Roger Mills Memorial Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/27,28/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer and general supervisor at the conclusion of the survey. D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on observation, and interview with the general supervisor, the laboratory failed to ensure three of three bottles of Fisher Brand Sun-Dex 50 glucose tolerance beverages were stored to minimize contamination. Findings include: (1) On 08/28 /2024 at 2:00 pm observation of the contents of the laboratory refrigerator identified the following materials: (a) Patient blood and urine specimens for storage; (b) Blood and urine quality control specimens; (c) Three bottles of Fisher Sun-Dex 50 glucose tolerance beverages for patient consumption. (2) Interview with the general supervisor 08/28/2024 at 2:00 pm confirmed the laboratory failed to minimize contamination by storing patient beverages for consumption with biohazard materials. D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. This STANDARD is not met as evidenced by: 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 -- Based on a review of records, written policy, and interview with the general supervisor, the laboratory failed to follow policies to ensure positive identification of a blood or blood product recipient. Findings include: (1) On 08/28/2024 at 11:00 am, the general supervisor stated that the laboratory collected specimens for blood transfusion testing performed by the Oklahoma Blood Institute (OBI); (2) A review of the OBI policy titled, "Pre and Post Transfusion guidelines for transfusion service clients" stated in section 6.2.4, "Attach the bracelet to the patient, tearing off the remaining strip of numbers. The bracelet must remain on the patient until completion of the transfusion."; (3) A review of the hospital policy titled, "Oklahoma Blood Institute: packaging" stated, "Patient armband to be placed on patient and armband tail with remaining stickers go with the specimen."; (4) Observation of the blood bank on 08/28/2024 at 11:00 am revealed a patient blood bank armband, that was paper clipped to a laboratory blood component issuance form along with the remaining stickers; (5) On 08/28/2024 at 11:00 am, the general supervisor confirmed that the armband was not placed on the patient according to their policy to ensure positive identification of a blood product recipient. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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, observation, and interview with the technical consultant, the laboratory failed to ensure one of one box of Triage total 5 calibration verification materials were stored as required by the manufacturer. Findings include: (1) On 08/28/2024 at 11:00 am observation of the contents of the laboratory freezer identified the following: (a) One box of Triage Total 5 calibration verification materials, lot# 492350N (2) The storage requirement, as stated on the box was -20 degrees C (Celsius) or colder. (3) Observation of the freezer temperature logs from July 2023 to December 2023 identified the following: (a) The temperatures were warmer than -20 degrees C for 16 of 180 days reviewed. (3) The findings were reviewed with the technical consultant who stated on 08/28/2024 at 11:00 am, the freezer temperatures were not within the manufacturer's storage requirements. 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: -- 2 of 4 -- Based on a review of records, written policy, and interview with the general supervisor, 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 two of five emergency releases reviewed. Findings include: (1) On 08/28/2024 at 9:00 am, the general supervisor stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for patient transfusions; (2) On 08/28/2024 a review of the policy titled, "Emergency Blood Transfusion Request" required an Emergency Release form be completed which stated, "I believe the life of (last, first, date of birth, patient identification #) will be in jeopardy without an emergency blood transfusion". The form included a space for the medical provider's signature; (3) A review of documentation of emergency issue identified the following for two of five patient records: (a) One unit of O positive packed red blood cells had been released to a patient on 10/25/2023. The "Emergency Blood Transfusion Request" form appeared to be signed by a mid-level provider and not a physician; (b) One unit of O negative packed red blood cells had been released to a patient on 06/24/2024. The "Emergency Blood Transfusion Request" form appeared to be signed by a mid-level provider and not a physician. (4) The documentation was reviewed with the general supervisor who stated on 08/28/2024 at 9:00 am, the emergency releases had not been signed by a physician. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to make therapeutic reference ranges available for INR (International normalized ratio) testing for one of one patient report and failed to make appropriate reference ranges available for one of one patient venous blood gas report. Findings include: INR TESTING (1) On 08/28/2024 at 11:30 am, the general supervisor stated INR testing was performed using the Hemochron Signature Elite analyzer; (2) A review of one patient report with INR results reported on 02/04/2024 at 1:06 pm, identified the report did not include a therapeutic range (range for treatment of venous thrombosis, treatment of pulmonary embolism, prevention of systemic embolism, etc); (3) The report was reviewed with the general supervisor who stated on 08/28/2024 at 11:30 am, the patient report did not include a therapeutic range for INR. VENOUS BLOOD GAS TESTING (1) On 08/28/2024 at 11:30 am, the general supervisor stated venous and arterial Blood Gas (pH, pO2, pCO2, BE, HCO3, TCO2, and SO2) testing were performed using CG4+ cartridge and the i-Stat analyzer ; (2) On 08/28 /2024, a review of two patient reports identified identical reference ranges for venous and arterial blood gas testing as follows: (a) A patient venous blood gas tested on 12 /19/2023 with the following reference intervals: (i) pH - 7.35-7.45 (ii) pO2 - 80-105.0 mmHg (iii) pCO2 - 32.0-45.0 mmHg (iv) BE - 2.0-3.0 mmol/L (v) HCO3 - 22-26 mmol/L (vi) TCO2 - 23-27 mmol/L (vii) SO2 - 95-98 % (b) A patient arterial blood gas tested on 03/23/2024 with the following reference intervals: (i) pH - 7.35-7.45 (ii) pO2 - 80-105.0 mmHg (iii) pCO2 - 32.0-45.0 mmHg (iv) BE - 2.0-3.0 mmol/L (v) HCO3 - 22-26 mmol/L (vi) TCO2 - 23-27 mmol/L (vii) SO2 - 95-98 % (3) The -- 3 of 4 -- reports were reviewed with the general supervisor, who stated on 08/28/2024 at 11:30 am, the patient report tested on 12/19/2023 did not include reference intervals for venous Blood Gas testing. 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 review of records and interview with the general supervisor, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for one of five proficiency testing events reviewed in 2023 and 2024. Findings include: (1) A review of 2023 and 2024 proficiency testing events identified attestation statements had been signed after the graded evaluation had been received for one of ten events reviewed: (a) Third event 2024 Chemistry Core - The sample testing had been completed on 01/29/2024 and the attestation statement had not been signed by the laboratory director until 03/08/2024. (2) The records were reviewed with the general supervisor who stated on 08/27/2024 at 2:00 pm the attestation statement had not been signed timely as stated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/04,05,06/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the CEO and laboratory manager during an exit conference performed at the conclusion of the survey. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory manager, the laboratory failed to ensure iSTAT cartridges had not exceeded their room temperature expiration date for one of four cartridge types observed. Findings include: (1) On 10/04/2022 at 11:30 am, the laboratory manger stated Blood Gas (pH, pCO2, pO2) testing was performed using the CG4+ cartridge and the iSTAT 1 analyzer; (2) Observation of the laboratory on 10/04/2022 at 11:35 am identified CG4+ cartridges stored at room temperature, with a date of 07/13/22 documented on the boxes: (a) Lot #D22116 - One box containing five cartridges and two boxes, each containing 25 cartridges. (3) Review of the manufacturer's storage requirements showed the following: (a) The cartridges were stable at 2-8 degrees C (Centigrade) until the expiration date listed on the box; (b) The cartridges were stable at room temperature (18-30 degrees C) for two months. (4) Interview with the laboratory manager on 10/04 /2022 at 11:42 am confirmed the cartridges had been placed at room temperature on 07 /13/2022 and therefore, the cartridges had been stored at room temperature beyond the manufacturer's room temperature expiration date. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 laboratory manager, the laboratory failed to ensure the demonstrated reportable ranges were utilized, and failed to ensure the performance specification data had been evaluated prior to implementing the new test for one of two new test methods introduced into the laboratory. Findings include: (1) On 10/04/2022 at 11:30 am, the laboratory manager stated the laboratory began performing D-dimer testing using the Biosite Triage Meter Pro analyzer on 05/11/2021; (2) On 10/05/2022, a review of the performance specification records for the new test system identified the following: (a) The laboratory had demonstrated a reportable range of 153-4900 ng/ml; (b) There was no evidence the data had been reviewed and evaluated by the laboratory. (3) The records were reviewed with the laboratory manager who stated the following on 10/05/2022 at 09:47 am: (a) The laboratory was using the manufacturer's reportable range of 100- 5000 ng/ml instead of the reportable range of 153-4900 ng/ml that had been demonstrated by the laboratory; (c) There was no documentation to prove the data had been reviewed and evaluated by the laboratory. 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 manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for one of two analyzers reviewed. Findings include: (1) On 10/04/2022 at 11:43 am, the laboratory manager stated Albumin, Alcohol, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Amylase, AST (Aspartate Aminotransferase), BUN (Blood, Urea, Nitrogen), Calcium, CK (Creatine Kinase), Creatinine, Chloride, CO2, Glucose, HDL (High Density Lipoprotein), Lactate, Magnesium, Potassium, Sodium, Total Bilirubin, Total Cholesterol, Total Protein, and Triglyceride testing were performed on the Ortho Vitros 350 analyzer; (2) On 10/05/2022, a review of the manufacturer's maintenance requirements, as stated on the manufacturer's maintenance log revealed the following requirements: (a) Weekly (i) Clean tray platform and transport arm (ii) Clean cup retainer (iii) Clean diluent bottles (iv) Clean tip locator assembly (v) Clean control unit screen (vi) Clean keypad cover (vii) Inspect, clean, and/or replace air filter (3) A review of maintenance logs from January 2022 through September 2022 identified the weekly maintenance had not been documented as performed between 08/29/2022 and 09/12/2022; (4) The -- 2 of 6 -- records were reviewed with the laboratory manager who stated on 10/05/2022 at 04: 29 pm, the weekly maintenance had not been documented as performed as shown above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to perform calibration verification procedures at least once every six months for one of five test systems. Findings include: (1) On 10/04/2022 at 11:30 am, the laboratory manager stated the laboratory began performing D-dimer testing using the Biosite Triage Meter Pro analyzer on 05/11/2021; (2) Calibration verification records could not be located since the procedure had been performed during the implementation of the analyzer in 05/2021, and the laboratory manager was questioned. The laboratory manager stated on 10/04/2021 at 03:50 pm, calibration verification procedures had not been performed since 05/2021. 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. -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on a review of records, quality control package inserts, and interview with the laboratory manager, the laboratory failed to have control procedures that monitored the accuracy and precision of the testing process; and that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for Alkaline Phosphatase and Amylase testing for four of four months reviewed. Findings include: (1) On 10/04/2022 at 11:43 am, the laboratory manager stated Alkaline Phosphatase and Amylase testing were performed on the Ortho Vitros 350 analyzer; (2) On 10/05/2022 at 10:00 am, the laboratory manager stated the following: (a) Three levels of MAS ChemTRAK H Liquid Assayed QC (quality control) materials were performed each day of patient testing; (b) When new lot numbers of control materials were put into use, the laboratory established means for each analyte and utilized historic two SD (Standard Deviation) ranges; (c) The following lot numbers of control materials were currently in use: (i) Level 1 lot #CHA22101 (ii) Level 2 lot #CHA22102 (iii) Level 3 lot #CHA22103 (3) A review of the package insert for the QC materials identified the manufacturer's listed ranges were not listed as SD ranges and were listed as guideline ranges. The instructions stated under the heading "Control Ranges", "Instrument values provided are specific to this lot of control only and are intended to assist the laboratory in establishing its own means and ranges"; (4) A review of QC records (Levey-Jennings graphs and cumulative calculated data) from May 2022 through August 2022 (the current lot numbers were in use during the review period) identified the following: (a) Amylase - The laboratory was using ranges wider than the package insert guideline ranges for one of three levels of QC materials: (i) Level One - The laboratory was using a range of 49.2-96.28 from May through July and a range of 62.7-109.8 in August which was wider than the package insert guideline range of 61.9-92.9. (b) Alkaline Phosphatase - The laboratory was using ranges wider than the package insert guideline ranges for one of three levels of QC materials: (i) Level One - The laboratory was using a range of 29.32-58.86 during the review period which was wider than the package insert guideline range of 40-60. (5) The records were reviewed with the laboratory manager who stated on 10/06/2022 at 10:20 am, the laboratory was using ranges wider than the package insert guideline ranges and those ranges were currently being used to determine patient acceptability. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (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 two levels of quality control materials each day of patient Troponin I testing for two of eight days reviewed. Findings include: (1) On 10/04 /2022 at 11:30 am, the laboratory manger stated the following: (a) Troponin I testing was performed using the TPNI cartridge and the iSTAT 1 analyzer; (b) Two levels of iSTAT quality control (QC) materials were performed each 24 hours of patient testing. (2) On 10/05/2022, a review of QC and patient testing records in August 2022 -- 4 of 6 -- identified two levels of QC testing had not been performed each 24 hours of patient testing reviewed for two of eight days as follows: (a) 08/09/2022 - Patient testing had been performed at 02:01 pm. There was no documentation QC testing had been performed in the previous 24 hour time period. QC had not been performed until 03: 38 pm; (b) 08/28/2022 - Patient testing had been performed at 10:58 am. There was no documentation QC testing had been performed in the previous 24 hour time period. QC had not been performed until 12:23 pm. (3) The records were reviewed with the laboratory manager who stated on 10/05/2022 at 10:33 am, the laboratory had not performed two levels of QC testing each 24 hours of patient testing as stated above. 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 positive control procedures each day of blood bank testing for six of 12 days of patient testing reviewed. Findings include: (1) On 10/04 /2022 at 11:40 am, the laboratory manager stated the laboratory performed Crossmatch Testing, which consisted of ABO Group testing, using the tube method; (2) On 10/05/2022, a review of records for blood bank testing performed from February 2022 through September 2022 identified positive QC (quality control) for the A-Antisera, B-Antisera, and A,B Antisera had not been performed for six of 12 days of patient testing (only negative QC testing had been performed). The specific days were 02/11/2022, 03/09/2022, 03/24/2022, 09/05/2022, 09/08/2022, and 09/24 /2022; (3) The records were reviewed with the laboratory manager who stated on 10 /05/2022 at 01:05 pm, positive QC had not been documented as performed for the antisera used for ABO Group testing as stated above. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to perform two levels of quality control materials each eight hours of D-dimer testing 15 of 15 days of patient testing reviewed. Findings include: (1) On 10 /04/2022 at 11:30 am, the laboratory manager stated the following: (a) The laboratory began performing D-dimer testing using the Biosite Triage Meter Pro analyzer on 05 /11/2021; (b) Two levels of QC (Quality Control) materials were performed with new lot numbers of test devices; (c) An IQCP (Individualized Quality Control Plan) had not been developed for the test system. (2) Since an IQCP had not been developed for -- 5 of 6 -- the test system, it was determined two levels of QC materials must be performed each eight hours of patient testing; (3) On 10/05/2022, a review of QC and patient testing records for testing performed during March and August 2022 identified two levels of QC materials had not been performed each 8 hours of patient testing (QC had not been performed on the days of testing) for 15 of 15 days with the specific days as follows: (a) March 2022 - 03/06, 03/07, 03/08, 03/12, 03/18 (b) August 2022 - 08/01, 08/02, 08/04, 08/08, 08/09, 08/14, 08/16, 08/22, 08/28, 08/30 (4) The records were reviewed with the laboratory manager who stated on 10/05/2022 at 11:15 am, two levels of QC materials had not been performed each eight hours of patient testing. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (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 and interview with the laboratory manager, the laboratory failed to ensure units of blood were stored under appropriate conditions for five of 27 blood bank refrigerator temperature charts. Findings include: (1) On 10/04 /2022 at 11:40 am, the laboratory manager stated units of packed red blood cells were stored in the Helmer blood bank refrigerator with a recorder connected to it to continuously record the temperature on thermograph charts, which monitored the temperature for a seven day period: (2) A review of 27 refrigerator charts dated from 12/27/2021 through 07/05/2022 identified that five of 27 charts had not been changed by the seventh day as follows: (a) Chart #1 - The chart had been put into use on 02/14 /2022 and removed on 02/23/2022 (9 days); (b) Chart #2 - The chart had been put into use on 03/21/2022 and removed on 03/29/2022 (8 days); (c) Chart #3 - The chart had been put into use on 05/02/2022 and removed on 05/10/2022 (8 days); (d) Chart #4 - The chart had been put into use on 05/23/2022 and removed on 05/31/2022 (8 days); (e) Chart #5 - The chart had been put into use on 06/27/2022 and removed on 07/05 /2022 (8 days). (3) The charts were reviewed with the laboratory manager who stated on 10/05/2022 at 02:10 pm, the above charts had not been changed by the 7th day. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/04,05/2021. The findings were reviewed with the general supervisor and chief executive officer at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1409; D6033: Technical Consultant 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 the general supervisor, the laboratory failed to ensure attestation statements were signed by the laboratory director or designee for seven of 26 events. Findings include: (1) On 01/04/2021, the surveyor reviewed 2019 and 2020 proficiency testing records, with the following identified: (a) Second 2019 Microbiology Event - The attestation statement had not been signed by the laboratory director or designee; (b) Second 2020 Microbiology Event - The attestation statement had not been signed by the laboratory director or designee; (c) Third 2020 Microbiology Event - The attestation statement had not been signed by the laboratory director or designee; (d) Second 2020 Hematology/Coagulation Event - Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- The attestation statement had not been signed by the laboratory director or designee; (e) Third 2020 Hematology/Coagulation Event - The attestation statement had not been signed by the laboratory director or designee; (f) Third 2020 Chemistry Core Event - The attestation statement had not been signed by the laboratory director or designee; (g) Second 2020 Immunohematology Event - The attestation statement had not been signed by the laboratory director. (2) The surveyor reviewed the records with the general supervisor. The general supervisor stated on 01/04/2021 at 01:00 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 the general supervisor, the laboratory failed to review and evaluate proficiency testing results for three of 26 events. Findings include: BIASES (1) On 01/04/2021, 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 Chemistry Core Event (i) Cholesterol HDL (High Density Lipoprotein) - 5 of 5 results exhibited a positive bias (aa) Sample CH-06 - SDI of 3.4 (bb) Sample CH-07 - SDI of 2.7 (cc) Sample CH-08 - SDI of 3.9 (dd) Sample CH-09 - SDI of 3.8 (ee) Sample CH-10 - SDI of 3.8 (ii) Triglycerides - 4 of 5 results exhibited a positive bias (aa) Sample CH-06 - SDI of 2.0 (bb) Sample CH-07 - SDI of 2.1 (cc) Sample CH-08 - SDI of 2.4 (dd) Sample CH-09 - SDI of 2.1 (b) Third 2020 Chemistry Core Event (i) Calcium - 5 of 5 results exhibited a positive bias (aa) Sample CH-11 - SDI of 2.3 (bb) Sample CH-12 - SDI of 2.0 (cc) Sample CH-13 - SDI of 2.1 (dd) Sample CH-14 - SDI of 2.2 (ee) Sample CH-15 - SDI of 2.7 (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 general supervisor. The general supervisor stated on 01/04/2021 at 11:30 am the biases had not been addressed. FAILURE (1) On 01/04/2021, the surveyor reviewed 2019 and 2020 proficiency testing records and identified the following failure: (a) First 2020 Hematology Event (i) Urinalysis - The laboratory failed the results for one of two samples (UA-02). (2) The surveyor could not locate any evidence to prove

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/22/18 through 08/24/18. The laboratory was found out of compliance with the following CLIA regulations: 493.1409; D6033: Technical Consultant The findings were reviewed with the chief executive officer and laboratory manager/general supervisor during an exit conference performed at the conclusion of the survey. 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 the laboratory manager/general supervisor, 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) First 2018 Chemistry Core Event (i) Chloride - 3 of 5 results exhibited a positive bias (aa) Sample CH-02 - SDI of 2.3 (bb) Sample CH-03 - SDI of 2.2 (cc) Sample CH-05 - SDI of 2.0 (b) Second 2018 Chemistry Core Event (i) Creatinine - 4 of 5 results exhibited a positive bias (aa) Sample CH-06 - SDI of 3.0 (bb) Sample CH-07 - SDI of 2.2 (cc) Sample CH-08 - SDI of 2.0 (dd) Sample CH-10 - SDI of 3.3 (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/general supervisor who stated the biases had not been addressed. FAILURES (1) During the review of proficiency testing records, the surveyor identified the following failures in which there was no evidence of