Neosho Memorial Regional Medical Center

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the review of the Quality Assurance (QA) plan and Blood Bank policies, lack of post analytical review documentation, review of patients' Electronic Medical Records (EMR) or electronic health record and interview, the laboratory failed to perform post analytical quality assessment to ensure the accurate transfer of patient test information for emergency release of blood and transfusion reactions into the patients' EMR or patient's electronic health record since March 1, 2022 at time of survey. Findings: 1. Review of the "Quality Assurance Plan" and Blood Bank policies revealed no process to ensure nine completed written Emergency Release forms were placed into the patient's EMR or electronic health record. a. A total of fourteen O negative units of red packed cells were emergency released to patients with written Emergency Release forms not entered in the patients' EMR or electronic health record since March 1, 2022. b. There were nine patients receiving blood components with written Emergency Release forms not entered into the patients' EMR or electronic health record since March 1, 2022. 2. Review of the "Quality Assurance Plan" and Blood Bank policies revealed no process to ensure completed written suspected "Transfusion Reaction Investigation" forms were placed into the patient's EMR or electronic health record. a. There are five written pages involved in the "Transfusion Reaction Investigation" form that are completed by nursing, laboratory, physicians, and the pathologist that are not placed in the patient's EMR or electronic health record since March 1, 2022. b. A total of five patients had suspected transfusion reactions with the written "Transfusion Reaction Investigation" forms not entered in the patient's EMR or electronic health record since March 1, 2022. 3. Interview with 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 -- Technical Consultant #3 on February 7, 2024, at 2:00 p.m. confirmed, the laboratory failed to perform post analytical quality assessment to ensure the accurate transfer of patient test information. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of Siemens BFT ll coagulation back up instrument procedure and interview with the technical supervisor on October 5,2018 at 12:30 PM confirmed the laboratory failed to have a procedure with approved reference intervals (normal values) for the BFT ll. 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 for the Roche Accu-Chek Inform ll glucose meter and interview with the technical supervisor, the laboratory director failed to ensure the test methodology for point of care glucose testing had the capability of providing quality results on critically ill patients and neonatal use. Findings: 1. Review of the Roche Accu-Chek Inform ll manufacturer's instructions 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 -- revealed "the performance of this meter has not been evaluated on critically ill patients. This system is also not for neonatal use." 2. No documentation was available to show the laboratory verified performance specifications for off-label (modified) use of the Accu-Chek meters for critically ill patients and neonatal use. 3. Interview with the technical supervisor on October 5, 2018 at 12:30 PM confirmed the laboratory uses the Accu-Chek meter for critically ill patients, neonatal use and confirmed the laboratory did not have documentation to show verification of performance specifications for modified use of the Accu-Check meter on critically ill patients and neonatal patients. Interviews confirmed the director failed to ensure the test methodology provided accurate glucose results for critically ill patients and neonatal use. 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 review of personnel records and interview with the technical supervisor confirmed the laboratory failed to have academic qualifications for 32 of 32 testing personnel performing high complexity point of care glucose testing (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 -- 2 of 3 -- 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 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: Based on lack of academic credentials and interview with the technical supervisor, the laboratory failed to provide academic credentials to qualify 32 of 32 testing personnel performing high complexity point of care glucose testing. 1. The laboratory did not have documentation (academic credentials) to show 32 testing personnel were qualified to perform high complexity point of care glucose testing. 2. Interview with the technical supervisor on October 5, 2018 at 12:30 PM confirmed the documents needed to qualify testing personnel were not available for review on day of survey. -- 3 of 3 --