Center For Orthopaedic Reconstruction & Excellence

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/14,15,16/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and testing person #2 during an exit conference performed at the conclusion of the survey. 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, ACL Elite manufacturer's maintenance logs, and interview with the laboratory manager, the laboratory failed to perform maintenance procedures as required by the manufacturer for one of 17 months. Findings include: (1) On 06/14/2022 at 11:30 am, the laboratory manager stated the laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) testing using the ACL Elite analyzer; (2) On 06/15/2022, a review of the manufacturer's maintenance log showed the following required maintenance procedures: (a) Daily (i) Check Wash R-Emulsion Level (ii) Empty Liquid Waste if Necessary (iii) Perform Needle Cleaning Procedure (iv) Priming (b) Monthly (i) Check and Clean Air Filters (ii) Backup/Archive (3) A review of maintenance logs from January 2021 through May 2022 revealed the following for one of 17 months: (a) The daily maintenance procedures had not been documented as performed for one of 24 days in March 2021. The specific day was 03/29/2021; (b) The monthly maintenance procedures had not been documented as performed during March 2021. (4) The records were reviewed with the laboratory manager who stated on 06/15/2022 01:20 pm, the maintenance as shown above had not been documented as performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records, Quidel Triage TOX Drug Screen Instructions for Use, and interview with the laboratory manager, the laboratory failed to ensure test reports for Urine Drug Screen testing included information required for interpretation for one of one patient report. Findings include: (1) On 06/14/2022 at 11:40 am, the laboratory manager stated Urine Drug Screen testing was performed using Quidel Triage Meter Pro and the Quidel Triage TOX Drug Screen test device; (2) On 06/15/2022, a review of the Quidel Triage TOX Drug Screen "Instructions for Use" stated, "This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectroscopy (GC /MS), Liquid Chromatography/Mass Spectroscopy/Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods"; (3) A review of one patient report with Urine Drug Screen test results reported on 06/06/2022 revealed the report did not include a disclaimer with the manufacturer's statement that the results were preliminary and guidance on obtaining a confirmed analytical result; (4) The findings were discussed with the laboratory manager who stated on 06/15/2022 at 03:12 pm, the patient reports did not include the disclaimer. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/15/2020 through 09/17/2020. The findings were reviewed with the general supervisor at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 general supervisor, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results for 2 of 12 events. Findings include: (1) On the first day of the survey, the surveyor reviewed 2019 and 2020 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Hematology (i) 2019 Third Event (aa) Blood Cell Identification ECI-15 (ii) 2020 First Event (aa) Blood Cell Identification ECI-01 (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 general supervisor if the results had been documented as evaluated. The general supervisor reviewed the records and stated on 09/17/2020 at 02:45 pm the non-graded results had not been documented as reviewed. 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 3 -- 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, procedure manual, laboratory information system, manufacturer specifications, and interview with the general supervisor, the laboratory failed to demonstrate the performance specifications for new test methods; Findings include: (1) On the first day of the survey, the general supervisor stated to the surveyor arterial blood gas (PCO2, PO2, and pH) testing was performed on the Abbott iSTAT analyzer using the EG7+ cartridge; (2) On the second day of the survey, the general supervisor stated to the surveyor the new test system was available for patient arterial blood gas testing on 04/23/2020; (3) The surveyor reviewed the manufacturer's reportable range for the following: (a) PCO2: 15 - 90 mmHg (b) PO2: 50 - 450 mmHg (c) pH: 6.50 - 8.20 (4) On the third day of the survey, the surveyor reviewed the validation records for the analyzer with the following identified: (a) The reportable range had been verified as follows: (i) PCO2: 19 - 83 mmHg (ii) PO2: 59 - 434 mmHg (iii) pH: 6.50 - 7.8 (5) The surveyor reviewed the written procedure manual titled "iSTAT"and identified the following: (a) Section titled, "Expected Values" (i) The manufacturer's reportable range were documented as the the laboratory's reportable ranges and not the laboratory's verified reportable ranges. (6) The surveyor then observed in the laboratory's information system (Healthland Centriq), the manufacturer's reportable range was in use and not the laboratory's verified reportable ranges; (7) The surveyor then reviewed the validation records with the general supervisor. The general supervisor stated on 09/17/2020 at 02:50 pm the laboratory was using the manufacturer's reportable ranges, but they had not been verified as indicated above. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of written policies and interview with the nursing manager and the general supervisor, the laboratory failed to ensure that written policies provided safety for individuals being transfused for 8 of 26 packed red blood cell units. Findings -- 2 of 3 -- include: (1) On the first day of the survey, the general supervisor stated the laboratory stored units of packed red blood cells in the blood bank refrigerator. The units were to be used for patient transfusions; (2) The surveyor reviewed the hospital policy regarding blood administration. The policy titled, "ADMINISTERING BLOOD AND BLOOD PRODUCTS" stated the following: (a) "D. Administration" (i) "3. Obtain vital signs prior to initiating the transfusion (baseline), 5 to 15 minutes of initiating the transfusion, every one hour until the transfusion is complete and after the transfusion. The rate of transfusion should be increased after 15 minutes to ensure the unit is administered within the 4-hour window." (3) The surveyor then reviewed records for 26 units of PRBCs (Packed Red Blood Cells) transfused between 02/01/2019 through 05/15/2019 and 01/03/2020 through 05/05/2020 for 26 patients, with the following identified: (a) Start time of the infusion (i) Patient #124833 - Transfused with 1 unit of PRBCs (unit #W091019141022) on 03/22/2019. There was no documentation indicating the start time of the infusion; (ii) Patient #133320 - Transfused with 1 unit of PRBCs (unit #W091020153684) on 03/15/2020. There was no documentation indicating the start time of the infusion. (b) Vital Signs 5 to 15 minutes after transfusion begins (i) Patient #97079 - Transfused with 1 unit of PRBCs (unit #W091019147985) on 04/03/2019 at 01:55 pm vitals taken at 12:19 (2 hours and 3 minutes after transfusion started (c) Vital Signs every one hour until the transfusion is complete (i) Patient #120437 - Transfused with 1 unit of PRBCs (unit #W091019161236) on 05/05/2019 at 03:43 pm and ending at 07:18 pm vitals taken at 05:20 pm and 07:18 pm (1 hour and 58 minutes during the transfusion); (ii) Patient #133320 - Transfused with 1 unit of PRBCs (unit #W091020133846) on 03/15/2020 at 11:10 am and ending at 01:45 pm vitals taken at 12:25 pm and 14:05 pm (1 hour and 20 minutes during the transfusion); (iii) Patient #105804 - Transfused with 1 unit of PRBCs (unit #W091020179187) on 05/05/2020 at 05:23 am and ending at 07:30 am vitals taken at 06:01 am and 07:30 am (1 hour and 29 minutes during the transfusion). (d) Post-transfusion vital signs (i) Patient #123389 - Transfused with 1 unit of PRBCs (unit #W091018283863) on 02/01/2019. There was no evidence of post-transfusion vital signs documentation; (ii) Patient #125461 - Transfused with 1 unit of PRBCs (unit #W091019126900) on 03/18/2019. There was no evidence of post-transfusion vital signs documentation; (iii) Patient #124833 - Transfused with 1 unit of PRBCs (unit #W091019141022) on 03/22/2019. There was no evidence of post-transfusion vital signs documentation; (iv) Patient #133320 - Transfused with 1 unit of PRBCs (unit #W091020153684) on 03/15/2020. There was no evidence of post-transfusion vital signs documentation. (4) The above transfusion records were reviewed with the nursing manager on 09/17/2020 who stated at 02:30 pm the records were not complete as indicated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The survey was performed on 07/24,25,26/18 The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the CEO and laboratory manager during an exit conference performed at the conclusion of the survey. 