Avala

Summary Statement of Deficiencies D0000 A Validation Survey was performed at Avala, CLIA ID # 19D0979467 on February 3, 2020 through February 4, 2020. Avala was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1215 CONDITION: Hematology 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1421 CONDITION: Laboratories Performing Moderate Complexity Testing; Testing Personnel D3017 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(a) Arrangement for services. The facility must have a transfusion service agreement reviewed and approved by the responsible party(ies) that govern the procurement, transfer, and availability of blood and blood products. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have a current contract with The Blood Center. Findings: 1. In interview on February 3, 2020 at 9:47 am,Technical Consultant 2 stated the laboratory transfuses blood only. Technical Consultant 2 further stated the laboratory receives the blood from The Blood Center of New Orleans, who performs the type and screen. 2. Review of the laboratory's "Addendum to Agreement For Provision of Compatibility Testing Services" for The Blood Center revealed the following: "The Blood Center is extending its original agreement terms through December 31, 2019." 3. In interview on February 4, 2020 at 1:45 pm, Technical Consultant 2 stated she was unaware the contract with The Blood Center had expired. D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure continuous temperature monitoring of the blood bank refrigerator. Findings: 1. Review of the 2018 and 2019 circular temperature charts for the blood bank refrigerators revealed the temperature was not recorded for the following four (4) dates: Refrigerator 1: January 2, 2018 from 12:00 am to 8:00am January 8, 2018 from 8:00 am to 12:00am May 29, 2018 from 12:00 am to 7:00 am June 4, 2018 from 8:30 am to June 5, 2018 at 12:00am Refrigerator 2: January 2, 2018 from 12:00 am to 8: 00am January 8, 2018 from 8:00 am to 12:00am May 29, 2018 from 12:00 am to 7:00 am June 4, 2018 from 8:30 am to June 5, 2018 at 12:00am 2. In interview on February 4, 2020 at 8:57 am, Technical Consultant 2 stated the gaps on the circular temperature charts were due to the chart removed late due to the weekend. Technical Consultant 2 confirmed the laboratory did not document cause of the gaps for the identified dates. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing for the specialty of Hematology. Findings: 1. The laboratory failed to have a complete policy and procedure manual. Refer to D5401 I. 2. The laboratory failed to follow their procedure for Complete Blood Count (CBC) flags. Refer to D5401 II. 3. The laboratory failed to ensure the policy and procedure manual contained complete policies and procedures. Refer to D5403. 4. The laboratory failed to have procedure for Complete Blood Counts (CBC) signed by the Laboratory Director. Refer to D5407. 5. The laboratory failed to use normal donors as required by manufacturer to verify reference intervals and establish their own normal Prothrombin (PT) mean with each new lot of thromboplastin. Refer to D5411 II. 6. The laboratory failed to have complete reference range studies for Coagulation testing. Refer to D5421. 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: I. Based on record review and interview with personnel, the laboratory failed to establish complete procedures for testing personnel competency assessments. Findings: 1. Review of the laboratory's "Laboratory Competencies/Inservices" policy -- 2 of 12 -- revealed the laboratory did not include the frequency ( initial training, semi-annual, and annual assessments thereafter). 2. Further review of the "Laboratory Competencies /Inservices" policy and assessment forms revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 3. In interview on February 3, 2020 at 10:00 am, the Technical Consultant stated she plans on updating the competency forms. The Technical Consultant 2 confirmed the laboratory's competency assessment policy did not include the identified information. II. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for Technical Consultant were complete. Findings: 1. Review of the laboratory's " Laboratory Competencies/Inservices" policy revealed the laboratory did not include competency assessment criteria and frequency of performance for personnel serving as the Technical Consultant. 2. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed the Laboratory Director and Technical Consultant 2 serve as Technical Consultants. 3. Review of personnel records for Technical Consultant 2 revealed the Laboratory Director did not perform a competency assessment for her duties as Technical Consultant. 4. In interview on February 3, 2020 at 9:47 am, Technical Consultant 2 confirmed the Laboratory Director did not perform a competency assessment for her duties as Technical Consultant. 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: I. Based on record review and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's electronic policy and procedure manual revealed the following procedures were not included: a) Flag Policy for Complete Blood Counts (CBC) b) Manual INR calculation including frequency 2. In interview on February 3, 2020 at 12:51 pm, Technical Consultant 2 stated the flag policy for CBC's was not included in the laboratory's policy manual . Technical Consultant 2 confirmed the laboratory's electronic manual did not include the identified policies. II. Based on record review and interview with personnel, the laboratory failed to follow their procedure for Complete Blood Count (CBC) flags. Findings: 1. Review of the laboratory's "Sysmex XNL 430 Procedure" revealed the following: a)"Review results in IPU to determine whether repeat or reflex testing is required b) "There are different methods for handling samples with platelet clumping or 'platelet satellitism'. These methods include vortexing of the original sample and reanalyzing or adding amikacin to the -- 3 of 12 -- original sample and reanalyzing. Laboratories should define and validate the method (s) used by their facility." 2. Review of the laboratory's "Flags and Rule Comments" for "PLT Flags" revealed the following: a) "Remix and rerun sample, report if no flag b) If flag is still present , check specimen for clots and redraw if indicated c) If not clot present and results are consistent with history, result final" 3. Review of random selection of patients with CBC testing in October 2019 revealed the following patient was not retested: October 17, 2019: Patient 10059562 : Instrument Flags: "# 75 : Make smear and scan PLT IP Message: PLT Clumps?" 4. In interview on February 3, 2020, Technical Consultant 2 confirmed the laboratory did not repeat the identified patient with the platelet flag. 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)