Pawhuska Hospital Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/13,14,15,16/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the administrator, technical consultant, laboratory manager, and chief clinical officer during an exit conference performed at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the technical consultant and laboratory manager, the laboratory failed to assess the competency of the technical consultant based on the position responsibilities as listed in subpart M, and the policy failed to define the frequency of assessments were to be performed. Findings include: (1) A review of the laboratory policy and procedure manual identified a written policy for assessing the competency of the technical consultant based on the position responsibilities. The policy did not define the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of February 2022 through the current date identified competencies based on the position responsibilities, had not been performed for the technical consultant listed on the CMS-209; (3) The findings were reviewed with the technical consultant and laboratory manager who stated on 05/15/2024 at 4:45 pm, competency assessments had not been performed for the technical consultant during the review period, and the policy failed to define the frequency of assessments as stated 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 4 -- D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager and testing person #3, the laboratory failed to provide written instructions to clients collecting and referring specimens for testing performed in the laboratory. Findings include: (1) On 05/13 /2024 at 02:15 pm, the laboratory manager and testing person #3 stated the following testing were performed and specimens were transported to the laboratory from nursing homes and home health care agencies: (a) CBC testing using the Sysmex KX-21N analyzer; (b) Routine Chemistry testing using the Siemens Dimension EXL 200 analyzer; (2) Interview with the laboratory manager and testing person #3 on 05/13 /2024 at 02:20 pm confirmed the laboratory did not provide written instructions (i.e., client service manual) to the clients to explain the laboratory's specimen collection and transportation policies. 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 observation and interview with the laboratory manager, central supply manager, and ER (emergency room) nurse the laboratory failed to ensure eight of eight types of blood collection tubes were stored as required by the manufacturer in the central supply room, and failed to ensure seven of seven types of tubes were stored as required by the manufacturer in the ER #3. Findings include: CENTRAL SUPPLY ROOM: (1) Observation of the central supply room and interview with the central supply manager and laboratory manager on 05/14/2024 at 09:00 am, identified the following: (a) Three packages of BD Vacutainer PST Gel and Lithium Heparin tubes, lot 3318898, storage temperature of 4-25 degrees (C) centigrade; (b) One package of BD Vacutainer K2 EDTA 10.8mg tubes, lot # 3318891, storage temperature of 4-25 degrees C; (c) Three packages of BD Vacutainer K2 EDTA 7.2mg tubes, lot # 3289512, storage temperature of 4-25 degrees C; (d) One package of BD Vacutainer K2 EDTA 3.6mg tubes, lot # 3257669, storage temperature of 4-25 degrees C; (e) One package of BD Vacutainer Blood Collection tubes, lot # 3215487, storage temperature of 4-25 degrees C; (f) Two packages of BD Vacutainer SST Blood Collection tubes, lot # 3333244, storage temperature of 4-25 degrees C; (g) One package of BD Vacutainer Sodium Fluoride 10mg Potassium Oxalate 8mg tubes, lot 3222752 storage temperature of 4-25 degrees C; (h) One package of Vacuette 9NC Coagulation Sodium Citrate 3.2% tubes, lot B240133R, storage temperature of 4-25 -- 2 of 4 -- degrees C. (2) Interview with the laboratory manager and the central supply manager on 05/14/2024 at 09:15 am confirmed the laboratory was not monitoring the temperature of the Central Supply Room. EMERGENCY ROOM #3: (1) Observation of the emergency room and interview with the ER nurse and the laboratory manager on 05/14/2024 at 10:00 am, identified the following: (a) Two BD Vacutainer PST Gel and Lithium Heparin tubes 83 units, lot 3163707, storage temperature of 4-25 degrees (C) centigrade; (b) Two BD Vacutainer PST Gel and Lithium Heparin tubes 56 units, lot 3318898, storage temperature of 4-25 degrees C; (c) One Vacuette 9NC Coagulation Sodium Citrate 3.2% tube, lot B231133Y, storage temperature of 4-25 degrees C; (d) One BD Vacutainer K2 EDTA 10.8 mg tube, lot # 2292095, storage temperature of 4-25 degrees C; (e) Two BD Vacutainer K2 EDTA 3.6 mg tubes, lot # 3074254, storage temperature of 4-25 degrees C; (f) One BD Vacutainer Sodium Fluoride 10mg Potassium Oxalate 8mg tubes, lot 3016650 storage temperature of 4-25 degrees C; (g) One BD Vacutainer Sodium Fluoride 10mg Potassium Oxalate 8mg tubes, lot 3257749 storage temperature of 4-25 degrees C; (h) Two BD Vacutainer SST tubes, lot # 333244, storage temperature of 4-25 degrees C. (2) Interview with the ER nurse and the laboratory manager on 05/14/2024 at 10:15 am confirmed temperature was not monitored in the ER room. 48517 Based on observation and interview with the laboratory manager the laboratory failed to ensure one of one Vacutainer brand tubes was stored as required by the manufacturer in the laboratory freezer. Findings include: (1) Observation of the laboratory freezer and interview with the laboratory director on 05/13/2024 at 2:25 pm, identified the following: (a) One Vacutainer K2, EDTA tube, lot # 2347066, storage temperature of 4-25 degrees Celsius. (2) Interview with the laboratory manager on 05/13/2024 at 2:25 pm confirmed the tube was being stored below the manufacterer's stated temperature. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory manager and testing person #3, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 05/13/2024 at 02:30 pm, identified the following expired supplies that appeared to be available for use: (a) 15 BD Vacutainer PST Gel and Lithium Heparin tubes 56 Units, lot 3074294, expired 03 /31/2024; (b) Three BD Vacutainer K2 EDTA 10.8 mg tubes, lot 2259083, expired 02 /29/2024; (c) Two Vacuette 9NC Coagulation Sodium Citrate 3.2% tubes, lot B230433L, expired 03/31/2024. (2) Interview with the laboratory manager and testing person #3 on 05/13/2024 at 02:35 pm confirmed the expired supplies were available for use. 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and laboratory manager, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for one of four persons during the review period of 02/01/2022 through the current date. Findings include: (1) A review of personnel records for four persons performing moderate complexity testing from February 2022 through the current date identified no evidence annual competency evaluations had been performed for one of four persons as follows: (a) Testing Person #4 - Not performed between 02/01/2022 and 09/28 /2023 (2) The records were reviewed with the technical consultant and laboratory manager who stated on 05/14/2024 at 10:55 am, the annual evaluations had not been performed as stated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/10,11/2022 The findings were reviewed with the laboratory manager, technical consultant, and the quality manager during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 29 events. Findings include: (1) On 01/10/2022, the surveyor reviewed 2020 and 2021 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 2021 Chemistry Core Event (i) Cholesterol HDL (High Density Lipoprotein) - 3 of 5 results exhibited a positive bias (aa) Sample CH-02 - SDI of 2.3 (bb) Sample CH-03 - SDI of 3.2 (cc) Sample CH-04 - SDI of 2.0 (dd) Sample CH-05 - SDI of 2.9 (b) First 2021 Chemistry Core Event (i) Albumin - 3 of 5 results exhibited a positive bias (aa) Sample CH-01 - SDI of 2.0 (bb) Sample CH-02 - SDI of 2.3 (cc) Sample CH-04 - SDI of 2.0 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the laboratory manager. The laboratory manager stated on 01/10 /2022 at 01:25 pm the biases had not been addressed. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant and laboratory manager, the laboratory failed to follow the manufacturer's instructions for test timing for Ammonia testing for three of three test reports. Findings include: (1) On 01/10/2022 at 10:10 am, the laboratory manager state to the surveyor: (a) The laboratory performed Ammonia testing using the Siemens Dimension EXL 200. (2) On 01/11/2022, the surveyor reviewed the manufacturer's instructions under the section titled, "Specimen Collection and Handling" the following was identified: (a) Ammonia - "The tube should be completely filled, stored tightly capped on ice, centrifuged immediately and analyzed within 20 minutes. Concentrations may more than double in plasma when stored at room temperature for 6 hours". (3) The surveyor then reviewed patient testing records on 12/06/2021 and 12/09/2021 and identified the following for three of three patient test reports: (a) Ammonia (i) Patient #14240 - The collection date and time was on 12 /06/2021 at 04:10 pm and the result date and time was on 12/06/2021 at 07:05 pm (two hours and 55 minutes later); (ii) Patient #25591 - The collection date and time was on 12/06/2021 at 06:45 pm and the result date and time was on 12/06/2021 at 07: 25 pm (40 minutes later); (iii) Patient #25591 - The collection date and time was on 12 /09/2021 at 05:10 am and the result date and time was on 12/09/2021 at 06:03 am ( 53 minutes later). (4) The surveyor reviewed the findings with the technical consultant and the laboratory manager. The laboratory manager stated on 01/11/2021 at 12:46 pm, the laboratory could not prove the specimen was collected, tested, and resulted as required by the manufacturer. 