Hot Springs County Memorial Hospital Laboratory

Summary Statement of Deficiencies D0000 A recertification survey was conducted at Hot Springs Health on 10/29/25 through 10 /30/25. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The laboratory was found out of compliance with the following condition: 42 CFR 493.1441, Laboratory Director; High Complexity D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 patient test reports, review of the VITROS XT 5600 analyzer manufacturer's instructions for use, review of the ImmunoCard STAT Crypto/Giardia Rapid Assay manufacturer's instructions, and staff interview, the laboratory failed to follow the manufacturer's instructions to include the prostate specific antigen (PSA) test assay method on 1 of 1 PSA patient test reports (patient #1) reviewed. In addition, the laboratory failed to follow the manufacturer's instructions to not use the Crypto /Giardia kit beyond the expiration date for 1 of 4 patient tests (patient #2) reviewed. The laboratory performed 484 PSA and 24 Crypto/Giardia patient tests annually. The findings were: 1. Review of the VITROS XT 5600 analyzer manufacturer's instructions stated "Different test methods cannot be used interchangeably. PSA results in a given patient sample determined with different tests and from different manufacturers can vary due to differences in test methods and reagent specificity. A change to a different method during serial monitoring of a patient should be accompanied by additional sequential testing to confirm baseline values. The results reported by the laboratory to the physician must include the identity of the PSA test used." Review of the VITROS XT 5600 new instrument verification study showed it 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 -- was approved by the laboratory director on 11/8/23. The following concerns were identified: a. Review of the test report for patient #1, dated 2/24/25, failed to include the PSA test methodology. b. Interview with the general supervisor on 10/30/25 at 3: 30 PM revealed she was unaware of the requirement. 2. Review of the ImmunoCardSTAT Crypto/Giardia Rapid Assay manufacturer's instructions showed under "Warnings and Precautions...2. Do not use kit beyond the printed expiration date." The following concerns were identified. a. Review of the laboratory's testing logs showed lot #08241412 had an expiration date of 8/31/25. Further review of the patient testing logs showed a Crypto/Giardia test was performed on patient #2 on 9/5 /25 using lot #08241412. b. Interview with the general supervisor on 10/30/25 at 9:15 AM confirmed the patient test was performed using an expired kit. D5455 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(v)(g) (d)(3)(v) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient testing logs, review of quality control (QC) records, lack of documentation, review of the laboratory's individualized quality control plan (IQCP), review of quality assurance documentation, and staff interview, the laboratory failed to perform two levels of control every 30 days for 1 of 9 test systems reviewed (Alethia Clostridium difficile DNA Amplification Assay test system) from 1 /1/25 through 9/30/25. The failure affected 4 patient tests performed between 7/15/25 and 7/21/25. The laboratory performed approximately 85 C. difficile patient tests per year. The findings were: 1. Review of the patient testing log and QC records for the Alethia C. difficile DNA Amplification Assay test system showed the following concerns: a. QC was performed on lot #480050T032 on 6/12/25 and not again until 7 /25/25. b. Patient testing was performed on 7/15/25, 7/16/25, 7/18/25, and 7/21/25. c. Review of the laboratory's C. difficile IQCP, last reviewed by the laboratory director on 4/23/25, showed QC was to be performed every 30 days, with a new lot number, or with a new shipment. 2. Interview with the general supervisor on 10/30/25 at 9:13 AM confirmed QC had not been completed within the 30-day timeframe as outlined in the IQCP. THIS IS A REPEAT DEFICIENCY, last cited on 7/21/21 and 6/27/23. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, the patient testing log, and the individualized quality control plan (IQCP), lack of documentation, review of quality -- 2 of 3 -- assurance documentation, and staff interview, the laboratory failed to have a system in place to correct identified problems related to control procedures. The findings were: 1. Review of the patient testing log and QC records for the Alethia C. difficile DNA Amplification Assay test system showed the following concerns: a. QC was performed on lot #480050T032 on 6/12/25 and not again until 7/25/25. b. Patient testing was performed on 7/15/25, 7/16/25, 7/18/25, and 7/21/25. c. Review of the laboratory's C. difficile IQCP, last reviewed by the laboratory director on 4/23/25, showed QC was to be performed every 30 days, with a new lot number, or with a new shipment. d. Review of the laboratory's quality assurance documentation showed a pre-analytic, analytic, and post-analytic random audit of patient testing was performed on a monthly basis; however, the documentation failed to show an ongoing audit was performed to ensure QC was performed as directed by the laboratory's IQCPs. e. Review of the CMS-2567 form the previous recertification surveys showed the laboratory was cited for failing to perform two levels of control every 30 days as directed by the IQCP on 7/21/21 and 6/27/23. 