Exam Corp Lab

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with the American Association of Bioanalysts (AAB) PT program representative confirmed the laboratory's SUBSEQUENT unsuccessful PT performance for the specialty of hematology (See D2131) and the following hematology analytes: cell identification /white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets (See D2130) for three of three PT events in 2022 and two of three events in 2020 through 2021 (event 3 of 2021 and events 1 of 2021). 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 -- 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with the American Association of Bioanalysts (AAB) PT program representative the laboratory failed to achieve satisfactory performance for the hematology analytes cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for three of three consecutive PT events in 2022 and two of three events in 2020 and 2021 (event 3 of 2020 and event 1 of 2021) resulting in subsequent unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 12-01-2022, and the AAB PT records the laboratory received the following unsatisfactory analyte scores: Cell Identification /White Blood Cell Differential EVENT 3, 2020 0% Unsatisfactory EVENT 1, 2021 0% Unsatisfactory EVENT 1, 2022 0% Unsatisfactory EVENT 2, 2022 0% Unsatisfactory EVENT 3, 2022 0% Unsatisfactory Red Blood Cells EVENT 3, 2020 0% Unsatisfactory EVENT 1, 2021 0% Unsatisfactory EVENT 1, 2022 0% Unsatisfactory EVENT 2, 2022 0% Unsatisfactory EVENT 3, 2022 0% Unsatisfactory Hematocrit EVENT 3, 2020 0% Unsatisfactory EVENT 1, 2021 0% Unsatisfactory EVENT 1, 2022 0% Unsatisfactory EVENT 2, 2022 0% Unsatisfactory EVENT 3, 2022 0% Unsatisfactory Hemoglobin EVENT 3, 2020 0% Unsatisfactory EVENT 1, 2021 0% Unsatisfactory EVENT 1, 2022 0% Unsatisfactory EVENT 2, 2022 0% Unsatisfactory EVENT 3, 2022 0% Unsatisfactory White Blood Cells EVENT 3, 2020 0% Unsatisfactory EVENT 1, 2021 0% Unsatisfactory EVENT 1, 2022 0% Unsatisfactory EVENT 2, 2022 0% Unsatisfactory EVENT 3, 2022 0% Unsatisfactory Platelets EVENT 3, 2020 0% Unsatisfactory EVENT 1, 2021 0% Unsatisfactory EVENT 1, 2022 0% Unsatisfactory EVENT 2, 2022 0% Unsatisfactory EVENT 3, 2022 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 12-02-2022 at 3:24 PM, confirmed the subsequent unsuccessful PT performance for the hematology analytes cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for PT event 3 of 2020, event 1 of 2021, and events 1, 2, and 3 of 2022. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with the American Association of Bioanalysts (AAB) PT program representative the -- 2 of 3 -- laboratory failed to achieve satisfactory performance for the specialty of hematology for three of three PT events in 2022 and two of three PT events from 2020 through 2021 (event 3 of 2020 and event 1 of 2021) resulting in subsequent unsuccessful PT performance for the overall specialty of hematology. Findings include: 1. Review of the CASPER Report 0155D, generated on 12-02-2022, and AAB PT records, the laboratory received the following unsatisfactory scores for the specialty of hematology. HEMATOLOGY EVENT 3, 2020 0% Unsatisfactory EVENT 1, 2021 0% Unsatisfactory EVENT 1, 2022 0% Unsatisfactory EVENT 2, 2022 0% Unsatisfactory EVENT 3, 2022 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 12-02-2022 at 3:24 PM, confirmed the subsequent unsuccessful performance for the overall specialty of hematology for event 3 of 2020, event 1 of 2021, and events 1, 2, and 3 of 2022. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with an AAB PT program representative the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the specialty of hematology (see D6016) resulting in the laboratory's subsequent unsuccessful PT performance for the overall specialty of hematology and the following hematology analytes: cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with an AAB PT program representative the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the specialty of hematology (see D2130 and D2131) resulting in the laboratory's subsequent unsuccessful PT performance for the overall specialty of hematology and the following hematology analytes: cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and interview with the American Association of Bioanalysts (AAB) PT program representative the laboratory's SUBSEQUENT unsuccessful PT performance for the specialties of chemistry (See D2097) and hematology (See D2131) and the following analytes: alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), total bilirubin, total calcium (CA), chloride (CL), total cholesterol, high-density lipoprotein (HDL) cholesterol, total creatine kinase (CK), creatine, glucose, total iron, total lactate dehydrogenase (LDH), magnesium (MG), potassium (K), sodium (NA), total protein, triglycerides (TRIGL), Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- blood urea nitrogen (BUN), uric acid (See D2096), cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets (See D2130) was confirmed for PT event three of 2020, event one of 2021, and events one and two of 2022. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and interview with the PT provider American Association of Bioanalysts (AAB) program representative the laboratory's SUBSEQUENT unsuccessfully PT performance for the routine chemistry analytes alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, total calcium (CA), chloride (CL), total cholesterol, creatine, glucose, potassium (K), sodium (NA), total protein, triglycerides (TRIGL), blood urea nitrogen (BUN), and uric acid was confirmed for PT event three of 2020, event one of 2021, and events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D, generated on 08-01- 2022, identified the SUBSEQUENT unsuccessful performance for the routine chemistry analytes identified below. ROUTINE CHEMISTRY ALT - EVENT 3, 2020 - 0% Unsatisfactory ALT - EVENT 1, 2021 - 0% Unsatisfactory ALT - EVENT 1, 2022 - 0% Unsatisfactory ALT - EVENT 2, 2022 - 0% Unsatisfactory Albumin - EVENT 3, 2020 - 0% Unsatisfactory Albumin - EVENT 1, 2021 - 0% Unsatisfactory Albumin - EVENT 1, 2022 - 0% Unsatisfactory Albumin - EVENT 2, 2022 - 0% Unsatisfactory ALP - EVENT 3, 2020 - 0% Unsatisfactory ALP - EVENT 1, 2021 - 0% Unsatisfactory ALP - EVENT 1, 2022 0% - Unsatisfactory ALP - EVENT 2, 2022 0% - Unsatisfactory AST - EVENT 3, 2020 - 0% Unsatisfactory AST - EVENT 1, 2021 - 0% Unsatisfactory AST- EVENT 1, 2022 0% - Unsatisfactory AST- EVENT 2, 2022 0% - Unsatisfactory Total Bilirubin - EVENT 3, 2020 - 0% Unsatisfactory Total Bilirubin- EVENT 1, 2021 - 0% Unsatisfactory Total Bilirubin - EVENT 1, 2022 0% - Unsatisfactory Total Bilirubin - EVENT 2, 2022 0% - Unsatisfactory Total Calcium - EVENT 3, 2020 - 0% Unsatisfactory Total Calcium - EVENT 1, 2021 - 0% Unsatisfactory Total Calcium - EVENT 1, 2022 0% - Unsatisfactory Total Calcium - EVENT 2, 2022 0% - Unsatisfactory Chloride - EVENT 3, 2020 - 0% Unsatisfactory Chloride - EVENT 1, 2021 - 0% Unsatisfactory Chloride - EVENT 1, 2022 0% - Unsatisfactory Chloride - EVENT 2, 2022 0% - Unsatisfactory Total Cholesterol - EVENT 3, 2020 - 0% Unsatisfactory Total Cholesterol - EVENT 1, 2021 - 0% Unsatisfactory Total Cholesterol - EVENT 1, 2022 0% - Unsatisfactory Total Cholesterol - EVENT 2, 2022 0% - Unsatisfactory Creatine - EVENT 3, 2020 - 0% Unsatisfactory Creatine - EVENT 1, 2021 - 0% Unsatisfactory Creatine - EVENT 1, 2022 0% - Unsatisfactory Creatine - EVENT 2, 2022 0% - Unsatisfactory Glucose - EVENT 3, 2020 - 0% Unsatisfactory Glucose - EVENT 1, 2021 - 0% Unsatisfactory Glucose - EVENT 1, 2022 0% - Unsatisfactory Glucose - EVENT 2, 2022 0% - Unsatisfactory K - EVENT 3, 2020 - 0% Unsatisfactory K - EVENT 1, 2021 - 0% Unsatisfactory K - EVENT 1, 2022 0% - Unsatisfactory K - EVENT 2, 2022 0% - Unsatisfactory NA - EVENT 3, 2020 - 0% Unsatisfactory NA - EVENT 1, 2021 - 0% Unsatisfactory NA - EVENT 1, 2022 0% - Unsatisfactory NA - EVENT 2, 2022 0% - Unsatisfactory Total Protein - EVENT 3, 2020 - 0% Unsatisfactory Total Protein - -- 2 of 6 -- EVENT 1, 2021 - 0% Unsatisfactory Total Protein - EVENT 1, 2022 0% - Unsatisfactory Total Protein - EVENT 2, 2022 0% - Unsatisfactory TRIGL - EVENT 3, 2020 - 0% Unsatisfactory TRIGL - EVENT 1, 2021 - 0% Unsatisfactory TRIGL - EVENT 1, 2022 0% - Unsatisfactory TRIGL - EVENT 2, 2022 0% - Unsatisfactory BUN - EVENT 3, 2020 - 0% Unsatisfactory BUN - EVENT 1, 2021 - 0% Unsatisfactory BUN - EVENT 1, 2022 0% - Unsatisfactory BUN - EVENT 2, 2022 0% - Unsatisfactory Uric Acid - EVENT 3, 2020 - 0% Unsatisfactory Uric Acid - EVENT 1, 2021 - 0% Unsatisfactory Uric Acid - EVENT 1, 2022 0% - Unsatisfactory Uric Acid - EVENT 2, 2022 0% - Unsatisfactory 2. A phone interview with the (AAB) PT representative on 08/01/2022 at 10:18 AM, confirmed the subsequent unsuccessful PT performance for the routine chemistry analytes alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, total calcium (CA), chloride (CL), total cholesterol, creatine, glucose, potassium (K), sodium (NA), total protein, triglycerides (TRIGL), blood urea nitrogen (BUN), and uric acid for PT event three of 2020, event one of 2021, and events one and two of 2022. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and interview with the PT provider American Association of Bioanalysts (AAB) program representative the SUBSEQUENT unsuccessful PT performance for the specialty of routine chemistry was confirmed for PT event 3 of 2020, event 1 of 2021, and events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D, generated on 08-01-2022, identified the subsequent unsuccessful performance for the specialty of routine chemistry. ROUTINE CHEMISTRY - EVENT 3, 2020 0% Unsatisfactory ROUTINE CHEMISTRY - EVENT 1, 2021 0% Unsatisfactory ROUTINE CHEMISTRY - EVENT 1, 2022 0% Unsatisfactory ROUTINE CHEMISTRY - EVENT 2, 2022 27% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 08/01/2022 at 10:18 AM, confirmed the subsequent unsuccessful performance for the specialty of routine chemistry for PT event 3 of 2020, event 1 of 2021, and events one and two of 2022. 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 review of the CASPER Report 0155D Proficiency Testing (PT) records and interview with the PT provider American Association of Bioanalysts (AAB) program representative the subsequent unsuccessful PT performance for the hematology analytes cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets was confirmed for PT event three of -- 3 of 6 -- 2020, event one of 2021, and events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D, generated on 08-01-2022, revealed the subsequent unsuccessful performance for the hematology analytes identified below. HEMATOLOGY Cell Identification/White Blood Cell Differential - EVENT 3, 2020 0% Unsatisfactory Cell Identification/White Blood Cell Differential - EVENT 1, 2021 0% Unsatisfactory Cell Identification/White Blood Cell Differential - EVENT 1, 2022 0% Unsatisfactory Cell Identification/White Blood Cell Differential - EVENT 2, 2022 0% Unsatisfactory Red Blood Cells- EVENT 3, 2020 0% Unsatisfactory Red Blood Cells- EVENT 1, 2021 0% Unsatisfactory Red Blood Cells - EVENT 1, 2022 0% Unsatisfactory Red Blood Cells - EVENT 2, 2022 0% Unsatisfactory Hematocrit - EVENT 3, 2020 0% Unsatisfactory Hematocrit - EVENT 1, 2021 0% Unsatisfactory Hematocrit - EVENT 1, 2022 0% Unsatisfactory Hematocrit - EVENT 2, 2022 0% Unsatisfactory Hemoglobin - EVENT 3, 2020 0% Unsatisfactory Hemoglobin - EVENT 1, 2021 0% Unsatisfactory Hemoglobin - EVENT 1, 2022 0% Unsatisfactory Hemoglobin - EVENT 2, 2022 0% Unsatisfactory White Blood Cells - EVENT 3, 2020 0% Unsatisfactory White Blood Cells - EVENT 1, 2021 0% Unsatisfactory White Blood Cells - EVENT 1, 2022 0% Unsatisfactory White Blood Cells - EVENT 2, 2022 0% Unsatisfactory Platelets - EVENT 3, 2020 0% Unsatisfactory Platelets - EVENT 1, 2021 0% Unsatisfactory Platelets - EVENT 1, 2022 0% Unsatisfactory Platelets - EVENT 2, 2022 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 08/01/2022 at 10:18 AM, confirmed the subsequent unsuccessful PT performance for the hematology analytes cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for PT event three of 2020, event one of 2021, and events one and two of 2022. 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 review of the CASPER Report 0155D Proficiency Testing (PT) records and interview with the PT provider American Association of Bioanalysts (AAB) program representative the SUBSEQUENT unsuccessful PT performance for the specialty of hematology was confirmed for PT event 3 of 2020, event 1 of 2021, and events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D, generated on 08-01-2022, identified the subsequent unsuccessful performance for the specialty of hematology. HEMATOLOTY - EVENT 3, 2020 0% Unsatisfactory HEMATOLOTY - EVENT 1, 2021 0% Unsatisfactory HEMATOLOTY - EVENT 1, 2022 0% Unsatisfactory HEMATOLOTY - EVENT 2, 2022 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 08/01/2022 at 10:18 AM, confirmed the subsequent unsuccessful performance for the specialty of hematology for event 3 of 2020, event 1 of 2021, and events one and two of 2022. 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. -- 4 of 6 -- This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and interview with the American Association of Bioanalysts (AAB) PT program representative the laboratory director failed to ensure the laboratory enrolled in event 1 of 2022 AAB PT (See D6015) and failed to ensure the laboratory submitted PT results to AAB for PT event two of 2022 (see D6016) resulting in the laboratory's SUBSEQUENT unsuccessful PT performance for the specialties of chemistry and hematology and the following analytes: alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), total bilirubin, total calcium (CA), chloride (CL), total cholesterol, high-density lipoprotein (HDL) cholesterol, total creatine kinase (CK), creatine, glucose, total iron, total lactate dehydrogenase (LDH), magnesium (MG), potassium (K), sodium (NA), total protein, triglycerides (TRIGL), blood urea nitrogen (BUN), uric acid, cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and interview with the American Association of Bioanalysts (AAB) PT program representative the laboratory director failed to ensure the laboratory maintained enrollment for PT event one of 2022 contributing to the SUBSEQUENT unsuccessful PT performance for the specialties of chemistry and hematology and the following analytes: alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), total bilirubin, total calcium (CA), chloride (CL), total cholesterol, high-density lipoprotein (HDL) cholesterol, total creatine kinase (CK), creatine, glucose, total iron, total lactate dehydrogenase (LDH), magnesium (MG), potassium (K), sodium (NA), total protein, triglycerides (TRIGL), blood urea nitrogen (BUN), uric acid, cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets. Findings Include: 1. Review of the CASPER Report 0155D, generated on 08-01-2022, identified the 0% unsatisfactory scores for PT event one of 2022. (See D2096, D2097, D2130, D2131) 2. A phone interview with the (AAB) PT representative on 08-01- 2022 at 10:18 AM, confirmed the laboratory failed to pay for their PT enrollment with AAB prior to the cut-off date for PT event one of 2022 shipment, resulting in the laboratory receiving scores of 0% for all analytes. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of -- 5 of 6 -- 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 review of the CASPER Report 0155D Proficiency Testing (PT) records and interview with the American Association of Bioanalysts (AAB) PT program representative the laboratory director failed to ensure the laboratory submitted results for PT event two of 2022 contributing to the SUBSEQUENT unsuccessful PT performance for the specialties of chemistry and hematology and the following analytes: alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), total bilirubin, total calcium (CA), chloride (CL), total cholesterol, high-density lipoprotein (HDL) cholesterol, total creatine kinase (CK), creatine, glucose, total iron, total lactate dehydrogenase (LDH), magnesium (MG), potassium (K), sodium (NA), total protein, triglycerides (TRIGL), blood urea nitrogen (BUN), uric acid, cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets. Findings Include: 1. Review of the CASPER Report 0155D, generated on 08-01-2022, identified the 0% unsatisfactory scores for PT event two of 2022. (See D2096, D2097, D2130, D2131) 2. A phone interview with the (AAB) PT representative on 08-01- 2022 at 10:18 AM, confirmed the laboratory failed to submit PT results for PT event two of 2022 for hematology and routine chemistry analytes. -- 6 of 6 --

Summary Statement of Deficiencies 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 laboratory records and interview with the laboratory owner the laboratory director failed to attest to the routine testing of proficiency testing (PT) samples for two of three PT events in 2021 for chemistry and hematology. Findings Include: 1. Proficiency testing records from the American Association of Bioanalysts (AAB) were reviewed for 2021. 2. Review of AAB PT records for hematology and chemistry revealed the laboratory testing personnel and laboratory director failed to attest that PT samples were handled in the same manner as patient samples for the following events: Chemistry a. 2021 - Event 2 b. 2021 - Event 3 Hematology a. 2021 - Event 2 b. 2021 - Event 3 3. On survey date 12-29-21, at 2:40 pm the findings were confirmed by the laboratory owner. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of laboratory records and interview with the laboratory owner; the laboratory failed to meet general immunology testing 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 -- requirements specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299. Findings Include: 1. The laboratory failed to ensure specimen integrity was maintained throughout the testing process by failing to follow the laboratory's specimen labeling requirements for COVID-19 specimens for five of five patient specimens reviewed. See D5203. 2. The laboratory failed to monitor the room temperature and humidity of the laboratory where the Quidel Solana analyzers were located to ensure accurate and reliable operation, affecting 631 patient test results and the laboratory failed to monitor storage of Quidel Solana SARS-CoV-2 assay reagents to ensure accurate and reliable operation, affecting 631 patient test results. See D5413. 3. The laboratory failed to demonstrate it can obtain performance specification comparable to those established by the manufacturer for SARS-CoV-2 testing performed on the two Quidel Solana analyzers, affecting 631 patient tests. See D5421. 4. The laboratory failed to include two control materials (positive and negative) for each molecular amplification procedure for SARS-CoV-2 testing on the Quidel Solana analyzers, affecting 631 patient test results. See D5455. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observations, and interviews with the laboratory owner; the laboratory failed to ensure specimen integrity was maintained throughout the testing process by failing to follow the laboratory's specimen labeling requirements for COVID-19 specimens for five of five patient specimens reviewed. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "Specimens Processing", which stated on page one of two under the heading of "Specimen Rejection Criteria": "1. Specimen is labeled with Name of Patient, Date of Collection and for microbiology source and time of collection, if this information is missing it is called unlabeled and it will be rejected." 2. During tour of the laboratory facility on 12-29-2021, at 5:37 pm, a patient specimen was identified that failed to include the required elements as indicated in the laboratory's specimen processing procedure. a. No name b. No collection date and time c. Source 3. During tour of the laboratory facility on 12-30-2021, at 11:04 am, four additional patient specimens were identified that failed to include the required elements as indicated in the laboratory's specimen processing procedure. a. Incomplete name (First name only) b. No collection date and time c. Source 4. On survey date 12-30-2021, at 2:400 pm, the laboratory owner confirmed the laboratory was not following the specimen handling procedure as outlined in the laboratory policy and procedure manual. 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 -- 2 of 9 -- 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: A. Based on direct observation, review of laboratory records, and interview with the laboratory owner; the laboratory failed to monitor the room temperature and humidity of the laboratory where the Quidel Solana analyzers were located to ensure accurate and reliable operation, affecting 631 patient test results. Findings Include: 1. Direct observation of the laboratory facility on 12-29-2019 at 1:08 pm identified the room where two Quidel Solana analyzers were located. No thermometer was observed in the room to monitor room temperature and humidity. 2. Review of preventative maintenance logs for 2020 through 2022 found no documented recordings of room temperature and humidity where the Quidel Solana analyzers were located. 3. Review of the Quidel Solana operations manual on page 67 revealed the following operating conditions: "Operating Conditions - Only for indoor use - Temperatures between +15 to 35 Celsius - Elevation up to 2000 meters high - Highest relative humidity 80% for temperatures up to 31 Celsius" 5. Interview with the laboratory owner on 12-29-2021, at 6:44 pm, confirmed room temperature and humidity were not monitored for the room where the Quidel Solana analyzers were located. 6. Review of test volume records found the laboratory reported 631 patient test results for SARS-CoV-2 on the Quidel Solana analyzers when temperatures and humidity were not monitored. 7. On survey date 12-30-2021, at 2:40 pm the findings were confirmed by the laboratory owner. B. Based on direct observation, review of laboratory records, and interviews; the laboratory failed to monitor storage of Quidel Solana SARS-CoV-2 assay reagents to ensure accurate and reliable operation, affecting 631 patient test results. Findings Include: 1. Direct observation of the laboratory facility on 12-29-2019 at 1:08 pm identified a Thermo Scientific ULT185-5-V Ultra Low Temperature Benchtop -80 Celsius (C) freezer used to store master mix reagents for the Quidel SARS-CoV-2 assay performed on the Quidel Solana analyzers. 2. Review of preventative maintenance logs for 2021 through 2022 found no documented recordings of the -80C freezer where the Quidel SARS-CoV-2 assay master mix reagents were stored. 3. Review of the Quidel Solana SARS-CoV-2 assay instructions for use manual on page 4 of 14 indicated the following storage conditions: "Store the Master Mix at -70 Celsius or below" 5. Interview with laboratory testing personnel #3 on 12-29-2021, at 4:35 pm, confirmed the temperature of the -80 C freezer was not monitored and recorded. 6. Review of test volume records found the laboratory reported 631 patient test results for SARS-CoV-2 on the Quidel Solana analyzers when storage temperatures for the master mix were not monitored and recorded. 7. On survey date 12-30-2021, at 2:40 pm the findings were confirmed by the laboratory owner. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. -- 3 of 9 -- This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with the laboratory owner; the laboratory failed to demonstrate it can obtain performance specification comparable to those established by the manufacturer for SARS-CoV-2 testing performed on the two Quidel Solana analyzers, affecting 631 patient tests. Findings Include: 1. Direct observation of laboratory equipment during a tour of the laboratory facility, on 12-29-2021, at 1:08 pm, identified two Quidel Solana analyzers, serial numbers 20021839 and 20021833. 2. Laboratory records indicate patient testing started on 11-23-21 for SARS-CoV-2 on the Quidel Solana analyzers. 2. Review of laboratory records for the Quidel Solana SARS-CoV-2 assay found no documented verification of performance specifications for the two Quidel Solana analyzer prior to the start of patient testing. 3. Review of test volume records revealed the laboratory performed 631 tests for SARS-CoV-2 on the Quidel Solana analyzers since the start of patient testing 11-23-21 to 12-30-2021. 4. On survey date 12-30-21, at 2:40 pm, the laboratory owner confirmed the laboratory failed to have verification of performance documentation for the two Quidel Solana analyzer for the SARS-CoV- 2 assay performed. D5455 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(v)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with the laboratory owner; the laboratory failed to include two control materials (positive and negative) for each molecular amplification procedure for SARS-CoV-2 testing on the Quidel Solana analyzers, affecting 631 patient tests. Findings Include: 1. Direct observation of laboratory on 12-29-21 at 1:08 pm, identified two Quidel Solana analyzers used for SARS-CoV-2 testing. 2. Review of the laboratory procedure manual identified the procedure, "Solana SARS-CoV-2 assay", which indicated a "maximum of 12 tests can be performed per test run in a single Solana instrument". The procedure goes on to state " a positive control (such as a positive patient sample) should be processed and tested with each batch of specimens" and "the external negative control may be treated as a patient specimen. The control should be sampled and tested as if it were a patient specimen". 3. Review of Patient/Quality Control logs for testing dates in December of 2021 found the laboratory failed to perform positive and negative quality controls with each batch of patient specimens for six of six patient testing dates reviewed. Test Date Patients Tested Controls Performed 12-04-21 10 None documented 12-06-21 Run #1 10 None documented 12-06-21 Run #2 3 None documented 12-06-21 Run#3 11 None Documented 12-10-21 Run#1 11 Positive Only 12-10-21 Run#2 11 Positive Only 12-10-21 Run#3 11 Positive Only 12- 11-21 Run#1 9 Positive Only 12-11-21 Run#2 11 Positive Only 12-12-21 8 Positive Only 12-18-21 Run#1 11 Positive Only 12-18-21 Run#2 11 Positive Only 12-18-21 Run#3 11 Positive Only 12-18-21 Run#4 11 Positive Only 12-18-21 Run#5 11 -- 4 of 9 -- Positive Only 12-18-21 Run#6 9 Positive Only 12-18-21 Run#7 11 Positive Only 12- 18-21 Run#8 8 None documented 5. Further review of the December 2021 patient testing/quality control logs found the laboratory failed to perform two levels of control materials for each amplification procedure and no documented negative control samples were identified for any testing run or date of testing. 6. Review of the laboratory test volume records found 631 patients were tested for SARS-CoV-2 using the Quidel Solana analyzer. 7. Interview with the laboratory owner on 12-30-2021, at 2:40 pm, confirmed the above findings. 