Mcbride Orthopedic Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/28, 29, 30, 31/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #2 and technical consultant #5 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, the general nursing policy and interview with general supervisor #1, the facility failed to ensure written policies were followed for preventing transfusion reactions for one of nine units reviewed. Findings include: (1) On 05/29/2024 at 2:30 pm, general supervisor #1 stated that the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit (s)); (2) The policy "Administration of Blood Products" defined the parameters for ensuring blood products are transfused safely; (3) The surveyor reviewed the policy which stated, "The blood must be transfused within four hours of check-out from the lab"; (4) A review of transfusion records for nine units of blood transfused with general supervisor #1 identified for one of nine units transfused, the policy was not followed by nursing personnel: (a) Unit #W091024151058 - The unit was checked out from the blood bank at 09:25 am and was completed at 1:30 pm, exceeding the four hour window. (5) Interview with general supervisor #1 on 05/29/2024 at 02:30 pm confirmed the facility failed to ensure the policy was being followed as written. 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 -- 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 review of records, written policies, and interview with technical consultant #2 and technical consultant #5, the laboratory failed to establish a written technical consultant, technical supervisor, and general supervisor competency assessment policy, based on the position responsibilities as listed in the Subpart M. Findings include: (1) A review of the policy titled, "Laboratory Personnel Competency Assessment" and interview with technical consultant #2 and technical consultant #5 on 05/29/2024 at 09:25 am identified the policy did not define the specific responsibilities based on each position for the technical consultant, technical supervisor, and general supervisor; (2) A review of Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of May 2022 through the current date identified no documentation competency assessments had been performed based on position responsibilities for four of four technical consultants, four of four general supervisors, and one of one technical supervisor; (3) The findings were reviewed with technical consultant #1 and technical consultant #5 on 05/29/2024 at 09:30 am, who confirmed the laboratory failed to define and perform assessments based on the specific position responsibilities. 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 policies and procedures and interview with technical consultant #2, technical consultant #4, and technical consultant #5, the laboratory failed to have a written procedure that explained the current practices and procedures for one of four procedure reviewed. Findings include: (1) On 05/30/2024 at 02:57 pm, technical consultant #4 stated the laboratory began testing arterial and venous blood gas (pH, pO2, and pCO2) on the i-STAT analyzer (Serial Number 406592) using the CG4+ cartridges on 07/10/2023; (2) A review of the policy titled, "I-STAT PROCEDURE" stated the G3+ cartridge was used for blood gas testing instead of the CG4+ cartridge; (3) The findings were reviewed with technical consultant #2, technical consultant #4, and technical consultant #5, who stated on 05/30/2024 at 03:00 pm, the I-STAT procedure had not been revised to include the CG4+ cartridge. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system -- 2 of 4 -- 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 #2, technical consultant #4, and technical consultant #5, the laboratory failed to utilize the demonstrated reportable range for one of one new test method. Findings include: (1) On 05/30/2024 at 02:57 pm, technical consultant #2, technical consultant #4, and technical consultant #5 stated the laboratory began performing pH, pCO2 and pO2 using the CG4+ cartridge and i-STAT1 analyzer (Serial Number 406952) on July 10, 2023; (2) A review of the performance specification records identified the laboratory had demonstrated the following reportable range: (a) pCO2 - 20.0-103.1 mm/Hg (3) Interview with technical consultant #2 and technical consultant #5 on 05/30/2024 at 03:33 pm confirmed the laboratory was using the previous test method's reportable range for the analyzer instead of the reportable ranges that had been demonstrated by the laboratory: (a) pCO2 - 5-130 mm/Hg 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 technical consultant #2, technical consultant #4, and technical consultant #5, the laboratory failed to perform calibration verification procedures at least once every six months for one of four i-STAT1 test system during the review period of 04/15/2022 through the current date. Findings include: (1) On 05/30/2024 at 01:45 pm, technical consultant #2, technical consultant #4, and technical consultant #5 stated the laboratory performed Troponin I testing -- 3 of 4 -- using the cTnI cartridge on the i-STAT 1 analyzer: (2) A review of records from 04/15 /2022 through the current date identified no evidence the