Millennium Physicians Dba Millenium Oncology

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 D2016 Condition: Successful participation [proficiency testing 493.807 D2017 Reinstatement After Failure 493.1403 D6000 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company College of American Pathologists (CAP), 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 Routine Chemistry for the analyte Creatinine. (Refer to D2096 and D2097) 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 desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing records from College of American Pathologists (CAP), it was determined the laboratory had not successfully participated in proficiency testing for the analyte Creatinine under the specialty of Routine Chemistry for 3 of 3 consecutive testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings include: 1. WBCR -B 2020 (Whole Blood Creatinine second event) the laboratory received an unsatisfactory score of 40% for the specialty of Routine Chemistry. 2. WBCR- C 2020 (Whole Blood Creatinine third event) the laboratory received an unsatisfactory score of 20% for the specialty of Routine Chemistry. 3. WBCR- A 2021 (Whole Blood Creatinine first event) the laboratory received an unsatisfactory score of 0% for the specialty of Routine Chemistry. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 College of American Pathologists (CAP) proficiency test results, it was revealed the laboratory failed to attain a score of at least 80% for the analyte Creatinine in 2020 and 2021. -- 2 of 5 -- Findings include: 1. WBCR -B 2020 (Whole Blood Creatinine second event) the laboratory received an unsatisfactory score of 40% for the analyte Creatinine. 2. WBCR- C 2020 (Whole Blood Creatinine third event) the laboratory received an unsatisfactory score of 20% for the analyte Creatinine. 3. WBCR- A 2021 (Whole Blood Creatinine first event) the laboratory received an unsatisfactory score of 0% for the analyte Creatinine. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's College of American Pathologists (CAP) proficiency test results, it was revealed the laboratory failed to attain an overall testing score of at least 80% in the specialty of Routine Chemistry for 3 of 3 events in 2020 and 2021. Findings include: 1. WBCR -B 2020 (Whole Blood Creatinine second event) the laboratory received an unsatisfactory score of 40% for the specialty of Routine Chemistry. 2. WBCR- C 2020 (Whole Blood Creatinine third event) the laboratory received an unsatisfactory score of 20% for the specialty of Routine Chemistry. 3. WBCR- A 2021 (Whole Blood Creatinine first event) the laboratory received an unsatisfactory score of 0% for the specialty of Routine Chemistry. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing records from College of American Pathologists (CAP), it was revealed the laboratory failed to participate in the Whole Blood Creatinine first event for 2021(WBCR-A 2021), resulting in unsatisfactory performance. Findings include: 1. WBCR- A 2021 (Whole Blood Creatinine first event) the laboratory failed to participate and received an unsatisfactory score of 0%. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) -- 3 of 5 -- 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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing records from College of American Pathologists (CAP), it was revealed the laboratory failed to achieve satisfactory performance for the analyte Creatinine for 3 of 3 consecutive testing events in 2020 and 2021. Findings include: 1. WBCR -B 2020 (Whole Blood Creatinine second event) the laboratory received an unsatisfactory score of 40% for the analyte Creatinine. 2. WBCR- C 2020 (Whole Blood Creatinine third event) the laboratory received an unsatisfactory score of 20% for the analyte Creatinine. 3. WBCR- A 2021 (Whole Blood Creatinine first event) the laboratory received an unsatisfactory score of 0% for the analyte Creatinine. Three out of three unsatisfactory scores results in subsequent (non-initial) unsuccessful proficiency testing performance. 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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing records from College of American Pathologists (CAP), it was revealed the laboratory failed to achieve satisfactory performance for the specialty of Routine Chemistry for 3 of 3 consecutive testing events in 2020 and 2021. Findings include: 1. WBCR -B 2020 (Whole Blood Creatinine second event) the laboratory received an unsatisfactory score of 40% for the specialty of Routine Chemistry. 2. WBCR- C 2020 (Whole Blood Creatinine third event) the laboratory received an unsatisfactory score of 20% for the specialty of Routine Chemistry. 3. WBCR- A 2021 (Whole Blood Creatinine first event) the laboratory received an unsatisfactory score of 0% for the specialty of Routine Chemistry. Two out of three unsatisfactory scores results in unsuccessful proficiency testing 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 College of American Pathologists (CAP) proficiency test results, it was revealed that the -- 4 of 5 -- 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 following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D2017 - 42 C.F.R. 493.807 (a) - Reinstatement After Failure D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologist (CAP) proficiency testing records from 2020, it was determined the laboratory has not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analytes: TOTAL CREATININE; (Refer to D2087, D2088, D2096, D2097) D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2020, it was determined the laboratory had not successfully participated in proficiency testing for the satisfactory performance in the specialty of chemistry for the analyte TOTAL CREATININE resulting in a non-initial PT failure. Findings were: 1. A review of the CMS national proficiency testing database from 2019-2020 revealed the laboratory failed to attain a satisfactory score of 80% or greater for Creatinine in 3 of 3 Chemistry testing events in 2020. WBCR-A 2020 - 40% WBCR-B 2020 - 40% WBCR-C 2020 - 20% 2. A proficiency desk review of the CAP proficiency testing records from 2020 confirmed that the laboratory received the following chemistry score in Creatinine for 3 of 3 consecutive testing. WBCR-A 2020 - 40% WBCR-B 2020 - 40% WBCR-C 2020 - 20% 3. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2020, it was determined the laboratory failed to attain a score of -- 2 of 5 -- 80% or greater for the analyte Creatinine for 3 of 3 testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database from 2019-2020 revealed the laboratory failed to attain a satisfactory score of 80% or greater for Creatinine in 3 of 3 Chemistry testing events in 2020. WBCR-A 2020 - 40% WBCR- B 2020 - 40% WBCR-C 2020 - 20% 2. A proficiency desk review of the CAP proficiency testing records from 2020 confirmed that the laboratory received the following Creatinine score for 3 of 3 consecutive Chemistry testing events in 2020. WBCR-A 2020 - 40% WBCR-01 lab result 7.35 (acceptable range 8.59 - 11.63) WBCR-04 lab result 2.56 (acceptable range 3.03 - 4.11) WBCR-05 lab result 4.54 (acceptable range 4.98 - 6.75) WBCR-B 2020 - 40% WBCR-06 lab result 4.13 (acceptable range 4.76 - 6.46) WBCR-08 lab result 2.63 (acceptable range 2.88 - 3.91) WBCR-09 lab result 1.53 (acceptable range 1.67 - 2.28) WBCR-C 2020 - 20% WBCR-11 lab result 4.22 (acceptable range 4.77 - 6.47) WBCR-12 lab result 2.28 (acceptable range 2.92 - 3.96) WBCR-14 lab result 7.69 (acceptable range 8.33 - 11.28) WBCR-15 lab result 1.65 (acceptable range 1.66 - 2.27) D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2020, it was determined the laboratory failed to attain a score of 80% or greater for the specialty of Chemistry for 3 of 3 testing events in 2020 resulting in an unsatisfactory performance for the specialty of Chemistry. Findings were: 1. A review of the CMS national proficiency testing database from 2019-2020 revealed the laboratory failed to attain a satisfactory score of 80% or greater in the specialty of Chemistry in 3 of 3 Chemistry testing events in 2020. WBCR-A 2020 - 40% WBCR-B 2020 - 40% WBCR-C 2020 - 20% 2. A proficiency desk review of the CAP proficiency testing records from 2020 confirmed that the laboratory received the following Chemistry score for 3 of 3 consecutive testing in 2020. WBCR-A 2020 - 40% WBCR-B 2020 - 40% WBCR-C 2020 - 20% 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2020, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the analyte Creatinine in 3 of 3 consecutive testing events in 2020 which resulted in unsuccessful performance for the analyte Creatinine in 2020. Findings were: 1. A review of the CMS national proficiency testing database from 2019-2020 revealed the laboratory failed to attain a -- 3 of 5 -- satisfactory score of 80% or greater for Creatinine in 3 of 3 Chemistry testing events in 2020. WBCR-A 2020 - 40% WBCR-B 2020 - 40% WBCR-C 2020 - 20% 2. A proficiency desk review of the CAP proficiency testing records from 2020 confirmed that the laboratory received the following Creatinine score for 3 of 3 consecutive Chemistry testing events in 2020. WBCR-A 2020 - 40% WBCR-B 2020 - 40% WBCR-C 2020 - 20% 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2020, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the specialty of Chemistry in 3 of 3 consecutive testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database from 2019-2020 revealed the laboratory failed to attain a satisfactory score of 80% or greater for the specialty of Chemistry in 3 of 3 Chemistry testing events in 2020. WBCR-A 2020 - 40% WBCR-B 2020 - 40% WBCR-C 2020 - 20% 2. A proficiency desk review of the CAP proficiency testing records from 2020 confirmed that the laboratory received the following Chemistry score for 3 of 3 consecutive Chemistry testing events in 2020. WBCR-A 2020 - 40% WBCR-B 2020 - 40% WBCR-C 2020 - 20% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. 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 -- 4 of 5 -- director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an approved proficiency testing program. (refer to D2088, D2097) -- 5 of 5 --

