American Healthcare Services

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 45:9-42.28. License; necessity; categories, the laboratory failed to maintain NJCLL for calendar year 2024. A Surveyor for the Clinical Laboratory Improvement Services (CLIS) confirmed on 12/23/24 that the laboratory did not have a NJCLL license for 2024. 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), Rhesus factor testing (Rh) and interview with the Testing Personnel (TP), the laboratory failed to have a procedure for Rh Tests performed with ALBAclone Anti-D blend Blood grouping reagent from 3/7/23 to the date of survey. The finding includes: 1. The laboratory did not have the Manufactuers Package Insert for ALBAclone Anti-D blend Blood grouping reagent. 2. The PM did not have a procedure for Rh testing using 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 -- ALBAclone Anti-D blend Blood grouping reagent 2. The TP confirmed on 12/18/24 at 1:00 pm that the aforementioned procedure was missing. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of Blood Grouping Reagent Anti-D blend ALBAclone Manufactuers Package Insert (MPI), laboratory Quality Control and Daily Laboratory Log (QCADLL) and interview with the Testing Personnel (TP), the laboratory failed to follow MPI for "Slide Technique" from 3/7/23 to the date of survey. The finding includes: 1. The MPI stated "Incubate the test for 5 minutes at 18-24c" 2. The TP stated they "incubate the slide on a heated view box" 3. The QCADLL recorded the view box temperature between 45-50C on each day of testing. 4. Approximately 1536 patients are run and reported annually. 5. The laboratory did not follow the MPI. 6. The TP confirmed on 12/18/24 at 1:30 pm that the MPI was not followed. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Manufacturer's Package Insert (MPI), the Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed to follow the manufacturer's instruction for Rhesus Factor (RH) testing from 4/6/18 to the date of survey. The finding includes: 1. The MPI states "Tests that show no agglutination within 2 minutes are considered negative". 2. The PM states "If no agglutination is seen in 2 minutes the tests are considered positive."(RH pos) 3. The laboratory perfoms approximately 1850 RH tests/year 4. The TP #5 listed on CMS form 209 confirmed on 6/17/21 at 11:00 am that the laboratory did not follow the MPI. 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 (PM) and interview with the 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 -- Testing Personnel (TP), the laboratory failed to correct problems identified in the Rhesus Factor (RH) procedure from 4/6/18 to the date of survey. The findings include: 1. The RH procedure written in the PM stated "If no agglutination is seen in 2 minutes the tests are considered positive. (RH pos) but the Manufacturer's Insert (MPI) stated "Tests that show no agglutination within 2 minutes are considered negative".. 2. The laboratory performs approximately 1850 RH tests per year. 3.The TP confirmed on 6/17/21 at 11:00 am the PM had the incorrect procedure for RH 4. The TP #5 as listed on CMS form 209 confirmed that the laboratory did not correct problems in the analytic system. -- 2 of 2 --