Dublin Hematology & Oncology Care Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on Februry 10, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the procedure for proper labeling of samples, laboratory tour, and staff interview, the laboratory failed to properly label specimens for testing on the Abbott Cell-Dyn Emerald (Emerald), Hematology analyzer. Findings: 1. Observed during the lab tour, 10 sample tubes were placed in a rack after running the samples through the Emerald. The tubes were only labeled with the patient's first and last name. 2. Review of the procedure for labeling specimens for hematology, from the Operator's Manual for the Emerald, states that all samples should be labeled with patient's name, date of birth, MR number, and doctors name. 3. Interview with staff #2, and office manager, on 02/10/2022, at appoximately 12 pm in the laboratory, confirmed the aforementioned statements. 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on September 3, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of the American Proficiency Institute(API) Proficiency testing (PT) documents for Hematology, and staff interview, the laboratory failed to provide signed attestation statements signed by the Laboratory Director (LD). Findings: 1. A review of the API PT documents for 2018 and 2019 Hematology revealed that the LD did not sign attestation statements for the first or second events in 2018. The first and second events for 2019 also failed to include the signature by the laboratory director. 2. Interview with the office manager and staff # 4 (CMS form 209) on September 3, 2019 at approximately 4 pm in the Laboratory, confirmed that the aforementioned attestation documents were not signed by the LD. 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 -- D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require