Mercy Hospital Healdton, Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/26,27,28/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, technical consultant, administrator, and testing person #4 during an exit conference performed at the conclusion of the survey. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, policy and interview with the technical consultant, the facility failed to ensure written policies were followed for preventing transfusion reactions for three of seven units reviewed. Findings include: (1) On 06/27/2024 at 11: 00 am, the technical consultant stated the laboratory performed transfusion services for emergency release blood and blood products that have been tested by Mercy Hospital Ardmore; (2) The policy "Administration Transfusion of Blood or Blood Products" defined the parameters for ensuring safe administration of blood or blood products for transfusion therapy; (3) The surveyor reviewed the policy which stated, "Assess, obtain vital signs, and monitor for signs and symptoms of transfusion reaction": (a) "Within 30 minutes before transfusion begins"; (b) "Within 10-15 minutes after the start of transfusion" (c) "At the end of the transfusion, but not more than 60 minutes after the transfusion has been discontinued"; (d) "Continue to assess and monitor the patient for signs and symptoms of a delayed transfusion reaction for 4- 6 hours after the transfusion. If outpatient, provide patient teaching about signs and symptoms of a delayed transfusion reaction". (4) A review of transfusion records for seven units of blood transfused identified for three of seven units transfused, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- policy was not followed by nursing personnel: (a) Unit #W09102322015 - The unit was started at 2:12 pm and ended at 4:17 pm. There were no vitals documented for the 4-6 hour post transfusion assessment; (b) Unit #W091024129278 - The unit was started at 6:23 pm and ended at 8:55 pm. There were no vitals documented for the 4-6 hour post transfusion assessment; (c) Unit #W091024242316 - The unit was started at 1:32 pm and ended at 4:06 pm, there were no vitals documented for the 4-6 hour post transfusion assessment. (5) Interview with the technical consultant on 06/27/2024 at 11:00 am confirmed the facility failed to ensure the policy was being followed as written. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to evaluate the accuracy of testing when a proficiency result had not been graded by the proficiency testing program for two of seven Hematology /Coagulation events reviewed from August 2022 through the current date. Findings include: (1) A review of Hematology/Coagulation proficiency testing records for the period of 2022 through 2024 identified the following for two of seven events: (a) Third 2022 Event - four of four results had not been graded by the proficiency testing program for Educational Blood Cell Identification (samples DIF-03). There was no documentation to prove the laboratory performed a self-evaluation of the non-graded results. (b) Second 2023 Event - 11 of 11 results had not been graded by the proficiency testing program for Educational Blood Cell Identification (samples DIF- 02) and (samples ECI-06, ECI-07, ECI-08, ECI-09, and ECI-10). There was no documentation to prove the laboratory performed a self-evaluation of the non-graded results. (2) The records were reviewed with the technical consultant who stated on 06 /26/2024 at 2:23 pm, the laboratory had not performed a self-evaluation to evaluate the non-graded results. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of written policies and procedures and interview with the technical consultant and testing person #4, the laboratory failed to have a written procedure for two of two i-STAT1 test systems. Findings include: (1) On 06/26/2024 at 10:45 am, the technical consultant and testing person #4 stated the laboratory performed arterial and venous blood gases (pH, pO2 and pCO2) on i-STAT1 analyzer (SN373548) using -- 2 of 4 -- the EG6+, and Troponin I testing using the cTnI cartridges; (2) A review of the test volume list completed for the survey identified the laboratory performed approximately 546 blood gas and 781 troponin I tests annually; (3) A review of the laboratory policies and procedures identified no evidence of a written procedure for i- STAT EG6+ and cTNI test systems; (4) The findings were reviewed with technical consultant #1 who stated on 06/27/2024 at 3:00 pm, the laboratory did not have a written procedure for performing the test. 48517 Based on a review of policies and procedures and interview with the technical consultant, the laboratory failed to have a written procedure that explained the current practices and procedures for two of three procedures reviewed. Findings include: URINALYSIS (1) On 06/26/2024 at 02:57 pm, the technical consultant stated the laboratory performed urine microscopic testing by spinning them at 1500 revolutions per