Plains Memorial Hospital

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations f 493. 1487 Condition: Laboratories Performing High Complexity Testing; Testing Personnel D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for use, the laboratory's own written policy, quality control records, patient test records and interview of facility personnel, the laboratory failed to check each batch of media for, sterility, its ability to support and or inhibit growth and document the physical characteristics , for BD BACTEC Peds Plus/F Culture Vials, BD BACTEC Standard/10 Aerobic/F Culture Vials and the BD BACTEC Standard Anaerobic/F culture vials used for patient testing between January 1, 2021 and September 20, 2022. The findings included: 1. Review of the manufacturer's instructions found: a. BD BACTEC Peds Plus/F Culture Vials- On page 2 under the heading QUALITY CONTROL: "Quality control requirements must be performed in accordance with local, state and/or federal regulations or accreditation requirements and your laboratory's standard quality control procedures." b. BD BACTEC Standard/10 Aerobic/F Culture Vials - On page 2 under the heading QUALITY CONTROL: "Quality control requirements must be performed in accordance with local, state and/or federal regulations or accreditation 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 -- requirements and your laboratory's standard quality control procedures." c. BD BACTEC Standard Anaerobic/F culture vials - On page 2 under the heading QUALITY CONTROL: "Quality control requirements must be performed in accordance with local, state and/or federal regulations or accreditation requirements and your laboratory's standard quality control procedures." 2. Review of the laboratory's own written procedure titled QUALITY CONTROL OF COMMERCIALLY PREPARED MEDIA(Revised October 2012) found ON PAGE 2 "V. Blood culture media are received from BD BACTEC. The bottles are shipped with QC certification Forms that should be filed in the Blood Culture QC Log Book. The bottles are checked visually for breakage and gross contamination before being put into use." 3. Review of quality control records found the laboratory retained the certificates of analysis for the following lot numbers used: a. BD BACTEC Peds Plus /F Culture Vials- lot 1202910 expiration 2022/05/31 opened 12/1/2021 lot 1027297 expiration 2021/11/30 opened 6/3/2021 lot 0288773 expiration 2021/07/31 opened 1 /18/2021 b. BD BACTEC Standard/10 Aerobic/F Culture Vials - lot 1231018 expiration 2022/05/31 opened 3/2/2022 lot 1195582 expiration 2022/04/30 opened 12 /1/2021( received 10/1/2021) lot 1195582 expiration 2022/04/30 opened 10/30/2021 ( received 9/17/2021) lot 1125352 expiration 2022/02/28 ( no date of opening documented) lot 1041552 expiration 2021/11/30 opened 07/08/2021 lot 1014467 expiration 2021/10/31 opened 9/9/2021 lot 0329026 expiration 2021/09/30 opened 2 /24/2021 lot 0274601 expiration 2021/07/31 opened 1/05/2021 c. BD BACTEC Standard Anaerobic/F culture vials - lot 1280544 expiration 2022/07/31 Opened 1/3 /2022 lot 1245599 expiration 2022/06/30 opened 2/5/2022 lot 1125355 expiration 2022/02/28 opened 10/1/2021 lot 1061248 expiration 2021/12/31 opened 9/10/2021 lot 0336016 expiration 2021/09/30 opened 8/2/2021 lot 0281039 expiration 2021/07 /11 opened 6/8/2021 lot 0281039 expiration 2021/07/31 opened 3/25/2021 lot 0267248 expiration 2021/07/31 opened 2/08/2021 d. The laboratory tested the following lot numbers using ATCC organisms on these dates when performing the weak light source check: January 11, 2021 BD BACTEC Peds Plus/F Culture Vials lot 0092360 expiration 01/31/2021 BD BACTEC Standard Aerobic/F culture vials lot 0195729 expiration 04/30/2021 BD BACTEC Standard Anaerobic/F culture vials lot 091273 expiration 05/31/2021 January 14, 2022 BD BACTEC Peds Plus/F Culture Vials lot 1202910 expiration 2022/05/31 BD BACTEC Standard Aerobic/F culture vials lot 1195582 expiration 2022/04/30 BD BACTEC Standard Anaerobic/F culture vials lot 1245599 expiration 2022/06/30 4. Review of patient records between January 1, 2021 and September 20,2022 indicated 408 blood cultures had been tested using the various media as described above without performing quality control procedures for each new lot and shipment of blood culture media used. 4. Interview of the general supervisor conducted on September 20, 2022 at 11:15 AM found that the laboratory had historically accepted the manufacturer's quality control certificate and had not performed end user quality control procedures for blood culture media, and does not document the condition of the media upon receipt. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of the Laboratory Personnel Report, personnel records and staff -- 2 of 4 -- interview, it was revealed that one of ten testing personnel performing high complexity testing did not have the appropriate education credentials. (refer to D6171) D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have -- 3 of 4 -- earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found the laboratory failed to ensure one of ten testing personnel listed on the CMS report 209 met the minimum education requirements to perform High complexity testing in Bacteriology. The findings included: 1. Review of the CMS report 209 Laboratory Personnel Report found the laboratory documented 10 individuals as testing personnel performing high complexity testing. 2. Review of personnel records found she was educated in the Phillipines with no evaluation of foreign education records available for review for testing person six ( hire date 11/23 /2018). 