Women's Choice Of Bergen County Pa

Summary Statement of Deficiencies 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 interview with the Techincal Consultant (TC), the laboratory failed to submit ABO Rho(D) Groups and D(Rho) Typing results to the American Association of Bioanalysts (AAB) in event 2, 2022. The TC confirmed on 5/31/2023 at 11:00am the laboratory failed to submit PT results to AAB. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Techincal Consultant (TC), the laboratory failed to retain all PT records for Nonchemistry event Q1- 2021 performed with the American Association of 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 -- Bioanalysts (AAB) at the time of survey. The TC confirmed on 5/31/23 at 10:45 am that all records for event Q1- 2021 were not retained. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the lack of Laboratory Temperature Logs (LTL) and interview with the Techincal Consultant (TC), the laboratory failed to monitor and document Room temperature, where Rhesus (Rh) tests are performed from 10/04/19 to the date of survey. The TC confirmed on 5/31/23 at 11:35 am that Room temperature was not documented . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor lack of Maintenance Records and interview with the Techincal Consultant (TC), the laboratory failed to perform and document maintenance of the Centrifuge used for Rhesus (Rh) testing from 10/4/19 to the date of survey. The TC confirmed on 5/31/23 at 11:15 am the laboratory failed to perform and document maintenance on the centrifuge. 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 -- 2 of 3 -- 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 Techincal Consultant (TC), the laboratory failed to verify Panoscreen QC material before use for Rhesus (Rh) tests from 10/4/19 to the date of survey. The TC confirmed 5/31/23 at 11:15 am that QC material was not verified before putting in use. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with Techincal Consultant (TC) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 10/04/19 to the date of survey. The finding includes: 1. The laboratory failed to have a procedure to verify new lots of controls before they were put in use. 2. The TC confirmed on 5/31/23 at 10:45 am that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. -- 3 of 3 --

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 Testing Personnel (TP), the laboratory failed to maintain a copy of all records for Rhesus factor test performed with the American Association of Bioanalyst for Q1,Q2 & Q3 2016. The finding includes: 1. The attestation statements were not signed by the Laboratory Director for PT events Q1,Q2 & Q3 2016 2. The TP confirmed on 1/17/18 at 10:15 am that all PT records were not maintained. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel 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 -- who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Logs (AL) and interview with the Testing Personal (TP), the laboratory failed to document the date of specimen collection for Rhesus factor test were performed from October to November 2017. The finding includes: 1. There were no dates recorded in the AL when patient testing occurred between 10/27/17 and 11/4/2017 on four separate days. 2. The TP confirmed on 1/18 /18 at 10:00 am that the laboratory did not document the dates patient testing was performed in the AL. -- 2 of 2 --