Christus Bossier Emergency Hospital

Summary Statement of Deficiencies D0000 A VALIDATION SURVEY was performed at Christus Bossier Emergency Hospital - CLIA # 19D2139728 on December 17, 2018 through December 18, 2018. Christus Bossier Emergency Hospital 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 moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing, Technical Consultant. 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 ensure written policies and procedures to assess competency for the Technical Consultant were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 2 serves as Technical Consultant. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of Technical Consultant. 3. Review of personnel records revealed competency assessments for the duties of Technical Consultant on Personnel 2 were not documented. 4. In interview on December 17, 2018 at 1:10 pm, Personnel 2 stated that competency assessments were not performed for the Technical Consultant. II. Based on record review and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel 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 -- 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. 2. In interview on December 17, 2018 at 1:54 pm, Personnel 2 stated the laboratory has established a new policy for competency assessments. Personnel 2 confirmed the competency assessments performed did not include the required information. 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 patient samples for Lactic Acid testing are received and separated within 15 minutes according to the manufacturer for twenty nine (29) of four hundred seventy seven (477) patients reviewed. Findings: 1. Observation by the surveyor on December 17, 2018 revealed the laboratory was performing Lactic Acid testing on the Siemens Dimension EXL 200 Chemistry Analyzer. 2. Review of the Siemens Dimension Lactic Acid package insert revealed "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 patient records for Lactic Acid from March 1, 2018 through December 17, 2018 revealed the laboratory did not receive the following patients within 15 minutes in order to separate as required by the manufacturer: On November 20, 2018 Patient 101 was collected at 20:05 pm and received at 20:34 pm - exceeding the fifteen (15) minutes required by the manufacturer by fourteen (14) minutes. On November 21, 2018 Patient 102 was collected at 12:20 pm and received at 12:43 pm - exceeding the fifteen (15) minutes required by the manufacturer by eighteen (18) minutes. On November 23, 2018 Patient 103 was collected at 02:25 am and received at 03:08 am - exceeding the fifteen (15) minutes required by the manufacturer by twenty eight (28) minutes. On November 17, 2018 Patient 104 was collected at 14:45 pm and received at 16:50 pm - exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour fifty (50) minutes. On November 17, 2018 Patient 105 was collected at 18:40 pm and received at 19:03 pm - exceeding the fifteen (15) minutes required by the manufacturer by eight (8) minutes. On November 17, 2018 Patient 106 was collected at 21:39 pm and received at 22:01 pm - exceeding the fifteen (15) minutes required by the manufacturer by seven (7) minutes. On November 18, 2018 Patient 107 was collected at 10:20 am and received at 10:40 am - exceeding the fifteen (15) minutes required by the manufacturer by five (5) minutes. On November 8, 2018 Patient 108 was collected at 04:45 am and received at 05:22 am -- 2 of 12 -- - exceeding the fifteen (15) minutes required by the manufacturer by twenty two (22) minutes. On September 22, 2018 Patient 109 was collected at 16:15 pm and received at 18:27 pm - exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour fifty seven (57) minutes. On September 23, 2018 Patient 110 was collected at 23:50 pm and received September 24, 2018 at 00:24 am - exceeding the fifteen (15) minutes required by the manufacturer by nineteen (19) minutes. On September 18, 2018 Patient 111 was collected at 22:58 pm and received at 23:18 pm - exceeding the fifteen (15) minutes required by the manufacturer by five (5) minutes. On September 18, 2018 Patient 112 was collected at 23:32 pm and received September 19, 2018 at 00:03 am - exceeding the fifteen (15) minutes required by the manufacturer by twenty (20) minutes. On September 7, 2018 Patient 114 was collected at 09:58 am and received at 11:35 am - exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour twenty two (22) minutes. On September 7, 2018 Patient 115 was collected at 10:30 am and received at 12:04 pm - exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour nineteen (19) minutes. On September 7, 2018 Patient 116 was collected at 12:30 pm and received at 13:14 pm - exceeding the fifteen (15) minutes required by the manufacturer by twenty nine (29) minutes. On September 5, 2018 Patient 117 was collected at 02:17 am and received at 04:13 am - exceeding the fifteen (15) minutes required by the manufacturer by one (1) hour forty one (41) minutes. On September 5, 2018 Patient 118 was collected at 19:33 pm and received at 20:38 pm - exceeding the fifteen (15) minutes required by the manufacturer by fifty (50) minutes. On September 3, 2018 Patient 119 was collected at 03:10 am and received at 03:48 am - exceeding the fifteen (15) minutes required by the manufacturer by twenty three (23) minutes. On September 4, 2018 Patient 120 was collected at 15:40 pm and received at 16:25 pm - exceeding the fifteen (15) minutes required by the manufacturer by thirty (30) minutes. On July 26, 2018 Patient 121 was collected at 16:12 pm and received at 16:40 pm - exceeding the fifteen (15) minutes required by the manufacturer by thirteen (13) minutes. On July 27, 2018 Patient 122 was collected at 16:45 pm and received at 17:03 pm - exceeding the fifteen (15) minutes required by the manufacturer by three (3) minutes. On July 18, 2018 Patient 124 was collected at 22:15 pm and received at 22:41 pm - exceeding the fifteen (15) minutes required by the manufacturer by eleven (11) minutes. On July 20, 2018 Patient 125 was collected at 09:25 am and received at 10:21 am - exceeding the fifteen (15) minutes required by the manufacturer by forty one (41) minutes. On June 1, 2018 Patient 126 was collected at 18:14 pm and received at 18:48 pm - exceeding the fifteen (15) minutes required by the manufacturer by nineteen (19) minutes. On May 23, 2018 Patient 127 was collected at 16:38 pm and received at 17:16 pm - exceeding the fifteen (15) minutes required by the manufacturer by twenty three (23) minutes. On April 20, 2018 Patient 128 was collected at 18:40 pm and received at 19: 21 pm - exceeding the fifteen (15) minutes required by the manufacturer by twenty six (26) minutes. On April 16, 2018 Patient 129 was collected at 22:00 pm and received at 22:27 pm - exceeding the fifteen (15) minutes required by the manufacturer by twelve (12) minutes. On March 22, 2018 Patient 130 was collected at 20:42 pm and received at 21:06 pm - exceeding the fifteen (15) minutes required by the manufacturer by nine (9) minutes. 4. In interview on December 18, 2018 at 1:41 pm, Personnel 2 confirmed the above patient samples were not received for Lactic Acid testing within the fifteen (15) minutes required by the manufacturer. 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 -- 3 of 12 -- 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 perform a one hundred twenty (120) donor study for Prothrombin Time (PT) normal mean and failed to utilize acceptable donors with complete documentation per manufacturer requirements. Refer to D5411 I. 2. The laboratory failed to ensure that patient samples for Ammonia testing are analyzed within thirty (30) minutes according to the manufacturer for three (3) of sixty three (63) patients reviewed. Refer to D5411 II. 3. The laboratory failed to perform complete reference range studies for the Stago Compact Max Coagulation analyzer. Refer to D5421. 4. The laboratory failed to document instrument maintenance as defined by the manufacturer for the Siemens Dimension EXL 200. Refer to D5429. 5. The laboratory failed to assure the quarterly blood bank alarm checks recorded on the circular temperature charts. Refer to D5555. 6. The laboratory failed to take