Stuart Oncology Associates Pa

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 09 /29/2026 for Stuart Oncology Associates PA. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2016 493.803(a)(b)(c) Condition: Successful Participation D6000 493.1403 Condition: Moderate Complexity 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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, the laboratory 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 -- failed to successfully participate in the Specialty of Hematology for the analyte of Hematocrit (HCT) non-waived for 2 out of 3 testing events in 2025 and 2026, and in the Subspecialty of Routine Chemistry for the analyte of Chloride (CL) for 2 out of 2 testing events in 2024 and 2025 (See D2096 and D2130). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, the laboratory failed to successfully participate in the Subspecialty of Routine Chemistry for the analyte of Chloride (CL) for 2 out of 2 testing events in 2024 and 2025. Findings included: 1. Review of the laboratory's API PT records and CMS CASPER 153 and 155 reports revealed the following scores: A. Event #3 2024 CL - 0% B. Event #1 2025 CL - 40% D2130 HEMATOLOGY CFR(s): 493.851(f) (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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, the laboratory failed to successfully participate in the Specialty of Hematology for the analyte of Hematocrit (HCT) non-waived for 2 out of 3 testing events in 2025 and 2026. Findings included: 1. Review of the laboratory's API PT records review of the CMS CASPER 153 and 155 reports revealed the following scores: A. Event #3 2025 HCT non-waived - 0% B. Event #2 2026 HCT non-waived - 60% 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 surveyor Proficiency Testing (PT) desk review, a review of the Centers for Medicare & Medicaid Services (CMS) Casper 155 and 155, and the laboratory's American Proficiency Institute (API) PT records, the Laboratory Director failed to provide overall management to ensure the laboratory performed PT in such a manner -- 2 of 3 -- as to achieve and maintain satisfactory performance with successful PT in the Specialty of Hematology and Subspecialty of Routine Chemistry (See D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor Proficiency Testing (PT) desk review, a review of the CMS Casper 155 and 155, and the laboratory's American Proficiency Institute (API) PT records, the Laboratory Director failed to ensure the laboratory performed PT in such a manner as to achieve satisfactory performance in PT in the Specialty of Hematology for 2 out of 3 testing events in 2025 and 2026 and in the Subspecialty of Routine Chemistry for 2 out of 2 testing events in 2024 and 2025 (See D2096 and D2130). -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on June 22, 2018 on or about 8:15 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell differential (WBC differential) for two out of three testing events in 2017 and 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 3 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the specialty of hematology. Findings include: On June 18, 2018 on or about 8:15 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, white blood cell differential (WBC differential), as shown below. Event #3, 2017 WBC differential-73% Event #1, 2018 WBC differential-47% 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 review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On June 18, 2018, on or about 8:15 AM, the American Institute proficiency (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On June 21, -- 2 of 3 -- 2018, on or about 8:15 AM, the American Institute Proficiency (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. -- 3 of 3 --