Assoc In Hematology-Oncology

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 lack of documentation and interview with laboratory supervisor (LS), the laboratory failed to have a written procedure manual for the Hematology Complete Blood Count (CBC) , Calibration and Calibration Verification performed. Findings include: 1. On the date of survey, 07/06/2022 at 11:15 am, the laboratory was unable to provide a procedure for the CBC, Calibration and Calibration Verification. 2. The laboratory supervisor confirmed during an interview on 07/06/2022 at 12:20 pm, that the laboratory did not have a written procedure for the above tests performed. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures 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 2 -- This STANDARD is not met as evidenced by: Based on lack of documenation, and interview of the laboratory supervisor (LS), it was determined that the laboratory did not maintain their quality control (QC) records to adequately monitor the accuracy and precision of each tests performance. Findings include: 1. On the day of survey 07/06/2022 at 1041am, the laboratory failed to produce daily documentation of

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 upon a review of proficiency testing records and interview with the Laboratory Supervisor,on the date of the survey (06/30/2020), the Laboratory Director failed to sign the College of American Pathologists (CAP) Attestation Statement, for CAP Hematology FH1-C-2019 proficiency test. The (CAP) Attestation Statements,was 1 of 6 CAP testing events from 2018 through the end of 2019. Findings: 1. At the time of the survey, (09:15 06/30/2020), 1 of 6 CAP testing event attestation statements reviewed (CAP Hematology FH1-C-2018), did not have the Laboratory Director's signature. 2. Testing events reviewed include: CAP Hematology FH1-C-2018 1st event, CAP Hematology FH1-C- 2018 2nd event, CAP Hematology FH1-C- 2018 3rd event, CAP Hematology FH1-C- 2019 1st event, CAP Hematology FH1-C- 2019 2nd event, and CAP Hematology FH1-C- 2019 3rd event. 3. During the survey (11:30 06 /30/2020), the Laboratory Supervisor confirmed the above findings. Hematology FH1- C-2018 proficiency test review D5401 PROCEDURE MANUAL 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(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 personnel interview of the Laboratory Manager and the General Supervisor and review of the laboratory procedure manual in use on the date of the survey (06/30 /2020), the procedure manual failed to include all procedures required by 493.1251 (b). Findings include: 1. The procedure manual in use on the date of the survey (06/30 /2020), did not include a description of the course of action, for reporting test results when results exceed the laboratory's reportable range. 2. During the survey (11:30 04 /04/2019), the General Supervisor confirmed the above finding. 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