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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 Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 03/30/2020, the laboratory failed to successfully participate in the BUN certified analyte in three consecutive testing events. See D2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 03/30/2020, the laboratory failed to attain a satisfactory score of at least eighty (80) percent on the Blood Urea Nitrogen (BUN) certified analyte. Findings include: 1. The laboratory failed to achieve a satisfactory score for the Blood Urea Nitrogen (BUN) analyte in the second (2nd) testing event of 2019 with a score of sixty (60) percent. 2. The laboratory failed to achieve a satisfactory score for the Blood Urea Nitrogen (BUN) analyte in the third (3rd) testing event of 2019 with a score of forty (40) percent. 3. The laboratory failed to acheive a satisfactory score for the Blood Urea Nitrogen (BUN) analyte in the first (1st) of 2020 with a score of sixty (60) percent. 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 03/30/2020, the laboratory failed to successfully achieve satisfactory performance for the Blood Urea Nitrogen (BUN) certified analyte in three (3) consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the Blood Urea Nitrogen (BUN) in the second testing event of 2019. 2. The laboratory failed to achieve a satisfactory performance for the Blood Urea Nitrogen (BUN) in the third testing event of 2019. 3. The laboratory failed to acheive a satisfactory performance for the Blood Urea Nitrogen (BUN) in the first event of 2020. 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 chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 03/30/2020, the laboratory director failed to fulfill the responsibility of evaluating the laboratory's performance of the failed Blood Urea Nitrogen (BUN) certified analyte. Findings include: The

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 Hematology proficiency testing results from the American Proficiency Institute proficiency testing agency on 02/03/2020, the laboratory failed to successfully participate in the Prothrombin Time certified analyte in two consecutive testing events. See D2121 and D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency test results from the American Proficiency Institute on 02/03/2020, the laboratory failed to attain a satisfactory score of at least eighty percent for Prothrombin Time in two consecutive testing events. Findings include: The facility scored 60 percent in the second testing event of 2019 and scored 60 percent in the third testing event of 2019 for an unsatisfactory performance. 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 Hematology proficiency test results from the American Proficiency Institute on 02/03/2020, the laboratory failed to successfully achieve satisfactory performance for Prothrombin Time in two consecutive testing events. Findings include: The facility scored 60 percent in the second testing event of 2019 and scored 60 percent in the third testing event of 2019 for an unsuccessful performance. -- 2 of 2 --

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 Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 11/19/2019, the laboratory failed to successfully participate in the Cholesterol High Density Lipoprotein (HDL) certified analyte in three consecutive testing events. This is the second unsuccessful proficiency failure. See the first unsuccessful failure dated 06/28/2019. See D2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 11/19/2019, the laboratory failed to attain a satisfactory score of at least 80 percent on the HDL Cholesterol certified analyte. Findings include: 1. The laboratory failed to achieve a satisfactory score for the HDL Cholesterol analyte in the first testing event of 2019 with a score of 60 percent. 2. The laboratory failed to achieve a satisfactory score for the HDL Cholesterol analyte in the second testing event of 2019 with a score of 40 percent. 3. The laboratory failed to achieve a satisfactory score for the HDL Cholesterol analyte in the third testing event of 2019 with a score of 40 percent. 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 11/19/2019, the laboratory failed to successfully achieve satisfactory performance for the HDL Cholesterol certified analyte in three consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the HDL Cholesterol in the first testing event of 2019 with a score of 60 percent. 2. The laboratory failed to achieve a satisfactory performance for the HDL Cholesterol in the second testing event of 2019 with a score of 40 percent. 3. The laboratory failed to achieve a satisfactory performance for the HDL Cholesterol in the third testing event of 2019 with a score of 40 percent. 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 Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 11/19/2019, the laboratory director failed to fulfill the responsibility of evaluating the laboratory's performance of the failed Cholesterol High Density Lipoprotein (HDL) certified analyte. Findings include: The

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 Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 11/14/2019, the laboratory failed to successfully participate in the Total Cholesterol certified analyte in two of three consecutive testing events and failed to successfully participate in the Blood Urea Nitrogen (BUN) certified analyte in two consecutive testing events. See D2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 11/14/2019, the laboratory failed to attain a satisfactory score of at least 80 percent for the Total Cholesterol and BUN certified analytes. Findings include: 1. The laboratory failed to achieve a satisfactory score for the Total Cholesterol analyte in the first testing event of 2019 with a score of 0 percent. 2. The laboratory failed to achieve a satisfactory score for the Total Cholesterol analyte in the third testing event of 2019 with a score of 20 percent. 3. The laboratory failed to achieve a satisfactory score for the BUN analyte in the second testing event of 2019 with a score of 60 percent. 4. The laboratory failed to achieve a satisfactory score for the BUN analyte in the third testing event of 2019 with a score of 40 percent. 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 11/14/2019, the laboratory failed to successfully achieve satisfactory performance for the Total Cholesterol in two of three consecutive testing events and failed to successfully achieve satisfactory performance for the BUN certified analyte in two consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the Total Cholesterol in the first and second testing events of 2019. 2. The laboratory failed to achieve a satisfactory performance for the BUN in the second and third testing events of 2019. -- 2 of 2 --