2. Interview with the general supervisor on 10/30/25 at 9:13 AM confirmed QC had not been completed within the 30-day timeframe as outlined in the IQCP. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of quality control records, the patient testing log, and the individualized quality control plan, lack of documentation, review of quality assurance documentation, and staff interview, the laboratory director failed to ensure an effective quality control program was maintained to assure the quality of laboratory services provided. Refer to D5445 and D5791. THIS IS A REPEAT DEFICIENCY, last cited on 7/21/21 and 6/27/23. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of quality control records, the patient testing log, and the individualized quality control plan, lack of documentation, and staff interview, the laboratory director failed to ensure a quality control and quality assessment program was established to assure the quality of laboratory services provided. Refer to D5445 and D5791. THIS IS A REPEAT DEFICIENCY, last cited on 7/21/21 and 6/27/23. -- 3 of 3 --

Summary Statement of Deficiencies 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 proficiency testing records, lack of documentation, and staff interview, the laboratory director failed to attest to the routine integration of the American Proficiency Institute (API) and the College of American Pathologists (CAP) proficiency tests into the patient workload for 9 of 23 proficiency testing events reviewed from August 2021 through June 2023. The findings were: 1. Review of the API and CAP proficiency testing records failed to include an attestation statement signed by the laboratory director for the following events: a. 2021 API microbiology event #2 b. 2021 API microbiology event #3 c. 2021 API miscellaneous chemistry event #2 d. 2022 API hematology/coagulation event #3 e. 2022 API immunohematology/immunology event #3 f. 2022 API microbiology event #3 g. 2022 API miscellaneous chemistry event #2 h. 2022 CAP blood gas event C i. 2023 CAP blood gas event A 2. Interview with the general supervisor and the technical supervisor on 6/27/23 at 8:35 AM confirmed the attestations statements for the proficiency testing events had not been signed by the laboratory director. THIS IS A REPEAT DEFICIENCY, last cited on 7/21/21 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or 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 -- examining specimens. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to have a written procedure for the Meridian ImmunoCard STAT test system for Shiga Toxin 1 and Shiga Toxin 2. The laboratory performed 8 patient tests for Shiga Toxin 1 and Shiga Toxin 2 from 1/1/23 through 5/31/23. The findings were: 1. Review of the laboratory's procedure manuals showed no evidence the laboratory had developed a policy and procedure for the Meridian ImmunoCard STAT test system for the detection of Shiga Toxin 1 and Shiga Toxin 2. 2. Interview with the general supervisor on 6/27/23 at 12:38 PM confirmed the laboratory did not have a written procedure for the Meridian ImmunoCard STAT test system for the detection of Shiga Toxin 1 and 2. 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 review of patient testing logs, review of quality control (QC) records, lack of documentation, review of the laboratory's individualized quality control plan (IQCP), and staff interview, the laboratory failed to perform two levels of control every 30 days for 2 of 4 test systems reviewed (AmniSure ROM used for detecting fetal membrane rupture, Bio-Rad Tox/See test system used for urine drugs of abuse screening). The failure affected 29 AmniSure patient tests and 18 Bio-Rad Tox/See patient urine drug screens. The findings were: 1. Review of the patient testing log and QC records for the AmniSure ROM test system showed the following concerns: a. QC was performed on lot #57901769 on 4/2/22 and on lot #57204165 on 4/2/23. b. 29 patient tests had been performed between 4/2/22 and 4/2/23. c. Review of the laboratory's AmniSure ROM IQCP, effective 8/2017 and last reviewed 6/27/23, showed QC was to be performed every 30 days or with the start of a new lot number. 2. Review of the patient testing log and QC records for the Bio-Rad Tox/See test system showed the following concerns: a. QC was performed on lot #0000625470 on 2 /5/23 and on lot #0000634313 on 3/29/23. b. 18 patient tests had been performed between 3/5/23 and 3/29/23. c. Review of the laboratory's Bio-Rad Tox/See IQCP, effective 8/2017 and last reviewed on 6/21/23, showed QC was to be performed every 30 days or with the start of a new lot number. 