Choctaw Regional Medical Center

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: 1. Based on review of the Abbott i-STAT System Manual, patient test results for blood gas testing with the Abbott i-STAT System from 8/23/2021 through 1/22/2023, and lack of documentation of the room temperature of the Respiratory Department where Abbott i-STAT testing was performed, the laboratory failed to follow manufacturer's instructions for the operating temperature of the Abbott i-STAT System from 8/23/2021 through 12/31/2021 when the room temperature was not monitored and documented. A total of 44 patient specimens were tested for pH, pCO2, and pO2 on the Abbot i-STAT System during this time frame. Findings include: The Abbott i-STAT System Manual states the operating temperature for i- STAT System testing is 16 to 30 degrees Celsius or 61 to 86 degrees Fahrenheit. On 2 /8/2023, there was no documentation of the room temperature of the Respiratory Department, where Abbott i-STAT testing was performed from 8/23/2021 through 12 /31/2021 to ensure manufacturer's instructions for operating temperature were followed. Review of patient test results for blood gas testing with the Abbott i-STAT System revealed a total of 44 patient specimens were tested for pH, pCO2, and pO2 between 8/23/2021 and 12/31/2021. 2. Based on review of the Ortho Diagnostics MicroTyping System (MTS) Dispenser Instructions for Use, lack of documentation of MTS dispenser calibration checks and weekly cleaning, and interview with the technical consultant on 2/9/2023 at 10:25 a.m., the laboratory failed to follow manufacturer's instructions for performing calibration checks and weekly cleaning of the MTS Diluent 2 dispenser and the MTS Diluent 2 Plus dispenser, in use for patient 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 -- ABO/ Rh typing, antibody detection testing, and compatibility testing, since the last survey on 6/16/2021. Findings include: Ortho Diagnostics MTS Dispenser Instructions for Use state for Calibration Check: "A calibration check should be done as part of a routine laboratory quality control schedule and after each repair." The Instructions for Use state for Cleaning: "The dispenser should be cleaned on a weekly basis." There was no documentation on the day of the survey of calibration checks or weekly cleaning of the MTS Diluent 2 dispenser or MTS Diluent 2 Plus dispenser. In an interview on 2/9/2023 at 10:25 a.m., the technical consultant confirmed there was no documentation of calibration checks or weekly cleaning of the dispensers. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of printouts of patient test results from the Abbott i-STAT System since the last survey on 6/16/2021, interview on 2/8/2023 at 12:10 p.m. with the technical consultant, and lack of documentation of verification of performance specifications for pH, pCO2, and pO2 blood gas testing, the laboratory failed to verify the manufacturer's performance specifications for blood gas testing with the Abbott i- STAT CG8+ reagent cartridge before patient testing with this cartridge began on 8/23 /2021. Findings include: Review of printouts of patient test results from the Abbott i- STAT System since 6/16/2021 revealed the CG8+ reagent cartridge was put in use for patient pH, pCO2, and pO2 testing on 8/23/2021. On 2/8/2023 there was no documentation of verification of performance specifications for pH, pCO2, and pO2 testing on the CG8+ reagent cartridge available for review, to include accuracy, precision, reportable range of test results, and verification of the manufacturer's reference intervals for the laboratory's patient population. In an interview on 2/8/2023 at 12:10 p.m., the technical consultant confirmed verification of performance specifications were not performed for the Abbott i-STAT CG8+ reagent cartridge. A total of 164 patient specimens were tested for pH, pCO2, and pO2 blood gases with the CG8+ reagent cartridge from 8/23/2021 through 1/22/2023. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the Abbott i-STAT System Manual, interview on 2/8/2023 at 1:30 p.m. with Respiratory Testing Personnel #1, listed on the Centers for Medicare and -- 2 of 4 -- Medicaid Services (CMS) 209 personnel form, and lack of documentation of thermal probe checks since the last survey on 6/16/2021, the laboratory failed to perform and document thermal probe checks every six months, as required by the manufacturer. Findings include: The Abbott i-STAT System Manual states to check the thermal probes on each analyzer every six months. There was no documentation available on 2 /8/2023 of the performance of thermal probe checks on the i-STAT System since the last survey on 6/16/2021. In an interview on 2/8/2023 at 1:30 p.m., Respiratory Testing Personnel #1 confirmed there was no documentation of thermal probe checks on the Abbott i-STAT System. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration and calibration verification records for the Siemens Dimension EXL 200 chemistry analyzer since it was installed on 9/30/2021 and interview with the technical consultant on 2/9/2023 at 3:30 p.m., the laboratory failed to perform calibration verification at least once every six months for sodium, potassium, and chloride testing since 9/30/2021. Findings include: Review of calibration records for the Siemens Dimension EXL 200 chemistry analyzer since installation on 9/30/2021 revealed the sodium, potassium, and chloride tests have only two calibrators. There was no documentation available on 2/9/2023 of calibration verification performed on sodium, potassium, and chloride tests since the initial calibration verification on 9/30/2021. In an interview on 2/9/2023 at 3:30 p.m., the technical consultant confirmed calibration verification had not been performed on sodium, potassium, and chloride testing since the initial verification on 9/30/2021. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control -- 3 of 4 -- materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and patient test results for blood gas testing with the Abbott i-STAT System from 6/20/2021 through 1/22/2023, lack of documentation of an Individualized Quality Control Plan (IQCP) for testing with the Abbott i-STAT CG8+ reagent cartridge, and interview with the technical consultant on 2/8/2023 at 12:10 p.m., the laboratory failed to include a control each eight hours of patient testing from 8/23/2021 through 1/22/2023, when a total of 164 patient blood gas results were reported. Findings include: Review of QC records and patient test results for blood gas testing with the Abbott i-STAT System from 6/20/2021 through 1 /22/2023 revealed blood gas results, which include pH, pCO2, and pO2, were reported for 164 patients during this time frame with no documentation of performance of a control each eight hours of patient testing. There was no documentation of establishment of an IQCP for Abbott i-Stat testing with the CG8+ reagent cartridge, which was put in use for patient testing on 8/23/2021. In an interview on 2/8/2023 at 12:10 p.m., the technical consultant confirmed an IQCP was not developed for blood gas testing with the Abbott i-STAT CG8+ reagent cartridge. -- 4 of 4 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Abbott i-Stat blood gas records from installation on 12/21/20 through 6/11/21, patient blood gas log, lack of documentation of an Individualized Quality Control Plan (IQCP), and interview with testing personnel (TP) #12 (respiratory supervisor) at 4:00 pm on 6/16/21, the blood gas testing staff failed to include two levels of control material each day of patient testing from 12/26/20 through 6/11/21. Approximately 65 patient blood gas results were reported on days when no QC was performed during this time period. Findings include: 1. Review of Abbott i-Stat quality control (QC) records from 12/21/20 through 6/11/21 revealed QC was performed only during lot number/reagent changes or troubleshooting the analyzer. QC was performed on 12/21/20, 1/22/21, 1/25/21, 1/26/21, 3/2/21, 3/24/21, 4 /28/21, and 5/26/21. 2. Review of blood gas patient test records from 12/26/20 through 6/11/21 revealed approximately 65 patient blood gas results were reported during this time with no documentation of performance of two levels of QC (QC 1 and QC 3 Precision) each day of patient testing. 3. There was no documentation of establishment of an IQCP, required after 1/1/16, if two levels of control are not included each day of patient testing. 4. Interview with the respiratory supervisor (TP #12) on 6/16/21 at 4:00 pm confirmed no IQCP was written for blood gas testing on the Abbott i-Stat and QC was only performed during lot number change of cartridges or troubleshooting with the analyzer. 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 -- D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on personnel records available the day of survey (6/16/21), the CMS (Centers for Medicare and Medicaid Services) 209 form and interview with testing personnel (TP) #12 (respiratory supervisor), the laboratory director had not ensured that TP #13 through #17 as listed on the CMS-209 personnel form had received the appropriate training to perform blood gas testing with the Abbott i-Stat analyzer prior to testing patients. Findings Include: 1. Based on lack of training documentation available the day of survey, TP #13 through #17 had no documented training prior to performing blood gas testing on patients beginning on 12/21/2020. All TP had signed an attestation that they had read the Abbott i-Stat Operator's manual, but there was no documentation to indicate TP #13 - #17 had demonstrated adequate performance of the testing procedure. 2. Interview with TP #12 at 4:00 pm on 6/16/21 confirmed that initial training for TP #13 through #17 had not included demonstrating proper performance of the testing procedure to include testing, quality control performance, and maintenance. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records from 11/7/18 through 6/16/21, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and interview with testing personnel (TP) #12 (respiratory supervisor), the technical consultant (TC) failed to evaluate and document the performance of TP #14 and #16 who perform moderate complexity blood gas testing at least semiannually during the first year of employment. Findings include: 1. Review of the personnel records for TP #14 and #16 revealed there was no semiannual evaluation/competency documented by the technical consultant during the first year of testing patients using a moderate complexity blood gas testing procedure. TP #14 began employment on 11/8/19 and TP #16 began employment on 1/21/20. 2. Interview with TP #12 at 4:00 pm on 6/16 /21 confirmed there was no semiannual evaluation/competency performed on TP #14 or #16 during their first year of testing patient samples. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) -- 2 of 3 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with TP #12 as listed on the CMS-209 (respiratory supervisor), the technical consultant (TC) failed to evaluate annually and document the performance of TP #12 through #16 who are responsible for performing moderate complexity blood gas testing. Findings include: 1. Based on personnel records available for review on the day of survey, there were no annual evaluations/competencies performed by the technical consultant on the following TP since the last suvey on 11/7/18: a. TP # 12, # 13, #15 - No annual evaluations performed in 2019, 2020 or 2021. b. TP # 14 - No annual evaluations performed in 2020 or 2021. c. TP # 16 - No annual evaluation performed in 2021 2. Interview with TP#12 confirmed that the annual evaluation/competencies for TP #12 through #16 that were available for review had not been documented as performed by the technical consultant. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 11/5/2020, the laboratory has not successfully participated in proficiency testing for pO2 BLOOD GAS. Findings include: Our records indicate the following proficiency testing scores for your laboratory for pO2 BLOOD GAS: PROFICIENCY TESTING PROVIDER: American Proficiency Institute pO2 BLOOD GAS: Year 2020 2nd Event 0% Year 2020 3rd Event 60% Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 11/5/2020, the laboratory has not successfully participated in proficiency testing for pO2 BLOOD GAS. Findings include: Our records indicate the following proficiency testing scores for your laboratory for pO2 BLOOD GAS: PROFICIENCY TESTING PROVIDER: American Proficiency Institute pO2 BLOOD GAS: Year 2020 2nd Event 0% Year 2020 3rd Event 60% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of blood gas records for the EPOC Blood Gas System from last survey, 11/11/16 through 11/7/18, and confirmation with staff at 4:00 pm on day of survey, the respiratory department failed to perform calibration verification on the EPOC blood gas analyzer every 6 months for pH, PCO2 and PO2 testing. The lab had documented calibration verification once on 6/29/17. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --