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Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the CMS 209 form, personnel records, the laboratory's API (American Proficiency Institute) proficiency testing results, and staff interview, it was revealed that the laboratory failed to ensure that proficiency testing samples were analyzed by personnel who routinely performed patient testing in the laboratory for four of four proficiency testing events in 2023. Findings include: 1. A review of the laboratory's CMS 209 form revealed 21 testing personnel performing moderate complexity testing. 2. A review of the laboratory's personnel records revealed 12 of 21 testing personnel were hired prior to 2023: Testing person #1 Hire date: 4/2022 Testing person #2 Hire date: 12/2022 Testing person #3 Hire date: 12/2022 Testing person #5 Hire date: 1/2014 Testing person #6 Hire date: 9/2015 Testing person #7 Hire date: 12/2017 Testing person #8 Hire date: 1/2022 Testing person #9 Hire date: 1 /2021 Testing person #10 Hire date: 7/2020 Testing person #11 Hire date: 7/2020 Testing person #12 Hire date: 5/2021 Testing person #19 Hire date: 7/2022 3. A review of the laboratory's API proficiency testing records from 2023 revealed the laboratory participated in the following 4 testing events: - Chemistry 2023 first event - Hematology/Coagulation 2023 first event - Chemistry 2023 second event - Hematology/Coagulation 2023 second event 4. Further review of the proficiency testing events from 2023 revealed all 4 events were tested by Testing person #3. 5. An 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 -- interview with the technical consultant (as indicated on the CMS 209 form) on 7/25 /23 at 12:55 p.m. in the break room, after review of the records, confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the laboratory's validation records, QC records from March 2023 to May 2023, and confirmed in an interview, the laboratory failed to have documentation of monitoring quality control values over time for one of three months reviewed for Medonic M-series hematology analyzer. The findings were: 1. Review of the laboratory's validation records revealed the laboratory validated Medonic M- series hematology analyzer (SN: 62138) on March 9, 2023. 2. Review of the laboratory's QC records from March 2023 to May 2023 revealed the laboratory failed to have documentation of monitoring quality control values over time for one of three months reviewed for Medonic M-series hematology analyzer. April 2023 3. An interview with the technical consultant on 7/25/2023 at 12:29 pm in the breakroom confimed the above findings. 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 the review of the laboratory's policy, the laborartory's validation records, QC records from March 2023 to July 2023, and confirmed in an interview, the laboratory filaed to follow its own policy to verify the criteria for acceptilibility for -- 2 of 4 -- two of two lot numbers for Medonic M-series hematology analyzer. The findings were: 1. Review of the laboratory's validation records revealed the laboratory validated Medonic M-series hematology analyzer (SN: 62138) on March 9, 2023. 2. Review of the laboratory's policy titled QUANTITATIVE CONTROL VALIDATIONS revealed "Method: New controls shall be run at least once a day for 5 days along with current controls." 3. Review of the laboratory's QC records from March 2023 to July 2023 revealed no documentation of verifying the criteria for acceptilibility for two of two lot numbers on Medonic M-series hematology analyzer. Lot# 22303 Exp. 2023-07-27 From 3/9/2023 to 7/20/2023 Lot# 22306 Exp. 2023-10- 30 From 7/21/2023 to 7/25/2023 (current) 4. An interview with the TP#3 and the tecniclal consultant on 7/25/2023 at 10:42 am in the breakroom confirmed the above findings. Key: QC=Quality Control TP=Testing personnel D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on a review of the laboratory's annual competency assessments performed in 2022, proficiency testing records, and staff interview, it was revealed that the technical consultant failed to include the testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for 10 of 12 annual competency assessments performed in 2022. Findings include: 1. A review of the annual competency assessments forms revealed the technical consultant noted the following for all testing personnel competency assessments performed in 2022: "Assessment of test performance: A. through testing previously analyzed specimens- NO B. internal blind testing specimens-NO C. or external proficiency testing samples- YES" 2. A review of the laboratory's American Proficiency Institute (API) proficiency testing records for 2022 revealed no documentation of the following 10 testing personnel performing any of the proficiency testing samples in 2022: - Testing person #1 - Testing person #4 - Testing person #5 - Testing person #6 - Testing person #7 - Testing person #8 - Testing person #9 - Testing person #10 - Testing person #11 - Testing person #12 3. Further review of the laboratory's competency assessments performed in 2022 on the above listed testing personnel revealed no documentation of testing previous analyzed samples or internal blind testing. 4. An interview with the technical consultant (as indicated on the CMS 209 form) on 7/25/23 at 12:55 p.m. in the break room, after review of the records, confirmed the above findings. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, it was revealed that thirteen of twenty one testing personnel failed to have documentation of training prior to performing patient -- 3 of 4 -- testing on the Medonic M Series hematology analyzer. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 21 testing personnel who performed moderate complexity testing. 2. A review of the laboratory's personnel records revealed that the following 13 testing personnel failed to have documentation of training on the Medonic M Series hematology analyzer: - Testing person #1 - Testing person #2 - Testing person #5 - Testing person #6 - Testing person #7 - Testing person #8 - Testing person #9 - Testing person #10 - Testing person #11 - Testing person #12 - Testing person #13 - Testing person #18 - Testing person #21 3. An interview with the technical consultant on 7/25/23 at 12:55 p.m. in the break room, after review of the records, confirmed the above findings. -- 4 of 4 --

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 verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 records obtained from the CMS national 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 -- database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Hematology for the analyte Cell I.D. or WBC Diff. (Refer to D2130) Key: CMS=Center for Medicare and Medicaid Services D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in the specialty of Hematology for the Cell I.D. or WBC Diff analyte for three of three proficiency testing events in 2022. The findings were: 1. API 2022 Hematology/Coagulation for the first event revealed the laboratory received an unsatisfactory score of 67% for the analyte Cell I.D. or WBC Diff. 2. API 2022 Hematology/Coagulation for the second event revealed the laboratory received an unsatisfactory score of 73% for the analyte Cell I.D. or WBC Diff. 3. API 2022 Hematology/Coagulation for the third event revealed the laboratory received an unsatisfactory score of 73% for the analyte Cell I.D. or WBC Diff. 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 records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory director failed to provide overall management and direction of the laboratory services. (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: -- 2 of 3 -- Based on a desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company American Proficiency Institute (API) found the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. (Refer to D2130). -- 3 of 3 --

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 verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 review of the CMS (Center for Medicare Services) national database and a 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 -- proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2022, it was determined the laboratory had not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for the analyte Cell ID/WBC Differential. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Pathologist Institute (API) proficiency test results, it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events in the specialty of Hematology for the Cell ID/WBC Differential analyte in 2022. Findings include: Cell ID/WBC Differential: 1. 2022 Hematology/Coagulation - 1st Event unacceptable score of 67%. 2. 2022 Hematology /Coagulation - 2nd Event unacceptable score of 73%. 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 an HHS approved proficiency testing program for the analyte Cell ID/WBC Differential. 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 results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services -- 2 of 3 -- provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2130 -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced recertification survey was performed in response to complaint TX00374137. The laboratory failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780 resulting in the following IMMEDIATE JEOPARDY findings: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; Complaint TX 00374137 was substantiated. Laboratory provided a letter to state agency on 5/19/21 that abated the immediate jeopardy. Testing is only performed per the manufacturer's instructions. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: I. Based on a review of the manufacturer's instructions for the Siemens Multistix Reagent Strips, a review of the laboratory's quality control records from January 2020 to April 2021, and staff interview, it was revealed the laboratory failed to have documentation of following the manufacturer's instructions for performing quality control testing for 10 of 16 months on the Siemens Multistix Reagent Strips for urinalysis testing from January 2020 to April 2021. Findings include: 1. A review of the manufacturer's instructions for the Siemens Multistix Reagent Strips (Document: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- TN30516A, 06/2010) under the section titled 'Quality Control' revealed the following: "Test negative and positive controls when you first open a new bottle." 2. A review of the laboratory's quality control records from January 2020 to April 2021 for the Siemens Multistix Reagent Strips revealed the laboratory runs 2 levels of quality control material each month. 3. Further review of the laboratory's quality control records for each month revealed there is no documentation of the Multistix lot number for the following months, making it impossible to determine if the quality control was run per the manufacturer's instructions ("when you first open a new bottle"): January 2020 February 2020 March 2020 May 2020 July 2020 December 2020 January 2021 February 2021 March 2021 April 2021 4. An interview with testing person #1 (as indicated on the CMS 209 form) on 5/13/21 at 1:25 p.m. in the laboratory, after review of the records, confirmed the above findings. II. Based on a review of the Henry Schein One Step Plus Strep A Dipstick Test Instructional Insert, surveyor observation, a review of patient test records from May 2021, and staff interview, it was revealed that the laboratory failed to follow the manufacturer's instructions by using reagents from multiple kits for Strep A testing on 3 of 3 patient samples in May 2021. Findings include: 1. A review of the Henry Schein One Step Plus Strep A Dipstick Test Instructional Insert (document number 1156110502, 05/15/18) revealed the following: "Only use reagents provided in the kit". 2. Further review of the Henry Schein One Step Plus Strep A Dipstick Test Instructional Insert revealed each kit contained: - 50 Test dipsticks (2 cannisters of 25 test strips) - 2 Reagent A - 2 Reagent B 3. Surveyor observation of the laboratory on 5/13/21 at 9:30 a.m. revealed one kit of Henry Schein One Step Plus Strep A Dipstick Test lot number: STA0042071 expire: 4 /30/22. The following reagents were found inside the kit: - 1 vial containing 23 test dipsticks lot: STA0042053 exp: 3/31/22 - 1 vial containing 3 test dipsticks lot: STA0042053 exp: 3/31/22 - 1 vial containing 21 test dipsticks lot: STA0042053 exp: 3 /31/22 - 2 vials containing 25 test dipsticks lot: STA0042071 exp: 4/30/22 - 2 bottles of Reagent A lot: 20040014 exp: 6/30/22 - 1 bottle of Reagent A lot: 20040013 exp: 6 /30/22 - 3 bottles of Reagent B lot: 0040046 exp: 7/15/22 4. A review of patient test records from May 2021 revealed the laboratory ran the following 3 patient samples using the Henry Schein One Step Plus Strep A Dipstick Test kit with reagents from multiple test kits: Patient ID: 12232009 Run date: 5/12/21 Patient ID: 11151978 Run date: 5/12/21 Patient ID: 08142002 Run date: 5/12/21 5. An interview with testing person #1 (as indicated on the CMS 209 form) on 5/13/21 at 9:40 a.m. in the laboratory, after review of the records, confirmed the above findings. Key: exp = expiration date III. Based on a review of the Henry Schein One Step Plus Pro Mono Test Kit package insert, surveyor observation, a review of patient test records from April and May 2021, and staff interview, it was revealed that the laboratory failed to ensure reliable patient results when 1 of 1 patient's sample was tested for mononucleosis (mono) using the test device from one kit and expired developer solution from another manufacturer's mono kit. Findings include: 1. A review of the Henry Schein One Step Plus Pro Mono Test Kit package insert (document number 1156110502, 05/15/18) revealed the following: "Kit Contents: - 20 test devices - 1 developer solution" 2. Surveyor observation of the laboratory on 5/13/21 at 9:20 a.m. found 1 Henry Schein One Step Plus Pro Mono Test Kit ( lot: 229M11A exp: 7/31/21) with an open date of 3/20/21. 3. Further review of the Henry Schein One Step Plus Pro Mono Test Kit revealed the following kit components inside: - 4 test devices lot: 229M11 exp: 9/30/21 - 1 bottle Consult Diagnostics Mononucleosis Developer Solution lot: 229C04091 exp: 2/28/21 *** The developer solution was a different manufacturer and expired.*** 4. A review of patient test records from April and May 2021 revealed the following patient was tested using the Henry Schein One Step Plus Pro Mono Test kit with the expired developer solution: Patient ID: 09021977 Mono test: negative 5. An interview with testing person #1 (as indicated on the CMS 209 -- 2 of 21 -- form) on 5/13/21 at 9:40 a.m. in the laboratory, after review of the records, confirmed the above findings. 44697 IV. Based on direct observation and review of manufacture's insert, temperature logs, patient COVID TEST KIT LOGs from 12/30 /20 to 3/23/21, and confirmed in an interview that the laboratory had no mechanism to follow the CareStart COVID-19 Antigen manufacturer's instruction for storage temperature requirement for 4 of 10 days. The findings were: 1. Direct observation of surveyor on 5/14/21 at 10:10 am revealed the CareStart COVID-19 Antigen test kit (Ref RCHM-02071, Lot# CH21A22, Expiration date: June 2021) stored in the receptionist area. 2. Review of CareStart COVID-19 Antigen manufacturer's insert revealed the storage requirement was "Store the test kit as packaged between 1- 30 C." 3. Review of temperature logs revealed the laboratory had no mechanism to monitor the storage temperature following manufacturer's instruction. 4. Review of patient COVID TEST KIT LOGs from 12/30/20 to 3/23/21 revealed 45 of 45 patient COVID nasal swabs/Antigen testing performed without documentation of storage temperatures. Refer to Patient Alias List for COVID Ag and Ab. 5. An interview with testing personnel#5 (TP#5) on 5/14/21 at 10:12 am in the receptionist area confirmed that the receptionist area was not monitoring the storage temperature. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: I. Based on review of the manufacturer's instructions, review of patient test records from Feb 1, 2021 - May 12, 2021 and staff interview, it was revealed the laboratory failed to report 661 SARS-CoV-2 positive and negative Antigen test results as required by 400.200 for 75 of 75 days reviewed from February 1, 2021 to May 12, 2021. Findings include: 1. Review of the Instructions for Use for the Sofia 2 Flu + SARS Antigen FIA test cassettes under CONDITIONS OF AUTHORIZATION FOR THE LABORATORY revealed "authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 2. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 Antigen patient testing Sofia 2 Flu + SARS Antigen FIA test cassettes on 02/2021. 3. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS- CoV-2 test reporting. 4. Review of the laboratory SARS-CoV-2 Antigen patient test records from February 1, 2021 to May 12, 2021 revealed no documentation the laboratory reported 661 of 661 patient positive and negative test records for 75 of 75 days of testing. Refer to Covid Antigen Patient Alias list. 5. An interview with the testing personnel number 1 (as listed on Form CMS 209) on 5/13/21 at 1010 hours in the laboratory confirmed the above findings II. Based on review of the manufacturer's instructions, review of patient test records from Febuary 1, 2021 to May 12, 2021, and staff interview, revealed the laboratory failed to report 20 postive and negative SARS- -- 3 of 21 -- CoV-2 Antibody test results as required by 42 CFR 493.41 and 493.1100(a) for 14 of 14 days when testing occurred. Findings were: 1. Review of the Instructions for Use for the Healgen Covid-19 IgG/IgM Rapid Test cassette (Ref: GCCOV-402a, Revision 2020-5-2) under CONDITIONS OF AUTHORIZATION FOR THE LABORATORY revealed "authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 2. Review of the laboratory test records revealed the laboratory started SARS-CoV-2 IgG/IgM patient testing using Healgen Covid-19 IgG/IgM Rapid Test cassette on 6/16/20. 3. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS-CoV-2 test reporting. 4. Review of the laboratory SARS-CoV-2 IgG/IgM patient test records from February 1, 2021 to May 12, 2021 revealed no documentation the laboratory reported 20 of 20 postivie and negative patient test records for 14 of 14 days of testing. Refer to Covid Antibody Patient Alias list. 5. An interview with the testing personnel number 1 (as listed on Form CMS 209) on 5/13/21 at 1010 hours in the laboratory confirmed the above findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records and staff interview, it was revealed that the laboratory failed to retain documentation of the IQCP (Individualized Quality Control Plan) for the Alere Triage meter. Findings include: 1. A review of the laboratory's records revealed the laboratory failed to retain documentation of the IQCP for the Alere Triage meter to support the laboratory's reduction in the frequency of quality control testing to every 30 days for the following analytes: CK-MB (creatine kinase myocardial band) TNI (troponin) MYO (myoglobin) DDIM (d-dimer) 2. An interview with testing person #1 (as indicated on the CMS 209 form) on 5/14/21 at 10:40 a.m. in the laboratory, after review of the records, confirmed the above findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency tests (PT) records from 2019 to 2021, Proficiency Testing policy (2017), and confirmed in an interview revealed the laboratory failed to retain attestation sheets for 7 of 7 PT events. 1. Review of Proficiency Testing policy (2017) revealed "All records, reports, and

Summary Statement of Deficiencies D0000 An unannounced recertification survey was performed in response to complaint TX00374137. The laboratory failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780 resulting in the following IMMEDIATE JEOPARDY findings: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; Complaint TX 00374137 was substantiated. Laboratory provided a letter to state agency on 5/19/21 that abated the immediate jeopardy. Testing is only performed per the manufacturer's instructions. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: I. Based on a review of the manufacturer's instructions for the Siemens Multistix Reagent Strips, a review of the laboratory's quality control records from January 2020 to April 2021, and staff interview, it was revealed the laboratory failed to have documentation of following the manufacturer's instructions for performing quality control testing for 10 of 16 months on the Siemens Multistix Reagent Strips for urinalysis testing from January 2020 to April 2021. Findings include: 1. A review of the manufacturer's instructions for the Siemens Multistix Reagent Strips (Document: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- TN30516A, 06/2010) under the section titled 'Quality Control' revealed the following: "Test negative and positive controls when you first open a new bottle." 2. A review of the laboratory's quality control records from January 2020 to April 2021 for the Siemens Multistix Reagent Strips revealed the laboratory runs 2 levels of quality control material each month. 3. Further review of the laboratory's quality control records for each month revealed there is no documentation of the Multistix lot number for the following months, making it impossible to determine if the quality control was run per the manufacturer's instructions ("when you first open a new bottle"): January 2020 February 2020 March 2020 May 2020 July 2020 December 2020 January 2021 February 2021 March 2021 April 2021 4. An interview with testing person #1 (as indicated on the CMS 209 form) on 5/13/21 at 1:25 p.m. in the laboratory, after review of the records, confirmed the above findings. II. Based on a review of the Henry Schein One Step Plus Strep A Dipstick Test Instructional Insert, surveyor observation, a review of patient test records from May 2021, and staff interview, it was revealed that the laboratory failed to follow the manufacturer's instructions by using reagents from multiple kits for Strep A testing on 3 of 3 patient samples in May 2021. Findings include: 1. A review of the Henry Schein One Step Plus Strep A Dipstick Test Instructional Insert (document number 1156110502, 05/15/18) revealed the following: "Only use reagents provided in the kit". 2. Further review of the Henry Schein One Step Plus Strep A Dipstick Test Instructional Insert revealed each kit contained: - 50 Test dipsticks (2 cannisters of 25 test strips) - 2 Reagent A - 2 Reagent B 3. Surveyor observation of the laboratory on 5/13/21 at 9:30 a.m. revealed one kit of Henry Schein One Step Plus Strep A Dipstick Test lot number: STA0042071 expire: 4 /30/22. The following reagents were found inside the kit: - 1 vial containing 23 test dipsticks lot: STA0042053 exp: 3/31/22 - 1 vial containing 3 test dipsticks lot: STA0042053 exp: 3/31/22 - 1 vial containing 21 test dipsticks lot: STA0042053 exp: 3 /31/22 - 2 vials containing 25 test dipsticks lot: STA0042071 exp: 4/30/22 - 2 bottles of Reagent A lot: 20040014 exp: 6/30/22 - 1 bottle of Reagent A lot: 20040013 exp: 6 /30/22 - 3 bottles of Reagent B lot: 0040046 exp: 7/15/22 4. A review of patient test records from May 2021 revealed the laboratory ran the following 3 patient samples using the Henry Schein One Step Plus Strep A Dipstick Test kit with reagents from multiple test kits: Patient ID: 12232009 Run date: 5/12/21 Patient ID: 11151978 Run date: 5/12/21 Patient ID: 08142002 Run date: 5/12/21 5. An interview with testing person #1 (as indicated on the CMS 209 form) on 5/13/21 at 9:40 a.m. in the laboratory, after review of the records, confirmed the above findings. Key: exp = expiration date III. Based on a review of the Henry Schein One Step Plus Pro Mono Test Kit package insert, surveyor observation, a review of patient test records from April and May 2021, and staff interview, it was revealed that the laboratory failed to ensure reliable patient results when 1 of 1 patient's sample was tested for mononucleosis (mono) using the test device from one kit and expired developer solution from another manufacturer's mono kit. Findings include: 1. A review of the Henry Schein One Step Plus Pro Mono Test Kit package insert (document number 1156110502, 05/15/18) revealed the following: "Kit Contents: - 20 test devices - 1 developer solution" 2. Surveyor observation of the laboratory on 5/13/21 at 9:20 a.m. found 1 Henry Schein One Step Plus Pro Mono Test Kit ( lot: 229M11A exp: 7/31/21) with an open date of 3/20/21. 3. Further review of the Henry Schein One Step Plus Pro Mono Test Kit revealed the following kit components inside: - 4 test devices lot: 229M11 exp: 9/30/21 - 1 bottle Consult Diagnostics Mononucleosis Developer Solution lot: 229C04091 exp: 2/28/21 *** The developer solution was a different manufacturer and expired.*** 4. A review of patient test records from April and May 2021 revealed the following patient was tested using the Henry Schein One Step Plus Pro Mono Test kit with the expired developer solution: Patient ID: 09021977 Mono test: negative 5. An interview with testing person #1 (as indicated on the CMS 209 -- 2 of 21 -- form) on 5/13/21 at 9:40 a.m. in the laboratory, after review of the records, confirmed the above findings. 44697 IV. Based on direct observation and review of manufacture's insert, temperature logs, patient COVID TEST KIT LOGs from 12/30 /20 to 3/23/21, and confirmed in an interview that the laboratory had no mechanism to follow the CareStart COVID-19 Antigen manufacturer's instruction for storage temperature requirement for 4 of 10 days. The findings were: 1. Direct observation of surveyor on 5/14/21 at 10:10 am revealed the CareStart COVID-19 Antigen test kit (Ref RCHM-02071, Lot# CH21A22, Expiration date: June 2021) stored in the receptionist area. 2. Review of CareStart COVID-19 Antigen manufacturer's insert revealed the storage requirement was "Store the test kit as packaged between 1- 30 C." 3. Review of temperature logs revealed the laboratory had no mechanism to monitor the storage temperature following manufacturer's instruction. 4. Review of patient COVID TEST KIT LOGs from 12/30/20 to 3/23/21 revealed 45 of 45 patient COVID nasal swabs/Antigen testing performed without documentation of storage temperatures. Refer to Patient Alias List for COVID Ag and Ab. 5. An interview with testing personnel#5 (TP#5) on 5/14/21 at 10:12 am in the receptionist area confirmed that the receptionist area was not monitoring the storage temperature. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: I. Based on review of the manufacturer's instructions, review of patient test records from Feb 1, 2021 - May 12, 2021 and staff interview, it was revealed the laboratory failed to report 661 SARS-CoV-2 positive and negative Antigen test results as required by 400.200 for 75 of 75 days reviewed from February 1, 2021 to May 12, 2021. Findings include: 1. Review of the Instructions for Use for the Sofia 2 Flu + SARS Antigen FIA test cassettes under CONDITIONS OF AUTHORIZATION FOR THE LABORATORY revealed "authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 2. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 Antigen patient testing Sofia 2 Flu + SARS Antigen FIA test cassettes on 02/2021. 3. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS- CoV-2 test reporting. 4. Review of the laboratory SARS-CoV-2 Antigen patient test records from February 1, 2021 to May 12, 2021 revealed no documentation the laboratory reported 661 of 661 patient positive and negative test records for 75 of 75 days of testing. Refer to Covid Antigen Patient Alias list. 5. An interview with the testing personnel number 1 (as listed on Form CMS 209) on 5/13/21 at 1010 hours in the laboratory confirmed the above findings II. Based on review of the manufacturer's instructions, review of patient test records from Febuary 1, 2021 to May 12, 2021, and staff interview, revealed the laboratory failed to report 20 postive and negative SARS- -- 3 of 21 -- CoV-2 Antibody test results as required by 42 CFR 493.41 and 493.1100(a) for 14 of 14 days when testing occurred. Findings were: 1. Review of the Instructions for Use for the Healgen Covid-19 IgG/IgM Rapid Test cassette (Ref: GCCOV-402a, Revision 2020-5-2) under CONDITIONS OF AUTHORIZATION FOR THE LABORATORY revealed "authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 2. Review of the laboratory test records revealed the laboratory started SARS-CoV-2 IgG/IgM patient testing using Healgen Covid-19 IgG/IgM Rapid Test cassette on 6/16/20. 3. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS-CoV-2 test reporting. 4. Review of the laboratory SARS-CoV-2 IgG/IgM patient test records from February 1, 2021 to May 12, 2021 revealed no documentation the laboratory reported 20 of 20 postivie and negative patient test records for 14 of 14 days of testing. Refer to Covid Antibody Patient Alias list. 5. An interview with the testing personnel number 1 (as listed on Form CMS 209) on 5/13/21 at 1010 hours in the laboratory confirmed the above findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records and staff interview, it was revealed that the laboratory failed to retain documentation of the IQCP (Individualized Quality Control Plan) for the Alere Triage meter. Findings include: 1. A review of the laboratory's records revealed the laboratory failed to retain documentation of the IQCP for the Alere Triage meter to support the laboratory's reduction in the frequency of quality control testing to every 30 days for the following analytes: CK-MB (creatine kinase myocardial band) TNI (troponin) MYO (myoglobin) DDIM (d-dimer) 2. An interview with testing person #1 (as indicated on the CMS 209 form) on 5/14/21 at 10:40 a.m. in the laboratory, after review of the records, confirmed the above findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency tests (PT) records from 2019 to 2021, Proficiency Testing policy (2017), and confirmed in an interview revealed the laboratory failed to retain attestation sheets for 7 of 7 PT events. 1. Review of Proficiency Testing policy (2017) revealed "All records, reports, and

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program. The conditions not met were: D2016- 42 C.F.R. 493.803 Condition: Successful participation in a proficiency testing program D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Hematology for the analytes White Blood Cell Differential (WBC DIFF) for 2 of 3 events. (refer to D2121) D2121 HEMATOLOGY CFR(s): 493.851(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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed the laboratory failed to attain a score of at least 80% for 1 of 6 regulated analytes (WBC Diff) in the specialty of Hematology for 2 of 3 events in 2019 and 2020. Findings include: 1. Review of the CMS national database proficiency testing report for 2109 third events and 2020 second event, the laboratory failed to attain at least 80% for WBC Diff: WBC Diff 2019 - Third event: 0 % 2020 - Second Event: 0% 2. Review of API proficiency records for the 2019 third event and 2020 second revealed the laboratory failed to attain a score of at least 80 percent on the following analytes: WBC Diff 2019 - Third event: 0 % 2020 - Second Event: 0% D2122 HEMATOLOGY CFR(s): 493.851(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 CMS national database and American Proficiency Institute (API) proficiency testing records, the laboratory failed to attain an overall testing event score of at least 80 % for each event which constitutes unsatisfactory performance in 1of 3 events for 2019. Findings were: 1. Review of the CMS national database revealed the laboratory received "0" for Hematology for third testing event in 2019. 2019- Third event Hematology - 0% 2. Review of the laboratory API test records revealed the laboratory received "0" for the specialty of Hematology for third testing event in 2019. 2019 Third event Hematology - 0% D2123 HEMATOLOGY CFR(s): 493.851(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 -- 2 of 4 -- 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 review of the CMS national database and 2019 and 2020 American Proficiency Institute (API) proficiency testing records, the laboratory failed to participate in the specialty of hematology for 2019 third testing event. Findings were: 1. Review of the CMS national database revealed the laboratory received "0" for all the analytes in hematology for the third testing event in 2019. 2019 Third event WBC - 0% RBC - 0% HGB - 0% HCT - 0% PLT - 0% WBC Diff - 0% 2. Review of the laboratory API test records revealed the laboratory received "0" for Failure to Participate for all analytes in hematology for third testing event in 2019. 2019 Third event WBC - 0% RBC - 0% HGB - 0% HCT - 0% PLT - 0% WBC Diff - 0% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with records from American Proficiency Institute (API), the laboratory did not successfully participate in the specialty of Hematology/Coagulation for the analytes Cell ID or WBC Diff in 2 of 3 events between 2019 and 2020. The findings included: 1. Review of the CMS national database revealed the laboratory received "0" for Cell ID or WBC Diff for the following test events: 2019 - Third event: 0 percent 2020 - Second event: 0 percent 2. Review of the API testing records from 2019 and 2020 revealed the laboratory received "0" for the Cell ID or WBC Diff for the following test events: 2019 - Third event: 0 percent 2020 - Second event: 0 percent Score of less than 80 percent are unsatisfactory performance. Unsatisfactory performance on two (2) consecutive events or two out of three (2 out of 3) events is 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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) -- 3 of 4 -- 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 results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. (refer to D2121, D2130) -- 4 of 4 --

