1st Choice Pediatrics

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on July 13, 2022 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 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 College of American Pathology (CAP) records, the facility failed to achieve successful performance in two 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 -- of two consecutive Hematology testing events for 2022, resulting in unsuccessful performance. Refer to D2122. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American Pathology (CAP) proficiency testing records from 2022, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of two consecutive testing events for the specialty of Hematology. Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CASPER Report 155 listed the following overall scores for the 2022 Hematology PT Program: Hematology 2022 Event 1 - "0" Hematology 2022 Event 2 - "70" 2. A proficiency desk review of the College of American Pathology (CAP) proficiency testing records from 2022 confirmed that the laboratory received the following Hematology scores: Hematology 2022 Event FH1-A - 0 Hematology 2022 Event FH1-B - 70 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the College of American Pathology testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for Hematology. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American -- 2 of 3 -- Pathologist proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for Hematology for two of two events in 2022. Refer to 2122 and 6000. -- 3 of 3 --

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 of Participation in the CLIA program, and recertification is recommended. . D2009 Based on the review of the API proficiency testing records from 2020-2021, and confirmed in an interview found the laboratory failed to ensure the TP and/or LD documented attestation sheets to the routine integration of the samples into the patient workload using the laboratory's routine methods for five of six PT testing events. The findings were: 1. Review of the API proficiency testing records from 2020-2021 revealed no documentation of the TP and/or LD attestation for five of six test events. 2020 Hematology/Coagulation-1st event 2020 Hematology/Coagulation-2nd event 2021 Hematology/Coagulation-1st event 2021 Hematology/Coagulation-2nd event 2021 Hematology/Coagulation-3rd event 2. An interview with the manager on 4/7/22 at 10:15 am in the office confirmed the above findings. Key: API= American Proficiency Institute TP=Testing personnel LD=Laboratory director PT=Proficiency testing D2121 Based on the review of the laboratory's API proficiency test results from 2020-2021 and confirmed in an interview found the laboratory failed to attain a score of at least 80 percent for six of six regulated analytes in 2020 Hematology/Coagulation-1st event. The findings were: 1. Review of the laboratory's API proficiency test results from 2020-2021 revealed the laboratory received scores of less than 80% for six of six regulated analytes in 2020 Hematology/Coagulation-1st event. Regulated Analyte Score (%) Erythrocyte Count 40% Hematocrit 40% Hemoglobin 40% Leukocyte Count 40% Platelets 20% White Blood Cell Differential 60% 2. Further review of the API proficiency test results for the 2020 Hematology/Coagulation-1st event reveled the following proficiency samples received unacceptable performance for the above analytes. Erythrocyte Count (x 10E9/L) HSY-01 Reported Result: 4.32 Expected Results: 4.89-5.53 HSY-02 Reported Result: 2.34 Expected Results: 4.04-4.56 HSY- 03 Reported Result: 6.21 Expected Results: 2.26-2.56 Hematocrit (%) HSY-01 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Reported Result: 36 Expected Results: 41-47 HSY-02 Reported Result: 18 Expected Results: 32-37 HSY-03 Reported Result: 54 Expected Results: 16-19 Hemoglobin (g /dL) HSY-01 Reported Result: 12.4 Expected Results: 14.7-17.1 HSY-02 Reported Result: 6.1 Expected Results: 11.4-13.2 HSY-03 Reported Result: 19.1 Expected Results: 5.6-6.5 Leukocyte Count (x 10E9/L) HSY-01 Reported Result: 7.8 Expected Results: 15.1-20.6 HSY-02 Reported Result: 3.6 Expected Results: 6.0-8.3 HSY-04 Reported Result: 17.6 Expected Results: 10.6-14.3 Platelets (x 10E9/L) HSY-01 Reported Result: 226 Expected Results: 385-644 HSY-02 Reported Result: 53 Expected Results: 163-274 HSY-03 Reported Result: 119 Expected Results: 40-68 HSY-04 Reported Result: 483 Expected Results: 91-152 White Blood Cell Differential Lymphocytes (%) HSY-02 Reported Result: 25.6 Expected Results: 27.0- 31.9 HSY-03 Reported Result: 38.3 Expected Results: 19.8-26.4 Neut/Gran (%) HSY- 01 Reported Result: 57.0 Expected Results: 47.7-53.2 HSY-02 Reported Result: 64.0 Expected Results: 55.7-62.1 HSY-03 Reported Result: 48.1 Expected Results: 62.6- 70.6 3. An interview with the manager on 4/7/22 at 10:40 am in the office confirmed the above findings. Key: API=American Proficiency Institute D2122 Based on the review of the CASPER Report 155 report, the review of the laboratory's API proficiency test results from 2020-2021 and confirmed in an interview found the laboratory failed to attain an overall acceptable score of at least 80 percent for six of six regulated analytes in 2020 Hematology/Coagulation-1st event. The findings were: 1. Review of the CASPER 155 report revealed the laboratory attained an overall unacceptable score of 40% in Hematology in 2020 Hematology/Coagulation-1st event. 