minute (RPM) for five minutes and examining the sediment using the Kova system; (2) A review of the policy titled, "Urinalysis - Microscopic Exam policy and procedure" stated to centrifuge the sample for five minutes at 2500 RPM; (3) A review of the Kova system package insert stated to centrifuge at a relative centrifugal force (RCF) of 400 for five minutes (approximately 1500 RPM); (4) The findings were reviewed with the technical consultant, who stated on 06/26/2024 at 03:00 pm, the urine microscopic procedure did not reflect their current practice. BLOOD BANK (1) On 06/27/2024 at 03:30 pm, the technical consultant stated the laboratory performed blood bank alarm checks electronically for the Cardinal blood bank refrigerator; (2) A review of the policy titled, "Blood Bank Refrigerator Temperature Check" stated to place the thermocouple into a salt/ice solution to check the low alarm and into a pan with 12-15 degree Celsius water to check the high alarm; (3) The findings were reviewed with the technical consultant, who stated on 06/27/2024 at 03:30 pm, the blood bank refrigerator temperature check procedure did not reflect their current practice. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and testing -- 3 of 4 -- person #4, the laboratory failed to perform calibration verification procedures at least once every six months for two of two i-STAT1 test systems during the review period of 05/11/2022 through the current date. Findings include: (1) On 06/26/2024 at 10:45 am, the technical consultant and testing person #4 stated the laboratory performed arterial and venous blood gas (pH, pO2 and pCO2) on i-STAT1 analyzer (SN373548) using the EG6+, and Troponin I testing using the cTnI cartridges; (2) A review of records from 05/11/2022 through the current date identified no evidence the calibration verification procedures had been performed for the EG6+ and cTnI test systems; (3) The findings were reviewed with the technical consultant and testing person #4, who stated on 06/27/2024 at 01:13 pm, the calibration verification procedures had not been performed every six months as stated above. 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. 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 personnel performing moderate complexity testing had been evaluated at least annually for one of nine persons during the review period of May 10, 2022 through the current date. Findings include: (1) A review of personnel records for nine persons performing moderate complexity testing from May 2022 through the current date identified no evidence annual competency evaluations had been performed for one of nine persons and follows: (a) Testing person #7 - not performed in 2022 (2) The records were reviewed with the technical consultant who stated on 06/26/2024 at 10:00 am, the competency for testing person #7 had not been performed as stated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/09,10/2022 The findings were reviewed with the laboratory director, laboratory consultant #1, laboratory consultant #2, technical consultant, testing person #4, and hospital administrator during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with laboratory consultant #1, the laboratory failed to follow the manufacturer's instructions for Lactic Acid testing for one of six test reports. Findings include: (1) On 05/10/22 at 10:15 am, laboratory consultant #1 stated Lactic Acid testing was performed on the Cobas C311 analyzer; (2) A review of the manufacturer's instructions for the analyzer stated: (a) "Specimen collection and preparation" (i) "Centrifuge within 15 minutes of collecting the specimen."; (b) "cobas c 311 test definition" (i) "Reaction time" 10 minutes (3) A review of patient testing records on 04 /04/22, 04/15/2022, 04/20/2022, 04/21/2022, 04/24/2022, and 05/07/2022 revealed the following for one of six patient test reports (NOTE: Result time correlates to time sample tested): (a) Patient Report #22HD-114C0003 - The collection date and time were documented as 04/24/2022 at 08:35 am and the result date and time were 04/24 /2022 at 09:19 am (44 minutes later). (4) The findings were reviewed with laboratory 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 -- consultant #1 who stated on 05/10/22 at 02:30 pm, the laboratory could not prove the specimens were collected and centrifuged within the timeframe required by the manufacturer. 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 and interview with the technical consultant and laboratory consultant #1, the laboratory failed to follow the written technical consultant competency policy based on the job responsibilities as listed in Subpart M for one of one technical consultant. Findings include: (1) On 05/09/2022, a review of personnel records for competency assessments performed during 2020 and 2021 revealed no evidence competencies had been performed for the technical consultant based on job responsibilities since 12/17/2019; (2) A review of the laboratory's written policy titled, "Competency Assessment Policy" required an annual evaluation of the technical consultant; (3) The records were reviewed with laboratory consultant #1 and the technical consultant who stated on 05/09/2022 at 02:10 pm, the technical consultant competency, based on job responsibilities, had not been documented as performed in 2020 and 2021. 