Prostate Oncology Specialist, Inc

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 CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performances. (See D2096) 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 -- 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 CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analytes, Bilirubin, Total and Cholesterol, Total, as follows: 2021 Q3 2022 Q1 2022 Q2 Bilirubin 100% 60% 20% Cholesterol 60% 100% 60% Q1 = First testing event Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performances for the analytes, Bilirubin and Cholesterol. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analytes, Bilirubin and Cholester, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (see D2016 and D2096) -- 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 CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting subsequent unsuccessful PT performance. (See D2096) 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 -- 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 CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Albumin, as follows: 2020 Q1 2020 Q2 Albumin 20% 60% Q1 = First testing event Q2 = Second testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an non-initial unsuccessful performance for the analyte, Albumin. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Albumin, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies 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 first quarter (Q1-2016), third quarter (Q3-2016), first quarter (Q1-2017) of the American Proficiency Institute (API) proficiency testing records, laboratory's proficiency testing comparative results records, random patient sampling test results and interview (9/10/2018, 1300) with the testing personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Bilirubin (Bili), Total, Cholesterol (Chol), Total, and Sodium (Na) analytes.The findings included: a. API reported the following unsatisfactory scores for the following analytes. Analyte: Score: Event/Year: Bili, Total 60% Q1 /2016 Chol, Total 40% Q3/2016 Na 40% Q1/2018 b. For twelve (12) out of twelve (12) random patient test results reviewed covering period from 7/11/2016 to 8/14 /2018, the laboratory analyzed and reported patients test results during the time the laboratory received unsatisfactory proficiency testing results which cannot be assured. Based on the laboratory's testing declaration submitted for 2016-2018, the laboratory analyzed and reported 125,000 Routine Chemistry tests which included the above failed analytes. c. The testing personnel affirmed (9/10/2018, 1300) that the laboratory received the above unsatisfactory proficiency testing scores. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 -- This STANDARD is not met as evidenced by: Based on review of the first quarter (Q1-2018), of the American Proficiency Institute (API) proficiency testing records, laboratory's proficiency testing comparative results records, random patient sampling test results and interview (9/10/2018, 1300) with the testing personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for White Blood Cell (WBC) differential, Eosinophils, and Neutrophils a. API reported the following unsatisfactory scores for the following analytes. Analyte: Score: Event/Year: WBC Diff 52% Q1/2018 Eosinophils 0% Q1/2018 Neutrophils 0% Q1/2018 b. For twelve (12) out of twelve (12) random patient test results reviewed covering period from 7/11/2016 to 8/14 /2018, the laboratory analyzed and reported patients test results during the time the laboratory received unsatisfactory proficiency testing results which cannot be assured. Based on the laboratory's testing declaration submitted for 2016-2018, the laboratory analyzed and reported 45,000 Hematology tests which included the failed proficiency testing analytes. c. The testing personnel affirmed (9/10/2018, 1300) that the laboratory received the above unsatisfactory proficiency testing scores. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the first quarters (Q1-2016), (Q1-2017)of the American Proficiency Institute (API) proficiency testing records, laboratory's proficiency testing comparative results records, and interview (9/10/2018, 1300) with the testing personnel, it was determined that the laboratory at least twice annually, the laboratory must verify the accuracy of: Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Bilirubin (Bili), Direct The findings included: a. API reported the following unsatisfactory scores for the following analytes. Analyte: Score: Event /Year: FSH 50% Q1/2016 LH 0% Q1/2016 Bili, Direct 40% Q1/2017 b. For one (1) out of twelve (12) random patient test results reviewed covering period from 7/11 /2016 to 8/14/2018, the laboratory analyzed and reported patients test results during the time the laboratory received unsatisfactory proficiency testing results which cannot be assured. Based on the laboratory's testing declaration submitted for 2016- 2018, the laboratory analyzed and reported 1,000 Endocrinology tests, which included the FSH and LH tests, and 125,000 Routine Chemisrty test which insluded the Bili, Direct test. c. The testing personnel affirmed (9/10/2018, 1300) that the laboratory received the above unsatisfactory proficiency testing scores. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's refrigerator temperature logs, and interview with the testing personnel, it was determined that the laboratory failed to document