calibration verification procedures had been performed between 04/15/2022 and 07/05/2023 for the cTnI test system; (3) The findings were reviewed with technical consultant #2, technical consultant #4, and technical consultant #5 who stated on 05/30/2024 at 02:00 pm, the calibration verification procedures had not been performed every six months as stated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/12,13,14/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the director of clinical laboratory services, chemistry supervisor, hematology supervisor, and blood bank supervisor 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 policy, and interview with the director of clinical laboratory services, the laboratory failed to have a written technical consultant, general supervisor, and technical supervisor competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On 04/12 /2022, a review of the competency assessment policy revealed there was no guidance, including the frequency, for assessing the competency of the technical consultant(s), general supervisor(s), and technical supervisor(s); (2) A review of personnel records for competency assessments performed during 2021 and to date in 2022 revealed no evidence of competencies performed for the technical consultants, general supervisors, and technical supervisor based on job responsibilities; (3) The findings were reviewed with the director of clinical laboratory services who stated on 04/12 /2022 at 11:40 am, a policy had not been written and the above competencies had not been performed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of clinical laboratory services and hematology supervisor, the laboratory failed to demonstrate the performance specifications for 3 of 3 new test methods. Findings include: (1) On 04/12 /2022 at 09:45 am, the director of clinical laboratory services stated the laboratory performed the following testing: (a) Blood Gas (pH, pCO2, pO2) using the G3+ cartridge and the iSTAT 1 analyzer; (b) BNP (B-Type Natriuretic Peptide) using the BNP cartridge and the iSTAT 1 analyzer; (c) Troponin I using the CTnI cartridge and the iSTAT 1 analyzer as a back-up method to the Ortho Vitros 5600 analyzer. (2) During a review of records on 04/13/2022 at 09:15 am, the hematology supervisor stated the laboratory began using a new iSTAT 1 analyzer (serial #406592) on 07/01 /2020; (3) A review of records revealed the performance specifications had not been demonstrated as follows: (a) G3+ Cartridge - The accuracy, precision, and reportable ranges had not been demonstrated; (b) BNP Cartridge - The precision had not been demonstrated; (c) Troponin I - The precision had not been demonstrated. (4) The findings were reviewed with the hematology supervisor who stated on 04/13/2022 at 09:20 am the laboratory had not demonstrated the performance specifications as shown above. 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 director of clinical laboratory services, hematology supervisor, and chemistry supervisor, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for two of four analyzers. Findings include: HEMATOLOGY (1) On 04/12/2022 at 09:50 am, the director of clinical laboratory services stated the laboratory performed CBC testing using the Sysmex XT 1800i analyzer as the back-up method; (2) On 04/13/2022, a review of the manufacturer's maintenance log showed the following manufacturer required monthly maintenance procedures: (a) "Clean Sample Right Rack Pool, Left Rack Pool, Analysis Line, and Sample Rack" (3) A review of maintenance logs from March 2021 through March 2022 revealed the monthly maintenance had not been documented as performed for 8 of 13 months (August 2021, September 2021, October 2021, November 2021, December 2021, January 2022, February 2022, and March 2022; (4) The records were reviewed with the hematology supervisor who stated on 04/13/2022 at 11:15 am, the above maintenance had not been documented as performed. COAGULATION (1) On 04/12/2022 at 09:50 am, the director of clinical laboratory services stated the -- 2 of 4 -- laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing using the Sysmex CA-600 analyzer; (2) On 04/13/2022, a review of the manufacturer's maintenance log showed the following manufacturer required weekly maintenance procedures: (a) "Clean Instrument Interior/Exterior" (3) A review of maintenance logs from March 2021 through March 2022 revealed the weekly maintenance had not been documented as performed between: (a) 04/14/2021 and 04/28/2021 (b) 08/18/2021 and 09/01/2021 (4) The records were reviewed with the chemistry supervisor who stated on 04/13 /2022 at 03:30 pm, the above maintenance had not been documented as performed. 