Chicot Memorial Medical Center

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based upon observation made during a tour of the laboratory, review of reagent package insert, review of the laboratory's "Coagulation QC/Patient Log" review of the laboratory policy and procedure for Prothrombin Time (PT) assay, lack of documentation, and interview with laboratory staff determined that the laboratory failed to document the time that Prothrombin Time (PT) reagents were place on the CA 600 coagulation anayzer as required. Findings follow: A) During a tour of the laboratory on 1/15/25 at 10:55 a.m., the surveyor observed a bottle of reagent labeled only as "INN"placed in the slot used for innovin on the CA 600 coagulation anayzer. B) In an interview on 1/15/25 at 10:55 a.m., the laboratory staff members (#2 and 4 on CMS form 209) confirmed that the bottle contained innovin reagent used in PT testing and stated that the reagent is changed "daily". C) When asked if the date and time the reagent was changed is documented, staff member (# 4 on CMS form 209) produced a copy of the "Coagulation QC/Patient Log" for the CA 600 coagulation analyzer. D) Review of the Coagulation QC/Patient Log revealed that entries are documented as to date, time, "QC01, QC02 and patient names and no entry specifies a change of innovin reagent . E) The manufacturer insert for innovin reagent specified that the reagent was stable for a period of 24 hours on the CA 600 coagulation analyzer. F) Review of the laboratory policy and procedure for PT assays revealed that "after reconstitution the Dade Innovin is stable for 24 hours on board". F) In an interview on 1/15/25 at 10:55 a..m. the laboratory staff members (#2 and #4 on CMS 209 form) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- confirmed that the date and time Dade Innovin was placed on the CA-600 analyzer was not documented. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Control Summary Reports for Prothrombin Time assays (PT) for March 2024, July 2024, and November 2024, laboratory policy and procedure CMMC/LAB-GEN-027 titled "General Quality Control Policy, the "Coagulation QC/Patient Log", patient result reports, and interview determined that the laboratory failed to ensure two levels of quality control material are performed every eight hours of patient testing in one of three months reviewed . Findings follow: A) Review of the Quality Control Summary Reports for March 2024 revealed that quality control for PT assays was performed at 05:20 a.m. on 3/24/24 and not performed again until 05:25 a.m on 3/25/24. B) Review of the Coagulation QC/Patient Log for 3/24/24 and 3/25/24 confirmed that PT QC was performed at 05:20 a.m. and not performed again until 05:25 a.m. on 3/25/24 . C) Review of patient result reports revealed that a PT assay was performed for patient, identified as number 1 on a separate patient identification list at 02:42 p.m. on 3/24 /24, ( a period of 9 hours since QC was performed), and a PT assay was performed on patient identified as number 2 on a separate patient identification list, on 3/24/24 at 04: 08 p.m., (a period of over 10 hours since QC was performed). D) Review of laboratory policy and procedure CMMC/LAB-GEN-027 titled "General Quality Control Policy" revealed "The coagulation analyzer (CA600) two levels of controls are performed every 8 hours of testing. Daytime schedule: 5-530 AM and 1-130 PM and after 9 PM only if patient testing if performed". E) In an interview on 1/15/24 at 10:56 a.m., the laboratory staff member identified as number 4 on the CMS 209 form confirmed that the PT assays identified above were performed and reported greater than eight hours since the last succesful performance of quality control. D5783

Summary Statement of Deficiencies 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: Through observations made during a tour of the laboratory as well as interviews with laboratory staff, it was determined the laboratory had Airlife 0.45% sodium chloride solution available for use when it had exceeded its expiration date. Survey findings include: A) During a tour of the laboratory, conducted on 3/31/23 at 10:05 a.m., the surveyor observed 4 bottles of Airlife 0.45% sodium chloride solution (lot #21- 2101019) which expired on 2023-01-11. B) During an interview at the time of the tour, Employee ( # 2 from the CMS-209 form) confirmed the sodium chloride solution was available for use when it had exceeded its expiration and the solution was used for dilutions required in microbiological sensitivity testing. D5783

