Atoka County Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/7,8/2025. The laboratory was found out of compliance with the following CLIA Conditions: 493.1210; D5016: Routine Chemistry 493.1403; D6000: Laboratory Director 493.1409; D6033: Technical Consultant The findings were reviewed with the technical consultant, laboratory manager, chief executive officer, and human resource director during an exit conference performed on 01/09/2025. 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 technical consultant and laboratory manager, the laboratory director failed to sign a proficiency testing attestation statement for one of five Immunohematology events reviewed in 2023 and 2024. Findings include: (1) On 01/07/2025, a review of 2023 and 2024 Immunohematology proficiency testing events identified the following for one of five events: (a) First 2024 Event - The attestation statement had not been signed 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 10 -- laboratory director. (2) The findings were reviewed with the laboratory manager and technical consultant. Both stated on 01/07/2025 at 03:25 pm, the attestation statement had not been signed by the laboratory director. 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 and laboratory manager, the facility failed to ensure written policies were followed for preventing transfusion reactions for two of six units of packed red-blood cells transfused. Findings include: (1) On 01/07/2025 at 11:00 am, the technical consultant and laboratory manager stated blood transfusions were performed by nursing staff; (2) A review of the hospital policy titled, "Blood Transfusion" stated, "Check vital signs": (a) "Every 5 minutes for the first 15 minutes" (b) "Every 15 minutes for the first hour" (3) A review of transfusion records for six units transfused identified the policy had not been followed for two of the six units as follows: (a) Unit #W091023352269 - The transfusion started on 12/16/2023 at 09:50 am. The 15 minute vital signs had not been taken as follows: (i) Between 10:05 am and 10:35 am; (ii) Between 10:35 am and 11:05 am. (b) Unit #W091024135193 - The transfusion started on 03/01/2024 at 11:30 am. The 15 minute vital signs had not been taken as follows: (i) Between 12:00 pm and 12:30 pm. (4) The records were reviewed with the laboratory manager who stated on 01/07/2025 at 03:20 pm, the vital signs had not been documented according to policy. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure the requirements were met for the subspecialty of Routine Chemistry for Blood Gas testing on two of two iSTAT 1 analyzers. Findings include: (1) The laboratory failed to demonstrate the performance specifications for Blood Gas testing. Refer to D5421; (2) The laboratory failed to perform calibration verification procedures at least every six months. Refer to D5439; (3) The laboratory failed to have a system that evaluated and defined the relationship between two of two i-STAT 1 analyzers at least twice a year. Refer to D5775. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system -- 2 of 10 -- 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 laboratory failed to demonstrate the performance specifications for two of two replacement i-STAT handheld analyzers. Findings include: (1) On 01/07/2025 at 10: 58 am, the technical consultant stated the laboratory performed arterial and venous blood gas (pH, pO2 and pCO2) testing using two i-STAT 1 handheld analyzers (serial #388665 and serial #386325) and the EG6+ cartridges; (2) Interview with the technical consultant on 01/07/2025 at 02:30 pm, confirmed the laboratory began using analyzer serial #388665 on 01/27/2024 and analyzer serial #386325 on 03/27/2024; (3) A review of records for the test systems identified no evidence the performance specifications (accuracy, precision, and reportable range) had been demonstrated; (4) Interview with the technical consultant on 01/07/2025 at 02:53 pm confirmed the performance specifications had not been demonstrated prior to putting the analyzers into use for patient testing; (5) A review of instrument printouts for blood gas testing performed from January through December 2024 confirmed 248 patients had been reported; (6) The following were examples of patient testing performed when the performance specifications had not been performed: (a) i-STAT 1 ANALYZER SERIAL #386325 (i) Patient # 82105 - testing performed on 03/27/2024 (ii)Patient # 65432 - testing performed on 04/15/2024 (iii) Patient # 84346 - testing performed on 04/19/2024 (iv) Patient # 84530 - testing performed on 04/21/2024 (v) Patient # 84694 - testing performed on 04/22/2024 (vi) Patient #85132 - testing performed on 04 /26/2024 (vii) Patient # 88009 - testing performed on 05/19/2024 (viii)Patient # 88323 - testing performed on 05/22/2024 (ix) Patient # 10128226 - testing performed on 06 /09/2024 (x) Patient # 91487 - testing performed on 06/15/2024 (xi) Patient # 96784 - testing performed on 07/28/2027 (xii) Patient # 99144 - testing performed on 08/16 /2024 (xiii) Patient # 99306 - testing performed on 08/18/2024 (xiv) Patient # 99450 - testing performed on 08/19/2024 (xv) Patient # 3488 - testing performed on 09/19 /2024 (xvi) Patient # 03814 - testing performed on 09/22/2024 (xvii) Patient # 6208 - testing performed on 10/11/2024 (xviii) Patient # 6502 - testing performed on 10/14 /2024 (xix) Patient # 7471 - testing performed on 10/21/2024 (xx) Patient # 1234 - testing performed on 10/25/2024 (xxi) Patient # 8227 - testing performed on 10/26 /2024 (xxii) Patient # 8671 - testing performed on 10/30/2024 (xxiii) Patient # 8821 - testing performed on 10/31/2024 (xxiv) Patient # 8913 - testing performed on 11/01 /2024 (xxv) Patient # 9348 - testing performed on 11/05/2024 (xxvi) Patient # 9643 - testing performed on 11/08/2024 (xxvii) Patient # 10405 - testing performed on 11/14 /2024 (xxviii) Patient # 10486 - testing performed on 11/15/2024 (xxix) Patient # 12004 - testing performed on 11/30/2024 (xxx) Patient # 12230 - testing performed on 12/02/2024 (xxxi) Patient # 13954 - testing performed on 12/14/2024 (xxxii) Patient # 15381 - testing performed on 12/27/2024 (b) i-STAT 1 ANALYZER SERIAL #388665 (i) Patient # 74794 - testing performed on 01/26/2024 (ii) Patient # 74958 - testing performed on 01/27/2024 (iii) Patient # 75695 - testing performed on 02/01 /2024 (vi) Patient # 76322 - testing performed on 02/07/2024 (v) Patient # 77237 - testing performed on 02/14/2024 (vi) Patient # 77292 - testing performed on 02/15 /2024 (vii) Patient # 78492 - testing performed on 02/23/2024 (viii) Patient # 78851 - testing performed on 02/26/2024 (ix) Patient # 10125828 - testing performed on 03/02 -- 3 of 10 -- /2024 (x) Patient # 10125851 - testing performed on 03/03/2024 (xi) Patient # 80032 - testing performed on 03/08/2024 (xii) Patient # 80232 - testing performed on 03/10 /2024 (xiii) Patient # 80028 - testing performed on 03/14/2024 (xiv) Patient # 81949 - testing performed on 03/26/2024 (xv) Patient # 83196 - testing performed on 04/09 /2024 (xvi) Patient # 83313 - testing performed on 04/10/2024 (xvii) Patient # 83551 - testing performed on 04/12/2024 (xviii) Patient # 83648 - testing performed on 04/13 /2024 (xix) Patient # 83680 - testing performed on 04/14/2024 (xx) Patient # 83807 - testing performed on 04/15/2024 (xxi) Patient # 84089 - testing performed on 04/17 /2024 (xxii) Patient # 9999 - testing performed on 04/22/2024 (xxiii) Patient # 85849 - testing performed on 05/03/2024 (xxiv) Patient # 86326 - testing performed on 05/08 /2024 (xxv) Patient # 86769 - testing performed on 05/10/2024 (xxvi) Patient # 87026 - testing performed on 05/12/2024 (xxvii) Patient # 87826 - testing performed on 05/17 /2024 (xxviii) Patient # 88015 - testing performed on 05/19/2024 (xxix) Patient # 88646 - testing performed on 05/23/2024 (xxx) Patient # 89234 - testing performed on 05/28/2024 (xxxi) Patient # 89437 - testing performed on 05/29/2024 (xxxii) Patient # 90123 - testing performed on 06/05/2024 (xxxiii) Patient # 90456 - testing performed on 06/08/2024 (xxxiv) Patient # 91216 - testing performed on 06/13/2024 (xxxv) Patient # 91468 - testing performed on 06/15/2024 (xxxvi) Patient # 91548 - testing performed on 06/16/2024 (xxxvii) Patient # 94727 - testing performed on 07/11/2024 (xxxviii) Patient # 94863 - testing performed on 07/12/2024 (xxxix) Patient # 95794 - testing performed on 07/20/2024 (xl) Patient # 95969 - testing performed on 07/22 /2024 (xli) Patient # 97195 - testing performed on 07/31/2024 (xlii) Patient # 97441 - testing performed on 08/02/2024 (xliii) Patient # 97587 - testing performed on 08/04 /2024 (xliv) Patient # 98277 - testing performed on 08/09/2024 (xlv) Patient # 98521 - testing performed on 08/12/2024 (xlvi) Patient # 98656 - testing performed on 08/13 /2024 (xlvii) Patient # 99553 - testing performed on 08/19/2024 (xlviii) Patient # 15 - testing performed on 08/23/2024 (xlix) Patient # 363 - testing performed on 08/26 /2024 (l) Patient # 554 - testing performed on 08/27/2024 (li) Patient # 01596 - testing performed on 09/06/2024 (lii) Patient # 1901 - testing performed on 09/09/2024 (liii) Patient # 2693 - testing performed on 09/14/2024 (liv) Patient # 2977 - testing performed on 09/16/2024 (lv) Patient # 3499 - testing performed on 09/19/2024 (lvi) Patient # 3607 - testing performed on 09/20/2024 (lvii) Patient # 3927 - testing performed on 09/23/2024 (lviii) Patient # 4377 - testing performed on 09/26/2024 (lix) Patient # 4645 - testing performed on 09/29/2024 (lx) Patient # 5402 - testing performed on 10/05/2024 (lxi) Patient # 0000 - testing performed on 10/15/2024 (lxii) Patient # 7471 - testing performed on 10/21/2024 (lxiii) Patient # 10131564 - testing performed on 10/22/2024 (lxiv) Patient # 8155 - testing performed on 10/25/2024 (lxv) Patient # 8227 - testing performed on 10/26/2024 (lxvi) Patient # 10133119 - testing performed on 12/14/2024 (lxvii) Patient # 14036 - testing performed on 12/15 /2024 (lxviii) Patient # 14293 - testing performed on 12/16/2024 (lxix) Patient # 14568 - testing performed on 12/18/2024 (lxx) Patient # 14815 - testing performed on 12/21/2024 (lxxi) Patient # 15298 - testing performed on 12/27/2024 (lxxii) Patient # 15576 - testing performed on 12/29/2024 (lxxiii) Patient # 15634 - testing performed on 12/30/2024 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 -- 4 of 10 -- 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 the technical consultant, the laboratory failed to define a written function check protocol to ensure the urine centrifuge was functioning properly during the review period of February 2023 through the current date. Findings include: (1) On 01/07/2025 at 11:15 am, the laboratory manager stated the laboratory performed urine microscopic testing and urine specimens were processed at a speed of 1500 rpm (revolutions per minute) for 5 minutes using the Drucker Company model 614V centrifuge; (2) A function check protocol that defined the frequency of the urine centrifuge speed and timer checks and the acceptable limits for the checks could not be located; (3) Interview with the technical consultant on 01/07/2025 at 02:59 pm confirmed the laboratory did not have a written function check protocol but the centrifuge was checked semi-annually; (4) A review of centrifuge records from February 2023 through the current date identified the following: (a) 02/21/2023 - Although the speed had been documented as checked at 1500 rpm, there was no documentation the timer had been checked; (b) 02/21/2024 - Although the speed had been documented as checked at 1500 rpm, there was no documentation the timer had been checked; (c) 08/21/2024 - Although there was a record for this date, the actual speed and time obtained had not been recorded. (5) The findings were reviewed with the technical consultant who stated on 01/07/2025 at 02: 59 pm, the laboratory did not have a written function check protocol for the urine centrifuge and the checks 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 technical consultant, the -- 5 of 10 -- laboratory failed to perform calibration verification procedures at least once every six months for two of two i-STAT 1 test systems during the review period of January 2024 through the current date. Findings include: (1) On 01/07/2025 at 10:58 am, the technical consultant stated the laboratory performed arterial and venous blood gas (pH, pO2 and pCO2) testing on two i-STAT 1 analyzers (serial #388665 and serial #386325) using the EG6+ cartridges; (2) A review of records from January 2024 through the current date identified no evidence the calibration verification procedures had been performed for the test systems prior to 12/09/2024; (3) The findings were reviewed with the technical consultant, who stated on 01/07/2025 at 03:02 pm, the calibration verification procedures had not been performed every six months 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 technical consultant, the laboratory failed to perform positive and negative control materials for one of two days of patient serum pregnancy testing reviewed from January through December 2024. Findings include: (1) On 01/07/2025 at 11:00 am, the technical consultant stated the laboratory performed qualitative pregnancy testing using the Quidel QuickVue One Step Combo test kit on serum samples; (2) A review of QC (Quality Control) and patient testing records for testing performed from January through December 2024 identified positive and negative QC materials had not been performed one of two days of patient testing (12/29/2024); (3) The records were reviewed with the technical consultant who stated on 01/07/2025 at 12:30 pm, QC materials had not been performed each day 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 and interview with the technical consultant and laboratory manager, 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 eight emergency release forms reviewed. Findings include: (1) On 01/07/2025 at 11:00 am, the technical consultant and laboratory manager stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for patient transfusions; (2) A review of "Emergency -- 6 of 10 -- Request for Uncrossmatched Blood Products" forms dated 09/21/2023 through 10/09 /2024 identified two of eight forms had not been signed by a physician for the following: (a) One unit of O negative packed red blood cells had been released to a patient on 09/21/2023; (b) One unit of O negative packed red blood cells had been released to a patient on 10/09/2024. (3) The documentation was reviewed with the laboratory manager who stated on 01/07/2024 at 02:45 pm, the emergency releases as stated above, had not been signed by a physician. 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 evaluated and defined the relationship between two of two i-STAT 1 analyzers at least twice a year during the review period of January 2024 through the current date. Findings include: (1) On 01/07/2025 at 10:58 am, the technical consultant stated the laboratory performed arterial and venous blood gas (pH, pO2 and pCO2) testing using two i-STAT 1 handheld analyzers (serial #388665 and serial #386325) and the EG6+ cartridges; (2) On 01/08/2025 a review of records for the testing from January 2024 through the current date identified no evidence the relationship between the test results using the two analyzers had been evaluated at least twice annually prior to 12/09/2024; (3) The findings were reviewed with the technical consultant, who stated on 01/08/2025 at 10:52 am, the relationship between the analyzers had not been evaluated as stated above. 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 review of records and interview with the technical consultant, the laboratory director failed to provide overall management and direction during the review period of January 2024 through the current date. Findings include: (1) The laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Refer to D6013; (2) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services during the review period of January 2024 through the current date. Refer to D6020. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) -- 7 of 10 -- 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Findings include: (1) The laboratory director failed to ensure the laboratory demonstrated performance specifications for two of two replacement i-STAT handheld analyzers. Refer to D5421. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Findings include: (1) The laboratory director failed to ensure calibration verification procedures were performed at least once every six months for two of two i-STAT 1 test systems. Refer to D5439; (2) The laboratory director failed to ensure a system was in place that evaluated and defined the relationship between two of two i-STAT 1 test systems. Refer to D5775. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure that verification procedures were adequate to determine the performance characteristics. Refer to D6040; (2) The technical consultant failed to ensure the laboratory participated in a proficiency testing program commensurate with the services offered for Hemoglobin A1c testing. Refer to D6041; (3) The technical consultant failed to -- 8 of 10 -- establish a quality control program which ensured the establishment and maintenance of acceptable levels of analytic performance. Refer to D6042. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to ensure that verification procedures were adequate to determine the performance characteristics. Findings include: (1) The technical consultant failed to ensure the laboratory demonstrated performance specifications for two of two replacement i-STAT handheld analyzers. Refer to D5421. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to participate in a proficiency testing program commensurate with the services offered for Hemoglobin A1c testing for five of five events reviewed in 2023 and 2024. Findings include: (1) On 01/07/2025 at 11:45 am, the technical consultant stated Hemoglobin A1c testing was performed using the Beckman Coulter AU 480 analyzer; (2) A review of Chemistry Core proficiency testing records for 2023 (second and third events) and 2024 (first, second, and third events) identified for five of five events, the laboratory had participated using the method code for the Siemens Dimension analyzer instead of the Beckman Coulter AU 480 analyzer; (3) The records were reviewed with the technical consultant who stated on 01/07/2025 at 12:15 pm, the laboratory had participated in proficiency testing using the incorrect method code for Hemoglobin A1c testing. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to establish a quality control program which ensured the -- 9 of 10 -- establishment and maintenance of acceptable levels of analytic performance. Findings include: (1) The technical consultant failed to ensure calibration verification procedures were performed at least once every six months for two of two i-STAT1 test systems. Refer to D5439; (2) The technical consultant failed to ensure a system was in place that evaluated and defined the relationship between two of two i-STAT 1 test systems at least twice a year prior. Refer to D5775. -- 10 of 10 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/06,07,08/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief operating officer, compliance, technical consultant, and laboratory manager during an exit conference performed at the conclusion of the survey. 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 technical consultant, the laboratory director failed to sign a proficiency testing attestation statement for one of five Immunohematology proficiency testing events reviewed. Findings include: (1) On 02/06/2023, a review of the 2021 and 2022 Immunohematology proficiency testing records identified the following for one of five events: (a) Second 2021 Immunology/Immunohematology Event - The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the technical consultant who stated on 02/07/2023 at 10:00 am the attestation statement had not been signed by the laboratory director. 