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 director of clinical laboratory services, the laboratory failed to have a policy for monitoring the effectiveness of their IQCP for 4 of 4 test systems. Findings include: (1) On 04/12/2022 at 09:45 am, the director of clinical laboratory services stated: (a) The following testing was performed: (i) Blood Gas (pH, pCO2, pO2) using the G3+ cartridge and the iSTAT 1 analyzer; (ii) BNP (B-Type Natriuretic Peptide) using the BNP cartridge and the iSTAT 1 analyzer; (iii) Troponin I using the CTnI cartridge and the iSTAT 1 analyzer as a back-up method to the Ortho Vitros 5600 analyzer; (iv) Creatinine, Glucose, Ionized Calcium, BUN, Sodium, Potassium, Chloride, CO2 using the Chem 8+ cartridge and the iSTAT 1 analyzer as a back-up method to the Ortho Vitros 5600 analyzer. (b) IQCP's (Individualized Quality Control Plans) had been developed for the test systems. (2) A review of the IQCP's (dated as approved on 12/11/2015) revealed the QA (Quality Assessment) portion of the IQCP did not include a schedule for evaluating the QCP (Quality Control Plan) to ensure it continued to provide accurate and reliable results; (3) The findings were reviewed with the director of clinical laboratory services who stated on 04/12/2022 at 04:25 pm, the QA plan did not include an evaluation of the QCP, and the frequency of the reviews. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of clinical laboratory services, the failed to make appropriate reference ranges available. Findings include: (1) On 04/12/2022 at 09:50 am, the director of clinical laboratory services stated the laboratory performed PTT (Partial Thromboplastin Time) testing using the Sysmex CA-600 analyzer; (2) On 04/13/2022, a review of implementation records for the current lot number of reagent revealed the following: (a) Siemens Actin FSL reagent, -- 3 of 4 -- lot #562635 was put into use on 06/11/2021; (b) The laboratory had verified a normal reference range of 22.0-27.4. (3) A review of a patient PTT report with testing performed on 03/29/2022 revealed the reference range on the patient report was 23.0- 30.0; (4) The findings were reviewed with the director of clinical laboratory services who stated on 04/13/2022 at 03:50 pm, the normal reference range that had been verified by the laboratory for PTT was not included on the patient report. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 01/13/20-01/16/20. The findings were reviewed with the director of laboratory services at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 director of laboratory services, the laboratory failed to perform calibration verification procedures at least once every 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 -- 6 months. Findings include: (1) At the beginning of the survey, the director of laboratory services, stated to the surveyor the laboratory put a new Ortho Vitros chemistry analyzer into use for patient testing on 05/06/19. The testing included the analyte B12; (2) On the third day of the survey, the surveyor reviewed calibration verification records for testing performed in 2019 and to date in 2020 (since routine calibration procedures were performed using less than three calibrators for B12, calibration verification procedures, using three or more levels of calibration materials, were required every 6 months). The surveyor identified calibration verification procedures had not been performed since 05/03/19 when the manufacturer's specifications for the new analyzer had been demonstrated; (3) The surveyor reviewed the findings with the director of laboratory services, who stated to the surveyor, the laboratory had not performed calibration verification procedures for B12 at least once every 6 months in 2019. 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 the director of laboratory services, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process. Findings include: PT/INR AND PTT (1) On the first day of the survey, the director of laboratory services stated to the surveyor: (a) PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin) testing were performed using the Sysmex CA660 analyzer, which was put into use on 01/16/19; (b) The laboratory analyzed two levels of QC (Quality Control) materials (Normal Control Level 1 and Abnormal Control Level 3) each 8 hours of patient testing; (c) The acceptable QC limits were established during lot rollover studies before new lot numbers of PT and PTT reagents, and/or new lot numbers of QC materials were put into use. (2) The surveyor reviewed QC records from 2019 and identified the laboratory had not utilized the QC ranges that had been established during the reagent rollover, but used ranges which were wider. The specific findings follow: (a) Normal Control Level 1, Lot #54805 was put into use on 02/21/2019: (i) PTT: (aa) A 2SD range of 26.2-26.9 had been established; (bb) A range of 25.4-27.8 was utilized from 02/21/19 through 12/31/19. (b) Abnormal Control Level 3, Lot #556511 was put into use on 02/21/19: (i) PT: (aa) A 2SD range of 41.1-46.5 had been established; (bb) A range of was 38.9-48.7 utilized from 02/21 /19 through 12/31/19. (3) The surveyor reviewed the findings with the director of laboratory services and asked why the laboratory had not utilized the QC ranges established by the laboratory. The director of laboratory services stated to the surveyor, the laboratory used the mean obtained during the lot rollover but used historic SD's instead of the SD's determined during the lot rollover; (4) The surveyor -- 2 of 4 -- explained to the director of laboratory services, the manufacturer's instructions required the use of SD's determined during the lot rollover. In addition, the ranges utilized by the laboratory