Ascension St John Jane Phillips Nowata

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions of Participation: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the first and third 2022 events, the laboratory failed to 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 -- successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three consecutive testing events for the analyte BUN. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte BUN in two of three consecutive testing events. Findings include: (1) The laboratory received a score of 40% on the first 2022 event and a score of 0% on the third 2022 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte BUN in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the first 2022 event and third 2022 event. Refer to D6016. 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 desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte BUN in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the first 2022 event and third 2022 event. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/14/2022. The findings were reviewed with the technical consultant, testing person #2, and outpatient laboratory manager during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for test timing for a blood gas cartridge for one of three test reports. Findings include: (1) On 01/14/2021 at 09:40 am, technical consultant stated the following to the surveyor: (a) The laboratory performed Chemistry (Sodium, Potassium, Ionized Calcium, and Glucose) and Blood Gas (pH, pCO2, pO2) testing using the iSTAT 1 analyzer (serial number: 373078) and the CG8 cartridge. (2) The surveyor reviewed the manufacturer's instructions under the section titled, "Mixing and Test Timing (time from collection to cartridge fill) for Chemistry and Blood Gas Cartridge". For test timing, the instructions stated, "Samples for pH, PCO2, PO2, TCO3 and ionized calcium should be tested within 10 minutes."; (3) The surveyor then reviewed patient testing records on 12/04/2021, 12/15/2021, and 12/29/2021 and identified the following for one of three patient test reports: (a) Patient specimen# 21-349-001461- The collection date and time was on 12/15/2021 at 07:14 am and the result date and 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 -- time was on 12/15/2021 at 07:41 am (36 minutes later). (4) The surveyor reviewed the findings with the technical consultant. The technical consultant stated on 01/14/2021 at 02:26 pm, the laboratory could not prove the specimen was collected and tested within 10 minutes as required by the manufacturer. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written coagulation procedures, and interview with the technical consultant, the laboratory failed to follow coagulation procedures for two of two patients. Findings include: (1) On 01/14/2022 at 09:50 am, the technical consultant stated to the surveyor: (a) The laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) testing using the Hemochron Signature+ analyzer. (2) The surveyor reviewed the laboratory's written coagulation procedure log which stated, "INR>5, check for clots and repeat"; (3) The surveyor reviewed two patient records and identified the following: (a) Patient sample# 21-239-001215C - Test performed on 08/27/2021 with a INR result of 5.5; (b) Patient sample# 21-304- 001807A 0 Test performed on 10/31/2021 with an INR result of 5.6. (4) The surveyor reviewed the findings with the technical consultant and asked the technical consultant if the patient sample had been checked for a clot and repeated. On 01/14/2021 at 03: 15 pm, the technical consultant stated there was no documentation to prove the laboratory had followed the laboratory procedure as indicated above. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for implementing coagulation reagents for nine of nine lot numbers. Findings include: (1) On 01/14/2022 at 09:50 am, the technical consultant stated to the surveyor: (a) The laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) testing using the Hemochron Signature+ analyzer; (b) Two levels of Accriva direct Check whole blood quality control materials were performed each eight hours of patient testing. (2) The surveyor reviewed the manufacturer's instructions contained in the manufacturer's "Package Insert" for implementing new quality control material, which stated, "Accriva recommends that each institution establish its own expected range of response based on the mean 2 standard deviations of at least 20 repeated test results. The local mean values established should fall within the manufacturer's acceptable performance range. Studies show that intra-laboratory variation in test -- 2 of 5 -- results should produce a coefficient of variation of approximately 14% or less for coagulation control tests."; (3) The surveyor reviewed the implementation records for nine quality control lot numbers and identified the coefficient of variation had not been calculated for the following quality control lot numbers: (a) Normal Control (i) Lot# E9DA003 put into use 08/16/2019 (ii) Lot# G9DNC013 put into use 03/31/2020 (iii) Lot# HODNC005 put into use 01/25/2021 (iv) Lot# E1DNC003 put into use 07/25 /2021 (v) Lot# A1DNC004 put into use 08/01/2021 (b) Abnormal Control (i) Lot# C9DNC004 put into use 08/16/2019 (ii) Lot# J9OAC008 put into use on 03/31/2020 (iii) Lot# DODAC002 put into use 01/25/2021 (iv) Lot# D1DAC001 put into use 07 /25/2021 (4) The findings were reviewed