Princeton Women's Services

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 ABO and Rh Factor testing with the American Association of Bioanalysts. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for 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 3 -- 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 attain an overall testing event score of at least 100 percent for D (Rho) typing with the American Association of Bioanalysts PT in the Sewcond and third event of 2023. The finding includes: 1. The laboratory scored 0 % for ABO Group and D (Rho) Typing in the second and third events of 2023 D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. 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 attain an overall testing event score of at least 100 percent for D (Rho) typing prformed the findings include. 1. The laboratory scored 0% for D (Rho) Typing and ABO Group event 2, 2023 with American Association of Bioanalysts (AAB). 2. The laboratory scored 0% for D (Rho) Typing and ABO Group event 3, 2023 with AAB. D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 review of CASPER reports 153 and 155, the laboratory failed to submit ABO Group and D (Rho) Typing results to the American Association of Bioanalysts in events 2 and 3 in 2023. 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. -- 2 of 3 -- 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. -- 3 of 3 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: a) Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J. S.A. 45:9-42.28. License; necessity; categories, the laboratory failed to obtain a NJCLL before the laboratory started patient testing. The Supervisor for the Clinical Laboratory Improvement Services (CLIS) confirmed on 11/28/22 that the laboratory did not obtain its NJCLL license before the laboratory started testing. b) Based on interview with the office manager, and an in-office interview with Supervisor for the CLIS both confirmed on 11/30/22 that Laboratory Director (LD) did not hold a license for bioanalytical laboratory director under New Jersey State Administrative Code: N.J.A.C. 8:44-2.3. The the LD listed on the CMS 209 form is not a qualified LD as stated above. 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 Office Manager (OM) the laboratory failed to review and evaluate results when they received an unacceptable score in ASBO and RHo(D) Group tests performed with the American Association of Bioanalysts (AAB), for event S1-2021. 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 -- findings include: 1. The laboratory received an 0% grade for D(Rho) Typing. 2. There was no documented evidence that the laboratory ran the PT samples and compared them with AAB PT results. 3. The OM confirmed on 11/26/22 at 10:45 am that the laboratory did not review and document an evaluation of unacceptable PT results. 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 interview with the Office Manager (OM) and in-office interview with the Supervisor for the Clinical Laboratory Improvement Services (CLIS) The laboratory failed have a a qualified Laboratory Director (LD) an the date of survey. Cross refer 3009 -- 2 of 2 --