Olol-North Baton Rouge Clinical Laboratory

Summary Statement of Deficiencies D0000 A Validation/Initial Survey was conducted at OLOL-North Baton Rouge Clinical Laboratory-CLIA # 19D2138973 on August 20, 2018 through August 22, 2018. OLOL-North Baton Rouge Clinical Laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderatre complexity testing, Laboratory Director D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains 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 observation, record review, and interview with personnel, the laboratory failed to ensure the quarterly blood bank alarm checks registered on the circular temperature charts for one (1) of three (3) quarters reviewed. Findings: 1. Observation by surveyor during laboratory tour on August 20, 2018 revealed the laboratory utilizes a Helmer refrigerator for storage of blood units for emergency release. 2. Review of the laboratory's policy and procedure manual for emergency release of blood products revealed the laboratory performs quarterly high/low alarm checks on the blood bank refrigerator. 3. Review of the 2018 blood bank circular temperature charts revealed the low alarm did not register on the circular chart for the following one (1) of three (3) quarters: 2nd Quarter: May 21, 2018 4. In interview on August 21, 2018 at 6:15 pm, Personnel 17 stated he did not see the low alarm spike on the temperature chart for the 2nd quarter. D3033 RETENTION REQUIREMENTS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to maintain raw data for performance verification studies for the Architect instrument. Findings: 1. Review of the laboratory's performance verification studies for the Architect instrument revealed the laboratory performed method comparison (accuracy), precision, reference interval and reportable range (linearity) studies. 2. Further review of the performance verification studies revealed the laboratory did not have the raw data associated with the method comparison and reference interval studies. 3. In interview on August 21, 2018 at 4:25 pm, Personnel 18 stated the laboratory did not have the identified raw data. Personnel 18 stated she contacted the service technician who compiled the submitted data to see if they had a copy of the raw data files. 4. In interview on August 22, 2018, Personnel 18 stated the laboratory was unable to find the identified raw data. 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 record review and interview with personnel, the laboratory failed to follow written policies and procedures to assess competency for seventeen (17) of twenty one (21) Clinical Consultants and Technical Consultants reviewed. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the following seventeen (17) personal were listed as Clinical Consultants and/or Technical Consultants: Personnel 2 Personnel 3 Personnel 4 Personnel 5 Personnel 6 Personnel 7 Personnel 8 Personnel 9 Personnel 10 Personnel 11 Personnel 12 Personnel 13 Personnel 14 Personnel 15 Personnel 19 Personnel 20 Personnel 21 2. Review of the laboratory's Technical Consultant Competency assessment form revealed the laboratory performs assessments upon hire and every two (2) years thereafter. 3. Review of personnel records for the fifteen (15) identified personnel revealed the competency assessments for the duties of Clinical Consultant and/or Technical Consultant were not performed. 4. In interview on August 20, 2018 at 10:46 am, Personnel 20 stated the Laboratory Director did not perform competency assessments for Technical Consultant duties for Respiratory. 5. In interview on August 20, 2018 at 11:30 am, Personnel 32 stated the main laboratory performs competency assessments for Technical Consultants upon hire and every two (2) years thereafter. In further interview, Personnel 32 stated the laboratory did not perform competency assessments for the Pathologists serving as Clinical Consultants and Technical Consultants. 6. In interview on August 20, 2018 at 12:12 pm, Personnel 21 stated the Laboratory Director did not perform a competency assessment for her duties as Technical Consultant. -- 2 of 13 -- D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure that patient blood samples for Coagulation were centrifuged according to manufacturer requirements. Findings: 1. Observation by surveyor during laboratory tour on August 20, 2018 revealed the laboratory utilizes Greiner Bio-One Vacuette Sodium Citrate tubes for Coagulation test and a Hettich EBA 200 centrifuge. 2. Review of the Greiner Bio-One Vacuette package insert revealed the centrifugation recommendations for Coagulation tubes, Platelet Poor Plasma (PPP) samples, are "1500-2000 g for 10 minutes." 3. Review of the laboratory's "Annual QC-Coagulation Coagulation Centrifuge Packing Check-Platelet-Poor Plasma" form revealed the laboratory performed a platelet poor plasma check in November 2017 with the centrifuge set at 5693 RPM (2500 g). The laboratory collected three (3) sodium citrate tubes from the same person, spun one tube for three (3) minutes, one for five (5) minutes, and one for ten (10) minutes. The laboratory tested PT and platelet counts on all samples. 4. Review of the user manual of the Hettich EBA 200 centrifuge revealed no specific settings by the manufacturer for centrifugation of tube types or testing. 5. In interview on August 20, 2018 at 9:35 am, Personnel 16 confirmed the laboratory utilizes the Hettich EBA 200 Centrifuge set at 5693 RPM (2500 g) for 5 minutes for coagulation samples. 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 observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Refer to D5403. 2. 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. 3. The laboratory failed to have complete performance verification precision studies. Refer to D5421 I. 4. The laboratory failed to have complete verification studies for coagulation testing prior to patient testing. Refer to D5421 II. 5. The laboratory failed to perform quality control each day of patient testing for HIV -- 3 of 13 -- testing. Refer to D5447 I. 6. The laboratory failed to perform quality control each day of patient testing for Chemistry testing. Refer to D5447 II. 7. The laboratory failed to perform positive and negative controls for Acetone testing for seventeen (17) of forty two (42) days reviewed. Refer to D5449. 8. The laboratory failed to establish to their own means and ranges for Quality Control (QC) material utilized for Prothrombin Time (PT) testing. Refer to D5469. 9. The laboratory failed to perform quality control for two (2) of two (2) cerebrospinal fluid cell counts reviewed. Refer to D5543. 10. The laboratory's Quality Assurance monitors failed to identify and correct quality issues. Refer to D5793. 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)