Union Internal Medicine Group Pa

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on May 2, 2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and proficiency testing 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 -- provider reports, the laboratory failed to achieve 80% or more in two out of three events for Routine Chemistry for the analyte Alanine Transaminase (ALT) with the American Association of Bioanalysts (AAB). Refer to D2097 D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive events in the subspecialty Routine Chemistry for the analyte Alanine Transaminase (ALT), The findings include: 1) A Review of the CASPER 155 report revealed the following: a) The laboratory scored 60% in event 1- 2025 b) The laboratory scored 20% in event 2-2024 2. A review of AAB graded results confirmed the aforementioned failed PT events. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CASPER 155 report and graded results from American Association of Bioanalysts (AAB), the Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. Cross refer D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from American Association of Bioanalysts (AAB) the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved Proficiency Testing (PT) program for two consecutive PT events for the analyte Alanine Transaminase (ALT), resulting in initial unsuccessful performance. Refer to D2097. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Clinical Consultant (CC), the laboratory failed to have complete attestation records for all College of American Pathologists (CAP) PT events for Endocrinology, Chemistry and hematology tests for events one and two 2024. The findings include: 1. The attestation records for PT events one and two 2024 did not have the name of the analyst that performed PT. 2. The CC confirmed on 9/18/24 at 1:35 pm the attestation records were not complete. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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: a) Based on surveyor review of the Procedure Manual (PM), and interview with the Clinical Consultant (CC)), the laboratory failed to follow the PM for "Control Range verification procedure" from 1/17/23 to the date of the survey. The finding includes: 1. The PM stated "Before a new lot number of controls is started the controls are to be run in triplicate. The values are to be compared to the affiliated control ranges", "These are to be kept in a separate log book". 2. There was no documented evidence that the aforementioned procedures were performed. 3. The CC confirmed on 9/18/24 at 12:00pm the laboratory did not follow the PM. b) Based on surveyor review of the Procedure Manual (PM), and interview with the Clinical Consultant (CC), the laboratory failed to include new shipments of control material as part of the laboratories Quality Control Verification (QCV) procedure from 1/17/23 to the date of survey. The CC confirmed on 9/18/24 at 12:00pm the laboratory failed to have the aforementioned procedure. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control Verification (QCV) records and interview with the Clinical Consultant (CC), the laboratory failed to verify QC material before use for Alfa Wassweman Ace Alera from 1/17/23 to the date of survey. The findings include. 1) There was no documented evidenced that the QCV was performed on the current lot of Alfa Wassermsan Controls. 2) The CC confirmed 9/18/24 at 11:15 am that QC material was not verified before putting in use. Note: this was previously cited 1/7/23 D5781

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve 80% or more in two out of three events for Routine Chemistry testing with the American Association of Bioanalysts (AAB). D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve at least 80% for Total Cholesterol. The finding includes: 1) The laboratory scored 0% for Total Cholesterol in event 3-2023 with the American Association of Bioanalysts (AAB) 2) The laboratory scored 0% for Total Cholesterol in event 2-2024 with the AAB. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration Verification (CV) records, Operators Manual (OM) and interview with the Testing Personnel (TP), the laboratory failed to follow the manufacturer's test systems instructions for performing and documenting Calibration at least once every six months for Hematology Tests performed on the Abbott Cell Dyn Emerald analyzer in the calendar years 2021 and 2022. The findings include: 1. The the manufacturer's test systems instructions stated prior to calibration: "Verify instrument precision by running a fresh, normal whole blood specimen ten times into the PRECISION file. Refer to Section 9: Service and Maintenance, Subsection: Precision for information on using QC files. Ensure that CV% results are within the limits as provided in Section 4: Performance Characteristics and Specifications. Record the results below or attach a printout to this document". 2. A review of CV records revealed that the laboratory did not perform "Precision Check" as required prior to CV. 3. The TP confirmed on 1/17/23 at 11:30 am that the laboratory failed to follow the manufacturer's test systems instructions as stated above. 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 -- D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of Quality Control Verification (QCV) records and interview with the Testing Personnel (TP), the laboratory failed to verify QC material before use for Alfa Wassweman Ace Alera on the date of survey. The findings include. 1) There was no documented evidenced that the QCV was performed on the current lot of Alfa Wassermsan Chemistry Controls. 2) There was no documented evidenced that the QCV was performed on the current lot of Alfa Wassermsan Lipid Controls. 3) The TP confirmed 1/17/23 at 11:15 am that QC material was not verified before putting in use. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR), Manufacturer Package Insert (MPI) and interview with the Testing Personnel (TP), the laboratory failed to identify the source of the Reference Intervals (RI) used for Total Bilirubin (TBILI), and Albumin (ALB) tests on the date of survey. The findings include: 1. The TP stated the laboratory used the RI listed in the MPI. 2. The MPI RI for TBILI was .3-1.2 mg/dL but the FR had 0.0-1.0 mg/dL. 3. The MPI RI for ALB was 3.5-5.2 mg/dL but the FR had 3.5-5.0 mg/dL. 4. The TP confirmed on 1/17/23 at 11:32 am that the RI on the FR was not that of the RI in the MPI. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PS procedures were performed on the Cell Dyn Emerald analyzer for Hematology from 3/23/18 to the date of survey. The finding includes: 1. The laboratory did not perform Precision. 2. The TP #1 listed on the CMS form 209 confirmed on 9/25/19 at 11:15 am that all PS records were not performed. 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 --