Grace Er

Summary Statement of Deficiencies D0000 An unannounced recertification survey was performed in response to complaint TX00374136. 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 IMMEDIATELY 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 TX00374136 was substantiated. Laboratory provided a letter to state agency on 5/19/21 that abated the immediate jeorpardy. 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 review of the manufacturer's instructions, laboratory maintenance records from 2020 to 2021, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions to document required maintenance for the Piccolo Xpress chemistry analyzer. Findings were: 1. Review of the Piccolo Xpress operation manual under Maintenance & Services revealed "clean the analyzer's external case and display at least weekly." 2. Review of the Piccolo Xpress Quality Assurance from September 2020 to April 2021 revealed no documentation of the 31 of 32 required Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 19 -- weekly maintenance. September 2020 October 2020 November 2020 December 2020 January 2021 February 2021 March 2021 April 2021 3.An interview with the testing person #1 on 5/14/21 at 0920 hours in the laboratory confirmed the above findings. II. Based on review of the manufacturer's instructions, laboratory quality control and patient test records from August 2020 to April 2021, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions and document negative and positive controls for the Siemens Multistix for urinalysis. Findings were: 1. Review of the package insert for the Siemens Multistix 10SG reagent strips under quality control revealed "test positive and negative quality controls with new lots, new shipments of reagents, and when you open a new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days." 2. Surveyor observations on 5/14/21 at 0930 hours in the laboratory revealed an opened Siemens Multistix 10SG reagent strips (lot 011082, exp 5/31/22) with no documentation of an opened date. 3. Review of the laboratory quality control records from August 2020 to April 2021 available revealed no documentation of the lot number when control were documented. 4. Review of the laboratory quality control records from August 2020 to April 2021 revealed no documentation of quality control for 4 of the 8 months reviewed. April 2021 December 2020 September 2020 August 2020 5. Random review of the laboratory patient test records from August 2020 to April 2021 revealed the laboratory performed 9 urinalysis patients. Refer to urinalysis patient alias list. 6. An interview with the testing person #1 on 5/14/21 at 1010 hours in the laboratory confirmed the above findings. He acknowledged that the laboratory should document the lot number and quality control performed. III. Based on manufacturer's instructions, surveyor observations, review of laboratory quality control and patient test records from May 2021, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions and document at least one level of quality control each day of testing for the HemoCue glucose meter. Findings were: 1. Review of the package insert for the Hemocue Glucose 201 Microcuvettes and Glucose 201 analyzer under quality control revealed "the hemocue glucose 201 system must be verified on the days of testing using at least one level of commercially available controls." 2. Surveyor observations on 5/14/21 at 1050 revealed testing person # 16 performing a glucose analysis using the hemocue glucose analyzer. 3. Review of the laboratory quality control records from 2020 to 2021 revealed no documentation of at least 1 level of quality control for the hemocue on 5/14/21. 4. Review of the laboratory records revealed the laboratory reported glucose of 152. Refer to glucose patient alias. 5. An interview with testing person #1 on 5/14/21 at 1100 hours in the laboratory confirmed the above findings. IV. Based on review of the manufacturer's instructions, surveyor observations, laboratory and patient test records from 2020 to 2021, and confirmed in interview, the laboratory failed to follow the manufacturers instructions for storage of the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test. Findings were: 1. Review of the package insert for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test ( IFU-RCHM71-E Revision number: E, Effective date: Apr. 15, 2021) under storage and stability revealed "Store the test kit as packaged between 1 - 30C." 2. Surveyor observations on 5/13/21 at 1050 hours revealed a box of opened AccessBio CareStart Covid-19 Antigen Rapid diagnostic test stored in a cabinet in the check in area of the facility. 3. An interview with the testing person #3 on 5/13/21 at 1052 hours in the check in area confirmed that the test kits are stored in the front prior to use. 4. Review of the laboratory and patient records from January 2021 to May 2021 revealed the laboratory performed 724 Covid Antigen tests. 5. Review of the laboratory records from 2020 to 2021 revealed no documentation of the laboratory monitoring the temperature of the check in area. 6. An interview with the testing person #1 on 5/14 /21 at 0935 hours in the laboratory confirmed the above findings. V. Based on review of the manufacturer's instructions, surveyor observations, laboratory and patient test -- 2 of 19 -- records from 2020 to 2021, and confirmed in interview, the laboratory failed to follow the manufacturers instructions to ensure training for 22 of 22 operators for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test. Findings were: 1. Review of the package insert for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test ( IFU-RCHM71-E Revision number: E Effective date: Apr. 15, 2021) under conditions of Authorization for Laboratory revealed: "All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling." 2. Review of the laboratory records revealed the laboratory started Covid-19 Antigen testing in 07 /2020. 3. Review of the laboratory records from 2020 to 2021 revealed no documentation of the training for 22 of 22 testing person for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test. 4. An interview with the testing person # 3 on 5/13/21 at 1410 hours in the break room confirmed the above findings. She stated that there were some videos that were provided but she didn't know if training was documented. 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 a review of the American Proficiency Institute (API) proficiency testing records from 2020 to 2021, laboratory policy, and confirmed in interview, the laboratory failed to document the attestation to the routine integration of the samples into the patient workload using the laboratory's routine methods by the laboratory director and/or testing person for 3 of 7 test events reviewed. The findings were: 1. Review of the API proficiency test records from 2020 to 2021 revealed no documentation of the attestation to the routine integration of the samples into the patient workload using the laboratory's routine methods by the laboratory director and /or testing person for 3 of 7 test events reviewed. 2020 3rd event Hematology (Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID) 2021 1st event Chemistry (Creatine kinase-MB (CK-MB)) 2021 1st event Hematology (Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID) 2. Review of the laboratory policy Proficiency Testing signed by the laboratory director on 2/19/19 revealed "the attestation statement shall be signed and dated by testing personnel and the lab director at the time of testing." 3. An interview of testing person # 5 on 5/13/21 at 1520 hours in the break room confirmed the above findings. 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 -- 3 of 19 -- 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, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 724 SARS-CoV-2 positive and negative Antigen test results as required by 400.200 for 73 of 73 days reviewed from 01/08/2021 to 5/14/2021. Findings were: 1. Review of the Instructions for Use for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test ( IFU-RCHM71-E Revision number: E Effective date: Apr. 15, 2021) 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 using AccessBio CareStart Covid-19 Antigen Rapid diagnostic test on 6/16/20. 3. 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." 4. 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. 5. Review of the laboratory policies available revealed no documentation of a policy /procedure related to SARS-CoV-2 test reporting. 6. Review of the laboratory SARS- CoV-2 Antigen patient test records from 2021 revealed no documentation the laboratory reported 724 of 724 patient positive and negative test records for 73 of 73 days of testing. Refer to Covid Antigen Patient Alias list. 7. An interview with the testing person #1 on 5/14/21 at 1010 hours in the laboratory confirmed the above findings II. Based on review of the manufacturer's instructions, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 12 postive and negative SARS-CoV-2 Antibody test results as required by 42 CFR 493.41 and 493.1100(a) for 6 of 6 days reviewed from 01/08/2021 to 5/14/2021. 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 from 2020 to 2021 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 2021 revealed no documentation the laboratory reported 12 of 12 postivie and negative patient test records for 6 of 6 days of testing. Refer to Covid Antibody Patient Alias list. 5. An interview with the testing person #1 on 5/14/21 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 -- 4 of 19 -- 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: I. Based on review of the laboratory quality control records from 2020 to 2021, patient test records, and confirmed in interview, the laboratory failed to retain the INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP) for the Quidel Triage testing for CKMB, Troponin, Myoglobin, and DDimer that reduced the frequency of quality control to once monthly. Findings were: 1. Review of the laboratory quality control records from September 2020 to May 2021 revealed the laboratory performed monthly quality control for the Triage CKMB, Troponin, Myoglobin, and DDimer testing. 