Monmouth Medical Center Vantage Point

Summary Statement of Deficiencies D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on the lack of Quality Assessment Records (QAR), surveyor review of the Procedure Manual and interview with the Technical Consultants (TC), the Laboratory Director (LD) failed to ensure that the Quality Assessment (QA) program was maintained to assure the quality of laboratory services provided from 8/3/23 to 4/15 /25. The findings include: 1. The laboratory did not follow the Quality Management System Annual Assessment procedure. 2. There were no QAR available for review. 3. The TC confirmed on 4/15/25 at 10:45 am, the LD did not ensure the QA program was maintained. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on the surveyor review of the Proficiency Testing (PT) records and interview with the Director of Laboratory Operations (DLO), the laboratory failed to maintain the attestation statements provided by College of American Pathologists (CAP) for Hematology and ReticulocyteTesting with the LD and analyst's signature. The findings include: 1. The attestation statements were not signed by the LD and analyst for Hematology events FH9-C-2021, FH2-B-2022, FH9-B-2023 and FH9-A-2023. 2. The attestation statements were not signed by the LD and analyst for Reticulocyte event. FT4-A-2023. 3. The DLO confirmed on 8/2/23 at 11:00 am the attestation statements for the above events were not signed. 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 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 -- 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 Director of Laboratory Operations (DLO) ,the laboratory failed to have a procedure for performing correlation studies for Hematology tests performed on the Sysmex XN 10 analyzers From February 2023 to the date of survey. The DOL confirmed on 8/2 /23 at 11:00 am that the laboratory did not have a procedure for performing correlation studies. D5783

Summary Statement of Deficiencies D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Technical Consultant (TC) the Laboratory failed ensure that the laboratory failed to notify Health and Human Services (HHS) of the approved PT program in which it participates at the time of survey. The findings include: 1) The Clinical Laboratory Improvement Amendment (CLIA) number on the PT evaluation sheet was 31D0114688. 2) The mailing address on the PT evaluation sheet was Monmouth Medical Center, Long Branch NJ, 07740-6303 3) The CLIA number of the laboratory performing the PT was 31D2157832 4) The address of the laboratory performing PT was Monmouth Medical Center Vantage Point, 100 Route 36 East Suite 18, West Long Branch. 5) The TC confimed at 10:30 am on 5/13/21 that the laboraotry failed to notify HHS of the approved PT program in which it participates. 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. 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 observation of the Quality Control (QC) vials and interview with the Technical Consultant (TC), the laboratory failed to put an appropriate expiration dates on the Coulter 4C-ES Cell QC reagents in use on the Beckman Coulter AcT diff 2 analyzer on the date of the survey. The findings include: 1. The Manufacturers Package Insert (MPI) stated "open vial stability is 31 days or open vial 20 times" 2. The laboratory wrote the open date 4/15/21 and the expiration date 5/25/21 on the Coulter 4C-ES Cell QC vials. 3. The TC confirmed on 5/13/21 at 11:00 am the laboratory failed to put appropriate expiration dates on the QC vials. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) 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 Proficiency Testing (PT) records and interview with the Technical Consultant (TC) the Laboratory director failed ensure that the laboratory is enrolled in an Health and Human Services (HHS) approved proficiency testing program at the time of survey. The findings include: 1) The Clinical Laboratory Improvement Amendment (CLIA) number on the PT evaluation sheet was 31D0114688. 2) The mailing address on the PT evaluation sheet was Monmouth Medical Center, Long Branch NJ, 07740-6303 3) The CLIA number of the laboratory performing the PT was 31D2157832 4) The address of the laboratory performing PT was Monmouth Medical Center Vantage Point, 100 Route 36 East Suite 18, West Long Branch. 5) The TC confimed at 10:30 am on 5/13/21 that the LD failed ensure that the laboratory was enrolled in an HHS approved proficiency testing program. -- 2 of 2 --