Pa Dermatology Partners Ov

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 lack of documentation and interview with the Director of training and compliance (DTC), the laboratory failed to perform twice annually the verification of accuracy of Mohs microscopic examinations from 01/05/2022 to the date of survey. Findings include: 1. On the day of survey, 10/19/2023 at 10:48 am, the laboratory could not provide the biannual documentation for the verification of accuracy of Mohs microscopic examinations from 01/15/2022 to the date of survey. 2. According to the laboratory's proficiency testing policy, "Semi-annually, the tech or risk manager will send five cases containing the original slide, and send out for a microscopic examination by a board certified Dermatopathologyst". 3. The laboratory reported an annual volume of 1222 microscopic examinations/tests performed in Histopathology (CMS 116). 4. The DTC confirmed the above findings on 10/19/2023 at 12:10am. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records and interview with the Director of training and compliance (DTC), the laboratory failed to document Hematoxylin and Eosin (H&E) QC monitoring activities for intended reactivity each day of patient testing for MOHS micrographic examinations performed from 01/04 /2023 to 10/19/2023. Findings Include: 1. On the day of the survey, 10/19/2023 at 09: 54 am, review of the staining QC records revealed the laboratory did not document QC monitoring activities for intended reactivity each day of patient testing for MOHS micrographic surgery slide examinations stained using H&E for 50 of 50 days from 01 /04/2023 to 10/19/2023. 2. The DTC confirmed the finding above on 10/19/2023 around 12:10 pm. D5781

Summary Statement of Deficiencies 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 review of the procedure manual, interview with the office manager and the physician assistant (PA), the laboratory director (LD) failed to ensure quality assessment (QA) programs were established to assure the quality of laboratory services provided from 2017 to the day of survey. Findings Include: 1. On the date of survey, 05/30/2019, the Laboratory could not provide a QA procedure or documentation of periodic evaluation of the laboratory, that assess its preanalytical, analytical, and postanalytical processes from September 25th, 2017 to May 30th, 2019. 2. The office manager and PA confirmed on 05/30/2019 around 09:45 am, that a QA policy does not exist. 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: 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 review of the laboratory procedure manual, personnel competency assessment records, interview with the office manager and physician assistant (PA), the technical supervisor (laboratory director) failed to ensure the competency of 1 of 2 testing personnel (TP) performing dermatopathology slide reading and 1 of 1 clinical consultant (CC) was assessed for competency in 2018 and 2019. Findings Include: 1. On the day of survey, 05/30/2019, the office manager and PA could not provide documentation of competency assessments performed for 1 of 2 TP who read dermatopathology slides and 1 of 1 CC in 2018 and 2019. 2. The office manager and PA confirmed the findings above on 05/30/2019 around 8:55 am. **** THIS IS A REPEAT DEFICIENCY**** -- 2 of 2 --