Baptist Medical Center Leake

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 AccuTest PT and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 11/16/2022, the 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 -- laboratory failed to maintain satisfactory performance in three of three testing events (2021 - Event 3 and 2022 - Events 2 & 3) resulting in unsuccessful participation in Routine Chemistry for the analyte pH Blood Gas. Refer to D2096. 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 AccuTest PT and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 11/16/2022, the laboratory has not successfully performed proficiency testing for pH Blood Gas in three of three testing events. Findings include: A review of the laboratory records from AccuTest PT and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for pH Blood Gas: : Year 2021-3rd Event: 0% Year 2022-2nd Event: 60% Year 2022-3rd Event: 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from AccuTest PT and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 11/16/2022, the laboratory director failed to provide overall management and direction for ensuring Routine Chemistry proficiency testing was tested for three of three events as required under Subpart H. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from AccuTest PT and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 11/16/2022, the -- 2 of 3 -- laboratory director failed to ensure Routine Chemistry proficiency testing was tested as required under Subpart H. The laboratory failed to maintain satisfactory performance in three of three testing events (2021 - Event 3 and 2022 - Events 2 and 3) resulting in the subsequent unsuccessful performance for pH Blood Gas. Refer to D2096. -- 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 8/18/22, the laboratory has not successfully performed proficiency testing for TOTAL CHOLESTEROL, pH (BLOOD GAS), pO2 (BLOOD GAS), and pCO2 (BLOOD GAS). Findings include: Our records indicate the following proficiency testing scores for your laboratory for TOTAL CHOLESTEROL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute TOTAL CHOLESTEROL: Year 2022 1st Event 20% Year 2022 2nd Event 0% PROFICIENCY TESTING PROVIDER: AccuTest pH (BLOOD GAS): Year 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 -- 2021 3rd Event 0% Year 2022 2nd Event 60% pO2 (BLOOD GAS): Year 2021 3rd Event 0% Year 2022 2nd Event 60% PCO2 (BLOOD GAS): Year 2021 3rd Event 0% Year 2022 2nd 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. 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 8/18/22, the laboratory has not successfully performed proficiency testing for TOTAL CHOLESTEROL, pH (BLOOD GAS), pO2 (BLOOD GAS), and pCO2 (BLOOD GAS). Findings include: Our records indicate the following proficiency testing scores for your laboratory for TOTAL CHOLESTEROL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute TOTAL CHOLESTEROL: Year 2022 1st Event 20% Year 2022 2nd Event 0% PROFICIENCY TESTING PROVIDER: AccuTest pH (BLOOD GAS): Year 2021 3rd Event 0% Year 2022 2nd Event 60% pO2 (BLOOD GAS): Year 2021 3rd Event 0% Year 2022 2nd Event 60% PCO2 (BLOOD GAS): Year 2021 3rd Event 0% Year 2022 2nd 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 D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) data system for proficiency testing and the laboratory's proficiency testing (PT) records since the last survey on 11/11/20, the laboratory failed to enroll in an HHS approved proficiency testing program for blood gas testing - pH, pO2, and pCO2 - performed on the Radiometer ABL80 Co-Ox Flex analyzer for Event 1 of 2021 and Event 1 of 2022. Findings include: Review of the CMS data system for proficiency testing and the laboratory's PT records since the last survey on 11/11/20 revealed no documentation of the performance of proficiency testing for blood gas testing - pH, pO2, and pCO2 - performed on the Radiometer ABL80 Co-Ox Flex analyzer for Event 1 of 2021 and Event 1 of 2022. The laboratory's annual test volume for pH, pO2, and pCO2 is 645. 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 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 -- 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 verification records since the last survey on 11/11/20 and confirmation by Testing Personnel #8 listed on the CMS 209 personnel form, the laboratory failed to perform calibration verification on the Radiometer ABL80 Co-Ox Flex analyzer for blood gas testing - pH, pO2, and pCO2 - at least every six months from 2/2/21 until 7/27/22. Findings include: Review of calibration verification records since the last survey on 11/11/20 revealed calibration verification was performed on blood gas testing on the Radiometer ABL80 Co-Ox Flex analyzer on 2/2/21 and 7/27 /22. There was no documentation of performance of calibration verification for the sixteen months from 2/2/21 until 7/27/22. Testing Personnel #8 confirmed calibration verification was not performed on blood gas testing from 2/2/21 until 7/27/22. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of temperature logs and external quality control (QC) records, including total hemoglobin calibration records, for the Radiometer ABL80 Co-Ox Flex analyzer since the last survey on 11/11/20, a technical consultant failed to document review of QC records, total hemoglobin calibration records, and temperature logs since 11/11/20, for the evaluation of the competency of the staff. Findings include: Review of temperature logs and external quality control records, including total hemoglobin calibration records, for the Radiometer ABL80 Co-Ox Flex analyzer revealed no documentation of review of these records by a technical consultant since the last survey on 11/11/20. -- 2 of 2 --