East Texas Border Health Clinic

Summary Statement of Deficiencies D0000 An onsite survey conducted 12/15/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 review of laboratory policy, proficiency testing (PT) records, and confirmed in interview, the laboratory failed to ensure that patient remedial action was taken for three of three unsatisfactory analyte test performances for the Chemistry 2022 3rd event. The findings included: 1. A review of the laboratory policy titled "Proficiency Testing Policy for Genesis PrimeCare" stated the following: "For all PT specimen failure of 60% or below,

Summary Statement of Deficiencies D0000 . An onsite survey conducted 05/05/2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. . 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: Review of manufacturer's instructions, instrument printouts, and patient final reports and confirmed in interview, the laboratory failed to follow the manufacturer's instructions for the handling of patient sample flags for four out of four random patients reviewed in March and April 2022 for the Sysmex XP-300 hematology analyzer. The findings include: 1. Review of the Sysmex Automated Hematology Analyzer XP-300 Instructions for Use, chapter 8 "Display and Output for Analysis Results" 8.3 "Histogram Flags" had the following statement for the meanings of signs displayed on the left of the analysis data: "Sign - Explanation [*] - Result is unreliable [AG] Flag Probable Sample Cause: Presence of nucleated red blood cells, effects of fragmented red blood cells, increase of large platelets, platelet aggregation or agglutination, precipitation of fibrin, etc. Correction (reference): 1) Check smear, ect." 2. Review of random patient instrument printouts and final patient results had the following patients with histogram flags resulted without

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, American Proficiency Institute (API) proficiency testing (PT) records from 2019 to 2021 and confirmed in interview, the laboratory failed to test proficiency testing materials the same number of times as patient samples for CBC (complete blood count) on the Cell-Dyn Emerald hematology analyzer for three of eight PT events reviewed. Findings were: 1. Review of the laboratory policy Proficiency Testing Policy revealed "PT specimens are to be treated the same as patient samples. The lab should document all steps taken in PT performance." 2. A review of the CELL-DYN Emerald Operators Manual (9140848E- June 2010) Section 3: Instrument Alarms, Operational Alerts and Measurand Data Flags revealed that: "An asterisk (*) for count invalidation or (s) suspect measurand 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 -- flags are displayed with corresponding results." "These flags are generated after the instrument evaluates the measured data for a particular measurand or group of measurands. The result may be suspect due to interference substances or the inability of the instrument to measure a particular measurand due to sample abnormality." "s" (Suspect Measurand Flags) flags may indicate the presence of myelocytes, lymphoblasts, basophils, eosinophils or myelocytes. Differential "s" flag L2 May indicate the presence of myelocytes, lymphoblasts, or basophils. Differential "s" flag L5 Large-size cells present. Count Invalidation Flags (*) WBC and Differential "*" flag L5 Large-size cells present The actions indicated by the manufacturer for "s" flags was "check the specimen for clots or agglutination. Follow your laboratory's review criteria or review a stained smear to confirm the differential results. Redraw and retest the specimen as required." For "*" flags the actions indicated by the manufacturer was "check the specimen for clots or agglutination. Follow your laboratory's review criteria or review a stained smear to confirm the differential results and verify the WBC count. Redraw and retest the specimen as required." 3. Review of the CBC instrument printout from the 2019 - 2021 API Hematology PT events revealed three of eight events that the laboratory had flags for the following PT specimens with no documentation of the rerun result per the laboratory policy. 2020- 2nd event specimen flag Hem-06 L5 Hem-07 L5 Hem-08 L5 Hem-09 L5 Hem-10 L5 2020-3rd event specimen flag Hem-11 L5 Hem-12 L2, L5 Hem-13 L5 Hem-14 L5 Hem-15 L5 2021-2nd event specimen flag Hem -06 L5 Hem-07 L5 Hem-08 L5 Hem- 09 L5 Hem-10 L5 4. An interview with the laboratory director and testing person #1 on 9/9/21 at 1340 hours in the conference room confirmed the above findings. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of laboratory records, American Proficiency Institute (API) proficiency testing records from 2019 to 2021 and confirmed in interview, the laboratory failed to test all proficiency samples in the same manner as it tests patient specimens by personnel who routinely performed the testing in the laboratory for 13 of 15 test events reviewed . Findings were: 1. Review of the CMS209 revealed five testing personnel performing nonwaived hematology and chemistry (TP#1 to TP#5). 2. Review of the API test records from 2019 to 2021 proficiency testing events revealed that for 13 of 15 events only testing person #1 who performed the proficiency testing. By not involving all testing personnel who normally test patient specimens in the testing of proficiency testing samples, the facility failed to treat proficiency samples in the same manner as patient samples. 2019 API hematology 1st event: TP#1 2019 API hematology 3rd event: TP#1 2019 API chemistry 1st event: TP#1 2019 API chemistry 2nd event: TP#1 2019 API chemistry 3rd event: TP#1 2020 API hematology 1st event: TP#1 2020 API hematology 2nd event: TP#1 2020 API chemistry 1st event: TP#1 2020 API chemistry 2nd event: TP#1 2021 API hematology 1st event: TP#1 2021 API hematology 2nd event: TP#1 2021 API chemistry 1st event: TP#1 2021 API chemistry 1st event: TP#1 3. An interview with testing person #1 on 9/9/21 at 1310 hours in the conference room confirmed the above findings. She acknowledged that all testing persons should perform the PT. key: CMS - Center for Medicare and Medicaid Services -- 2 of 6 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation, a review of the QC package insert, and confirmed in an interview revealed the laboratory failed to indicate the opened dates and expiration dates on three of three QC materials for CBC on Sysmex XP-300 hematology analyzer. The findings were: 1. Direct observation of the surveyor's revealed the QC materials, EIGHTCHECK-3WPX-TRA Hematology control ((Ref: 140-3004-0) had no documentation of the opened dates or revised expiration on three tubes of Sysmex EIGHTCHECK-3WPX-TRA Hematology QCs (Ref: 140-3004-0) EIGHTCHECK-3WPX-TRA Hematology control Level I: Lot: 12230710 Exp. 2021 /11/17 Level II: Lot: 12230711 Exp. 2021/11/17 Level III: Lot: 12230712 Exp. 2021 /11/17 2. Review of the Sysmex EIGHTCHECK-3WPX-TRA Hematology control package insert (350493-6, Date of issue or revision: 03/2021, Rev.19) under Storage and shelf life after first opening revealed "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8C after being re- capped." 3. An interview with the lab manager on 9/9/21 at 10:38 am in the walk-in Clinic lab confirmed the above findings. Key: QC=Quality Control CBC=Complete Blood Count 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 Sysmex XP-300 Instruction for use, review of the laboratory's maintenance records, patient records, and confirmed in an interview revealed the laboratory failed to document the required maintenance procedures for three of thirty- five weekly maintenance from Jan to Aug, 2021. The findings were: 1. Review of Sysmex XP-300 Instruction for use (Code No: AU553517, Date of Last Revision: November 2017, Software Version: 00-14 and onwards) under Chapter 12 Cleaning and Maintenance revealed "To ensure proper functioning of the instrument, it is necessary to periodically clean and service the instrument. Perform maintenance according to the schedule below, and record the results in the Maintenance checklist." Weekly Clean SRV tray 2. Random review of the laboratory's maintenance records revealed the laboratory had no documentation of performing the required weekly maintenance procedures on Sysmex XP-300 (SN# B5888) for three of thirty-five weekly maintenance from Jan to Aug, 2021. Weekly: 5/9/21-5/15/21 5/30/21-6/5/21 8 /22/21-8/28/21 3. Random review of patient records from 1/1/21-8/31/21 revealed the following eight patient testing without required weekly maintenance procedures performed on Sysmex XP-300. 5/12/21 Accession#: 135577 5/12/21 Accession#: -- 3 of 6 -- 135581 5/12/21 Accession#: 135610 6/2/21 Accession#: 136805 6/2/21 Accession#: 136762 6/2/21 Accession#: 136794 8/27/21 Accession#: 141881 8/27/21 Accession#: 141893 4. An interview with laboratory manager on 9/9/21 at 11:15 am in the walk-in Clinic breakroom confirmed the above findings. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(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-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, the laboratory's records from 5/1/21 to 9/9 /21, patient records, and confirmed in an interview revealed the laboratory failed to document a quality control after a change in reagents on the Sysmex XP-300 hematology analyzer for one of ten days reviewed. The findings were: 1. Review of the laboratory's Quality Control Assessment policy revealed under Hematology, "3. It is also important to check the QC in the following situations: a. change in reagent lot number..." 2. Random review of the 5/1/21 to 9/9/21 Reagent Replacement log revealed no documentation of the quality control run after the following reagent change on the Sysmex XP-300 (SN#B5888) hematology analyzer for one of ten days reviewed. 5/12/21 Stromatolyser-WH Lot: Y0006 Exp: 11/12/21 3. Review of the patient test records for the above dates revealed the laboratory performed three patient testing after the reagent change above with no documentation of the quality control run. 5/12/21 Accession#: 135610 5/12/21 Accession#: 135577 5/12/21 Accession#: 135581 4. An interview with the lab manager on 9/9/21 at 9:30 am in the walk-in Clinic lab confirmed a quality control was not run after a change of reagent on the Sysmex XP-300. Key: QC=Quality Control 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: Based on a review of the QC package insert, the laboratory's QC records for the -- 4 of 6 -- Sysmex XP-300 from 5/28/21 to 9/9/21, patients records from 5/28/21 to 9/9/21, and confirmed in an interview revealed the laboratory failed to verify new lot numbers of external QCs for CBC testing on the Sysmex XP-300 hematology analyzer before putting them in use for nine of nine lot numbers reviewed. The findings were: 1. Review of the EIGHTCHECK-3WPX-TRA package insert revealed under Performance Characteristics and Limitations "Sysmex recommends that each laboratory uses the targets and limits provided on the assay sheet included with each lot of EIGHTCHECK-3WPX-TRA, or establish laboratory specific targets and limits." 2. Review of the laboratory's QC records for Sysmex XP-300 (SN# B5888) hematology analyzer from 5/1/21 to 9/9/21 revealed no documentation of the laboratory verifying the following nine external QC materials lot numbers: EIGHTCHECK-3WPX-TRA Hematology control XP-series Started on 8/27/21 Level I: Lot: 12230710 Exp. 2021/11/17 Level II: Lot: 12230711 Exp. 2021/11/17 Level III: Lot: 12230712 Exp. 2021/11/17 Started on 6/9/21 Level I: Lot: 1139070 Exp. 2021/08 /25 Level II: Lot: 1139071 Exp. 2021/08/25 Level III: Lot: 1139072 Exp. 2021/08/25 Started on 5/28/21 Level I: Lot: 10550710 Exp. 2021/06/02 Level II: Lot: 10550711 Exp. 2021/06/02 Level III: Lot: 10550712 Exp. 2021/06/02 3. Random review of patient records from 5/28/21 to 9/9/21 revealed the laboratory performed the following five patient CBC testing. 6/2/21 Accession#: 136762 6/2/21 Accession#: 136794 6/2/21 Accession#: 136805 8/27/21 Accession#: 141881 8/27/21 Accession#: 141893 4. An interview with the lab director and the lab manager on 9/9/21 at 4:50 pm in the conference room confirmed Sysmex XP-300 (SN# B5888) did not verify new lot of QC materials before putting in use. Key: QC=Quality Control CBC=Complete blood count . D5781

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on April 12, 2021 and August 5, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D2017 - 42 C.F.R. 493.807 Condition: Reinstatement of laboratories performing non-waived testing D6000 - 42 C.F.R. 493.1403 Condition: 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Institute proficiency testing records, the facility failed to achieve successful performance in five of five consecutive testing events for the analyte Digoxin, resulting in unsuccessful participation in the specialty of Toxicology. Refer to D2118 and D2119. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the facility failed to achieve successful performance in five of five consecutive testing events for the analyte Digoxin, resulting in a non-initial proficiency testing failure in the specialty of Toxicology. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Digoxin in the specialty of Toxicology in five of five consecutive events: 2020 API 1st event - Digoxin 60% 2020 API 2nd event- Digoxin 0% 2020 API 3rd event- Digoxin 40% 2021 API 1st event - Digoxin 60% 2021 API 2nd event - Digoxin 20% 2. Based on review of the American Proficiency Institute (API) Comparative Evaluations, the facility failed to achieve an overall testing event score for Toxicology in five of five consecutive testing events in 2020 and 2021. 2020 API 1st event - Toxicology 60% 2020 API 2nd event- Toxicology 0% 2020 API 3rd event- Toxicology 40% 2021 API 1st event - Toxicology 60% 2021 API 2nd event - Toxicology 20% D2109 TOXICOLOGY CFR(s): 493.845(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency -- 2 of 4 -- Institute (API) Comparative Evaluations, the facility failed to attain a score of at least 80 percent for the analyte Digoxin in five of five consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Digoxin in the specialty of Toxicology in five of five consecutive events: 2020 API 1st event - Digoxin 60% 2020 API 2nd event- Digoxin 0% 2020 API 3rd event- Digoxin 40% 2021 API 1st event - Digoxin 60% 2021 API 2nd event - Digoxin 20% D2110 TOXICOLOGY CFR(s): 493.845(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the facility failed to attain an overall testing event score of at least 80 percent for the specialty of Toxicology in five of five consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Digoxin in the specialty of Toxicology in five of five consecutive events: 2020 API 1st event - Toxicology 60% 2020 API 2nd event- Toxicology 0% 2020 API 3rd event- Toxicology 40% 2021 API 1st event - Toxicology 60% 2021 API 2nd event - Toxicology 20% 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the facility failed to achieve satisfactory performance for the analyte Digoxin in five of five consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Digoxin in the specialty of Toxicology in five of five consecutive events: 2020 API 1st event - Digoxin 60% 2020 API 2nd event- Digoxin 0% 2020 API 3rd event- Digoxin 40% 2021 API 1st event - Digoxin 60% 2021 API 2nd event - Digoxin 20% D2119 TOXICOLOGY -- 3 of 4 -- CFR(s): 493.845(g) Failure to achieve an overall testing event score of satisfactory performance 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the facility failed to achieve an overall testing event score of satisfactory performance for Toxicology in five of five consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Digoxin in the specialty of Toxicology in five of five consecutive events: 2020 API 1st event - Toxicology 60% 2020 API 2nd event- Toxicology 0% 2020 API 3rd event- Toxicology 40% 2021 API 1st event - Toxicology 60% 2021 API 2nd event - Toxicology 20% 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Digoxin and the specialty of Toxicology. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Digoxin in the specialty Toxicology. Refer to D2118 and D2119. -- 4 of 4 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel competency verification documentation for 2017 and 2018, confirmed by staff interview, the technical consultant failed to evaluate the competency of 2 of 5 testing personnel semiannually during the first year of testing patient specimens. Findings: 1. Staff training and competency documentation was reviewed. Documents for testing person 2, hire date 02-16-2016, included a competency evaluation checkoff sheet dated 12-21-2017. No other competency evaluation documents for testing person 2 could be made available. 2. Documents for testing person 3, hire date 02-06-2017, included a competency evaluation checkoff sheet dated 12-21-2017. No other competency evaluation documents for testing person 3 could be made available. 3. In an interview at the site on 04-04-2018, the laboratory manager stated that no semiannual competency evaluations had been performed on testing persons 2 and 3 during the first year of testing patient specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --