College Park Medical Center

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 review of the procedure, review of proficiency testing (PT) results, and interview with the technical supervisor (TS), the laboratory failed to investigate the cause of a PT score less than 100% as required in the procedure. Findings: 1. The "Proficiency Testing" section of the "Quality Management Plan" stated "Survey performance that demonstrates a score of less than 100% will require further investigation and

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to test PT samples in the same manner as patient samples. Findings: 1. American Proficiency testing (API) 2019 1st event Hematology attestation and performance review were signed by the laboratory director and the testing person on 3/28/2019. 2. PT samples were ran on 3/20/2019 and samples 1/3 were ran twice. 3. The TC stated that if they have problems with patients samples they run them twice but the TC did have a written procedure stating that patient samples are ran twice when problems arise. 4. The TC was unable to explain why the attestation and the performance review were completed and signed on the same date. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to have all copies of PT records that were obtained when performing PT. Findings: 1. The laboratory did not have the American Proficiency testing (API) 2019 2nd event Hematology attestation signed by the appropriate staff that performed the PT testing. 2. The TC confirmed that the API 2019 2nd event Hematology attestation was not available 3. The laboratory did not have raw data, attestation, nor performance review for the API 2018 3rd event Hematology. 4. The TC confirmed that the API 2018 3rd event Hematology raw data, attestation, nor performance review was available D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to review proficiency testing results. Findings: 1. The laboratory did not have the American Proficiency testing (API) 2019 2nd and 3rd event Hematology performance review reviewed and signed by the appropriate staff. 2. The TC confirmed that the API 2019 2nd and 3rd event Hematology performance review was not available. 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 review of the written procedure manual and interview with the technical consultant (TC), the laboratory did not have a written proficiency testing (PT) procedure. Findings: 1. The laboratory did not have a written proficiency testing procedure with step by step instructions for the testing personal to follow when performing PT. 2. The TC confirmed that a written PT procedure was not available. D5781

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 quality control (QC) record review and interview with the laboratory staff, the laboratory did not retain QC records for at least 2 years. Findings: 1. Review of hematology QC records from May to July, 2018 showed that on 5/14/18 the platelet was out of range/unacceptable for the low level control. The QC was repeated but the print out for the initial run (out of range control) was not available at the time of the survey; and 2. On 5/18/18, the platelet was out of range/unacceptable for the low level control. The QC was repeated 3 times before the control was acceptable but the print outs for the out of range controls were not not available at the time of the survey. 3. During an interview on 7/19/18 at 2:00 PM, the laboratory staff confirmed that the laboratory did not retain QC records for at least 2 years. 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 review of the standard operating procedure manual (SOPM) and interview Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- with the technical consultant (TC), the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory system. Findings: 1. A review of the SOPM showed that there was no written policy for conducting quality assurance (QA) reviews of the laboratory. 2. During an interview on 7/19/18 at 12:00 PM, the TC confirmed that there was no written QA policy in the SOPM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)