Oncology Specialties, Pc

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 laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 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 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for K (Potassium), an analyte in the specialty of Chemistry. The laboratory failed two PT events in 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2096. 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for K (Potassium). The laboratory failed two PT events in 2025, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for K in two API PT events, as follows: A) 2025 Chemistry Event 1: K 60% B) 2025 Chemistry Event 2: K 40% 2. A review of the laboratory's proficiency testing evaluation reports provided by API confirmed these findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute -- 2 of 3 -- (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for K (Potassium) for two 2025 API PT events. Refer to D2096. -- 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 a review of the Centers for Medicare and Medicaid Services (CMS) CASPER Reports and American Proficiency Institute (API) testing evaluations, the laboratory failed to successfully participate in proficiency testing for Chloride (Chemistry) for two of three testing events (Event #1, 2023 and Event #3). These failures resulted in an initial unsuccessful participation. The findings include: Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 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 Centers for Medicare and Medicaid Services (CMS) CASPER Reports and American Proficiency Institute (API) testing evaluations, the laboratory failed to satisfactorily perform in proficiency testing for Chloride (Chemistry) for two of three testing events (Event #1 and Event #3, 2023). The findings include: 1. A review of the CMS CASPER report #155 revealed the laboratory scored the following for Chloride: Event #1, 2023 = 40 % Event #3, 2023 = 60 % 2. A review of the API testing evaluations confirmed the above noted scores. -- 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 a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) reports, and telephone interviews with the laboratory staff, the surveyor determined the laboratory failed to successfully participate in proficiency testing for the WBC Differential (White Blood Cell Diff) for two of three consecutive testing events. These failures resulted in an initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored 60 percent (%) for the WBC Diffs for Events #1 and #3, 2021. 2. Further review of the MLE reports revealed the laboratory results for the automated differential (5-part diff via the Pentra 60C+) 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 -- were scored as N/A, (Not Applicable). 3. On 12/15/2021 at 8:45 AM, via a telephone call, testing personnel stated the laboratory normally reported out the automated diffs for patient specimens. This personnel member added that the laboratory supervisor needed to be consulted for further information, regarding the absence of reporting to MLE of the automated diff (primary method of testing Complete Blood Counts). 4. At 10:13 AM on 12/15/2021, via telephone interview, the laboratory supervisor stated the automated differentials were routinely reported on patient samples. Additionally, she stated the blood cell identification (which was reported and resulted in the failures) was what was set-up by the previous management. According to this supervisor, she has updated MLE for year 2022 (automated diffs will be performed and reported). The laboratory supervisor confirmed the laboratory staff did not report the automated diff for Events #1 and #3 of 2021, but read the pictures/graphs provided by MLE for the Blood Cell Identification and reported the results. Note: The laboratory must participate in PT using the primary method of testing, at the time of the PT event. 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 a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) reports, and telephone interviews with the laboratory staff, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for the WBC Differential (White Blood Cell Diff) for two of three consecutive testing events. These failures resulted in an initial unsuccessful PT participation (Refer to D2016). The findings include: 1. A review of the CASPER reports revealed the laboratory scored 60 percent (%) for the WBC Diffs for Events #1 and #3, 2021. 2. Further review of the MLE reports revealed the laboratory results for the automated differential (5-part diff via the Pentra 60C+) were scored as N/A, (Not Applicable). 3. On 12/15/2021 at 8:45 AM, via a telephone call, testing personnel stated the laboratory normally reported out the automated diffs for patient specimens. This personnel member added that the laboratory supervisor needed to be consulted for further information, regarding the absence of reporting to MLE of the automated diff (primary method of testing Complete Blood Counts). 