it was confirmed personnel did not meet the high complexity educational requirements for grossing histopathology specimens. -- 2 of 2 --

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on patient test records review, lack of documentation, and interview with staff, the laboratory failed to verify accuracy, precision, analytical specificity and sensitivity for the Immunohistochemical staining process for Mart 1 test kits prior to reporting patient test results. The laboratory performed approximately 10 to 12 tests per year. Findings include: 1. Patient test records review for patient cases 18-365 on 08/09 /2018 and 18-439 on 09/25/2018 document the laboratory performed Mart 1 immunohistochemical (IHC) staining to aid in reporting the histology specimen to be clear of the persistence of melanocytes associated with a melanoma in situ diagnosis through the Mohs micrographic surgical process. 2. The laboratory failed to document the laboratory verified Mart 1 staining test accuracy and precision and verified the test was specific for reporting the presence or absence of melanocytes and possessed sensitivity to document the lab could determine the difference between a positive and negative response in order to provide diagnostic confirmation of melanocytes 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 -- presence or absence. 3. In an interview with staff on 10/11/2018 at approximately 4: 45 P.M. staff confirmed they had not documented verification of test accuracy, precision, specificity or sensitivity prior to reporting patient tests results. 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. This STANDARD is not met as evidenced by: Based on patient test records review, lack of documentation, and interview with staff, the laboratory failed to document they checked the staining process for positive and negative reactivity each time of use for Mart 1 immunohistochemical (IHC) stains for 2 of 2 days of IHC staining reviewed. The laboratory performed approximately 8 to 12 stains per year. Findings include: 1. Patient test records review included documentation that Mohs surgical cases 18-365 on 08/09/2018 and 18-439 09/24 /2018 had Mart 1 IHC stains performed to aid in the detection of the presence or absence of melanocytes from Mohs surgery histology specimens. 2. The laboratory failed to document they included Mart 1 control slides of positive and negative reactivity for the presence of melanocytes. 3. In an interview with staff on 10/11/2018 at approximately 4:45 P.M. staff stated they did not document they checked stain reactivity with control slides that demonstrated positive and negative reactivity. -- 2 of 2 --