from 03/01/19 through 12/31/19 were wider than the QC ranges established by the laboratory. D-DIMER (1) The director of laboratory services stated to the surveyor: (a) D-Dimer testing was performed using the Sysmex CA660 analyzer, which was put into use on 01/16/19; (b) The laboratory analyzed two levels of QC materials (Level 1 and Level 2) each 8 hours of patient testing; (c) The acceptable QC limits were established during the implementation studies performed between 12/06/18-12/10/18. (2) The surveyor reviewed QC records from 2019 and identified the laboratory had not utilized the QC ranges established during the implementation study but used ranges which were wider. The specific findings follow: (a) Control Level 1, Lot #562240: (i) A 2SD range of 0.34-0.38 had been established; (ii) A range of 0.22-0.50 was utilized from 03/01/19 through 12/31/19. (b) Control Level 2, Lot #562140: (i) A 2SD range of 2.70-2.89 had been established; (ii) A range of 1.61-3.73 was utilized from 03/01/19 through 12/31/19. (3) The surveyor reviewed the findings with the director of laboratory services and asked why the laboratory did not utilize the QC ranges established by the laboratory. The director of laboratory services stated to the surveyor, the laboratory used the mean obtained during the implementation study but used historic SD's instead of the SD's determined during the implementation study; (4) The surveyor explained to the director of laboratory services the manufacturer's instructions required the use of SD's determined by the laboratory for the QC materials being used. In addition, the ranges utilized by the laboratory from 03/01/19 through 12/31/19 were wider than the QC ranges established by the laboratory 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 director of laboratory services and the hematology technical consultant, the laboratory failed to follow the manufacturer's specifications for control materials. Findings include: (1) On the first day of the survey, the the director of laboratory services stated to the surveyor the laboratory used the two Sysmex XT-1800i analyzers to perform CBC testing (i.e. WBC (White Blood Count), RBC (Red Blood Count), Hemoglobin, Hematocrit, Platelet count, etc). The analyzer designated as #1 (SN#14237) was the primary analyzer and analyzer #2 (SN#1234) served as the backup analyzer; (2) The director of laboratory services also stated to the surveyor, the laboratory tested three levels (Level 1, Level 2, and Level 3) of Sysmex e-CHECK control materials on the primary and back up analyzers each day of testing, and tested three levels again on the primary analyzer during the evening shift; (3) On the second day of the survey, the surveyor asked the hematology technical consultant how the laboratory implemented a new lot number of QC materials. The hematology technical consultant stated to the surveyor, before the old QC lot numbers wer retired, and before the new lot numbers were put into use, the three levels of the new QC lot number were tested two times per day on both analyzers (morning and evening shifts) for 5 days. From those 10 values, the laboratory calculated the mean and SD -- 3 of 4 -- (Standard Deviation) for each analyte of each level. The laboratory then utilized the mean and 2SD for the acceptable limits when the new lot numbers of QC materials were put into use; (4) The surveyor then reviewed the assay values (package insert) for the QC materials. The assay value sheet included an expected range of means for each analyte. The manufacturer's instructions for the QC materials stated, "The mean assay values for each parameter of e-CHECK are derived from replicate analyses on whole blood calibrated instrumentation. The mean values obtained on e-CHECK should be within the expected ranges. The expected ranges should not be used as QC file limits. Inter-laboratory variation is usually accounted for by analyzer calibration, maintenance and operating technique;" (5) The surveyor reviewed QC records from both analyzers of 21 lot numbers used from 11/28/18 through 01/14/20. The surveyor identified the laboratory began using a new lot number of QC materials at the same time the mean and SD's were being established. In addition, the documentation showed the laboratory utilized the manufacturer's mean and expected ranges from the package insert for its acceptable QC limits on 2 days (08/06/20-08/07/20) and did not follow the manufacturer's specifications to establish its own mean and limits of acceptability, for 3 of the 21 QC lot numbers used during the review period: (a) Used from 08/06/19-09/30/19: (i) Level 1, Lot #91910801 (ii) Level 2, Lot #91910802 (iii) Level 3, Lot #91910803 (6) The surveyor reviewed the findings with the director of laboratory services and the hematology technical consultant, who stated to the surveyor, the laboratory used the package insert means and expected ranges as its acceptable QC limits on both analyzers for the 3 lot numbers of QC materials listed above, and failed to follow the manufacturer's specifications for the QC materials. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The survey was performed 3/26/18 through 3/28/18. The findings were reviewed with the director of laboratory services at the conclusion of the survey. 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 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 and 2017 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Cardiac Markers (i) CAR-A 2016 Event (aa) 1 of 5 Troponin I, quant CR-05 (b) General Chemistry/Therapeutic Drugs (i) C-A 2017 Event (aa) 5 of 5 LDL Cholesterol, calc CHM-01, CHM-02, CHM-03, CHM-04, CHM-05 (bb) 5 of 5 Iron Saturation % CHM-01, CHM-02, CHM-03, CHM-04, CHM-05 (c) Ligand Assay - General (i) K-A 2017 Event (aa) 1 of 2 Vitamin B-12 K-02 (d) Diagnostic Immunology (i) S-B 2017 Event (aa) 1 of 2 CRP, quant CRP-03 (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 director of laboratory services if the results had been documented as evaluated. The director of laboratory services reviewed the records and stated the non- graded results had not been documented as reviewed. 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 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the director of laboratory services, the laboratory failed to ensure analyzers was stored as required by the manufacturer. Findings include: HEMATOLOGY (1) At the beginning of the survey, the director of laboratory services stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex XT 1800i analyzer; (b) Routine Chemistry testing was performed on the Ortho Vitros 5600 analyzer; (c) Coagulation testing was performed on the Sysmex CA-540 analyzer. (2) On the second day of the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzers. The manufacturer's required the relative humidity be maintained as follows: (a) Sysmex XT-1800i within the range of 45-85% (b) Ortho Vitros 5600 within the range of 15-60% (c) Sysmex CA-540 within the range of 30-80% (3) The surveyor reviewed laboratory humidity records from September 2017 through the second day of the survey, which verified the humidity readings were less than 45% (minimum to accommodate all analyzers) for 7 of 7 months as follows: (a) September 2017- 2 of 30 humidity readings were documented as less than 45% (days 6,7); (b) October 2017 - 17 of 31 humidity readings was documented as less than 45% (days 2,8,10,11,16,17,18,19,23,24,25,26,27,28,29,30,31); (c) November 2017 - 25 of 30 humidity readings were documented as less than 45% (days 1,2,3,4,6,7,8,9,10,11,13,16,18,19,20,21,22,23,24,25,26,27,28,29,30); (d) December 2017 - 30 of 31 humidity readings was documented as less than 45% (days 1,2,3,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31); (g) January 2018 - 31 of 31 humidity readings were documented as less than 45% (h) February 2018 - 28 of 28 humidity readings was documented as less than 45% (i) March 2018 - 27 of 27 humidity readings was documented as less than 45% (4) The surveyor reviewed the records with the director of laboratory services who stated the humidity of the laboratory had been maintained below 45% as indicated above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the laboratory failed to ensure reagents had not exceeded their expiration date. Findings include: (1) At the beginning of the survey, the immunohematology general -- 2 of 4 -- supervisor verified to the surveyor Crossmatch testing was performed in the laboratory which included: (a) ABO Typing and Antibody Screen using the Ortho ID- MTS gel system (2) On the second day of the survey, the surveyor reviewed quality control (QC) and patient testing records for 6 months (September 2017 through February 2018). It was identified that expired Affirmagen (used for reverse ABO typing) and Surgiscreen (used for Antibody Screen testing) had been used during 1 of 6 months reviewed: (a) Affirmagen lot #8A689, expiration date of 10-10-17 and Surgiscreen lot #V55939, expiration date of 10/10/17 had been used to perform QC and patient testing on 10/11/17 and 10/12/17; (3) The surveyor reviewed the records with the director of laboratory services and immunohematology general supervisor who stated expired reagents had been used as indicated above; 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 director of laboratory services and hematology supervisor/technical consultant #2, the laboratory failed to ensure equipment maintenance was performed as required by the manufacturer. Findings include: (1) At the beginning of the survey, the director of laboratory services stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex XT-1800i analyzer; (2) The surveyor reviewed records from June 2017 through February 2018 (9 months) of manufacturer's maintenance logs for the analyzer with the following identified: (a) Daily - Execute Shutdown (i) The daily maintenance procedures had not been documented as performed: (aa) June 2017 - Days 2,9,11,16,23,28,29 (bb) September 2017 - Days 4,28 (cc) November 2017 - Day 27 (b) Monthly - Clean sampler right rack pool, left rack pool, analysis line, and sample rack (i) The monthly maintenance procedure had not been documented as performed between the following: (aa) 11/03/17 and 01/5/18 (3) The surveyor reviewed the records with the director of laboratory services and hematology supervisor/technical consultant #2 who stated there was no evidence the above maintenance had been documented as performed. D5783