4. At 10:13 AM on 12/15/2021, via telephone interview, the laboratory supervisor stated the automated differentials were routinely reported on patient samples. Additionally, she stated the blood cell identification (which was reported and resulted in the failures) was what was set-up by the previous management. According to this supervisor, she has updated MLE for year 2022 (automated diffs will be performed and reported). The laboratory supervisor confirmed the laboratory staff did not report the automated diff for Events #1 and #3 of 2021, but read the pictures/graphs provided by MLE for the Blood Cell Identification and reported the results. -- 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 a review of CMS CASPER Reports (#153/#155) and a review of MLE (Medical Laboratoy Evaluation) proficiency testing records, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Chloride (Chemistry testing). The laboratory scored sixty percent (60 %) for the Chloride for Events #2 and #3 of 2019, and 40 % for Event #3 of 2018. These failing scores resulted in a non-initial (two unsuccessful participations) proficiency testing participation for the laboratory. The findings include: 1. A review of the Casper reports revealed the laboratory failed Chloride testing for Event 2018 MLE M3 and 2019 MLE M2 and 2019 MLE M3. 2. A review of the MLE proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- records revealed the laboratory scored 40 % (percent) for Chloride for 2018 MLE M3 and 60 % for 2019 MLE M2 and 2019 MLE M3. 3. These failures resulted in a non- initial proficiency testing participation. . 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 CMS CASPER Reports (#153/#155) and a review of MLE (Medical Laboratoy Evaluation) proficiency testing records, the surveyor determined the laboratory failed to perform satisfactorily in Chloride (Chemistry testing) for Events #2 and #3 of 2019. The laboratory scored sixty percent (60 %) for the Chloride for Events #2 and #3 of 2019, resulting in an unsuccessful participation. The findings include: 1. A review of the Casper reports revealed the laboratory failed Chloride testing for Events MLE M2 and MLE M3 of 2019. 2. A review of the MLE proficiency testing records revealed the laboratory scored 60 % for 2019 MLE M2 and 2019 MLE M3, resulting in the second unsuccesful participation. 3. This second unsuccessful, together with the first unsuccessful participation (cited in August, 2019), resulted in a non-initial proficiciency testing participation for the laboratory. -- 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 a review of the Casper reports (#153 and #155) for proficiency testing and a review of the MLE (Medical Laboratory Evaluation) proficiency testing reports, the surveyor determined the laboratory failed Chloride testing (Chemistry) for two of three consecutive testing events, 2018 MLE M3 and 2019 MLE M2. These failures resulted in the laboratory's initial unsuccessful proficiency testing participation. The findings include: 1. A review of the Casper reports revealed the laboratory failed Chloride testing for Event 2018 MLE M3 and 2019 MLE M2, two of three consecutive testing events. 2. A review of the MLE proficiency testing records revealed the laboratory scored 40 % (percent) for Chloride for 2018 MLE M3 and 60 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 -- % for 2019 MLE M2. 3. These failures resulted in the laboratory's initial unsuccessful proficiency testing participation. 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 Casper reports (#153 and #155) for proficiency testing and a review of the MLE (Medical Laboratory Evaluation) proficiency testing reports, the surveyor determined the laboratory failed to perform satisfactorily in Chloride testing (Chemistry) for two of three consecutive testing events, 2018 MLE M3 and 2019 MLE M2. These failures resulted in the laboratory's initial unsuccessful proficiency testing participation. The findings include: 1. A review of the Casper reports revealed the laboratory failed Chloride testing for Event 2018 MLE M3 and 2019 MLE M2, two of three consecutive testing events. 2. A review of the MLE proficiency testing records revealed the laboratory scored 40 % (percent) for Chloride for 2018 MLE M3 and 60 % for 2019 MLE M2. 3. These unsatisfactory scores in Chloride testing resulted in the laboratory's initial unsuccessful proficiency testing participation. -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on reviews of the Horiba ABx 60C+ calibration procedure, calibration and quality control (QC) records, patient results in the Electronic Medical Record (EMR), and an interview with the Technical Consultant (also the Laboratory Manager), the surveyor determined the laboratory failed to follow the laboratory procedure to verify calibrations by running quality controls (QC) before patient CBC (Complete Blood Count) testing resumed, for one out of six calibrations of the Hematology analyzer performed in 2017 - 2019. The findings include: 1. A review of calibration records for the Horiba ABx 60C+ revealed the instrument was calibrated on 7/11/2018 at 12:11 PM. A review of Hematology records for this date revealed QC was performed only in the early morning at 7:07 AM. 2. During an interview on 5/29/2019 at 3:10 PM, the surveyor and the Technical Consultant reviewed the Horiba ABx 60C+ calibration procedure which required performance of three levels of QC to verify the calibration. The Technical Consultant confirmed the testing personnel had failed to run QC after the calibration, as per procedure. 3. As the interview continued at 3:15 PM, the surveyor then asked if patient CBC's were performed after the calibration on 7/11 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 -- /2018. The Consultant reviewed patients in the Onco EMR, and stated ten CBC's were performed after completion of the calibration. Thus the above noted findings were confirmed. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --