Hackensack Meridian Health Network

Summary Statement of Deficiencies 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 Testing Personnel (TP), the laboratory failed to retain graded results for Hematology /coagulation PT events 2-2023 1-2023 performed with the American Proficiency Institute. The TP confirmed on 5/7/24 at 10:45 am that all PT graded results were not retained. 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 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 Testing Personnel (TP), the laboratory failed to retain graded results for Hematology /coagulation PT events 3-2022, 2-2022 1-2022 performed with the American Proficiency Institute. The TP confirmed on 4/18/22 at 10:45 am that all PT graded results were not retained. 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), monthly Quality Control (QC) and interview with the Testing Personnel (TP), the laboratory failed to have a procedure for failed QC for Hematology testing from 8/2/5/19 to the date of survey. The findings include: 1) Two out of three levels of QC on controls failed on 2/23/22. 2) Control lot # 2221031 was run six times. 3) There were no

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: a. Based on surveyor review of the Procedure Manual (PM), calibration records, and interview with the Nurse Manger (NM), the laboratory failed to follow the procedure for calibration of the Medonic analyzer from 11/30/18 to the date of survey. The finding includes: 1. The PM maintenance and calibration schedule stated calibration was due in month 6 and 12 but the laboratory had no record of calibration after 11/30 /18. 2. The NM confirmed on 8/15/19 at 1:15 pm that the laboratory did not follow the calibration procedure. b. Based on surveyor review of the PM, lack of