Summary:
Summary Statement of Deficiencies D0000 During an initial survey the laboratory was found out of compliance with the following condition: 493.1250 Condition: Analytic systems 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 review of the laboratory procedure manual, the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), lack of documentation, and staff interview, the laboratory failed to follow its' own policies for testing personnel training and evaluation of competency for eight of eight testing personnel in 2023. The findings include: 1. Review of the laboratory's policy titled "QUALITY ASSURANCE (QA) FOR THE LABORATORY under the section for new employees revealed that new employees would be trained for each section they work, and that performance would be review at 90 days, six months and then annually. The policy titled "Competency Evaluation" revealed that "each individual's performance in the laboratory will be evaluated at orientation, at 6 months, and yearly thereafter." "Prior to implementation of new equipment or procedures - orientation, inservice and competency must be performed prior to test performance by technical staff." 2. Review of the FORM CMS 209 revealed eight testing personnel who perform patient testing. 3. There was no documentation of laboratory training /assessment of competency for testing personnel as follows: Testing person number one: Urine microscopic, manual differential, ABO, Rh, Antibody Screen, Compatibility testing, mono test, wet prep. Testing person number two: Beckman Coulter AU and Beckman Coulter Access chemistry instruments, urine microscopic, testing performed on the Abbott i-STAT instrument (blood gas and troponin I), and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- wet prep. Testing person number three: Triage meter for performance of D-Dimer, urine microscopic, manual differential, Beckman Coulter DxH complete blood count instrument, wet prep, and Sysmex CA 600 for performance of Prothrombin Time (PT) and activated Partial Thromboplastin Time (PTT). Testing person number four: Triage meter for performance of D-Dimer, urine microscopic, Beckman Coulter DxH complete blood count instrument, manual differential, Abbott i-STAT for performance of arterial blood gas and troponin I, mono test, Sysmex CA 600 for performance of PT and PTT, and serum pregnancy test on the ICON test kit. Testing person number five: Beckman Coulter DxH complete blood count instrument, urine microscopic, manual differential, Abbott i-STAT instrument for performance of blood gas and troponin I, mono test, wet prep, serum pregnancy test on the ICON test kit. Testing person number six: Triage meter for performance of D-Dimer, urine microscopic, Beckman Coulter DxH complete blood count instrument, manual differential, transfusion medicine testing to include ABO, Rh, antibody screen and compatibility testing, Abbott i-STAT for performance of arterial blood gas and troponin I, wet prep, and Sysmex CA 600 for performance of PT and PTT. Testing person number seven: Triage meter for performance of D-Dimer, Beckman Coulter AU and Access 2 chemistry instruments, Beckman Coulter DxH complete blood count instrument, urine microscopic, manual differential, Abbott i-STAT instrument for performance of blood gas and troponin I, wet prep, and Sysmex CA 600 for performance of PT and PTT. Testing person number eight: Beckman Coulter AU and Access 2 chemistry instruments, Beckman Coulter DxH complete blood count instrument, Abbott i-STAT instrument for performance of blood gas and troponin I and wet prep. 4. Interview with the general supervisor on 12/11/23 at 4 pm confirmed the laboratory failed to follow its' own policy for testing personnel training and competency assessment for all eight personnel who perform patient testing. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on laboratory observations, review of laboratory procedures, patient test reports, manufacturer instructions for use, quality control records, patient test logs, lack of documentation, staff interview and electronic communications, the laboratory failed to maintain compliance with analytic systems when it failed to have a complete procedure manual for performance of hematology testing on the Beckman Coulter DxH 690T (Refer to D5403), failed to ensure the procedure for the Beckman Coulter DxH 690T hematology instrument was approved by the laboratory director before use (Refer to D5407), failed to perform Mean Normal Patient Prothrombin Time for the current lot of Innovin (Refer to D5411), failed to verify the performance of the moderately complex Respiratory Syncytial Virus (RSV) performed on the Quidel Sophia 2 (Refer to D5421-Citation One), failed to verify the performance specifications of the cardiac Troponin I performed on the i-STAT instrument (Refer to D5421-Citation Two), failed to establish performance specifications for RSV test performed on patients outside the manufacturer specified age groups (Refer to -- 2 of 10 -- D5423), failed to ensure at two levels of controls were performed each day of patient testing for the cardiac Troponin I performed on the i-STAT instrument (Refer to D5447), failed to ensure two levels of quality control were performed for the qualitative serum pregnancy test for the ICON test kit (Refer to D5449-Citation number one), failed to ensure two levels of quality control were performed each day of patient testing for the non-waived RSV test performed on the Quidel Sophia 2 (Refer to D5449-Citation number two), failed to verify the quality control (QC) ranges that were in use for the Thyroid Stimulating Hormone (Refer to D5469), and failed to ensure an anti-human globulin (AHG) crossmatch was performed when the patient had a positive antibody screen (Refer to D5551). 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)