Barnabas Health Medical Group

Summary Statement of Deficiencies 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, 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)

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 Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to follow written procedures to perform a CA on one of seven TP for the calendar year 2020. The TP # 2 as listed on CMS form 209 confirmed on 8/17/21 at 1:00 pm that the CA procedure was not followed . 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 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. 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 Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment of Hematology QC used on the Beckman Coulter Act diff 2 analyzer from 4/18/19 to the date of the survey.The findings include: 1. Coulter 4C-ES Cell Controls had no documented evidence that QC verification was performed. 2. Coulter 4C-ES Cell Controls lots expire every three months. 3. The TP #2 listed on CMS form 209 confirmed on 8/17/21 at 12:30 pm that assayed QC material was not verified before putting in use. -- 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 review of the Competency Assessment (CA) records, review of the personnel files and interview with the General Supervisor (GS), the laboratory failed to perform a CA on one the GS in the calendar years 2017 and 2018. The GS confirmed on 2/18/19 at 12:20 pm that CA was not performed on GS. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR), work records, Electronic Medical Records (EMR) and interview with the General Supervisor (GS), the laboratory failed to ensure test results were transcribed accurately for Throat Culture (TC) test from 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 -- November 2017 to the date of survey. The finding includes: 1. One out of three patients test results was not entered in the EMR. 2. The GS confirmed on 4/18/19 at 2: 00 pm that the laboratory did not transcribe results accurately in the EMR. -- 2 of 2 --