Northeastern Health System-Sequoyah

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/14,15,16/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer, technical consultant, chief medical technologist, and director of respiratory during an exit conference performed at the conclusion of the survey. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, nursing policy, and interview with the technical consultant, the facility failed to ensure written policies were followed for preventing transfusion reactions for four of five units of packed red-blood cells transfused. Findings include: (1) On 10/15/2024 at 03:30 pm, the technical consultant stated blood transfusions were performed by nursing staff; (2) On 10/16/2024, a review of the hospital policy titled, "Blood/Blood Components - Transfusions" stated, "Vital signs (blood pressure, pulse, and temperature) shall be obtained and documented on the Transfusion Record": (a) "Prior to transfusion" (b) "Every 5 minutes x 3 upon initiation of the transfusion, every 30 x 2 after infusion begins, then hourly thereafter" (c) "Upon completion of the transfusion" (3) A review of transfusion records for five units transfused, identified the policy had not been followed for four of the five units as follows: (a) Unit #W091023261828 - The transfusion started at 04:52 pm. Vital signs had not been taken as follows: (i) Five Minute Vital Signs - Not taken between 04:57 pm and 05:07 pm (ii) 15 Minute Vital signs - Not taken between 05:07 pm and 05:22 pm (b) Unit #W091023259475 - The transfusion started at 06:32 pm. Vital 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 -- signs had not been taken as follows: (i) Five Minute Vital Signs - Not taken between 06:34 pm and 06:44 pm (ii) 15 Minute Vital Signs - Not taken between 06:44 pm and 06:59 pm (c) Unit #W091024316685 - The transfusion started at 10:40 am. Vital signs had not been taken as follows: (i) Five minute vital Signs - not taken between 10:45 am and 10:55 am (ii) 15 Minute Vital Signs -not taken between 10:55 am and 11:10 am (iii) 30 Minute Vital Signs -not taken between 11:40 am and 12:40 pm (d) Unit #W091024288851 - The transfusion started at 12:25 pm. Vital signs had not been taken as follows: (i) Five Minute Vital Signs - Not taken between 12:30 pm and 12:40 pm (ii) 15 Minute Vital Signs - Not taken between 12:40 pm and 12:55 pm (iii) 30 minute Vital Signs - Not taken between 01:25 pm and 02:25 pm (4) The records were reviewed with the technical consultant who stated on 10/16/2024 at 09:55 am , the vital signs had not been documented according to policy. 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 a review of policies and procedures and interview with the technical consultant, the laboratory failed to have a written procedure that explained the current practices and procedures for one of six procedures reviewed. Findings include: (1) On 10/14/2024 at 12:35 pm, the technical consultant and chief medical technologist stated the laboratory began using the Sysmex XN-550 analyzer to perform CBC (Complete Blood Count) testing on 01/12/2024; (2) A review of the Hematology procedure titled "General Hematology", identified the procedure was for the Sysmex XS-1000i analyzer instead of the Sysmex XN-550 analyzer; (3) The findings were reviewed with the technical consultant, who stated on 10/16/2024 at 10:00 am, the CBC procedure had not been revised to include the Sysmex XN-550. 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 a review of written procedures and interview with the technical consultant, the laboratory failed to ensure one of six procedures had been approved, signed, and dated by the current laboratory director. Findings include: (1) On 10/14/2024 at 12:45 pm, the technical consultant stated the laboratory performed Troponin I testing using the iSTAT-1 analyzer (SN 316043) and the cTnI cartridge; (2) A review of the Troponin procedure identified no evidence it had been approved, signed, and dated by the current laboratory director; (3) The findings were reviewed with the technical consultant who stated on 10/14/2024 at 2:35 pm, the procedure had not been signed and dated by the current laboratory director. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 2 of 4 -- CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant and chief medical technologist, the laboratory failed to label three of three containers with the identity, expiration date, and lot number of the contents. Findings include: (1) On 10/14/2024 at 12:35 pm, the technical consultant and chief medical technologist stated the laboratory stained peripheral blood smears to perform manual differential testing; (2) Observation on 10/14/2024 at 12:35 pm identified three unlabeled Copeland jars, appearing to contain materials used to stain peripheral blood smears; (3) The findings were reviewed with the technical consultant and chief medical technologist who on 10 /14/2024 at 12:40 pm stated the Copeland jars contained staining materials had not been labeled with the identity, expiration date, and lot numbers. 