3. Interview with the general supervisor and the technical supervisor on 6/27/23 at 1:48 PM confirmed QC had not been performed as required. THIS IS A REPEAT DEFICIENCY, last cited on 7/21/21. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) -- 2 of 4 -- 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the quality control (QC) records and the patient testing log, and staff interview, the laboratory failed to perform two levels of QC each day of patient testing from 12/6/22 to 6/27/23 for 3 of 3 microbiology test kits reviewed (Meridian ImmunoCard STAT for Campylobacter, Meridian ImmunoCard STAT for Cryptosporidium and Giardia antigens, Meridian ImmunoCard STAT for Shiga Toxin 1 and Shiga Toxin 2). This failure affected 47 patient samples. The findings were: 1. Review of the QC and patient testing records for the Campylobacter test kit showed 18 patient tests were performed between 12/6/22 and 6/27/23 without QC being performed. 2. Review of the QC and patient testing records for the Cryptosporidium /Giardia test kit showed 21 patient tests were performed between 12/6/22 and 6/27/23 without QC being performed 3. Review of the QC and patient testing records for the Shiga Toxin 1 and 2 test system showed 8 patient tests were performed between 12/28 /22 and 6/27/23 without QC being performed. 4. Interview with the general supervisor and the technical supervisor on 6/27/23 at 1:48 PM confirmed QC had not been performed as required. THIS IS A REPEAT DEFICIENCY, last cited on 7/21/21 and 10/20/21. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency testing records, quality control records, the patient testing log, the individualized quality control plan, lack of documentation, and staff interview, the laboratory director failed to sign and date the American Proficiency Institute and the College of American Pathology proficiency testing attestation statements (D6089); and failed to ensure a quality control program was established to assure the quality of laboratory services provided (D6093). THIS IS A REPEAT DEFICIENCY, last cited on 7/21/21 and 10/20/21. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 proficiency testing records, lack of documentation, and staff interview, the laboratory director failed to attest to the routine integration of American Proficiency Institute and the College of American Pathologists proficiency tests into -- 3 of 4 -- the patient workload for 9 of 23 proficiency testing events reviewed from August 2021 through June 2023. Refer to D2009. THIS IS A REPEAT DEFICIENCY, last cited on 7/21/21 D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of quality control records, the patient testing log, and the individualized quality control plan, lack of documentation, and staff interview, the laboratory director failed to ensure a quality control program was established to assure the quality of laboratory services provided. Refer to D5445 and D5449. THIS IS A REPEAT DEFICIENCY, last cited on 10/20/21. -- 4 of 4 --

Summary Statement of Deficiencies D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, lack of documentation, review of the patient testing log, policy and procedure review, and staff interview, the technical supervisor failed to ensure a quality control program was established to assure the quality of laboratory services provided. The findings were: 1. Review of the QC records showed the laboratory performed a positive and a negative control for the Biofire respiratory panel 2.1 on 8/31/21, 9/1/21, 9/2/21, 9/3/21, 9/7/21, 9/9/21, 9/16 /21, 9/20/21, and 10/20/21. 2. Review of the patient testing log showed 27 respiratory panels and 225 SARS-CoV-2 patient tests had been performed between 8/30/21 and 10 /20/21. There was no evidence QC had been performed each day prior to patient testing for 18 of the respiratory panels and 164 of the SARS-CoV-2 tests performed during that timeframe. 3. Review of the BioFire Quality Control for Respiratory Panel 2.1 policy signed by the laboratory director on 9/17/21 showed "Respiratory Panel 2.1 QC, both positive and negative must be run every 30 days or when a new lot of cartridges is put into use...COVID-19 is part of this QC group and cannot be run by itself..." 4. There was no evidence an IQCP (individualized quality control plan) had been developed for the BioFire respiratory panel 2.1. 5. Telephone interview with the technical supervisor on 10/20/21 at 11:41 AM revealed she was unaware the laboratory was not performing QC on the BioFire respiratory panel every day prior to patient testing. The technical supervisor confirmed an IQCP had not been developed for the respiratory panel. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 proficiency testing records, lack of documentation, and staff interview, the laboratory director failed to attest to the routine integration of the American Proficiency Institute (API) proficiency tests into the patient workload for 19 of 19 proficiency testing events reviewed from January 2020 to July 2021. The findings were: 1. Review of the API proficiency testing records failed to include the attestation statements signed by the laboratory director for the following events: a. 2020 Core Chemistry event #1, #2, and #3. b. 2020 Hematology and Coagulation event #1, #2, and #3. c. 2020 Microbiology event #1, #2, and #3. d. 2020 Immunology event #1, #2, and #3. e. 2021 Miscellaneous Chemistry event #1. f. 2021 Microbiology event #1, and #2. g. 2021 Immunology event #1. h. 2021 Hematology and Coagulation event #1. i. 2021 Core Chemistry event #1, and #2. 2. Interview with the technical consultant on 7/21/21 at 5:15 PM revealed the laboratory director had not delegated his responsibility for signing the attestation statement, however a policy was currently being developed. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- This CONDITION is not met as evidenced by: Based on review of new instrument verification studies, review of quality control (QC) records, lack of documentation, review of patient testing logs, and staff interview, the laboratory failed to ensure the BioFire respiratory panel 2.1 was verified for accuracy prior to testing patient samples (D5421); and failed to ensure QC was performed each day of patient testing for the BioFire respiratory panel 2.1 (D5449). D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of new instrument verification studies, review of quality control (QC) records, lack of documentation, review of patient testing logs, and staff interview, the laboratory failed to ensure the BioFire respiratory panel 2.1 was verified for accuracy prior to testing patient samples (D5421); and failed to ensure QC was performed each day of patient testing for the BioFire respiratory panel 2.1 (D5449). D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, review of manufacturer's instructions, lack of documentation, review of the i-STAT Blood Gas Log, review of quality control (QC) records, review of the laboratory's individualized quality control plan (IQCP), review of patient testing logs, and staff interview, the laboratory failed to ensure reagents were not used beyond their expiration date (D5417); failed to ensure manufacturer's instructions were followed to perform function checks every 8 hours on the Abbott i-STAT instrument for blood gas analysis (D5431); failed to ensure calibration verification was performed on the Abbott i-STAT instrument every 6 months (D5439); and failed to ensure QC was performed as outlined in the IQCP for blood gas analysis (D5445). D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) -- 2 of 11 -- records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 12 of 19 testing events reviewed from January 2020 to July 2021. The findings were: 1. Review of the API proficiency testing reports failed to include documentation the laboratory had evaluated testing results. The following concerns were identified: a. Review of the 2020 Core Chemistry event #1 and #2 showed no documentation the laboratory director (LD) had reviewed the results. b. Review of the 2020 Hematology and Coagulation event #1 showed no documentation the LD had reviewed the results. c. Review of the 2020 Microbiology event #1, #2, and #3 showed no documentation the LD had reviewed the results. d. Review of the 2020 Immunology event #1, #2, and #3 showed no documentation the LD had reviewed the results. e. Review of the 2021 Miscellaneous Chemistry event #1 showed no documentation the LD had reviewed the results. f. Review of the 2021 Microbiology event #1 showed no documentation the LD had reviewed the results. g. Review of the 2021 Immunology event #1 showed no documentation the LD had reviewed the results. h. Review of the 2021 Core Chemistry event #1 and #2 showed no documentation the LD had reviewed the results. 2. Interview with the technical consultant on 7/21/21 at 5:15 PM revealed the laboratory director had not delegated his responsibility for reviewing PT results; however a policy was currently being developed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The findings were: 1. Review of the laboratory's procedure manuals showed no evidence a policy and procedure had been developed in regard to reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 2. Interview with the laboratory manager on 7/21/21 at 5:15 PM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 test results. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, review of the manufacturer's instructions, and staff interview, the laboratory failed to ensure the Abbott i-STAT CG4+ cartridges for performing blood gases (arterial and cord blood) pH, partial pressure of carbon dioxide, partial pressure of oxygen, and lactic acid tests were not used past their expiration date as the laboratory failed to record the date the cartridges were removed from refrigerated storage. In addition the laboratory failed to ensure blood collection tubes were not -- 3 of 11 -- used beyond their expiration date in 3 of 3 blood collections sites (blood collection room #1, blood collection room #2, and the mobile blood collection tray).The laboratory performed approximately 52 blood gases per year and approximately 487 immunohematology procedures per year. The findings were: Related to the Abbott i- STAT CG4+ cartridges; 1. Observation on 7/21/21 at 2:30 PM showed 6 CG4+ test cartridges (lot number D21080 with an expiration date of 11/18/21) were stored at room temperature next to the Abbott i-STAT analyzer. The test cartridges failed to include a revised expiration date for room temperature storage. 2. Review of the Abbott i-STAT manufacturer's instructions showed the expiration date for the CG4+ reagent cartridges changed from the printed expiration date to 14 days at room temperature. 3. Interview with the respiratory therapy director and the laboratory manager on 7/21/21 at 2:45 PM confirmed there was not a revised expiration date on the cartridges. THIS IS A REPEAT DEFICIENCY, previously cited on 8/27/19. Related to blood collection tubes: 1. Observation of blood collection room #1, blood collection room #2, and the mobile blood collection tray on 7/21/21 at 9:30 AM showed the following concerns: a. Blood collection room #1 showed 15 K2EDTA (used for immunohematology) blood collection tubes with an expiration date of 7/14 /21 were available for use. b. Blood collection room #2 showed 19 heparinized blood collection tubes with an expiration date of 7/1/21, 2 serum separator tubes with an expiration date of 7/11/21, and 5 K2EDTA tubes with an expiration date of 7/14/21 were available for use. c. The mobile blood collection tray showed 5 K2EDTA blood collection tubes with an expiration date of 7/14/21 were available for use. 2. Interview with phlebotomist #1 on 7/21/21 at 9:50 AM confirmed the blood collection tubes had expired and discarded them at that time. 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 the BioFire new instrumentation verification study and staff interview, the laboratory failed to verify accuracy for 21 of 22 tests included in the BioFire 2.1 respiratory panel (4 bacteria and 17 viruses). The findings were: 1. Review of the BioFire new instrumentation study, initiated on 11/30/20, showed precision studies for all the analytes and an accuracy study for SARS-CoV-2 had been completed, however an accuracy study had not been completed for the 4 bacteria and 17 remaining viruses. 2. Interview with the laboratory director on 7/21/21 at 11:15 AM revealed it was his understanding since the test method had been given an Emergency Use Authorization by the FDA, the verification study was not required. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with -- 4 of 11 -- at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of documentation, review of the laboratory's "i-STAT Blood Gas Log", review of the Abbott i-STAT operator's manual, and staff interview, the facility failed to follow the i-STAT manufacturer's instructions to perform a function check every 8 hours, as required, for blood gases for 7 of 7 months reviewed (1/1/21 through 7/19 /21). The laboratory tested approximately 52 blood gas samples per year. The findings were: 1. Review of the i-STAT Blood Gas Log showed no documentation the laboratory had verified the performance of the i-STAT instrument by using the internal or external Electronic Simulator every 8 hours. 2. Interview with the respiratory therapy director and the laboratory manager on 7/21/21 at 2:50 PM confirmed the laboratory did not perform the function checks as required. 3. Review of the Abbott i-STAT operator's manual showed "Verify the performance of each handheld in the i-Stat System using the internal or external Electronic Simulator every 24 hours of use, or as needed for regulatory compliance. In the USA, verification is required every 8 hours for blood gases, hematocrit..." 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 lack of documentation and staff interview, the laboratory failed to verify the reportable range at least every 6 months using testing materials with values at the zero or minimal level, the mid-level, and the upper-level of the reportable range for pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), and lactate analyzed on the Abbott i-STAT instrument for 2 of 2 years reviewed (2019, 2020). The laboratory performed approximately 52 blood gases per year. The findings were: 1. Review of the laboratory's records showed no documentation the laboratory had verified the reportable range every 6 months for pH, PO2, PCO2, and lactate on -- 5 of 11 -- the Abbott i-STAT instrument. 2. Interview with the technical consultant on 7/21/21 at 5:15 PM confirmed the reportable range had not been verified as required. 