Planned Parenthood Ncsnj - Washington

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 surveyor review of the Quality Control (QC) records and interview with the Quality Risk Manager (QRM), the laboratory failed to perform and document Immunohematolgy QC on each day of patient testing from 2/23/22 to the date of the survey. The findings include: 1. The QC records reviewed showed that the lab did not perform positive and negative QC on the following dates: 2/23/22, 4/4/22, 4/12/22. 2. Approximatly six patients where run and reported. 3. The RQM confirmed on 7/28/22 at 2:30 pm that positive and negative QC were not run every day of patient testing. 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 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 -- 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 (QC) records and interview with the Quality Risk Manager (QRM), the laboratory failed to verify commercial QC material with each new lot and/or shipment of QC used for Rhesus factor tests performed on EldonCards at the time of survey. The finding includes: 1. There was no documented evidence that Negative control lot HMN689492 was verified. 2. The QRM confirmed on 7/28/22 at 2:00 pm that the QC material was not verified before putting in use. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control records, Quality Control (QC) material, and interview with the Quality Risk Manager (QRM), the laboratory used expired QC material for Rhesus (Rh) factor tests in July and October 2016 and January 2018. The findings include: 1. Bioreclamation Whole Blood Negative Control Lot # BRH1177317 expired on 7/21/16 and BRH1217875 expired on 10/13/16 but the laboratory ran samples on 7/23/16 and 10/15/16 accordingly. 2. The laboratory performed and reported 8 patient results during the above time frame. 3. The Rh positive control expired on 1/11/18 and the laboratory performed and reported 3 patient results after the expiration date. 4. The QRM confirmed on 1/19/18 at 10:35 am that the laboratory used expired QC. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 Final Reports (FR) and interview with the Quality Risk Manager (QRM), the laboratory failed to indicate all the required information on the FR from June 2015 to the date of survey. The findings include: 1. A review of ten final reports revealed one out of ten did not have the test result and one of ten did not have the date test was performed. 2. The QRM confirmed on 1/19/18 at 11:00 am the FR did not have all the required information. -- 2 of 2 --