Pennsylvania Dermatology Partners Laurys Station

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 the laboratory's peer review records, and interview with the Director of Training and Compliance (DTC), the laboratory failed to ensure that the verification of accuracy for histopathology slide examinations stained using hematoxylin and eosin (H&E) were performed at least twice annually in 2023. Findings Include: 1. On the day of the survey, 12/23/2024 at 10:00 am, the laboratory failed to provide documentation for the verification of accuracy for histopathology slide examinations stained using H&E, were performed at least twice annually in 2023. 2. The laboratory performed 530 histopathology examinations in 2023 (estimated annual volume CMS-116). 3. The DTC confirmed the findings above on 12 /23/2024 at 10:00 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 documentation, review of the Quality Assurance (QA) procedure, and interview with Director of Training and Compliance (DTC), the 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 -- Director (LD) failed to ensure a QA program was established and maintained to ensure the quality of services provided by the laboratory for 12 out of 12 months in 2023. Findings include: 1. The laboratories QA procedure states the following: - " Monthly the nurse or tech will check off the monthly quality assurance checklist." - " This check list is used to evaluate General Laboratory systems, pre-analytic systems, analytic systems, and post-analytic Systems." - " The Laboratory Director will also review and sign off the check list monthly." 2. On the day of survey 12/23/2024 at 09: 30 am, the laboratory could not provide QA documentation that reviews the pre- analytical, analytical, and post-analytical phases of the laboratory for 12 out of 12 months in 2023. 3. The DTC confirmed there were no QA records on 12/23/2023 at 09:45am. *Repeat Deficiency D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the Director of Training and Comliance (DTC), the laboratory failed to have the required records accessible during the laboratory survey performed on 12/23/2024. Findings Include: 1. On the day of the survey, 12/23/2024 at 09:30 am, the laboratory could not provide the following records upon request: - Current Board Certifications for Laboratory Director. 2. The DTC confirmed the finding above on 12/23/2024 at 09:30 am. -- 2 of 2 --

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 review of laboratory procedures manuals and interview with the Laboratory Manager (LM), the laboratory failed to have the current director's signature for the procedures currently in use from 11/05/2020 to 01/18/2023. Findings include: 1. On the date of the survey (01/18/2023) at 09:10am, Review of the Policies and Procedures manuals revealed the Laboratory Director did not review and sign the current manual before it was put in use. 2. The LM confirmed the finding above on 01 /18/2023 around 10:05am. 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 microscope and interview with the Laboratory Manager (LM), the laboratory failed to perform maintenance/calibration on 1 of 1 microscope used for Mohs microscopic examinations from 04/2022 to 01/18/2023. Findings include: 1. On the day of the survey, 01/18/2023 at 09:51am, observation of 1 of 1 microscope revealed that the microscope used for Mohs microscopic examinations 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 -- was due for maintenance /calibration on 04/2022. 2. The LM confirmed the finding above on 01/18/2023 around 10:05am. 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 a review of quality control (QC) records and interview with the Laboratory Manager (LM), the laboratory did not document Hematoxylin and Eosin (H & E) stain QC monitoring activities for intended reactivity from 11/05/2020 to the day of the survey. Findings include: 1. On the day of the survey, 01/18/2023 at 09:45 a.m., the laboratory could not provide QC documentation for staining characteristics for the H&E stain performed from 11/05/2020 to 01/18/2023 2. The LM confirmed the finding above on 01/18/2023 at 10:05 a.m. 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, review of the Quality Assurance procedure, and interview with the Laboratory Manager (LM), 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. The laboratories QA procedure states the following: - " Monthly the nurse or tech will check off the monthly quality assurance checklist." - " This check list is used to evaluate General Laboratory systems, pre-analytic systems, analytic systems, and post-analytic Systems" - " The Laboratory Director will also review and sign off the check list monthly." 2. On the day of survey 1/18/2023 at 09: 45am, the laboratory could not provide QA documentation that reviews the pre- analytical, analytical, and post-analytical phases of the laboratory in 2021 and 2022. 3. The LM confirmed there were no QA records on 01/18/2023 at 10:05am. -- 2 of 2 --

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 review of Laboratory procedure manuals and interview with a medical assistant (MA), the laboratory failed to establish a complete procedure to assess supervisor competency assessment for 1 of 2 personnel from 06/27/2018 to the day of survey. Findings include: 1. On the day of survey, 11/05/2020, the laboratory failed to provide a complete written policy to assess the competency of 1 of 2 personnel (TP#2), listed on the CMS Testing Personnel form 209, as general supervisor and technical supervisor for 2018, 2019 and 2020. 2. The MA confirmed the finding above on 11/05/2020 around 1:35 pm. 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 the peer review records and interview with an medical assistant (MA), the laboratory failed to perform at least twice annually verification of accuracy for Mohs microscopic examinations analyzed in 2019. Findings Include: 1. The Proficiency Testing policy states, "Semi-annually, the tech or risk manager will send 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 -- two cases..". 2. On the day of survey, 11/05/2020, review of peer reviews records revealed, twice annual verification of accuracy for Mohs microscopic examinations were not performed in 2019. 3. The verification of accuracy for Mohs microscopic examinations in 2019 were only performed in July. 4. The MA confirmed the findings above on 11/05/2020 at 1:20 pm. *** REPEAT DEFICIENCY*** D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must 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. The laboratory must 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 observation of the laboratory and interview with the a medical assistant (MA), the laboratory failed to establish a maintenance policy to assess the maintenance /function for 1 of 1 Extech Instruments Big Digit Hygro Thermometer used to monitor the temperature of Mohs micrographic examination reagents stored at room temperature from 2018 to the day of survey. Findings Include: 1. On the day of survey, 11/05/2020, observation of the laboratory revealed, 1 of 1 Extech Instruments Big Digit Hygro thermometer was used to monitor the temperature Mohs micrographic examination reagents stored at room temperature from 06/27/2018 to 11 /05/2020. 2. The laboratory could not provide a maintenance policy or maintenance /function records for the room temperature thermometer. 3. The MA confirmed the findings above on 11/05/2020 around 1:50 pm. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on the Quality Assurance (QA) Program Policy and interview with a medical assistant (MA), the laboratory failed to follow written policies and procedures for ongoing mechanism to monitor and assess its Pre-analytical, Analytical and Post- analytical system activities in 2019 (12 of 12 months). Findings include: 1. The quality assurance program policy states, "The Laboratory director must hold monthly staff meeting. Minutes should be taken and retained as documentation." 2. On the day of survey, 11/05/2020, review of QA records revealed, the laboratory did not document monthly meeting minutes for 12 of 12 months in 2019. 3. The MA confirmed the finding above on 11/05/2020 around 01:45 pm. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) -- 2 of 3 -- (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 review of personnel records and interview with a medical assistant (MA), the laboratory failed to evaluate the competency for 1 of 2 testing personnel (TP) who performed Mohs micrographic examinations in 2019 and 2020. Findings Include: 1. The competency evaluation policy states, "The competency of all individuals will be evaluated, initially and at regular intervals. Evaluations will be held on a semi annual to annual basis for all tasks performed in the laboratory". 1. On the day of survey, 11 /05/2020, the laboratory could not provide 2019 and 2020 competency assessment documentation for 1 of 2 TP (TP#2), for their review of Mohs micrographic examinations. 2. In 2019, 119 Mohs micrographic examinations were analyzed by TP#2. 3. In 2020, 24 Mohs micrographic examinations were analyzed by TP#2. 4. The MA confirmed the findings above on 11/05/2020 around 1:30 pm. *** REPEAT DEFICIENCY*** -- 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 Interview with the Histotechnologist and review of the laboratories peer review procedure, the laboratory failed perform at least twice annually the accuracy of Mohs slides read on site from 2017 to the date of survey. Findings Include: 1. On the day of survey, 06/27/2018, the laboratory could not provide documention of peer reviews performed for 2 of 2 testing personnel in 2017 and in 2018 (January 1st, 2018 to June 27th, 2018). 2. The Histotechnologist confirmed the findings above on 06/27 /2018 around 9:10 am. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on Quality Assurance (QA) Program Policy and interview with the Histotechnologist, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor and assess its Pre-analytical, Analytical and Post- analytical system activities from 2017 to the time of survey. Findings include: 1. On 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 day of survey, 06/27/2018, after review of the laboratories Quality Assurance Program Policy, it was revealed that the laboratory is not following their own procedure to perform QA assessments on a monthly bases in 2017 (12 of 12 months) and from January to May 2018 (5 of 5 months). 2. The Histotechnoologist confirmed the finding above on 06/27/2018 around 09:45 am. 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 review of the laboratories Mohs Maps (Test Reports), and interview with the histotechnologist, the laboratory failed to ensure that all test reports include the address of the laboratories location where the pathology slides are read from January 1st, 2017 to June 27th, 2018. Findings Include: 1. On the day of survey, 06/27/2018, all test reports had one of two of the following address printed on the upper left hand corner of the test report: a). 2913 Windmill Road, Suite 7 Sinking Springs PA, 19608 b). 2588 Ben Franklin Highway Birdsboro PA, 19508 2. The correct address where pathology slides are read is, 5649 Wynnewood Drive, Suite 202 Laurys Station, PA 18059. 3. In 2017, 349 Patients slide were read on site. 4. The Histotechnologist confirmed the findings above on 06/27/2018 around 9:20 am. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 review of personnel records and interview with the Histotechnologist, the laboratory failed to evaluate the competency of all testing personnel (TP) who review Mohs pathology slides in 2017. Findings Include: 1. On the day of survey, 06/27 /2018, the laboratory could not provide 2017 competency assessment documention for TP #2, for review of pathology slides read on site. 2. In 2017, 349 pathology slide were reviewed. 3. The Histotechnologist confirmed the findings above on 06/27/2018 around 9:30 am. -- 2 of 2 --