Hackensack Meridian Health Network

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (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 lacked copies of all PT records for testing performed with the American Proficiency Institute (API) for the 2nd Hematology PT event of 2025. The findings include: 1. The laboratory lacked the work records and the attestation page for the 2nd Hematology PT event of 2025. 2. TP #1 as listed on the CMS 209 form confirmed on 11/25/25 at 11:30 am, all PT records were not retained. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records, the lack of a Procedure Manual (PM) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to have complete established procedures for assessing 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 -- the competency of TP from 6/18/24 to 11/25/25. The findings include: 1. The laboratory did not have a complete written CA procedure that included the following: a) How the competency of new TP will be initially assessed. b) How the competencey of new TP will be assessed 6 months after the initial assessment. c) The frequency for competencey assessment of TP. d) How TP will be assessed for the six required CA procedures. 2. TP #1 as listed on the CMS 209 form confirmed on 11/25/25 at 10:30 am, the LD failed to establish written policies and procedures for CA. *Note: This deficiency was previously cited on the survey performed on 6/18/24. -- 2 of 2 --

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM) and interview with Testing Personnel (TP) 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 preanalytic systems from 12/9/21 to the date of survey. The TP confirmed on 6/18/24 that the laboratory failed to establish the aforementioned procedures. 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 the lack of a Procedure Manual (PM) and interview with Testing Personnel (TP) the laboratory failed to have written procedures for all tests, assays, and examinations performed by the laboratory from 12/9/21 to the date of survey. The TP confirmed on 6/18/2024 at 10:30 am the laboratory did not have a PM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of Quality Control (QC) material in use, review of the Boule Con-Diff Tri-Level Control Kit Manufacture Package Insert (MPI) and interview with the Testing Personnel (TP), the laboratory failed to put open and expiration dates on QC material for the Hematology tests at the time of survey. The findings include: 1. The expiration date of the QC material shortens once opened. 2. The laboratory did not put open or expiration dates on the Boule controls in use. 3. The TP confirmed on 6/18/24 at 11:45 am the laboratory failed to put open and expiration dates on the control material. 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 Testing Personnel (TP) 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 12/9/21 to the date of survey. The findings include: 1. The laboratory did not have a policy with criteria on when to repeat a patient test. 2. The laboratory failed to have a procedure to verify new lots of controls before they were put in use. 3. The Laboratory failed to have a procedure on how Quality Control is reviewed, monitored and maintained. 4. The TP confirmed on 6/18/2024 at 11:45 am that 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. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP)), the Laboratory Director (LD) failed to ensure that PS procedures performed on the Medonic M-series analyzer were adequate from March 2024 to the date of survey. The findings include: 1. The LD did not review and sign the PS results. 2. The TP confirmed on 6/18/24 at 10:35 am that PS records were not adequate. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the lack of a procedure manual (PM) and interview with Testing Personnel (TP) the Laboratory Director (LD) failed to ensure that a Quality Control (QC) program was established and maintained to assure the quality of laboratory services provided from 12/9/21 to the date of survey. The TP confirmed on 6/18/24 at 11:00am that the LD failed to established and maintain a QC program. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM) and interview withe Testing Personnel (TP) the laboratory Director (LD) failed to ensure that Quality Assessment (QA) programs were established and maintained to assure the quality of laboratory services provided from 12/9/21 to the date of survey. The TP confirmed on 6/18/24 at 11:20 am that a QA program was not established and maintained. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for -- 3 of 4 -- monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records, the lack of a Procedure Manual (PM) and interview with the Testing Personnel (TP) the Laboratory Director (LD) failed to have established written procedures for assessing the competency of TP from 12/9/21 to the date of survey. The findings include: 1. There was no written procedure or policy for how to assess the competency of new employees and the annual competency of TP. 2. The TP confirmed on 6/18/2024 at 10: 30 am the LD failed to establish written policies and procedures for CA. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the lack of the Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to specify in detail the duties and responsibilities TP engaged in the performance of Hematology testing from 12/9/21 to the date of survey. The TP confirmed on 6/18/24 at 12:15 am that the LD did not specify the duties and responsibilities of TP. D6074 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(5) Each individual performing moderate complexity testing must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the LD failed to identify problems that may affect test performance by not reviewing and evaluating trends and/or shifts for tests performed on the Medonic-M series analyzer from from 12/9/21 to the date of survey. The TP confirmed on 6/18/24 at 11:35 pm that trends and shifts were not reviewed. -- 4 of 4 --

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 Office Manger (OM), the laboratory failed to retain graded results for Hematology /coagulation PT event 2-2021 performed with the American Proficiency Institute. The OM confirmed on 12/9/21 at 11:45 am that all PT graded results were not retained. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of Manufactures Instructions (MI), Procedure Manual, Quality Control (QC) Records, Calibration Records (CR) and interview with the Office Manager (PM), the laboratory failed to ensure that quality systems for the pre- analytic, analytic and post-analytical phases of Hematology testing were monitored at the date of survey. 1. The laboratory failed to maintain Proficiency Testing (PT) records. Cross refer to D3037. 2. The laboratory failed to follow the manufacturer's instructions for the Medonic M-Series analyzer used fro hematology testing. Cross refer to D5411. 3. The laboratory failed to put open and expiration dates on QC material. Cross refer to D5415. 4. The laboratory use expired QC for Hematology tests. Cross refer to D5417. 5. The laboratory failed to perform and document Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Calibration procedures . Cross refer to D5437 6. The laboratory failed to take the

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personal (TP), the laboratory failed to evaluate results when they received an unacceptable score in Hematology tests performed with the the American Proficiency Institute for first and second events for the calendar year 2019. The finding include: 1. The laboratory received an "Unacceptable" result for Mean Corpuscular Hemoglobin Concentration sample number HSY-04 in 1-2019. 2. The laboratory received an "Unacceptable" result for Hematocrit sample number HSY-10 in 2-2019. 3. There was no documented evidence that the laboratory investigated the failures. 4. The TP confirmed on 10/15/19 at 1:10 pm that the laboratory did not perform and document an evaluation of unacceptable PT results. 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 --