3. Interview of the general supervisor listed on the CMS report 209 Laboratory Personnel Report conducted September 21,2022 at 09:36 AM confirmed the laboratory did not have an evaluation of foreign education records to ensure the personnel met the minimum education requirements to perform high complexity testing. -- 4 of 4 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, patient reports, and interview, the laboratory failed to perform the gram stain for blood cultures in conjunction with the BioFire FilmArray Blood Culture Identification (BCID) Panel on the Biomerieux BioFire FilmArray 2.0 from May 13, 2021 to survey date, July 2, 2021. Findings follow. A. Review of the BioFire FilmArray BCID Panel Instruction Booklet, rev Feb 2021, under Summary and Explanation of the Test stated, "Sepsis (defined as system inflammatory response syndrome in response to infection) is the 11th leading cause of death in the United States. Life-threatening bacterial and fungal sepsis currently strikes approximately 240 out of 100,000 people per year in the U.S. (750,000 total cases) with severe sepsis (associated with acute organ dysfunction) in 95 out of 100,000 people. Timely diagnosis and administration of effective treatment can significantly reduce mortality, duration of hospital stays, and costs due to sepsis. The FilmArray Blood Culture Identification (BCID) Panel simultaneously tests a single positive blood culture sample to provide results for 24 different organisms and organism groups that cause bloodstream infections and thee genetic markers that are known to confer antimicrobial resistance. The test can be performed on blood culture bottles that are flagged as positive by continuously monitoring blood culture instrument. Results are intended to be interpreted in conjunction with Gram stain results." B. Review of patient test reports from June 2021 showed patient with MRN 101157 had a BCID ordered on 06/05/2021. One of 2 blood culture bottles drawn was positive. The BCID panel was performed and was reported on 06/08/2021 as none for 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 -- the organisms tested. Cultures were sent to the reference laboratory on 06/09/2021. On 06/11/2021 the gram stain was reported by the reference laboratory as gram positive cocci in pairs, chains observed. C. Interview with the Technical Consultant #1 on June 30, 2021 at 1040 hours acknowledged they were no longer performing gram stains because the laboratory dropped from high complexity to moderate complexity. Interview with the Technical Consultant #1 on July 2, 2021 at 1105 hours confirmed MRN 101157 had a BCID report of "none" testing negative for the 24 organisms in the panel but was found to have gram positive cocci on the test report from the reference laboratory. The facility's laboratory had stopped reporting the gram stain. Phone interview with Technical Consultant #1 on July 16, 2021 at 1415 hours confirmed 3 BCID panels were performed from May 13, 2021 - July 2, 2021 where the gram stain was not reported. KEY: MRN = Medical Record Number 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: I. Based on review of quality control results and interview, the laboratory failed to monitor over time the accuracy and precision of the test system for D-Dimer performed on the Triage Meter using the Triage Control Total 5 for 2 of 2 years reviewed. Findings follow. A. Review of quality control results showed mean and standard deviation (SD) were not calculated for the D-Dimer quality control results. B. Interview with the Technical Consultant on June 30, 2021 at 1540 hours confirmed statistical analysis was not performed on the D-Dimer quality control results. II. Based on review of quality control results and interview, the laboratory failed to monitor over time the accuracy and precision of blood gases performed on the Instrumentation Laboratory GEM Premier 3500 using GEM Calibration Valuation Product (CVP 1&2) for 2 of 2 years reviewed. Findings follow. A. Review of quality control results showed mean and standard deviation (SD) were not calculated for the blood gas quality control results. B. Interview with the Technical Consultant on July 1, 2021 at 1550 hours confirmed statistical analysis was not performed on the blood gas quality control results. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of Complete Blood Count (CBC) test records, correlation of test results and interview, the laboratory failed to correlate test results twice a year between the automated differential and manual differential for 2 of 2 years reviewed. Findings follow. A. Review of CBC test records showed the laboratory was performing automated differentials using the Beckman Coulter DXH600 and manual differentials. B. Correlation of test results was requested on June 29, 2021 at 1555 hours but not provided. C. Interview with the Technical Consultant on June 29, 2021 at 1555 hours confirmed they were not enrolled in proficiency testing for the manual differential, and a comparison between automated differentials and manual differentials were not performed. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview, the laboratory failed to include the test report date on the test reports for 10 of 10 test reports reviewed. Findings follow. A. Review of patient test reports MRN Collected Tested 42670 06/23/2021 HgbA1C, Cardiac panel, Lipid panel, UA, CMP, CBC, D-Dimer 104554 05/11/2021 Blood gases 36730 05/11/2021 Blood gases 106958 06/14/2021 CMP, Cardiac panel, TSH, CBC, PT, APTT, D-Dimer 317670 06/14/2021 UA 42670 06/23/2021 Urine drug screen 105695 06/17/2021 CMP, Lipid panel, TSH, PSA, CBC 101491 06/29 /2021 CMP, Lipid panel, TSH, PSA, CBC 12077 06/23/2021 CBC 103474 06/14 /2021 CMP, Mg, Cardiac panel, TSH, Procalcitonin, CBC showed no reported date for the various tests performed. B. Interview with the Technical Consultant on July 2, 2021 at 1345 hours confirmed the EMR test reports do not have the reported date and the test reports are used for outpatient services. KEY: MRN = Medical Record Number EMR = Electronic Medical Record D6085 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3) The laboratory director must ensure that the test methodologies selected have the capability of providing the quality of results required for patient care. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, patient reports, and interview, the Laboratory Director failed to ensure the gram stain was performed for blood cultures required for quality of patient care. See D5411. -- 3 of 3 --