Summary Statement of Deficiencies 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: An unannounced revisit was performed on 9/27/19 Based on review of the laboratory policy, quality control report records, laboratory patient logs, and confirmed in interview, the laboratory failed to document 2 acceptable levels of controls prior to reporting patient test results for CBC analysis on the Cell-Dyn Emerald hematology analyzer. Findings were: 1. Review of the laboratory policy Control Policy revealed "for quantitative testing, two levels of controls shall be run for every procedure on each day of use...patient testing must not be performed or reported when controls results are outside the expected range for two of three controls per analyte." 2. Review of the laboratory quality control report from August and September 2019 for the Cell Dyn Emerald hematology analyzer revealed no quality control documented on 9/19 /19. 3. Review of the laboratory patient logs from September 2019 revealed the laboratory performed 3 patient testing without documentation of 2 acceptable levels of quality control for the above date. See patient alias list. 4. An interview with the primary testing person on 09/27/19 at 1050 hours confirmed the above findings. He was unaware the staff were not performing quality control per the laboratory policy. D5783

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F. R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. 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 review of the laboratory records, review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2017 to 2019, and confirmed in interview revealed the laboratory failed to have documentation of rotating proficiency testing among all testing personnel for hematology and chemistry. Findings were: 1. Review of the laboratory's CMS 209 signed by the laboratory director on 5/21/19 revealed 19 testing personnel for the laboratory. 2. A review of the laboratory's API proficiency testing records from 2018 revealed testing person #14 (TP#14) performed 3 of 3 testing events for hematology and 3 of 3 testing events for chemistry. 2018 Hematology 1st event 2018 Hematology 2nd event 2018 Hematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 3rd event 2018 Chemistry Core 1st event 2018 Chemistry Core 2nd event 2018 Chemistry Core 3rd event 3. An interview with the technical consultant on 5/21/19 at 1010 hours in the patient room confirmed the above findings. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on review of records and confirmed in interview, the laboratory failed to retain the linearity (reportable range study) for the Cell-Dyn Emerald hematology analyzer. Findings included: 1. In review of records, the laboratory could not provide linearity (reportable range study) for the Cell-Dyn Emerald hematology analyzer performed in 09/2013. 2. In an interview with the technical consultant on 5/21/19 at 1110 hours in the patient room he stated, "It was done." The laboratory could not provide the reportable range studies at the time of the survey. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of laboratory records and interview of laboratory personnel, it was revealed that the laboratory did not meet the applicable preanalytic system(s) requirements. Refer to D5311, D5317 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 review of the manufacturer's instructions, laboratory patient test records, laboratory policies, and confirmed in interview, the laboratory failed to follow the preanalytical procedures for blood specimen acceptability and rejection, and conditions for specimen transportation for CBC (complete blood count) for the Cell- -- 2 of 10 -- Dyn Emerald hematology analyzer. Findings were: 1. Review of the Cell-Dyn Emerald Operator's manual (9140851C, December 2009) under requirements for collecting, preparing and storing specimens revealed "maximum suggested elapsed time and storage temperatures after collection of venous whole blood: Four hours at room temperature." 2. Review of the laboratory records from the sister laboratory located at 10900 Gulf Freeway B102 revealed 1 specimen (refer to patient alias list) was collected on 2/28/19 at 1150 hours. Review of the instrument printouts from the sister laboratory revealed the specimen was analyzed for CBC (complete blood count) at 2/28/19 at 1158 hours; then again at 1205 hours; then again 1729 hours. All 3 runs had differential flags (L1, P1). 3. An interview with the testing person 12 (who is also a testing person at the sister laboratory) on 5/21/19 at 1005 hours confirmed that he ran the above specimen at the sister laboratory. He stated that per the physician's request to analyze the specimen at the sister laboratory, he transported the specimen at ambient temperature to this laboratory and performed the CBC on 2/28/19 at 2028; 8 hours, 38 minutes after the collection time. 4. Review of the laboratory policy Specimen Rejection (effective 10/28/17) revealed "specimen storage of transport was inappropriate for testing." 5. An interview with the technical consultant on 5/21/19 at 1015 hours in the patient room confirmed the above findings. He acknowledged that the testing person was "not following policy [for specimen rejection]." D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory records and policies, and confirmed in interview, the laboratory failed to document written instructions to laboratory clients for the preanalytical requirements for CBC (complete blood count) patient testing for the Cell- Dyn Emerald hematology analyzer. Findings were: 1. Review of the laboratory policy Procedures for specimen submission and handling revealed "this laboratory will have written policies and procedures for methods used for the preparation of patient specimen sollection, specimen preservation, and conditions of transportation. 2. Review of the laboratory records and policies available revealed no documentation of the above mentioned policy for CBC patient testing for the Cell-Dyn Emerald hematology analyzer. 3. An interview with the technical consultant on 5/21/19 at 1010 hours in the patient room confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: -- 3 of 10 -- Based on review of laboratory policies, review of quality control records, review of patient final reports, and confirmed in interview, the laboratory failed to monitor and evaluate the overall quality of its analytic systems. Refer to D5407, D5421, D5425, D5445 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedures, verification records, patient test reports, and confirmed in interview, the laboratory failed to have an approved procedure prior to start of CBC (complete blood count) patient testing for the Cell-Dyn Emerald hematology analyzer and Cardiac and DDimer testing on the Alere Triage Meter. Findings were: 1. Review of the laboratory policies and procedures revealed the laboratory director approved them on 10/23/17. 2. Review of the laboratory records revealed the laboratory began patient testing on 05/25/17. 3. An interview with the technical consultant on 5/21/19 at 1130 hours in the patient room confirmed the above findings. He acknowledged that the laboratory director should have signed them prior to patient testing. 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: A. Based on review of the laboratory policy, laboratory verification records, and confirmed in interview, the laboratory failed to document complete verification studies for the Cell-Dyn Emerald hematology analyzer. (accuracy, precision, and normal reference range) Findings were: 1. Review of the laboratory policy Validation of a New Test System revealed "it is the policy of this lab to validate a new test system prior to using it to report patient results...accuracy, precision, reportable ranges, and verification of manufacturer's normal values studies that meet the acceptance criteria validate the performance of the test system." 2. Review of the laboratory's verification studies revealed no documentation of the laboratory assessing the accuracy, precision, and normal reference range of CBC testing on the Cell-Dyn Emerald hematology analyzer. 3. An interview with the technical consultant on 5/21 /19 at 1105 hours in the empty patient room confirmed the above findings. B. Based on review of the laboratory policy, laboratory verification records, and confirmed in interview, the laboratory failed to document complete verification studies for CKMB, Troponin, Myoglobin, and DDimer testing on the Alere Triage meter. Findings were: 1. Review of the laboratory policy Validation of a New Test System revealed "it is the -- 4 of 10 -- policy of this lab to validate a new test system prior to using it to report patient results...accuracy, precision, reportable ranges, and verification of manufacturer's normal values studies that meet the acceptance criteria validate the performance of the test system." 2. Review of the laboratory's verification stuies revealed no documentation of the laboratory assessing the normal reference range for CKMB, Troponin, Myoglobin, and DDimer testing on the Alere Triage meter. 3. An interview with the technical consultant on 5/21/19 at 1105 hours in the empty patient room confirmed the above findings. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory records and confirmed in interview, the laboratory failed to document verification of control performance for CKMB, Troponin, Myoglobin, and DDimer testing on the Alere Triage meter. Findings were: 1. Review of the laboratory verfication records for CKMB, Troponin, Myoglobin, and DDimer testing on the Alere Triage meter revealed no documentation of the laboratory establishing the frequency of control performance to include test system instrument /reagent stability, including relocation; frequency with which the test is performed; technique dependence of the method; frequency of quality control failures; and training, experience, and competency of technical personnel. 2. An interview with the technical consultant on 5/21/19 at 1325 hours in the patient room confirmed the above findings. 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: A. Based on review of the laboratory test records, quality control records, manufacturer's instructions, and confirmed in interview, the laboratory failed to document a complete INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP) for the CKMB, Troponin, Myoglobin, and DDimer testing on the Alere Triage meter. (risk assessment) Findings were: 1. Review of the laboratory IQCP for CKMB, Troponin, Myoglobin, and DDimer testing on the Alere Triage meter revealed no documentation of the risk assessment evaluation that included all five components (specimen, test system, reagent, environment, testing personnel) and all phases (preanalytical, analytical, postanalytical) of testing. a. Review of the IQCP E -- 5 of 10 -- optimizer records under preanalytical phase of testing revealed "all staff will be trained in the preanalytic phase of testing." Review of the laboratory records available revealed no documentation of the training documents referenced in the IQCP. b. Review of the IQCP E optimer records under analytical phase of testing revealed "all storage temperatures are monitored and recorded daily." Review of the laboratory records available revealed no documentation of the temperature logs referenced in the IQCP. 2. An interview with the technical consultant on 5/21/19 at 1230 hours in the patient room confirmed the above findings. He acknowledged that the temperature logs and QC that were referenced in the IQCP were not maintained prior to establishing the IQCP; therefore, could not have been reviewed. Also, he was unaware the laboratory was required to document a 30 day QC study for the IQCP. B. Based on review of the laboratory records, quality control records, IQCP (Individualized Quality Control Plan) records, patient test logs and confirmed in interview, the laboratory failed to provide documentation of performing quality control each day of patient testing or complete documentation of an IQCP prior to modifying the frequency of quality control testing for CKMB, Troponin, Myoglobin, and DDimer testing on the Alere Triage meter. Findings were: 1. Random review of the laboratory quality control report from November 2018 - April 2019 for the Alere Triage meter revealed no quality control performed on the following days for the following analytes on the following days. Ddimer date 04/18/2019 04/04/2019 04/03/2019 03/06/2019 12 /17/2018 11/26/2018 Cardiac (CKMB, Troponin, Myoglobin) 04/04/2019 04/03/2019 03/22/2019 03/25/2019 01/19/2019 01/05/2019 12/17/2018 11/26/2018 2. Random review of the laboratory patient logs from November 2018 to April 2019 revealed the laboratory performed patient testing for the above days. Refer to patient alias list. 3. Review of the IQCP records revealed no documentation of the performance specifications for each analyte (CKMB, Troponin, Myoglobin, and DDimer) daily for 30 days to modify the QC to every 30 days. 4. An interview with the technical consultant on 5/21/19 at 1235 hours in the patient room confirmed the above findings. He was unaware the quality control study for the IQCP was insufficient. The laboratory only performed external quality control monthly. 