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 least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for two of two analyzers. Findings include: ACL ELITE (1) On 10/14/2024 at 12:35 pm, the technical consultant stated PT/INR, PTT, and D-Dimer testing were performed using the ACL Elite coagulation analyzer; (2) A review of the "ACL Elite Pro System Operator Manual", Section 5.2 - Maintenance Procedures, showed the following required maintenances: (a) Biweekly - Reboot analyzer, Rotor Holder and Optical Path Cleaning Procedure (b) Monthly - Checking and cleaning the air filter (3) A review of maintenance logs from January 2024 through September 2024 identified maintenance had not been documented as performed as follows: (a) Biweekly: (i) Between 04/16 /2024 and 05/14/2024 (b) Monthly: (i) Between 05/22/2024 and 07/17/2024 (ii) Between 07/17/2024 and 09/11/2024 (4) The records were reviewed with the technical consultant who stated on 10/15/2024 at 04:00 pm, maintenance procedures had not been documented as performed as stated above. ROCHE COBAS 6000 Findings include: (1) On 10/14/2024 at 10:40 am, the technical consultant stated the following: (a) Routine chemistry and immunoassay testing were performed using Roche Cobas 6000 modular analyzer; (b) The Cobas 6000 analyzer consisted of the sampling unit, c 501 (performed the routine chemistry testing), and e 601 (performed the immunoassay testing) modules. (2) On 10/15/2024, a review of the manufacturer's maintenance logs identified the following required maintenance procedures: (a) 6000 Sampling Unit: (i) Weekly: Perform system power off, and performed system power on (ii) Monthly: Clean rack sampler unit filter, Clean/Inspect DI water tank (b) c 501 -- 3 of 4 -- Module: (i) Weekly: Clean cell covers, Rinse stations, IS bath, and perform weekly pipe (ii) Monthly: Clean incubation water bath, KCl aspiration filter, Detergent aspiration filters, Circuit board rack filter, Power supply filter, Radiator filter, and replace Reaction cells (iii) Two months: Replace ISE measuring cartridges (c) e 601 Module (i) Weekly: Clean PC/CC reservoir fill nozzles, PC/CC reservoir positions, PreClean mixer, Preclean separation stations, incubator, AssayCup vortex mixer, Rinse stations, Replace PCC reservoirs, and Perform Monday Pipe (3) A review of maintenance logs from March 2024 through August 2024 identified maintenance had not been documented as performed for the following: (a) 6000 Sampling Unit (i) Weekly: Between 05/26/2024 and 06/09/2024 (ii) Monthly: Between 05/21/2024 and 07/29/2024 (b) c 501 Module (i) Weekly: Between 05/26/2024 and 06/09/2024 (ii) Monthly: Between 05/31/2024 and 07/29/2024 (iii) Every two months: Between 05/21 /2024 and 08/11/2024 (c) e 601 Module (i) Weekly: Between 05/26/2024 and 06/09 /2024 (4) The records were reviewed with the technical consultant who stated on 10/16 /2024 at 11:18 am, the required maintenance had not been documented as performed as shown above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, and Performance Summary and Comparative Evaluations obtained from American Proficiency Institute, the laboratory failed to successfully participate in a 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 -- proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance in three of four consecutive testing events for HCG (Human Chorionic Gonadotropin). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the Performance Summary and Comparative Evaluations obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte HCG (Human Chorionic Gonadotropin) in three of four consecutive testing events. Findings include: (1) The laboratory received the following scores: (a) 40% on the second 2023 event (b) 40% on the third 2023 event (c) 40% on the second 2024 event D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the Performance Summary and Comparative Evaluations obtained from American Proficiency Institute, the laboratory demonstrated non-initial unsuccessful participation for the analyte HCG (Human Chorionic Gonadotropin) in three of four consecutive events. The laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the Performance Summary and Comparative Evaluations obtained from American Proficiency Institute, the laboratory demonstrated non-initial unsuccessful -- 2 of 3 -- participation for the analyte HCG (Human Chorionic Gonadotropin) in three of four consecutive testing events. The laboratory director failed to ensure successful participation in an HHS Approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1403; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the second and third 2023 events, the laboratory failed to 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 -- successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte HCG (Human Chorionic Gonadotropin). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte HCG (Human Chorionic Gonadotropin) in two consecutive testing events. Findings include: (1) The laboratory received a score of 40% on the second 2023 event and a score of 40% on the third 2023 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte HCG (Human Chorionic Gonadotropin) in two consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2023 event and third 2023 event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte HCG (Human Chorionic Gonadotropin) in two consecutive events. The -- 2 of 3 -- laboratory failed to achieve a passing score of 80% for the second 2023 event and third 2023 event. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/17,18,19/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the administrator, laboratory director, cardiopulmonary director, technical consultant, and chief medical technologist during an exit conference performed at the conclusion of the survey. 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 a review of written policies and procedures, and interview with the technical consultant, the laboratory failed to have a written procedure for Manual Differential testing. Findings include: (1) On 10/17/2022 at at 09:40 am, the technical consultant stated Manual Differential testing was performed in the laboratory; (2) On 10/18 /2022, a review of the Hematology procedure manual identified no evidence of a written procedure for Manual Differential testing; (3) The manual was reviewed with the technical consultant who stated on 10/19/2022 at 09:55 am, the laboratory did not have a written procedure for performing manual differentials. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as 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 -- determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for verifying automated differential flags for two of 20 records; and failed to follow the manufacturer's implementation instructions for verifying the normal reference range for one of one new analyte reviewed. Findings include: AUTOMATED DIFFERENTIAL FLAGS (1) On 10/17/2022 at 09:40 am, the technical consultant stated CBC (Complete Blood Count) testing was performed on the Sysmex XS 1000i analyzer; (2) On 10/18/2022, a review of the manufacturer's instructions for verifying automated differential flags stated: (a) Immature Gran? - "Perform smear review send for further testing if present" (3) The surveyor randomly reviewed 20 patient CBC records, containing flags for testing performed during March and August 2022. For two of the records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the flag as follows: (a) Record #1 - Testing was performed on 03/29/2022 at 03:50 pm, with an Immature Gran? flag obtained. The result of the smear review stated "4 seen" next to the flag. There was no documentation the sample had been sent for further testing; (b) Record #2 - Testing was performed on 8/21/22 at 06:39 am, with an Immature Gran? flag obtained. The result of the smear review stated "4 seen" next to the flag. There was no documentation the sample had been sent for further testing. (4) The records were reviewed with the technical consultant who stated on 10/19/2022 at 09:40 am the patient samples had not been sent for further testing as shown above. IMPLEMENTING COAGULATION ANALYZER (1) On 10 /17/2022 at 09:45 am, the technical consultant stated the laboratory began using the ACL Elite analyzer to perform PT (Prothrombin Time) testing in May 2022; (2) On 10 /18/2022, a review of the manufacturer's implementation instructions under "Normal Reference Interval" stated to use a "minimum of 20 normal donors screened per lab policy". A review of the laboratory policy required using equal numbers of males and females of varying ages and include diseases/treatments; (3) A review of the records for the verification of the normal reference range identified the laboratory had not followed the manufacturer's instructions as follows: (a) 38 donors had been used which included 21 males, five females, and 12 did not specify whether the donor was male or female; (b) There was no documentation of the donor's medication or health history. (4) The records were reviewed with the technical consultant who stated on 1018/2022 at 02:54 pm the laboratory had not followed the manufacturer's instructions for verifying the normal reference range. 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 a review of records and interview with the technical consultant, the -- 2 of 4 -- laboratory failed to ensure the reportable range had been demonstrated for one of two new test methods. Findings include: (1) On 10/18/2022 at 10:50 am, the technical consultant stated the laboratory began performing PT/INR (Prothrombin Time /International Normalized Ratio) testing using the iSTAT 1 analyzer and the PT/INR cartridge on 03/12/2022; (2) A review of performance specification records identified no documentation to prove the laboratory had demonstrated the reportable range; (3) The findings were reviewed with the technical consultant who stated on 10/18/22 at 10:52 am, the laboratory had not demonstrated the reportable range. 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 a review of records and interview with the technical consultant, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different test methods for one of one analyte. Findings include: (1) On 10/17/2022 at at 09:47 am, the technical consultant stated Troponin I testing was performed using two methods: (a) Ortho Vitros 5600 analyzer as the primary method; (b) iSTAT 1 analyzer and the cTnIas the back-up method. (2) On 10/19/2021, a review of records from June 2022 through the current date identified the relationship between the different test methods had been evaluated on 07/09/2021; (3) Interview with the technical consultant on 10/19/2022 at 11:07 am confirmed the relationship between the test methods had not been evaluated since 07/09/2021. 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP for one of one test system. Findings include: (1) On 10/17/22 at 11:50 am, the technical consultanat stated the following: (a) Troponin I testing was performed using the iSTAT 1 analyzer and the cTnI cartridge as a backup method to the Ortho Vitros 5600 analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) A review of the IQCP identified that QA (Quality Assessment) reviews of the QCP (Quality Control Plan) were to be performed on an annual basis; (3) A review of records for the test systems for 2021 and to date in 2022 revealed the IQCP had been approved on 10/16/2018. There was no documentation -- 3 of 4 -- QA reviews had been performed during 2021 and to date in 2022; (4) The records were reviewed with the technical consultant who stated on 10/18/2022 at 10:36 am annual QA reviews had not been documented as performed as stated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A complaint survey was performed on 10/22/2021 (State Complaint OK00057845). The findings were reviewed with the director of operations, director of ancillary services, and the hospital administrator, available by phone, at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.801; D2000: Enrollment and Testing of Samples 493.1403; D6000: Laboratory Director D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of records, policies and procedures, phone call and email received from laboratory director on 09/14/2021, and interview with the hospital administrative manager, director of operations, director of ancillary services, and interim laboratory manager, the laboratory failed to follow Subpart H for Lipase testing for one of three events in 2021. Findings include: (1) The laboratory referred Lipase proficiency testing samples to another laboratory for testing for one of three events in 2021. Refer to D2013. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, phone call and email received from laboratory director on 09/14/2021, and interview with the hospital administrative manager, director of operations, director of ancillary services, and interim laboratory manager, the laboratory referred Lipase proficiency testing samples to another laboratory for testing for one of three events in 2021. Findings include: (1) On 09/14 /2021, the laboratory director contacted the Oklahoma State Agency to self-report proficiency testing referral for the analyte Lipase for the third 2021 event and provided the following information: (a) A testing person had referred Lipase proficiency testing samples to a sister facility - Eastern Oklahoma Medical Center in Poteau, OK (37D0476010) on 09/13/2021. The samples had been sent prior to the proficiency testing provider, API (American Proficiency Institute) submission cut-off date of 09/15/2021; (b) When the laboratory discovered the samples had been referred to the sister facility, the laboratory did not submit their results to API and reported the laboratory had a testing problem instead; (c)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/17/2020 and 12/18/2020. The findings were reviewed with technical consultant #1, technical consultant #2, cardiopulmonary director, director of nursing, and hospital administrator at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1447; D6108: Technical Supervisor D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure attestation statements were signed by the laboratory director or designee for 3 of 18 events. Findings include: (1) On 12/17/2020, the surveyor reviewed 2019 and 2020 proficiency testing records, with the following identified: (a) First 2020 Chemistry Core Event - The attestation statement had not been signed by the laboratory director or designee; (b) First 2020 Chemistry Miscellaneous Event - The attestation statement had not been signed by the laboratory director or designee; (c) Second 2020 Immunohematology Event - The attestation statement had not been signed by the laboratory director or designee. (2) The surveyor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- reviewed the records with technical consultant #1, who stated on 12/17/2020 at 01:15 pm the attestation statements had not been signed by the laboratory director as indicated above. 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 a review of records and interview with technical consultant #1, the laboratory failed to review and evaluate proficiency testing results for 2 of 18 events. Findings include: BIAS (1) On 12/17/2020, the surveyor reviewed 2019 and 2020 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2019 Hematology Event (i) MCV (Mean Corpuscular Volume) - 5 of 5 results exhibited a negative bias (aa) Sample XE-01- SDI of -2.1 (bb) Sample XE-02 - SDI of -2.0 (cc) Sample XE-03 - SDI of -2.1 (dd) Sample XE-04 - SDI of -2.5 (ee) Sample XE-05 - SDI of -2.1 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with technical consultant #1. Technical consultant #1 stated on 12/17/2020 at 01:10 pm the biases had not been addressed. FAILURES (1) On 12/17 /2020, the surveyor reviewed 2019 and 2020 proficiency testing records and identified the following failure: (a) Second 2020 Chemistry Core Event (i) Cholesterol - The laboratory failed the result for 1 of 5 samples (CH-08). (2) The surveyor could not locate evidence in the records proving the failure had been addressed; (3) The surveyor reviewed the records with technical consultant #1, and asked if

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/23,24,25,26/18. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant The findings were reviewed with the administrator, vice- president of clinical systems, cardiopulmonary director, and laboratory manager during an exit conference performed at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant #1, the laboratory failed to perform a technical consultant competency based on the position responsibilities as listed in Subpart M. Findings include: (1) On the first day of the survey, the surveyor reviewed reviewed personnel records for competency assessments performed during 2017 and 2018. There was no evidence a technical consultant competency for technical consultant #2, based on their job responsibilities, had been performed; (2) The surveyor asked the laboratory manager and technical consultant #1 if a technical consultant competency based on job responsibilities had been performed for technical consultant #2. The laboratory manager and technical consultant #1 stated a technical consultant competency based on job responsibilities had not been performed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant #1, the laboratory failed to review and evaluate proficiency testing results. Findings include: BIASES (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Third 2017 Chemistry Core Event (i) Potassium - 3 of 5 results exhibited a negative bias (aa) Sample CH-11 - SDI of -2.2 (bb) Sample CH-13 - SDI of -2.2 (cc) Sample CH-14 - SDI of -2.2 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the laboratory manager and technical consultant #1 who stated the biases had not been addressed. FAILURES (1) During the review of proficiency testing records, the surveyor identified the following failure in which there was no evidence of

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for Compatbility Testing. Refer to D2179 and D2181. 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 -- D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the first event in 2017 and the third event in 2017. Refer to D2181. NOTE: The only acceptable