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 the policy and procedure manual and interview with the laboratory manager, the laboratory failed to follow written procedures for establishing Quality Control ranges for four of four control lot numbers. Findings include: (1) On 0 /10/2022 at 10:10 am, the laboratory manager stated to the surveyor chemistry testing was performed on the Siemens Dimension EXL 200 analyzer; (2) On 05/11/2022, the surveyor reviewed written laboratory procedure titled, "PROCEDURE MANUAL" under the procedure titled, "ESTABLISHING QC RANGES" stated, (a) "1. Before the old lot expires, run each level of the new lot of QC material at least 10 times (over 10 days if possible) and determine the mean for the new lot.". (3) The surveyor reviewed six QC (quality control) lot numbers. For four of four lot numbers there was no indication the laboratory staff followed their written procedure as follows: (a) Bio- -- 2 of 5 -- Rad Liquichek Ethanol/Ammonia Lot# 54361 ran 5 times before put into use; (b) Bio- Rad Liquichek Ethanol/Ammonia Lot# 54363 ran 5 times before put into use; (c) Bio- Rad Liquichek Immunology Control Lot# 68961 ran 5 time before put into use; (d) Bio-Rad Liquichek Immunology Control Lot# 68963 ran 5 time before put into use; (4) The surveyor reviewed the findings with the laboratory manager and technical consultant. The laboratory manager stated on 01/11/2020 at 01:20 pm 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 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, observation, and interview with the technical consultant and laboratory manager, the laboratory failed to follow the manufacturer's instructions for implementing one of one coagulation reagents. Findings include: (1) On 01/10/2022 at 10:20 am, the laboratory manager stated to the surveyor 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); (2) On 01/10/2022 at 10:30 am, the surveyor observed the following: (a) Refrigerator where the testing reagents were maintained and identified the following reagent which appeared to be currently in use: (i) PT - HemosIL Recombiplastin2 reagent, lot #N0512868. (b) Geometric Mean - The analyzer stored a geometric mean of 11.8. (3) The laboratory manager stated to the surveyor on 01/10 /2022 at 10:40 am, the reagent lot number was currently in use, and had initially been put into use as follows: (a) HemosIL Recombiplastin2 reagent - 12/31/2021 (4) On 01 /11/2022, the surveyor reviewed the manufacturer's instructions contained in the "Hemostasis Performance Verification Manual" for implementing new reagents, which stated, "When changing to a new lot number of reagent or a new reagent, it is important to establish a new normal reference interval, establish new assay control ranges, and perform a comparison study for all tests". In addition, the manufacturer required the following: (a) Section titled "Establishing a Normal Reference Interval" (i) "Reference Interval should be established whenever there is a change in: * Instrumentation and/or methodology. * Lot number of reagent. * Sample collection procedures. * At least once a year." (ii) "Reference Intervals should be established for each assay the lab performs."; (iii) "Reference Intervals should be established over several days, at different times of the day, including such variables as age of reagent, different vials of reagent, different operators."; (iv) "Donors should be healthy and have no known pathological conditions. Don't use samples from in-patients (due to medical conditions and treatment regiments). Donors should not be on medication affecting coagulation, including (but not limited to) oral contraceptives, estrogen therapy (HRT), anticoagulants, high-does aspirin, etc."; (v) "Donors should span the adult age range. Pediatric ranges should be established separately."; (vi) "Donors should be equally divided between male/female."; (vii) "If the INR system is utilized to report PT's, note the geometric mean value of the PT normal reference interval in seconds and use along with the lot-specific ISI value in the INR setup calculation page". (b) Under the section, "Results" (i) Determine the mean, standard deviation (SD) and range once the data has been collected. The range is usually defined as the -- 3 of 5 -- mean +/- 2 SD. (5) The surveyor reviewed the implementation records for Recombiplastin2 reagent lot #N0512868 with the following identified: (a) Recombiplastin2 lot #N0512868 (i) Although the laboratory had established a geometric range of 12.1 seconds, there was no evidence the laboratory had entered the value into the analyzer; (ii) There was no evidence the laboratory has defined a range of +/- 2SD. (6) The surveyor reviewed the findings with the technical consultant and laboratory manager. The laboratory manager stated on 01/11/2022 at 01:25 pm, the manufacturer's instructions had not been followed for the reagent lot change as specified above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's reportable ranges, and interview with the technical consultant, the laboratory failed to ensure the reportable ranges were utilized for one of one new test methods. Findings include: (1) On 01/10/2022 at 10: 15 am, the laboratory manager stated the following to the surveyor: (a) The iSTAT 1 analyzer and the EG8+ cartridge were used to perform Blood Gas (pH, pO2, and pCO2) testing. (2) The surveyor reviewed the performance specification records for the two new test systems and identified the laboratory had demonstrated the following reportable ranges for the following: (a) EG8+ (i) pH - 6.5 - 7.877 (ii) pCO2 - 17.80 - 92.30 mmHg (iii) pO2 - 57 - 414 mmHg (3) The surveyor then reviewed the manufacturer's reportable ranges, which were being used by the laboratory. The manufacturer's reportable ranges were as follows: (a) EG8+ (i) pH - 6.50 - 8.20 (ii) pCO2 - 5.0 - 130.0 mmHg (iii) pO2 - 5 - 800 mmHg (4) The surveyor reviewed the findings with the technical consultant, who stated on 01/10/2022 at 03:37 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory as shown 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 laboratory manager and technical consultant, the laboratory failed to make appropriate reference ranges available for two of two patient Hematology reports; and failed to make appropriate therapeutic reference intervals available for one of one patient coagulation report. Findings include: SYSMEX KX-21N (1) On 01/10/2022 at 10:25 am, the laboratory manager -- 4 of 5 -- stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex KX-21N analyzer; (2) On 01/11/2022, the surveyor reviewed two patient CBC reports - the first report was for an adult female patient with the testing performed on 02/05/2021 at 04:03 pm; the second report was for an adult male patient with the testing performed on 02/05/2021 at 11:25 am. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), Hemoglobin, and Hematocrit which were: (a) RBC - 3.6 - 6.00 M/l (b) Hemoglobin - 12.0 - 18.0 g /dL (c) Hematocrit - 36.0 - 55.0 % (3) The surveyor reviewed the findings with the technical consultant. The technical consultant stated on 01/11/2022 at 12:54 pm the patient reports did not include gender specific reference ranges. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. ACL ELITE (1) On 01/11/2022, the surveyor reviewed a patient INR (International Normalized Ratio) report for a patient who had testing performed on 01/10/2022 at 11:58. It did not include a therapeutic range (range for treatment of venous thrombosis, treatment of pulmonary embolism, prevention of systemic embolism, etc); (2) The report was reviewed with the technical consultant and laboratory manager. The laboratory manager and technical consultant stated on 01 /11/2022 at 01:20 pm that INR report did not include a therapeutic range. D6053 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 semiannually during the first year the individual tests patient specimens. 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 persons performing moderate complexity testing had been evaluated semiannually during the first year of testing for one of two persons hired after the previous recertification survey. Findings include: (1) On 01/10/2022, the surveyor reviewed personnel records. The following was identified: (a) Testing Person #5 - The initial training for this person was completed on 10/19/2019. There was no evidence that a semiannual evaluation had been performed (the next competency evaluation had been performed on 10/13/2020). (2) The surveyor reviewed the records with the technical consultant, who stated on 01/10/2022 at 02:15 pm, there were no records to prove the above persons had been evaluated semiannually. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/28/20 through 01/30/20. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager, technical consultant #2, hospital administrator, and chief clinical officer during an exit conference performed at the conclusion of the survey. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant #2, the laboratory failed to test proficiency testing samples the same number of times that patient samples were tested for 1 of 6 events. Findings include: (1) At the beginning of the survey, the laboratory manager and technical consultant #2 stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing using the Sysmex KX-21N analyzer; (2) The surveyor reviewed Hematology proficiency testing records for 6 events (First 2018, Second 2018, Third 2018, First 2019, Second 2019, and Third 2019 Events) and identified a specimen had been tested multiple times for 1 of 4 events as follows: (a) Third 2019 Event (i) Sample HSY-13 was tested two times (11/19/19 at 01:15 pm and 11/19/19 at 01:17 pm) with the results obtained from the first run reported to the proficiency testing program. (3) The surveyor reviewed the records with the laboratory manager and technical consultant #2 and asked if patient samples were tested in the same manner. The laboratory manager and technical consultant #2 stated patient specimens were routinely tested one time and not in duplicate as the proficiency testing specimens had been tested. D3021 REQUIREMENTS FOR TRANSFUSION SERVICES 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 -- CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant #2, the laboratory failed to ensure blood products were stored under appropriate conditions in the blood bank refrigerator for 3 of 35 thermograph charts. Findings Include: (1) On the second day of the survey, the laboratory manager and technical consultant #2 stated to the surveyor the laboratory routinely maintained 2 units of O negative packed red blood cells in the Allegiance S/P Brand blood bank refrigerator. The units were available for emergency patient transfusions (packed red blood cells must be stored at 1-6 degrees Centigrade-C); (2) The surveyor observed the thermograph temperature recorder for the blood bank refrigerator. The refrigerator had a recorder connected to it for continuously recording the temperature on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees Centigrade). Each chart monitored the temperature for a 7 day period; (3) The surveyor reviewed 35 refrigerator charts dated from 04/24/19 through 12/27/19. The review indicated that 3 of 35 charts had not been changed by the 7th day of usage. The findings include: (a) Chart #6 - The chart was put into use on 05/29/19 and removed on 06/06/19 (8 days); (b) Chart #8 - The chart was put into use on 06/12/19 and removed 06/20/19 (8 days); (c) Chart #10 - The chart was put into use on 06/27/19 and removed 07/05/19 (8 days); (4) The surveyor reviewed the charts with the laboratory manager and technical consultant #2, who both stated the charts had not been changed by the 7th day of usage as indicated above. D3021 was cited on the recertification survey performed on 01/29,30,31/18. 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 and technical consultant #2, the laboratory failed to review and evaluate proficiency testing results for 1 of 27 events. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following failure: (a) First 2018 Chemistry Core Event (i) Alcohol (ALC-04) The laboratory received a score of 80% (failed 1 of 5 results). There was no evidence that

Summary Statement of Deficiencies D0000 The survey was performed on 01/29,30,31/2018 The findings were reviewed with the assistant administrator and technical consultant #1 during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1215; D5024: Hematology 493.1403; D6000: Laboratory Director D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with technical consultant #1, the laboratory failed to ensure an adequate alarm system was in place for the blood bank refrigerator. Findings include: (1) On the first day of the survey, technical consultant #1 verified to the surveyors the laboratory routinely maintained 2 units of O negative packed red blood cells in the Allegiance S/P Brand Cryo Frige Series blood bank refrigerator. The units were available for emergency patient transfusions (packed red blood cells must be stored at 1-6 degrees Centigrade-C); (2) Surveyor #1 reviewed the laboratory's written policy for performing alarm checks on the refrigerator. The policy required the alarm checks be performed on a quarterly basis; (3) Surveyor #1 then reviewed the alarm check records for 2016 and 2017. It was identified that 1 of 8 high alarm checks were documented as sounding at a temperature warmer than 6.0 degrees C (the warmest temperature allowed for the storage of packed red blood cells) as follows: (a) 11/01/16 - The temperature sounded Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- at 7.7 degrees C. (4) Surveyor #1 reviewed the records with technical consultant #1 who stated the alarm for the warm alarm check, had sounded at a temperature beyond the acceptable storage for the products as indicated above. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, policies and procedures, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to ensure the requirements were met for the specialty of Hematology. Findings include: (1) The laboratory failed to demonstrate the performance specification of reportable range for a new analyzer. Refer to D5421; (2) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on the coagulation analyzer. Refer to D5429; (3) The laboratory failed to follow their written protocol for ensuring the coagulation centrifuge was functioning properly. Refer to D5435; (4) The laboratory failed to have control procedures that monitored the accuracy and precision of the analytic process for PTT testing. Refer to D5441; (5) The laboratory failed to follow the manufacturer's specifications for establishing normal reference intervals for a new coagulation analyzer. Refer to D5479; (6) The laboratory failed to have an ongoing mechanism for performing quality assessment. Refer to D5791. 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 policies and procedures, and interview with technical consultant #1, the laboratory failed to have written policies and procedures for assessing employee competency. Findings include: (1) On the first day of the survey, surveyor #2 reviewed the laboratory's policies and procedures. A policy that explained how employees were assessed for competency could not be located; (2) Surveyor #2 asked technical consultant #1 if a competency policy was available for review. Technical consultant #1 stated a policy had not been written. NOTE: For non-waived testing, the regulations require initial training, a semiannual evaluation during the first year, and an annual evaluation thereafter for each testing person for ensuring competency. The policy/procedure for evaluating competency must include, but is not limited to: *Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing *Monitoring the recording and reporting of test results *Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records *Direct observation of performance of instrument maintenance and function -- 2 of 12 -- checks *Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples *Assessment of problem solving skills D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to demonstrate the performance specification of reportable range for a new analyzer. Findings include: (1) At the beginning of the survey, technical consultant #1 stated to surveyors the IL ACL Elite analyzer was put into use to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing on 01/21/17; (2) On the third day of the survey, the surveyors reviewed the records of the validation study performed on 12/05/16. There was no evidence the reportable ranges had been demonstrated for PT and PTT; (3) The surveyors asked technical consultant #1 if there was documentation to prove the reportable ranges had been demonstrated. Technical consultant #1 stated there was no documentation which proved the reportable ranges had been demonstrated; (4) Refer to D5479 for examples of patient PT and PTT testing performed when the reportable ranges had not been demonstrated prior to beginning patient testing. 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 and interview with technical consultant #1, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on the hematology analyzer. Findings include: (1) On the first day of the survey, technical consultant #1 stated to the surveyors CBC (Complete Blood Count) testing was performed using the Sysmex KX-21N analyzer; (2) Surveyor #1 reviewed the maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for maintenance were as follows: (a) Monthly (i) Clean Waste Chamber (ii) Clean Transducer (b) Every 3 Months (i) Clean Sample Rotor Valve (SRV) (3) Surveyor #1 then reviewed maintenance records for 19 months (June 2016 through December 2017) with the following identified: (a) The monthly maintenance had not been documented as performed as follows: (i) The Clean Waste Chamber had not been performed during the following months: (aa) June 2017 (bb) August 2017 (cc) September 2017 (dd) November 2017 (ee) December 2017 (ii) The Clean Transducer -- 3 of 12 -- had not been performed during the following months: (aa) May 2017 (bb) July 2017 (cc) August 2017 (dd) October 2017 (ee) December 2017 (4) The surveyors reviewed the records with technical consultant #1 who stated there was no evidence the above maintenance had been performed as required. 39088 Based on a review of records and interview with technical consultant #1, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on the coagulation analyzer. Findings include: (1) On the first day of the survey, technical consultant #1 stated to the surveyors IL ACL Elite analyzer was put into use on 01/21/17 to perform PT/INR (Prothrombin Time/Inertnational Normalized Ratio) and PTT (Partial Thromboplastin Time) testing; (2) Surveyor #2 reviewed the maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for maintenance were as follows: (a) Daily (i) Check Wash R-Emulsion Level (ii) Perform Needle Cleaning Procedure (iii) Priming - 1st shift (iv) Priming - 2nd shift (v) Priming - 3rd shift (b) Weekly (i) Clean instrument (ii) Clean Rinse Reservoir (iii) Clean Waste Line (c) Biweekly (i) Reboot the analyzer (ii) Clean Rotor Holder and Optic Path (d) Monthly (i) Check and Clean Air Filter (ii) Backup/Archive (3) Surveyor #2 then reviewed maintenance records for 11 months (February 2017 through December 2017) with the following identified: (a) The daily maintenance had not been documented as performed as follows: (i) Priming - 1st shift: (aa) February 2017 - Day 8 (bb) May 2017 - Day 21 (cc) June 2017 - Days 1,4 (ii) Priming - 2nd shift: (aa) February 2017 - Days 7,8 (bb) May 2017 - Day 21 (cc) June 2017 - Days 1,4,7,8,13,29 (iii) Priming - 3rd shift: (aa) June 2017 - Days 1,2,3,4,10,11,19,20,21,22 (bb) July 2017 - Day 6 (iv) Check Wash R-Emulsion Level (aa) May 2017 - Day 21 (bb) June 2017 - Days 1,2 (v) Perform Needle Cleaning Procedure (aa) May 2017 - Day 21 (bb) June 2017 - Days 1,2, (b) The weekly maintenance had not been documented as performed as follows: (i) Between 02/28/17 and 04/08/17 (c) The biweekly maintenance had not been documented as performed as follows: (i) Between 02/25/17 and 04/07/17 (ii) Between 10/27/17 and 12/07/17 (d) Monthly maintenance had not been documented as performed as follows: (i) Between 02/25/17 and 04/08/17 (ii) Between 06/10/17 and 08/08/17 (iii) Between 09/09/17 and 12/23/17 (4) The surveyors reviewed the records with technical consultant #1 who stated there was no evidence the above maintenance had been performed as required. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with technical consultant #1, the laboratory failed to follow their written protocol for ensuring coagulation and urine centrifuges were functioning properly. Findings include: COAGULATION CENTRIFUGE (1) On the first day of the survey, technical consultant #1 stated the following to the surveyors: (a) The laboratory began performing PT/INR (Prothrombin Time/International Normalized Ratio) and PTT -- 4 of 12 -- (Partial Thromboplastin Time) testing on the IL ACL Elite analyzer on 01/21/17; (b) The Horizon Model 642 VES centrifuge processed patient specimens at a speed on 3800 rpm (revolutions per minute) for 10 minutes to obtain plasma for testing. (2) On the second day of the survey, surveyor #1 reviewed a policy titled "Laboratory Equipment Maintenance and Function Checks". It stated "The centrifuge(s) speed and spin time will be checked annually with a tachometer to validate the rpm setting. Time will be checked by a timer"; (3) Surveyor #1 reviewed the centrifuge maintenance records. Although the centrifuge speed checks had been performed on 04/01/16 and 08 /03/17, there was no evidence the centrifuge timer had been checked during the review period; (4) Surveyor #1 reviewed the findings with technical consultant #1, who stated the centrifuge timers had not been checked for accuracy during 2016 and 2017. URINE CENTRIFUGE (1) On the first day of the survey, technical consultant #1 stated to the surveyors urine sediment examinations were performed in the laboratory. The specimens were processed in the LW Scientific centrifuge at a speed of 1500 rpm for 5 minutes; (2) On the second day of the survey, surveyor #1 reviewed a policy titled "Laboratory Equipment Maintenance and Function Checks". It stated "The centrifuge(s) speed and spin time will be checked annually with a tachometer to validate the rpm setting. Time will be checked by a timer"; (3) Surveyor #1 reviewed the centrifuge maintenance records. Although the centrifuge speed checks had been performed on 04/01/16 and 08/03/17, there was no evidence the centrifuge timer had been checked during the review period; (4) Surveyor #1 reviewed the findings with technical consultant #1, who stated the centrifuge timers had not been checked for accuracy during 2016 and 2017. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to have control procedures that monitored the accuracy and precision of the analytic process for PTT testing. Findings include: (1) At the beginning of the survey, technical consultant #1 stated the following to surveyors (a) The IL ACL Elite analyzer was put into use to perform PTT (Partial Thromboplastin Time) testing on 01 /21/17; (b) Three levels of control materials were performed each eight hours of patient testing. From 01/21/17 through 12/13/17, the laboratory used Bio-Rad Lyphochek Coagulation control materials. Beginning 12/14/17, the laboratory used HemoSIL control materials; (c) The laboratory established their own means and 2 SD (standard deviation) ranges before new lot numbers of control materials were put into use. (2) On the second day of the survey, the surveyors reviewed quality control (QC) records for testing performed during 01/10/17 through 12/13/17 (during the time the Bio-Rad control materials were in use). The records showed that, although the -- 5 of 12 -- laboratory had established a mean and 2 SD limit of acceptability for level 2 PTT, the package insert mean and limits of acceptability had been used as follows: (a) PTT Level 2 Lot# 78442 - The laboratory had established a mean of 57.6 and limits of acceptability of 52.9-62.3. The laboratory had used a mean of 58.3 and limits of acceptability of 46.7-69.9 to evaluate QC results. (3) The surveyors reviewed the records with technical consultant #1, who stated the laboratory had utilized the package insert mean and limits of acceptability, as indicated above, to evaluate PTT QC results for level 2 from January through December 2017. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to follow the manufacturer's specifications for establishing normal reference intervals for a new coagulation analyzer. Findings include: (1) At the beginning of the survey, technical consultant #1 stated the following to the surveyors: (a) The IL ACL Elite analyzer was put into use to perform PT/INR (Protime/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing on 01/21/17; (b) The previous analyzer, which had been removed from service on 08/11/15, was the Sysmex CA-500 analyzer; (c) Prior to obtaining the ACL Elite analyzer, PT/INR and PTT testing had been sent to the reference laboratory. (2) On the third day of the survey, the surveyors reviewed the manufacturer's instructions for establishing a normal reference interval which stated: (a) "You must decide before starting which type of study to perform. Will you perform a full reference interval study or will you be verifying a previous reference interval? Either 120 or 20 normal donors following these screening guidelines": (i) "Donors should be healthy and have no known pathological conditions. Don't use patients (they are at the hospital for a medical reason). Donors should not be on