Crmc Abg Lab

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and interview with the testing personnel (TP) #1, the laboratory failed to ensure a written procedure is available for evaluating competency, blood gas panic values, and proficiency testing performance. Findings: 1. Review of laboratory procedures showed no procedure for evaluating competency, reporting and documenting blood gas panic values, and evaluating proficiency testing performance and identify any problems that require

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on May 22, 2024, the laboratory was found to be out of compliance with the following condition level deficiencies: 42 C.F.R 493.803 Condition: Successful Participation 42 C.F.R 493.1403 Condition: Moderate Complexity Laboratory Director 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 review of WSLH proficiency testing (PT) chemistry results for 2024 and 2023 and interview with the technical consultant (TC) #2 on May 16, 2024 at 4:30 PM 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 -- , the laboratory failed to successfully participate in PT. Refer to D-tag 2096, unsatisfactory performance in three out of four consecutive PT events for PO2 (oxygen partial pressure) blood gas. 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 review of WSLH proficiency testing (PT) chemistry results for 2024 and 2023 and interview with the technical consultant (TC) #2, the laboratory failed to achieve satisfactory performance for PO2 (oxygen partial pressure) blood gas in three out of four consecutive testing events. Findings: 1. Review of the WSLH PT chemistry results for the first event of 2024 showed the laboratory obtained an unsatisfactory score of 0 percent for the analyte PO2 blood gas. 2. Review of the WSLH PT chemistry results for the third event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 3. Review of the WSLH PT chemistry results for the first event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 4. Interview with the technical consultant (TC) #2 on May 16, 2024 at 4:30 PM confirmed the laboratory failed to achieve satisfactory performance for PO2 blood gas in three out of four consecutive testing events. 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 review of WSLH proficiency testing (PT) chemistry results for 2024 and 2023, and interview with the technical consultant (TC) #2, the laboratory director (LD) failed to provide overall management and direction to the laboratory. (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: -- 2 of 3 -- Based on review of WSLH proficiency testing (PT) chemistry results for 2024 and 2023, and interview with the technical consultant (TC) #2, the laboratory director (LD) failed to ensure successful participation in an HHS approved proficiency testing program. Findings: 1. Review of the WSLH PT chemistry results for the first event of 2024 showed the laboratory obtained an unsatisfactory score of 0 percent for the analyte PO2 blood gas. 2. Review of the WSLH PT chemistry results for the third event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 3. Review of the WSLH PT chemistry results for the first event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 4. Interview with the technical consultant (TC) #2 on May 16, 2024 at 4:30 PM confirmed the laboratory director (LD) failed to ensure successful participation in an HHS approved proficiency testing program. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on May 22, 2024, the laboratory was found to be out of compliance with the following condition level deficiencies: 42 C.F.R 493.803 Condition: Successful Participation 42 C.F.R 493.1403 Condition: Moderate Complexity Laboratory Director 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 review of WSLH proficiency testing (PT) chemistry results for 2024 and 2023 and interview with the technical consultant (TC) #2 on May 16, 2024 at 4:30 PM 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 -- , the laboratory failed to successfully participate in PT. Refer to D-tag 2096, unsatisfactory performance in three out of four consecutive PT events for PO2 (oxygen partial pressure) blood gas. 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 review of WSLH proficiency testing (PT) chemistry results for 2024 and 2023 and interview with the technical consultant (TC) #2, the laboratory failed to achieve satisfactory performance for PO2 (oxygen partial pressure) blood gas in three out of four consecutive testing events. Findings: 1. Review of the WSLH PT chemistry results for the first event of 2024 showed the laboratory obtained an unsatisfactory score of 0 percent for the analyte PO2 blood gas. 2. Review of the WSLH PT chemistry results for the third event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 3. Review of the WSLH PT chemistry results for the first event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 4. Interview with the technical consultant (TC) #2 on May 16, 2024 at 4:30 PM confirmed the laboratory failed to achieve satisfactory performance for PO2 blood gas in three out of four consecutive testing events. 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 review of WSLH proficiency testing (PT) chemistry results for 2024 and 2023, and interview with the technical consultant (TC) #2, the laboratory director (LD) failed to provide overall management and direction to the laboratory. (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: -- 2 of 3 -- Based on review of WSLH proficiency testing (PT) chemistry results for 2024 and 2023, and interview with the technical consultant (TC) #2, the laboratory director (LD) failed to ensure successful participation in an HHS approved proficiency testing program. Findings: 1. Review of the WSLH PT chemistry results for the first event of 2024 showed the laboratory obtained an unsatisfactory score of 0 percent for the analyte PO2 blood gas. 2. Review of the WSLH PT chemistry results for the third event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 3. Review of the WSLH PT chemistry results for the first event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 4. Interview with the technical consultant (TC) #2 on May 16, 2024 at 4:30 PM confirmed the laboratory director (LD) failed to ensure successful participation in an HHS approved proficiency testing program. -- 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 review of chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider for 2023 and interview with the technical consultant (TC) on December 29, 2023 at 11:00 AM , the laboratory failed to successfully participate in PT. Refer to D-tag 2096, unsatisfactory performance in two out of three consecutive PO2 blood gas PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 review of chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider for 2023 and interview with the technical consultant (TC), the laboratory failed to achieve satisfactory performance for PO2 (oxygen partial pressure) blood gas in two out of three consecutive testing events. Findings: 1. Review of the chemistry PT results for the first event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 2. Review of the chemistry PT results for the third event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte PO2 blood gas. 3. Interview with the technical consultant (TC) on December 29, 2023 at 11:00 AM confirmed the laboratory failed to achieve satisfactory performance for PO2 blood gas in two out of three consecutive testing events. -- 2 of 2 --

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of 2021 and 2022 proficiency testing (PT) results and interview with technical consultant (TC) #2, the laboratory failed to verify the accuracy of analytes that are not evaluated or scored by a CMS-approved PT program. Findings: 1. Review of "WSLH PT 2021-Blood Gas 1" PT results showed the analyte chloride was "not scored-non consensus" and the laboratory failed to evaluate. 2. Interview with the TC #2 on November 15, 2022 at 12:30 PM confirmed the laboratory failed to verify the accuracy of PT event 2021 Blood gas 1 for the analyte chloride that was not evaluated or scored by a CMS-approved PT program. 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 review of EPOC blood gas procedure, EPOC calibration verification and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- EPOC blood gas quality control (QC), lack of calibration records for the EPOC blood gas analyzer and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to ensure a written procedure is available for the EPOC blood gas analyzer (Refer to D5401); the laboratory failed to test one sample of control material each 8 hours of testing (Refer to D5537), and the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for 2021 and to date November 15, 2022 (Refer to D5439). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and interview with the technical consultant (TC) #2, the laboratory failed to ensure a written procedure is available for the EPOC blood gas analyzer. Findings: 1. Review of laboratory procedures showed no procedure for the EPOC blood gas analyzer. 2. Interview with the TC #2 on November 15, 2022 at 12:00 PM confirmed the laboratory failed to ensure a written procedure for the EPOC blood gas analyzer is available. 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 lack of calibration records for the EPOC blood gas analyzer and interview -- 2 of 6 -- with the technical consultant (TC) #2, the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for 2021 and to date November 15, 2022. Findings: 1. Lack of calibration records for the EPOC blood gas analyzer for 2021 and to date November 15, 2022 showed no calibration that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for the analytes: pH, pCO2 and pO2, sodium, potassium, chloride, ionized calcium, total CO2, glucose and lactic acid. 2. Interview with the TC #2 on November 15, 2022 at 12:00 PM confirmed the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for pH, pCO2 and pO2, sodium, potassium, chloride, ionized calcium, total CO2, glucose and lactic acid. 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 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 2021 and to date November 15, 2022 EPOC blood gas quality control (QC) and interview with the technical consultant (TC) #2, the laboratory failed to test one sample of control material each 8 hours of testing. Findings: 1. Review of the EPOC blood gas QC showed the laboratory did not perform blood gas QC every 8 hours of patient testing in 2021 and to date November 15, 2022. 2. Interview with the TC #2 on November 15, 2022 at 12:00 PM confirmed the laboratory failed to test one sample of blood gas control material each 8 hours of testing. 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 review of the Siemens Rapid Point 500 blood gas analyzer quality control, proficiency testing and interviews, the laboratory failed to meet the condition of laboratory director (LD). The LD failed to ensure all PT reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 review of the Siemens Rapid Point 500 and the Siemens EPOC instrumentation performing similar tests on different methodologies, lack of documentation of the comparison studies between instruments performing blood gas analysis and interview with testing personnel # 2 the laboratory failed to meet the condition of analytic systems. (Refer to D5775 ) This is a repeat deficiency cited during previous survey conducted August 18, 2018. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on review of temperature and humidity logs, policies and procedures and interview with testing personnel (TP) #1, the laboratory failed to define criteria for the accurate and reliable test system operation and test result reporting for blood gas analyzers from Nov 19, 2019 to date April 28, 2021. Findings: 1. The Siemens Rapidpoint 500 blood gas manual specifies the room temperature range must be between 15-30 degrees C and humidity must be between 5-85%. 2. Review of temperature logs showed a lack of documentation for room temperature and humidity from November 19, 2019 to date April 28, 2021. 3. Interview with TP #2 on April 28 at 130 P.M. confirmed the laboratory failed to define criteria for humidity and ambient temperature and monitor and document room temperature and humidity. 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 2019 and 2020 performance specifications for the Siemens Rapid Point 500 blood gas analyzer, the Siemens EPOC blood gas analyzer and interview with testing personnel #2, the laboratory failed to verify the manufacturer's reference intervals (normal values) for 9 out of 9 analytes for the two new test systems prior to patient testing. Findings: 1. Review of verification of method performance of Siemens Rapid Point 500 Blood Gas tests of pCO2, pH, pO2, glucose, Ionized Calcuim, Sodium, Potassium, Chloride and Lactate revealed the laboratory failed to evaluate and verify the reference intervals (normal values) were appropriate for the laboratory's patient population prior to patient testing in Novemeber 2019. 2. Review of verification of method performance of Siemens EPOC Blood Gas tests of pCO2, pH, pO2, glucose, Sodium, Potassium, Chloride and Lactate revealed the laboratory failed to evaluate and verify the reference intervals (normal values) were appropriate for the laboratory's patient population prior to patient testing in Novemeber 2019. 2. Interview with testing personnel #2 on August 28, 2021 at 1:15 PM confirmed the laboratory failed to verfiy Siemens RapidPoint 500 and Siemens EPOC reference intervals (normal values) were appropriate for their own patient population prior to patient testing in Novemeber 2019. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of blood gas instrument records for 2019-2020 and interview with the testing personnel#2, the laboratory failed to evaluate and define the relationship between instruments / methodologies performing the same tests. Findings: 1. Review of blood gas instrument records revealed the laboratory performs blood gases on the Siemens RapidPoint 500 and the Siemens EPOC. The instrument comparison records failed to show how the laboratory defined limits of acceptability and evaluate the variance between instruments/methodologies performing the same tests. 2. Interview with the Testing Personnel #2 on April 28, 2021 at 1:30 PM confirmed, the laboratory failed to establish criteria for acceptable differences between instruments /methodologies performing the same tests. -- 3 of 3 --