Mitchell County Hosp Blood Gas Lab

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard deficiencies were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's AccuTest proficiency testing (PT) records, laboratory policy, and confirmed in interview, the laboratory failed to provide documentation of

Summary Statement of Deficiencies D0000 An onsite survey conducted January 11, 2023 thru January 12, 2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory policy, proficiency testing records from 2022 and interview with testing personnel, the laboratory failed to ensure the individual testing and the laboratory director attested to the routine integration of the samples into the patient workload for two of three proficiency testing events in 2022. The findings included: 1. Based on the laboratory policy "AccuTest Program", the policy stated the following: "The blood gas lab participates in blind study testing of it blood gas instruments, for the purpose of Quality Control and to meet CLIA requirement The blood gas lab is enrolled in a third-party Quality Assurance Pogrom called AccuTest. The blood gas lab shall follow all procedures in accordance with the standards set by Accutest testing services. The blood gas lab shall maintain all records in accordance to AccuTest testing services. Samples are run 3 times per year: April/June/ October Samples will be stored, handled, analyzed, and submitted according to AccuTest testing services. The Medical Director of the Blood Gas Lab will review and sign all outgoing and incoming results. " 2. Based on review of the AccuTest proficiency testing records, the individual testing and the laboratory director did not attest to the integration of the samples into the patient workload using the laboratory's routine methods for the second and third events of 2022. 3. In an interview at 15:15 hours on 1 /12/2023, Testing Person 1 (as listed on the CMS-209 Laboratory Personnel Report) stated she was not aware of the attestation requirement for proficiency testing. 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 -- 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 laboratory policy, calibration verification records, blood gas operator's manual, and interview with testing personnel, the laboratory failed to perform calibration verification at least every six months for three of three routine chemistry analytes in 2022. The findings included: 1. Based on review of the laboratory policy "PVP TESTING", the policy stated: "The blood gas lab participates in PVP testing every six months as part of Quality Control standards to meet CLIA requirements. All results have to be reviewed and approved by ABG Laboratory Director PVP material will be analyzed according to product instructions. PVP material will be stored according to product recommendations. PVP material will not be used passed expiration date. Testing results will be submitted to I.L. for Linearity results. I.L. technical support may be contacted for assistance in evaluating results." 2. Based on review of laboratory calibration verification data, the last calibration verification procedures were performed for pH, pCO2, and pO2 on 10/04/2021 and evaluated on 10/13/2021, approximately one year and three months prior to the date of survey. 3. Based on review of the GEM Premier 3500 Operator's Manual, on page 11.11, the reportable ranges were listed as: The reportable range of pH is 6.8 to 7.8 The reportable range of pCO2 is 5 to 115 mmHg The reportable range of pO2 is 0 to 760 mmHg. 4. In an interview at 12:04 p.m. on 1/12/2023, Testing Person 1 stated the laboratory had failed to order the PVP calibration verification material for 2022. Key: pH: potential hydrogen pCO2: partial pressure of carbon dioxide pO2: partial pressure of oxygen PVP: Performance Verification Product ABG: arterial blood gas D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report -- 2 of 4 -- destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of blood gas analyzer analytic records, patient final reports, and interview with facility personnel, two of eight patient final reports reviewed between June 2022 and December 2022 contained errors. The findings included: 1. Based on patient records, two patient final reports had different values than those reported on the analytic record from the GEM Premier 3500 blood gas analyzer. Accession Number 10026122 Analytic record from analyzer: SO2c was 91 percent The patient final report was reported as 93 percent. Accession Number 10026572 Analytic record from analyzer: pH was 7.32 The patient final report was reported as 7.33 2. In an interview at 14:42 hours on 1/12/2023, Testing Person 1 stated the laboratory did not have an electronic interface for transmission of results from the analyzer to the patient records and each result must be manually entered into the patient record and confirmed the patient records above contained transcription errors. Key: pH: potential hydrogen SO2c: oxygen saturation D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, proficiency testing records from 2022 and interview with testing personnel, the Laboratory Director failed to ensure the laboratory was enrolled in an HHS approved proficiency testing program for one of three events in 2022. The findings included: 1. Based on the laboratory policy "AccuTest Program", the policy stated the following: "The blood gas lab participates in blind study testing of its blood gas instruments, for the purpose of Quality Control and to meet CLIA requirement The blood gas lab is enrolled in a third-party Quality Assurance Pogrom called AccuTest. The blood gas lab shall follow all procedures in accordance with the standards set by AccuTest testing services. The blood gas lab shall maintain all records in accordance with AccuTest testing services. Samples are run 3 times per year: April/June/ October Samples will be stored, handled, analyzed, and submitted according to AccuTest testing services. The Medical Director of the Blood Gas Lab will review and sign all outgoing and incoming results. " 2. Based on review of the AccuTest proficiency testing records, the laboratory participated in the second and third events of 2022. There were no scores or documentation of the first event of 2022. 3. In an interview at 15:15 hours on 1/12/2023, Testing Person 1 (as listed on the CMS-209 Laboratory Personnel Report) stated the laboratory failed to enroll at the end of 2021 for the 2022 calendar year and didn't realize the laboratory had failed to enroll until they did not receive event one in April 2022. Key: CMS - -- 3 of 4 -- Centers for Medicare & Medicaid Services HHS - Health and Human Services CLIA - Clinical Laboratory Improvement Amendments -- 4 of 4 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Review of the CASPER report 155 Individual Proficiency Testing report, proficiency testing records and interview of facility personnel found the laboratory received an overall score of 0% for the analytes pH, PO2 and PCO2 in one of four Blood Gas/ Electrolytes testing events due to failure to participate. The findings included: 1. Review of the CASPER Report 155 found the laboratory received a score of 0% for pH, PO2 and PCO2 in the first testing event of 2021. 2. Review of the AccuTest proficiency testing records for 2020 and 2021 (three events per year) found the laboratory received a score of 0% for pH, PO2 and PCO2 in the Cycle 01 Blood Gas/ Electrolytes testing event due to non participation. 3. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on August 25, 2021 at 3:47 PM confirmed the laboratory did not test the proficiency specimens and submit the results to the proficiency agency for grading.. She stated that she "received the specimens but didn't know what they were for so they just didn't get run." She was asked if there was any documentation for the failure to participate and she stated " no, they just caught it the other day when they were going through everything to get ready for the survey." D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended 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 -- during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Review of the CASPER report 155 Individual Proficiency Testing report, proficiency testing records and interview of facility personnel found the laboratory received an overall score of 0% in one of four Blood Gas/ Electrolytes testing events due to failure to participate. The findings included: 1. Review of the CASPER Report 155 found the laboratory received an overall score of 0% for Routine Chemistry in the first testing event of 2021. 2. Review of the AccuTest proficiency testing records for 2020 and 2021 (three events per year) found the laboratory received an overall score of 0% in the Cycle 01 Blood Gas/ Electrolytes testing event due to non participation. 3. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on August 25, 2021 at 3:47 PM confirmed the above findings. She stated that she "received the specimens but didn't know what they were for so they just didn't get run." She was asked if there was any documentation for the failure to participate and she stated " no, they just caught it the other day when they were going through everything to get ready for the survey." D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Review of the CASPER report 155, proficiency testing records and interview of facility personnel found the laboratory director failed to ensure the proficiency testing results were submitted to the proficiency testing agency within the specified timeframe in one of four proficiency testing events in 2020 and 2021 (three events per year). (See D 2089 and D 2087) 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: Review of the CMS report 209, personnel records and interview of facility personnel found the technical consultant failed to evaluate the competency of one of five testing -- 2 of 3 -- personnel performing blood gas analysis at least semi-annually in the first year of testing The findings included: 1. Review of the CMS report 209 Laboratory Personnel report found the laboratory listed five testing personnel performing moderate complexity testing. 2. Review of personnel files found no documentation of semiannual competency assessment for testing person one (hired March 17, 2020). Initial training was completed March 26,2020. An Incomplete competency assessment form signed by the Laboratory director and dated November 2, 2020 with no identification of testing personnel was offered as documentation of competency assessment. 3. Interview of testing person one on the CMS report 209 conducted August 28, 2021 at 3:17 AM confirmed there was no other competency assessments available for review. -- 3 of 3 --

Summary Statement of Deficiencies 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: Based on review of the laboratory's quality control records from 2017 and 2018, and staff interview, it was revealed the laboratory failed to have documentation of monitoring quality control results performed on the Gem Premier 3500 blood gas analyzer over time to detect errors. The findings were: 1. A review of the laboratory's quality control records from 2017 and 2018 revealed the laboratory tested two levels of quality control material once each month for pH, PO2, and PCO2. The laboratory did not use a Levy Jennings graph or have some other means of monitoring the performance of the control material over time. The laboratory was asked to provide documentation of having a mechanism in place to monitor quality control values over time. No documentation was provided. 2. The laboratory was currently using CVP lot number 835 expiration September 30, 2019. 2. Interview of testing person two on the CMS report 209 laboratory personnel report conducted on February 12, 2019 at 09:25 AM confirmed the laboratory only assessed quality control results daily and did not monitor them over time. 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 --