Perry County General Hospital Lab

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of quality control records and patient test counts for the Beckman Coulter AU480 chemistry system, interview on 11/09/2022 at 10:00 a.m. with Technical Consultant #2, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and lack of documentation of verification of performance specifications for C-reactive protein (CRP) testing, the laboratory failed to verify the manufacturer's performance specifications for CRP testing before patient testing began in July 2021. Findings include: Review of quality control records for the Beckman Coulter AU480 chemistry system and the laboratory's patient test counts revealed CRP testing was added to the Beckman Coulter AU480 chemistry system. In an interview on 11/09/2022 at 10:00 a.m., Technical Consultant #2, listed on the CMS 209 personnel form, stated CRP testing was added to the Beckman Coulter AU480 chemistry system in July 2021. On the day of the survey, 11/09/2022, there was no documentation of verification of performance specifications for C-reactive protein (CRP) testing available for review, to include accuracy, precision, reportable range of test results, and verification of the manufacturer's reference intervals for the laboratory's patient population. The laboratory's annual patient test count for CRP testing was 92. 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 -- D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the manufacturer's procedure manual for the Abbott i-STAT analyzer, interview on 11/09/2022 at 3:00 p.m. with Technical Consultant (TC) #1, listed on the CMS 209 personnel form, and lack of documentation of thermal probe checks since the analyzer was put in use in May 2021, the laboratory failed to perform and document thermal probe checks every six months, as defined by the manufacturer. Findings include: The manufacturer's procedure manual for the Abbott i-STAT analyzer states to check the thermal probes on each analyzer every six months. There was no documentation available on the day of the survey, 11/09/2022, of the performance of thermal probe checks on the i-STAT analyzer since it was put in use for patient testing in May 2021. In an interview on 11/09/2022 at 3:00 p.m., TC #1 confirmed there was no documentation of thermal probe checks on the Abbott i-STAT analyzer. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for urine microalbumin and creatinine testing on the Siemens DCA System and patient test result logs from 04/30 /2022 through 11/03/2022, interview on 11/09/2022 at 4:50 p.m. with Technical Consultant (TC) #2, listed on the CMS 209 personnel form, and lack of establishment of an Individualized Quality Control Plan (IQCP), the laboratory failed to include two levels of control at least once each day patient testing was performed, on a total of 78 days during this time frame when a total of 127 patient specimens were assayed for urine microalbumin and creatinine. Findings include: Review of QC records for urine microalbumin and creatinine testing on the Siemens DCA System from 04/30/2022 through 11/03/2022 revealed two levels of control were performed on 04/30/2022, 05 /28/2022, 06/28/2022, 07/19/2022, 08/17/2022, 09/13/2022, 10/11/2022, and 11/03 /2022. Review of patient test result logs from 04/30/2022 through 11/03/2022 revealed 127 patient specimens were assayed for urine microalbumin and creatinine on a total of 78 days during this time frame when controls were not performed. In an interview on 11/09/2022 at 4:50 p.m., TC #2 confirmed an IQCP was not established for urine microalbumin and creatinine testing on the Siemens DCA System. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) -- 2 of 3 -- (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter Access 2 immunoassay system quality control and calibration records, confirmation by Technical Consultant (TC) #1, listed on the CMS 209 personnel form, and lack of documentation of comparison of results for creatine kinase-MB (CK-MB) and troponin I testing between the Beckman Coulter Access 2 and the Quidel Triage Meter Pro, the laboratory failed to evaluate the relationship between the results of CK-MB and troponin I tests performed using different methods, at least twice a year, since the last survey on 04/08/2021. Findings include: Review of Beckman Coulter Access 2 immunoassay system quality control and calibration records revealed no documentation of comparison of results for creatine kinase-MB (CK-MB) and troponin I testing between the Beckman Coulter Access 2 and the Quidel Triage Meter Pro since the last survey on 04/08/2021. TC #1, listed on the CMS 209 personnel form, confirmed the Quidel Triage Meter Pro is used for back-up testing for CK-MB and troponin I. -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 12/20/21, the laboratory has not successfully participated in proficiency testing for HDL CHOLESTEROL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HDL CHOLESTEROL: PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts HDL CHOLESTEROL: Year 2021 2nd Event: 0% Year 2021 3rd Event: 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 -- 0% Scores less than 80% for this analyte or