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 review of patient testing logs, review of quality control (QC) records, lack of documentation, review of the laboratory's individualized quality control plan (IQCP), and staff interview, the laboratory failed to perform two levels of control once a week for blood gas testing on the Abbott i-STAT instrument for 1 of 25 weeks reviewed. The failure affected 2 patient samples (#30041924 and #113715). The findings were: 1. Review of the QC records showed 2 levels of control were performed on 6/28/21 and again on 7/12/21. An arterial blood gas (ABG) was run on patient #30041924 on 7/6/21 (8 days after the last QC) and an ABG was run on patient #1137519 on 7/10/21 (12 days after the last QC). 2. Review of the laboratory's IQCP, last revised 9/15/18, showed "...external QC with each new lot number and weekly." 3. Interview with the technical consultant on 7/21/21 at 5:15 PM confirmed the QC had not been performed as required. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, review of the patient testing log, lack of documentation, and staff interview, the laboratory failed to perform two levels of QC each day of testing from 4/15/21 to 6/30/21 for the bioMerieux Biofire respiratory panel 2.1 which included 18 viruses (including SARs-CoV-2), and 4 bacteria. This failure affected 20 patient samples. The findings were: 1. Review of the QC records showed the laboratory performed a positive and a negative control for the Biofire respiratory panel 2.1 on 3/26/21, 4/28/21, 5/3/21, and 6/25/21. Review of the patient testing log showed patient samples were run on 4/15, 2 on 4/27, 4/29, 5/4, 5/6, 5/12, 5 /13, 6/2, 2 on 6/3, 6/4, 6/8, 6/15, 6/16, 6/19, 6/22, 2 on 6/24, and 6/30. There was no documentation a positive and negative control had been run on each day of patient testing. 2. Interview with the laboratory manager on 7/21/21 at 5:15 PM revealed it was his understanding since the test method had been given an Emergency Use -- 6 of 11 -- Authorization by the FDA a risk assessment for an Individualized Quality Control Plan was not necessary and the laboratory was only required to perform quality control once per lot number or shipment. The laboratory manager confirmed the laboratory had failed to perform positive and negative control materials each day of respiratory panel testing. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the CMS-209 Laboratory Personnel Report, review of personnel files, lack of documentation, and staff interview, the laboratory failed to ensure testing personnel were qualified to perform moderate complexity testing on the Abbott i- STAT analyzer (D6065) for 2 consecutive survey cycles (2019, 2021). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the CMS-209 Laboratory Personnel Report, review of personnel files, staff interview, and lack of documentation, the laboratory failed to ensure testing personnel had the appropriate education required prior to testing patient specimens for 2 of 3 testing personnel (#1, #2) that performed arterial and cord blood gas testing. The findings were; 1. Review of the CMS-209 Laboratory Personnel Report showed the laboratory employed 3 testing personnel that performed arterial and cord blood gas testing. Review of the laboratory's personnel files showed no evidence of the required qualifications for testing personnel (TP) #1 and TP #2. 2. Interview with the laboratory manager on 7/21/21 at 5:15 PM revealed the testing personnel were respiratory therapists which performed testing on the Abbott i-STAT analyzer. In addition the laboratory manager stated the hospital's human resource department did not require transcripts or a diploma upon hire. THIS IS A REPEAT DEFICIENCY, previously cited on 8/27/21. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 7 of 11 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the BioFire respiratory panel 2.1 verification documentation, lack of documentation, review of proficiency testing records, and staff interview, the laboratory director failed to ensure the test verification study was complete for the BioFire respiratory panel 2.1 (D5421); failed to sign the API proficiency testing attestation statements (D6089); and failed to review and evaluate proficiency testing results (D6091). D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the BioFire respiratory panel 2.1 test verification documentation, lack of documentation, and staff interview, the laboratory director failed to ensure the test verifications of accuracy, precision, analytic specificity, and analytic sensitivity was complete and met the laboratory's performance characteristics specified by the manufacturer. Refer to D5421. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 proficiency testing records, lack of documentation, and staff interview, the laboratory director failed to attest to the routine integration of American Proficiency Institute (API) proficiency tests into the patient workload for 19 of 19 proficiency testing events reviewed from January 2020 to July 2021. Refer to D2009. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on direct observation, reagent and manufacturer's instructions review, and interview with staff, the laboratory failed to record the open date expiration on test reagents removed from refrigerated storage to room temperature storage for iSTAT CD 4+ reagent cartridges for performing blood gas (arterial and cord blood) pH, partial pressure Carbon Dioxide, partial pressure Oxygen and lactic acid tests. The laboratory performed approximately 4 tests per week. Findings include: 1. Direct observation of two CD4+ test cartridges (lot number 191068 with an expiration date of 12/18/2019) at room temperature on 08/26/2019 at approximately 12:00 noon failed to include a revised expiration date for room temperature storage. 2. The i Stat reagent instructions included that room temperature storage altered the expiration date to 14 days after removal from refrigerated (2-8 degrees C) storage. The manufacturer's instructions also state the expiration date for CD4+ cartridges changed from the printed expiration date to 14 days at room temperature. 3. In an interview with testing personnel on 08/26/2019 at approximately 12:00 noon arterial blood gas testing personnel confirmed the test cartridges were not relabeled with the room temperature storage expiration dates. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on instrument manufacturer's preventive maintenance chart records review, lack of documentation, and interview with staff, the laboratory failed to document they performed daily and weekly maintenance at the frequency the manufacturer prescribed for two of two years reviewed for 5 of 7 instruments, (Dimension EXL, Sysmex xs1000i cell counter, CA 600 Coagulation, and Beckman Coulter Walk Away Microbiology instruments). Findings include: 1. Manufacturer's preventive maintenance records reviewed failed to include documentation the laboratory followed analyzer manufacturer's preventive maintenance instructions frequency for: A. Siemens EXL +LM chemistry analyser weekly preventive maintenance for the week of 06/05/2019 for patient #HSCMH01099142 tested on 06/05/2019; B. CA600 coagulation analyzer weekly preventive maintenance for 2 weeks (1 and 4) in February 2019 for patient HSCMH 01093447 on 02/08/2019 for prothrombin time and activated partial thrombin time tests and for the previous Stago instrument daily, weekly and monthly maintenance for 05/03/2017 for patient HSCMH01077879 for prothrombin time coagulation tests; C. Sysmex XS1000i blood cell counter weekly maintenance the week of 07/07/2019 for patient HSCMH01100535, daily and weekly preventive maintenance for patient HSCMH01093447 on 02/08/2019; and D. Beckmman coulter Walk Away Daily preventive maintenance was not performed on 01/23/2019 for ear culture HSCMH 01092679 and monthly preventive maintenance was not performed for June 2019 for patient # HSCMH01099282 wound culture collected on 06/08/2019 test reviewed. 2. In an interview with staff on 08/27/2019 at approximately 9:00 A.M. staff stated they had missed recording instrument maintenance in the past. . D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on patient test records review, lack of documentation, Individual Quality Control Plan review, and quality control records review, the laboratory failed to document they followed the Individual Quality Control Plan (IQCP) for 1 of 3 moderate complexity kits, serum pregnancy tests. The laboratory performed approximately 1 to 3 serum pregnancy tests per month. Findings include: 1. Patient test record review included documentation the laboratory performed a serum pregnancy test on 04/09/2018 for patient accession number 300336434 reporting a negative result for kit lot number hCG7030198. 2. The IQCP stated quality control for serum pregnancy tests included a positive and negative control is performed with each new test kit lot number. 3. Staff offered the quality control record log for documentation of quality control performance on 08/26/2019. 4. QC records review lacked documentation hCG serum quality control was performed since 0725/2017 for a different kit lot number and prior to or on 04/09/2018 for kit lot number hCG7030198. . -- 2 of 7 -- D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: . Based on patient test reports review, lack of documentation, and interview with staff, the laboratory failed to follow their procedure to immediately notify the individual requesting 1 of 2 critical value test reports reviewed. Findings include: 1. The laboratory reported a critical value of ".69 mg/L" (plus a "c" super script) for a D- Dimer assay for patient HSCMH01100761 on 07/11/2019 (normal range is 0.19 -0.59). 2. The laboratory report failed to include documentation the laboratory followed their policy to record the name of the individual they reported the result and date and time of the communication. 3. In an interview with staff on 08/27/2019 at approximately 8:15 A.M., staff stated the laboratory policy was to call critical values to the provider or unit were the patient was located and to document the report was communicated on the test report and the report did not include this information. . D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: . Based on proficiency testing records review, lack of documentation, and interview with staff, the blood gas technical consultant failed to ensure the laboratory enrolled in an approved proficiency testing program to ensure the laboratory received 2 of 6 blood gas proficiency testing events reviewed, the first testing events in 2018 and 2019. The laboratory tested approximately 4 specimens per month. Findings include: 1. Proficiency testing records review failed to include documentation the laboratory participated in the first College of American Pathologists (CAP) arterial blood gas proficiency testing program in 2018 and 2019 for blood pH, partial pressure carbon dioxide, partial pressure oxygen, and lactic acid. 2. In an interview with staff on 08/26 /2019 at approximately 12:30 P.M. staff stated the laboratory failed to enroll in the proficiency testing program in time to receive the first events of 2018 and 2019. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on competency evaluation reports review, lack of documentation, and interview with staff, the technical consultant failed to evaluate 1 of 1 new moderate -- 3 of 7 -- complexity testing personnel semi-annually from 2017 to 2019 for arterial and cord blood gas testing. Findings include: 1. The laboratory lacked competency evaluations for test person F from August 2017 to August 2019 for blood gas testing (initial testing date was not determined). 2. In an interview on 08/26/2019 at approximately 12:45 P.M. the blood gas lab manager stated he was unaware of competency evaluations for August 2017 through August 2019. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the general supervisor the technical consultant failed to evaluate one testing person performing arterial blood gas testing for two of two years of testing reviewed 2017 and 2018. Findings include: 1. The laboratory lacked documentation test person G was evaluated for arterial blood gas and cord blood venous pH and partial pressure test competency from August 2017 to August 2019. 2. In an interview with staff on 08/26/2019 at approximately 12:00 P. M. staff was asked for testing personnel competency evaluations. The competency evaluations were not produced by the survey exit at 9:45 A.M. on 08/27/2019. . D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on lack of documentation and interview with staff, 1 of 1 new testing person lacked documentation to qualify as a moderate complexity testing person for arterial and cord blood gas testing. (See D6065). . D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and -- 4 of 7 -- This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with staff, 1 of 1 testing person lacked documentation to qualify as a moderate complexity testing person to perform arterial and cord blood gas testing. Findings include: 1. Testing person F lacked documentation to qualify as a moderate complexity testing personnel in meeting the educational benchmark of a minimum of an high school diploma or equivalent. 2. In an interview with staff on 08/26/2019 at approximately 11:30 A.M. staff stated testing persons F did not have a copy of their diplomas or transcripts to qualify as moderate complexity testing personnel. . D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Based on competency evaluations review, lack of documentation, and interview with staff, the technical supervisor failed to evaluate 1 of 1 high complexity testing personnel annually in 2018 for blood bank, microbiology, and hematology abnormal cell identification testing. Findings include: 1. The laboratory lacked competency evaluations for test person B from August 2017 to August 2018. 2. In an interview on 08/26/2019 at approximately 12:45 P.M. the laboratory technical supervisor stated he was unaware of competency evaluation performance from August 2017 through August 2018 for test person B. . 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 lack of documentation and interview with staff, 3 of 3 testing personnel lacked documentation to qualify as high complexity testing personnel for blood bank, microbiology, and hematology testing. (See 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 -- 5 of 7 -- 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 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 documentation, CMS 209 personnel form and interview with staff, 3 of 3 testing personnel lacked documentation to qualify as high complexity testing personnel to perform abnormal differentials, microbiology identification and susceptibility testing, and compatibility testing. Findings include: 1. Testing personnel C, D, and E lacked documentation to qualify as high complexity testing personnel in -- 6 of 7 -- meeting the educational benchmarks of a minimum of an associates degree or equivalent in a laboratory science or medical laboratory technology. 2. In an interview with staff on 08/26/2019 at approximately 11:30 A.M. staff stated testing persons C, D, and E did not have a copy of their diplomas or transcripts to qualify as high complexity testing personnel. . -- 7 of 7 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --