Glenwood Regional Medical Center Lab

Summary Statement of Deficiencies D0000 A Complaint survey was performed at GLENWOOD REGIONAL MEDICAL CENTER LABORATORY, CLIA # 19D0049226, on December 13, 2023 through December 15, 2023. GLENWOOD REGIONAL MEDICAL CENTER LABORATORY was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1100 CONDITION: Facility administration 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 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation by surveyors, review of laboratory records and interview with personnel, the facility failed to ensure that procedures were established to provide quality services. Findings: 1. The facility failed to ensure the ventilation tubing for the Siemens Dimension Vista 500 analzyer was connected to the laboratory ventilation Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 22 -- system. Refer to D3001. 2. The facility failed to ensure sufficient laboratory reagents and supplies were maintained to perform the type and volume of testing on the laboratoy test menu. Refer to D3007. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation by surveyor and interview with personnel, the facility failed to ensure the ventilation tubing for the Siemens Dimension Vista 500 analzyer was connected to the laboratory ventilation system. Findings: 1. Direct observation by surveyor during the laboratory tour on December 14, 2023 revealed the laboratory utilizes the Siemens Dimension Vista 500 (Serial Number DV330985) analyzer for chemistry testing. 2. Further observation by the surveyor noted the ventilation tube attached to the Vista 500 (SN DV330985) was not properly attached to the laboratory ventilation system in the ceiling. 3. In interview on December 14, 2023 at 10:52 am, General Supervisor 3 confirmed the ventilation tubing was not properly attached to laboratory ventilation system. D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on observation, record review and interview with laboratory personnel, the facility failed to ensure sufficient laboratory reagents and supplies were maintained to perform the type and volume of testing on the laboratoy test menu. Findings: 1. Observation during laboratory tour on December 13, 2023 at 9:30am revealed the laboratory utilized two Sysmex hematology analyzers for patient testing. Direct observation by surveyors identified one bottle remaining of CleanCell reagent required for daily maintenance of Sysmex analyzers. 2. Interview with the Hematology supervisor on December 13, 2023 at 10am confirmed only one CleanCell was remaining. The Hematology supervisor further stated the laboratory had been trying to order more CleanCell solution along with many other necessary supplies, and that the laboratory had borrowed from a sister facility. The laboratory planned to clean the instrument with a 5% bleach solution in the barcoded CleanCell tube until the manufacturer supply was received by the laboratory. 3. Observation by surveyors of supply receipt confirmed the laboratory received the necessary CleanCell solution on December 15, 2023. 4. Interview with the director of laboratory services and pathologist on December 14, 2023 at 11:00am revealed the laboratory has been unable to obtain necessary supplies for numerous laboratory services for nearly 6 months. When the laboratory cannot obtain the supplies necessary for patient testing due to stock and payment issues, the laboratory contacts other third party vendors or borrows from neighboring facilities. The director of laboratory services and pathologist stated the laboratory notifies administration and corporate in Dallas when there is a critical need for laboratory supplies but the payment issues are not always resolved, resulting -- 2 of 22 -- in the laboratory being unable to perform testing required or referencing testing to another laboratory, delaying results. 5. Review of laboratory records from September 2023 - December 2023 revealed the following tests in which the laboratory was unable to obtain the supplies necessary for testing: culture media (all microbiology cultures resulting in send out for identification and sensitivity), Cepheid PCR reagents (Strep A, MRSA, COVID, COVID/Flu/RSV combo), Procalicitonin, Biomerieux organism ID panels, Verigene blood culture panels, Iron, Cortisol, Lipase, Abbott I- Stat cartridges, ACT, blood culture bottles, Radiometer, Sysmex Flourocell, Hemoglobin A1C, urine drug screen reagents, Urinalysis strips and all reagents, Mueller Hinton media, halogen lamps for chemistry instruments, Immucor blood bank quality control. 6. Review of task 1&3 form provided to surveyors revealed the laboratory performs the following annual test volumes for the identified testing supplies: a) Cepheid PCR: * Strep A - 594 tests * MRSA - 717 tests * Covid/Flu/RSV - 1315 tests b) Procalcitonin - 1606 tests c) BioMerieux ID panels - 4237 tests d) Verigene Blood Culture panels - 650 tests e) Iron - 653 tests f) Cortisol - 1254 tests g) ACT - 610 tests h) Blood Cultures - 11684 tests i) Hemoglobin A1C - 3944 tests j) Urine Drug Screens - 6292 tests k) Urinalysis dipsticks - 16007 tests 7. Further record review of quality control, quality assessment records and email communications revealed the laboratory utilized expired quality control material to include Anti-A, Anti-B, Anti-D, corQC and Complement Control Cells from October 13, 2023 - October 25, 2023 due to a credit hold with the manufacturer, Immucor. The laboratory notified administration and corporate by email daily from October 16 - 25, 2023 of the critical need and inability to obtain the quality control reagents from the manufacturer prior to their expiration. 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 by surveyors, review of laboratory policy, manufacturer's instructions, patient records 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 patient samples for Ammonia testing were centrifuged without delay of collection per the manufacturer's instructions for twenty four (24) of one hundred forty one (141) patients reviewed from September 2023 through October 2023. Refer to D5311 I. 2. The laboratory failed to ensure patient samples for Lactic Acid testing were separated within fifteen (15) minutes per seventy nine (79) of two hundred six (206) patients reviewed from September 9, 2023 through October 10, 2023. Refer to 5311 II. 3. The laboratory failed to ensure quality assessment (QA) monitors identified issues within the preanalytic system. Refer to D5393. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) -- 3 of 22 -- 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: I. Based on observation by surveyors, review of manufacturer's package insert and patient test logs, and interview with personnel, the laboratory failed to ensure patient samples for Ammonia testing were centrifuged without delay of collection per the manufacturer's instructions for twenty four (24) of one hundred forty one (141) patients reviewed from September 2023 through October 2023. Findings: 1. Observation by surveyors during the laboratory tour on December 13, 2023 at 10:02 am revealed the laboratory utilizes the Siemens Dimenstion Vista 500 analyzer for Ammonia testing. 2. Review of the Siemens Dimension Vista 500 package insert for Ammonia revealed tubes are to be "completely filled, stored tightly capped on ice and centrifuged without delay". 3. Review of the laboratory's patient test logs for Ammonia from September 2023 through October 2023 revealed the following twenty four (24) of one hundred forty one (141) patients were not centrifuged without delay from collection: a) PT 0903:C00071R: collected September 3, 2023 at 07:35 am and received September 3, 2023 at 08:20 am (centrifuged after a forty five (45) minute delay) b) PT 0903:C000104R: collected September 3, 2023 at 06:09 am and received September 3, 2023 at 06:56 am (centrifuged after a forty seven (47) minute delay) c) PT 0903:C00950S: collected September 3, 2023 at 19:14 pm and received September 3, 2023 at 19:48 pm ( centrifuged after a thirty four (34) minute delay) d) PT 0906: C00883R: collected September 6, 2023 at 11:24 am and received September 6, 2023 at 12:10 am (centrifuged after a forty six (46) minute delay) e) PT 0916:C00160R: collected September 16, 2023 at 05:07 am and received September 16, 2023 at 06:21 am (centrifuged after a seventy four (74) minute delay) f) PT 0919:C01450S: collected September 19, 2023 at 20:25 pm and received September 19, 2023 at 20:58 pm (centrifuged after a thirty three (33) minute delay) g) PT 0922:C00453R: collected September 22, 2023 at 06:24 am and received September 22, 2023 at 07:10 am (centrifuged after a forty six (46) minute