4/29/21 CKMB, Myoglobin, TROP, DDimer level 1 lot 03661 level 2 lot 03673 4/01/21 DDimer Level 1 lot 03652 level 2 lot 03669 2/27/21 CKMB, Myoglobin, TROP, DDimer level 1 lot 03656 level 2 lot 03669 1/23/21 CKMB, Myoglobin, TROP, DDimer level 1 lot 03656 level 2 lot 03669 11/26/20 CKMB, Myoglobin, TROP, DDimer Level 1 lot 03653 Level 2 lot 03668 10/12/20 CKMB, Myoglobin, TROP, DDimer Level 1 lot 03652 level 2 lot lot 03664 (no DDimer) 9/19 /20 CKMB, Myoglobin, TROP, DDimer Level 1 lot 03553 level 2 lot 03664 2. Review of the laboratory records available revealed no documentation of the IQCP to reduce the frequency of quality control for the above testing to every 30 days. 3. Review of the CMS116 revealed the laboratory performed 1872 chemistry testing annually. 4. An interview with the testing person #1 on 5/14/21 at 1000 hours in the laboratory confirmed the above findings. He was unaware of where the IQCP was kept. 44698 II. Based on random review of the laboratory's quality control records for the Cell-Dyn Emerald hematology analyzer for 2021 and 2020, review of a random sampling of patient records and interview with the staff it was revealed the laboratory failed to retain documentation of background checks for the minimum required time of 2 years for 5 of 15 days reviewed. The findings were: 1. A random review of the Cell-Dyn Emerald hematology analyzer quality control records for 2021 and 2020 revealed the quality control performed included 3 levels of controls and background checks on each day of testing. 2. A random review of the laboratory's quality control records for the Cell-Dyn Emerald hematology analyzer revealed the laboratory performed quality control on the following days: 05/10/2021 04/26/2021 03/06/2021 05/07/2021 04/18/2021 02/27/2021 05/06/2021 04/07/2021 02/16/2021 05/05/2021 03 /23/2021 10/25/2020 05/04/2021 03/07/2021 09/22/2020 3. A further review of the quality control records for the Cell-Dyn Emerald hematology analyzer revealed the laboratory failed to retain documentation of the background checks for 5 of 15 days reviewed for days quality controls were performed. The missing documentation was from: 10/25/2020 02/16/2021 03/06/2021 03/07/2021 05/05/2021 4. A review of a random sampling of patient records revealed patient sample testing was performed on the following days: On 05/07/2021 samples tested for patients 01181992 and 07131992 On 05/06/2021 samples tested for patients10221976 and 12.17.1989 5. In an interview on 5/13/21 at 1300 hours in the laboratory, testing person number 3 (as listed on the CMS Form 209 and signed by the medical director on 05/13/2021) stated that he was unaware of having to retain background check records as it was part of the instrument startup. This confirmed the findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. -- 5 of 19 -- This STANDARD is not met as evidenced by: Based on review of CMS report 155, laboratory policy, American Proficiency Institute (API) proficiency testing (PT) records from 2020 to 2021, and confirmed in interview, the laboratory failed to retain the proficiency testing records for 5 of 7 PT events reviewed. . Findings were: 1. The CMS report 155 showed PT event scores for the following test events: 2020 1st event Hematology 2020 1st event Chemistry 2020 2nd event Hematology 2020 2nd event Chemistry 2020 3rd event chemistry 2. Review of the laboratory policy Proficiency Testing signed by the laboratory director on 2/19/19 revealed "all records, reports, and

Summary Statement of Deficiencies D0000 An unannounced recertification survey was performed in response to complaint TX00374136. 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 IMMEDIATELY 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 TX00374136 was substantiated. Laboratory provided a letter to state agency on 5/19/21 that abated the immediate jeorpardy. 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 review of the manufacturer's instructions, laboratory maintenance records from 2020 to 2021, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions to document required maintenance for the Piccolo Xpress chemistry analyzer. Findings were: 1. Review of the Piccolo Xpress operation manual under Maintenance & Services revealed "clean the analyzer's external case and display at least weekly." 2. Review of the Piccolo Xpress Quality Assurance from September 2020 to April 2021 revealed no documentation of the 31 of 32 required Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 19 -- weekly maintenance. September 2020 October 2020 November 2020 December 2020 January 2021 February 2021 March 2021 April 2021 3.An interview with the testing person #1 on 5/14/21 at 0920 hours in the laboratory confirmed the above findings. II. Based on review of the manufacturer's instructions, laboratory quality control and patient test records from August 2020 to April 2021, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions and document negative and positive controls for the Siemens Multistix for urinalysis. Findings were: 1. Review of the package insert for the Siemens Multistix 10SG reagent strips under quality control revealed "test positive and negative quality controls with new lots, new shipments of reagents, and when you open a new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days." 2. Surveyor observations on 5/14/21 at 0930 hours in the laboratory revealed an opened Siemens Multistix 10SG reagent strips (lot 011082, exp 5/31/22) with no documentation of an opened date. 3. Review of the laboratory quality control records from August 2020 to April 2021 available revealed no documentation of the lot number when control were documented. 4. Review of the laboratory quality control records from August 2020 to April 2021 revealed no documentation of quality control for 4 of the 8 months reviewed. April 2021 December 2020 September 2020 August 2020 5. Random review of the laboratory patient test records from August 2020 to April 2021 revealed the laboratory performed 9 urinalysis patients. Refer to urinalysis patient alias list. 6. An interview with the testing person #1 on 5/14/21 at 1010 hours in the laboratory confirmed the above findings. He acknowledged that the laboratory should document the lot number and quality control performed. III. Based on manufacturer's instructions, surveyor observations, review of laboratory quality control and patient test records from May 2021, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions and document at least one level of quality control each day of testing for the HemoCue glucose meter. Findings were: 1. Review of the package insert for the Hemocue Glucose 201 Microcuvettes and Glucose 201 analyzer under quality control revealed "the hemocue glucose 201 system must be verified on the days of testing using at least one level of commercially available controls." 2. Surveyor observations on 5/14/21 at 1050 revealed testing person # 16 performing a glucose analysis using the hemocue glucose analyzer. 3. Review of the laboratory quality control records from 2020 to 2021 revealed no documentation of at least 1 level of quality control for the hemocue on 5/14/21. 4. Review of the laboratory records revealed the laboratory reported glucose of 152. Refer to glucose patient alias. 5. An interview with testing person #1 on 5/14/21 at 1100 hours in the laboratory confirmed the above findings. IV. Based on review of the manufacturer's instructions, surveyor observations, laboratory and patient test records from 2020 to 2021, and confirmed in interview, the laboratory failed to follow the manufacturers instructions for storage of the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test. Findings were: 1. Review of the package insert for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test ( IFU-RCHM71-E Revision number: E, Effective date: Apr. 15, 2021) under storage and stability revealed "Store the test kit as packaged between 1 - 30C." 2. Surveyor observations on 5/13/21 at 1050 hours revealed a box of opened AccessBio CareStart Covid-19 Antigen Rapid diagnostic test stored in a cabinet in the check in area of the facility. 3. An interview with the testing person #3 on 5/13/21 at 1052 hours in the check in area confirmed that the test kits are stored in the front prior to use. 4. Review of the laboratory and patient records from January 2021 to May 2021 revealed the laboratory performed 724 Covid Antigen tests. 5. Review of the laboratory records from 2020 to 2021 revealed no documentation of the laboratory monitoring the temperature of the check in area. 6. An interview with the testing person #1 on 5/14 /21 at 0935 hours in the laboratory confirmed the above findings. V. Based on review of the manufacturer's instructions, surveyor observations, laboratory and patient test -- 2 of 19 -- records from 2020 to 2021, and confirmed in interview, the laboratory failed to follow the manufacturers instructions to ensure training for 22 of 22 operators for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test. Findings were: 1. Review of the package insert for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test ( IFU-RCHM71-E Revision number: E Effective date: Apr. 15, 2021) under conditions of Authorization for Laboratory revealed: "All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling." 2. Review of the laboratory records revealed the laboratory started Covid-19 Antigen testing in 07 /2020. 3. Review of the laboratory records from 2020 to 2021 revealed no documentation of the training for 22 of 22 testing person for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test. 4. An interview with the testing person # 3 on 5/13/21 at 1410 hours in the break room confirmed the above findings. She stated that there were some videos that were provided but she didn't know if training was documented. 