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 laboratory consultant #1, the laboratory failed to follow written procedures for implementing new PT(Prothrombin Time) and PTT (Partial Thromboplastin Time) normal reference ranges for one of one lot reagent change. Findings include: (1) On 05/10/2022 at 03: 00 pm, laboratory consultant #1 stated the following: (a) PT (Prothrombin Time) and PTT (Partial Thromboplastin Time) testing were performed using the Stago STA Satellite analyzer; (b) The following reagents were put into use on 05/27/21: (i) STA- Neoplastine C1 Plus lot #257595; (ii) STA- Automate lot# 257957 (2) A review of the electronic laboratory procedures stated the following (a) "Stago PT Procedure" (i) "REFERENCE INTERVAL" (aa) "Normal values may vary depending on local conditions. Therefore, it is necessary that each laboratory establish its own normal ranges and acceptable control values for their particular local patient population. In general, values are considered normal if they fall within the range of: mean 2 standard deviations (X 2 SD)". (b) "Stago PTT Procedure" (i) "REFERENCE INTERVAL" (aa) "Normal values may vary depending on local conditions. Therefore, it is necessary that each laboratory establish its own normal ranges and acceptable control values for their particular local patient population. In general, -- 2 of 5 -- values are considered normal if they fall within the range of: mean 2 standard deviations (X 2 SD)". (3) A review of the reagent lot change revealed the following normal reference ranges: (a) PT - Normal Reference Range (11.9 - 14.2) seconds (b) PTT - Normal Reference Range (24.3 - 37.0) seconds (4) A review of one patient report from 04/23/2022 at 05:26 pm revealed the following normal reference ranges: (a) PT - Normal Reference Range (11.7 - 14.4) seconds (b) PTT - Normal Reference Range (23.9 - 36.0) seconds (5) The patient record was reviewed with laboratory consultant #1 who stated on 05/10/2022 at 01:10 pm, the normal reference ranges had not been changed with the reagent lot change 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 and interview with laboratory consultant #1 and the technical consultant, the laboratory failed to follow the manufacturer's instructions for two of two coagulation reagent lot changes; and failed to follow manufacturer's instructions for one of one quality control lot changes. Findings include: REAGENT LOT CHANGE (1) On 05/10/2022 at 03:00 pm, laboratory consultant #1 stated the following: (a) PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Stago STA Satellite analyzer; (b) The following reagents were put into use on 05/27/21: (i) STA- Neoplastine C1 Plus lot #257595; (ii) STA- Automate lot# 257957; (2) A review of the manufacturer's instructions for reagent lot changes stated the following: (a) "Current Lot vs. New Lot Correlation" (i) "Collect 40 samples spanning across the reportable range, of which 20 of these samples should be normal samples" (b) "Criteria for reference range 'normal' donors" (i) "Sex-Equal numbers of males and females"; (ii) "Drug History-Patients should be excluded if taking birth control or estrogen containing products, Coumadin, Heparin (UFH, LMWH or heparinoid), Direct Thrombin Inhibitors and antibiotics". (3) A review of the records for the reagent lot changes revealed following: (a) For the Current Lot vs. New Lot Correlation (i) The laboratory tested 25 samples, nine males and 18 females (not equal number males and females); (ii) The medical history documentation for one donor sample included birth control; (iii) The medical history documentation for two donor samples included anticoagulants; (4) The records were reviewed with laboratory consultant #1, who stated on 05/10/2022 at 11:45 am the manufacturer's instructions had not been followed as indicated above. QUALITY CONTROL LOT CHANGE (1) On 05/10/2022 at 03:00 pm, laboratory consultant #1 stated the following: (a) PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Stago STA Satellite analyzer; (b) The following QC (quality control) materials were put into use on 08/30/21: (i) STA-Coag Control Normal lot #257810 (iv) STA-Coag Control Abnormal lot #257810 (2) A review of the manufacturer's instructions for QC lot changes which stated the following: (a) "Total Precisions" (i) "Use control materials that will be used for the assay" (ii) "Run each level six (6) times per day over five (5) days" (iii) "Data will be used to create 'site specific' quality control range" (iv) "Total 30 data points per analyte is recommended for routine assays. This is to verify