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 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, College of American Pathologists (CAP), 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 routine chemistry for the analyte: Creatinine for two consecutive events in 2020. (Refer to D2087, 2096) D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 Centers for Medicare and Medicaid Services (CMS) national database and verified with laboratory's College of American Pathologists (CAP) proficiency testing results from 2020, the laboratory failed to achieve successful score of 80% on 2 of 2 events for the analyte of Creatinine in Chemistry. The findings were: 1. A review of CMS national database testing results from 2020 first and second events, revealed the laboratory failed to achieve a successful score of 80% on 2 of 2 events for the analyte creatinine in chemistry. Chemistry Creatinine 2020- First event : 40% Creatinine 2020- Second event: 40% 2. A review of the laboratory's CAP proficiency testing results from 2020 first and second events, revealed the laboratory failed to achieve a successful score of 80% on 2 of 2 events for the analyte creatinine in chemistry Creatinine 2020 - First event: 40% CAP Specimen Result Expected result 1 7.35 8.59 - 11.63 (unacceptable) 4 2.56 3.03 - 4.11 (unacceptable) 5 4.54 4.98 - 6.75 (unacceptable) Creatinine 2020 - Second event: 40% CAP Specimen Result Expected result 6 4.13 4.76 - 6.46 (unacceptable) 8 2.63 2.88 - 3.91 (unacceptable) 9 1.53 1.67 - 2.28 (unacceptable) D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based upon a review of Centers for Medicare and Medicaid Services (CMS) national data base and College of American Pathologists (CAP) proficiency desk review from 2020, the laboratory failed to attain an overall testing event score of at least 80 % for the first and second Chemistry events. Findings were: 1. Review of the (CMS) national data base, revealed the laboratory failed to achieve an overall testing score of at least 80% in the 2020 1st Testing Event and the 2020 2nd testing event for Chemistry. Chemistry - 2020- First event: 40% 2020- Second event: 40% 2. Review of the CAP proficiency testing records for 2020 revealed the laboratory failed to attain an overall testing event score of at least 80 % for 2 of 2 Chemistry testing events. CAP Chemistry 2020- First event : 40% 2020- Second event: 40% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) -- 2 of 4 -- 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 Centers for Medicare and Medicaid Services (CMS) national database and verified with laboratory's College of American Pathologists (CAP) proficiency testing results from 2020, the laboratory failed to achieve successful score of 80% on 2 of 2 events for the analyte of Creatinine in Chemistry, which constitutes unsuccessful performance. The findings were: 1. A review of CMS national database testing results from 2020 first and second events, revealed the laboratory failed to achieve a satisfactory score of 80% on 2 of 2 events for the analyte creatinine in chemistry. Chemistry Creatinine 2020- First event : 40% Creatinine 2020- Second event: 40% 2. A review of the laboratory's CAP proficiency testing results from 2020 first and second events, revealed the laboratory failed to achieve a satisfactory score of 80% on 2 of 2 events for the analyte creatinine in chemistry Chemistry CAP Creatinine 2020 - First event: 40% CAP Creatinine 2020 - Second event: 40% Score of less than 80 percent are unsatisfactory performance. Unsatisfactory performance on two (2) consecutive events or two out of three (2 out of 3) events is unsuccessful performance. 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2020, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance of 80% or greater for 2 of 2 consecutive testing events for the specialty of chemistry. Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of 40 % for the 2020 Chemistry first event and second event. 2. A proficiency desk review of the College of American Pathologists proficiency testing records from 2020 confirmed that the laboratory received a chemistry score of 40% for the 2020 Chemistry first event and second event. 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: -- 3 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 laboratory's College of American Pathologists (CAP) 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) 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 records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's College of American Pathologists (CAP) proficiency test results, it was revealed the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. (Refer to D2087, D2088, 2096, 2097). -- 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, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.807 (a) Reinstatement after Failure 493.1403 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 3 -- Based on a desk review of proficiency testing records, it was determined that the laboratory has 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 chemistry for the analyte Creatine. Refer to D2096. 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 desk review of proficiency testing scores from CAP found the laboratory failed to participate successfully for the analyte creatine. Findings: 1. The laboratory received the following failing scores (passing = >80%) for the analyte creatine: CAP 2017 - 2nd event laboratory received an unsatisfactory score of 0% for creatine CAP 2017 - 3rd event laboratory received an unsatisfactory score of 60% for creatine CAP 2018 - 2nd event laboratory received an unsatisfactory score of 0% for creatine CAP 2018 - 3rd event laboratory received an unsatisfactory score of 60% for creatine. 2. These four consecutive failures result in a third unsuccessful performance for the analyte creatine. 3. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing desk review of CMS form 155 and CAP records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte Creatine. Findings: 1. CAP 2017 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. 2. CAP 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for Creatine. 