Bryn Mawr Skin And Cancer Institute

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 lack of documentation, review of laboratory procedures, and interview with the Histotech (HT), the laboratory failed to establish and follow written procedures to monitor employee competency 1/6/2023 to 12/30/2024 Findings include: 1. On the day of the survey, 12/30/2024 at 10:00 am, the laboratory failed to provide a written policy for the assessment of competency for laboratory personnel and supervisors for their regulatory responsibilities from 1/6/2023 to 12/30/2024. 2. The HT confirmed the above findings on 12/30/2024 at 10:30 am. 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, lack of documentation, and interview with the Histotech (HT), the laboratory failed to verify twice annually the accuracy of Mohs micrographic slide examinations performed in 2023 and 2024. Findings include: 1. The laboratory's procedure "External Quality Control" states the following: "Annually, a Mohs surgeon or Pathologist not affliated with BMSCI will review at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- least ten (10) cases per Mohs surgeon in order to provide external quality control in reference to both laboratory slide preparation, and physician proficiency at histologic interpretation." 2. On the day of survey, 12/30/2024 at 10:00 am, the laboratory could not provide documentation for verification of accuracy for Mohs micrographic slide examinations performed twice annually in 2023 and 2024. 3. The HT confirmed the findings above on 12/30/2024 at 10:15 am. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of laboratory temperature records and interview with the Histotech (HT), the laboratory failed to monitor and document room temperature(RT) and humidity to ensure proper operating conditions for 2 of 2 Olympus microscopes, used for Mohs micrographic slide examinations performed from 1/6/2023 to 12/30/2024. Findings include: 1. The Olympus instruction manual states, "Operating and storage environments should be maintained at temperatures between 0 to 40 degrees Centrigrade and humidity of 30 to 90%. Failure to do so may lead to microscope malfunction." 2. On the day of the survey, 12/30/2024 at 11:50 pm, the laboratory failed to provide RT and humidity monitoring records to ensure reliable test system operation for 2 of 2 Olympus microscopes(models: Bx45 and Cx41) prior to reporting Mohs micrographic slide examinations from 1/6/2023 to 12/30/2024. 3. The laboratory performed 3,330 histopathology procedures( CMS 116 estimated annual volume) in 2024. 4. The HT confirmed the findings above on 12/30/2024 at 12:00 pm. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with the Histotech (HT), the laboratory failed to perform and document weekly maintenance per laboratory procedure for 3 of 3 microscopes used to perform MOHS micrographic slide examinations from 1/6/2023 to 12/30/2024. Findings Include: 1. On the day of survey, 12/30/2024, review of policy "Cryostat Temperatures and Daily Maintenance" revealed that "microscopes are to be inspected weekly and recorded on maintenance charts". 2. Review of microscope maintenance logs revealed the laboratory failed to perform and document weekly maintenance performed on 3 of 3 microscopes used for MOHS micrographic -- 2 of 4 -- slide examinations from 1/6/2023 to 12/30/2024. 3. The laboratory performed 3,330 histopathology procedures(CMS 116 estimated annual volume) in 2024. 4. The HT confirmed the findings above on 12/30/2024 at 12:15 pm. D5781

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 review of peer review records and interview with the Practice Manager (PM), the laboratory failed to ensure that verification of accuracy of Mohs micrographic exams was performed twice annually for 2 of 2 years, in 2021 and 2022 as required. Findings include: 1. On the day of the survey, 01/06/2023 at 11:06 am, record review revealed that the laboratory only verified the accuracy of H&E stain examinations once annually in 2021 and 2022. 2. The PM confirmed the finding above on 01/06/2023 at 11:45 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of Quality Assurance (QA) documentation and interview with the Practice Manager (PM), the Laboratory Director (LD) failed to ensure a QA program was established and maintained to ensure the quality of services provided by the laboratory in 2021 and 2022. Findings include: 1. On the day of survey 1/06/2023 at 11:21 a.m., the laboratory could not provide QA documentation that reviews the pre- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- analytical, analytical, and post-analytical phases of the laboratory in 2021 and 2022. 2. The PM confirmed there were no QA records on 01/06/2023 at 11:45 am. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory competency assessment records and interview with the Practice Manager (PM), the Technical Supervisor (TS) failed to evaluate the semiannual competency assessment for 2 of 2 Testing Personnel (TP) who performed grossing and inking examinations from June, 2021 to the day of the survey. Findings include: 1. On the day of survey 01/06/2023 at 10:10 am, the laboratory could not provide semiannual competency assessment record for 2 of 2 TP (CMS 209 personnel #2 and #3) who performed grossing and inking examinations from June, 2021 to the day of survey: - TP #2 ( hired in June 2021) - TP#3 (hired in February, 2022) 2. The annual test volume for histopathology is 6720 examinations. 3. The PM confirmed the findings above on 01/06/2023 at 11:45 am. 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 review of the laboratory competency assessment records and interview with the Practice Manager (PM), the Technical Supervisor (TS) failed to evaluate the annual competency assessment for 1 of 2 Testing Personnel (TP) who performed MOHS Micrographic surgery slides examined from 10/26/2020 to the day of survey. Findings include: 1. On the day of survey 01/06/2023 at 10:44 am, the laboratory could not provide competency assessment record for 1 of 2 TP (CMS 209 personnel #4) who performed MOHS Micrographic surgery slide examinations from 10/26/2020 to the day of survey. 2. The laboratory performed 6,720 MOHS Micrographic surgery slide examinations annually. 3. The PM confirmed the findings above on 01/06/2023 around 11:45am. 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. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on review of the CLIA ' s Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Practice Manager (PM), the laboratory failed to ensure that each individual performing High Complexity testing (1 of 4) is qualified. 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 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 -- 3 of 4 -- 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 review of the CLIA's Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Practice Manager (PM), the laboratory failed to ensure that each individual performing High Complexity testing (1 of 4 TP) had the minimum qualifications required for grossing and inking from February 2022 to the date of survey. Findings Include: 1. On the date of survey 01/06/2023 at 11:22 am, the surveyor reviewed the credentials of the testing personnel listed on the CMS 209 (TP #3) and discovered that 1 of 4 TP who performed grossing and inking examinations from February, 2022 through the day of survey, did not have the minimum qualifications. 2. The document provided during the inspection indicated that TP#3 has an associate degree in Medical Assistant. 3. Review of the course by course transcript revealed that TP#3 does not have the minimum credentials for biology, chemistry and medical technology. 4. The PM confirmed the findings above on 01/06/2023 around 11:45 a.m. -- 4 of 4 --

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 laboratory personnel interview with the Practice Administor and the MOHS Technician review of the competency records, the Laboratory failed to establish written policies to assess employee competency for 1 of 2 Technical Supervisors, from (06/15/2018) through the date of the survey (10/26/2020). Findings: 1. Laboratory policies and procedures reviewed at the time of the survey, revealed that the laboratory had no policy to assess consultant competency. 2. Review of the competency records revealed no documentation of competency for Technical Supervisor-2 from (06/15/2018) through the date of the survey. 3. The Laboratory Director acted as Technical Supervisor #2 at the time of the survey. 4. During the survey (09:54 10/26/2020), the Laboratory Supervisor confirmed, the above findings. 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 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 review of Laboratory Quality Control records and interview with the Mohs Technician and the Practice Operations Manager, the Laboratory failed to document all quality control procedures performed from 01/01/2017 and the date of the survey (06/15/2018). Findings include: 1. Quality Control records for Immuno Histo Chemistry and Periodic Acid Schiff slides read between 2017 and 2018 were not found.during the survey. 2. During the survey, the Practice Operations Mananager confirmed the above finding. 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 --