Atlanticare Regional Medical Center - Hammonton

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 surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to sign attestation statements for the 2021 Chemistry Core first PT event with the American Proficiency Institute. The OM confirmed on 10/28/21 at 10:30 am that PT records were not maintained. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can 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 -- perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Office Manager (OM), the Laboratory Director (LD) failed to have appropriate education documentation for all Testing Personnel (TP) performing laboratory testing from 2/14 /19 to the date of survey. The findings include: 1. The laboratory did not have education records for three out of fifteen TP listed on the CMS form 209. 2. The OM confirmed on 10/28/21 at 12:00 pm the above records were not on file. -- 2 of 2 --

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: Based on surveyor review of the Hematology Procedure Manual (PM) and Final Reports and interview with the Technical Consultant (TC), the laboratory failed to follow Sysmex pocH100i PM, section Reference Ranges (RR) from 3/1/17 to the date of survey. The finding includes: 1. The PM had Male and Female RR but the FR had same range for Male and Female patients. 2. The TC # 1 listed on CMS form 209 confirmed on 2/14/19 at 2:30 pm that the laboartory did not follow PM. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Individual Quality Control Plan (IQCP) and interview with Technical Consultant TC), the laboratory failed to perform and document controls each day of patient testing for Troponin, B- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Type Natriuretic Peptide and International Normalized Ratio tests performed on the iSTAT analyzer from 3/1/17 to the date of survey. The findings include: 1. The laboratory ran liquid QC once a month. 2. The TC stated that the laboratory developed IQCP but the Quality Control Plan was not established. 3. The TC did not know how many patient samples were run. 4. The TC # 1 listed on CMS form 209 confirmed on 2 /14/19 at 2:00 pm that QC was not done on each day of patient testing. D5781