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 Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 06/28/2019, the laboratory failed to successfully participate in the Cholesterol, High Density Lipoprotein (HDL) certified analyte in two consecutive testing events. See D2087 and D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 06/28/2019, the laboratory failed to attain a satisfactory score of at least 80 percent on the HDL Cholesterol certified analyte. Findings include: 1. The laboratory failed to achieve a satisfactory score for the HDL Cholesterol analyte in the first testing event of 2019 with a score of 60 percent. 2. The laboratory failed to achieve a satisfactory score for the HDL Cholesterol analyte in the second testing event of 2019 with a score of 40 percent. 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 06/28/2019, the laboratory failed to successfully achieve satisfactory performance for the HDL Cholesterol certified analyte in two consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the HDL Cholesterol in the first testing event of 2019. 2. The laboratory failed to achieve a satisfactory performance for the HDL Cholesterol in the second testing event of 2019. -- 2 of 2 --

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 Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 03/29/2019, the laboratory failed to successfully participate in the Creatinine certified analyte in three of four consecutive testing events. This is the second unsuccessful proficiency failure. See the first unsuccessful failure dated 10/08/2018. See D2087 and D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 desk review of Chemistry proficiency testing results from the American Proficiency testing agency on 03/29/2019, the laboratory failed to attain a satisfactory score of at least 80 percent on the Creatinine certified analyte. Findings include: The laboratory scored 40 percent in the first testing event of 2018, scored 20 percent in the third testing event of 2018, and scored 60 percent in the first testing event of 2019. 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 03/29/2019, the laboratory failed to successfully achieve satisfactory performance for the Creatinine certified analyte in three of four consecutive testing events. Findings include: The laboratory had an unsatisfactory performance in the first testing event of 2018 with a score of 40 percent, had an unsatisfactory performance in the third testing event with a score of 20 percent, and had an unsatisfactory performance in the first testing events of 2019 with a score of 60 percent for a second 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 03/29/2019, the laboratory director failed to fulfill the responsibility of evaluating the laboratory's performance of the failed Creatinine certified analyte. Findings include: The

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 Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 03/29/2019, the laboratory failed to successfully participate in the Uric Acid certified analyte in two consecutive testing events. See D2087 and D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 03/29/2019, the laboratory failed to attain a satisfactory score of at least 80 percent on the Uric Acid certified analyte. Findings include: The laboratory scored 0 percent in the third testing event of 2018 and scored 20 percent in the first testing event of 2019. 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute proficiency testing agency on 03/29/2019, the laboratory failed to successfully achieve satisfactory performance for the Uric Acid certified analyte in two consecutive testing events. Findings include: The laboratory had an unsatisfactory performance in the third testing event of 2018 with a score of 0 percent, and had an unsatisfactory performance in the first testing events of 2019 with a score of 20 percent. -- 2 of 2 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on staff interview and record review on October 24, 2018, the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personel. Competency assessment was performed using zero (0) of six (6) methods of assessment for two (2) out of two (2) employees from October 5, 2016 through October 23, 2018. Findings include: Record review on October 24 revealed there was no documented competency assessments between October 5, 2016 and October 23, 2018, for two (2) employees that included the folowing: competency assessments failed to include direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintence records, assessment of testing external proficiency testing samples and problem solving skills. An interview with the staff on October 24, 2018 at 11:47 AM revealed the facility failed to have a system in place between October 5, 2016 and October 23, 2018 to ensure competency was performed using all six (6) mandated competency assessment requirements from October 5, 2016 and October 23, 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 Chemistry proficiency testing results from the American Proficiency Institute on 10/08/2018, the laboratory failed to successfully participate in the Creatinine certified analyte in two of three consecutive testing events. See D2087 and D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results from the American Proficiency Institute on 10/08/2018, the laboratory failed to attain a satisfactory score of at least 80 percent on the Creatinine certified analyte. Findings include: The laboratory scored 40 percent in the first testing event of 2018 and scored 20 percent in the third testing event of 2018. 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute 10/08/2018, the laboratory failed to successfully achieve satisfactory performance for the Creatinine certified analyte in two of three consecutive testing events. Findings include: The laboratory had an unsatisfactory performance in the first event of 2018 with a score of 40 percent and had an unsatisfactory performance in the third testing events of 2018 with a score of 20 percent. -- 2 of 2 --

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 Chemistry proficiency testing results from American Proficiency Institute on 07/27/2018, the laboratory failed to successfully participate in the Glucose certified analyte in two of three consecutive testing events. See D2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results from American Proficiency Institute on 07/27/2018, the laboratory failed to attain a satisfactory score of at least 80 percent on the Glucose certified analyte. Findings include: The laboratory scored 50 percent in the third testing event of 2017 and scored 20 percent in the second testing event of 2018. 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 desk review of Chemistry proficiency testing results from American Proficiency Institute on 07/27/2018, the laboratory failed to successfully achieve satisfactory performance for the Glucose certified analyte in two of three consecutive testing events. Findings include: The laboratory had an unsatisfactory performance in the third event of 2017 with a score of 40 percent and had an unsatisfactory performance in the second testing events of 2018 with a score of 20 percent.. -- 2 of 2 --