Wellspring Health Access

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to ensure the individual testing the proficiency samples and the laboratory director attested to the routine integration of the American Proficiency Institute (API) proficiency tests into the patient workload for 3 of 3 Immunohematology proficiency testing events reviewed from October 2023 through November 2024. The findings were: 1. Review of the 2023 API Immunohematology Event #3, the 2024 Immunohematology Event #1, and the 2024 Immunohematology Event #2 records showed the testing personnel and laboratory director failed to sign the attestation statements. 2. Interview with testing personnel #1 on 12/4/24 at 2:15 PM confirmed no further documentation was available. 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 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 -- 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 review of proficiency testing records and staff interview, the laboratory failed to maintain a copy of each step in the testing and reporting process for 3 of 3 American Proficiency Institute Immunohematology proficiency testing events reviewed from October 2023 through November 2024 (2023 Event #3, 2024 Event #1, 2024 Event #2). The findings were: 1. Review of the laboratory's proficiency testing records showed no evidence the attestation statements, submission forms, and documentation of the testing results had been maintained. 2. Interview with testing personnel #1 on 12/4/24 at 2:15 PM confirmed no further documentation was available. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on lack of documentation and staff interview, the laboratory failed to ensure a policy and procedure was established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure they were competent and maintained their competency to process specimens, perform test procedures, and report test results promptly and proficiently. The findings were: 1. Review of the laboratory's documentation failed to show a policy and procedure to monitor each individual's competency had been developed. 2. Interview with the practice manager and testing personnel #1 on 6/29/23 at 10:30 AM confirmed the laboratory had not developed a policy to ensure the competency of the laboratory personnel. . D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Based on procedure manual review, lack of documentation, and staff interview, 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 3 -- laboratory failed to establish a quality assessment plan for general laboratory, pre- analytic, and post-analytic systems for the Eldoncard test system for determining a patient's Rh blood type. The laboratory estimated it would perform approximately 100 Rh blood type tests per year. The findings were: 1. The laboratory procedure manual failed to include a quality assurance plan that included the items the laboratory reviewed, the frequency of the review, and the method used to document the review in the following areas: a. General laboratory tasks which include proficiency testing review, testing personnel competency procedures, and complaint documentation and resolution. b. Pre-analytic tasks which include specimen collection, patient identification verification, and specimen labeling. c. Analytic tasks which include review of quality control and test record logs. d. Post-analytic tasks which include test report accuracy. 2. Interview with the practice manager and testing personnel #1 on 6 /29/23 at 10:30 AM confirmed the laboratory had not established a quality assessment plan. . 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 lack of documentation and staff interview, the laboratory failed to have a written procedure for the Eldoncard test system for determining Rh blood type. The laboratory estimated it would perform approximately 100 Rh blood type tests per year. The findings were: 1. Review of the laboratory's procedure manuals showed no evidence the laboratory had developed a policy and procedure for the Eldoncard test system for determining Rh blood type. 2. Interview with the practice manager and testing personnel #1 on 6/29/23 at 10:30 AM confirmed the laboratory did not have a written procedure for the Eldoncard test system. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on lack of documentation and staff interview, the laboratory failed to verify the accuracy and precision of the Eldoncard test system for determining Rh blood type prior to patient testing. The laboratory estimated it would perform approximately 100 patient blood types per year. The findings were: 1. Review of the laboratory's records -- 2 of 3 -- showed no evidence a verification study had been completed for the Eldoncard test system. 2. Interview with the practice manager and testing personnel #1 on 6/29/23 at 10:30 AM confirmed the verification study had not been completed. -- 3 of 3 --