medication affecting coagulation, including (but not limited to) oral contraceptives, estrogen therapy (HRT), anticoagulants, high dose aspirin, etc. Donors should span the adult age range. Pediatric ranges should be established separately. Donors should be equally divided between male/female". (b) In addition, the instructions stated, "If you choose to do a full reference interval study, test 120 donors. Ideally specimens will be analyzed over a number of days, resulting in values that represent average run- to-run variation. If you choose to verify a range, you may use a 20-donor study under specific conditions. The main conditions are as follows: The original site must have done a full reference range study The original site must have used the identical type of analytical system (method, instrument and reagents)". (3) Based on the manufacturer's guidelines, the surveyors determined an initial 120 sample study was required, then subsequent studies may be performed using 20 samples due to the following: (a) The laboratory had previously used the Sysmex CA-500 analyzer (which was a different analytic system). (4) The surveyors reviewed the implementation records for the analyzer. The following was identified for PT and PTT: (a) The lot numbers that were in use when the analyzer was implemented (and currently in use) were: (i) PT Reagent - RecombiPlasTin 2G lot #N0462242 (ii) PTT Reagent - SynthASil Lot #N0764155 (b) The normal reference intervals had been established for each test performed on the -- 6 of 12 -- analyzer as follows: (i) PT and PTT (aa) 25 donors had been utilized; (bb) For 10 of the donors, there was no evidence of their health status, medication history, age and gender; (cc) For 15 of the donors, 2 were male and 13 were female (not equally divided between male and female). (5) The surveyors reviewed the records with technical consultant #1 who stated the following: (a) The laboratory did not perform the 120 sample study; (b) The laboratory had not documented the health status, medication history, age, and gender for 10 of the donors; (c) The laboratory had not ensured the 15 donors were equally divided between male and female. (6) The following were examples of patient testing performed when the normal reference intervals had not been established for the new analyzer as required: (a) Patient #1 - PT /INR testing performed on 01/27/17 (b) Patient #2 - PT/INR testing performed on 01 /30/17 (c) Patient #3 - PT/INR and PTT testing performed on 02/01/17 (d) Patient #4 - PT/INR testing performed on 02/08/17 (e) Patient #5 - PT/INR testing performed on 02/20/17 (f) Patient #6 - PT/INR testing performed on 02/24/17 (g) Patient #7 - PT /INR testing performed on 03/14/17 (h) Patient #8 - PT/INR testing performed on 03 /20/17 (i) Patient #9 - PT/INR and PTT testing performed on 03/31/17 (j) Patient #10 - PT/INR testing performed on 04/04/17 (k) Patient #11 - PT/INR testing performed on 04/11/17 (l) Patient #12 - PT/INR and PTT testing performed on 04/17/17 (m) Patient #13 - PT/INR testing performed on 04/30/17 (n) Patient #14 - PT/INR testing performed on 05/03/17 (o) Patient #15 - PT/INR testing performed on 05/08/17 (p) Patient #16 - PT/INR and PTT testing performed on 05/24/17 (q) Patient #17 - PT /INR and PTT testing performed on 05/27/17 (r) Patient #18 - PT/INR testing performed on 06/02/17 (s) Patient #19 - PT/INRand PTT testing performed on 06/16 /17 (t) Patient #20 - PT/INR testing performed on 06/29/17 (u) Patient #21 - PT/INR testing performed on 07/11/17 (v) Patient #22 - PT/INR testing performed on 07/18 /17 (w) Patient #23 - PT/INR and PTT testing performed on 07/26/17 (x) Patient #24 - PT/INR testing performed on 08/08/17 (y) Patient #25 - PT/INR and PTT testing performed on 08/16/17 (z) Patient #26 - PT/INR testing performed on 08/23/17 (aa) Patient #27 - PT/INR and PTT testing performed on 08/31/17 (bb) Patient #28 - PT /INR testing performed on 09/10/17 (cc) Patient #29 - PT/INR testing performed on 09 /14/17 (dd) Patient #30 - PT/INR testing performed on 09/20/17 (ee) Patient #31 - PT /INR testing performed on 09/28/17 (ff) Patient #32 - PT/INR testing performed on 10 /09/17 (gg) Patient #33 - PT/INR testing performed on 10/11/17 (hh) Patient #34 - PT /INR testing performed on 10/15/17 (ii) Patient #35 - PT/INR testing performed on 10 /24/17 (jj) Patient #36 - PT/INR testing performed on 10/31/17 (kk) Patient #37 - PT /INR and PTT testing performed on 11/06/17 (ll) Patient #38 - PT/INR testing performed on 11/17/17 (mm) Patient #39 - PT/INR and PTT testing performed on 11 /21/17 (nn) Patient #40 - PT/INR testing performed on 12/04/17 (oo) Patient #41 - PT /INR testing performed on 12/14/17 (pp) Patient #42 - PT/INR and PTT testing performed on 12/17/17 (qq) Patient #43 - PT/INR and PTT testing performed on 12/26 /17 (rr) Patient #44 - PT/INR testing performed on 01/02/18 (ss) Patient #45- PT/INR testing performed on 01/14/18 (tt) Patient #46 - PT/INR testing performed on 01/23 /18 (uu) Patient #47 - PT/INR testing performed on 01/30/18 (vv) Patient #48 - PTT testing performed on 01/30/18 D5781