that the new reagent is -- 3 of 5 -- working within the manufacturer's specifications. It is acceptable to use the assigned control range for a short period of time (30 days) while the control data is being collected". (4) A review of the records for the QC lot change revealed no evidence the QC material had been performed according to manufacturer's instructions; (a) For the Total Precisions (i) PT Normal QC included 21 data points (not the recommended 30 data points) (ii) PT Abnormal QC included 21 data points (iii) PTT Normal QC included 24 data points (iv) PTT Abnormal QC included 21 data points (5) The records were reviewed with laboratory consultant #1 and the technical consultant. The technical consultant stated on 05/10/2022 at 01:00 pm the laboratory could not locate the documentation to prove the manufacturer's instructions had been followed. 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, written policy, and interview with laboratory consultant #1, the laboratory failed to follow their written protocol for ensuring the centrifuge used to process urine sediment samples was functioning properly for one of one function checks performed. Findings include: (1) On 05/09/2022 at 01:15 pm, laboratory consultant #1 stated the following: (a) The laboratory processed urine specimens using the Cardinal Horizon 6 Flex at 1500 rpm (revolutions per minute) for five minutes. (2) A review of the laboratory's written procedure titled, "Microscopic Urinalysis and Culture Criteria" under the section "III. Procedure Steps" stated the following: (a) "5. Place tube in balanced centrifuge. Centrifuge for 5 minutes @ 1500.". (3) A review of 2022 centrifuge records revealed the following for one of one checks performed: (a) The centrifuge had been checked at 1900 rpm on 02/20/2022. (4) The findings were reviewed with laboratory consultant #1 who stated on 05/09 /2022 at 02:00 pm, the centrifuge function checks had not been performed according to laboratory policy as indicated above. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with laboratory consultant #1, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for Aspartate Aminotransferase for one of one lot numbers. Findings include: (1) On 05/10/22 at 10:15 am, laboratory consultant #1 stated: (a) AST (Aspartate Aminotransferase) testing was performed on the Cobas C311 analyzer; (b) Two levels of Liquicheck Unassayed Chemistry QC (quality control) materials (level 1 and level 2) were performed each day of patient testing; (c) Established ranges were used for determining acceptability of QC results. (2) QC records were reviewed which included documentation of establishing QC ranges, Levey-Jennings graphs, and cumulative data for level 1 lot #92911 and level 2 lot #92912 used during the review period of 12/28/2021 through the second day of the survey (05/10/22). The documentation showed the ranges that had been utilized by the laboratory to determine acceptability of QC results for level 2 were wider than the established QC ranges as follows: (a) AST (i) Level 2 - On 12/28/2022, the laboratory had changed the established mean and standard deviation (SD) to a mean of 190 and SD of 1.5 (range of 187 - 193); (ii) Level 2 - The Levey Jennings documentation showed a mean of 190 and SD of 15.0 (range of 160 - 220). (3) The records were reviewed with laboratory consultant #1 who stated on 05/10/2022 at 01:45 pm the laboratory ranges wider than the established ranges, as shown above, had been used to evaluate QC results. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/12,13,14/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, hospital administrator, administrative assistant, technical consultant from Mercy Hospital Tishomingo, technical consultant #1, testing person #4, and testing person #6 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 technical consultant #1, the laboratory failed to review and evaluate proficiency testing results for 1 of 13 events. Findings include: (1) On 10/12/2020, the surveyor reviewed 2019 and 2020 proficiency testing records and identified the following failure:Second 2018 Chemistry Miscellaneous Event (i) Second 2020 Hematology/Coagulation Event - The laboratory failed the results for 1 of 2 samples (US-06). There was no evidence

