Cherry Hill Women's Center

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 Laboratory Administrator (LA), Testing Personnel (TP) failed to sign attestation statements for ABO and Rh Factor Proficiency Testing events provided by American Association of Bioanalysts (AAB) from 5/26/23 to 12/11/24. The finding includes: 1. Review of PT records revealed TP did not sign the attestation statements for the following PT events for ABO and RH factor: a) 2nd event of 2023 b) 3rd event of 2023 c) 1st event of 2024 d) 2nd event of 2024 2. The LA confirmed on 12/19/24 at 11:45 am TP did not sign the attestation statements for the above listed PT events. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 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 -- CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Administrator (LA), the laboratory lacked a procedure specifying when testing for weak D must be performed from 8/22/23 to 12/19/24. The finding includes: 1. The PM states "Slide techniques are not recommended for the detection of weak D or partial RhD samples. If the detection of antigens exhibiting weakened or modified expression is required, negative slide tests should be confirmed by tube testing." 2. The laboratory lacked a a procedure specifying when testing for weak D must be performed. 3. The laboratory lacked a procedure to perform tube testing for the detection of weak D or partial RhD samples. 4. The LA confirmed on 12/19/24 at 11: 38 am, the laboratory did not have the above procedures. 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 perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Testing Personnel (TP) files and interview the Laboratory Administrator (LA), the Laboratory Director (LD) failed to ensure that all TP who performed Immunohematology testing had all education records from 9/1/24 to 12/19/24 . The findings include: 1. There were no education records for TP #4 as listed on the CMS 209 form. 2. The LA confirmed on 12/19/24 at 11:40 am, the LD failed to ensure TP had all education records. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel #1 and #2 (TP #1 and TP #2) on the CMS-209 provided during the survey, the laboratory failed to provide a written procedure for and documentation of calibration for all thermometers used for Rh(D) testing. The finding include: 1. The laboratory could not provide a written procedure for the calibration of the refrigerator thermometer where the Rh(D) reagents are stored nor the Acu-Rite thermohygrometer used for room temperature and humidity in Exam Room 1 where Rh(D) testing is performed from 4/8/21 to the date of the survey. 2. The laboratory could not provide documentation of calibration for the refrigerator thermometer nor the Acu-Rite thermohygrometer from 4/8/21 to the date of the survey. 3. TP #1 and TP #2 confirmed on 8/22/23 at 11:45am that they could not provide a written procedure for performing calibration of the thermometer and thermohygrometer nor provide documention of calibration as it was not performed. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL), Final Report (FR) and interview with the Deputy Administrator (DA), the laboratory failed to retain FR for Rhesus Factor (RH) tests from 12/2/20 to the date of the survey. The finding includes: 1. From a random sample of ten patients found in the AL one out of ten FR was not available for review. 2. The DA confirmed on 4/8/21 at 1:00 pm all patient FR was 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 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) and interview with the Deputy Administrator (DA), the laboratory failed to follow "Quality Control Testing with Anti-D Reagent"" procedure from 3/10/16 to the date of survey. The finding includes: 1.The PM stated that control material was stable for 90 days. 2. The laboratory did not put new expiration date on control material. 2. The DA confirmed on 4/12/18 at 12:45 pm that PM was not followed. 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 perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of Personnel Files and interview with the Deputy Administrator (DA), the Laboratory Director failed to have education records for five out of six Testing Personnel from 3/10/16 to the date of the survey. The DA confirmed on 4/12/18 at 12:30 pm that there were no education records for five out of six TP. -- 2 of 2 --