Naspac1, Llc - Cherry Hill

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the General Supervisor (GS), the laboratory failed to follow the PM for "5. Quality Control (QC) Data" from 6/2/22 to the date of the survey. The findings include: 1. The PM stated "5.3 All QC Data will be maintained and monitored by the designees to include", "5.3.1 Monthly reports on results", "5.3.2 Identification of upward or downward trends". 2. There was no documented evidence that the aforementioned procedures were performed. 3. The GS confirmed on 7/16/24 at 12:00pm the laboratory did not follow the PM. 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 the Quality Control (QC) procedure and interview with the General supervisor (GS), the laboratory failed to to verify QC material with each new lot and/or shipment of QC for urine toxicology tests performed on the AB Sciex 4500 and 4000 from 6/2/22 to the date of survey. The GS confirmed on 7/16/24 at 12: 20 pm that the QC material was not verified before putting in use. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Laboratory Records and interview with the General Supervisor (GS), the laboratory failed to perform and document correlation studies for Toxicology test performed on the AB Sciex 4000 and 4500 analyzers twice per year from 6/2/22 to the date of the survey. The GS confirmed on 7/16/24 at 12:20 pm that the laboratory did not do correlation studies. -- 2 of 2 --

Summary Statement of Deficiencies D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the Laboratory Director (LD) failed to ensure that PT samples were tested for all analytes run on the AB Sciex analyzers from 12/20/19 to the date of the survey. The findings include: 1. Not all analytes run on the AB Sciex analyzer are offered for PT testing in each College of American Pathologists (CAP) survey events. 2. The GS confirmed on 6/2/22 at 11:35 pm that the LD did not ensure PT samples were tested for all tests performed in the laboratory. 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 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Requisitions (TR) and interview with the General Supervisor (GS), the laboratory failed to ensure that TR included all relevant and necessary information for accurate and reliable testing and reporting from March 2019 to the date of survey. The finding includes: 1. A review of 26 TR revealed 14 were missing specimen validation. 2. The GS confirmed on 12/20/19 at 12:50 pm that all relevant and necessary information was not on the TR. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)