Weatherford Regional Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/13,14,15,16/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the director of nursing 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 laboratory manager, the laboratory director failed to sign proficiency testing attestation statements for three of 20 proficiency testing events reviewed in 2023 and 2024. Findings include: (1) On 01 /13/2025, a review of 2023 and 2024 proficiency testing events identified the following for three of 20 events: (a) Chemistry/Core 2024 Third Event - The attestation statement had not been signed by the laboratory director; (b) Chemistry /Core 2024 First Event - The attestation statement had not been signed by the laboratory director; (c) Microbiology 2024 Third Event - The attestation statement 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 -- had not been signed by the laboratory director. (2) The findings were reviewed with the laboratory manager, who stated on 01/13/2025 at 02:25 pm, the attestation statements 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 laboratory manager and nursing manager, the facility failed to ensure written policies were followed for preventing transfusion reactions for three of seven units of packed red- blood cells transfused. Findings include: (1) On 1/16/2024 at 09:00 am, the laboratory manager stated blood transfusions were performed by nursing staff; (2) A review of the nursing policy titled, "Blood Product Checkout and General Guidelines for Administration" stated: (a) "Obtain baseline vital signs then"; (b) "Every 15 minutes twice, then"; (c) "Every 30 minutes until the transfusion is complete." (3) A review of transfusion records for seven units transfused, identified the policy had not been followed for three of seven units as follows: (a) Unit #W091024438786 - The transfusion started on 01/14/2024 at 05:20 am and ended at an undocumented time. Vital signs had not been taken as follows; (i) Every 30 minutes until complete - Not taken between 06:35 am and 07:33 am; (ii) There was no completion time documented for this unit. (b) Unit #W091024423690 - The transfusion started on 01 /14/2024 at 01:56 am and ended at 04:32 am. Vital signs had not been taken as follows; (i) Every 15 minutes twice - Not taken between 02:13 am and 02:46 am. (c) Unit # W091024431175 - The transfusion started on 01/02/2025 at 11:34 am and ended at 01:45 pm. Vital signs had not been taken as follows; (i) Every 15 minutes twice - Not taken between 11:34 am and 12:00 pm. (4) The records were reviewed with the laboratory manager and nursing manager who confirmed on 01/16/2024 at 3: 30 pm, the vital signs had not been documented according to policy. 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, the laboratory failed to review and evaluate proficiency testing results for two of five Chemistry proficiency testing events reviewed in 2023 and 2024. Findings include: (1) On 1/13/2025, a review of Chemistry proficiency testing records for 2023 (second and third events) and 2024 (first, second, and third events) identified the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program) for two of five events: (a) Chemistry Core - Third Event 2023 (i) Alcohol - five of five results exhibited a positive bias (aa) Sample ALC-11 - SDI of 2.8 (bb) Sample ALC-12 - SDI of 2.7 (cc) Sample ALC-13 - -- 2 of 6 -- SDI of 3.3 (dd) Sample ALC-14 - SDI of 1.7 (ee) Sample ALC-15 - SDI of 2.6 (ii) Acetaminophen - five of five results exhibited and negative bias (aa) Sample CH-11 - SDI of - 1.3 (bb) Sample CH-12 - SDI of - 1.5 (cc) Sample CH-13 - SDI of - 2.2 (dd) Sample CH-14 - SDI of - 2.2 (ee) Sample CH-15 - SDI of -2.3 (b) Chemistry Core - Third Event 2024 (i) Alcohol - five of five samples exhibited a positive bias (aa) Sample ALC-11 - SDI of 2.8 (bb) Sample ALC-12 - SDI of 3.9 (cc) Sample ALC-13 - SDI of 2.1 (dd) Sample ALC-14 - SDI of 2.5 (ee) Sample ALC-15 - SDI of 2.7 (2) There was no evidence in the records to prove the biases had been identified and addressed; (3) The records were reviewed with the laboratory manager who stated on 11/13/2025 at 01:40 pm, the biases had not been addressed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policy, and interview with the laboratory manager, the laboratory failed to follow their written policy for documentation on the transfusion service record for two of 16 days of patient testing during the review period of January 1, 2025 through the current date. Findings include: (1) A review of blood bank policies and procedures on 01/16/2025, identified a policy titled, "ABO-Rh Policy" which stated the following: (a) "The results of all blood bank testing must be documented in the Blood Bank log and in Epic. This log must be filled in completely for each test performed. Leaving out patient information or testing results can lead to unnecessary clerical errors when entering results into EPIC." (2) A review of the transfusion service record for patients tested from 01/01/2025 through the current date identified the following; (i) 01/02/2025 - The ABO and Rh interpretation had not been documented when unit #W091024436468 and unit #W091024431175 had been tested; (ii) 01/15/2025 - The ABO and Rh interpretation had not been documented when unit #W091024438786 had been tested. (3) The findings were reviewed with the laboratory manager who stated on 01/16/2025 at 10:00 am, the blood bank log had not been documented as required. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of policies and procedures and interview with the laboratory manager, the laboratory failed to ensure five of five policies; and two of two procedure manuals had been approved, signed, and dated by the current laboratory director. Findings include: QUALITY CONTROL PLANS (1) On 01/14/2025 at 10: 00 am, the laboratory manager stated the laboratory performed the following testing and IQCP's (Individualized Quality Control Plans) had been developed for the test systems: (a) Urine drug screen testing using the Med Tox Profile II test system; (b) -- 3 of 6 -- Blood Gas (pH, pCO2, pO2) using the iSTAT 1 analyzer and the EG6+ cartridge; (c) D-dimer testing using the BioSite Triage Meter test system; (d) Clostridium difficile testing using the Solana test system; (e) Campylobacter antigen testing using the Meridian Bioscience Immunocard STAT! test system. (2) A review of the IQCP's identified the QCP's (Quality Control Plans) for the above test systems had not been approved, signed, and dated by the current laboratory director; (3) The records were reviewed with the laboratory manager who stated on 01/14/2025 at 3:00 pm, the QCP's for the test systems had not been approved, signed, and dated by the current laboratory director. PROCEDURE MANUALS Based on a review of procedure manuals and interview with the laboratory manager, the laboratory failed to ensure two of two procedure manuals had been approved, signed, and dated by the current laboratory director. Findings include: (1) A review of two procedure manuals on 01/15 /2025 and 01/16/2025 identified no evidence they had been signed and dated as approved by the current laboratory director as follows: (a) The manual titled "Microbiology Procedure Manual". Examples of procedures contained in the manual were: (i) "Microbiology Quality Control" (ii) "Gram Stain" (iii) Urine Culture" (iv) Blood Culture Procedure" (b) The manual titled, "Chemistry and Special Chemistry". Examples of procedures contained in the manual were: (i) "Serum Beta HCG" (ii) "iSTAT Quality Control Policy and Procedure" (2) The manuals were reviewed with the laboratory manager who stated on 01/16/2025 at 02:00 pm, the manuals had not been signed and dated as approved by the current laboratory director. 48517 Based on a review of procedure manuals and interview with the laboratory manager, the laboratory failed to ensure two of two procedure manuals had been approved, signed, and dated by the current laboratory director. Findings include: (1) A review of two procedure manuals on 01/15/2025 and 01/16/2025 identified no evidence they had been signed and dated as approved by the current laboratory director as follows: (a) The manual titled "Lab Policy and Procedures". Examples of procedures contained in the manual were: (i) "Complete Blood Count" (ii) "Erythrocyte Sedimentation Rate" (iii) "Manual Diffs, NRBC Correction, and slide preparation and review" (iv) "PT and PTT" (v) "Saline replacement procedure for CBC" (b) The manual titled, "Blood bank procedures". Examples of procedures contained in the manual were: (i) "ABO/Rh" (ii) "Weak D Testing" (2) The manuals were reviewed with the laboratory manager who stated on 01/16/2025 at 02:00 pm, the manuals had not been signed and dated as approved by the current laboratory director. D5781

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/28/23 through 03/03/2023. The laboratory was found out of compliance with the following CLIA Conditions: 493.1409; D6033: Technical Consultant 493.1447; D6108: Technical Supervisor The findings were reviewed with the chief executive officer, laboratory director, and laboratory manager 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, the laboratory failed to review and evaluate proficiency testing results for one of three Immunohematology Proficiency testing events reviewed in 2022. Findings include: (1) On 02/28/2023, a review of Immunohematology Proficiency testing records for three events (First 2022, Second 2022, and Third 2022) identified the following failure with no evidence that

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/19,20,21/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager at the conclusion of the survey. 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, manufacturer's instructions, observation, and interview with the laboratory manager and general supervisor #2, the laboratory failed to ensure control materials were stored as required for 34 of 51 days; and failed to ensure the humidity was acceptable for the Microscan Walkaway for 4 of 4 months. Findings include: STORAGE OF CONTROL MATERIALS (1) On 05/21/2021 at 08:40 am, the surveyor observed the contents of the white Whirlpool freezer in the laboratory. The following control materials were being stored in the freezer, with the manufacturer's storage requirements: (a) Bio-Rad Liquichek Unassayed Chemistry controls - 1 box of 12 bottles each of level 1 lot #56951 and level 2 lot #56952; the storage requirement was -20 to -70 degrees C (Centrigrade). (2) The surveyor reviewed temperature records from 04/01/2021 through 05/21/2021. The documented temperatures were warmer than -20 degrees C (the warmest temperature allowed for the materials for 34 of 51 days as follows: (a) April 2021 - 22 of 30 documented temperatures were warmer than -20 degrees C (b) May 2021 - 12 of 21 documented 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 -- temperatures were warmer than -20 degrees C (3) The surveyor reviewed the records with the laboratory manager, who stated on 05/21/2021 at 09:00 am, the freezer temperatures were unacceptable as shown above. HUMIDITY FOR MICROSCAN WALKAWAY (1) On 05/20/021 at 01:00 pm, general supervisor #2 stated to the surveyor the Microscan Walkaway analyzer was used to perform identification and susceptibility testing procedures on culture isolates; (2) The surveyor reviewed the operator's manual contained in the analyzers memory, with the assistance of general supervisor #2. The manufacturer required the humidity be maintained at 30-80%; (3) The surveyor reviewed humidity records for 4 months (January through April 2021). It was identified the documented humidity readings were less than 30% for 4 of 4 months reviewed as follows: (a) January 2021 - 31 of 31 days (b) February 2021 - 28 of 28 days (c) March 2021 - 18 of 31 days (d) April 2021 - 25 of 30 days (4) The surveyor reviewed the records with general supervisor #2 who stated on 05/20/2021 at 01:20, the humidity was not acceptable for the Microscan Walkaway as listed above. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory manager, the laboratory failed to follow the function check protocol to ensure the urine centrifuge was functioning properly for 1 of 2 function checks performed. Findings include: (1) On 05/19/2021 at 09:40 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed microscopic urine sediment examinations; (b) The laboratory used the Drucker Horizon 642 VES centrifuge to process urines at a speed of 1500 rpm (revolutions per minute) for 5 minutes; (2) On 05/20/2021 the surveyor reviewed the function check policy titled, "Centrifuge RPM Verification/Calibration, and Timer Verification" which stated, "Centrifuges timer and RPM nominal setting will be verified yearly"; (3) The surveyor reviewed the centrifuge maintenance records for 2019 and 2020. The following was identified for 1 of 2 checks performed: (a) 08/28/2020 - The speed had been checked at 3190 rpm an the timer had been checked at 10 minutes, which were not the speed and time settings that urine specimens were processed. (4) The surveyor reviewed the findings with the laboratory manager who stated on 05/20/2021 at 09:29 am, the laboratory did not ensure the urine centrifuge was functioning properly as indicated above. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (g) The laboratory -- 2 of 4 -- 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 use control materials of a similar matrix to that of patient specimens 7 of 30 days of patient testing. Findings include: (1) On 05/19/2021 at 09: 30 am, the laboratory manager stated the following to the surveyor: (a) Serum Ketone testing was performed using the Germaine Laboratories Aim Tab ketone tablets; (b) When quality control (QC) testing was performed on the tablets, a negative and a positive urine control was performed instead of blood based (serum/plasma) controls; (c) The QC materials used by the laboratory were Bio-Rad Liquichek Urinalysis control materials Levels 1 & 2. (2) The surveyor reviewed QC and patient Serum Ketone records from 10/13/2020 through 03/23/2021, which showed that patient testing had been performed on 14 days using negative and positive urine controls specimens. The specific days were 10/13,20,23,24,30/2020; 11/03/2020; 12/11/2020; 01/08,15,21,29/2021; 02/09,19/2021, and 03/23/2021; (3) The surveyor reviewed the records with the laboratory manager who stated on 05/19/2021 at 04:00 pm, the laboratory had performed QC using urine controls instead of serum based controls. NOTE: The interpretive guidelines at D5465 (493.1256) state "Control materials of a similar matrix to that of patient specimens should be utilized, if available, and the control materials must be treated in the same manner as patient specimens and go through all analytic test phases." 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 laboratory manager, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different analyzers. Findings include: (1) On 05 /19/2021 at 09:44, the laboratory manager stated to the surveyor Sodium, Potassium, Chloride, CO2, Glucose BUN, and Creatinine testing were performed using two methods: (a) Beckman Coulter DXC AU 700 analyzer as the primary method; (b) iSTAT 1 analyzer and the Chem 8+ cartridge as the back-up method. (2) On 05/20 /2021 the surveyor asked the laboratory manager if the relationship between the test results using the two different analyzers had been evaluated at least twice annually during 2020 and to date in 2021. The laboratory manager stated on 05/20/2021 at 09: 40 am the relationship between the analyzers had not been evaluated. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The -- 3 of 4 -- laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to have a policy for monitoring the effectiveness of their IQCP; and failed to perform reviews to ensure the accuracy of Prothrombin Time calculations. Findings include: IQCP (1) On 05/19/2021 at 09:30 am, the laboratory manager stated the following to the surveyor: (a) Urine drug screen testing was performed using the MedTox Profile II ER test; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP (dated as approved on 05/12/2019), which stated, "This QC Plan will be reviewed for effectiveness at least annually"; (3) The surveyor reviewed records for 2020 and to date in 2021 and could not locate annual QA reviews since the IQCP had been approved on 05/12/2019; (4) ON 05/20/2021, the surveyor reviewed the records with the laboratory manager and asked if there was documentation of QA reviews to evaluate the QCP annually. The laboratory manager stated to the surveyor on 05/20 /2021 at 04:30 pm the QA reviews had not been performed annually as stated in the policy. PROTHROMBIN TIME CALCULATIONS (1) On 05/19/2021 at 10:15 am, the laboratory manager/technical consultant #1 stated the following to surveyor #1: (a) The ACL Elite analyzer was used to perform PT/INR (Prothrombin Time /International Normalized Ratio) testing (the INR was calculated using the PT reference interval mean); (b) The PT reagent, HemoSil RecombiplasTIN 2G reagent, lot #N0696619 was put into use on 01/30/2020. (2) On 05/21/2021, the surveyor reviewed the Normal Patient Mean (PT reference interval mean) that had been programmed into the analyzer, with the assistance of the laboratory manager and reviewed the records for the PT reagent lot change. The surveyor identified that, although the laboratory had followed the manufacturer's instructions for calculating a normal patient geometric mean, they did not ensure the calculated mean had been programmed into the analyzer as required to ensure the accurate calculation of the INR. The following was identified: (a) The geometric mean that had been programmed into the analyzer was 11.3; (b) The geometric mean that had been calculated by the laboratory was 11.03. (3) The surveyor asked the laboratory manager if the laboratory performed QA reviews to check the accuracy of PT calculations, to include ensuring the correct values were programmed into the analyzer. The laboratory manager stated on 05/21/2021 at 10:20 am, the laboratory had not accurately entered the normal patient mean into the analyzer and had not performed QA reviews to verify the values. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/11/19 through 02/14/2019. The findings were reviewed with technical consultant #2/general supervisor #1 at the conclusion of the survey. The laboratory was found to be in compliance with standard- level deficiencies cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2/general supervisor #1, the laboratory failed to ensure proficiency testing attestation statements 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 proficiency testing records. The following was identified for 1 of 28 testing events: (a) Second 2018 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee. (2) The findings were reviewed with technical consultant #2 /general supervisor #1 who stated the attestation had not been signed 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 7 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy and interview with technical consultant #2/general supervisor #1, the laboratory failed to have a written technical consultant and general supervisor competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) On the first day of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017 and 2018. There was no evidence competencies had been performed for the technical consultant and general supervisor, based on their job responsibilities; (2) The surveyor asked technical consultant #2/general supervisor #1 if a written policy to evaluate the technical consultant and general supervisor based on job responsibilities was available. Technical consultant #2/general supervisor #1 stated a policy to evaluate the technical consultant and general supervisor based on job responsibilities had not been written; and competencies had not been performed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2/general supervisor #1, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed the 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 2017 Chemistry Core Event (i) Lipase - 3 of 5 results exhibited a positive bias (aa) Sample CH-01 - SDI of 2.8 (bb) Sample CH-04 - SDI of 2.0 (cc) Sample CH-05 - SDI of 2.2 (ii) Phenytoin - 3 of 5 results exhibited a positive bias (aa) Sample CH-02 - SDI of 2.4 (bb) Sample CH-04 - SDI of 2.9 (cc) Sample CH- 05 - SDI of 2.3 (b) Second 2017 Chemistry Core Event (i) Total Protein - 3 of 5 results exhibited a positive bias (aa) Sample CH-07 - SDI of 2.4 (bb) Sample CH-08 - SDI of 2.6 (cc) Sample CH-09 - SDI of 4.0 (ii) Cholesterol HDL (High Density Lipoprotein) - 4 of 5 results exhibited a positive bias (aa) Sample CH-07 - SDI of 2.5 (bb) Sample CH-08 - SDI of 3.0 (cc) Sample CH-09 - SDI of 3.7 (dd) Sample CH-10 - SDI of 2.1 (iii) Creatinine - 4 of 5 results exhibited a positive bias (aa) Sample CH- 07 - SDI of 3.0 (bb) Sample CH-08 - SDI of 2.7 (cc) Sample CH-09 - SDI of 4.4 (dd) Sample CH-10 - SDI of 2.3 (c) Third 2017 Chemistry Core Event (i) Cholesterol HDL - 5 of 5 results exhibited a positive bias (aa) Sample CH-11 - SDI of 2.4 (bb) Sample CH-12 - SDI of 2.8 (cc) Sample CH-13 - SDI of 2.1 (dd) Sample CH-14 - SDI of 2.8 (ee) Sample CH-15 - SDI of 2.6 (ii) Potassium - 3 of 5 results exhibited a negative bias (aa) Sample CH-12 - SDI of -2.7 (bb) Sample CH-14 - SDI of -2.0 (cc) Sample CH-15 - SDI of -2.4 (iii) Phenobarbital- 3 of 5 results exhibited a negative bias (aa) Sample CH-11 - SDI of -2.3 (bb) Sample CH-13 - SDI of -2.2 (cc) Sample CH-14 - -- 2 of 7 -- SDI of -2.1 (d) First 2018 Chemistry Core Event (i) Albumin - 4 of 5 results exhibited a positive bias (aa) Sample CH-02 - SDI of 2.2 (bb) Sample CH-03 - SDI of 2.0 (cc) Sample CH-04 - SDI of 2.1 (dd) Sample CH-05 - SDI of 2.4 (ii) Cholesterol HDL - 3 of 5 results exhibited a negative bias (aa) Sample CH-01 - SDI of -2.3 (bb) Sample CH-02 - SDI of -2.8 (cc) Sample CH-03 - SDI of -2.0 (iii) Creatinine - 3 of 5 results exhibited a positive bias (aa) Sample CH-01 - SDI of 2.5 (bb) Sample CH-03 - SDI of 2.6 (cc) Sample CH-05 - SDI of 3.2 (e) Second 2018 Chemistry Core Event (i) Albumin - 3 of 5 results exhibited a positive bias (aa) Sample CH-06 - SDI of 2.6 (bb) Sample CH-08 - SDI of 2.6 (cc) Sample CH-09 - SDI of 2.5 (ii) Cholesterol Total - 4 of 5 results exhibited a positive bias (aa) Sample CH-07 - SDI of 2.3 (bb) Sample CH- 08 - SDI of 2.0 (cc) Sample CH-09 - SDI of 2.1 (dd) Sample CH-10 - SDI of 2.1 (iii) Uric Acid - 4 of 5 results exhibited a negative bias (aa) Sample CH-06 - SDI of -4.0 (bb) Sample CH-07 - SDI of -2.2 (cc) Sample CH-08 - SDI of -2.3 (dd) Sample CH- 10 - SDI of -2.6 (f) Third 2018 Chemistry Core Event (i) Total Iron - 5 of 5 results exhibited a positive bias (aa) Sample CH-11 - SDI of 5.5 (bb) Sample CH-12 - SDI of 2.9 (cc) Sample CH-13 - SDI of 3.0 (dd) Sample CH-14 - SDI of 3.3 (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 technical consultant #2/general supervisor #1 who stated the biases had not been addressed. 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 technical consultant #2/general supervisor #1, the laboratory failed to follow written procedures for performing manual differentials. Findings include: (1) On the first day of the survey, technical consultant #2/general supervisor #1 stated to the surveyor manual differential testing was performed in the laboratory; (2) On the third day of the survey, the surveyor requested the manual differential procedure from technical consultant #2 /general supervisor #2; (3) The surveyor reviewed the "Criteria for a manual differential reflex & further review of smears, Correct WBC for nRBCs" which stated, (i) "Manual differential counts or review of slide, will be done on a reflex basis if the automated results, meet any one or more of the following criteria: (ii) "3. Platelet counts of less than 60 or greater than 500 uL/fL" (3) The surveyor reviewed 44 patient records. For 1 of 44 patient records there was no indication the laboratory staff followed their written procedure as follows: (a) Patient #1 tested 12/21/18 at 11:17 am - Platelet result: 514 uL/fL (3) The surveyor reviewed the findings with technical consultant #2/general supervisor #2 who stated that the procedure had not been followed as indicated above. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results -- 3 of 7 -- within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #2/general supervisor #1, the laboratory failed to follow the manufacturer's instructions for Hematology and Coagulation. Findings include: HEMATOLOGY (1) On the first day of the survey, technical consultant #2/general supervisor #1 stated that CBC (Complete Blood Count) testing was performed on the Sysmex XT 4000i analyzer; (2) On third day of the survey, the surveyor reviewed the manufacturer's instructions for verifying morphology flags obtained on the analyzer: (a) "Iron Deficiency?" - " 1. Scan the peripheral smear for the presence of microcytic and hypochromic RBCs." (3) The surveyor randomly reviewed 2 patient records which contained "Iron Deficiency?" flags from CBC testing performed during 12/01 /18 and 12/29/18. For 2 of 2 records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the flags. The findings for the 2 records were: (a) Patient #2 - Testing was performed on 12/26/18 at 07:15 am (b) Patient #3 - Testing was performed on 12/29/18 at 12:14 pm (4) The surveyor reviewed the records with technical consultant #2/general supervisor #1, who stated that the flags obtained for the above 2 patients had not been documented as verified. COAGULATION (1) On the third day of the survey, technical consultant #2/general supervisor #1 stated the following to the surveyor: (a) The IL ACL Elite analyzer was used to perform PTT (Partial Thromboplastin Time) testing; (b) Hemosil PTT Reagent Lot#0587978 was put into use 08/31/18. (2) The surveyor reviewed the manufacturer's Hemostasis Performance Verification Manual instructions for "Changing of Lot Numbers of Reagents", which stated: (a) "2. Perform 'Changing Lot Number of Control' procedure for each test using the new lot numbers of reagent and all related levels of controls." (3) The surveyor reviewed the "Changing Lot Number of Control" procedure which required the following: (a) "1. Ensure all maintenance is current."; (b) "2. Perform at least 20 runs (once per day for 20 days) of each test for each level of control. A greater number of runs may improve the statistics of the assay range. The attached worksheet has space for up to 40 values."; (c) "3. It is good lab practice to run the new lot of material in parallel with the current lot."; (d) "4. Test the control values over several days, using controls and reagents over the time period and conditions under which they would normally be used for patient testing. It is inadvisable to perform testing on all fresh reagents or from the same bottle of control since these conditions will not be representative of how the material will be used, and will result in very tight assay ranges. "; (e) "5. Record the data on the Controls Assay worksheet (attached)."; (f) "6. Calculate the mean and +2 sd range as the target once the materials are put into routine use.". (3) The surveyor reviewed Changing of Lot Numbers of Reagents records and was not able to locate evidence that control assays ranges had been established as required by the manufacturer; (4) The surveyor review the manufacturer's instructions with technical consultant #2/general supervisor #1 who stated the Changing Lot Number of Control procedure had not been performed. 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 -- 4 of 7 -- laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2/general supervisor #1, the laboratory failed to have control procedures that monitored the accuracy and precision of the analytic process. Findings include: BIASES (1) On the third day of the survey, technical consultant #2/general supervisor #1 stated the following to the surveyor: (a) Vitamin B12 and Folate testing were performed using the Beckman Coulter Access II analyzer; (b) Three levels (Level 1, Level 2, and Level 3) of Bio Rad control materials were performed each day of patient testing. (2) The surveyor reviewed quality control records for testing performed between 11/01/18 through 01/31/19. The following biases were identified for level 3 control (Lot# 40963): (a) Vitamin B12 - 32 out of 43 control results were consistently above the established mean; (b) Folate - 39 out of 44 control results were consistently below the established mean. (3) There was no evidence in the records the control biases had been identified and addressed; (4) The surveyor reviewed the records with technical consultant #2/general supervisor #1 and asked if there was documentation to prove the biases had been identified and addressed. The technical consultant #2/general supervisor #1 stated the biases had not been addressed; (5) Since the above biases had not been identified and addressed, the surveyor determined the laboratory failed to have control procedures that monitored the accuracy of testing for the above analytes. CONTROL LIMITS (1) On the first day of the survey, technical consultant #2/general supervisor #1 stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Sysmex XT 4000i analyzer; (b) Three levels (low, normal, and high) of Sysmex e-check XS quality control materials were tested each day that patient testing was performed; (c) The laboratory utilized the Sysmex Evidence Based Control Limits, which were provided by the manufacturer. (2) On the second day of the survey, technical consultant #2/general supervisor #1 assisted the surveyor in reviewing the Sysmex Evidence Based Control Limits that had been entered into the analyzer's Limit Range (%). The surveyor identified the values provided by the manufacturer had not been entered into the analyzer as follows: (a) Low Control (i) RBC (Red Blood Cell) - The manufacturer's Limit Range (%) value was 4.3 and a value of 4.5 had been entered by the laboratory. (ii) Hemoglobin - The manufacturer's Limit Range (%) value was 4.5 and a value of 5.26 had been entered by the laboratory. (iii) Hematocrit - The manufacturer's Limit Range (%) value was 5.2 and a value of 5.95 had been entered by the laboratory. (iv) Platelet - The manufacturer's Limit Range (%) value was 20.9 and a value of 18.97 had been entered by the laboratory. (b) Normal Control (i) RBC (Red Blood Cell) - The manufacturer's Limit Range (%) value was 3.8 and a value of 4.31 had been entered by the laboratory. (ii) Hemoglobin - The manufacturer's Limit Range (%) value was 3.2 and a value of 3.97 had been entered by the laboratory. (iii) Hematocrit - The manufacturer's Limit Range (%) value was 4.6 and a value of 5.88 had been entered by the laboratory. (iv) Platelet - The manufacturer's Limit Range (%) value was 10.6 and a value of 11.37 had been entered by the laboratory. (c) High Control (i) RBC (Red Blood Cell) - The manufacturer's Limit Range (%) value was 3.6 and a value of 4.3 had been entered by the laboratory. (ii) Hemoglobin - The manufacturer's Limit Range (%) value was 2.8 and a value of 4.32 had been entered by the laboratory. (iii) -- 5 of 7 -- Hematocrit - The manufacturer's Limit Range (%) value was 4.5 and a value of 5.88 had been entered by the laboratory. (iv) Platelet - The manufacturer's Limit Range (%) value was 8.1 and a value of 10.83 had been entered by the laboratory. (3) The records were reviewed with technical consultant #2/general supervisor #1. Technical consultant #2/general supervisor #1 did not know where the above ranges came from, but stated they were not ranges that would not detect immediate error. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with technical consultant #2/general supervisor #1, the laboratory failed to follow written quality control policies. Findings include: (1) At the beginning of the survey, technical consultant #2 /general supervisor #1 stated the following to the surveyor: (a) The ImmunoCard STAT! EHEC Rapid test for Shiga toxins 1 and 2 in human stool was performed in the laboratory; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP that had been developed for the test system. The QCP (Quality Control Plan) portion of the IQCP required 2 levels of external quality control materials be tested with each new lot or shipment or every 6 months (whichever is first); (3) The surveyor then reviewed quality control records from January 2017 through July 2018 and identified the laboratory failed to follow the written QCP of performing quality control testing every 6 months. Quality control testing had not been performed between: (a) 11/19/17 and 06/18/18 (4) The findings were reviewed with technical consultant #2/general supervisor #1 who stated the laboratory had not performed quality control testing as required by the QCP. 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 technical consultant #2/general supervisor #1, the laboratory failed to ensure units of FFP (Fresh Frozen Plasma) were stored under appropriate conditions. Findings include: (1) On the second day of the -- 6 of 7 -- survey, technical consultant #2/general supervisor #1 stated to the surveyor units of FFP were stored in the Sanyo Biomedical Freezer. The units were to be used for patient transfusions; (2) The surveyor observed the thermograph temperature recorder for the blood bank freezer. The freezer had a recorder connected to it for continuously recording the temperature on thermograph charts (Note: units of FFP must be stored at -20 degrees Centigrade or colder). Each chart monitored the temperature for a 7 day period; (3) The surveyor reviewed 19 freezer charts dated from 10/02/17 through 02 /05/18. The review indicated that 1 of 18 charts had not been changed by the 7th day of as follows: (a) Chart #8 - The chart was put into use on 11/20/17 and removed on 12 /04/17 (13 days). (4) The surveyor reviewed the charts with technical consultant #2 /general supervisor #1 who stated the 1 chart had not been changed by the 7th day, as indicated above. 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 technical consultant #2/general supervisor #1, 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. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. It was identified for 5 of 28 events, the attestation statements had been signed approximately 2 - 4 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Second 2017 Chemistry Core Event - The samples had been tested on 05/26/17 and the attestation statement had not been signed by the laboratory director until 07/07 /17; (b) Second 2017 Chemistry Miscellaneous Event - The samples had been tested on 10/20/17 and the attestation statement had not been signed by the laboratory director until 01/03/18; (c) First 2017 Microbiology Event - The samples had been tested on 03/06/17 and the attestation statement had not been signed by the laboratory director until 05/08/17; (d) First 2018 Chemistry Core Event - The samples had been tested on 11/29/18 and the attestation statement had not been signed by the laboratory director until 03/06/18; (e) First 2018 Chemistry Miscellaneous Event - The samples had been tested on 04/27/18 and the attestation statement had not been signed by the laboratory director until 06/08/18. (2) The surveyor reviewed the findings with technical consultant #2/general supervisor #1 and explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 7 of 7 --