2020 Hematology/Coagulation-1st event 40% 2. Review of the laboratory's API proficiency test results from 2020-2021 revealed the laboratory received scores of less than 80% for six of six regulated analytes in 2020 Hematology/Coagulation-1st event. Regulated Analyte Score (%) Erythrocyte Count 40% Hematocrit 40% Hemoglobin 40% Leukocyte Count 40% Platelets 20% White Blood Cell Differential 60% 3. An interview with the manager on 4/7/22 at 10:40 am in the office confirmed the above findings. Key: CASPER=Certification and Survey Provider Enhanced Reporting API=American Proficiency Institute D3000 Based on the surveyor's direct observation, IFU from FDA website, the review of the laboratory's COVID testing records from 2020-2022, and confirmed in an interview found the laboratory failed to report 71 positive Rapid SARS-CoV-2 Antigen test results as required by 42 CFR 493.41 and 493.1100(a) for 15 of 15 months reviewed from 12/2/2020 to 2/11/2022. The findings were: 1. Review BD Veritor system for Rapid Detection of SARS-CoV-2 with the BD Veritor Plus Analyzer IFU (REF: 256082; 2021-03; L012304(05)) under Conditions of Authorization for the Laboratory revealed "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 2. Review Quidel Sofia2 Flu+SARS Antigen IFU (RED: 20390) under Conditions of Authorization for the Laboratory and Patient Care Settings 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." 3. Review of the laboratory COVID testing log from December 2020 to May 2021 revealed the laboratory used BD Veritor rapid COVID device (SN#: 2010160JC9620) from December 2020 to May 2021. 4. Surveyor's direct observation revealed the laboratory performs rapid Flu+SARS antigen on two of two Quidel Sofia2 devices (SN#: 25020437 and SN#: 25004550) starting from January 2021 to current. 5. Review of the COVID testing records from 12/2/2020 to 2/11/2022 provided by the facility revealed 438 patients were tested for SARS-CoV-2. Refer to Patient alias List for 45D2072399 for Rapid COVID testing. 6. An interview with the -- 2 of 5 -- manager on 4/7/2022 at 9:30 am in the office confirmed the above findings. The manager stated the facility reported to a local health authority in the beginning of pandemic via phone and the facility stopped reporting thinking it was not necessary. Key: IFU=Instruction for Use FDA=Food and Drug Administration D3031 Based on review of the laboratory's CBC QC records from 2020-2021 and confirmed in an interview found that the laboratory failed to retain 22 of 24 QC lots of Sysmex EIGHTCHECK-3WP X-TRA hematology control assay sheets for a minimum of 2 years. The findings were: 1. Review of the laboratory Sysmex EIGHTCHECK-3WP X-TRA hematology control assay sheets revealed the laboratory failed to retain assay sheets for 22 of 24 quality control assay sheets used in 2020 and 2021. The two hematology control assay sheets found were: Lot# 20260710 Exp 04-May-22 Lot# 03370710 Exp 03-Jan-21 2. An interview with the manager on 4/8/22 at 9:24 am in the office confirmed the laboratory did not retain the hematology control assay sheets for a minimum of 2 years. Key: CBC=Complete Blood Count QC=Quality Control D5413 Based on the review of the manufacturer's instructions for use, the laboratory's temperature and humidity logs from 2020-2021, and confirmed in an interview found the laboratory failed to document the operating room temperature and humidity as required by the manufacturer for 24 of 24 months on one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the manufacturer's manual titled Sysmex Automated Hematology Analyzer XP-300 Instructions for Use (North American Edition) (Code No. AU553517. Date of Last Revision: June 2013. Software Version: 00-12 and onwards.) in chapter 14. Technical Information 14.1 Specification revealed the operating environment in ambient temperature was 15C-30C and relative humidity was 30% to 85%. 2. Review of the laboratory's temperature and humidity logs from 2020-2021 revealed no documentation of the required operating temperature and humidity for 24 of 24 months. 3. Review of CMS 116 signed by the LD on 3/30/2022 revealed the annual volume for Sysmex XP-300 hematology instrument was 415. 4 An interview with the manager on 4/7/22 at 11:45 am in the office confirmed the above findings. The manager stated the facility did not have temperature and humidity logs. Key: CMS=Center of Medicare and Medicaid Service LD=Laboratory Director D5429 Based on the review of the manufacturer's manual, the laboratory's maintenance records from 2020-2021, CMS 116 records, and confirmed in an interview found the laboratory failed to perform and document maintenance as defined by the manufacturer's instructions for 24 of 24 months for one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the manufacturer's manual titled Sysmex Automated Hematology Analyzer XP-300 Instructions for Use (North American Edition) (Code No. AU553517. Date of Last Revision: June 2013. Software Version: 00-12 and onwards.) in Chapter 12. Cleaning and Maintenance 12.1 Maintenance schedule revealed daily and weekly maintenance are scheduled for the XP-300 Hematology analyzer (SN#:A5008). Daily Clean TD chambers and diluted sample lines (Shutdown) Check trap chamber level and discard Weekly Clean SRV tray 2. Review of the laboratory's maintenance records from 2020-2021 revealed no documentation of daily and weekly maintenance from 2020-2021. 