Alpine Dermatology Clinic Pc

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 lead histotechnician on 9/9/2024, the laboratory failed to follow written procedures to assess testing personnel's competency for Mohs mechanical procedures. The findings include: 1. A lack of competency assessment records identified four testing personnel listed on the CMS 209 that failed to have documentation of training and competency assessments for Mohs mechanical procedures including inking in 2023 and 2024. 2. An interview with the lead histotechnician on 9/9/2024 at 2:15 pm confirmed the above finding. 3. The laboratory reports performing 200 Mohs slide examinations annually. 4. This is a repeat deficiency from the previous inspection on 11/29/2022. 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 a review of Mohs peer review documents and an interview with the office manager on 9/9/2024, the laboratory failed to verify the accuracy of Mohs slide examinations at least twice annually in 2023 and 2024. The findings include: 1. A Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- record review of peer review documents for Mohs slide examinations identified that the laboratory failed to verify the accuracy of Mohs slide examinations at least twice annually in 2023 and 2024. 2. An interview with the office manager on 9/9/2024 at 2: 42 pm confirmed that the laboratory did not verify the accuracy of Mohs slide examination twice annually for 2023 and 2024. 3. The laboratory reports performing 200 Mohs slide examinations annually. 4. This is a repeat deficiency for failure to perform biannual verification for Mohs slide examinations from surveys performed on 9/19/2018 and 2/25/2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a direct observation of laboratory equipment, a review of maintenance records, and an interview with the office manager on 9/9/2024, the laboratory failed to perform maintenance as required by the manufacturer for one of two cryostats. Findings include: 1. A direct observation in the laboratory identified two cryostats; a Leica CM 1510S and an Avantik QS12. 2. A review of the cryostat maintenance log identified that the laboratory failed to have a maintenance log and document maintenance for both of the cryostats in 2024. 3. An interview with the office manager on 9/9/2024 at 3:52 pm confirmed the lack of documentation for the Leica CM 1510S cryostat maintenance. 4. The laboratory reports performing 200 Mohs slide examinations annually. D5781

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 lead histotechnician on 11/29/2022, the laboratory failed to follow written procedures to assess testing personnel's competency for Mohs mechanical procedures. The findings include: 1. A lack of competency assessment records identified four testing personnel listed on the CMS 209 that failed to have documentation of competency assessments for Mohs mechanical procedures in 2021 and 2022. 2. An interview with the lead histotechnician on 11/29/2022 at 10:31 am confirmed the above finding. 3. The laboratory reports performing 200 Mohs surgery procedures annually. 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 direct observations, a lack of documentation and an interview with the lead 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 -- histotechnician on 11/29/2022, the laboratory failed to have documentation of the minimum educational requirements for two of three testing personnel performing Mohs mechanical procedures. 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 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) -- 2 of 3 -- (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 direct observation, lack of documentation and an interview with the lead histotechnician on 11/29/2022, the laboratory failed to have documentation of educational requirements for three of four testing personnel. The findings include: 1. Direct observation of the Mohs surgery procedure identified the histotechnician performing Mohs mechanical procedures including inking. 2. Lack of educational documents identified that the laboratory failed to have documentation of educational requirements for three of four testing personnel performing Mohs mechanical procedures. 3. An interview with the lead histotechnician on 11/29/2022 at 10:30 am identified that four of four histotechnician's perform Mohs mechanical procedures and they failed to have diplomas for three of four histotechnicians. 4. The laboratory reports performing 200 Mohs surgery procedures annually. -- 3 of 3 --

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 a record review of bi-annual verification and an interview with the laboratory technician and office manager on 2/25/2021, the laboratory failed to at least twice annually verify the accuracy of Mohs slide examinations. The findings include: 1. A record review of bi-annual verification identified that the laboratory failed to verify the accuracy of Mohs slide examinations at least twice annually for 2019 and 2020. 2. This deficient practice was identified during the previous inspection in 2018. 3. An interview with the office manager and laboratory technician on 2/25 /2021 at 1:50 pm confirmed that the laboratory did not verify the accuracy of Mohs slide examination twice annually for 2019 and 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 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 a record review and an interview with the operations manager, the laboratory failed to verify the accuracy of both microscopic examinations for histopathology specimens and the presence of fungal elements using potassium hydroxide (KOH) at least twice a year since the last survey on July 20, 2017. Findings: 1. A record review revealed the laboratory failed to document the accuracy of microscopic examinations for KOH, used for the detection of fungal elements on the skin and histopathology specimens at least twice a year since the last survey in 2017. 2. An interview on September 19, 2018 at 8:20 AM, with the operations manager, confirmed the laboratory failed to document the accuracy of fungal and histopathology examinations at least twice a year. 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: 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 a review of quality control records and an interview with the operations manager, the laboratory failed to document the known reactivity of hematoxylin and eosin (H&E) stain used in the microscopic examinations of histopathology specimens for the dates reviewed from July through August 2018. Findings: 1. A review of the quality control worksheet in the laboratory revealed the reactivity of a known control slide for H & E stains failed to be documented on the following dates: July 24, 2018, July 31, 3018, and August 11, 2018. 2. An interview on September 19, 2018 at 9:00 AM, with the operations manager, confirmed the laboratory failed to document the quality control for the H & E stain for 24 patient results reported during the dates of review. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review and an interview with the operations manager, the laboratory failed to document the lot numbers of hematoxylin and eosin (H & E) stain since August 2016. Findings: 1. A record review of laboratory worksheets revealed the laboratory failed to document the lot numbers for the H & E stains used in the microscopic examinations of histopathology specimens since 2016. 2. An interview on September 19, 2018 at 9:05 AM, with the operations manager, confirmed the laboratory failed to document lot numbers for the H & E stains. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a record and an interview with the operations manager, the technical consultant who is the laboratory director failed to evaluate the competency of 1 out of 1 testing personnel performing microscopic examinations of potassium hydroxide (KOH) since the last survey on July 20, 2017. Findings: 1. A review of personnel documents revealed the technical consultant failed to evaluate the competency of 1 physician assistant performing KOH exams since the last survey. 2. An interview on September 19, 2018 at 8:20 AM, with the operations manager, confirmed the technical consultant failed to assess and document the competency for one practitioner performing KOH examinations. -- 2 of 2 --