Avoyelles Hospital Laboratory

Summary Statement of Deficiencies D0000 A Validation survey was performed at Avoyelles Hospital-CLIA # 19D0668410 on April 9 2018 through April 13, 2018. Avoyelles Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1240 CONDITION: Preanalytic systems 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories performing high complexity testing; Technical Supervisor 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 ensure written policies and procedures to assess competency for one (1) of three (3) Technical Consultants were complete. Findings: 1. Review of the laboratory's CMS- 209 form (Laboratory Personnel Report) revealed Personnel 1, Personnel 2, and Personnel 12 serve as the Technical Consultants. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of the Technical Consultant. 3. Review of personnel records revealed competency assessments for the duties of Technical Consultant were not performed for Personnel 2. 4. In interview on April 11, 2018 at 10:06 am, Personnel 2 stated if a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 23 -- competency assessment for Technical Consultant was not seen in his personnel records then there was not one performed. Personnel 2 confirmed a competency assessment was not performed for his duties as Technical Consultant. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 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's system failed to monitor, assess, and correct problems identified with the preanalytic system. Findings: 1. The laboratory failed to ensure that patient samples for Lactic Acid testing are separated within fifteen (15) minutes after collection and analyzed promptly according to the manufacturer for eight (8) of forty seven (47) patients reviewed. Refer to D5311. 2. The laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Refer to D5317. 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 samples for Lactic Acid testing are separated within fifteen (15) minutes after collection and analyzed promptly according to the manufacturer for eight (8) of forty seven (47) patients reviewed. Findings: 1. Observation by the surveyor on April 9, 2018 revealed the laboratory was performing Lactic Acid testing on the Siemens Dimension EXL Chemistry Analyzer. 2. Review of the Siemens Dimension Lactic Acid package insert revealed under "Specimen Collection and Handling" that " Blood is best collected without stasis in a container of sodium fluoride/potassium oxalate, followed by immediate chilling of the specimen and separation of the cells within 15 minutes. Keep sample on ice and analyze promptly." 3. Review of a random selection of patient records for Lactic Acid from November 1, 2017 through April 9, 2018 revealed the laboratory did not separate Lactic Acid samples within 15 minutes and analyze promptly for the following eight (8) of forty seven (47) patients: On November 24, 2017 Patient 91 was documented as collected at 18:00 pm and received by the laboratory at 20:44 pm - two (2) hours twenty nine (29) minutes over the manufacturer's instructions of separation within 15 -- 2 of 23 -- minutes On January 13, 2018 Patient 92 was documented as collected at 08:45 am and received by the laboratory at 09:31 am - thirty one (31) minutes over the manufacturer's instructions of separation within 15 minutes On March 7, 2018 Patient 93 was documented as collected at 15:18 pm and received by the laboratory at 16:04 pm - thirty one (31) minutes over the manufacturer's instructions of separation within 15 minutes On November 23, 2017 Patient 94 was documented as received at 16:19 pm and resulted by the laboratory at 18:37 pm - two (2) hours eighteen (18) minutes over the manufacturer's instructions to analyze promptly On January 10, 2018 Patient 95 was documented as received at 11:13 am and resulted by the laboratory at 13:15 pm - two (2) hours two (2) minutes over the manufacturer's instructions to analyze promptly On January 12, 2018 Patient 96 was documented as received at 13:14 pm and resulted by the laboratory at 15:34 pm - two (2) hours twenty (20) minutes over the manufacturer's instructions to analyze promptly On February 6, 2018 Patient 97 was documented as received at 09:46 am and resulted by the laboratory at 11:12 am - one (1) hour twenty six (26) minutes over the manufacturer's instructions to analyze promptly On April 2, 2018 Patient 98 was documented as received at 10:30 am and resulted by the laboratory at 12:43 pm - two (2) hours thirteen (13) minutes over the manufacturer's instructions to analyze promptly 4. Interview with Personnel 2 on April 11, 2018 at 10:10 am confirmed the laboratory did not ensure Lactic Acid samples were separated within 15 minutes and analyzed promptly as required by the manufacturer. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. Review of the laboratory's " Laboratory Specimen Collection Reference Manual" given to providers revealed the following information was not included: a) Shipping/Transport requirements b) Test requirements to include time requirement for receipt of samples 2. In interview on April 11, 2018 at 10:35 am, Personnel 2 stated the identified items were not included in the laboratory's "Laboratory Specimen Collection Reference Manual." 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: -- 3 of 23 -- 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 have a complete policy and procedure manual. Refer to D5403. 2. The laboratory failed to perform and document visual inspections on blood culture bottles before use per manufacturer's requirements. Refer to D5411 I. 3. The laboratory failed to ensure that patient samples for Ammonia testing are analyzed within twenty (20) minutes according to the manufacturer for ten (10) of twenty eight (28) patients reviewed. Refer to D5411 II. 4. The laboratory failed to document acceptable patient donors for Prothrombin Time (PT) normal patient mean studies. Refer to D5411 III. 5. The laboratory failed to ensure the Sickle Sol kit test in use had not exceeded its expiration date. Refer to D5417 I. 6. The laboratory failed to ensure Blood Bank Quality Control reagents had not exceeded their expiration date. Refer to D5417 II. 7. The laboratory failed to establish and verify performance specifications for accuracy, precision, reportable and reference ranges, analytical sensitivity, and specificity for the Siemens Dade Sickle Sol Test. Refer to D5423. 8. The laboratory failed to have a complete Individualized Quality Control Plan (IQCP). Refer to D5445. 9. The laboratory failed to perform three (3) levels of controls prior to patient testing for Complete Blood Counts (CBC) per laboratory policy. Refer to D5447 I. 10. The laboratory failed to perform two (2) levels of Quality Control prior to patient testing for eleven (11) of twelve (12) analytes. Refer to D5447 II. 11. The laboratory failed to perform two (2) levels of Quality Control prior to patient testing for Alkaline Phosphatase for one (1) of thirty one (31) days reviewed. Refer to D5447 III. 12. The laboratory failed to establish their own means and ranges for Quality Control (QC) material utilized for chemistry testing. Refer to D5469. 13. The laboratory failed to document the Quality Control (QC) for ABO, Rh, Antibody Screen (AbScr), and Compatibility (Xmatch) testing prior to patient testing for one (1) of three hundred seventy three (373) days reviewed. Refer to D5551. 14. 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)