North Caddo Medical Center

Summary Statement of Deficiencies D0000 A Certification Survey was performed on January 25, 2021 through January 29, 2021 at North Caddo Medical Center, CLIA ID # 19D0463303. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation by surveyor and interview with personnel, the laboratory failed to ensure laboratory supplies did not exceed their expiration dates. Findings: 1. Direct observation by surveyor during laboratory tour on January 25, 2021 at 1:20 pm revealed the following expired items: a) Mayo Clinic Covid Testing Media T846; Lot 062520-4; Expiration 12/25/2020; Quantity sixteen (16) 3mL vials 2. In interview on January 25, 2021 at 1:25 pm, Personnel 8 stated the media vials were used with the original send out Covid testing and discontinued in October 2020 since the laboratory no longer sends specimens using this media. Personnel 8 confirmed the media vials were expired. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, and interview with personnel, the laboratory failed to document positive and negative controls for Serum Acetone testing for two (2) of twenty nine (29) patients reviewed. Findings: 1. Review of the laboratory's "Clinitest, Ketone, & Ictotest QC Log" revealed "Ketone QC performed when opening a new bottle of reagent and every 24 hours of patient testing". 2. Review of patient records and quality control (QC) logbook from January 2020 through December 2020 revealed the laboratory did not document external positive and negative controls each day of patient testing for the following two (2) of twenty nine (29) patients reviewed: a) Accession 27-20-049-00035 performed February 18, 2020 at 05:36 am b) Accession 27-20-072-00051 performed March 12, 2020 at 05:30 am 3. In interview on January 28, 2021 at 10:17 am, the General Supervisor confirmed external QC was not performed for each of the above cited patients. 4. Review of the task 1&3 form provided by staff revealed the laboratory performs thirty (30) Serum Acetone tests annually. D5781

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at North Caddo Medical Center - CLIA # 19D0463303 on May 21, 2018 through May 25, 2018. North Caddo Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems. 42 CFR 493.1403 CONDITION: Laboratory Director performing moderate complexity testing. 42 CFR 493.1409 CONDITION: Technical Consultant performing moderate complexity testing 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 address competency for the Technical Consultant and General Supervisor were complete. Findings: 1. Review of the laboratory's CMS- 209 form (Laboratory Personnel Report) revealed the following: *Personnel 2 and Personnel 3 serves as the laboratory's Technical Consultants *Personnel 4 serves as the laboratory's General Supervisor 2. Review of the laboratory's policies and procedures revealed the laboratory did have a policy for competency assessment for the Technical Consultant and General Supervisor; However, the policy did not include the frequency in which the competency assessment for each should be performed. 3. Review of personnel records for Personnel 4 revealed a competency assessment for the duties of General Supervisor was not performed in 2017. 4. In interview on May 22, 2018, Personnel 4 confirmed the laboratory did not perform a competency assessment for his duties as General Supervisor. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on record review and inteview with personnel, the laboratory failed to ensure the collection time for samples received from outside facilities was entered accurately for the two (2) of six (6) patients reviewed. Findings: 1. Review of the laboratory's "Requests for Laboratory Services" policy revealed "When a specimen is collected by nursing service or respiratory department, the date and time of collection and initials of the collector must be placed on the request and the properly labeled specimen tube. The laboratory personnel then writes the time the specimen is received into the lab." 2. Review of patient test requisitions and final reports revealed the laboratory did not accurately enter the collection times of patient samples into the Laboratory Information System (LIS) for the following two (2) of six (6) Home Health patients: a. Patient 1: collection time on the test requisition - Collection Time 15:00 collection time on the LIS final report - Collected Time 16:26 b. Patient 2: collection time on the test requisition - Collection Time 12:40 collection time on the LIS final report - Collection Time 12:10 3. In interview on May 24, 2018 at 3:55 pm, Personnel 4 stated the collection date and time on lab reports are supposed to match that of the requisition. Personnel 4 confirmed the above patients collection time was entered incorrectly. 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 centrifuged and separated from the cells within fifteen (15) minutes and analyzed promptly as required by the manufacturer. Findings: 1. Observation by the surveyor on May 21, 2018 revealed the laboratory was performing Lactic Acid testing on the Siemens Dimension Xpand Plus Chemistry analyzer. 2. Review of the Siemens Dimension Lactic Acid package insert revealed under "Specimen Collection and Handling" that specimens are to be centrifuged and plasma is to be separated from the cells within fifteen (15) minutes from collection and analyzed promtly. 3. In interview on May 24, 2018 at 8: 55 am, Personnel 4 stated the result time listed on the report given to surveyors indicates the collection time and that he wrote the completion time on the report. 4. Review of the report of patient records given to surveyors for Lactic Acid from February 22, 2018 through May 22, 2018 revealed the laboratory did not maintain documentation of the receipt times to ensure plasma was separated from blood cells -- 2 of 14 -- within fifteen minutes (15) for the following twenty six (26) patients: On May 6, 2018 Patient 3 was collected at 17:45 pm, no documentation of the receive time, result time of 18:47 pm -- total of sixty two (62) minutes from collection time to result time On March 31, 2018 Patient 4 was collected at 5:25 am, no documentation of the receive time, result time of 6:08 am -- total of forty three (43) minutes from collection time to result time On March 25, 2018 Patient 5 was collected at 19:20 pm, no documentation of the receive time, result time of 20:00 pm -- total of forty (40) minutes from collection time to result time On March 22, 2018 Patient 6 was collected at 17:00 pm, no documentation of the receive time, result time of 17:32 pm -- total of thirty two (32) minutes from collection time to result time On March 17, 2018 Patient 7 was collected at 22:13 pm, no documentation of the receive time, result time of 22:56 pm -- total of forty three (43) minutes from collection time to result time On February 26, 2018 Patient 8 was collected at 9:05 am, no documentation of the receive time, result time of 9:47 am -- total of forty two (42) minutes from collection time to result time On March 1, 2018 Patient 9 was collected at 6:40 am, no documentation of the receive time, result time of 7:08 am -- total of twenty eight (28) minutes from collection time to result time On March 17, 2018 Patient 10 was collected at 4:55 am, no documentation of the receive time, result time of 5:39 am -- total of forty four (44) minutes from collection time to result time On March 26, 2018 Patient 11 was collected at 4:40 am, no documentation of the receive time, result time of 5:18 am -- total of thirty eight (38) minutes from collection time to result time On April 2, 2018 Patient 12 was collected at 00:20 am, no documentation of the receive time, result time of 1:57 am -- total of one (1) hour thirty seven (37) minutes from collection time to result time On April 8, 2018 Patient 13 was collected at 22:15 pm, no documentation of the receive time, result time of 22:54 pm -- total of thirty nine (39) minutes from collection time to result time On April 28, 2018 Patient 14 was collected at 06:00 am, no documentation of the receive time, result time of 08:30 am -- total of two (2) hours thirty (30) minutes from collection time to result time On March 25, 2018 Patient 15 was collected at 09:06 am, no documentation of the receive time, result time of 09:42 am -- total of thirty six (36) minutes from collection time to result time On May 1, 2018 Patient 17 was collected at 10:40 am, no documentation of the receive time, result time of 11:22 am -- total of forty two (42) minutes from collection time to result time On April 4, 2018 Patient 18 was collected at 08:00 am, no documentation of the receive time, result time of 10:32 am -- total of two (2) hours thirty two (32) minutes from collection time to result time On March 13, 2018 Patient 19 was collected at 23:10 pm, no documentation of the receive time, result time of 23: 57 pm -- total of forty seven (47) minutes from collection time to result time On March 16, 2018 Patient 20 was collected at 14:10 pm, no documentation of the receive time, result time of 14:42 pm -- total of thirty two (32) minutes from collection time to result time On February 24, 2018 Patient 21 was collected at 23:55 pm, no documentation of the receive time, result time of February 25, 2018 at 00:30 am -- total of thirty five (35) minutes from collection time to result time On April 3, 2018 Patient 22 was collected at 21:30 pm, no documentation of the receive time, result time of 22:06 pm -- total of thirty six (36) minutes from collection time to result time On April 1, 2018 Patient 23 was collected at 00:15 am, no documentation of the receive time, result time of 00:41 am -- total of forty one (41) minutes from collection time to result time On March 30, 2018 Patient 24 was collected at 02:30 am, no documentation of the receive time, result time of 04:45 am -- total of two (2) hours fifteen (15) minutes from collection time to result time On March 15, 2018 Patient 25 was collected at 14:15 pm, no documentation of the receive time, result time of 15:25 pm -- total of one (1) hour ten (10) minutes from collection time to result time On April 23, 2018 Patient 26 was collected at 22:10 pm, no documentation of the receive time, result time of 23:10 pm -- total of one (1) hour from collection time to result -- 3 of 14 -- time 5. In interview on May 24, 2018, Personnel 4 confirmed the laboratory could not ensure patient samples for Lactic Acid testing were centrifuged and separated from the cells within fifteen (15) minutes and analyzed promptly as 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 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 have a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to follow the manufacturer's instructions for flags appearing on Complete Blood Counts (CBC). Refer to D5411. 3. The laboratory failed to have complete verification studies for Troponin testing. Refer to D5421. 4. The laboratory failed to use normal donors as required by manufacturer to verify reference intervals and establish their own normal mean Prothrombin Time (PT) with each new lot of Thromboplastin. Refer to D5545. 5. The laboratory failed to have a system in place for twice a year comparison testing for Troponin testing performed on the Abbott iSTAT. Refer to D5775. 6. The laboratory failed to take