Acadia-St Landry Hospital

Summary Statement of Deficiencies D0000 An offsite PT Desk Review was performed on August 1, 2023 at Acadia St Landry Hospital , 19D1015749, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratory Director, Moderate Complexity 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 laboratory's College of American Pathologist proficiency testing records, CASPER 153D & 155D report the laboratory failed to successfully perform for PCO2 in two consecutive General Chemistry proficency testing events in 2022- 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 -- 2023. Findings: 1. The laboratory failed to achieve a score of at least 80% for PCO2 Blood Gas in two consecutive events, resulting in initial unsuccessful performance. Refer to D2096. 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 a review of proficiency testing results from the CASPER 153D & 155D and College of America Pathologist (CAP), the laboratory failed to achieve a score of at least 80% for PCO2 Blood Gas in two consecutive events, resulting in initial unsuccessful performance. Findings are: 1. Review of College of America Pathologist (CAP) proficiency testing results and CASPER Report 0153D and 0155D revealed the laboratory received unsatisfactory score for the following two events resulting in the first unsuccessful performance for PCO2 Blood Gas: Event 3 of 2022 received a score of 00% Event 1 of 2023 received a score of 60% 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 laboratory's proficiency testing records, CASPER 155D report, and interview with personnel, the Laboratory Director failed to provide overall management and direction. 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: Based on review of the CMS-153D and CMS-155D reports and the College of American Pathologists (CAP) proficiency testing records, the laboratory director failed to achieve a score of at least 80% for PCO2 Blood Gas in two consecutive events, resulting in initial unsuccessful performance. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 13, 2023 through February 14, 2023 at Acadia St. Landry Hospital-Respiratory, CLIA ID # 19D1015749. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 the laboratory's proficiency test records and interview with the laboratory personnel, the laboratory failed to ensure that proficiency testing attestation statements were signed by the laboratory director for 2 of 3 proficiency testing (PT) events reviewed. The findings are as follows: 1. Review of the College of American Pathologists (CAP) proficiency testing records from the second testing event of 2021 through the second testing event of 2022 for Critical Care Blood Gas with Chemistry proficiency testing revealed no signature present on the attestation form by the laboratory director or designee for the below events: 2021 Critical Care Blood Gas with Chemistry Testing Event 2 2022 Critical Care Blood Gas with Chemistry Testing Event 1 2. In interview on February 13, 2023 at 3:13 PM, Testing Personnel 1 confirmed that the Laboratory Director had not signed the attestation statements identified above. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- 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 record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were established for assessing clinical consultant competency. Findings: 1. Review of the laboratory's policy and procedure manual no policy or process specific to competency assessment of the clinical consultant to include, but not limited to, qualification, basis of determination of competency, and frequency of competency assessment required. 2. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed the following personnel are listed as Clinical Consultant: Personnel 7 3. Review of personnel records revealed no record of competency assessment performed for the duties of Clinical Consultant for Personnel 7. 4. In interview on February 13, 2023 at 3:13 PM, Laboratory Director confirmed a competency assessment was not performed for the duties of Clinical Consultant, and he was unaware that he needed to perform a competency for the Clinical Consultant. II. Based on review of the laboratory's Policy and Procedure manual, personnel files, as well as interviews with laboratory staff, the laboratory failed to follow written policies and procedures to assess employee competency for one (1) of five (5) Testing Personnel. Findings: 1. Review of personnel competency files revealed that a 2022 annual competency assessment was documented for Testing Personnel 2. 2. Further review of the 2022 annual competency assessment completed on June 1, 2022 for Testing Personnel 2 revealed that for the skill "Records/reports test results," the laboratory assessed Testing Personnel 2 as "Needs Improvement." 3. Review of the laboratory's policy "Employee Competency" revealed the following statement: "If evaluation of competency is "needs improvement," the testing personal (sic) shall not continue to perform testing on patients until re-education/training followed by successful reassessment of competency. This shall be initiated by the technical consultant." 4. Review of the laboratory's 2022 Arterial Blood Gas Log revealed the initials of Testing Personnel 2 next to a total of four (4) patients tested on the following dates: a. 7/26/2022 b. 11/01 /2022 c. 12/03/2022 d. 12/07/2022 5. In interview on February 14, 2023 at 9:15 am, Testing Personnel 1 confirmed the initials of Testing Personnel 2 next to patients tested after June 1, 2022 on the 2022 Arterial Blood Gas Log. 6. In interview on February 13, 2023 at 2:46 PM, Laboratory Director confirmed that no reeducation or training was initiated after performing the 2022 annual competency for Testing Personnel 2. The Laboratory Director also serves as the Technical Consultant. 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 laboratory policy and procedure and proficiency testing records, as well as interview with laboratory personnel, the laboratory failed to assess one (1) unacceptable result on one (1) of three (3) testing events. Findings: 1. Review of the laboratory's 2022 College of American Pathologists (CAP) proficiency test results revealed the laboratory received the following unacceptable result: 2nd Event: Sample AQ-07 for PCO2 2. Further review of the laboratory's CAP documents revealed no documentation of review or investigation for the identified unacceptable result. 3. -- 2 of 5 -- Review of the laboratory's "Proficiency Testing" policy under the "Survey Result Evaluation" section revealed "Unacceptable Challenge--a graded, missed result. An Action Needed Form must be completed for an unacceptable challenge. All related data (QC, maintenance, calibration, lot#/expiration date log, report, raw data printout, etc.) must be reviewed to determine the exact cause for the failure and this data attached to the ANF. Once the problem is identified, appropriate

Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 21, 2021 through June 25, 2021 at Acadia St. Landry Hospital-Respiratory, CLIA ID # 19D1015749. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation by surveyor, review of validation records, test menu, and interview with personnel, the laboratory failed to have complete performance verification studies for the Nova Biomedical Stat Profile Prime blood gas analyzer. Findings: 1. Observation by surveyor during laboratory tour on June 21, 2021 at 11:08 am revealed the laboratory utilizes the Nova Biomedical Stat Profile Prime analyzer for blood gas testing. 2. In interview on June 21, 2021 at 10:40 am, the Respiratory Manager stated the laboratory has utilized the Nova Biomedical Stat Profile prime instrument for blood gas testing for patient testing since June 2020. The Laboratory Director reviewed/approved the "Verification of Performance Specifications" studies on June 3, 2020. 3. Review of the laboratory's summary page, received on June 21, 2021, for the verification of performance specifications (validation) revealed the following: a) " Accuracy was verified by testing quality control materials over time (minimum 20 days)." b) "Precision was verified by day to day (minimum 20 samples 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 -- of each level of external and internal quality control material analyzed once per day) and within day (10 samples of each level of quality control material analyzed in one day) quality control analysis. 4. Review of the laboratory's validation summary page received on June 23, 2021, which differed from the summary presented to surveyor on June 21, 2021, revealed the following: a) "Accuracy was verified by testing quality control materials over time (minimum 20 days)." b) "Precision was verified by day to day (minimum 20 samples of each level of external and internal quality control material analyzed once per day) and within day (5 samples of each level of quality control material analyzed in one day) quality control analysis." 5. Review of the laboratory's validation studies revealed the the laboratory did not include the following: a) Accuracy: raw data to include the minimum number of samples /frequency indicated in the laboratory's summary b) Precision (including run to run, day to day, within run, operator variance): raw data to include the minimum number of samples/frequency indicated in the laboratory's summary The raw data presented to surveyor did not match either of the laboratory's validation summary procedures. 6. In interview on June 23, 2021 at 10:00 am the Technical Consultant stated via telephone that there may have been an error in the number of samples used for the accuracy and precision studies. The Technical Consultant further stated there should have been a spreadsheet included. 7. Review of the laboratory's test menu revealed the laboratory performs 159 blood gas tests annually. 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-- (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 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) for blood gas testing. Findings: 1. In interview on June 21, 2021 at 10:40 am, the Respiratory Manager stated the laboratory has utilized the Nova Biomedical Stat Profile prime instrument for blood gas testing for patient testing since June 2020. 2. Review of the laboratory's IQCP documents revealed the laboratory did not include the following: a) Quality Assessment Plan specific to the laboratory's location and frequency of review 3. Further review of the laboratory's IQCP Quality Assessment Plan revealed the plan was for a hospital in a neighboring city, not the laboratory's respiratory department. 4. In interview on June 23, 2021 at 10:00 am the Respiratory Manager confirmed the laboratory's IQCP Quality Assessment Plan did not include frequency of review and not specific to their laboratory. 5. Review of the laboratory's test menu revealed the laboratory performs 159 blood gas tests annually. D5785

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Acadia St Landry Hospital - Respiratory - CLIA # 19D1015749 on December 3, 2018 through December 6, 2018. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to label control material for the Abbott iSTAT 1 analyzer with expiration dates for proper use. Findings: 1. Observation by surveyor during the laboratory tour on December 3, 2018 revealed the laboratory utilizes the Abbott iSTAT 1 analyzer with i- STAT Control Levels 1 and 3 stored at 2 to 8 degrees celsius for blood gas testing. 2. Review of the i-STAT package insert for Quality Control under "Storage" revealed "Refrigerated storage at 2 to 8 degrees celsius should be maintained until the printed expiration date on the box and ampule labels. Control solutions may also be stored at room temperature for up to 5 days (18 to 30 degrees celsius)". 3. Further observation by surveyor revealed the laboratory did have Quality Control (QC) ampules placed at room temperature with a date written; However, the laboratory did not label the ampules to specify the date in which QC material was removed from the refrigerator and placed at room temperature for the following controls: i-STAT Level 1 Control Lot # 101104 ( 2 vials) i-STAT Level 3 Control Lot # 121104 ( 2 Vials) 4. In interview on December 4, 2018 at 2:28 pm, Personnel 3 stated the date written on the 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 -- ampules was the expiration date but it does not specify when they are taken out of the refrigerator. Personnel 3 confirmed the laboratory did not label the control materials as needed. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Refer to D5415 -- 2 of 2 --