Lewisgale Hospital Alleghany

Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at LewisGale Alleghany Hospital-Blood Gas Laboratory on February 12, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's quality control (QC) records, Blood Gas Radiometer ABL 800 patient test logs, and an interview, the laboratory failed to retain instrument print out records and manufacturer's assay information package inserts documenting daily blood gas QC while reporting two thousand one hundred twenty- six (2,126) blood gas panels in eighteen (18) of eighteen (18) months reviewed. Findings include: 1. Review of Blood Gas Radiometer ABL 800 QC records from January 2016 to June 27, 2017 revealed no original QC print outs or data. The inspector requested to review original QC data from the ABL 800 analyzer with the QC manufacturer's acceptable limits. No documentation was available for review. 2. Review of the ABL 800 patient test logs revealed one thousand five hundred ninety- seven (1,597) patient results were reported in 2016, and five hundred twenty-nine (529) were reported from January to June 27, 2017. A total of two thousand one hundred twenty-six (2,126) blood gas panels during the timeframe of the review. 3. In an interview with the Technical Consultant at approximately 4:30 PM on 2/12/18, it was confirmed that the laboratory failed to retain instrument print out records of QC for the timeframe and number of patients listed above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report Form (CMS 209), procedure and policy manual, laboratory personnel files, and an interview, the laboratory did not establish and follow a policy for one (1) technical consultant's competency assessment in calendar years 2016, 2017 and up to the date of the survey on February 12, 2018. Findings include: 1. Review of the CMS 209 revealed that Testing Personnel A serves as Technical Consultant (TC). (See Personnel Code Sheet) 2. Review of the laboratory procedure and policy manual revealed no protocol outlining documentation of the competency assessment of the blood gas laboratory's TC. 3. Review of the personnel files revealed that the laboratory director failed to document competency assessments in 2016 and 2017 for Testing Personnel A in the role of TC. 4. In an interview with the TC at approximately 4:30 PM on 2/12/18, it was confirmed that laboratory did not establish and follow a policy for documenting competency assessment for the duties of the one (1) TC for the timeframe outlined above. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a tour, review of manufacturer's user guide, laboratory procedure and policy manual, equipment maintenance records, and an interview, the laboratory failed to follow the maintenance protocols for two (2) of two (2) thermometers located in the Respiratory Care Arterial Blood Gas (ABG) laboratory in calendar year 2016 while reporting one thousand five hundred ninety-seven (1,597) patient blood gas panels. Findings include: 1. During a laboratory tour on 2/12/18 at approximately 2:00 PM, the inspector noted two (2) ThermCo Digital thermometers in use for monitoring room and refrigerator temperature. The thermometers and serial numbers (SN) are listed below: ThermCo Digital Thermometer SN 33494 utilized for room temperature monitoring, ThermCo Digital Thermometer SN 45504 utilized for reagent refrigerator monitoring. The inspector noted the following reagents in use with storage requirements: Radiometer QualiCheck Control Vials (Level 1 Lot Number 159, Level 2 Lot Number 160, Level 3 Lot Number 159): Storage requirement of 2 to 25 Celsius (C); conditioning prior to use at stable temperature of 18-32 C. ABL 80 FLEX Solution packs (Lot Numbers 249682, 250347, 251432, 250804, 251629): Storage at 5-25 C. 2. Review of the Blood Gas Radiometer ABL 80 FLEX manufacturer's user guide revealed that the analyzer's operating temperature should be maintained -- 2 of 5 -- between 12-28 C. 3. Review of the laboratory's procedure and policy manual revealed a written quality assurance (QA) policy that stated "all thermometer calibrations will be performed annually". 4. Review of the laboratory's 2016 and 2017 equipment maintenance records revealed no records of thermometer calibrations in 2016. The inspector requested to review thermometer calibrations for calendar year 2016. No documentation was available for review. 5. In an interview with the Technical Consultant on 2/12/18 at approximately 4:30 PM, it was confirmed that the Respiratory Care ABG laboratory failed to follow the maintenance protocol for two (2) of two (2) digital temperature meters located in the laboratory in calendar year 2016 while reporting one thousand five hundred ninety-seven (1,597) patient result panels. 