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Through a review of the manufacturer's instructions for the analyte Lactic Acid (LA), patient medical records, lack of documentation as well as interviews with staff, it was determined the laboratory failed to ensure the optimum integrity of patient specimens from the time of collection and receipt of the specimen through completion of testing and reporting of results. Survey findings Follow: A. A review of manufacturer's instructions for Lactic Acid revealed "Specimens for Lactic Acid analysis must be centrifuged and separated within fifteen minutes and analyzed immediately. If the test cannot be performed immediately, refrigerate the separate plasma for up to 24 hours or freeze specimen up to 30 days." B. A review of Lactic Acid patient results for March (one of four months) of 2021 revealed five of fifty-one patient results were not performed according to manufacturer' instructions. Patient #80113638 Lactic acid collected at 0410 completed at 0626; Patient #80113739 Lactic acid collected at 1125 completed at 1223; Patient #80114398 Lactic acid collected at 1557 completed 1654; Patient #80114278 Lactic acid collected at 1054 completed at 1159 and Patient #80114163 Lactic acid collected at 0012 completed at 0125. C. Upon request the laboratory could not provide documentation that the specimens had been refrigerated or frozen for future analysis. D. In an interview at 1300 on 05/05/2021, testing personnel #4 ( as listed on form CMS 209) confirmed the laboratory did not follow manufacturer's instructions when testing Lactic Acid. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Through observation, review of package insert, and interview it was determined that the laboratory failed to document the date opened and the expiration date of three of three vials of XN Check Hematology controls in current use. A. A review of the package insert of the XN Check Hematology controls revealed "the product expiration date changes to fourteen days after the vial is opened and the product is placed into use. B. During a tour of the laboratory on 5/6/2021 at 10:12 a.m. three vials of XN Check Hematology controls (lot 10960804, 10960805, and 10960806) were observed in the laboratory refrigerator without labels of the date opened or the amended expiration date. C. In an interview on 05/06/201 at 10:12 a.m., laboratory personnel #4 (as listed on form CMS-209) confirmed that the vials of controls were not labeled with the date opened and/or the amended expiration date. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of Respiratory policy and procedure manual, Quality Control (QC) documentation for January and March of 2021 and August 2020, lack of documentation, as well as interviews with staff, it was determined the Blood Gas laboratory failed to have documentation of QC performed for one of thirty days when patients were tested. Survey Findings follow: A. A review of the Blood Gas laboratory policy and procedure manual revealed the quality control protocol: " Two levels of QC are performed every eight hours of patient testing." B. A review of QC records for August 16, 2020 ( one of thirty days) revealed the times Blood Gas QC was analyzed: At 0603 level 1 and level 2 was in acceptable range for analytes PH, PCO2 and PO2: at 15:03 level 3 (only one level of QC was in range) was in acceptable range for analytes PH, PCO2 and PO2. C. A review of ten patient medical records revealed Patient #8010648 (one of ten patient medical records reviewed) was analyzed and resulted at 17:55 when only one level of QC was in acceptable range. D. In an interview at 11:00 on 05/4/2021, the technical consultant confirmed the Blood Gas laboratory resulted patients with only one level of QC in acceptable range. -- 2 of 3 -- D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Through a review of Coagulation policy and procedure manual, Quality Control (QC) documentation for January and March of 2021, August of 2020, laboratory patient logs, lack of documentation and interviews with staff, it was determined the laboratory failed to perform D-Dimer QC each eight hours of patient testing. Survey findings follow: A. A review of the Coagulation policy and procedure manual revealed "Two levels of quality control are performed every eight hours of testing. Patients results will not be reported until QC is properly verified." B. A review of QC documentation for August 2020 (one of three months reviewed) revealed that on August 12, 2020, D-Dimer QC was analyzed at 9:51 a.m. C. A review of laboratory patients logs revealed the patient #69845 was tested for D-Dimer ( tested at 1839) greater than eight hours after QC was performed. D. Upon request, the laboratory could not provide QC documentation for every eight hours of patient testing. E. In an interview on 05/04/2021, testing personnel #3 (as listed on form CMS-209) confirmed the laboratory failed to perform D-dimer QC each eight hours of patient testing. -- 3 of 3 --

Summary Statement of Deficiencies 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: Through a review of the Blood Bank Quality Control Data Sheet, a review of Microbiology Quality Control Logs, and interviews with laboratory staff, it was determined the laboratory used reagents when they exceeded their expiration date. Survey findings follow: A. A review of the Blood Bank Quality Control Data Sheets revealed the following which were documented in use past their expiration date: Reverse Grouping Cells (lot # 111167) expired 1/19/2018 but was documented in use on 1/20/2018; Screening Cells (lot # 46085) expired 1/19/2018 but was documented in use on 1/20/2018; Coombs Control Cells (lot # 46091) expired 1/19/2018 but was documented in use on 1/20/2018; B Reverse Typing Cells (lot # 113167) expired 1/19 /2018 but was documented in use on 1/20/2018; and Poly Anti IgG Cells (lot # 702022) expired 7/12/2018 but was documented in use on 7/13/2018 and 7/16/2018 through 7/20/2018. B. Through a review of the Micro Quality Control Logs for January through August of 2018 it was determined the laboratory documented using Coagulase Plasma (lot #C14132 expiration 12/31/2017) through 3/2/2018. C. In an interview on 9/6/2018 at 10:55 a.m. laboratory employee #3 (as listed on the form CMS-209) confirmed that reagents were used when they had exceeded their expiration date. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the Micro Quality Control Logs for January through August of 2018, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document quality control for each lot of coagulase plasma used in 2018. Survey findings follow: A. The Micro Quality Control Log included two different lots of Coagulase Plasma used in 2018. Lot #C14132 was documented in use until 3/2/2018. The new lot of Coagulase Plasma (lot #C15689) was documented in use starting on 3/6/2018. B. A review of the Micro Quality Control Log for January through August of 2018 revealed the laboratory did not document quality control on the new lot of Coagulase Plasma (lot # C15689) which was put in use on 3/6/2018. The laboratory failed to document quality control on one of two lots of Coagulase Plasma used in 2018. C. In an interview, at 10:36 on 9/6/2018, laboratory employee #3 (as listed on the form CMS-209) confirmed the lack of documented quality control on the current lot of Coagulase Plasma. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through a review of the Blood Bank Procedure Manual, a review of the Blood Transfusion Alarm Check Log, lack of documentation, and interviews with staff, it was determined the laboratory failed to inspect the alarm system as required by their written policies. Survey findings follow: A. A review of the Blood Bank Procedure Manual revealed the Alarm Check policy states that the blood bank alarm will be checked quarterly (four times per year). B. The Blood Transfusion Alarm Check Log is used to document four alarm checks each year. The Blood Transfusion Alarm Check Log includes spaces for alarm checks to be recorded in March, June, September, and December each year. C. A review of the Blood Transfusion Alarm Check Log revealed that the alarm check was only documented in two of four quarters in 2017. The alarm checks for 2017 were only documented on 3/16/2017 and 8/23 /2017. D. In an interview, at 11:01 on 9/6/2018, employee #3 (as listed on the form CMS-209) confirmed the laboratory did not document blood bank alarm checks each quarter of 2017. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) -- 2 of 3 -- The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Through a review of personnel files, lack of documentation, and interviews with laboratory staff, it was determined the technical supervisor failed to evaluate the competency of personnel at least semiannually the first year of testing. Survey findings follow: A. A review of eight personnel records revealed that employee #7 (as listed on the form CMS-209) had new employee training documented on 4/12/2017. The only competency evaluation documented for employee #7 was dated 10/25/2017. Although the employee has been testing over one year (16 months) there is only one documented competency. B. In an interview, at 9:31 a.m. on 9/5/2018, employee #3 (as listed on the form CMS-209) confirmed the competency of employee #7 had not been documented semiannually the first year that she tested patients. -- 3 of 3 --