Concord Hospital - Franklin

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to verify the accuracy of direct antiglobulin test (DAT) in 2023 and 2024. Findings include: 1. Review on 11/19/2024 of proficiency testing (PT) records from 2023 and 2024 revealed no PT enrollment for DAT. 2. Interview on 11/19/2024 with the Director of Lab Services at 12:15 a.m. confirmed the above finding and revealed the lab did not verify accuracy for DAT using other methods. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's (lab) bacteriology procedures were not approved, signed, and dated by the Laboratory Director in 2024. Findings include: 1. Review on 11/19/2024 of the lab's new procedures for Clostridium difficile (Cdiff); SARS-COV-2, Influenza A/B, and Respiratory Syncitial Virus (COV-2/Flu, RSV); SARS-CoV-2 (SARS-CoV-2 Plus); Methicillin Resistant Staphylococcus aureus and Staphylococcus aureus (MRSA/SA); Microorganisms Associated with Vaginitis and Bacterial Vaginosis Panel (MVP), revealed 4 (Cdiff, 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 -- COV-2/Flu/RSV, SARS-CoV-2 Plus, and MRSA/SA) of the 5 procedures were not signed and dated for approval by the Lab Director. 2. Interview on 11/19/2024 at 10: 00 a.m. with the microbiology Technical Supervisor confirmed the above finding and revealed testing for these procedures began September 8, 2024. 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 record review and staff interview, the laboratory (lab) failed to verify calibration every 6 months for 12 of 32 chemistry analytes performed in October 2024. Findings include: 1. Review on 11/19/2024 and 11/20/2024 of chemistry calibration verification records revealed calibration verification was performed for 32 chemistry analytes in April 2024. Further review revealed calibration verification performed in October 2024 failed to include 12 (chloride, direct bilirubin, creatinine, high density lipoprotein, iron, potassium, sodium, phosphorus, salicylate, total bilirubin, total iron binding capacity, and triglyceride) of the 32 chemistry analytes. 2. Interview on 11/20/2024 at 8:50 a.m. with Testing Personnel confirmed the above finding. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to obtain acceptable routine chemistry and endocrinology control results before reporting patient test results in 2024. Findings include: 1. Review on 11/20/2024 of control testing -- 2 of 3 -- performed in October 2024 for free thyroxine (FT4) and troponin revealed control failures for FT4 on 10/11/2024, 10/12/2024, 10/16/2024, and 10/18/2024 and control failures for Troponin on 10/11/2024 and 10/18/2024. 2. Review on 11/20/2024 of patient testing performed in October 2024 for FT4 and troponin revealed 3 patient test results had been reported before control testing failures had been resolved and found acceptable for FT4 on 10/16/2024 (1 patient) and 10/18/2024 (1 patient) and for troponin on 10/11/2024 (1 patient). 3. Interview on 11/20/2024 at 10:20 a.m. with the Chemistry Technical Supervisor confirmed the above findings. 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 record review and staff interview, the laboratory (lab) failed to perform comparison of test results for the i-STAT and Vista Dimension 500 chemistry instruments twice in 2023 and 2024. Findings include: 1. Review on 11/20/2024 of comparison studies between the i-STAT and Vista Dimension 500 revealed the last comparison study for i-STAT Chem8+ analytes (sodium, potassium, chloride, total carbon dioxide, glucose, blood urea nitrogen, and creatinine) performed on the Vista had last been performed in August 2023. There was no documentation of a second comparison for these analytes in 2023 and no documentation for any comparison done in 2024. 2. Interview on 11/20/2024 at 11:00 a.m. with Testing Personnel confirmed comparison studies had been performed 1 time in 2023 and not at all in 2024. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor failed to document semi-annual competency assessments for 1 of 2 new testing personnel in 2024. Findings include: 1. Review on 11/19/2024 of personnel records revealed 1 (TP1) of 2 new testing personnel failed to include documentation of a second semi- annual competency assessment in the first year. TP1 was hired 3/21/2023 and trained by the end of April 2023. TP1 had a semi-annual competency assessment for chemistry, hematology and immunohematology in October 2023 and for microbiology in November 2023. There was no documentation of a second competency assessment, due by April 2024, for TP1. 2. Interview on 11/19/2024 at 10:45 a.m. with the microbiology Technical Consultant confirmed the above finding. -- 3 of 3 --

Summary Statement of Deficiencies D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to perform control testing for Prothrombin Time (PT/INR) every 8 hours of patient testing in 2022. Findings include: 1. Review on 12/9/2022 of PT/INR control testing from 9/1 /22 to 12/9/22 revealed the lab performed control testing on 10/27/2022 at 4:15 p.m. and then on 10/28/2022 at 11:25 a.m. 2. Review on 12/9/2022 of PT/INR patient testing on 10/27/2022 and 10/28/2022 revealed one patient PT/INR test had been performed and reported on 10/28/2022 at 9:49 a.m. 3. Interview on 12/9/2022 at 10:30 a.m. with Testing Personnel (TP1) confirmed the above findings. Testing Personnel revealed the lab's quality assurance procedures includes review of third shift patient and control testing but does not review coagulation control testing from 1st and 2nd shifts to verify control testing was performed every 8 hours of operation before patient testing. 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 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 -- 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 record review and staff interview, the laboratory (lab) failed to report methemoglobin test results within the lab's reportable range in 2022. Findings include: 1. Review on 12/9/2022 of patient blood gas test records from December 2022 revealed on 12/8/2022 1 patient methemoglobin test result was reported as -0.3% (negative 0.3%) 2. Review on 12/9/2022 of the lab's reportable range for methemoglobin revealed a range of 0.0 to 29.5%. 3. Interview on 12/9/2022 at 12:00 with the Lab Manager confirmed the above findings. 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 record review and staff interview, two of five new laboratory testing personnel reviewed failed to meet education qualification requirements for high complexity 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 -- 2 of 3 -- 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 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 record review and staff interview, two of five new laboratory testing personnel reviewed failed to meet education qualification requirements for high complexity testing. Findings include: 1. Review on 12/8/2022 of five new personnel records revealed two traveling testing personnel (TP2, and TP3) obtained their degrees in the Philippines. The laboratory could not provide documentation that an education assessment of equivalency had been performed for TP2 and TP3. Further review of TP2 and TP3's records revealed they were trained and performing high and moderate complexity testing. 2. Interview on 12/9/2022 at approximately 1:00 p.m. with the Laboratory Manager confirmed the above finding. -- 3 of 3 --

Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to perform calibration verifications procedures every six months in 2020 for routine chemistry and toxicology analytes. Findings include: 1) Review on 12/7/2020 of the laboratory calibration verification records for the Siemens Vista 500 (Vista) analyzer revealed the most recent calibration verification was performed in January 2020. Further review of the calibration verification records revealed calibration verification is 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 -- required for the following (less than 3 calibration standards documented on the analyte list): acetaminophen, albumin, alkaline phosphatase, alanine aminotransferase, ammonia, amylase, aspartate aminotransferase, blood urea nitrogen, calcium, cholesterol, creatine kinase, carbon dioxide, creatinine, director bilirubin, ethanol, glucose, high-density lipoprotein, iron, lactate, lipase, magnesium, phosphate, prealbumin, salycilates, total bilirubin, total iron binding capacity, total protein, triglycerides, and uric acid. 2) Interview on 12/7/2020 at approximately 9:30 a.m. with the technical supervisor (TS1) confirmed calibration verification procedures for the Vista analyzer had not been performed since January 2020. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)