parameter indicate failure or unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 12/20/21, the laboratory has not successfully participated in proficiency testing for HDL CHOLESTEROL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HDL CHOLESTEROL: PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts HDL CHOLESTEROL: Year 2021 2nd Event: 0% Year 2021 3rd Event: 0% Scores less than 80% for this analyte or parameter indicate failure or unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 12/20/21, the laboratory has not successfully participated in proficiency testing for HDL CHOLESTEROL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HDL CHOLESTEROL: PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts HDL CHOLESTEROL: Year 2021 2nd Event: 0% Year 2021 3rd Event: 0% Scores less than 80% for this analyte or parameter indicate failure or unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on review of quality control (QC) records for the Beckman Coulter Access 2 immunoassay system from 1/1/21 through 2/28/21 and manufacturer's acceptable ranges for MAS CardioImmune XL controls, Lot #CXL21121A and Lot #CXL21123A, the laboratory failed to document, as performed, the establishment of statistical parameters for acceptable ranges for myoglobin testing with the MAS CardioImmune XL controls. Findings include: Review of QC records for the Beckman Coulter Access 2 immunoassay system from 1/1/21 through 2/28/21 revealed MAS CardioImmune XL controls were in use for myoglobin testing during this time frame. Review of the manufacturer's acceptable ranges for MAS CardioImmune Controls, Level 1 Lot #CXL21121A and Level 3 Lot #CXL21123A, revealed no acceptable range for myoglobin testing on the Beckman Coulter Access 2 immunoassay system. On the day of the survey, 4/7/21, there was no documentation of the establishment of statistical parameters for the myoglobin ranges listed 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 3 -- Access 2 QC records. 2. Based on review of QC records for the Beckman Coulter AU480 chemistry system from 1/1/21 through 2/28/21 and manufacturer's acceptable ranges for BioRad Liquid Assayed Multiqual Premium controls, Level 1 Lot #86921, Level 2 Lot #86922, and Level 3 Lot #86923, the laboratory failed to document, as performed, the establishment of statistical parameters for acceptable ranges for prealbumin testing with the BioRad Liquid Assayed Multiqual Premium controls. Findings include: Review of QC records for the Beckman Coulter AU480 chemistry system from 1/1/21 through 2/28/21 revealed BioRad Liquid Assayed Multiqual Premium controls were in use for prealbumin testing during this time frame. Review of the manufacturer's acceptable ranges for BioRad Liquid Assayed Multiqual Premium controls, Level 1 Lot #86921, Level 2 Lot #86922, and Level 3 Lot #86923, revealed no acceptable range for prealbumin testing on the Beckman Coulter AU480 chemistry system. On the day of the survey, 4/7/21, there was no documentation of the establishment of statistical parameters for the prealbumin ranges listed on the AU480 chemistry system QC records. THIS IS A REPEAT DEFICIENCY. 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 review of blood bank refrigerator continuous-monitoring temperature recorder graphs, blood bank refrigerator temperature logs, and blood bank transfusion records from 9/10/18 through 3/31/21, the laboratory failed to ensure blood for transfusion was stored under appropriate conditions for sixty-five weeks during this time frame, when the blood bank refrigerator temperature was not recorded on the graphs. Findings include: Review of blood bank refrigerator continuous-monitoring temperature recorder graphs from 9/10/18 through 3/31/21 revealed the blood bank refrigerator temperature was not recorded on the blank graphs for the following weeks: 2019 March 11 & 18; May 13 & 20; June 3, 17, & 24; July 2, 16, 23, & 30; August 1, 8, 15, & 22; November 12, 19, & 26. 2020 February 5 through March 18; April 1 through May 27; June 24 through August 12; September 9, 16, 30; October 7 & 28; November 4, 18, & 25; December 2, 9, & 23. 2021 January 6 through February 24; March 3, 17, 24, & 31. Review of the blood bank refrigerator temperature logs from 9/8/18 through 3/31/21 revealed the temperature of the blood bank refrigerator was manually recorded on the logs only once per day, which does not ensure continuous storage under appropriate conditions. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of blood bank refrigerator continuous-monitoring temperature recorder graphs, blood bank refrigerator temperature logs, and blood bank transfusion records from 9/10/18 through 3/31/21, the technical supervisor failed to detect the lack of temperature recording on the blank graphs for sixty-five weeks during this time frame. Findings include: Review of blood bank refrigerator continuous- monitoring temperature recorder graphs, blood bank refrigerator temperature logs, and blood bank transfusion records from 9/10/18 through 3/31/21 revealed the technical supervisor documented review of the weekly temperature recorder graphs from 9/10 /18 through 3/31/21, along with blood bank maintenance records, but failed to detect the lack of temperature recording on the blank graphs for sixty-five weeks during this time frame. Refer to D5555 (Failure to ensure blood for transfusion was stored under appropriate conditions). -- 3 of 3 --

Summary Statement of Deficiencies 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/20/2019, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts COMPATIBILITY TESTING: Year 2018 3rd Event 0% Year 2019 1st Event 60% Scores less than 100% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of 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 2 -- analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2174 COMPATIBILITY TESTING CFR(s): 493.863(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/20/2019, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts COMPATIBILITY TESTING: Year 2018 3rd Event 0% Year 2019 1st Event 60% Scores less than 100% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/20/2019, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts COMPATIBILITY TESTING: Year 2018 3rd Event 0% Year 2019 1st Event 60% Scores less than 100% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid data system) on 11/19/18, the laboratory has not successfully participated in proficiency testing for ALCOHOL (BLOOD). Findings include: Our records indicate the following proficiency testing scores for your laboratory for ALCOHOL (BLOOD). PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts ALCOHOL (BLOOD): Year 2018 1st Event 0% Year 2018 2nd Event 0% Year 2018 3rd Event 0% Scores less than 80% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter 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 -- for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. D2118 TOXICOLOGY CFR(s): 493.845(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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid data system) on 11/19/18, the laboratory has not successfully participated in proficiency testing for ALCOHOL (BLOOD). Findings include: Our records indicate the following proficiency testing scores for your laboratory for ALCOHOL (BLOOD). PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts ALCOHOL (BLOOD): Year 2018 1st Event 0% Year 2018 2nd Event 0% Year 2018 3rd Event 0% Scores less than 80% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 11/19/18, the laboratory director has not provided overall management and direction in accordance with 493.1407 of this subpart. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 11/19/18, the laboratory director has failed to -- 2 of 3 -- ensure the proficiency testing samples were tested as required under subpart H of this part. -- 3 of 3 --

Summary Statement of Deficiencies 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 10/11/18, the laboratory has not successfully participated in proficiency testing for ALCOHOL (BLOOD). Findings include: Records indicate the following proficiency testing scores for your laboratory for ALCOHOL (BLOOD) : PROFICIENCY TESTING PROVIDER: AAB 2018 1ST EVENT: 0% 2018 2ND EVENT: 0% Scores less than 80% for this analyte or 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 -- parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2118 TOXICOLOGY CFR(s): 493.845(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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 10/11/18, the laboratory has not successfully participated in proficiency testing for ALCOHOL (BLOOD). Findings include: Records indicate the following proficiency testing scores for your laboratory for ALCOHOL (BLOOD) : PROFICIENCY TESTING PROVIDER: AAB 2018 1ST EVENT: 0% 2018 2ND EVENT: 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of quality control (QC) records for D-Dimer testing on the Alere Triage Meter Pro from 12-22-16 through 8-20-18 and the laboratory's written Individualized Quality Control Plan (IQCP), the laboratory failed to follow its written IQCP for performing two levels of external quality control at least every thirty days and at change of kit lot number. Findings include: The laboratory's IQCP states, "Two levels of Alere Total 5 external controls, an abnormal level and a normal level, will be tested and documented at least every 30 days and at change of kit lot number." Review of QC records for D-Dimer testing on the Alere Triage Meter Pro from 12-22- 16 through 8-20-18 revealed: (1) External controls for D-Dimer testing were not documented, as performed, from 9-21-17 until 5-8-18. (2) Two levels of external control were not documented, as performed, on D-Dimer Cartridge Lot #62822, put in use on 2/17/17, and on Cartridge Lot #63029 on 5/20/17. 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. 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 -- This STANDARD is not met as evidenced by: A. Based on review of Beckman Coulter AU480 chemistry system maintenance logs from 10-20-16 through 8-31-18 and lack of documentation of Ion Specific Electrode (ISE) maintenance, the laboratory failed to document, as performed, the daily, weekly, and every-other-week ISE maintenance, as defined by the manufacturer, for twelve months during this time frame and failed to document, as performed, the every-three- month maintenance since April 2017. Findings include: 1. Review of Beckman Coulter AU480 chemistry system maintenance logs from 10-20-16 through 8-31-18 revealed the following ISE maintenance procedures were not documented as performed for the month of August 2017 and for the months of October 2017 through August 2018: Daily Check the buffer syringe for leaks. ISE cleaning. Weekly Enhanced cleaning of electrode line. Every Other Week Manually wash the mix bars, liquid level sensors, sample pot, and sample pot tubes. 2. Review of Beckman Coulter AU480 chemistry system maintenance logs from 10-20-16 through 8-31-18 revealed the following every-three-month ISE maintenance procedures were not documented as performed since 4-30-17: Every Three Months Replace the roller tubes for MID solution dispense and mixture aspiration. Replace the pinch valve tubing. B. Based on review of the ITC IRMA Blood Analysis System User Manual and maintenance records since the last survey on 10-19-16, the laboratory failed to document, as performed, the annual maintenance, as defined by the manufacturer, for the ITC IRMA Blood Analysis System since 10-19-16. Findings include: Review of the ITC IRMA Blood Analysis System User Manual revealed the manufacturer's instructions state, "The IRMA barometer should be calibrated annually to maintain analyzer accuracy." There was no documentation of the barometer calibration since 10-19-16. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the ITC IRMA Blood Analysis System User Manual, monthly temperature checks, and quality control records for November 2016 through July 2018, the laboratory failed to perform and document the monthly temperature check, as required by the manufacturer, for twelve months during this time frame when patient blood gas testing was being performed. Findings include: Review of the ITC IRMA Blood Analysis System User Manual revealed the manufacturer's instructions state to run a temperature test monthly to verify that the IRMA temperature control system is operating properly. Review of the instrument printouts for monthly temperature checks and quality control records for the ITC IRMA Blood Analysis System for November 2016 through July 2018 revealed no documentation of a monthly temperature check from August 2017 through July 2018. THIS IS A REPEAT DEFICIENCY. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the -- 2 of 6 -- manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration records for the Beckman Coulter DxH 600 hematology analyzer since the last survey on 10-19-16 and lack of documentation of calibration, the laboratory failed to document, as performed, calibration on the Beckman Coulter DxH 600 hematology analyzer every six months, according to laboratory policy. Findings include: Review of calibration records for the Beckman Coulter DxH 600 hematology analyzer since the last survey on 10-19-16 revealed no documentation of calibration of the DxH 600 hematology analyzer since 5-12-17. 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 review of calibration records for the Beckman Coulter AU480 chemistry system and lack of documentation of calibration verification, the laboratory failed to document, as performed, calibration verification for routine chemistry tests performed on the Beckman Coulter AU480 chemistry system at least once every six months since the last survey on 10-19-16. Findings include: Review of calibration records for the Beckman Coulter AU480 chemistry system revealed the routine chemistry tests performed on the chemistry system have fewer than three calibrators. There was no documentation of calibration verification performed for the routine chemistry tests on the Beckman Coulter AU480 chemistry system since the last survey on 10-19-16. -- 3 of 6 -- D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for the Beckman Coulter Access 2 immunoassay system from 3-1-18 through 5-31-18, the laboratory failed to include at least two controls for two days of cardiac panel testing during this time frame. Findings include: Review of QC records for the Beckman Coulter Access 2 immunoassay system from 3-1-18 through 5-31-18 revealed the laboratory failed to include one of two levels of control material for the following tests on these days: 5-1- 18--Level 1 control not performed for CKMB testing. 5-4-18--Level 3 control not performed for CKMB, Myoglobin, and Troponin I testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on review of quality control (QC) records for the Beckman Coulter Access 2 immunoassay system from 3-1-18 through 5-31-18 and manufacturer's acceptable ranges for MAS CardioImmune Controls, Lot #CXL20011A and Lot #CXL20013A, the laboratory failed to document, as performed, the establishment of statistical parameters for acceptable ranges for the CKMB test with the MAS CardioImmune Controls, in use for quality control testing during this time frame. Findings include: Review of QC records for the Beckman Coulter Access 2 immunoassay system from 3-1-18 through 5-31-18 revealed MAS CardioImmune Controls, Lot #CXL20011A and Lot #CXL20013A, were in use for CKMB testing during this time frame. Review of the manufacturer's acceptable ranges for MAS CardioImmune Controls, Lot #CXL20011A and Lot #CXL20013A, revealed no acceptable range for CKMB testing on the Beckman Coulter Access 2 immunoassay system. On the day of the survey, 9-7- 18, there was no documentation of establishment of statistical parameters for CKMB ranges listed on the Access 2 QC records. 2. Based on review of QC records for the Beckman Coulter AU480 chemistry system from 4-1-18 through 5-31-18, observation -- 4 of 6 -- of MAS ChemTrak-H Liquid Assayed Chemistry Controls Level 1, Lot #CHA19071A, and Level 2, Lot #CHA19073A, in the laboratory refrigerator on 9-7- 18 at 12:15 p.m., and manufacturer's acceptable ranges for Lot #CHA19071A and Lot #CHA19073A, the laboratory failed to document, as performed, the establishment of statistical parameters for acceptable ranges for MAS ChemTrak-H Liquid Assayed Chemistry Controls, Lot #CHA19071A and Lot #CHA19073A, currently in use for quality control testing for routine chemistry tests. Review of the manufacturer's ranges for these lot numbers revealed the manufacturer's ranges were not used for determining acceptability of quality control testing with these lot numbers 3. Based on review of QC records for the IRMA Blood Analysis System from 9-8-17 through 7-13- 18, observation of RNA Medical Liquid Controls Lot #502433 in the laboratory on 9- 7-18 at 1:30 p.m., and the manufacturer's assay sheet for this lot number of controls, the laboratory failed to document, as performed, the establishment of statistical parameters for acceptable ranges for pH, pO2, and pCO2 testing with the RNA Medical Liquid Controls, in use for quality control testing during this time frame. Findings include: Review of the manufacturer's acceptable ranges for RNA Medical Liquid Controls Lot #502433 revealed no acceptable range for pH, pO2, and pCO2 testing on the IRMA Blood Analysis System. On the day of the survey, 9-7-18, there was no documentation of establishment of statistical parameters for the ranges listed for pH, pO2, and pCO2 testing on the IRMA Blood Analysis System QC records. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on review of manufacturer's acceptable ranges for Alere Total 5 controls and quality control (QC) records for D-Dimer testing on the Alere Triage Meter Pro from 12-22-16 through 8-20-18, the laboratory failed to ensure the Level 2 control result met the manufacturer's criteria for acceptability on 3-16-17, 4-20-17, and 7-31-18. Findings include: Review of manufacturer's acceptable ranges for Alere Total 5 controls and QC records for D-Dimer testing on the Alere Triage Meter Pro from 12- 22-16 through 8-20-18 revealed Level 2, of two levels of control material performed every 30 days, was outside the manufacturer's acceptable range on 3-16-17, 4-20-17, and 7-31-18. 2. Based on review of instrument QC printouts for the ITC IRMA Blood Analysis System from 9-8-17 through 7-13-18, the laboratory failed to ensure at least 2 of 3 levels of control met the laboratory's criteria for acceptability for two days of testing during this time frame. Findings include: Review of instrument QC and patient printouts for the ITC IRMA Blood Analysis System from 9-8-17 through 7-13-18 revealed the laboratory failed to ensure two of three levels of control material met the laboratory's criteria for acceptability for the following tests on these days: 1-27-18-- Level 2 and Level 3 controls outside laboratory's acceptable range for pO2 testing when one patient result was reported. 7-13-18--Level 1 and Level 3 controls outside laboratory's acceptable range for pH testing when one patient result was reported. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the -- 5 of 6 -- laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of the ITC IRMA Blood Analysis System User Manual, monthly temperature checks, and quality control records for November 2016 through July 2018, testing personnel responsible for moderate complexity testing failed to document, as performed, the monthly temperature check on the ITC IRMA Blood Analysis System, as required by the manufacturer, for twelve months during this time frame when patient blood gas testing was being performed. Refer to D5431 (Failure to perform monthly temperature checks as required by the manufacturer). THIS IS A REPEAT DEFICIENCY. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form and personnel records since the last survey on 10-19-16, the laboratory director failed to ensure that Testing Personnel #1, responsible for high complexity and moderate complexity testing, had the appropriate education and training PRIOR to performing patient testing and that Testing Personnel #5, responsible for moderate complexity testing, had the appropriate education PRIOR to performing patient testing. Findings include: 1. Review of the CMS 209 personnel form and personnel records since 10-19-16 revealed no documentation of education or training for Testing Personnel #1, date of hire 8-6-18, responsible for high complexity and moderate complexity testing. 2. Review of the CMS 209 personnel form and personnel records since 10-19-16 revealed no documentation of education for Testing Personnel #5, whose initial evaluation for moderate complexity patient testing was performed on 4-13-17. -- 6 of 6 --