Princeton Medicine Physicians

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on the lack of daily quality control work records (QCWR) and surveyor interview with the Testing Personnel # 1 (TP #1) provided on the CMS-209, the laboratory failed to maintain daily QCWR print-outs from the analyzer for complete blood cell (CBC) and automated differnetial (AUTODIFF) tests performed on the Sysmex XN 530 analyzer from 1/31/24 to 2/20/25. The finding includes: 1. The TP #1 stated, "we are not saving the daily quality control print-outs since we print the monthly Levey-Jennnings reports." 2. The TP #1 confirmed on 2/20/25 at 10:45 am that the laboratory did not maintain the daily QCWR's from the Sysmex XN 530. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), patient work records (PWR) and test reports (TR) and interview with the Testing Personnel #1 (TP #1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- provided on the CMS-209, the laboratory failed to follow the procedure to verify flagged complete blood cell (CBC) and automated differential (AUTODIFF) results from 1/31/24 to 2/25/25. The findings include: 1. The PM states "If there are flags, the printed report will be repeated and then presented to the lab director or ordering physician for review and approval. If a flag persists after repeat testing, the physician may determine that a result is not to be used for diagnostic purposes, and testing personnel with not include it in the patient's EMR. All CBC results will be initialed by the provider." 2. Seven out of seven flagged CBC and AUTODIFF PWR and TR reviewed had no verification by repeat testing performed and/or documented: a. Sample No. 1040524749, 4/5/24, R flag on AUTODIFF b. Sample No. 1061224955, 6 /12/24, R flags on white blood cell (WBC), platelet (PLT) and AUTODIFF c. Sample No. 1061224954, 6/12/24, R flags on WBC, PLT and AUTODIFF d. Sample No. 1090624505, 9/9/24, R flags on WBC and AUTODIFF e. Sample No. 1112124915, 11 /22/24, R flags on WBC and AUTODIFF f. Sample No.1112224918, 11/22/24, R flags on WBC and AUTODIFF g. Sample No. 1011325903, 1/13/25, R flags on WBC and AUTODIFF 3. The TP #1 confirmed on 2/20/25 at 12:30 pm that the laboratory failed to follow the PM and repeat flagged patient results. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records, Procedure Manual (PM) and interview with the Lab Supervisor (LS), the laboratory failed to ensure that all Testing Personnel (TP) who perform Hematology testing participated in the American Proficiency Institute (API) PT events in the calendar years of 2022 and 2023. The findings include; 1. The PM states " Proficiency testing will be performed on a rotating basis by testing personnel." 2. A review of PT attestation records showed that the LS performed 2 out of 3 Hematology events in 2023 in which 7 total TP failed to participate in. 3. The LS performed 2 out of 3 Hematology events in 2022 in which 5 total TP failed to participate in. 4. The LS confirmed on 1/31/24 at 11:30 am that the laboratory failed to rotate all TP to participate in the Hematology PT events in calendar years 2022 and 2023. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Lab Supervisor (LS) the laboratory failed to document the evaluation of all unacceptable scores and

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to participate in American Proficiency Institute (API) PT for the first event of 2020 for Hematology tests. The TC confirmed on 9/14/21 at 2:00 pm that the laboratory did not participate in the first event of 2020. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology tests performed with the 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 -- American Proficiency Institute (API) for the third event in the calendar year 2020. The findings include: 1. The laboratory received an unacceptable score for Hematocrit (Hct), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Volume (MCV) and Red Cell Distribution Width (RDW) for sample HEM-14. 2. There was no documented evidence that the laboratory investigated the failure. 3. The TC confirmed on 9/14/21 at 1:30 pm that the laboratory did not review and document an evaluation of unacceptable PT results. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to ensure that PT samples were tested for Hematology tests for the first event of 2020 with the American Proficiency Institute (API). The TC confirmed on 9/14/21 at 2:00 pm that the LD did not ensure that PT samples were tested. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to have appropriate education documentation for all Testing Personnel (TP) performing laboratory testing from 4/3/18 to the date of survey. The findings include: 1. The laboratory did not have education records for three out of six TP listed on the CMS form 209. 2. The TC confirmed on 9/14/21 at 1:30 pm the above records were not on file. -- 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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA correctly on eight out of eight TP in the calendar years 2016 and 2017. The findings include: 1. The laboratory did not document when testing personnel were observed, what records were reviewed and how assessment was done. 2. Assessment of problem solving skills and test performance through external or blind specimenwas not documented on CA for all TP. 3. The TP # 1 listed on CMS form 209 confirmed on 4/3/18 at 1:20 pm that the CA was not performed correctly. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. 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 surveyor review of the Personnel Files (PF) and interview with the Testing Personnl (TP), the Laboratory Director failed to have training documented for four out of eight new TP from 2017. The TP # 1 listed on the CMS form 209 confirmed on 4/3 /18 at 1:00 pm that new TP did not have training records. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and 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 results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director (LD) did not specify in writing the duties and responsibilities of TP engaged in the performance of preanalytic, analytic and post analytic phases of Compltete Blood Count tests from 3/16/16 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 4/3/18 at 1:00 pm that the LD did not specify the duties and responsibilities of TP. -- 2 of 2 --