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 a review of the American Proficiency Institute (API) proficiency testing records from 2020 to 2021, laboratory policy, and confirmed in interview, the laboratory failed to document the attestation to the routine integration of the samples into the patient workload using the laboratory's routine methods by the laboratory director and/or testing person for 3 of 7 test events reviewed. The findings were: 1. Review of the API proficiency test records from 2020 to 2021 revealed no documentation of the attestation to the routine integration of the samples into the patient workload using the laboratory's routine methods by the laboratory director and /or testing person for 3 of 7 test events reviewed. 2020 3rd event Hematology (Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID) 2021 1st event Chemistry (Creatine kinase-MB (CK-MB)) 2021 1st event Hematology (Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID) 2. Review of the laboratory policy Proficiency Testing signed by the laboratory director on 2/19/19 revealed "the attestation statement shall be signed and dated by testing personnel and the lab director at the time of testing." 3. An interview of testing person # 5 on 5/13/21 at 1520 hours in the break room confirmed the above findings. 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 -- 3 of 19 -- 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, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 724 SARS-CoV-2 positive and negative Antigen test results as required by 400.200 for 73 of 73 days reviewed from 01/08/2021 to 5/14/2021. Findings were: 1. Review of the Instructions for Use for the AccessBio CareStart Covid-19 Antigen Rapid diagnostic test ( IFU-RCHM71-E Revision number: E Effective date: Apr. 15, 2021) 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 using AccessBio CareStart Covid-19 Antigen Rapid diagnostic test on 6/16/20. 3. 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." 4. 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. 5. Review of the laboratory policies available revealed no documentation of a policy /procedure related to SARS-CoV-2 test reporting. 6. Review of the laboratory SARS- CoV-2 Antigen patient test records from 2021 revealed no documentation the laboratory reported 724 of 724 patient positive and negative test records for 73 of 73 days of testing. Refer to Covid Antigen Patient Alias list. 7. An interview with the testing person #1 on 5/14/21 at 1010 hours in the laboratory confirmed the above findings II. Based on review of the manufacturer's instructions, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 12 postive and negative SARS-CoV-2 Antibody test results as required by 42 CFR 493.41 and 493.1100(a) for 6 of 6 days reviewed from 01/08/2021 to 5/14/2021. 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 from 2020 to 2021 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 2021 revealed no documentation the laboratory reported 12 of 12 postivie and negative patient test records for 6 of 6 days of testing. Refer to Covid Antibody Patient Alias list. 5. An interview with the testing person #1 on 5/14/21 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 -- 4 of 19 -- 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: I. Based on review of the laboratory quality control records from 2020 to 2021, patient test records, and confirmed in interview, the laboratory failed to retain the INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP) for the Quidel Triage testing for CKMB, Troponin, Myoglobin, and DDimer that reduced the frequency of quality control to once monthly. Findings were: 1. Review of the laboratory quality control records from September 2020 to May 2021 revealed the laboratory performed monthly quality control for the Triage CKMB, Troponin, Myoglobin, and DDimer testing. 4/29/21 CKMB, Myoglobin, TROP, DDimer level 1 lot 03661 level 2 lot 03673 4/01/21 DDimer Level 1 lot 03652 level 2 lot 03669 2/27/21 CKMB, Myoglobin, TROP, DDimer level 1 lot 03656 level 2 lot 03669 1/23/21 CKMB, Myoglobin, TROP, DDimer level 1 lot 03656 level 2 lot 03669 11/26/20 CKMB, Myoglobin, TROP, DDimer Level 1 lot 03653 Level 2 lot 03668 10/12/20 CKMB, Myoglobin, TROP, DDimer Level 1 lot 03652 level 2 lot lot 03664 (no DDimer) 9/19 /20 CKMB, Myoglobin, TROP, DDimer Level 1 lot 03553 level 2 lot 03664 2. Review of the laboratory records available revealed no documentation of the IQCP to reduce the frequency of quality control for the above testing to every 30 days. 3. Review of the CMS116 revealed the laboratory performed 1872 chemistry testing annually. 4. An interview with the testing person #1 on 5/14/21 at 1000 hours in the laboratory confirmed the above findings. He was unaware of where the IQCP was kept. 44698 II. Based on random review of the laboratory's quality control records for the Cell-Dyn Emerald hematology analyzer for 2021 and 2020, review of a random sampling of patient records and interview with the staff it was revealed the laboratory failed to retain documentation of background checks for the minimum required time of 2 years for 5 of 15 days reviewed. The findings were: 1. A random review of the Cell-Dyn Emerald hematology analyzer quality control records for 2021 and 2020 revealed the quality control performed included 3 levels of controls and background checks on each day of testing. 2. A random review of the laboratory's quality control records for the Cell-Dyn Emerald hematology analyzer revealed the laboratory performed quality control on the following days: 05/10/2021 04/26/2021 03/06/2021 05/07/2021 04/18/2021 02/27/2021 05/06/2021 04/07/2021 02/16/2021 05/05/2021 03 /23/2021 10/25/2020 05/04/2021 03/07/2021 09/22/2020 3. A further review of the quality control records for the Cell-Dyn Emerald hematology analyzer revealed the laboratory failed to retain documentation of the background checks for 5 of 15 days reviewed for days quality controls were performed. The missing documentation was from: 10/25/2020 02/16/2021 03/06/2021 03/07/2021 05/05/2021 4. A review of a random sampling of patient records revealed patient sample testing was performed on the following days: On 05/07/2021 samples tested for patients 01181992 and 07131992 On 05/06/2021 samples tested for patients10221976 and 12.17.1989 5. In an interview on 5/13/21 at 1300 hours in the laboratory, testing person number 3 (as listed on the CMS Form 209 and signed by the medical director on 05/13/2021) stated that he was unaware of having to retain background check records as it was part of the instrument startup. This confirmed the findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. -- 5 of 19 -- This STANDARD is not met as evidenced by: Based on review of CMS report 155, laboratory policy, American Proficiency Institute (API) proficiency testing (PT) records from 2020 to 2021, and confirmed in interview, the laboratory failed to retain the proficiency testing records for 5 of 7 PT events reviewed. . Findings were: 1. The CMS report 155 showed PT event scores for the following test events: 2020 1st event Hematology 2020 1st event Chemistry 2020 2nd event Hematology 2020 2nd event Chemistry 2020 3rd event chemistry 2. Review of the laboratory policy Proficiency Testing signed by the laboratory director on 2/19/19 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 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 D2017 - 42 C.F.R. 493.807 Condition: Reinstatement of laboratories performing nonwaived testing after failure to participate 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 4 -- Based on a desk review of proficiency testing records obtained from the CMS (Center 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 3 of 5 testing events (2019 first and third event and 2020 second event). (refer to D2121) 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 proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with records from American Proficiency Institute (API), the laboratory failed to successfully participate in the specialty of Hematology/coagulation for the analyte White Blood Cell Differential (WBC Diff) in 3 of 5 events between 2019 and 2020 resulting in a non-initial PT failure. Refer to D2121, D2130 The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. 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 review of the CMS (Center for Medicare and Medicaid Services) national database and verified by proficiency testing report, American Proficiency Institute records (API), the laboratory failed to attain a score of at least 80 percent for 1 of 6 regulated analytes White Blood Cell Differential (WBC Diff) in 3 of 5 events in 2019 and 2020. The findings included: 1. Review of the national database report for the WBC differential for 2019 first and third event and 2020 second event, the laboratory failed to attain a score of at least 80 percent on the following analytes: White Blood Cell Differential 2019 First Event - 67 percent 2019 Third Event - 0 percent 2020 -- 2 of 4 -- Second Event - 67 percent 2. Review of the American Proficiency Institute proficiency result records for WBC differential for 2019 first and third event and 2020 second event, the laboratory failied to attain a score of at least 80 percent on the following analytes: White Blood Cell Differential 2019 First Event - 67 percent 2019 Third Event - 0 percent 200 Second Event - 67 percent 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 Proficiency Institute (API) proficiency test results, the laboratory failed to achieve satisfactory performance of at least 80% for the same analyte in three out of five testing events from 2019 first and third event and 2020 second event in the specialty of Hematology for the regulated analyte White Blood Cell Differential (WBC Diff). The findings included: 1. Review of the national database report for the WBC differential, the laboratory scores for 2019 first and third event and 2020 second event, the laboratory failed to attain a score of at least 80 percent for WBC Diff: 2019 Hematology - 1st Event WBC Diff- 67 % 2019 Hematology - 3rd Event WBC Diff - 0 % 2020 Hematology- 2nd Event WBC Diff - 67% 2. A review of the API testing records for WBC differential, the laboratory scores for 2019 first and third event and 2020 second event, the laboratory failed to attain a score of at least 80 percent for WBC Diff 2019 Hematology - 1st Event WBC Diff - 67 % Granulocytes - 60% Monocytes - 60% 2019 Hematology - 3rd Event WBC Diff - 0 % Granulocytes - 0 % Lymphocytes - 0% Monocytes - 0% 2020 Hematology- 2nd Event WBC Diff - score of 67% . Monocyte - 40% 3. A score of less than 80 percent is unsatisfactory performance. Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing 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. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 3 of 4 -- 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 successful participation in a HHS approved proficiency testing program for the analyte WBC Differential in 2019 and 2020. (refer to D2121, D2130) -- 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 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) and Red Blood Cell Count (RBC). Refer to D2130. 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 each analyte in the specialty of Hematology. Findings include: 1. A review of the laboratory's American Proficiency Institute (API) proficiency test results for 2019 Hematology/Coagulation - 1st Event revealed the laboratory received an unacceptable score of 67% for the analyte White Blood Cell Differential (WBC DIFF). 2. A review of the laboratory's American Proficiency Institute (API) proficiency test results for 2019 Hematology/Coagulation - 1st Event revealed the laboratory received an unacceptable score of 20% for the analyte Red Blood Cell Count (RBC) 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 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 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 participate in 1 of 3 testing events for 2019, resulting in unsatisfactory scores for all analytes in the specialty of Hematology. Findings include: 1. 2019 Hematology /Coagulation - 3rd Event unacceptable score of 0% for the analyte Cell I.D. or WBC DIFF. 2. 2019 Hematology/Coagulation - 3rd Event unacceptable score of 0% for the analyte RBC. 3. 2019 Hematology/Coagulation - 3rd Event unacceptable score of 0% for the analyte HCT. 4. 2019 Hematology/Coagulation - 3rd Event unacceptable score of 0% for the analyte HGB. 5. 2019 Hematology/Coagulation - 3rd Event -- 2 of 4 -- unacceptable score of 0% for the analyte WBC. 6. 2019 Hematology/Coagulation - 3rd Event unacceptable score of 0% for the analyte PLATELETS. Key: Cell I.D.= Cell Identification WBC DIFF= White Blood Cell Differential RBC= Red Blood Cell HCT= Hematocrit HGB= Hemoglobin WBC= White Blood Cell 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 Proficiency Institute (API) proficiency test results, it was revealed the laboratory failed to achieve satisfactory performance of at least 80% for the same analyte in two out of three consecutive testing events in the specialty of Hematology for the analytes White Blood Cell Differential (WBC DIFF) and Red Blood Cell Count (RBC). Findings include: WBC DIFF: 1. 2019 Hematology/Coagulation - 1st Event unacceptable score of 67%. 2. 2019 Hematology/Coagulation - 3rd Event unacceptable score of 0% -failure to participate. RBC: 1. 2019 Hematology /Coagulation - 1st Event unacceptable score of 20%. 2. 2019 Hematology/Coagulation - 3rd Event unacceptable score of 0% -failure to participate. 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 D6018. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: 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; 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: Based on review of the manufacturer's instructions, laboratory quality control records, patient test records, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions to perform at least one quality control prior to glucose patient testing for the Hemocue glucose analyzer. Findings were: 1. Review of the Hemocue package insert (150728 140908 US) revealed under Quality Control "the Hemocue Glucose 201 system must be verified on days of testing using at least one level of commercially available controls." 2. Random review of the patient Glucose test logs from July 2018 to February 2019 revealed 11 of 20 days the laboratory performed patient testing with no documentation of the quality control performed prior to patient testing. 7/27/18 8/10/18 8/13/18 9/9/18 10/10/18 10/30/18 11/3/18 11 /23/18 12/27/18 1/16/19 2/26/19 3. An interview with the technical consultant on 3/6 /19 at 1205 hours in the laboratory confirmed the above findings. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) 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 -- The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, American Proficiency Institute (API) proficiency testing (PT) records and confirmed in interview, the laboratory failed to test proficiency testing materials the same number of times as patient samples for CBC (complete blood count) on the Cell-Dyn Emerald hematology analyzer. Findings were: 1. Review of the policy Proficiency Testing revealed "PT specimens are to be treated the same as patient samples." 2. Review of the laboratory policy Policy for Handling Flagged CBC Differentials signed by the laboratory director on 2/9/19 revealed "it will be the policy of this laboratory to rerun flagged CBC results. If the second run still shows flags, then the lab will evaluate flagged differentials according to the procedures in the unit operator's manual...if the flags persist, then the laboratory will confirm the abnormal differential by sending out to a reference laboratory." 3. A review of the CELL-DYN Emerald Operators Manual (9140848E-June 2010) Section 3: Instrument Alarms, Operational Alerts and Measurand Data Flags revealed that: "An asterisk (*) for count invalidation or (s) suspect measurand flags are displayed with corresponding results." "These flags are generated after the instrument evaluates the measured data for a particular measurand or group of measurands. The result may be suspect due to interference substances or the inability of the instrument to measure a particular measurand due to sample abnormality." "s" (Suspect Measurand Flags) flags may indicate the presence of myelocytes, lymphoblasts, basophils, eosinophils or myelocytes. Differential "s" flag L2 May indicate the presence of myelocytes, lymphoblasts, or basophils. Differential "s" flag L3 May indicate the presence of eosinophils or myelocytes. Count Invalidation Flags (*) WBC and Differential "*" flag L1 May be due to platelet aggregates, NRBCs, giant platelets, cryoglobulins, incomplete lysis of RBC, small lymphocytes, fibrin clots, shift in WBC distribution due to EDTA anticoagulant equilibration. Differential "*" flag L5 Large-size cells present The actions indicated by the manufacturer for "s" flags was "check the specimen for clots or agglutination. Follow your laboratory's review criteria or review a stained smear to confirm the differential results. Redraw and retest the specimen as required." For "*" flags the actions indicated by the manufacturer was "check the specimen for clots or agglutination. Follow your laboratory's review criteria or review a stained smear to confirm the differential results and verify the WBC count. Redraw and retest the specimen as required." 4. Review of the CBC instrument printout from the 2017 - 2018 API Hematology PT events revealed 6 of 6 events that the laboratory had flags for the following PT specimens with no documentation of the rerun result per the laboratory policy. 2017-1st event specimen flag Hem-01 L5 Hem-02 L5 Hem- 03 L5 Hem-04 L5 Hem-05 L5 2017-2nd event specimen flag Hem-06 L5 Hem-07 L2, L5 Hem-08 L5 Hem-09 L5 Hem-10 L5 2017-3rd event specimen flag Hem-11 L5 Hem-12 L5 Hem-13 L5 Hem-14 L5 Hem-15 L5 2018-1st event specimen flag Hem- 01 L5 Hem-02 L5 Hem-03 L5, P1 Hem-04 L5 Hem-05 L5 2018-2nd event specimen flag Hem -06 L1, L5 Hem-07 L5 Hem-08 L5 Hem-09 L2, L5 Hem-10 L5 2018-3rd event specimen flag Hem-11 L5 Hem-12 L2, L5 Hem-13 L5 Hem-14 L5 Hem-15 L5 -- 2 of 9 -- 5. An interview with the technical consultant on 03/06/19 at 1045 hours in the exam room confirmed the above findings. 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: A. Based on review of the 2017 - 2018 American Proficiency Institute (API) proficiency testing (PT) results and confirmed in interview, the laboratory failed to attain at least 80% for the analyte platelets for 2 of 6 Hematology events. Findings were: 1. Review of the 2017 - 2018 API Hematology PT results revealed the laboratory received the following scores for the analyte platelets. 2017 1st event (60% Platelets) Hem-02: lab result 81 (acceptable range 48-81) Hem-05: lab result 939 (acceptable range 267 - 446) 2018 1st event (40% Platelets) Hem-01: lab result 112 (acceptable range 50-85) Hem-03: lab result 971 (acceptable range 383 - 640) Hem- 04: lab result 458 (acceptable range 257 - 429) 2. An interview with the technical consultant on 03/06/19 at 1030 hours in the exam room confirmed the above findings. B. Based on review of the 2017 - 2018 American Proficiency Institute (API) proficiency testing (PT) results and confirmed in interview, the laboratory failed to attain at least 80% for the analyte Red blood Cell for 1 of 6 Hematology events. Findings were: 1. Review of the 2017 - 2018 API Hematology PT results revealed the laboratory received the following scores for the analyte red blood cells (RBC). 2017 2nd event (60% RBC) Hem-07: lab result 5.54 (acceptable range 4.83 - 5.46) Hem-10: lab result 6.48 (acceptable range 5.68 - 6.41) 2. An interview with the technical consultant on 03/06/19 at 1030 hours in the exam room confirmed the above findings. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, American Proficiency Institute (API) proficiency testing records, PT