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 review of instrument verification records, review of patient final reports, and confirmed in interview, the laboratory director failed to provide overall management and direction of the laboratory. (refer to D6007, D6013, and D6020) D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of -- 6 of 10 -- test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on a review of laboratory preanalytic and analytic systems it was revealed that the laboratory director failed to ensure that testing systems performed in the laboratory provided quality laboratory services for all aspects of test performance in Hematology and Chemistry. Refer to D5311, D5421, D5425. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of the laboratory verification records and confirmed in interview, the laboratory director failed to ensure the laboratory documented complete verification studies Alere Triage meter and Cell-Dyn Emerald hematology analyzer prior to start of patient testing. (Refer to D5421) D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control (QC) records and confirmed in interview, the laboratory failed to ensure the laboratory established and maintained a quality control program. Refer to D5425, D5445 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: -- 7 of 10 -- Based on review of the laboratory policies, verification studies, calibration records, and confirmed in interview, the technical consultant failed to provide technical oversight of the laboratory. (Refer to D6040, D6042, and D6053) D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Review of policies and procedures, quality control records, calibration records, and patient test records found that the technical consultant failed to ensure the laboratory documented complete verification studies for the Alere Triage meter and Celly-Dyn Emerald hematology analyzer. (See D5421) D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: The technical consultant failed to ensure that the quality control program had been established and maintained for the Alere Triage meter. (See D5425, D5445) D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the CMS form 209, personnel records and verified by interview, the Technical Consultant failed to perform the 2018 annual competency evaluations for 12 of 12 testing personnel for the moderately complex testing in the specialties of chemistry and hematology. Findings were: 1. Review of the laboratory's CMS 209 signed by the laboratory director on 5/21/19 revealed 19 testing personnel for the laboratory. 2. A random review of the facility's personnel files available revealed 12 of 12 testing personnel had no documentation of the 2018 annual competency for the moderately complex testing in the specialties of chemistry and hematology. The technical consultant provided documentation of competency assessments peformed at the sister laboratory located at 10900 Gulf Freeway B102. Date of hire Testing person 1 06/20/2014 Testing person 2 11/15/2016 Testing person 5 01/07/2017 Testing person 6 05/16/2014 Testing person 9 09/16/2017 Testing person 10 02/10/2016 -- 8 of 10 -- Testing person 11 09/06/2015 Testing person 12 02/08/2016 Testing person 13 10/19 /2017 Testing person 15 10/21/2015 Testing person 17 11/21/2017 Testing person 19 11/20/2017 Testing person 20 07/06/2017 3. An interview with the technical consultant on 5/21/19 at 1005 hours in the patient room confirmed the above findings. He was unaware the laboratory was required to document competency assessments separately for each laboratory. 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 the CMS form 209, personnel records and verified by interview, the Technical Consultant failed to perform the initial and second competency evaluations in the first year for 19 of 19 testing personnel for the moderately complex testing in the specialties of chemistry and hematology. Findings were: 1. Review of the laboratory's CMS 209 signed by the laboratory director on 5/21/19 revealed 19 testing personnel for the laboratory. 2. A random review of the facility's personnel files available revealed 19 of 19 testing personnel had no documentation of the intial and second competency in the first year for the moderately complex testing in the specialties of chemistry and hematology. The technical consultant provided documentation of competency assessments peformed at the sister laboratory located at 10900 Gulf Freeway B102. Date of hire Testing person 1 06/20/2014 Testing person 2 11/15/2016 Testing person 3 08/02/2018 Testing person 4 07/04/2018 Testing person 5 01/07/2017 Testing person 6 05/16/2014 Testing person 7 06/19/2018 Testing person 8 06/06/2018 Testing person 9 09/16/2017 Testing person 10 02/10/2016 Testing person 11 09/06/2015 Testing person 12 02/08/2016 Testing person 13 10/19 /2017 Testing person 15 10/21/2015 Testing person 16 06/25/2018 Testing person 17 11/21/2017 Testing person 18 07/09/2018 Testing person 19 11/20/2017 Testing person 20 07/06/2017 3. An interview with the technical consultant on 5/21/19 at 1005 hours in the patient room confirmed the above findings. He was unaware the laboratory was required to document competency assessments separately for each laboratory. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's submitted Form CMS-209, review of the laboratory's personnel records, and confirmed in interview, the laboratory failed to have documentation of education 2 of 19 testing personnel. Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) -- 9 of 10 -- (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS-209, review of the laboratory's personnel records, and confirmed in interview, the laboratory failed to have documentation of education to qualify 2 of 19 testing personnel for moderately complex testing for CBC (complete blood count) on the Cell-Dyn Emerald hematology analyzer. Findings were: 1. A review of personnel records available revealed no documentation of education for 2 of 19 testing personnel (TP#4, TP#14). 2. An interview with the technical consultant on 5/21/19 at 1030 hours in the patient room confirmed the above findings. CMS - Centers of Medicare and Medicaid Services -- 10 of 10 --