Trace Regional Hospital Abg

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 the Radiometer ABL 90 Flex Plus blood gas analyzer records including quality control, maintenance and calibration verification records from 10/12 /2021 through 5/18/23 and confirmation with testing personnel (TP) #7 (as listed on the Centers for Medicare and Medicaid Services 209 personnel form) at 12:00 p.m. on 5/18/2023, the laboratory failed to document as performed calibration verification on the Radiometer ABL 90 Flex Plus blood gas analyzer every 6 months for pCO2, pH, 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 -- pO2. One of four required calibration verifications was missed during the timeframe reviewed, and two of three calibration verifications exceeded the six month timeframe required by the manufacturer. Findings include: 1. Calibration verification is required every 6 months on any assay which is calibrated with less than 3 levels of calibration material. The Radiometer ABL 90 Flex Plus blood gas analyzer uses a single calibrator level to perform calibrations. 2. The Radiometer ABL 90 Flex Plus blood gas analyzer records revealed calibration verification was performed on 9/30/2021, 8 /31/2022 and on 5/16/2023. 3. TP #7 confirmed in an interview at 12:00 p.m. on 5/18 /2023 that calibration verifications on pH, pCO2 and pO2 were not performed at the appropriate timeframe or frequency during the period of time reviewed. One of four verifications required was not performed. Two of three calibration verifications performed exceeded the 6 month timeframe required by the manufacturer. -- 2 of 2 --

Summary Statement of Deficiencies 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 quality control (QC) records and patient test records for blood gas testing with the Radiometer ABL 90 Flex Plus blood gas analyzer from 8/7/20 through 9/27/21, lack of documentation of an Individualized Quality Control Plan (IQCP), and interview with respiratory supervisor at 1:00 p.m. on 10/12/21, the laboratory failed to include a control each eight hours of patient testing from 8/7/20 through 9/27/21 when approximately 89 patient results were reported. Findings include: Review of quality control records and patient test reports for blood gas testing with the ABL 90 Flex Plus blood gas analyzer from 8/7/20 through 9/27/21 revealed approximately 89 patient blood gas results including pH, pO2 and pCO2 were reported with no documentation of a control performed each eight hours of patient testing, to include both low and high values on each day of testing. The three levels of QC were performed monthly with the change of the sensor cassette and solution pack. There was no documentation of establishment of an IQCP, required after 1/1/16 if controls are not included each day of patient testing. In an interview on 10/12/21 at 1:00 p.m., the blood gas supervisor confirmed an IQCP was not developed for blood gas 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 1 --

Summary Statement of Deficiencies 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 laboratory personnel records from the last survey on 6/17/17 through the day of survey, 5/30/19, the CMS 209 personnel form and interview with the respiratory supervisor at 2:00 pm on the day of survey, the technical consultant failed to evaluate and document the performance of testing personnel (TP) #5, responsible for performing moderate complexity blood gas testing, at least semiannually during the first year of employment. The hire date for testing personnel #5 was 6/17/17. A semiannual evaluation must be performed during the first year of employment by the laboratory's technical consultant. Findings include: 1. Review of the personnel records for TP #5 revealed a hire date of 6/17/17. 2. There was no documentation of an evaluation/competency available for TP #5 though the date of survey. 3. Interview with the Respiratory supervisor at 2:00 pm on the day of survey confirmed no 6 month evaluation/competency had been performed for TP #5. 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 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --