St Helena Parish Hospital-Respiratory

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 10, 2022 at St. Helena Parish Hospital-Respiratory, CLIA ID # 19D0874986. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: I. Based on review of policies and procedures and interview with personnel, the laboratory failed to establish complete written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's "Employee Competency Evaluations" policy revised August 19, 2019 revealed the the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on February 10, 2022 at 11:26 am, the Respiratory Director confirmed the laboratory's revised personnel competency policy did not include the indicated information. II. Based on review of the laboratory's policies, personnel records, and interview with personnel, the laboratory 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 -- failed to perform a complete semi-annual competency assessment for one (1) of one (1) new hire personnel. Findings: 1. Review of the laboratory's "Employee Competency Evaluations" policy revised August 19, 20219 revealed the laboratory did not include the required six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing. Refer to D5209 I. 2. Review of personnel records revealed Testing Personnel 6 was hired in April 1, 2021. 3. Further review of personnel records for Testing Personnel 6 revealed the laboratory utilized a "Semiannual Evaluation of epoc Analyzer" form for semi-annual competency assessments. 4. Review of the "Semiannual Evaluation of epoc Analyzer" revealed the laboratory included the following "abbreviation key" on the form: 1-DO = Direct Observation or Verbal 2-MTR = Monitoring Test Results 3-RR= Record Review 4-PT = Proficiency Testing of Unknown 5-PM= Performance of Maintenance 6-PS= Problem Solving Skills 5. Review of the "Semiannual Evaluation of epoc Analyzer" for Testing Personnel 6 revealed the following procedures were assessed by "1-DO": Operation and function of epoc Instrument Specimen Handling, Processing & Testing Documenting & Reporting Test Results Documenting & Reporting Critical Values Disposal of Waste Retention of Records Policy on Performing Quality Controls Use of Liquid Quality Controls Maintenance of equipment Eye Wash Use and Location Temperature & Humidity Log 6. Further review of the "Semiannual Evaluation of epoc Analyzer" for Testing Personnel 6 revealed the following procedures were not assessed: a) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. b) Direct observation of performance of instrument maintenance and function checks. c) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. d) Assessment of problem solving skills. 7. In interview on February 10, 2022 at 12:30 pm, the Respiratory Director confirmed the semi-annual competency assessment did not include the minimum six (6) procedures. 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 record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were established. Refer to D5209 I and D5209 II. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on August 8, 2019 at St. Helena Parish Hospital-Respiratory, CLIA ID # 19D0874986. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to follow their established competency assessment policy for testing personnel. Findings: 1. Review of the laboratory's "Employee Competency Evaluations" policy "Any new hire respiratory employee will undergo an initial competency as part of department orientation and again with their 90 day evaluation." 2. In interview on August 8, 2019 at 9:49 am, the Respiratory Director stated Testing Personnel 7 was hired in November 2018. 3. Review of personnel records for Testing Personnel 7 revealed the initial assessment was completed February 25, 2019 and the ninety (90) day evaluation was completed February 14, 2019. 4. In interview on August 8, 2019, the Respiratory Director confirmed the 90 day evaluation was performed prior to the initial assessment. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- 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 -- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to have a complete Individualized Quality Control Plan (IQCP) to support the reduction in frequency of quality control (QC). Findings: 1 Observation by surveyor during the laboratory tour on August 8, 2019 revealed the laboratory utilized the EPOC analyzer for blood gas testing. 2. Review of the laboratory's IQCP Quality Control Plan revealed "Testing of appropriate QC material, level 1 and 3 in duplicate, on each new lot/shipment of test cards before or concurrently placing these materials into use for patient's specimens; and subsequently on the first of every month." 3. Review of the laboratory's IQCP documents revealed the laboratory did not include in- house data to support the reduction in frequency of external QC to monthly. 3. In interview on August 8, 2019 at 9:52 am, the Respiratory Director stated liquid controls level 1 and 3 are tested once a month and new lot/shipment of test cards. 4. In further interview on August 8, 2019, the Respiratory Director confirmed the laboratory did not have in-house QC data to support the QC reduction to monthly. The Respiratory Director stated the laboratory had ten (10) consecutive days of QC data. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure that a quality control program was established and maintained to assure quality laboratory services were provided. Refer to D5445. 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 -- 2 of 3 -- continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D5209. -- 3 of 3 --