Okeene Municipal Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/22,23,24,25/2025. The laboratory was found out of compliance with the following CLIA Conditions: 493.1213; D5022: Toxicology, High Complexity 493.1441; D6076: Laboratory Director, High Complexity The findings were reviewed with the laboratory director, testing person #1, and finance manager 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 testing person #1 and chief nursing officer, the facility failed to ensure written policies were followed for preventing transfusion reactions for one of two units of packed red-blood cells transfused. Findings include: (1) On 02/24/2025 at 04:00 pm, testing person #1 and testing person #2 stated blood transfusions were performed by nursing staff; (2) A review of the hospital policy titled, "Blood Administration, Blood Product Administration, Reaction Symptoms, Documentation, Consents/Refusals, and COVID 19 Convalescent Plasma Administration" under section B "Transfusion Procedures (PRBC, Whole Blood)" stated the following: (a) "Obtain base line vital signs and place on Vital signs flowsheet in EPIC"; (b) "Vital signs will be taken every 10 minutes during the first 30 minutes of infusion watching for transfusion reaction symptoms"; (c) "After the first 30 minutes, the patient should be assessed frequently and vital signs taken every 30 minutes and documented on the vital signs flowsheet in EPIC for the duration of the transfusion." (3) A review of transfusion records for two 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 -- units transfused, identified the policy had not been followed for taking vitals for one of two units transfused as follows: (a) Unit #W090124373845 - The transfusion began on 01/04/2025 at 04:36 pm and was completed on 01/04/2025 at 07:02 pm: (i) Vitals every ten minutes for the first 30 minutes - There was no documentation 10-minute vitals had been taken between 04:36 and 04:59 pm; (ii) Vitals Every 30 Minutes for the duration of the transfusion - There was no documentation vitals had been taken between 06:01 and 07:02 pm. (4) The findings were reviewed with the chief nursing officer who stated on 04/24/2025 at 04:35 pm, the vital signs had not been documented according to policy. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, urine drug screen package inserts, FDA database, email correspondence with FDA representative, and interview with the laboratory director and testing person #1, the laboratory failed to ensure the requirements were met for the subspecialty of toxicology for five of five months of patient testing. Findings include: (1) The laboratory failed to verify the accuracy for the Clearrapids Drug Test Card -12 Panel Drug Test Card at least twice annually. Refer to D5217; (2) The laboratory failed to establish the performance specifications for the Clearrapids Drug Test Card -12 Panel Drug Test Card not cleared or approved by the FDA. Refer to D5423; (3) The laboratory failed to perform a negative and positive control material each day of patient urine drug screen testing. Refer to D5449. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and testing person #1, the laboratory failed to verify the accuracy for one of one test method at least twice annually during the review period of November 2024 through the current date. Findings include: (1) On 04/22/2025 at 02:45 pm, testing person #1 stated the laboratory performed urine drug screen testing using the Clearrapids Drug Test Card -12 Panel Drug Test Card which included the following analytes; (a) Amphetamine (AMP) (b) Barbiturates (BAR) (c) Buprenorphine (d) Benzodiazepines (BZO) (e) Cocaine (COC) (f) Marijuana (THC) (g) Methylenedioxymethamphetamine (MDMA) (h) Methamphetamine (MET) (i) Oxycodone (OXY) (j) Phencyclidine (PCP) (k) Opiates (MOP) (l) Methadone (MTD) (2) A review of 2024 and 2025 proficiency testing records identified the laboratory had not enrolled and participated in proficiency testing for the above analytes, therefore, it was determined the laboratory must verify the accuracy of the testing at least twice annually; (3) Interview with the testing person 04/23/2025 at 04:10 pm confirmed the laboratory did not have a method in place to verify the accuracy of the testing at least twice annually and it had -- 2 of 8 -- not been verified during the review period of November 2024 through the current date because it was believed the test kit was categorized as waived; (4) The following were examples of patient testing performed on the Clearrapids Drug Test Card - 12 Panel Drug Test Card: (a) Specimen ID OOMH243070011 - testing performed on 11/02 /2024 (b) Specimen ID OOMH243110024 - testing performed on 11/06/2024 (c) Specimen ID OOMH243150003 - testing performed on 11/10/2024 (d) Specimen ID OOMH243230037 - testing performed on 11/18/2024 (e) Specimen ID OOMH243270034 - testing performed on 11/22/2024 (f) Specimen ID OOMH243370096 - testing performed on 12/02/2024 (g) Specimen ID OOMH243450053 - testing performed on 12/10/2024 (h) Specimen ID OOMH243460052 - testing performed on 12/11/2024 (i) Specimen ID OOMH250040012 - testing performed on 01/04/2025 (j) Specimen ID OOMH250150048 - testing performed on 01/15/2025 (k) Specimen ID OOMH250260008 - testing performed on 01/26/2025 (l) Specimen ID OOMH250270067 - testing performed on 01/27/2025 (m)Specimen ID OOMH250280050 - testing performed on 01/28/2025 (n) Specimen ID OOMH250350026 - testing performed on 02/04/2025 (o) Specimen ID OOMH250380039 - testing performed on 02/07/2025 (p) Specimen ID OOMH250440026 - testing performed on 02/13/2025 (q) Specimen ID OOMH250540016 - testing performed on 02/23/2025 (r) Specimen ID OOMH250550068 - testing performed on 02/24/2025 (s) Specimen ID OOMH250570016 - testing performed on 02/26/2025 (t) Specimen ID OOMH250590046 - testing performed on 02/28/2025 (u) Specimen ID OOMH250590046 - testing performed on 02/28/2025 (v) Specimen ID OOMH250630007 - testing performed on 03/04/2025 (w) Specimen ID OOMH250700060 - testing performed on 03/11/2025 (x) Specimen ID OOMH250780043 - testing performed on 03/19/2025 (y) Specimen ID OOMH250840044 - testing performed on 03/25/2025 (z) Specimen ID OOMH250890005 - testing performed on 03/30/2025 (aa) Specimen ID OOMH250940020 - testing performed on 04/04/2025 (bb) Specimen ID OOMH25097003 - testing performed on 04/07/2025 (cc) Specimen ID OOMH250980073 - testing performed on 04/08/2025 (dd) Specimen ID OOMH251030019 - testing performed on 04/13/2025 (ee) Specimen ID OOMH251060031 - testing performed on 04/16/2025 (ff) Specimen ID OOMH251090016 - testing performed on 04/19/2025 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 testing person #1, the laboratory failed to follow written procedures for blood bank alarm checks during the review period of May 2023 through January 2025. Findings include: (1) On 04/22/2025 at 03:15 pm, testing person #1 stated the laboratory routinely maintained two units of O negative and two units of O positive PRBCs (Packed Red Blood Cells) in the Helmer blood bank refrigerator. The units were available for emergency patient transfusions (PRBCs must be stored at 1-6 degrees -- 3 of 8 -- Celsius); (2) On 04/24/2025, a review of the laboratory's written policy, titled, "Blood Bank Alarm" under the section "Principle" required the alarm checks be performed three times a year; (3) A review of the alarm check records from May 2023 through January 2025 identified the alarm checks had not been performed three times a year in 2024 (it had only been documented as performed on 03/12/2024 and 09/10/2024); (4) Interview with the laboratory director on 04/24/2025 at 03:27 pm confirmed that the laboratory had not followed it's written policy for performing blood bank alarm checks three times a year as stated above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/31/2023 to 06/02/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, technical consultant #2, and testing person #6 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 chief nursing officer and technical consultant #2, the facility failed to ensure written policies were followed for preventing transfusion reactions for three of four units transfused. Findings include: (1) On 05/31/2023 at 11:00 am, technical consultant #2 stated the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit(s)); (2) On 06/01/2023 a review of the hospital policy titled, "Blood Administration, Blood Product Administration" stated the following: (a) "Vital signs will be taken every 10 minutes during the first 30 minutes of infusion watching for transfusion reaction symptoms"; (b) After the first 30 minutes, the patient should be assessed frequently and vital signs taken every 30 minutes and documented on the vital signs flowsheet in EPIC for the duration of the transfusion". (3) A review of transfusion records for three patients identified the policy had not been followed for taking vitals for three of four units transfused as follows: (a) Unit #W091021433160 - The transfusion began on 12/01/2021 at 06:50 pm and was completed on 12/01/2021 at 10:12 pm: (i) Vitals Every Ten Minutes for the first 30 Minutes - There was no Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- documentation vitals had been taken between 07:00 pm and 07:22 pm; (ii) Vitals Every 30 Minutes For the Duration of the Transfusion - There was no documentation vitals had been taken between 07:22 pm and 08:08 pm. (b) Unit #W091023411670 - The transfusion began on 02/23/2022 at 10:21 am and was completed on 02/23/2022 at 13:03 pm: (i) Vitals Every Ten Minutes for the first 30 Minutes - There was no documentation vitals had been taken between 10:22 am and 10:41 am; (ii) Vitals Every 30 Minutes For the Duration of the Transfusion - There was no documentation vitals had been taken between 10:49 am and 01:02 pm. (c) Unit #W091022240041 - The transfusion began on 07/06/2022 at 06:03 pm and was completed on 07/06/2022 at 08:17 pm: (i) Vitals Every 30 Minutes For the Duration of the Transfusion - There was no documentation vitals had been taken between 06:36 pm and 08:16 pm. (4) The findings were discussed with the chief nursing officer and technical consultant #2. Both stated on 06/01/2023 at 12:20 pm, the nursing policy had not been followed for taking vitals during patient transfusions. 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 records, policies and procedures, and interview with technical consultant #2, the laboratory failed to follow their written policy for documentation on the Emergency Release form for one of two patients receiving PRBC (Packed Red Blood Cells) in an emergency situation during the review period of January 2022 through the current date; and failed to follow their policy for documentation on the transfusion record for one of nine patient records reviewed from 08/01/2021 through the current date. Findings include: EMERGENCY RELEASE OF UNCROSSMATCHED BLOOD (1) On 05/31/2023 at 11:00 am, technical consultant #2 stated the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing, however in the event of an emergency, the laboratory would release uncrossmatched PRBC's according to laboratory policy; (2) On 06/01/2023 a review of the policy titled, "Emergency Issue of Non- Crossmatched Blood" required the laboratory complete "Authorization for Release of Uncrossmatched Blood in Emergency Situations" form, which contained a space to document the patient diagnosis; (3) A review of two patients receiving uncrossmatched blood during the review period of January 2022 through the current date identified the laboratory had not followed their policy for completing the form for one of two patients as follows: (a) Patient received blood on 08/19/2022 - The diagnosis had not been documented on the form. (4) The records were reviewed with technical consultant #2 who stated on 06/01/2023 at 01:20 pm, the laboratory had not followed their policy for completing the emergency release form. DOCUMENTATION ON TRANSFUSION RECORD (1) A review of blood bank policies and procedures on 06/01/2023, identified a policy titled, "Issuing Units" which stated the following: (a) "Before a unit of blood is release, transfusion service personnel must complete the following steps" (b) "Name and MRN of recipient must be recorded on the transfusion log". (2) A review of the transfusion record for patients tested from 08/01/2021 through the current date identified the MRN (medical record number) had not been documented on the log for one of nine patients reviewed -- 2 of 5 -- (testing had been performed on 12/01/2021); (3) The findings were reviewed with technical consultant #2 who stated on 06/01/2023 at 01:20 pm, the MRN had not been documented as required. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly for four of four function checks performed during the review period of November 2021 through the current date. Finding include: (1) On 05/31 /2023 at 10:35 am, technical consultant #2 stated the following: (a) Urine sediment examinations were performed in the laboratory; (b) The specimens were processed in the Select Medical Product PSS centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes; (2) A review of the policy titled, "Centrifuge Maintenance" stated "All centrifuge RPM's will be calibrated at least every 6 months" and provided the acceptable limits as follows: (a) 1500 rpm +/- 100 rpm (3) A review of centrifuge records from November 2021 through the current date identified the centrifuge speed had not been checked at the speed urines were processed for four of four checks performed as follows: (a) 11/19/2021 - The speed had been checked at 2161 rpm; (b) 05/10/2022 - The speed had been checked at 2120 rpm; (c) 11/11/2022 - The speed had been checked at 2056 rpm; (d) 05/12/2023 - The speed had been checked at 2062 rpm. (4) The records were reviewed with technical consultant #2 who stated on 05/31 /2023 at 01:40 pm, the laboratory had not followed their policy. 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 a review of records and interview with technical consultant #2, the laboratory failed to perform control procedures each day of blood bank testing for one of 24 days of patient testing reviewed from July 2022 through the current date. Findings include: (1) On 05/31/2023 at 11:00 am, technical consultant #2 stated the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing; (2) On 06/01/2023 a review of blood bank records -- 3 of 5 -- for testing performed from July 2022 through the current date identified QC (quality control) had not been documented as performed for one of 24 days when patient blood bank testing had been performed as follows: (a) 02/22/2023 - A patient crossmatch had been performed (3) The records were reviewed with technical consultant #2 who stated on 06/01/2023 at 01:35 pm, the QC had not been documented as performed as stated above. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to perform one sample of control material each 8 hours of patient blood gas testing using a combination of control materials that include both low and high values on each day of testing for one of 24 patients reviewed. Findings include: (1) On 05/31/2023 at 10:30 am, technical consultant #2 stated the following: (a) Blood gas testing (pH, pCO2, pO2) was performed on the Opti CCA TS2 analyzer; (b) Three levels of quality control (QC) material were performed each eight hours of patient testing. (2) A review of QC and patient records for testing performed from July 2022 through the current date identified that QC testing had not been performed each eight hours of patient testing (three levels had not been performed on the day of patient testing) for one of 24 patients reviewed (Date of testing was 02/22/2023); (3) The records were reviewed with technical consultant #2 who stated on 05/31/2023 at 03:15 pm, QC testing had not been performed each eight hours of patient testing. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with technical consultant #2, the laboratory failed to comply with 21 CFR 606.160(b)(3)(v). The laboratory failed to ensure that emergency release of blood forms had been signed by the physician for one of two emergency releases reviewed. Findings include: (1) On 05/31 /2023 at 11:00 am, technical consultant #2 stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for patient transfusions; (2) On 06/01/2023 a review of the policy titled, "Emergency Issue of Non- Crossmatched Blood" required an Emergency Release form be completed which stated, "The clinical situation of this patient requires the transfusion of uncrossmatched or partially crossmatch blood. I understand that the crossmatch will be completed as soon as possible". The form included a space for the Physician's -- 4 of 5 -- signature; (3) A review of documentation of emergency issue for two patients identified the following for one of two patient records: (a) One unit of O negative packed red blood cells had been released to a patient on 08/19/2022 at 11:21 am. The "Authorization for Release of Uncrossmatched Blood in Emergency Situations" form appeared to be signed by a physician's assistant and not a physician. (4) The documentation was reviewed with technical consultant #2 who stated on 06/01/2023 at 03:25 pm, the ER release had not been signed by a physician. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 06/30/2021 through 07/02/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager 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, written policy, and interview with the laboratory manager, the laboratory failed to have a written technical consultant and general supervisor competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On 06/30/2021 the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical consultant and general supervisor; (2) The surveyor then reviewed personnel records for competency assessments performed during 2019, 2020, and to date in 2021. There was no evidence of competencies performed for the technical consultant #2, general supervisor #1, and general supervisor #2 based on their job responsibilities; (3) The surveyor asked the laboratory manager if a written policy to evaluate the technical consultant and general supervisor based on job responsibilities was available. The laboratory manager stated a policy had not been written and the above competencies had not been performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 -- 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 laboratory manager, the laboratory failed to have a written procedure for Urine Microscopic testing. Findings include: (1) On 06/30/2021 at 03:25 pm, the laboratory manager stated to the surveyor Urine Microscopic testing was performed in the laboratory; (2) On 07/01/2021 the surveyor reviewed the manual titled, "Urinalysis Manual" and was unable to locate a written procedure for Urine Microscopic testing; (3) The surveyor reviewed the procedure manual with the laboratory manager, who stated on 07/01/2021 at 11:55 am, the procedure had not been written. 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, procedure manual, and interview with the laboratory manager, the laboratory failed to ensure the verified reportable ranges were used by the laboratory for a new test method. Findings include: (1) On 06/30/2021 at 03:43 pm, the laboratory manager stated to the surveyor the laboratory began performing pH, pCO2, and pO2 testing using the OPTI CCA TS2 analyzer on 08/22/2019; (2) On 07/01/2021 the surveyor reviewed the performance specification records and identified the laboratory had demonstrated the following reportable ranges: (a) pH - 6.919-7.614 (b) PCO2 - 15.3-88.4 (c) PO2 - 60-510.2 (3) The surveyor requested the reportable ranges that were being utilized by the laboratory. The laboratory manager provided the surveyor with the manual titled, "Blood Gas Procedure Manual" with showed the laboratory was using the manufacturer's reportable ranges as follows: (a) pH - 6.6-7.8 (b) pCO2 - 10-200 (c) pO2 - 10-700 (4) The surveyor reviewed the findings with the laboratory manager, who stated on 07/01/2021 at 05:50 pm the laboratory was not using the reportable ranges that had been demonstrated by the laboratory. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or -- 2 of 4 -- baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory manager, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly. Findings include: (1) On 06/30/2021 at 03:20 pm, the laboratory manager stated to the surveyor, urine sediment examinations were performed in the laboratory. The specimens were processed in the Select Medical Products PSS Select 602 centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes; (2) On 07/01/2021 the surveyor reviewed the policy titled "Centrifuge Maintenance" which stated, "All centrifuge RPM's will be calibrated at least every 6 months"; (3) The surveyor reviewed the centrifuge maintenance records. The records showed the centrifuge speed and timer checks had not been performed every six months as required by policy. The checks had not been performed between 11/27/2019 and 03/03/2021; (4) The surveyor reviewed the findings with the laboratory manager who stated on 07/01/2021 at 11:50 am the centrifuge speed and timer had not been checked as shown above. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for Free T4 testing for 2 of 2 lot numbers. Findings include: (1) On 06/30/2021 at 03:50 pm, the laboratory manager stated the following to the surveyor: (a) Free T4 (Thyroxine) testing was performed on the Ortho Vitros ECiQ analyzer; (b) Two levels of MAS Liquimmune QC (quality control) materials (level 1 and level 2) were performed each day of patient testing; (c) Established ranges were used for determining acceptability of QC results. (2) On 07/02/2021, the surveyor reviewed QC records which included documentation of establishing QC ranges, Levey-Jennings graphs, and cumulative data for level 1 lot #LIA22031 and level 2 lot #LIA 22032 used during the review period of January through May 2021. The documentation showed the ranges that had been utilized by the laboratory to determine acceptability of QC results were wider than the established QC ranges as follows: (a) MAS Level 1 - The laboratory had established a 2 standard deviation (SD) range of 1.378-1.022, but a range of 0.86-2.54 had been used; (b) MAS Level 2 - The laboratory had established a 2 SD range of 3.618-4.122, but a range of 3.08-4.62 had been used. (3) The surveyor reviewed the records with the laboratory manager -- 3 of 4 -- who stated on 07/02/2021 at 11:30 am, ranges wider than the laboratory established 2 SD ranges, as shown above, had been used to evaluate QC results. 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 a review of records and interview with the laboratory manager, the laboratory failed to perform quality control as stated in the IQCP for PTT testing for 1 of 17 months. Findings include: (1) On 06/30/2021 at 03:22 pm, the laboratory manager stated the following to the surveyor: (a) PTT (Partial Thromboplastin Time) testing was performed using the Hemochron Signature Elite Jr. analyzer; (b) Two levels of QC (quality control) materials were tested monthly, according to the laboratory IQCP (Individualized Quality Control Plan); (2) On 07/01/2021 the surveyor reviewed PTT QC records for testing performed from 01/13/2020 through 05 /12/2021 and identified the following for 1 of 17 months: (a) One level of QC (level 2) had been performed on 10/12/2020 (3) The surveyor reviewed the records with the laboratory manager who stated on 07/01/2021 at 05:45 pm, one level of QC had been performed instead of two levels 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 a review of records and interview with the laboratory manager, the laboratory failed to perform a positive AHG control 16 of 16 days of blood bank testing. Findings include: (1) On 06/30/2021 at 03:40 pm, the laboratory manager stated to the surveyor the laboratory utilized the AHG (Anti-Human Globulin) reagent to perform Antibody Screen and Compatibility testing using the tube method; (2) The surveyor reviewed records for blood bank testing performed from 01/06/2020 through 06/18/2021 and identified a positive AHG control had not been performed 16 of 16 days of patient testing. The specific days were 01/06/2020; 02/27/2020; 03/30/2020; 04/01/2020; 05/04,21/2020; 06/01,28/2020; 07/17/2020; 01/18/2021; 02/09,17/2021; 03/30/2021; 04/19,22/2021; and 06/18/2021; (3) The surveyor reviewed the records with laboratory manager who stated a positive AHG control was not being performed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 04/02/19 to 04/04/19. The laboratory was found out of compliance with the following CLIA regulation: 493.1447: D6108: Condition: Technical Supervisor The findings were reviewed with the laboratory supervisor at the conclusion of the survey. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for the testing performed in the laboratory. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor the laboratory began using the Vitros ECiQ Immunoassay analyzer on 06/22/17 to perform patient Troponin I testing; (2) The surveyor reviewed the manufacturer's implementation instructions for the analyzer. The manufacturer required the method comparison be performed using a minimum of 20 samples; (3) The surveyor then reviewed the laboratory's implementation records for the new test system and identified the laboratory failed to use the manufacturer's minimum of 20 samples but used 17; (4) The surveyor reviewed the findings with the laboratory supervisor, who stated to the surveyor, the laboratory had not used 20 samples as required by the manufacturer to perform the method comparison for Troponin I testing on the new analyzer. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the laboratory supervisor, the laboratory failed to ensure the manufacturers' environmental specifications were met. Findings include: SYSMEX XS-1000i (1) On the first of the survey, the laboratory supervisor stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing (e.g. WBC (White Blood Count), RBC (Red Blood Count), Hematocrit, Hemoglobin, Platelet count, etc.) using the Sysmex XS-1000i hematology analyzer; (2) On the third day of the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required a humidity between 30 and 85%; (3) The surveyor then reviewed the laboratory humidity records from October 2017 through February 2019. The surveyor identified the humidity was either less than 30%, or had not been documented during 11 of the 17 months reviewed. The specific findings follow: (a) October 2017: 1 of 31 humidity readings was less than 30% (Day 27) (b) November 2017: (i) 6 of 30 humidity readings were less than 30% (Days 7,8,9,19,21,23) (ii) 4 of 30 humidity readings had not been documented (Days 22,24,25,26) (c) December 2017: (i) 11 of 31 humidity readings were less than 30% (Days 8,11,14,16,18,21,22,25,26,28,29) (ii) 14 of 31 humidity readings had not been documented (Days: 2,5,6,7,9,10,12,13,15,23,24, 27,30,31) (d) January 2018: (i) 14 of 31 humidity readings were less than 30% (Days 2,4,5,6,8,11,13,14,16,17,22,23,25,29) (ii) 11 of 31 humidity readings had not been documented (Days 1,3,12,15,18,19,24,27,28,30,31) (e) February 2018: (i) 20 of 28 humidity readings were less than 30% (Days 1,2,3,4,5,6,7,8,9,11,12,13,14,16,17, 20,22,23,24,25) (ii) 1 of 31 humidity readings had not been documented (Day 10) (f) March 2019: (i) 12 of 31 humidity readings were less than 30% (Days 2,8,9,10,12,13,16,19,20,21,22,30) (ii) 9 of 31 humidity readings had not been documented (Days 1,5,6,7,11,14,15,17,18) (g) April 2018: (i) 16 of 30 humidity readings were less than 30% (Days 1,2,4,8,9,10,11,14,15,16,17,18,19, 20,26,27) (h) November 2018: (i) 14 of 30 humidity readings were less than 30% (Days 9,10,11,13,14,17,18,19,20,21,25, 26,27,28) (i) September 2018: (i) 2 of 30 humidity readings had not been documented (Days 1,2) (j) December 2018: (i) 13 of 31 humidity readings were less than 30% (Days 3,4,5,6,7,9,10,14,15,16,20,22,28) (ii) 1 of 31 humidity readings had not been documented (Day 8) (k) January 2019: (i) 4 of 31 humidity readings were less than 30% (Days 1,2,9,13) (l) February 2019: (i) 9 of 30 humidity readings were less than 30% (Days 7,8,9,13,15,18,19,24,28) (4) The surveyor reviewed the findings with the laboratory supervisor. The laboratory supervisor stated to the surveyor the laboratory failed to ensure the manufacturer's humidity requirement had been met as listed above. VITROS 350 AND VITROS ECIQ (1) On the first of the survey, the laboratory supervisor stated to the surveyor the laboratory performed the following: (a) Chemistry testing (i.e. Glucose, Potassium, Uric Acid, etc.) using the Vitros 350 analyzer; (b) Immunoassay testing (e.g., TSH (Thyroid Stimulating Hormone), PSA (Prostate Specific Antigen), FreeT4, and Troponin I) using the Vitros ECiQ analyzer (put into use on 06/22/17). (2) On the third day of the survey, the surveyor reviewed -- 2 of 16 -- the manufacturer's environmental specifications for the analyzers. The following was required: (a) Vitros 350: The manufacturer required humidity between 15 and 60%; (b) Vitros ECiQ: The manufacturer required humidity between 15 and 75%. (3) The surveyor then reviewed the laboratory humidity/temperature records from October 2017 through February 2019. The surveyor identified 9 of the 17 months reviewed, the humidity was either less than 15%, or had not been documented. The specific findings follow: (a) November 2017: (i) 3 of 30 humidity readings were less than 15% (Days 8,19,21) (ii) On 4 of 30 humidity readings had not been documented (Days: 22,24,25,26) (b) December 2017: (i) 8 of 31 humidity readings were less than 15% (Days 8,11,14,16,22,26,28,29) (ii) 14 of 31 humidity readings had not been documented (Days 2,5,6,7,9,10,12,13,15,23,25, 27,30,31) (c) January 2018: (i) 14 of 31 humidity readings were less than 15% (Days 2,4,5,6,8,11,13,14,16,17,22,23,25,29) (ii) 11 of 31 humidity readings had not been documented (Days 1,3,12,15,18,19,24,27,28,30, 31) (d) February 2018: (i) 12 of 28 humidity readings were less than 15% (Days 1,2,3,4,5,6,7,9,12,13,20,22) (ii) 1 of 28 humidity readings had not been documented (Day 10) (e) March 2018: (i) 5 of 31 humidity readings were less than 15% (Days 2,8,9,12,13) (ii) 9 of 31 humidity readings had not been documented (Days 1,5,6,7,11,14,15,17,18) (f) April 2018: (i) 6 of 30 humidity readings were less than 15% (Days 1,4,14,15,16,19) (g) September 2018: (i) 2 of 30 humidity readings had not been documented (Days 1,2) (h) November 2018: (i) 1 of 30 humidity readings was less than 15% (Day 13) (i) December 2018: (i) 1 of 31 humidity readings was less than 15% (Day 9) (ii) 1 of 31 humidity readings had not been documented (Day 8) (j) January 2019: (i) 1 of 31 humidity readings was less than 15% (Day 2) (4) The surveyor reviewed the findings with the laboratory supervisor. The laboratory supervisor stated to the surveyor the laboratory failed to ensure the manufacturer's humidity requirement for the Vitros 350 and the Vitros ECiQ analyzers had been met as listed above. REFRIGERATOR TEMPERATURE (1) The surveyor observed the laboratory refrigerators and their contents and the manufacturer's storage requirements. The following were examples of the contents: (a) Whirlpool SS (stainless steel) refrigerator: (i) 1 box of directCHECK Whole Blood PT/PTT (Prothrombin Time/Partial Thromboplastin Time) QC (Quality Control) material, Lot #K8DAC008 and Lot #K8DAT005. The manufacturer's acceptable storage range: 2-8 C (Centigrade); (ii) 2 boxes of Thyroid Stimulating Hormone Calibration materials, Lot #5805. The manufacturer's acceptable storage range: 2-8 C; (iii) 2 packs of Prostate Specific Antigen reagent, Lot #3680. The manufacturer's acceptable storage range: 2-8 C; (iv) 1 pack Free T4 reagent, Lot #4190. The manufacturer's acceptable storage range: 2-8 C; (v) 2 boxes of Hemochron Citrate PTT test cuvettes, Lot #J8JCC016. The manufacturer's acceptable storage range: 2-8 C. (b) Whirlpool white refrigerator: (i) 1 box of Vitros PV (Performance Verifier) I, Lot #A6018. The manufacturer's acceptable storage range: 2-8 C; (ii) 1 box of PV II, Lot #W5903. The manufacturer's acceptable storage range: 2-8 C; (iii) 1 vial each of eCHECK XS Sysmex QC materials in use during the survey. The manufacturer's acceptable storage range: 2-8 C: (aa) Level 1, Lot #90430804 (bb) Level 2, Lot #90430805 (cc) Level 3, Lot #90430806 (2) The surveyor reviewed temperature records for the laboratory refrigerators from 07/01/17 through 12/31/18. The laboratory's acceptable temperature range for the refrigerators was 2 to 6 degrees C. The surveyor identified 13 of the 487 days reviewed, the refrigerator temperature was than 2 degrees C. The specific findings follow: (a) Whirlpool SS refrigerator: (i) September 2017: (aa) 2 of 30 temperatures (Days 18,28) (ii) October 2017: (aa) 1 of 31 temperatures (Day 6) (iii) March 2018: (aa) 1 of 31 temperatures (Day 29) (iv) April 2018: (aa) 2 of 30 temperatures (Days 20,25) (v) June 2018: (aa) 1 of 30 temperatures (Day 24) (vi) November 2018: (aa) 3 of 30 temperatures (Days 5,16,27) (b) Whirlpool White refrigerator: (i) March 2018: (aa) 1 of 31 temperatures (Day 26) -- 3 of 16 -- (ii) April 2018: (aa) 1 of 30 temperatures (Day 18) (iii) May 2018: (aa) 1 of 31 temperatures (Day 3) (3) The surveyor reviewed the findings with the laboratory supervisor, who stated to the surveyor the laboratory failed to ensure the manufacturer's storage requirements for the testing materials had been met, as listed above. NOTE: D5413 was cited on the previous recertification survey performed 06 /05/17-06/07/17 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 laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: VITROS 350 (1) On the first of the survey, the laboratory supervisor stated to the surveyor the laboratory performed Chemistry testing (i.e. Glucose, Potassium, Uric Acid, etc.) using the Vitros 350 analyzer; (2) The surveyor reviewed the manufacturer's maintenance requirements, as stated on the manufacturer's maintenance log and identified the following procedures were required on a weekly basis: (a) Clean tray platform and transport arm (b) Clean cup retainer (c) Clean diluent bottles (d) Clean tip locator (e) Clean control unit screen (f) Clean keypad cover (g) Inspect, clean, and/or replace air filter (h) Back up QC/Config/Calibration Data (3) The surveyor reviewed the maintenance records from 07/01/17 through 2/28/19 and identified the weekly maintenance procedures had not documented as having been performed: (a) Between 01/23/18 and 02/07/18 (b) Between 07/25/18 and 08/08/18 (4) The surveyor reviewed the findings with the laboratory supervisor who stated to the surveyor there was no documentation the manufacturer's required weekly maintenance procedures had been performed as listed above. VITROS ECIQ (1) On the first day of the survey, the laboratory supervisor stated to the surveyor the laboratory performed Immunoassay testing (e.g., TSH (Thyroid Stimulating Hormone), PSA (Prostate Specific Antigen), FreeT4, and Troponin I) using the Vitros ECiQ analyzer. In addition, the laboratory supervisor stated the analyzer was put into use on 06/22/17; (2) The surveyor reviewed the manufacturer's maintenance requirements, as stated on the manufacturer's maintenance log and identified the following procedures were required: (a) Daily maintenance: (i) Verify slide inventory/load cartridges (ii) Empty mixing cup array/tip disposal box (iii) Empty slide disposal box (iv) Empty cartridge disposal box (v) Inspect sample trays; tube, cup, and height adaptors (vi) Load mixing cup arrays (vii) Load sample tips (viii) Change Reference Fluid micro tip and clean reference Fluid Proboscis (every 8 hours) (ix) Install new reference Fluid disposable reservoir (white label) (x) Clean Reference Fluid cover/seal (xi) Change Immuno- Wash Fluid micro tip and clean Immuno-Wash Fluid proboscis (every 8 hours) (xii) Clean Immuno-Wash Fluid cover/seal (xiii) Inspect diluent tray and bottles (xiv) Check diluent levels and replace if required (xv) Clean diluent caps (xvi) Load diluent tray on analyzer (xvii) Verify correct date/time on screen (xviii) Verify that QC has been run (b) Weekly maintenance - "Date/Initial Boxes" (i) Clean the metering proboscis (ii) Clean the tip disposal chute/cup retainer (iii) Clean the sample supply subsystem (iv) Clean the touchscreen monitor (v) Clean the keyboard and keyboard cover (vi) Perform subsystem cleaning (vii) Clean the processing center (3) The -- 4 of 16 -- surveyor reviewed the maintenance records from 9 months (October and December 2017; January, February, March, May, and November 2018; and January and February 2019) and identified the maintenance procedures listed above, had not been performed as required: (a) Daily: There was no documentation the maintenance procedures had been performed on 2 of 272 days reviewed: (i) 02/27/18 (ii) 02/28/18 (b) Weekly: (i) There was no documentation the maintenance procedures had been performed between: (aa) 04/23/18 and 05/06/18 (ii) Although the boxes for the weekly maintenance had been checked, the dates on which the maintenance was performed had not been documented. Therefore, the surveyor could not determine if the maintenance had been performed on a weekly basis as required, during the following months: (aa) October 2017 (bb) December 2017 (cc) January 2018 (dd) February 2018 (ee) March 2018 (ff) January 2019 (4) The surveyor reviewed the findings with the laboratory supervisor who stated to the surveyor there was no documentation the required maintenance procedures had been performed, as listed above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's specifications for quality control materials. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor: (a) The laboratory used the Hemochron Signature Elite Jr. analyzer to perform: (i) PT (Prothrombin Time) testing using the Citrate PT cuvettes (ii) PTT (Partial Thromboplastin Time) testing using the Citrate PTT cuvettes (b) An IQCP (Individualized Quality Control Plan) had been developed for the system, and the quality control plan required the laboratory test two levels (Normal and Abnormal) of directCHECK Whole Blood Control every 30 days, and with a new cassette lot number. (2) On the second day of the survey, the surveyor reviewed the manufacturer's instructions for the directCHECK Whole Blood Controls, which stated "ITC recommends that each institution establish its own expected range or response based on the mean +/- 2 standard deviation of at least 20 repeated test results. The local mean values established should fall within the manufacturer's acceptable performance range. Studies show that intra-laboratory variation in test results should produce a CV (Coefficient of Variation) of approximately 14%, or less for coagulation control tests"; (3) The surveyor then reviewed QC records from November 2017 through March 2019. For 3 of the 8 lot numbers of QC materials used during the review period, the laboratory failed to follow the manufacturer's instruction to obtain a CV of approximately 14% or less: (a) PT: Citrate Norman Control, Lot #A7DNC001 (In use from 11/12/17 through 02/28/18), the laboratory obtained a CV of 14.4% (b) PT: Citrate Normal Control, Lot #K8DNC008 (In use from 03/01/19 through 04/03/19), the laboratory obtained a CV of 14.6% (c) PTT: Citrate Normal Control, Lot #G7DNC0011 (In use from 02/28/18 through 10/02/18), the laboratory obtained a CV of 16.7% (4) The surveyor reviewed the finding with the laboratory supervisor, who stated to the surveyor, the laboratory obtained a CV% greater than 14%, for the QC materials listed above. -- 5 of 16 -- D5785