Pennsylvania Rheumotology Associates

Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records and interview with the laboratory director (LD), the Laboratory Director (LD) failed to specify, in writing, the duties and responsibilities of each consultant, supervisor, and testing personnel (TP) involved in the preanalytic, analytic, and postanalytic phases of patient testing from 05/08/2021 to the date of the survey. Findings include: 1. On the date of the survey, 06/21/2023 at 10:40 am, the laboratory could not provide written job responsibilities and duties for 1 of 1 LD, 1 of 1 clinical consultant (CC), 1 of 1 technical supervisor (TS), 1 of 1 general supervisor (GS) and 3 of 3 TP involved in patient testing. 2. The LD confirmed the findings above on 06/21/2023 around 11:30 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 D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with the laboratory director (LD), the laboratory failed to document quality control (QC) performed each day of patient testing for synovial fluid microscopic examinations form 2019 to the day of survey. Findings include: 1. On the day of survey, 05/28/2021, the laboratory could not provide documentation of daily QC performed for synovial fluid microscopic examinations from May 28, 2019 to May 28, 2021. 2. In 2019: 78 - synovial fluid microscopic examinations were analyzed. 3. In 2020: 56 - synovial fluid microscopic examinations were analyzed. 4. In 2021: 20 - synovial fluid microscopic examinations were analyzed. 5. The LD confirmed the findings above on 05/28/2021 around 09:45 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. 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 procedure manual, review of personnel competency assessment records and interview with the laboratory director (LD), the technical supervisor (laboratory director) failed to ensure the competency assessment of 2 of 3 testing personnel (TP) performing synovial fluid microscopic examinations were assessed and completed in 2019, 2020 and 2021. Findings Include: 1. On the day of survey, 05/28/2021, review of 2 of 3 TP competency assessment records from 2019, 2020 and 2021 revealed: - TP competency assessment records were not signed by the LD in 2020. - TP were only assessed for 1 of the 6 points of competency (peer review). 2. The LD confirmed the findings above on 05/28/2021 around 10:00 am. -- 2 of 2 --

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 procedure manual, review of peer review records, interview with the Laboratory director (LD) and Phlebotomist, the LD failed to ensure that 2 of 4 Testing personnel (TP) performed in the verification of accuracy of the synovial fluid examination in 2018. Findings Include: 1. On the day of survey, 03/12 /2019, the LD could not provide a procedure manual for the peer review performed on the synovial fluid examinations from 2017 to March, 12, 2019. 2. TP#1 (the LD) and TP #2 did not perform in peer review in 2018. 3. The LD confirmed the findings above on 3/12/2019 around 10:00 am. . D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 record review, interview of the laboratory director (LD) and phlebotomist, the LD failed to ensure that the quality control (QC) programs were established and maintained for synovial fluid examination performed from May 2017 to the date of survey. Findings Include: 1. On the date of survey, 03/12/2019, the LD could not provide documentation of QC procedures performed, each day of patient testing for 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 synovial fluid examination from May 2017 to 03/12/2019. 2. From May 2017 to December 2017, 18 synovial fluid examinations were performed. 3. In 2018 (January 2018 to December 2018), 31 synovial fluid examinations were performed. 4. From January 2019 to February 12, 2019, 9 synovial fluid examinations were performed. 5. The LD confirmed on 03/12/2019 around 11:00 am, that quality QC was not performed. 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 Labortaory director (LD) and Phlebotomist, the LD failed to ensure a quality assessment (QA) programs was established and to assure the quality of laboratory services provided from 2017 to the day of survey. Findings Include: 1. On the date of survey, 03/12/2019, the LD could not provide a QA procedure or documentation of periodic evaluation of the laboratory, that assess its preanalytical, analytical, and postanalytical processes from May 22, 2017 to March 12th, 2019. 2. From May 2017 to December 2017, 18 synovial fluid examinations were performed. 3. In 2018 (January 2018 to December 2018), 31 synovial fluid examinations were performed. 4. From January 2019 to February 12, 2019, 9 synovial fluid examinations were performed. 5. The LD confirmed on 03/12/2019 around 10:45 that a QA policy does not exist. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, personnel competency assessment records, interview with the Laboratory director (LD) and Phlebotomist, the LD failed to ensure the competency of 3 of 3 testing personnel (TP) performing synovial fluid examination was assessed and document from 2017 to the date of survey. Findings Include: 1. On the day of survey, 03/12/2019, the LD could not provide documentation of competency assessment performed on 3 of 3 synovial fluid TP in 2017 and 2018. 2. The laboratory could not provide a competency assessment procedure for the synovial fluid examination TP. 3. From May 2017 to December 2017, 18 synovial fluid examinations were performed. 4. In 2018 (January 2018 to December 2018), 31 synovial fluid examinations were performed. 5. From January 2019 to February 12, 2019, 9 synovial fluid examinations were performed. 6. The LD confirmed the findings above on 3/12/2019 around 9:45 am **** THIS IS A REPEAT DEFICIENCY**** -- 2 of 2 --