3. CAP 2018 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. 4. CAP 2018 - 3rd event the laboratory received an unsatisfactory score of 60% for Creatine. -- 2 of 3 -- 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 a desk review of CAP proficiency testing records, it was determined that laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of chemistry for the analyte Creatine. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. CAP 2017 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. 2. CAP 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for Creatine. 3. CAP 2018 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. 4. CAP 2018 - 3rd event the laboratory received an unsatisfactory score of 60% for Creatine. 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 laboratory proficiency testing 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) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.807 (a) Reinstatement after Failure 493.1403 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, College of American Pathologists (CAP), 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 chemistry for creatine. Refer to D2096 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 desk review of proficiency testing scores from CAP found the laboratory failed to participate successfully for the analyte creatine. Findings: 1. The laboratory received the following failing scores (passing = >80%) for the analyte creatine: CAP 2017 - 2nd event laboratory received an unsatisfactory score of 0% for creatine CAP 2017 - 3rd event laboratory received an unsatisfactory score of 60% for creatine CAP 2018 - 2nd event laboratory received an unsatisfactory score of 0% for creatine 2. These three consecutive failures result in a second unsuccessful performance for the analyte creatine. 3. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing desk review of CMS form 155 and CAP records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte Creatine. Findings: 1. CAP 2017 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. 2. CAP 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for Creatine. D2088 ROUTINE CHEMISTRY -- 2 of 4 -- CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Review of the CMS report 155 and CAP proficiency testing records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall chemistry testing event score. Findings: 1. CAP 2017 - 2nd event the laboratory received an overall unsatisfactory event score of 0% for chemistry. 2. CAP 2017 - 3rd event the laboratory received an overall unsatisfactory score of 60% for chemistry. 3. CAP 2018 - 2nd event the laboratory received an overall unsatisfactory event score of 0% for chemistry. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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: Review of the CMS report 155 and CAP proficiency testing records found that the laboratory failed to participate in the 2018 - 2nd Testing Event for Chemistry, resulting in a score of 0% for the analyte creatine, constituting unsatisfactory performance. Findings: 1. CAP 2018 - 2nd event laboratory failed to participate resulting in an unsatisfactory score of 0% for creatine. 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 a desk review of CAP proficiency testing records, it was determined that laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of chemistry for the analyte Creatine. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. CAP 2017 - 2nd event the laboratory received an unsatisfactory score of 0% for -- 3 of 4 -- Creatine. 2. CAP 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for Creatine. 3. CAP 2018 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 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, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 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 3 -- Based on a desk review of proficiency testing records, it was determined that the laboratory has 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 chemistry for the analyte Creatine. Refer to 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 in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and CAP records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte Creatine. Findings: 1. CAP 2017 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. 2. CAP 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for Creatine. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Review of the CMS report 155 and CAP proficiency testing records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall chemistry testing event score. Findings: 1. CAP 2017 - 2nd event the laboratory received an overall unsatisfactory event score of 0% for chemistry. 2. CAP 2017 - 3rd event the laboratory received an overall unsatisfactory score of 60% for chemistry. 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 a desk review of CAP proficiency testing records, it was determined that laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of chemistry for the analyte Creatine. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. CAP 2017 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. 2. CAP 2017 - 3rd event the laboratory received an unsatisfactory score of 60% for Creatine. -- 2 of 3 -- 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 laboratory proficiency testing 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) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program (refer to D2096). -- 3 of 3 --