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 -- 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 Post Vasectomy Qualitative Semen Analysis (presence or absence). Findings include: (1) On 02/06 /2023 at 10:00 am, the technical consultant stated the laboratory performed Post Vasectomy Qualitative Semen Analysis; (2) A review of the test volume list completed for the survey identified the laboratory performed approximately one Post Vasectomy Qualitative Semen Analysis annually; (3) A review of the manual titled "Laboratory Policy and Procedure Manual" identified no evidence of a written procedure for Post Vasectomy Qualitative Semen Analysis; (4) The findings were reviewed with the technical consultant who stated on 02/06/2023 at 10:10 am, the laboratory did not have a written procedure for performing the analysis. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/14,15,16/2021. The laboratory was found out of compliance with the following CLIA regulation: 493.801; D2000: Enrollment and Testing of Samples The findings were reviewed with the technical consultant, laboratory manager, testing person #2, chief nursing officer, and chief executive officer at the conclusion of the survey. 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 and interview with the technical consultant, the laboratory failed to enroll in a proficiency testing program for Uric Acid testing. Findings include: (1) On 06/14/2021 at 01:15 pm, the technical consultant stated to surveyor #1 the laboratory performed Uric Acid testing beginning 07/13/2020; (2) Surveyor #2 reviewed proficiency testing records for 2019, 2020, and 2021, but could not locate any evidence the laboratory had enrolled in an HHS approved proficiency testing program until the first 2021 Chemistry Core Event, which was tested in the laboratory on 01/30/2021 and 02/01/2021; (3) On 06/15/2021, surveyor #2 reviewed the findings with the technical consultant. On 06/15/2021 at 03:52 pm, the technical consultant stated the laboratory had not enrolled in a proficiency testing program as indicated above. 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 -- 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 technical consultant, the laboratory failed to ensure attestation statements were signed by the laboratory director or designee for one of 26 events. Findings include: (1) On 06/14/2021, surveyor #2 reviewed 2019, 2020, and 2021 proficiency testing records, with the following identified: (a) First 2020 Hematology/Coagulation Event - The attestation statement had not been signed by the laboratory director or designee; (2) Surveyor #2 reviewed the records with the technical consultant. The technical consultant stated on 06/14/2021 at 03:40 pm the attestation statement had not been signed by the laboratory director or designee 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 technical consultant, the laboratory failed to review and evaluate proficiency testing results for one of 27 events. Findings include: (1) On 06/14/2021, surveyor #2 reviewed 2019, 2020, and 2021 proficiency testing records and identified the following failures: (a) First 2020 Chemistry Core Event (i) ProBNP - The laboratory failed the results for one of 5 samples (CM-02). (2) Surveyor #2 could not locate evidence in the records proving the failures had been addressed; (3) Surveyor #2 reviewed the records with the technical consultant, and asked if

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/27,28,29/18. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the hospital chief executive officer, chief nursing officer, technical consultant, and laboratory supervisor during an exit conference performed at the conclusion of the survey. 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 technical consultant, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 Hematology proficiency testing records. The following was identified for 1 of 5 testing events: (a) Third 2017 Hematology Event - The attestation was not signed by the laboratory director or designee. (2) The findings were reviewed with the technical consultant who stated the attestation statement had not been signed. 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 -- 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 a written policy, and interview with the technical consultant, the laboratory failed to follow a written policy. Findings include: (1) On the first day of the survey, the technical consultant stated the following to the surveyor: (a) PT/INR and PTT testing were performed on the ACL Elite analyzer; (b) The laboratory had a policy to ensure the specimens tested on the analyzer were platelet poor. (2) On the second day of the survey, the surveyor reviewed the policy titled, "Platelet Poor Plasma Procedure" which stated, "Twice annually the lab will validate that platelet poor plasma is being achieved. Routine patient samples will be collected and processed as described above. The processed plasma sample will be tested on the hematology instrument to determine the platelet count. At least 5 samples will be tested for each validation period. Platelet counts should be less than 10,000. If the test determines the plasma is not platelet poor, centrifuge speed/time will be adjusted. The validation will be recorded and maintained for at least 2 years"; (3) The surveyor then reviewed records for 2017 and 2018 and identified the platelet-poor plasma checks had not been performed twice annually as required by policy, instead, the checks had been performed on an annual basis (the checks had been performed on 11/07/17 and 11/13/18: (4) The surveyor reviewed the records and policy with the technical consultant who stated the laboratory had not followed their written policy. 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 follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor *CMP, *Lipid Profile, Amylase, PBNP (Pro B-type Natriuretic Peptide), CK, Phosphorus, Lipase, Magnesium, Uric Acid, CKMB, Troponin I, Hemoglobin A1c, TSH (Thyroid Stimulating Hormone), Acetaminophen, Alcohol, and Salicylate testing were performed on the Siemens Dimension EXL 200 analyzer; (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements were as follows: (a) Weekly (i) Clean Outside of R2 Probe (ii) Clean Outside of HM Wash Probes (b) Monthly (i) Replace IMT Pump Tubing (ii) Clean IMT System (iii) Replace/Clean Air Filters (iv) Stylette HM Wash Probes (v) Replace HM Pump Heads (vi) Clean R2 Drain (3) The surveyor then reviewed maintenance records for the analyzer from May 2017 through October 2018. The following was identified: (a) Weekly - Not -- 2 of 6 -- documented as performed between: (i) 07/18/17 and 08/01/17 (ii) 08/24/17 and 09/25 /17 (iii) 05/24/18 and 06/06/18 (iv) 08/20/18 and 09/06/18 (b) Monthly - The following had not been documented as performed for 3 of 18 months: (i) May 2017 - Replace IMT Pump Tubing, Clean IMT System, Replace HM Pump Heads, and Clean R2 Drain; (ii) September 2017 - Replace IMT Pump Tubing, Clean IMT System, Replace/Clean Air Filters, Stylette HM Wash Probes, Replace HM Pump Heads, and Clean R2 Drain; (iii) March 2018 - Replace/Clean Air Filters and Clean R2 Drain. (3) The surveyor reviewed the records with the technical consultant who stated the above maintenance procedures had not been documented as being performed as required. *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), BUN (Blood Urea Nitrogen), Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein *Lipid Profile - Cholesterol, HDL Cholesterol, Triglyceride 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 technical consultant, the laboratory failed to perform calibration verification procedures at least once every 6 months. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor Chloride, Potassium, Sodium testing were performed using the Siemens Dimension EXL 200 analyzer; (2) On the second day of the survey, the surveyor reviewed calibration verification records for Chloride, Potassium, and Sodium (since routine calibration procedures were performed using less than three calibrators for the above analytes, calibration verification procedures, using three or more levels of calibration materials, were required every 6 months). There was no evidence calibration verification procedures had been performed prior to or after 02/06 /18; (3) The surveyor reviewed the records with the technical consultant who stated calibration verification had not been performed every 6 months during 2017 and to date in 2018. -- 3 of 6 -- 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 technical consultant and laboratory supervisor, the laboratory failed to perform a negative and positive control material each day of patient testing. Findings include: SERUM PREGNANCY TESTING (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory performed Serum Pregnancy testing using the Quidel QuickVue One Step hCG test kit; (2) The surveyor asked the technical consultant if an IQCP (Individualized Quality Control Plan) had been developed for the test system. The technical consultant stated to the surveyor at 1:25 pm that an IQCP had not been developed. Therefore, the surveyor determined negative and positive QC (quality control) materials must be performed each day of patient testing; (3) The surveyor reviewed QC and patient testing records from January 2018 through the first day of the survey. The review indicated negative and positive QC materials had not been performed 9 of 9 days of patient testing reviewed. The specific days were 02/22/18, 03 /28/18, 04/04/18, 05/10/18, 06/26/18, 07/04/18, 08/09/18, 08/27/18, and 10/16/18; (4) The surveyor reviewed the records with the technical consultant, who stated negative and positive QC materials had not been performed each day of patient testing. SERUM KETONE TESTING (1) On the first day of the survey, the technical consultant stated to the surveyor Serum Ketone testing was performed using the Germaine Laboratories Aim Tab Ketone tablets; (2) The laboratory supervisor stated to the surveyor at 1:47 pm that negative and positive QC materials were not performed each day of patient testing; (3) The surveyor requested serum Ketone test records from January 2018 through the first day of the survey. For 2 of 2 days of patient testing, a negative and positive control had not been performed. The specific days were 02/14/18 and 08/05/18: (4) The surveyor reviewed the findings with the technical consultant and laboratory supervisor. Both stated an IQCP (Individualized Quality Control Plan) had not been developed for the test system. 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, policies and procedures, and interview with the technical consultant, the laboratory failed to ensure that blood products were stored under appropriate conditions. Findings include: (1) On the first day of the survey, the -- 4 of 6 -- technical consultant stated to the surveyor units of packed red blood cells, which were stored in the blood bank refrigerator, were used for patient transfusions; (2) The surveyor reviewed the "Blood Bank Procedure Manual" and identified a procedure titled, "Blood Bank Alarm Checks" which stated, "The alarm on the refrigerator used to store blood is checked quarterly for proper functioning. The high and low temperatures of activation are checked and results recorded. AABB Standards require the alarm setting to activate at a temperature that will allow intervention before the blood or components reach an undesirable temperature. The acceptable range is 1 to 6 degrees Celsius. The alarm is set to sound at 2 degrees Celsius for low alarm and 5.5 degrees Celsius for the high alarm"; (2) The surveyor reviewed alarm check records from January 2017 through the first day of the survey, with the following identified: (a) The alarm checks had not been performed on a quarterly basis (every 3 months) as follows: (i) 2017 - Alarm checks had not been performed during the second quarter (not performed between 03/02/17 and 08/09/17). (b) The high alarm check result sounded at a temperature warmer than 6.0 degrees C-Centigrade (the warmest allowable temperature for blood products) as follows: (i) 2018 - The temperature for the alarm check performed on 07/03/18 sounded at 6.7 degrees C. (3) The surveyor reviewed the records with the technical consultant who stated the alarm checks had not been performed on a quarterly basis in 2017, and the high alarm had sounded at a temperature beyond the acceptable storage for the products as indicated above. 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 technical consultant, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed using Sysmex XS 1000i analyzer; (2) On the second day of the survey, the surveyor reviewed two patient CBC reports - the first report was for an adult male patient with the testing performed on 11/27/17 at 07:49 am; the second report was for an adult female patient with the testing performed on 10/31/18 at 09:31 am; (3) Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell) and Hemoglobin which were: (a) RBC - 4.69 - 6.13 10^6/L (b) Hemoglobin - 14.1 - 18.1 g/dL (4) The surveyor viewed the findings with the technical consultant who stated the patient reports did not include gender specific reference ranges for RBC and Hemoglobin. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to ensure evaluations included all moderate complexity testing performed. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor wet prep analysis was performed in the laboratory: (2) The surveyor then reviewed personnel records for 2 persons performing wet prep analysis in the laboratory (the laboratory supervisor/testing person #1 and testing person #2) The records verified that evaluations had been performed as follows: (a) Laboratory Supervisor/Testing Person #1 - Performed on 08/09/17 and 08/29/18 (b) Testing Person #2- Performed on 08/24/17 and 08/29/18 (3) There was no evidence the evaluations, performed for the above persons, included an assessment of Wet Prep analysis; (4) The surveyor reviewed the findings with the technical consultant, who stated the above evaluations did not include Wet Prep analysis. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the technical consultant and laboratory supervisor, testing personnel failed to follow the laboratory's policy for performing patient testing. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor manual differential testing was performed in the laboratory; (2) On the second day of the survey, the surveyor reviewed the manual differential policy. Under the heading "Differential Count" it stated, "The number of cells counted depends on the leukocyte count. 100 cells should be counted when the leudocyte count is normal"; (3) The surveyor randomly reviewed patient records that included manual differential results, for testing performed in February, April, July, and October 2018, and identified testing personnel had not followed the policy for 1 patient: (a) The patient specimen had been tested on 10/31/18 and met the laboratory criteria for performing a 100 cell count manual differential. The reported WBC (White Blood Cell) count from the manual differential testing did not equal 100, instead the WBC count from the manual differential was reported as 102; (4) The surveyor reviewed the report with the technical consultant and laboratory supervisor. Both stated testing personnel did not follow the laboratory policy for the patient. -- 6 of 6 --