3. Review of CMS 116 signed by the LD on 3/30/2022 revealed the annual volume for Sysmex XP-300 hematology instrument was 415. 4 An interview with the manager on 4/7/22 at 11:50 am in the office confirmed the above findings. The manager stated the facility did not know the maintenance schedule. Key: CMS=Center of Medicare and Medicaid Service LD=Laboratory Director -- 3 of 5 -- D5441 Based on the review of the laboratory's QC records from 2020-2021 and confirmed in an interview found the laboratory failed to have a method in place to monitor quality control values over time to detect shifts and trends for five of five analytes on one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the laboratory's QC records from 2020-2021 revealed the laboratory not have a method in place to monitor quality control values over time to detect shifts and trends for five of five analytes on one of one Sysmex XP-300 hematology instrument (SN#: A5008). RBC HCT HGB WBC PLT 2. Review of CMS 116 signed by the LD on 3/30/2022 revealed the annual volume for Sysmex XP-300 hematology instrument was 415. 3. An interview with the manager on 4/7/22 at 12:28 pm in the office confirmed the above findings. Key: QC=Quality Control RBC=Red Blood Cell HCT=Hematocrit HGB=Hemoglobin WBC=White Blood Cell PLT=Platelets CMS=Center of Medicare and Medicaid Service LD=Laboratory Director D5461 Based on the review of the manufacturer's manual, the laboratory reagent replacement history logs from 9/11/20 to 3/31/22 and confirmed in an interview found the laboratory failed to document a quality control run after a change in a reagent on eight of 15 days reviewed on one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the manufacturer's manual titled Sysmex Automated Hematology Analyzer XP-300 Instructions for Use (North American Edition) (Code No. AU553517. Date of Last Revision: June 2013. Software Version: 00-12 and onwards.) in Chapter 4. Reagents revealed two reagents were used in the XP-300 Hematology analyzer (SN#:A5008). Cellpack Stromatolyser-WH 2. Random review of the reagent replacement history logs from 9/11/20 to 3/31/22 revealed eight of 15 days reviewed with no documentation of the quality control run after the following reagent change on the Sysmex XP-300 (SN#A5008) hematology analyzer. 9/11/20 at 8:41 am Stromatolyser-WH Lot#Y0002 Exp 2/21/2021 10/12/21 at 9:56 am Stromatolyser-WH Lot#Y1002 Exp 4/29/2022 10/19/21 at 10:56 am Cellpack Lot#Y1008 Exp 1/30/2023 11/16/21 at 10:06 am Cellpack Lot#Y1008 Exp 1/30/2023 12/27/21 at 9:38 am Stromatolyser-WH Lot#Y1002 Exp 4/29/2022 01/14/22 at 10:01 am Cellpack Lot#Y1012 Exp 5/01/2023 3/04/22 at 9:27 am Stromatolyser-WH Lot#Y1002 Exp 4/29/2022 3/09/22 at 10:14 am Cellpack Lot#Y2002 Exp 7/12/2023 3. Review of the patient test records for the above date revealed the laboratory performed eight patient testing after the reagent change above with no documentation of the quality control run. Refer to Patients alias after Reagnet Replacement. 4. An interview with the manager on 4/7/22 at 12:25 pm in the office confirmed the above findings. D5793 Based on the review of the laboratory's policy, the laboratory's QA records from 2020- 2021, and confirmed in an interview found the laboratory failed to provide QA records for HHS or its designee review. The findings were: 1. Review of the laboratory's policy titled 1st Choice Pediatrics Quality Assurance Policies and Procedure under D. Quality Assurance Records revealed " All quality assurance records will be maintained by the laboratory for a period of two years and will be made available for review by HHS or its designee." 2. Review of the laboratory's QA records from 2020-2021 revealed no documentation of QA check list for QA indicators from 2020-2021. 3. An interview with the manager on 4/7/22 at 12:00 pm in the office confimed the above findings. The manager could not provide any QA records for review. Key: QA=Quality Assurance D5807 Based on the review of the laboratory's final reports and confirmed in an interview found the laboratory failed to provide the reference ranges or reference intervals to the authorized person who ordered the test for one of one Sysmex XP-300 hematology -- 4 of 5 -- instrument. The findings were: 1. Review of the laboratory's final reports revealed no reference ranges or reference intervals were provided to the authorized person who ordered the test for one of one Sysmex XP-300 hematology instrument (SN# A5008). 2. Review of CMS 116 signed by the LD on 3/30/2022 revealed the annual volume for Sysmex XP-300 hematology instrument was 415. 3. An interview with the manager on 4/8/22 at 10:00 am in the office confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Service LD=Laboratory Director D6018 Based on the review of the laboratory's policy, API proficiency test results from 2020- 2021 and confirmed in an interview found the LD failed to document the evaluation and verification for one of six PT events in 2020 Hematology/Coagulation-1st event. The findings were: 1. Review of the laboratory's policy titled 1st Choice Pediatrics Quality Assurance Policies and Procedure under B. Quality Assurance Indicators 3. Proficiency Testing revealed "All proficiency test results will be reviewed and

