Pennsylvania Dermatology Partners, Inc

Summary Statement of Deficiencies 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 observation of the laboratory, lack of maintenance records and interview with the Director of Training and Compliance (DTC), the laboratory failed to assess the maintenance and function checks as defined by the manufacturer for 1 of 1 Traceable thermometer/humidity monitor used in the Histopathology laboratory from 08/09/2022 to the day of survey. Findings Include: 1. On the day of survey, 04/10 /2024 at 10:10am, during observation of the laboratory the surveyor discovered 1 of 1 Traceable thermometer/humidity monitor (serial number 221553655) with no expiration date. 2. The laboratory could not provide maintenance/function check records for the Traceable thermometer/humidity monitor. 3. Interview with the DTC on 04/10/2024 at 10:16am confirmed the Traceable thermometer/humidity monitor was used to record room temperature and relative humidity in the Histopathology laboratory from 08/09/2022 to 04/10/2024. 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. 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 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Director of Training and Compliance (DTC), the laboratory failed to follow an established policy to assess the competency of 1 of 2 testing personnel (TP) that performed macroscopic Histopathology examinations in 2022 and 2023. Findings include: 1. The laboratory's Competency evaluation policy states, "Assessment of competency will be done on an annual basis and is subject to change within the year if deemed necessary by the attending pathologist based upon performance." 2. On the day of survey, 04/10/2024, the laboratory could not provide documentation of the annual competency assessments for TP #2 (CMS 209 personnel #2) who performed grossing and inking in 2022 and 2023. 3. The laboratory reported an annual test volume of 2503 in Histopathology. (CMS 116) 4. The DTC confirmed the findings above on 04/10/2024 at 10:16 am. 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 review of the CLIA Laboratory Personnel Report (CMS 209), personnel qualification records and interview with the Director of Training and Compliance (DTC), the laboratory failed to ensure that 1 of 2 testing personnel (TP) that performed macroscopic Histopathology examinations met the minimum requirements of 493.1489 from 01/02/2020 to 04/10/2024. 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 -- 2 of 3 -- 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 review of the CLIA Laboratory Personnel Report (CMS 209), personnel qualification records and interview with the Director of Training and Compliance (DTC), the laboratory failed to ensure that 1 of 2 testing personnel (TP) that performed macroscopic Histopathology examinations met the minimum requirements of 493.1489 from 01/02/2020 to 04/10/2024. Findings include: 1. On the day of survey, 04/10/2024 at 9:07 am review of personnel qualification records revealed TP #2 (CMS 209 personnel #2) did not meet the minimum qualifications of 493.1489 to perform High Complexity testing in Histopathology (grossing and inking) from 01/02 /2020 to 04/10/2024. 2. On 04/10/2024, the laboratory provided the following personnel qualification records for testing personnel (TP) #2: - Pennsylvania Homeschoolers-Home Education program High School diploma awarded on 06/30 /2004. - National Society of Histotechnology-Mohs Micrographic technician training certificate awarded on 05/23/2012. 3. Competency assessment records revealed that TP #2 has performed high complexity testing since January 2, 2020. 4. The laboratory reported an annual test volume of 2503 in Histopathology. (CMS 116) 5. The DTC confirmed the findings above on 04/10/2024 at 10:16 am. -- 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 review of proficiency testing records and interview with the laboratory supervisor, the laboratory failed to verify at least twice annually accuracy (blind test) of Mohs microscopic examinations for 1 of 1 testing personnel (laboratory director) in 2018 and 2019. Findings Include: 1. The Proficiency Testing Policy states, "Dermatologists will circulate slides within the Pennsylvania Dermatology Partners, PC group and assess slides in a blind test". 2. On the day of survey, 02/04/2020, the laboratory could not provide documentation of blind testing conducted at least twice annually for 1 of 1 testing personnel who performed Mohs microscopic examinations in 2018 and 2019. 3. Approximately 1,977 Mohs microscopic examinations were analyzed in 2019. 4. The laboratory supervisor confirmed the findings above on 02/04 /2020 around 8:45 am. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation, Mohs procedure manual review and interview with the Histology Technologist and Mohs Technician, the laboratory failed to have the current director's signature for the procedures currently in use. Findings include: 1. On the date of survey (01/18/2018), The first page of the Policies and Procedures manual reviewed, stated, the Laboratory Director will review the manual yearly. 2. Review of the procedure manual revealed, the laboratory director last reviewed the procedure in 08/01/2012. 3. The Histology Technologist and Mohs Technician confirmed the finding above on 01/18/2018 around 12:20 PM. 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 a laboratory tour and interview with the Histology Technologist and Mohs Technician, the laboratory failed to ensure expired reagents were not used beyond the expiration dates. Findings Include: 1. On the date of survey 01/18/2018, the laboratory tour revealed that the following reagents were expired: - 2 of 2 bottles of Avantik Ultra Clear Xylene Sub. Lot#151115V. Expired: 11/2017 - 1 of 1 bottle of Green 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 -- Tissue Marking Dye. Lot# H33850. Expire: 09/2016 2. In 2016, 1400 specimen were read. 3. The Histology Technologist and Mohs Technician confirmed the findings above on 01/18/2018 around 12:35 PM. 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 observation of cryostat and interview with the a Histology Technologist and Mohs Technician, at the time of the survey, the laboratory failed to document maintenance of 1 of 1 Cryostat Microtome. Findings include: 1. The Laboratory Cryostat Maintenance procedure states: Preventative maintenance and grounding checks are done and documented annually. 2. At the time of survey, (01/18/2018 at 12: 15) the laboratory could not provide documentation for the yearly maintenance of the Cryostat Microtome. 3. The last service sticker on the instrument revealed: Last serviced on: 4/24/2012 Due for Maintenance: 4/24/2013 4. In 2016, 1400 specimen were read. 5. The Histology Technologist and Mohs Technician confirmed the findings above on 01/18/2018 around 12:45 PM. 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 the review of Patient Mohs Reports, interview the Histology Technologist and Mohs Technician, the lab failed to include the location of where Mohs slides reading is performed on the Patient reports from 2016 to the date of survey. Finding Include: 1. On the date of survey (01/18/2018), review of 2 of 2 Mohs maps/ reports reveled that the address on the report was not the current location where slide reading is performed. 2. In 12 months 1,400 specimens were read. 3. The Histology Technologist and Mohs Technician confirmed the findings above on 01/18/2018 around 01:00 PM. -- 2 of 2 --