delay) h) PT 0923:C00297R: collected September 23, 2023 at 03:20 am and received September 23, 2023 at 04:00 am (centrifuged after a forty (40) minute delay) i) PT 0923:C00873S: collected September 23, 2023 at 16:52 pm and received September 23, 2023 at 17:49 pm (centrifuged after a fifty seven (57) minute delay) j) PT 0924:C00986S: collected September 24, 2023 at 20:02 pm and received September 24, 2023 at 20:37 pm (centrifuged after a thirty five (35) minute delay) k) PT 0925:C00906R: collected September 25, 2023 at 12:37 pm and received September 25, 2023 at 13:20 pm (centrifuged after a forty three (43) minute delay) l) PT 0925:C01476S: collected September 25, 2023 at 19:28 pm and received September 25, 2023 at 19:58 pm (centrifuged after a thirty (30) minute delay) m) PT 1003:C00814S: collected October 3, 2023 at 12:14 pm and received October 3, 2023 at 13:09 pm (centrifuged after a fifty five (55) minute delay) n) PT 1006:C00249R: collected October 6, 2023 at 03:17 am and received October 6, 2023 at 03:52 am (centrifuged after a thirty five (35) mintute delay) o) PT 1006:C01085S: collected October 6, 2023 at 19:20 pm and received October 6, 2023 at 19:52 pm (centrifuged after a thirty two (32) minute delay) p) PT 1007:C00153R: collected October 7, 2023 at 05:16 am and received October 7, 2023 at 05:53 am (centrifuged after a thirty seven (37) minute delay) q) PT 1008:C00585R: collected October 8, 2023 at 10:13am and received October 8, 2023 -- 4 of 22 -- at 10:53 am (centrifuged after a forty three (43) minute delay) r) PT 1013:C00563R: collected October 13, 2023 at 8:58 am and received October 13, 2023 at 1209 pm (centrifuged after a one hundred ninety one (191) minute delay) s) PT 1013:C00816R: collected October 13, 2023 at 13:09 pm and received October 13, 2023 at 14:20 pm (centrifuged after a seventy one (71) minute delay) t) PT 1014:C00664R: collected October 14, 2023 at 12:01 pm and received October 14, 2023 at 13:17 pm (centrifuged after a seventy six (76) minute delay) u) PT 1016:C00619R: collected October 16, 2023 at 08:32 am and received October 16, 2023 at 10:03 am (centrifuged after a ninety one (91) minute delay) v) PT 1021:C00640S: collected October 21, 2023 at 11:40 am and received October 21, 2023 at 12:13 pm (centrifuged after a thirty three (33) minute delay) w) PT 1021:C00767S: collected October 21, 2023 at 16:19 pm and received October 21, 2023 at 16:57 pm (centrifuged after a thirty eight (38) minute delay) x) PT 1026:C00120R: collected October 26, 2023 at 04:58 am and received October 26, 2023 at 05:34 am (centrifuged after a thirty six (36) minute delay) 4. In interview on December 14, 2023 at 03:00 pm, General Supervisor 1 confirmed the identified patient samples were not centrifuged without delay for Ammonia testing per manufacturer. 5. Review of the Task 1 & 3 form provided to surveyor revealed the laboratory performs 975 Ammonia tests annually. II. Based on observation by surveyors, review of manufacturer's package insert and patient test logs, and interview with personnel, the laboratory failed to ensure patient samples for Lactic Acid testing were separated within fifteen (15) minutes for seventy nine (79) of two hundred six (206) patients reviewed from September 9, 2023 through October 10, 2023. Findings: 1. Observation by surveyors during the laboratory tour on December 13, 2023 at 10:02 am revealed the laboratory utilizes the Siemens Dimension Vista 500 analyzer for Lactic Acid patient testing. 2. Review of the Siemens Dimension Vista 500 package insert for Lactic Acid revealed blood collection is to be "followed by immediate chilling of the specimen and separation of the cells within 15 minutes". 