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 a review of the procedure and policy manual, 2016 and 2017 Blood Gas Radiometer ABL instrument calibration verification records, patient test logs, and an interview, the laboratory failed to follow their written procedure to perform calibration verification on the Radiometer ABL twice in calendar year 2017 while reporting one thousand fifty-eight (1,058) patient panels. Findings include: 1. Review of the procedure manual revealed a quality assurance (QA) policy to perform calibration verification for the Blood Gas Radiometer ABL testing twice annually. The policy states, "Calibration verification or the analytical measurement range will be performed twice per year." 2. Review of the laboratory's calibration verification records for the blood gas analyzer from January 2016 to the date of the survey 2/12/18 revealed linearity studies performed twice in 2016 (05/13/16, 12/28/16) and once in 2017 (08/15/17). The inspector requested to review additional documentation of calibration verification performed in 2017. The documentation was not available for review. 3. Review of the laboratory's ABL 800 patient test logs revealed one thousand fifty-eight (1,058) blood gas panels were reported in 2017. 4. In an interview with the Technical Consultant at approximately 4:30 PM on 2/12/18, it was confirmed that the -- 3 of 5 -- laboratory failed to perform calibration verification for the Blood Gas Radiometer ABL 80 FLEX analyzer, according to the written QA policy, while reporting one thousand fifty-eight (1,058) patient results in calendar year 2017. 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. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of the policies and procedures, quality assurance (QA) documentation, and an interview, the laboratory failed to follow their written policy to perform six (6) month method comparison studies to verify correlation of results for the two (2) Blood Gas Radiometer ABL 80 FLEX instruments in calendar years 2016 and 2017. Findings include: 1. During a tour of the Respiratory Care ABG Laboratory at approximately 2 PM on 2/12/18, the inspector noted two (2) Blood Gas Radiometer ABL 80 FLEX instruments in use for patient blood gas testing: Instrument "A" Serial Number (SN) 314309, Instrument "B" SN 314310. 2. Review of the laboratory's policies and procedures revealed a QA policy titled Analyzer Correlations, which stated: "method comparison of the analyzers will be checked for correlation every six months". 3. Review of the laboratory's QA documentation from January 2016 through the date of the survey, 2/12/18, revealed method comparison performed and approved by Technical Consultant on the following dates: 02/03/16, 08 /24/17. The inspector requested to review additional comparison studies for 2016 and 2017. No documentation was available for review. 4. In an interview with the laboratory Technical Consultant at approximately 4:30 PM on 2/12/18, it was confirmed that the laboratory failed to follow their policy to document a comparison of blood gas test results performed for patient testing on the Blood Gas Radiometer ABL instruments twice per year in 2016 and 2017. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), procedure and policy manual, laboratory -- 4 of 5 -- personnel files, and an interview, the laboratory director did not follow the written policy for personnel competency assessments for ten (10) of ten (10) personnel in calendar years 2016, 2017 and up to the date of the survey on February 12, 2018. Findings include: 1. Review of the CMS 209 revealed that there are ten (10) testing personnel and that Testing Personnel A serves as Technical Consultant (TC). (See Personnel Code Sheet) 2. Review of the laboratory's procedure manual revealed a QA policy titled "Blood Gas Competency Assessment" which stated: "all six required elements of competency will be assessed at a six month interval after initial training and annually thereafter for all blood gas testing personnel. The lab director may appoint technical consultant to assess competency". 3. Review of the laboratory personnel files revealed that the laboratory director failed to document competency assessments in 2016 and 2017 for Testing Personnel A in the role of TC. Review of the laboratory personnel files revealed that the laboratory director and/or the TC failed to document competency assessments in 2016 for: Testing Personnel D, Testing Personnel E, Testing Personnel F, Testing Personnel H. Review of the laboratory personnel files revealed that the laboratory director and/or the TC failed to document competency assessments in 2017 for: Testing Personnel B, Testing Personnel C, Testing Personnel D, Testing Personnel E, Testing Personnel F, Testing Personnel G, Testing Personnel H, Testing Personnel I, Testing Personnel J. The inspector requested to review additional competency documentation for the testing personnel and the TC listed above. The documentation was not available for review. 4. In an interview with the TC at approximately 4:00 PM on 2/12/18, it was confirmed that the laboratory director failed to follow the written QA policy for personnel competency assessments for ten (10) of ten (10) personnel in the timeframe outlined above. -- 5 of 5 --