Summary Statement of Deficiencies D0000 A recertification survey was performed on 4/7/2022-4/8/2022. The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D3000 - 42 C.F.R. 493.1101 Condition: Facility Administration 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. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of the API proficiency testing records from 2020-2021, and confirmed in an interview found the laboratory failed to ensure the TP and/or LD documented attestation sheets to the routine integration of the samples into the patient workload using the laboratory's routine methods for five of six PT testing events. The findings were: 1. Review of the API proficiency testing records from 2020-2021 revealed no documentation of the TP and/or LD attestation for five of six test events. 2020 Hematology/Coagulation-1st event 2020 Hematology/Coagulation-2nd event 2021 Hematology/Coagulation-1st event 2021 Hematology/Coagulation-2nd event 2021 Hematology/Coagulation-3rd event 2. An interview with the manager on 4/7/22 at 10:15 am in the office confirmed the above findings. Key: API= American Proficiency Institute TP=Testing personnel LD=Laboratory director PT=Proficiency testing D2121 HEMATOLOGY CFR(s): 493.851(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 9 -- 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 the review of the laboratory's API proficiency test results from 2020-2021 and confirmed in an interview found the laboratory failed to attain a score of at least 80 percent for six of six regulated analytes in 2020 Hematology/Coagulation-1st event. The findings were: 1. Review of the laboratory's API proficiency test results from 2020-2021 revealed the laboratory received scores of less than 80% for six of six regulated analytes in 2020 Hematology/Coagulation-1st event. Regulated Analyte Score (%) Erythrocyte Count 40% Hematocrit 40% Hemoglobin 40% Leukocyte Count 40% Platelets 20% White Blood Cell Differential 60% 2. Further review of the API proficiency test results for the 2020 Hematology/Coagulation-1st event reveled the following proficiency samples received unacceptable performance for the above analytes. Erythrocyte Count (x 10E9/L) HSY-01 Reported Result: 4.32 Expected Results: 4.89-5.53 HSY-02 Reported Result: 2.34 Expected Results: 4.04-4.56 HSY- 03 Reported Result: 6.21 Expected Results: 2.26-2.56 Hematocrit (%) HSY-01 Reported Result: 36 Expected Results: 41-47 HSY-02 Reported Result: 18 Expected Results: 32-37 HSY-03 Reported Result: 54 Expected Results: 16-19 Hemoglobin (g /dL) HSY-01 Reported Result: 12.4 Expected Results: 14.7-17.1 HSY-02 Reported Result: 6.1 Expected Results: 11.4-13.2 HSY-03 Reported Result: 19.1 Expected Results: 5.6-6.5 Leukocyte Count (x 10E9/L) HSY-01 Reported Result: 7.8 Expected Results: 15.1-20.6 HSY-02 Reported Result: 3.6 Expected Results: 6.0-8.3 HSY-04 Reported Result: 17.6 Expected Results: 10.6-14.3 Platelets (x 10E9/L) HSY-01 Reported Result: 226 Expected Results: 385-644 HSY-02 Reported Result: 53 Expected Results: 163-274 HSY-03 Reported Result: 119 Expected Results: 40-68 HSY-04 Reported Result: 483 Expected Results: 91-152 White Blood Cell Differential Lymphocytes (%) HSY-02 Reported Result: 25.6 Expected Results: 27.0- 31.9 HSY-03 Reported Result: 38.3 Expected Results: 19.8-26.4 Neut/Gran (%) HSY- 01 Reported Result: 57.0 Expected Results: 47.7-53.2 HSY-02 Reported Result: 64.0 Expected Results: 55.7-62.1 HSY-03 Reported Result: 48.1 Expected Results: 62.6- 70.6 3. An interview with the manager on 4/7/22 at 10:40 am in the office confirmed the above findings. Key: API=American Proficiency Institute 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 the review of the CASPER Report 155 report, the review of the laboratory's API proficiency test results from 2020-2021 and confirmed in an interview found the laboratory failed to attain an overall acceptable score of at least 80 percent for six of six regulated analytes in 2020 Hematology/Coagulation-1st event. The findings were: 1. Review of the CASPER 155 report revealed the laboratory attained an overall unacceptable score of 40% in Hematology in 2020 Hematology/Coagulation-1st event. 2020 Hematology/Coagulation-1st event 40% 2. Review of the laboratory's API proficiency test results from 2020-2021 revealed the laboratory received scores of less than 80% for six of six regulated analytes in 2020 Hematology/Coagulation-1st event. Regulated Analyte Score (%) Erythrocyte Count 40% Hematocrit 40% -- 2 of 9 -- Hemoglobin 40% Leukocyte Count 40% Platelets 20% White Blood Cell Differential 60% 3. An interview with the manager on 4/7/22 at 10:40 am in the office confirmed the above findings. Key: CASPER=Certification and Survey Provider Enhanced Reporting API=American Proficiency Institute 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: Based on the surveyor's direct observation, IFU from FDA website, the review of the laboratory's COVID testing records from 2020-2022, and confirmed in an interview found the laboratory failed to report 71 positive Rapid SARS-CoV-2 Antigen test results as required by 42 CFR 493.41 and 493.1100(a) for 15 of 15 months reviewed from 12/2/2020 to 2/11/2022. The findings were: 1. Review BD Veritor system for Rapid Detection of SARS-CoV-2 with the BD Veritor Plus Analyzer IFU (REF: 256082; 2021-03; L012304(05)) under Conditions of Authorization for the Laboratory revealed "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 2. Review Quidel Sofia2 Flu+SARS Antigen IFU (RED: 20390) under Conditions of Authorization for the Laboratory and Patient Care Settings 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." 