3. Review of the laboratory's patient test logs for Lactic Acid from September 9, 2023 through October 10, 2023 revealed the following seventy nine (79) of two hundred six (206) patients reviewed were not separated within fifteen (15) minutes of collection: a) PT 0929:C01083S: collected September 29, 2023 at 16:30 pm and received September 29, 2023 at 16:53 pm (exceeding the manufacturer requirements by eight (8) minutes) b) PT 0929:C01207S: collected September 29, 2023 at 19:08 pm and received September 29, 2023 at 19:31 pm (exceeding the manufacturer requirements by eight (8) minutes) c) PT 0929:C01266S: collected September 29, 2023 at 20:36 pm and received September 29, 2023 at 21:02 pm (exceeding the manufacturer requirements by eleven (11) minutes) d) PT 0929:C01357S: collected September 29, 2023 at 23:00 pm and received September 29, 2023 at 23:26 pm (exceeding the manufacturer requirements by eleven (11) minutes) e) PT 0930:C00475S: collected September 30, 2023 at 06:00 am and received September 30, 2023 at 06:26 am (exceeding the manufacturer requirements by eleven (11) minutes) f) PT 0930: C00488S: collected September 30, 2023 at 07:25 am and received September 30, 2023 at 07:48 am (exceeding the manufacturer requirements by eight (8) minutes) g) PT 0930:C00703S: collected September 30, 2023 at 12:20 pm and received September 30, 2023 at 12:53 pm (exceeding the manufacturer requirements by eighteen (18) minutes) h) PT 0930:C00722S: collected September 30, 2023 at 12:18 pm and received September 30, 2023 at 12:48 pm (exceeding the manufacturer requirements by fifteen (15) minutes) i) PT 0930:C00876S: collected September 30, 2023 at 14:50 pm and received September 30, 2023 at 15:44 pm (exceeding the manufacturer requirements by thirty nine (39) minutes) j) PT 0930:C00912S: collected September 30, 2023 at 15:00 pm and received September 30, 2023 at 15:34 pm (exceeding the manufacturer requirements by nineteen (19) minutes) k) PT 0930: C00955S: collected September 30, 2023 at 15:05 pm and received September 30, -- 5 of 22 -- 2023 at 15:45 pm (exceeding the manufacturer requirements by twenty five (25) minutes) l) PT 0930:C01038S: collected September 30, 2023 at 17:23 pm and received September 30, 2023 at 17:49 pm (exceeding the manufacturer requirements by eleven (11) minutes) m) PT 1001:C00646T: collected October 1, 2023 at 12:56 pm and received October 1, 2023 at 13:19 pm (exceeding the manufacturer requirements by eight (8) minutes) n) PT1001:C00765S: collected October 1, 2023 at 14:35 pm and received October 1, 2023 at 15:02 pm (exceeding the manufacturer requirements by twelve (12) minutes) o) PT 1001:C00947S: collected October 1, 2023 at 19:09 pm and received October 1, 2023 at 19:39 pm (exceeding the manufacturer requirements by fifteen (15) minutes) p) PT 1002:C00297S: collected October 2, 2023 at 02:03 am and received October 2, 2023 at 02:44 am (exceeding the manufacturer requirements by twenty six (26) minutes) q) PT 1002:C00607S: collected October 2, 2023 at 08:40 am and received October 2, 2023 at 09:01 am (exceeding the manufacturer requirements by six (6) minutes) r) PT 1002:C00746S: collected October 2, 2023 at 12:30 pm and received October 2, 2023 at 12:51 pm (exceeding the manufacturer requirements by six (6) minutes) s) PT 1002:C00759S: collected October 2, 2023 at 11:10 am and received October 2, 2023 at 11:31 am (exceeding the manufacturer requirements by six (6) minutes) t) PT 1002:C00845R: collected October 2, 2023 at 13:45 pm and received October 2, 2023 at 15:41 pm (exceeding the manufacturer requirements by seventy four (74) minutes) u) PT 1002:C00854R: collected October 2, 2023 at 11:45 am and received October 2, 2023 at 12:30 pm (exceeding the manufacturer requirements by thirty (30) minutes) v) PT 1002:C01277S: collected October 2, 2023 at 18:00 pm and received October 2, 2023 at 18:27 pm (exceeding the manufacturer requirements by twelve (12) minutes) w) PT 1002:C01313S: collected October 2, 2023 at 17:35 pm and received October 2, 2023 at 18:41 pm (exceeding the manufacturer requirements by fifty one (51) minutes) x) PT 1002:C01346S: collected October 2, 2023 at 19:25 pm and received October 2, 2023 at 19:48 pm (exceeding the manufacturer requirements by eight (8) minutes) y) PT 1002:C01387S: collected October 2, 2023 at 19:52 pm and received October 2, 2023 at 20:12 pm (exceeding the manufacturer requirements by five (5) minutes) z) PT 1002:C01459S: collected October 2, 2023 at 20:43 pm and received October 2, 2023 at 21:44 pm (exceeding the manufacturer requirements by forty six (46) minutes) aa) PT 1003:C00807S: collected October 3, 2023 at 12:14 pm and received October 3, 2023 at 13:09 pm (exceeding the manufacturer requirements by forty (40) minutes) bb) PT 1003: C00945S: collected October 3, 2023 at 15:26 pm and received October 3, 2023 at 16: 02 pm (exceeding the manufacturer requirements by twenty one (21) minutes) cc) PT 1003:C01040S: collected October 3, 2023 at 16:30 pm and received October 3, 2023 at 17:06 pm (exceeding the manufacturer requirements by twenty one (21) minutes) dd) PT 1003:C01314S: collected October 3, 2023 at 21:36 pm and received October 3, 2023 at 22:24 pm (exceeding the manufacturer requirements by thirty three (33) minutes) ee) PT 1004:C00187R: collected October 4, 2023 at 04:30 am and received October 4, 2023 at 05:04 am (exceeding the manufacturer requirements by nineteen (19) minutes) ff) PT 1004:C00339S: collected October 4, 2023 at 05:23 am and received October 4, 2023 at 05:47 am (exceeding the manufacturer requirements by nine (9) minutes) gg) PT 1004:C00353T: collected October 4, 2023 at 04:15 am and received October 4, 2023 at 05:50 am (exceeding the manufacturer requirements by eighty (80) minutes) hh) PT 1004:C00712S: collected October 4, 2023 at 12:30 pm and received October 4, 2023 at 12:51 pm (exceeding the manufacturer requirements by six (6) minutes) ii) PT 1004:C01204S: collected October 4, 2023 at 23:06 pm and received October 4, 2023 at 23:38 pm (exceeding the manufacturer requirements by seventeen (17) minutes) jj) PT 1005:C00300S: collected October 5, 2023 at 02:43 am and received October 5, 2023 at 03:12 am (exceeding the manufacturer requirements by fourteen (14) minutes) kk) PT 1005:C00471S: collected October 5, 2023 at 05:09 -- 6 of 22 -- am and received October 5, 2023 at 06:14 am (exceeding the manufacturer requirements by fifty (50) minutes) ll) PT 1005:C00759R: collected October 5, 2023 at 12:48 pm and received October 5, 2023 at 13:35 pm (exceeding the manufacturer requirements by thirty two (32) minutes) mm) PT 1005:C00902S: collected October 5, 2023 at 13:29 pm and received October 5, 2023 at 14:03 pm (exceeding the manufacturer requirements by nineteen (19) minutes) nn) PT 1005:C00914S: collected October 5, 2023 at 14:07 pm and received October 5, 2023 at 14:47 pm (exceeding the manufacturer requirements by twenty five (25) minutes) oo) PT 1005: C01221S: collected October 5, 2023 at 22:40 pm and received October 5, 2023 at 23: 07 pm (exceeding the manufacturer requirements by twelve (12) minutes) pp) PT 1005:C01227S: collected October 5, 2023 at 22:00 pm and received October 5, 2023 at 22:26 pm (exceeding the manufacturer requirements by eleven (11) minutes) qq) PT 1005:C01232S: collected October 5, 2023 at 21:58 pm and received October 5, 2023 at 22:27 pm (exceeding the manufacturer requirements by fourteen (14) minutes) rr) PT 1006:C00305S: collected October 6, 2023 at 01:07 am and received October 6, 2023 at 01:53 am (exceeding the manufacturer requirements by thirty one (31) minutes) ss) PT 1006:C00360S: collected October 6, 2023 at 03:17 am and received October 6, 2023 at 05:50 am (exceeding the manufacturer requirements by one hundred thirty eight (138) minutes) tt) PT 1006:C00497S: collected October 6, 2023 at 07:15 am and received October 6, 2023 at 07:40 am (exceeding the manufacturer requirements by ten (10) minutes) uu) PT 1006:C00879S: collected October 6, 2023 at 13:45 pm and received October 6, 2023 at 14:12 pm (exceeding the manufacturer requirements by twelve (12) minutes) vv) PT 1006:C00904S: collected October 6, 2023 at 16:29 pm and received October 6, 2023 at 16:57 pm (exceeding the manufacturer requirements by thirteen (13) minutes) ww) PT 1006: C00921S: collected October 6, 2023 at 14:40 pm and received October 6, 2023 at 15: 08 pm (exceeding the manufacturer requirements by thirteen (13) minutes) xx) PT 1006:C00936S: collected October 6, 2023 at 15:53 pm and received October 6, 2023 at 16:35 pm (exceeding the manufacturer requirements by twenty seven (27) minutes) yy) PT 1006:C01109S: collected October 6, 2023 at 17:44 pm and received October 6, 2023 at 18:45 pm (exceeding the manufacturer requirements by forty six (46) minutes) zz) PT 1006:C01266S: collected October 6, 2023 at 21:34 pm and received October 6, 2023 at 22:59 pm (exceeding the manufacturer requirements by seventy (70) minutes) aaa) PT 1007:C00238S: collected October 7, 2023 at 01:24 am and received October 7, 2023 at 02:49 am (exceeding the manufacturer requirements by seventy (70) minutes) bbb) PT 1007:C00550S: collected October 7, 2023 at 10:40 am and received October 7, 2023 at 11:14 am (exceeding the manufacturer requirements by nineteen (19) minutes) ccc) PT 1007:C00706S: collected October 7, 2023 at 11:00 am and received October 7, 2023 at 12:51 pm (exceeding the manufacturer requirements by ninety six (96) minutes) ddd) PT 1007:C00903S: collected October 7, 2023 at 17:33 pm and received October 7, 2023 at 17:57 pm (exceeding the manufacturer requirements by nine (9) minutes) eee) PT 1007:C00946S: collected October 7, 2023 at 18:47 pm and received October 7, 2023 at 19:12 pm (exceeding the manufacturer requirements by ten (10) minutes) fff) 1008:C00460S: collected October 8, 2023 at 07:25 am and received October 8, 2023 at 07:46 am (exceeding the manufacturer requirements by six (6) minutes) ggg) PT 1008:C00530S: collected October 8, 2023 at 09:52 am and received October 8, 2023 at 10:26 am (exceeding the manufacturer requirements by nineteen (19) minutes) hhh) PT 1008:C00599S: collected October 8, 2023 at 11:24 am and received October 8, 2023 at 11:52 am (exceeding the manufacturer requirements by thirteen (13) minutes) iii) PT 1008: C00656S: collected October 8, 2023 at 12:40 pm and received October 8, 2023 at 13: 08 pm (exceeding the manufacturer requirements by thirteen (13) minutes) jjj) PT 1008:C00658S: collected October 8, 2023 at 12:13 pm and received October 8, 2023 -- 7 of 22 -- at 12:43 pm (exceeding the manufacturer requirements by fifteen (15) minutes) kkk) PT 1008:C00677S: collected October 8, 2023 at 19:50 pm and received October 8, 2023 at 20:23 pm (exceeding the manufacturer requirements by eighteen (18) minutes) lll) PT 1008:C00711S: collected October 8, 2023 at 19:02 pm and received October 8, 2023 at 20:24 pm (exceeding the manufacturer requirements by sixty seven (67) minutes) mmm) PT 1008:C00717S: collected October 8, 2023 at 14:48 pm and received October 8, 2023 at 15:11 pm (exceeding the manufacturer requirements by eight (8) minutes) nnn) PT 1008:C00883S: collected October 8, 2023 at 21:16 pm and received October 8, 2023 at 21:55 pm (exceeding the manufacturer requirements by twenty four (24) minutes) ooo) PT 1008:C00920R: collected October 8, 2023 at 20:52 pm and received October 8, 2023 at 21:17 pm (exceeding the manufacturer requirements by ten (10) minutes) ppp) PT 1008:C00936S: collected October 8, 2023 at 19:15 pm and received October 8, 2023 at 19:36 pm (exceeding the manufacturer requirements by six (6) minutes) qqq) PT 1008:C01027S: collected October 8, 2023 at 23:46 pm and received October 8, 2023 at 00:09 am (exceeding the manufacturer requirements by eight (8) minutes) rrr) PT 1009:C00249S: collected October 9, 2023 at 01:45 am and received October 9, 2023 at 02:17 am (exceeding the manufacturer requirements by seventeen (17) minutes) sss) PT 1009:C00362S: collected October 9, 2023 at 04:41 am and received October 9, 2023 at 05:31 am (exceeding the manufacturer requirements by thirty five (35) minutes) ttt) PT 1009:C00482S: collected October 9, 2023 at 09:10 am and received October 9, 2023 at 09:43 am (exceeding the manufacturer requirements by eighteen (18) minutes) uuu) PT 1009: C00766R: collected October 9, 2023 at 11:10 am and received October 9, 2023 at 11: 37 am (exceeding the manufacturer requirements by twelve (12) minutes) vvv) PT 1009:C01042S: collected October 9, 2023 at 15:55 pm and received October 9, 2023 at 16:23 pm (exceeding the manufacturer requirements by thirteen (13) minutes) www) PT 1009:C01078S: collected October 9, 2023 at 16:33 pm and received October 9, 2023 at 16:58 pm (exceeding the manufacturer requirements by ten (10) minutes) xxx) PT 1009:C01133S: collected October 9, 2023 at 18:43 pm and received October 9, 2023 at 19:17 pm (exceeding the manufacturer requirements by nineteen (19) minutes) yyy) PT 1009:C01285S: collected October 9, 2023 at 20:56 pm and received October 9, 2023 at 21:36 pm (exceeding the manufacturer requirements by twenty five (25) minutes) zzz) PT 1009:C01413S: collected October 9, 2023 at 23:38 pm and received October 9, 2023 at 00:03 am (exceeding the manufacturer requirements by ten (10) minutes) 4. In interview on December 14, 2023 at 03:00 pm, General Supervisor 1 confirmed the identified patient samples were not separated within fifteen (15) minutes of collection for Lactic Acid testing per manufacturer. 5. Review of the Task 1 & 3 form provided to surveyor revealed the laboratory performs 7263 Lactic Acid tests annually. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of