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 direct observation, review of laboratory records, and interviews with the laboratory owner and testing personnel; the facility failed to have a laboratory director (LD) that provided overall management and direction in accordance with 493.1407 of this subpart. Findings Include: 1. The LD failed to ensure a safe environment to protect testing personnel from biological hazards related to COVID-19 specimen disposal for two of two months since the start of Quidel Solana SARS-CoV-2 testing in 2021. See D6011. 2. The LD failed to ensure verification procedures were adequate to determine the accuracy, precision, and all other pertinent performance characteristics for COVID-19 testing performed using the Quidel Solana SARS-CoV- 2 assay, affecting 631 patients who had testing performed using this system. See D6013. 3. The LD failed to ensure testing personnel were performing the Quidel Solana SARS-CoV-2 assay as required for accurate and reliable results, affecting 631 patients' test results. See D6014. 4. The LD failed to document review of proficiency testing (PT) records for two of three PT events reviewed in 2021 for chemistry and hematology. See D6018. 5. The LD failed to ensure an approved

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the American Association of Bioanalysts (AAB) PT program representative; the laboratory failed to successfully participate in the testing of PT samples for the specialties of chemistry and hematology for event 3 of 2020 and event 1 of 2021. Findings include: 1. Review of CASPER Report 0155D (generated on 5-03- 2021) and communication with the (AAB) PT provider on 05/06/2021 at 8:37 AM, confirmed the initial unsuccessful performance for the sub-specialty routine chemistry anlytes alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), total bilirubin, total calcium (CA), 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 -- chloride (CL), total cholesterol, high-density lipoprotein (HDL) cholesterol, total creatine kinase (CK), creatine, glucose, total iron, total lactate dehydrogenase (LDH), magnesium (MG), potassium (K), sodium (NA), total protein, triglycerides (TRIGL), blood urea nitrogen (BUN), and uric acid for event 3 of 2020 and event 1 of 2021. See D2096. 2. Review of CASPER Report 0155D (generated on 5-03-2021) and communication with the (AAB) PT provider on 05/06/2021 at 8:37 AM, confirmed the initial unsuccessful performance for the sub-specialty routine chemistry for event 3 of 2020 and event 1 of 2021. See D2097. 3. Review of CASPER Report 0155D (generated on 5-03-2021) and communication with the (AAB) PT provider on 05/06 /2021 at 8:37 AM, confirmed the initial unsuccessful performance for the specialty hematology analytes cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for event 3 of 2020 and event 1 of 2021. See D2130. 4. Review of CASPER Report 0155D (generated on 5-03- 2021) and communication with the (AAB) PT provider on 05/06/2021 at 8:37 AM, confirmed the initial unsuccessful performance for the specialty of hematology for event 3 of 2020 and event 1 of 2021. See D2131. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the PT provider American Association of Bioanalysts (AAB) program representative; the laboratory failed to successfully participate in the testing of the routine chemistry analytes alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), total bilirubin, total calcium (CA), chloride (CL), total cholesterol, high-density lipoprotein (HDL) cholesterol, total creatine kinase (CK), creatine, glucose, total iron, total lactate dehydrogenase (LDH), magnesium (MG), potassium (K), sodium (NA), total protein, triglycerides (TRIGL), blood urea nitrogen (BUN), and uric acid for event 3 of 2020 and event 1 of 2021. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-03-2021, identified the initial unsuccessful performance for the routine chemistry analytes identified below. ROUTINE CHEMISTRY ALT - EVENT 3, 2020 0% Unsatisfactory ALT - EVENT 1, 2021 0% Unsatisfactory Albumin - EVENT 3, 2020 0% Unsatisfactory Albumin - EVENT 1, 2021 0% Unsatisfactory ALP - EVENT 3, 2020 0% Unsatisfactory ALP - EVENT 1, 2021 0% Unsatisfactory Amylase - EVENT 3, 2020 0% Unsatisfactory Amylase - EVENT 1, 2021 0% Unsatisfactory AST- EVENT 3, 2020 0% Unsatisfactory AST - EVENT 1, 2021 0% Unsatisfactory Total Bilirubin - EVENT 3, 2020 0% Unsatisfactory Total Bilirubin - EVENT 1, 2021 0% Unsatisfactory Total Calcium - EVENT 3, 2020 0% Unsatisfactory Total Calcium - EVENT 1, 2021 0% Unsatisfactory Chloride - EVENT 3, 2020 0% Unsatisfactory Chloride - EVENT 1, 2021 0% Unsatisfactory Total Cholesterol - EVENT 3, 2020 0% Unsatisfactory Total Cholesterol - EVENT 1, 2021 0% Unsatisfactory HDL Cholesterol - EVENT 3, 2020 0% Unsatisfactory HDL Cholesterol - EVENT 1, 2021 0% Unsatisfactory Total CK - EVENT 3, 2020 0% Unsatisfactory Total CK - EVENT 1, 2021 0% Unsatisfactory Creatine- EVENT 3, 2020 0% Unsatisfactory Creatine - EVENT 1, 2021 0% Unsatisfactory Glucose - EVENT 3, 2020 0% Unsatisfactory Glucose - EVENT 1, 2021 0% Unsatisfactory -- 2 of 4 -- Total Iron - EVENT 3, 2020 0% Unsatisfactory Total Iron - EVENT 1, 2021 0% Unsatisfactory Total LDH - EVENT 3, 2020 0% Unsatisfactory Total LDH - EVENT 1, 2021 0% Unsatisfactory MG - EVENT 3, 2020 0% Unsatisfactory MG - EVENT 1, 2021 0% Unsatisfactory K - EVENT 3, 2020 0% Unsatisfactory K - EVENT 1, 2021 0% Unsatisfactory NA - EVENT 3, 2020 0% Unsatisfactory NA - EVENT 1, 2021 0% Unsatisfactory Total Protein - EVENT 3, 2020 0% Unsatisfactory Total Protein - EVENT 1, 2021 0% Unsatisfactory TRIGL - EVENT 3, 2020 0% Unsatisfactory TRIGL - EVENT 1, 2021 0% Unsatisfactory BUN - EVENT 3, 2020 0% Unsatisfactory BUN - EVENT 1, 2021 0% Unsatisfactory Uric Acid - EVENT 3, 2020 0% Unsatisfactory Uric Acid - EVENT 1, 2021 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 05/06/2021 at 8:37 AM, confirmed the unsatisfactory scores for the routine chemistry analytes ALT, albumin, ALP, amylase, AST, total bilirubin, total CA, CL, total cholesterol, HDL cholesterol, total CK, creatine, glucose, total iron, total LDH, MG, K, NA, total protein, TRIGL, BUN, and uric acid for event 3 of 2020 and event 1 of 2021. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the PT provider American Association of Bioanalysts (AAB) program representative; the laboratory failed to successfully participate in the testing of the sub-specialty routine chemistry for event 3 of 2020 and event 1 of 2021. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-03-2021, revealed the initial unsuccessful performance for the sub-specialty of routine chemistry. ROUTINE CHEMISTRY - EVENT 3, 2020 0% Unsatisfactory ROUTINE CHEMISTRY - EVENT 1, 2021 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 05/06/2021 at 8:37 AM, confirmed the unsuccessful performance for the sub-specialty of routine chemistry for event 3 of 2020 and event 1 of 2021. 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 review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the PT provider American Association of Bioanalysts (AAB) program representative; the laboratory failed to successfully participate in the testing of the hematology analytes cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for event 3 of 2020 and event 1 of 2021. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-03-2021, revealed the initial unsuccessful performance for the hematology analytes identified below. HEMATOLOGY Cell Identification/White -- 3 of 4 -- Blood Cell Differential - EVENT 3, 2020 0% Unsatisfactory Cell Identification/White Blood Cell Differential- EVENT 1, 2021 0% Unsatisfactory Red Blood Cells- EVENT 3, 2020 0% Unsatisfactory Red Blood Cells- EVENT 1, 2021 0% Unsatisfactory Hematocrit - EVENT 3, 2020 0% Unsatisfactory Hematocrit- EVENT 1, 2021 0% Unsatisfactory Hemoglobin - EVENT 3, 2020 0% Unsatisfactory Hemoglobin- EVENT 1, 2021 0% Unsatisfactory White Blood Cells- EVENT 3, 2020 0% Unsatisfactory White Blood Cells- EVENT 1, 2021 0% Unsatisfactory Platelets- EVENT 3, 2020 0% Unsatisfactory Platelets- EVENT 1, 2021 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 05/06/2021 at 8:37 AM, confirmed the unsatisfactory scores for the hematology analytes cell identification /white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for event 3 of 2020 and event 1 of 2021. 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 review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the PT provider American Association of Bioanalysts (AAB) program representative; the laboratory failed to successfully participate in the testing of the specialty hematology for event 3 of 2020 and event 1 of 2021. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-03-2021, revealed the initial unsuccessful performance for the specialty of hematology. HEMATOLOGY - EVENT 3, 2020 0% Unsatisfactory HEMATOLOGY - EVENT 1, 2021 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 05 /06/2021 at 8:37 AM, confirmed the unsuccessful performance for the specialty of hematology for event 3 of 2020 and event 1 of 2021. -- 4 of 4 --