3. Review of the laboratory COVID testing log from December 2020 to May 2021 revealed the laboratory used BD Veritor rapid COVID device (SN#: 2010160JC9620) from December 2020 to May 2021. 4. Surveyor's direct observation revealed the laboratory performs rapid Flu+SARS antigen on two of two Quidel Sofia2 devices (SN#: 25020437 and SN#: 25004550) starting from January 2021 to current. 5. Review of the COVID testing records from 12/2/2020 to 2/11/2022 provided by the facility revealed 438 patients were tested for SARS-CoV-2. Refer to Patient alias List for 45D2072399 for Rapid COVID testing. 6. An interview with the manager on 4/7/2022 at 9:30 am in the office confirmed the above findings. The manager stated the facility reported to a local health authority in the beginning of pandemic via phone and the facility stopped reporting thinking it was not necessary. Key: IFU=Instruction for Use FDA=Food and Drug Administration 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. -- 3 of 9 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's CBC QC records from 2020-2021 and confirmed in an interview found that the laboratory failed to retain 22 of 24 QC lots of Sysmex EIGHTCHECK-3WP X-TRA hematology control assay sheets for a minimum of 2 years. The findings were: 1. Review of the laboratory Sysmex EIGHTCHECK-3WP X-TRA hematology control assay sheets revealed the laboratory failed to retain assay sheets for 22 of 24 quality control assay sheets used in 2020 and 2021. The two hematology control assay sheets found were: Lot# 20260710 Exp 04-May-22 Lot# 03370710 Exp 03-Jan-21 2. An interview with the manager on 4/8/22 at 9:24 am in the office confirmed the laboratory did not retain the hematology control assay sheets for a minimum of 2 years. Key: CBC=Complete Blood Count QC=Quality Control D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of the manufacturer's instructions for use, the laboratory's temperature and humidity logs from 2020-2021, and confirmed in an interview found the laboratory failed to document the operating room temperature and humidity as required by the manufacturer for 24 of 24 months on one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the manufacturer's manual titled Sysmex Automated Hematology Analyzer XP-300 Instructions for Use (North American Edition) (Code No. AU553517. Date of Last Revision: June 2013. Software Version: 00-12 and onwards.) in chapter 14. Technical Information 14.1 Specification revealed the operating environment in ambient temperature was 15C-30C and relative humidity was 30% to 85%. 2. Review of the laboratory's temperature and humidity logs from 2020-2021 revealed no documentation of the required operating temperature and humidity for 24 of 24 months. 3. Review of CMS 116 signed by the LD on 3/30/2022 revealed the annual volume for Sysmex XP-300 hematology instrument was 415. 4 An interview with the manager on 4/7/22 at 11:45 am in the office confirmed the above findings. The manager stated the facility did not have temperature and humidity logs. Key: CMS=Center of Medicare and Medicaid Service LD=Laboratory Director 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: -- 4 of 9 -- Based on the review of the manufacturer's manual, the laboratory's maintenance records from 2020-2021, CMS 116 records, and confirmed in an interview found the laboratory failed to perform and document maintenance as defined by the manufacturer's instructions for 24 of 24 months for one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the manufacturer's manual titled Sysmex Automated Hematology Analyzer XP-300 Instructions for Use (North American Edition) (Code No. AU553517. Date of Last Revision: June 2013. Software Version: 00-12 and onwards.) in Chapter 12. Cleaning and Maintenance 12.1 Maintenance schedule revealed daily and weekly maintenance are scheduled for the XP-300 Hematology analyzer (SN#:A5008). Daily Clean TD chambers and diluted sample lines (Shutdown) Check trap chamber level and discard Weekly Clean SRV tray 2. Review of the laboratory's maintenance records from 2020-2021 revealed no documentation of daily and weekly maintenance from 2020-2021. 3. Review of CMS 116 signed by the LD on 3/30/2022 revealed the annual volume for Sysmex XP-300 hematology instrument was 415. 4 An interview with the manager on 4/7/22 at 11:50 am in the office confirmed the above findings. The manager stated the facility did not know the maintenance schedule. Key: CMS=Center of Medicare and Medicaid Service LD=Laboratory Director 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 QC records from 2020-2021 and confirmed in an interview found the laboratory failed to have a method in place to monitor quality control values over time to detect shifts and trends for five of five analytes on one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the laboratory's QC records from 2020-2021 revealed the laboratory not have a method in place to monitor quality control values over time to detect shifts and trends for five of five analytes on one of one Sysmex XP-300 hematology instrument (SN#: A5008). RBC HCT HGB WBC PLT 2. Review of CMS 116 signed by the LD on 3/30/2022 revealed the annual volume for Sysmex XP-300 hematology instrument was 415. 3. An interview with the manager on 4/7/22 at 12:28 pm in the office confirmed the above findings. Key: QC=Quality Control RBC=Red Blood Cell HCT=Hematocrit HGB=Hemoglobin WBC=White Blood Cell PLT=Platelets CMS=Center of Medicare and Medicaid Service LD=Laboratory Director D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 5 of 9 -- 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 the review of the manufacturer's manual, the laboratory reagent replacement history logs from 9/11/20 to 3/31/22 and confirmed in an interview found the laboratory failed to document a quality control run after a change in a reagent on eight of 15 days reviewed on one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the manufacturer's manual titled Sysmex Automated Hematology Analyzer XP-300 Instructions for Use (North American Edition) (Code No. AU553517. Date of Last Revision: June 2013. Software Version: 00-12 and onwards.) in Chapter 4. Reagents revealed two reagents were used in the XP-300 Hematology analyzer (SN#:A5008). Cellpack Stromatolyser-WH 2. Random review of the reagent replacement history logs from 9/11/20 to 3/31/22 revealed eight of 15 days reviewed with no documentation of the quality control run after the following reagent change on the Sysmex XP-300 (SN#A5008) hematology analyzer. 9/11/20 at 8:41 am Stromatolyser-WH Lot#Y0002 Exp 2/21/2021 10/12/21 at 9:56 am Stromatolyser-WH Lot#Y1002 Exp 4/29/2022 10/19/21 at 10:56 am Cellpack Lot#Y1008 Exp 1/30/2023 11/16/21 at 10:06 am Cellpack Lot#Y1008 Exp 1/30/2023 12/27/21 at 9:38 am Stromatolyser-WH Lot#Y1002 Exp 4/29/2022 01/14/22 at 10:01 am Cellpack Lot#Y1012 Exp 5/01/2023 3/04/22 at 9:27 am Stromatolyser-WH Lot#Y1002 Exp 4/29/2022 3/09/22 at 10:14 am Cellpack Lot#Y2002 Exp 7/12/2023 3. Review of the patient test records for the above date revealed the laboratory performed eight patient testing after the reagent change above with no documentation of the quality control run. Refer to Patients alias after Reagnet Replacement. 4. An interview with the manager on 4/7/22 at 12:25 pm in the office confirmed the above findings. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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] D2017 - 42 C.F.R. 493.807 (a) - Reinstatement After Failure 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records and American Proficiency Institute (API) from 2019-2020, it was determined the laboratory has 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 Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID. (Refer to D2130, D2131) 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019 and American Proficiency Institute proficiency testing records from 2020, it was determined the laboratory had not successfully participated in proficiency testing for the satisfactory performance in the specialty of hematology for the analytes: Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID resulting in a non-initial PT failure. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of less than 80% for the analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 3 of 3 consecutive testing events in 2019 (Events 1 and 2) and 2020 (Event 1): 2019 AAB 2nd & 3rd event RBC - 0% HCT - 0% Hgb - 0% WBC - 0% PLT - 0% Cell ID - 0% 2020 API 1st event RBC - 40% HCT - 40% Hgb - 40% WBC - 60% PLT - 20% Cell ID - 60% 2. Review of AAB and API PT records for Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID revealed the laboratory received the following scores for the 2019 2nd and 3rd AABevents, and 2020 API 1st event: 2019 AAB 2nd & 3rd event RBC - 0% HCT - 0% Hgb - 0% WBC - 0% PLT - 0% Cell ID - 0% 2020 API 1st event RBC - 40% HCT - 40% Hgb - 40% WBC - 60% PLT - 20% Cell ID - 60% 3. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. D2121 HEMATOLOGY CFR(s): 493.851(a) -- 2 of 5 -- 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 review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing (PT) records from 2019 and American Proficiency Institute (API) from 2020, it was determined the laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analytes: Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID for 3 of 3 consecutive testing events in 2019 (2nd and 3rd event) and 2020 (1st event). Findings were: 1. A review of the CMS national proficiency testing database revealed a score of less than 80% for the analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 3 of 3 consecutive testing events in 2019 (2nd and 3rd event) and 2020 (1st event). 2019 AAB 2nd & 3rd event RBC - 0% HCT - 0% Hgb - 0% WBC - 0% PLT - 0% Cell ID - 0% 2020 API 1st event RBC - 40% HCT - 40% Hgb - 40% WBC - 60% PLT - 20% Cell ID - 60% 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2018-2020 confirmed that the laboratory received a hematology score of 0% on for the following analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 2 of 2 consecutive testing events in 2019 for the following test events: 2019 AAB 2nd & 3rd event 3. A proficiency desk review of the API proficiency testing records from 2020 confirmed that the laboratory received the following hematology scores for the following analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 1 of 3 testing events in 2020: 2020 API 1st event RBC - 40% HCT - 40% Hgb - 40% WBC - 60% PLT - 20% Cell ID - 60% 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 a review of the CMS (Center for Medicare Services) national database and a desk review of proficiency testing records from American Board of Bioanalysts (AAB) from 2019 and American Proficiency Institute (API) from 2020, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the specialty of hematology in 3 of 3 consecutive testing events in 2019 (Events 1 and 2) and 2020 (Event 1). Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores for the following Hematology testing events in 2019 and 2020: 2019 AAB 2nd & 3rd event - 0% 2020 API 1st event - 40% 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019 confirmed that the laboratory received a hematology score of 0% for 2 of 2 consecutive testing events in 2019 for the following test events: 2019 AAB 2nd & 3rd event 3. A proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2020 confirmed that the laboratory received a hematology score of 40% for 1 of 3 testing events in 2020 for the following test events: 2020 API 1st event - 40% D2130 HEMATOLOGY -- 3 of 5 -- 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 the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing (PT) records from 2019 and American Proficiency Institute (API) from 2020, it was determined the laboratory failed to achieve satisfactory performance for the same analyte in 3 of 3 consecutive testing events. The laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analytes: Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID for 3 of 3 consecutive testing events in 2019 (2nd and 3rd event) and 2020 (1st event). Findings were: 1. A review of the CMS national proficiency testing database revealed a score of less than 80% for the analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 3 of 3 consecutive testing events in 2019 (2nd and 3rd event) and 2020 (1st event). 2019 AAB 2nd & 3rd event RBC - 0% HCT - 0% Hgb - 0% WBC - 0% PLT - 0% Cell ID - 0% 2020 API 1st event RBC - 40% HCT - 40% Hgb - 40% WBC - 60% PLT - 20% Cell ID - 60% 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019 confirmed that the laboratory received a hematology score of 0% on for the following analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 2 of 2 consecutive testing events in 2019 for the following test events: 2019 AAB 2nd & 3rd event 3. A proficiency desk review of the API proficiency testing records from 2020 confirmed that the laboratory received the following hematology scores for the following analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 1 of 3 testing events in 2020: 2020 API 1st event RBC - 40% HCT - 40% Hgb - 40% WBC - 60% PLT - 20% Cell ID - 60% 4. Three out of three unsatisfactory scores of the same analytes result in unsuccessful PT performance. D2131 HEMATOLOGY CFR(s): 493.851(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 a review of the CMS (Center for Medicare Services) national database and a desk review of proficiency testing records from American Board of Bioanalysts (AAB) from 2019 and American Proficiency Institute (API) from 2020, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the specialty of hematology in 3 of 3 consecutive testing events. Three out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores for the following Hematology testing events in 2019 and 2020: 2019 AAB 2nd & 3rd event - 0% 2020 API 1st event - 40% 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019 confirmed that the laboratory received a hematology score of 0% for 2 of 2 consecutive testing events in 2019 for the following test events: 2019 -- 4 of 5 -- AAB 2nd & 3rd event 3. A proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2020 confirmed that the laboratory received a hematology score of 40% for 1 of 3 testing events in 2020 for the following test events: 2020 API 1st event - 40% 4. Three out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT 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 laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (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 provided. The laboratory director failed to ensure successful participation in an approved proficiency testing program. (refer to D2131and D2130) -- 5 of 5 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: . Based on review of manufacturer's instructions, laboratory documentation for 2018 and 2019 and staff interview, the laboratory failed to follow manufacturer's instructions for documentation of reagent replenishment for the Sysmex XP-300 hematology analyzer. Findings: 1. In the section titled "Reagent Replacement," the user's manual for the Sysmex XP-300, referring to the periodic replacement of reagents, states: "Document the change in the Reagent Replenishment Record." (XP- 300 Quick Guide-Document Number 1051-CFL, Revision 1, page 7, item 9) 2. Blank forms for recording this were available, but not filled out with the information indicated. 3. In an interview at the site on 02-05-2019, the clinic manager confirmed that the forms were not being used and could not provide evidence that the information was being recorded elsewhere. . D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. 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 -- This STANDARD is not met as evidenced by: . Based on review of manufacturer's instructions, laboratory documentation for 2018 and 2019 and staff interview, the laboratory failed to document background checks for the Sysmex XP-300 hematology analyzer. Findings: 1. In the section titled "Daily Operating Procedures," the user's manual for the Sysmex XP-300 states: "Record the background check on a daily checklist or keep a copy of the printout for documentation." (XP-300 Quick Guide-Document Number 1051-CFL, Revision 1, page 2, Power On/Self Check, item 2) 2. Blank forms for recording this were available, but not filled out with the information indicated. 3. In an interview at the site on 02-05-2019, the clinic manager confirmed that the forms were not being used and could not provide instrument printouts to verify performance of background checks. . 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 personnel competency verification documentation for 2018, 2019 and 2020, the laboratory technical consultant (CMS form 209) failed to evaluate the competency of 5 of 5 testing personnel using the required criteria. Findings: 1. Personnel training and competency documentation was reviewed. For 5 of 5 testing personnel listed, no competency verification specific to moderate complexity testing was found or could be offered. In an interview at the site on 02-05-2020, the clinic manager indicated a sheet marked "Skills Proficiency Checklist" and stated, "this is what we use for competency." The tests on the sheet did not include the required methods for evaluating competency for moderate complexity hematology testing and were not signed by the laboratory technical consultant. Note: the laboratory director and technical consultant are one and the same. . D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: . Based on review of personnel competency verification documentation for 2018, 2019 and 2020, the laboratory technical consultant failed to evaluate the competency of 5 of 5 testing personnel by direct observation of routine patient test performance. Refer to D 6046. . D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on review of personnel competency verification documentation for 2018, 2019 and 2020, the laboratory technical consultant failed to evaluate the competency of 5 of 5 testing personnel by monitoring the recording and reporting of test results. Refer to D 6046. . D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: . Based on review of personnel competency verification documentation for 2018, 2019 and 2020, the laboratory technical consultant failed to evaluate the competency of 5 of 5 testing personnel by review of quality control records and preventive maintenance records. Refer to D 6046. . D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: . Based on review of personnel competency verification documentation for 2018, 2019 and 2020, the laboratory technical consultant failed to evaluate the competency of 5 of 5 testing personnel by direct observation of performance of instrument maintenance and function checks. Refer to D 6046. . -- 3 of 3 --

Summary Statement of Deficiencies 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 American Proficiency Institute (API) proficiency testing (PT) documentation for 2016 and 2017, confirmed by staff interview, the laboratory failed to test PT samples using personnel who routinely perform hematology testing using the Sysmex XP-300 analyzer. Findings: 1. API PT attestation documentation for 2016 and 2017 was reviewed. Attestation statements for hematology testing in the second and third events of 2016 and the first event of 2017 were signed by the clinic manager (testing person 6, CMS form 209) as the person performing the tests. No other testing personnel signatures were found. 2. In an interview at the site on 03-27-2018, the clinic manager stated she had performed the testing herself and was at the time unaware of the requirement to test PT samples using personnel who routinely perform patient testing. . D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- documentation for 2016 and 2017, confirmed by staff interview, the laboratory director failed to attest to the routine integration of hematology PT samples into the patient workload using the laboratory's routine methods using the Sysmex XP-300 analyzer. Findings: 1. API PT attestation documentation for 2016 and 2017 was reviewed. Attestation statements for hematology testing in the second and third events of 2016 and the first event of 2017 were signed by the clinic manager as the lab director or designee. The clinic manager was not qualified by education or training to serve as director or designee. 2. In an interview at the site on 03-27-2018, the clinic manager stated she had signed the attestation forms herself and was at the time unaware of the regulatory requirements for delegation of signatory authority. . 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 personnel competency and training documentation for 2018, confirmed by staff interview, the laboratory technical consultant failed to evaluate the competency of 7 of 7 testing personnel using the required criteria. Findings: 1. Personnel training and competency documentation was reviewed. For 6 of 7 testing personnel listed on CMS form 209, competency documentation consisted of a "Nurse Skill Check-off" sheet listing tests and procedures performed by clinic staff, including a single entry for "CBC machine." No check-off sheet was found for the clinic manager. 2. The forms for testing personnel 2 and 4 were initialed by the clinic manager. The forms for testing personnel 1, 3, 5 and 6 were initialed by testing person 2. None of the forms were signed by the technical consultant. 3. None of the forms indicated that competency had been evaluated using the required criteria. In an interview at the site on 03-27-2018, the clinic manager identified her own initials and those of testing person 2, and stated the required methods of verifying competency for testing personnel had not been documented. . -- 2 of 2 --