with the technical consultant. The technical consultant stated on 01/14/2022 at 02:10 pm the manufacturer's instructions had not been followed for the reagent lot changes as indicated above; 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 storage instructions, observation of the laboratory chemistry freezer, and interview with the technical consultant, the laboratory failed to ensure materials were being stored as required for three of three months. Findings include: (1) On 01/14/2022 at 09:45 am, the technical consultant stated to the surveyor: (a) The laboratory performed chemistry testing using the Abbott Architect analyzer beginning 10/11/2021. (2) On 01/14/2022 at 01:35 pm, the surveyor observed the following in the laboratory freezer: (a) 12 boxes (25 bottles each box) of Bio-Rad LiquiChek Unassayed Chemistry Control materials (level one: lot# 92901 and level two: 92902) with a manufacturer's storage requirement of -20 to -70 degrees Centigrade (C). (3) The surveyor asked the technical consultant to explain what the materials were used for. The technical consultant stated on 01/14/2022 at 01: 40 pm the following: (a) The Bio-Rad LiquiChek Unassayed Chemistry Control materials were used to perform daily quality control on the Abbott Architect analyzer. (4) The surveyor then reviewed temperature records for three months (October 2021 through December 2021). It was identified that documented temperatures were warmer than -20 degrees C (the warmest temperature allowed for the materials) for three of three months reviewed as follows: (a) October 2021 - 31 of 31 temperatures were documented warmer than -20 degrees C; (b) November 2021 - 30 of 30 temperatures were documented warmer than -20 degrees C; (c) December 2021 - 31 of 31 temperatures were documented warmer than -20 degrees C. (5) The surveyor reviewed the records with the technical consultant. The technical consultant stated 01 /14/2022 at 02:10 pm, the materials had not been stored according to manufacturer's requirements as indicated above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 3 of 5 -- 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 technical consultant, the laboratory failed to verify normal patient reference ranges for one of one new test method. Findings include: (1) On 01/14/2021 at 10:20 am, the technical consultant stated the following to the surveyor: (a) Lactate testing was performed in the laboratory using the Nova Stat Strip analyzer beginning 06/10/2020; (2) On 01/14 /2021, the surveyor reviewed the performance specification records for the new test systems and could not locate documentation to prove the laboratory had verified the normal patient reference range; (3) The surveyor reviewed the finding with the technical consultant. The technical consultant stated on 01/14/2022 at 04:00 pm, the laboratory did not verify the normal patient reference range as indicated above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant, the laboratory failed to ensure data supported the QC frequency as defined in the QCP portion of the IQCP. Findings include: (1) On 01/14/2021 at 09:40 am, technical consultant stated the following to the surveyor: (a) The laboratory performed Chemistry (Sodium, Potassium, Ionized Calcium, and Glucose) and Blood Gas (pH, pCO2, pO2) testing using the iSTAT 1 analyzer (serial number: 373078) and the CG8 cartridge beginning 09/06/2020; (b) An IQCP had been developed for the test system. (2) The surveyor reviewed the IQCP (dated as effective on 09/06/2020 for the CG8 cartridge) and identified the QCP required two levels of external QC materials be performed once each month (i.e., approximately each 30 days); (3) The surveyor then reviewed the supporting documentation for the QCP and identified the following: (a) The laboratory had not tested external QC materials to support the QC frequency of monthly, as defined in the QCP; (b) Two levels of QC had been tested for three days (not at least 30 days). (4) The surveyor reviewed the records with technical consultant and asked if additional documentation was available to support the reduced external QC frequency of monthly. The technical consultant stated on 01/14/2022 at 02:40 pm QC had not been tested for at least 30 days. -- 4 of 5 -- D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure units of blood were stored under appropriate conditions that included an adequate temperature alarm system that is regularly inspected for one of eight alarm checks. Findings include: (1) On 01/14/2022 at 10:00 am, the technical consultant stated the laboratory stored units of O negative packed red blood cells in the blood bank refrigerator, to be used for emergency transfusions; (2) On 01/14/2022, the surveyor reviewed the quarterly refrigerator alarm records for 2020 and 2021. The records indicated the alarm checks had not been performed quarterly. They had not been performed between 01/04/2021 and 07/26/2021; (3) The surveyor reviewed the records with the technical consultant. The technical consultant stated on 01/14/2022 at 01:10 pm, the alarm checks had not been performed quarterly as required. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte Sodium. Refer to D2094 and D2096. 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for the analyte Sodium. Findings include: (1) The laboratory failed to achieve satisfactory performance on the First 2020 and the Second 2020 Events. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/30/19 and 10/31/19. The findings were reviewed with the technical consultant, Pathology Laboratory Associates support services, nurse manager, out-patient manager, and hospital administrator during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1409; D6033: Technical Consultant D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, nursing policy, and interview with the technical consultant the laboratory failed to ensure written policies were followed for preventing transfusion reactions for 2 of 9 patients. Findings include: (1) On the first day of the survey, the technical consultant stated the laboratory stored units of O negative packed red blood cells in the blood bank refrigerator, to be used for emergency transfusions; (2) On the second day of the survey, the surveyor reviewed the hospital policy regarding transfusion reactions. The policy "Transfusion and Transfusion Practices" defined the parameters of issuing blood products from the blood bank; (3) The surveyor further reviewed the policy which stated: (a) "ISSUING BLOOD PRODUCT(S) FROM BLOOD BANK" (i) "2. All blood and/or blood components signed out of the Blood Bank and NOT transfused or started within 20 minutes of being issued must be returned to the Blood Bank. If the blood is not used within 20 minutes of being issued, blood must be discarded, and lab notified of wastage." (4) The surveyor then reviewed transfusion records for 9 patients with 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 -- technical consultant. For 2 of the 9 units transfused the policy was not followed by nursing personnel. (a) Unit #W204919421595 - The unit was checked out from the blood bank on 09/20/19 at 11:11 am transfusion began at 11:34 pm on 09/20/19 (23 minutes after unit checked out from the blood bank). (b) Unit #W204919421595 - The unit was checked out from the blood bank on 09/27/19 at 11:00 pm transfusion began at 11:30 pm on 09/27/19 (30 minutes after unit checked out from the blood bank). (5) The surveyor explained to the technical consultant that in order to ensure a transfusion reaction is promptly identified, nursing personnel must follow their policy. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results for 2 of 18 events. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Third 2018 Chemistry Core Event (i) Total Bilirubin - 3 of 5 results exhibited a positive bias (aa) CH-12- SDI of 2.2 (bb) CH-13 - SDI of 2.6 (cc) CH-14 - SDI of 2.0 (b) Third 2018 Hematology Event (i) RDW (Red Blood Cell Distribution Width) - 4 of 5 results exhibited a negative bias (aa) XE-11- SDI of -2.3 (bb) XE-12- SDI of -2.2 (cc) XE-13- SDI of -2.4 (dd) XE-14- SDI of -2.3 (2) The surveyor further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) The surveyor then reviewed the records with the technical consultant and asked if the biases had been addressed. The technical consultant stated the biases had not been addressed. D5411 was cited on the recertification survey performed on 03/26,27,28/18. 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 technical consultant, the laboratory failed to ensure analyzers were stored as required by the manufacturer. Findings include: HUMIDITY - HEMATOLOGY (1) On the first day of the survey, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex XS-1000i analyzer; (2) On the second day of the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the relative humidity be -- 2 of 6 -- maintained within the range of 30-85%; (3) The surveyor reviewed laboratory humidity records from January 2019 through September 2019 which verified the humidity readings were less than 30% for 4 of 9 months as follows: (a) January 2019 - 27 of 31 humidity readings were documented as less than 30% (days 1,2,3,4,5,6,8,9,10,11,13,14,15,16,19,20,21,22,23,24,25,26,27,28,29,30,31); (b) February 2019 - 24 of 28 humidity readings was documented as less than 30% (days 5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28); (c) March 2019 - 28 of 31 humidity readings were documented as less than 30% (days 1,2,3,4,5,6,7,8,10,11,12,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,30,31); (d) April 2019 - 9 of 30 humidity readings were documented as less than 30% (days 1,2,3,4,5,12,13,14,15,); (4) The surveyor reviewed the records with the technical consultant who stated the humidity of the laboratory had been maintained below 30% as indicated above. TEMPERATURE - URINALYSIS (1) On the first day of the survey, the technical consultant stated to the surveyor Urinalysis testing was performed on the Clinitek 500 analyzer; (2) On the second day of 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 64 - 86 degrees Fahrenheit; (3) The surveyor reviewed laboratory temperature records between January 2019 through September 2019, which verified the temperature readings were less than 64 degrees Fahrenheit for 6 of 9 months as follows: (a) February 2019 - 1 of 28 temperature readings was documented as less than 64 degrees Fahrenheit (day 13); (b) May 2019 - 1 of 31 temperature readings was documented as less than 64 degrees Fahrenheit (day 6); (c) June 2019 - 3 of 30 temperature readings were documented as less than 64 degrees Fahrenheit (days 5,19,29); (d) July 2019 - 6 of 31 temperature readings were documented as less than 64 degrees Fahrenheit (days 1,2,4,5,7,12); (e) August 2019 - 3 of 31 temperature readings were documented as less than 64 degrees Fahrenheit (days 17,18,29); (f) September 2019 - 1 of 30 temperature reading was documented as less than 64 degrees Fahrenheit (day 6); (4) The surveyor reviewed the records with the technical consultant who stated the temperature of the laboratory had been maintained below 64 degrees Fahrenheit as indicated above. D5413 was cited on the recertification survey performed on 03/26,27,28/18. 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 technical consultant, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for 1 of 9 months. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor that CBC (Complete Blood Count) testing was performed on the Sysmex XS-1000i analyzer; (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for monthly maintenance were as follows: (a) Perform Monthly Rinse (3) The surveyor then reviewed maintenance records for 9 months (January 2019 through September 2019). There was no evidence the monthly maintenance had been performed: (a) Between 12/11/18 and 02/24/19 (4) The surveyor reviewed the records -- 3 of 6 -- with the technical consultant, who stated the maintenance had not been documented as performed as required. D5429 was cited on the recertification survey performed on 03 /26,27,28/18. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) 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 technical consultant, the laboratory failed to perform two levels of quality control materials each eight hours of PT/INR (Prothrombin Time/International Normalized Ratio testing for 3 of 12 days. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor PT/INR testing was performed on the Hemochron Jr. Signature+ analyzer; (2) On the second day of the survey, the technical consultant stated to the surveyor two levels of quality control (QC) materials were performed each eight hours of patient testing; (3) The surveyor reviewed QC and patient testing records for testing performed between 09/16/19 and 10/30/19 and identified that two levels of QC testing had not been performed each eight hours of patient testing for 3 of 12 days of patient testing: (a) QC testing had been performed on 10/01/19 at 06:49 am and patient testing had been performed on 10/05/19 at 08:14 am; (b) QC testing had been documented as performed on 10/07/19 at 09:00 am and patient testing had been performed on 10/12/19 at 02:48 pm; (c) QC testing had been performed on 10/07/19 at 09:00 am and patient testing had been performed on 10/16/19 at 07:27 pm. (4) The surveyor reviewed the records with the technical consultant, who stated two levels of QC materials had not been performed each eight hours of patient testing as indicated above. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, 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 for 8 of 18 events. Findings include: (1) On the first day of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records. It was identified for 8 of 18 events, the attestation statements had been signed approximately 2-3 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: -- 4 of 6 -- (a) Chemistry Core Second event of 2018 - The samples had been tested on 05/23/18 and the attestation statement had not been signed by the laboratory director until 07/19 /18; (b) Chemistry Core Third event of 2018 - The samples had been tested on 08/29 /18 and the attestation statement had not been signed by the laboratory director until 10 /15/18; (c) Chemistry Miscellaneous Second event of 2018 - The samples had been tested on 10/18/18 and the attestation statement had not been signed by the laboratory director until 01/14/19; (d) Hematology Second event of 2018 - The samples had been tested on 07/16/18 and the attestation statement had not been signed by the laboratory director until 10/15/18; (e) Hematology Third event of 2018 - The samples had been tested on 11/16/18 and the attestation statement had not been signed by the laboratory director until 01/14/19; (f) Immunology Second event of 2018 - The samples had been tested on 08/08/18 and the attestation statement had not been signed by the laboratory director until 10/15/18; (g) Chemistry Miscellaneous First event of 2019 - The samples had been tested on 04/23/19 and the attestation statement had not been signed by the laboratory director until 07/22/19; (h) Microbiology First event of 2019 - The samples had been tested on 01/20/19 and the attestation statement had not been signed by the laboratory director until 04/01/19; (2) The surveyor reviewed the findings with the technical consultant 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. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the -- 5 of 6 -- technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for 3 of 13 testing persons. Findings include: (1) At the beginning of the survey, the surveyor reviewed records for 13 persons performing moderate complexity urinalysis testing in 2018 and 2019. The records indicated the evaluations for 3 of 12 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #6 (i) The 2019 evaluation had been performed by the testing person #5 on 05/14/19 (this person had earned a bachelor of science degree with 5 months of experience in urinalysis). (b) Testing Person #7 (i) The 2019 evaluation had been performed by the testing person #5 on 05/15/19. (c) Testing Person #8 (i) The 2019 evaluation had been performed by the testing person #5 on 05/15/19. (2) The surveyor explained to the technical consultant that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). -- 6 of 6 --