Summary Statement of Deficiencies D0000 The findings were reviewed with regional director of laboraory services, laboratory director, technical consultant, hospital administrator, testing person #4 and testing person #7 D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the regional director of laboratory services, the laboratory failed to follow the manufacturer's storage insructions for a waived analyzer. Findings include: (1) On the first day of the survey, the director of laboratory services stated to the surveyor Urinalysis testing was performed on the Clinitek Status+ analyzer; (2) Later during the survey, the surveyor reviewed the manufacturer's environmental requirement for the analyzer. The manufacturer required the operating temperature be maintained within the range of 18 - 30 degrees Celsius; (3) The surveyor reviewed laboratory temperature records from December 2017 through the first day of the survey, which verified the temperature readings were less than 18 degrees Celsius (minimum to accommodate all analyzers) for 3 of 5 months as follows: (a) December 2017- 3 of 31 temperature readings were documented as less than 18 degrees Celsius (days 26,27,31); (b) January 2018 - 2 of 31 temperature readings were documented as less than 18 degrees Celsius (days 2,3); (c) February 2018 - 1 of 28 temperature readings were documented as less than 18 degrees Celsius (day 4); (4) The surveyor reviewed the records with the regional director of laboratory services who stated the temperature of the laboratory had been maintained below 18 degrees Celsius as indicated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the regional director of laboratory services, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2016, 2017 and 2018 proficiency testing records. The following was identified for 2 of 26 testing events: (a) Third 2016 Chemistry Group 2 Event (i) The attestation was not signed by the laboratory director or designee. (b) Second 2016 Chemistry Group 2 Event (i) The attestation was not signed by the laboratory director or designee. (2) The findings were reviewed with the regional director of laboratory services who stated the attestations were not signed as indicated above. 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 the regional director of laboratory services, the laboratory failed to have written policies and procedures for assessing employee competency. Findings include: (1) On the first day of the survey, the surveyor reviewed the laboratory's policies and procedures. A policy that explained how employees were assessed for competency could not be located; (2) The surveyor asked the regional director of laboratory services if a competency policy was available for review. The regional director of laboratory services 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 -- 2 of 6 -- performance of instrument maintenance and function checks *Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples *Assessment of problem solving skills D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the regional director of laboratory services, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results. Findings include: (1) On the first day of the survey, the surveyor reviewed 2016, 2017 and 2018 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Hematology/Coagulation (i) 2017 second event (aa) 2 of 2 Blood Cell ID - BCI-13 and BCI-14 (2) The surveyor further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non-graded results; (3) The surveyor asked the regional director of laboratory services if the results had been documented as evaluated. The regional director of laboratory services reviewed the records and stated the non-graded results had not been documented as reviewed. 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 regional director of laboratory services, the laboratory failed to ensure the verified reportable ranges for a new coagulation analyzer were used by the laboratory. Findings include: (1) On the first day of the survey, the regional director of laboratory services stated to the surveyor the laboratory began using the Stago Satellite analyzer to perform PT (Prothrombin Time), PTT (Partial Thromboplastin Time) and D-Dimer testing on 09/07/17; (2) On the second day of the survey, the surveyor reviewed validation records for the analyzer and identified the reportable ranges had been verified by the laboratory as follows: (a) PT - 12.8 - 97.3 (b) PTT - 28.1 - 118.3 (c) D-Dimer - 0.03 - 12.22 (3) The surveyor then requested a printout from the analyzer to verify the reportable ranges that had been programmed into the analyzer and were currently in use. The printout verified the laboratory was using reportable ranges that were wider than the verified -- 3 of 6 -- ranges: (a) PT - 0 - 120 (b) PTT - 10 - 240 (c) D-Dimer - 0.27 - 20 (4) The surveyor reviewed the findings with regional director of laboratory services. The regional director of laboratory services stated the laboratory was using the manufacturer's default reportable ranges for PT, PTT, and D-Dimer instead of the reportable ranges that had been verified by the laboratory. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the regional director of laboratory services, the laboratory failed to ensure equipment maintenance was performed as required by the manufacturer. Findings include: (1) On the first day of the survey, the regional director of laboratory services stated to the surveyor *CMP, Direct Bilirubin, Amylase, CK (Creatine Kinase), Triglycerides, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein), Lipase, Magnesium, Uric Acid, Acetaminophen, Digoxin, Ethanol and Phenytoin were performed using the Roche Cobas c 311 analyzer; (2) On the second day of the survey, the surveyor reviewed 2016, 2017 and 2018 maintenance records, and identified the following: (a) 2 month maintenance - Replace ISE Measuring Cartridge (i) The 2 month maintenance procedure had not been documented as performed: (aa) between 05/30/16 and 09/12/16 (due 07/2016) (b) Quarterly - Clean Sonic Mixer, Replace the Sipper Tubing, Replace ISE Valve (i) The quarterly maintenance procedure had not been documented as performed as follows: (aa) Replace the ISE valve (i) between 03/21/17 and 09/21/17 (bb) Clean Sonic Mixer (i) between 09/28/17 and 01/02/18 (3) The surveyor reviewed the records with the regional director of laboratory services who stated there was no evidence the above maintenance had been documented as performed. *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), BUN (Blood Urea Nitrogen), Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or -- 4 of 6 -- replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the regional director of laboratory services, the laboratory failed to perform calibration verification procedures at least once every 6 months. Findings include: (1) On the first day of the survey, the regional director of laboratory services stated to the surveyor Troponin I testing was performed using the Abbott iSTAT 1 analyzer; (2) On the third day of the survey, the surveyor requested 2016 and 2017 calibration verification records for the analyzer (since calibration procedures were not routinely performed, calibration verification procedures, using three or more levels of calibration materials, were required every 6 months). The regional director of laboratory services provided documentation that verified calibration verification procedures had not been performed as follows: (a) Between 06/29/16 and 4/14/17 (due in December 2016). (3) The surveyor reviewed the records with the regional director of laboratory services who stated calibration verification procedures had not been performed every six months as indicated above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the regional director of laboratory services, the laboratory failed to follow the manufacturer's specifications for a new coagulation analyzer. Findings include: (1) On the first day of the survey, the regional director of laboratory services stated to the surveyor the Stago STA Satellite was put into use to perform PT/INR (Protime /International Normalized Ratio) testing on 09/07/17; (2) On the second day of the survey, the surveyor reviewed the manufacturer instructions for the establishment of the geometric mean for PT reference intervals (used to calculate the INR value). After providing detailed instructions for establishing the normal reference intervals, the instructions stated: (a) "The data will be compiled to develop reference ranges to be used by the site." (i) "Determination of the Geometric Mean for INR calculation" (aa) "Using Excel software, the Geometric Mean of the individual reference ranges values of PT is computed. (See legend for complete definition of the Geometric Mean)." (bb) "This new geometric mean must be entered when a new lot number of Neoplastine reagent is put into use to allow for the correct calculation of the INR." (3) The surveyor reviewed the laboratory implementation records and identified the laboratory had calculated a Geometric Mean of 13.0; (4) The regional director of laboratory services then showed the surveyor the laboratory programmed Geometric Mean of 13.5 in the analyzer, which did not match the laboratory established Geometric Mean (13.0); (4) The findings were reviewed with the regional director of laboratory -- 5 of 6 -- services who stated the Geometric Mean had not been programmed into the analyzer correctly. 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 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 regional director of laboratory services, the laboratory failed to have a policy for monitoring the effectiveness of their IQCP. Findings include: (1) On the first day of the survey, the director of laboratory services stated the following to the surveyor: (a) The laboratory performed Urine Drug Screen testing on the MedTox Scan analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP (dated as effective 04/27/16). The QA (Quality Assessment) portion of the IQCP did not include a schedule for evaluating the QCP to ensure it continued to provide accurate and reliable test results. There was no evidence of QA reviews for the IQCP since the effective date; (3) The surveyor reviewed the records with the regional director of laboratory services and asked if there was a policy to address how the laboratory will monitor the IQCP, including the frequency of the reviews and if a QA review had been performed since 04/27/16. The regional director of laboratory services stated a policy had not been written and QA reviews had not been performed. -- 6 of 6 --