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 laboratory manager, the laboratory failed to have a written procedure for Wet Prep analysis; and failed to follow a written policy. Findings include: WET PREP ANALYSIS (1) On the first day of the survey, the laboratory manager stated to the surveyor microscopic Wet Prep analysis was performed; (2) Later on the first day, the surveyor asked the laboratory manager for dates of patient Wet Prep analysis performed during 2018. The laboratory manager stated to the surveyor patient Wet Prep analysis had been performed on 01/31/18, 03/14/18, and 06/14/18; (3) The surveyor then reviewed procedure manuals, and was unable to locate a written procedure for performing Wet Prep analysis; (3) The surveyor asked the laboratory manager if a written procedure was available for Wet Prep analysis. The laboratory manager stated a procedure had not been written. NOT FOLLOWING WRITTEN POLICY (1) On the first day of the survey, the laboratory manager stated the following to the surveyor: (a) PT/INR and PTT testing were performed on the ACL Elite analyzer; (b) The laboratory had a policy to ensure the specimens tested on the 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 -- analyzer were platelet poor. (2) On the second day of the survey, the surveyor reviewed the policy titled, "Centrifuge Calibration Verification for Platelet Poor Plasma" which stated, "Plasma used for coagulation studies must be platelet-poor. Centrifuge speed and duration must be established by the laboratory to ensure platelet counts are less than 10,000/uL. A minimum of 10 specimens should be validated every six months"; (3) The surveyor then reviewed records for 2017 and 2018 and identified the platelet-poor plasma checks had not been performed every six months as required by policy, instead, the checks had been performed on an annual basis. In addition, the laboratory had not tested a minimum of 10 specimens: (a) 05/05/17 - The platelet-poor plasma check had been performed using 5 specimens; (b) 05/18/18 - The platelet-poor plasma check had been performed using 5 specimens. (4) The surveyor reviewed the records and policy with the laboratory manager who stated the laboratory had not followed their written policy for ensuring platelet-poor plasma every six months using at least 10 specimens. 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 laboratory manager, the laboratory failed to perform maintenance procedures as required by the manufacturers. Findings include: ACL ELITE ANALYZER (1) On the first day of the survey, the laboratory manager stated to the surveyor PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed on the ACL Elite analyzer; (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance instructions for the analyzer which were: (a) Bi-Weekly (i) Reboot the Analyzer (ii) Clean Rotor Holder and Optic Path (3) Maintenance records were reviewed by the surveyor for 18 months (January 2017 through June 2018). The bi-weekly maintenance of Reboot the Analyzer had not been documented as performed: (a) Prior to 03/01/17 (b) Between 03 /13/17 and 01/02/18 (c) Between 04/04/18 and 05/03/18 (d) Between 05/03/18 and 06 /05/18 (4) The surveyor reviewed the records with the laboratory manager who stated there was no evidence the above maintenance had been performed as required. BIOMERIEUX VIDAS ANALYZER (1) On the first day of the survey, the laboratory manager stated to the surveyor Troponin I testing was performed on the Biomerieux Vidas analyzer; (2) On the second day of the survey, the surveyor reviewed the manufacturer's requirements for maintenance, which were: (a) Weekly (i) SPR Block Clean (ii) Computer Shutdown (b) Monthly (i) Reagent StripTray Clean (ii) Strip Preparation Tray Clean (iii) Drip Trays Clean (iv) QCV Assay Perform (v) Printer Clean (3) The surveyor then reviewed maintenance records for 18 months (January 2017 through June 2018). There was no evidence the maintenance had been performed as follows: (a) Weekly (i) SPR Block Clean had not been documented as performed between: (aa) 10/27/17 and 11/10/17 (bb) 06/20/17 and 07 /14/17 (cc) 01/05/18 and 01/19/18 (dd) 05/18/18 and 06/01/18 (ee) 06/21/18 and 07/05 /18 (ii) Computer Shutdown had not been documented as performed between: (aa) 10 /27/17 and 11/10/17 (bb) 06/29/17 and 07/14/17 (cc) 05/18/18 and 06/01/18 (b) Monthly (i) Reagent Strip Tray Clean, Strip Preparation Tray Clean, Dip Trays Clean, and Clean Lens had not been documented as performed between 01/26/18 and 03/02 -- 2 of 6 -- /18; (ii) QCV Assay Perform had not been documented as performed during January 2017 and July 2017; (iii) Clean Lens had not been documented as performed during March 2017 and June 2017. (4) The surveyor reviewed the records with the laboratory manager, who stated there was no evidence the maintenance, as indicated above, 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, written polices, and interview with the laboratory manager, the laboratory failed to follow their function check protocol for ensuring their centrifuges were functioning properly. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor the following centrifuges were used in the laboratory: (a) The Hettich Zentrifugen EBA 280 centrifuge was used to process coagulation specimens for PT/INR (Prothrombin Time/International Normalized Ratio and PTT (Partial Thromboplastin Time) testing at a speed of 3750 rpm (revolutions per minute) for 10 minutes; (b) The Hettich Zentrifugen EBA 270 centrifuge was used to process urine specimens for microscopic urine sediment analysis at a speed of 1500 rpm for 5 minutes; (c) The Ortho Workstation centrifuge was used to process blood bank specimens for ABO/Rh, Antibody Screen, and Compatibility testing at a speed of 1032 rpm for 10 minutes. (2) Later on the first day, the surveyor reviewed the policy titled, "Centrifuge Maintenance" which stated, "Twice yearly the centrifuge speed and timers should be checked to ensure proper functioning of the centrifuge"; (3) The surveyor reviewed the speed and timer checks for the centrifuges above and identified the checks had not been performed twice yearly as required by policy, instead, the checks had been performed on an annual basis: (a) Hettich Zentrifugen EBA 280 centrifuge (i) 05/01/17 - The speed had been checked at 3750 rpm and the timer had been checked at 10 minutes; (ii) 05/11/18 - The speed had been checked at 3750 rpm and the timer had been checked at 10 minutes. (b) Hettich Zentrifugen EBA 270 centrifuge (i) 05/01/17 - The speed had been checked at 1500 rpm and the timer had been checked at 5 minutes; (ii) 05/11/18 - The speed had been checked at 1500 rpm and the timer had been checked at 5 minutes. (c) Ortho Workstation centrifuge (i) 05/01/17 - The speed had been checked at 1032 rpm and the timer had been checked at 10 minutes; (ii) 05/11/18 - The speed had been checked at 1070 rpm and the timer had been checked at 10 minutes. The function check had been performed again on 05/29/18 to recheck the speed which was 1031 rpm and the timer was rechecked at 10 minutes. (4) The surveyor reviewed the records and policy with the laboratory manager who stated the laboratory had not followed their written policy for checking the speed and timers of the centrifuges twice annually. D5555 IMMUNOHEMATOLOGY -- 3 of 6 -- CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure that blood products were stored under appropriate conditions. Findings include: (1) On the first day of the survey, the laboratory manager stated to the following to the surveyor: (a) Units of packed red blood cells, which were stored in the Helmer blood bank refrigerator, were used for patient transfusions; (b) Alarm checks for the refrigerator were performed on a quarterly basis. (2) Later on the first day, the surveyor reviewed refrigerator alarm check records from March 2016 through April 2018. It was identified the alarm checks had not been performed on a quarterly basis (every 3 months) as follows: (a) 2017 - Alarm checks had not been performed during the second quarter (not performed between 03 /24/17 and 07/14/17). (3) The surveyor reviewed the records with the laboratory manager who stated the refrigerator alarm checks had not been performed on a quarterly basis as indicated above. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on a review of records, written procedure, literature reference, and interview with the laboratory manager, the laboratory director failed to ensure manual differentials were being performed as required for accurate and reliable results. Findings include: (1) On the first day of the survey, the laboratory manager stated the following to the surveyor: (a) CBC testing was performed using the Horiba ABX Micros 60 analyzer; (b) Manual differentials were performed as required by policy and /or the manufacturer's instructions (i.e., when automated differentials flags were obtained during analysis). (2) On the second day of the survey, the surveyor reviewed 14 patient records for manual differential testing performed during February 2017, June 2018, and July 2018. For 1 of the records, the reported white blood cell (WBC) count from the manual differential testing did not equal 100: (a) Report #1 - The testing was performed on 02//9/17, with a WBC count of 98 reported. (3) The surveyor then reviewed the procedure titled, "Manual Diff And Smear Review Criteria". The procedure did not specify the number of cells to count in a manual differential, however, it was standard laboratory practice to perform a manual WBC differential count of 100 cells; (4) The surveyor reviewed the report with the -- 4 of 6 -- laboratory manager, who stated the manual differential did not equal 100. NOTE: The following is a reference obtained by the surveyor following the survey which verifies 100 cells should be counted in a manual differential: (a) The textbook, "Hematology Clinical Principals and Applications, Second Edition" by Bernadette F. Rodak (W.B. Saunders Company), states "The manual differential, however, should always be performed in a systematic manner. Once the correct area has been selected, a back- and-forth serpentine or "battlement" track pattern is preferred for minimizing distributional errors. One hundred WBCs are counted and classified through the use of push-down button counters or newer computer-interfaced touch-pads". D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H. Findings include: (1) On the first day of the survey, the surveyor reviewed 2016, 2017 and 2018 proficiency testing records. It was identified for 12 of 14 events, the attestation statements had been signed approximately 1-2 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Third 2016 Chemistry Group 2 Event - The sample testing had been completed on 12/08/16 and the attestation statement had not been signed by the laboratory director until 01/18 /17; (b) Third 2016 Hematology/Coagulation Event - The sample testing had been completed on 11/17/16 and the attestation statement had not been signed by the laboratory director until 01/18/17; (c) Third 2016 Immunohematology Event -The sample testing had been completed on 12/21/17 and the attestation statement had not been signed by the laboratory director until 01/18/17; (d) First 2017 Chemistry Core Event - The sample testing had been completed on 02/02/17 and the attestation statement had not been signed by the laboratory director until 04/19/17; (e) First 2017 Hematology/Coagulation Event - The sample testing had been completed on 03/24/17 and the attestation statement had not been signed by the laboratory director until 04/19 /17; (f) Second 2017 Chemistry Core Event - The sample testing had been completed on 06/01/17 and the attestation statement had not been signed by the laboratory director until 07/26/17; (g) Second 2017 Immunohematology Event - The sample testing had been completed on 08/14/17 and the attestation statement had not been signed by the laboratory director until 10/26/17; (h) Third 2017 Chemistry Core Event - The sample testing had been completed on 09/08/17 and the attestation statement had not been signed by the laboratory director until 10/26/17; (i) Third 2017 Hematology/Coagulation Event - The sample testing had been completed on 12/01/17 and the attestation statement had not been signed by the laboratory director until 01/23 /17; (j) Third 2017 Immunohematology Event - The sample testing had been completed on 12/12/17 and the attestation statement had not been signed by the laboratory director until 01/23/18; (k) First 2018 Chemistry Core Event - The sample -- 5 of 6 -- testing had been completed on 02/07/18 and the attestation statement had not been signed by the laboratory director until 04/26/18; (l) First 2018 Hematology /Coagulation Event - The sample testing had been completed on 03/20/18 and the attestation statement had not been signed by the laboratory director until 04/26/18. (2) The surveyor reviewed the findings with the laboratory manager and explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 6 of 6 --