Delta Oncology

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records for 2022 and 2023, surveyor review of the Centers for Medicare & Medicaid Services (CMS) 209 personnel form and confirmation by testing personnel (TP) #1 at 2:00 p.m. on 10/5 /2023, the laboratory failed to ensure that all TP who routinely perform CBC testing on patient samples participated in proficiency testing. Four of five testing personnel responsible for CBC testing did not participate in proficiency testing for 2022-2023. Findings include: 1. Review of proficiency records since 2/15/2022 revealed that all events since the previous survey (1st, 2nd, 3rd events for 2022; 1st, 2nd, 3rd events for 2023) were performed by TP #1. 2. TP #1 in an interview at 2:00 p.m. on 10/5 /2023 confirmed that CBC testing on patient samples is routinely performed by testing personnel #1, #2, #3, #4, and #5 as listed on the CMS-209 personnel form. 3. Four of five TP (#2, #3, #4, #5) did not document participation in any proficiency testing events for CBC from 2/15/2022 through 10/5/2023. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/24/22, the laboratory has not successfully performed proficiency testing for SODIUM. Findings include: Our records indicate the following proficiency testing scores for your laboratory for SODIUM: PROFICIENCY TESTING PROVIDER: American Proficiency Institute SODIUM: Year 2022 1st Event 40% Year 2022 2nd Event 0% Scores less than 80% for this 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 -- analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/24/22, the laboratory has not successfully performed proficiency testing for SODIUM. Findings include: Our records indicate the following proficiency testing scores for your laboratory for SODIUM: PROFICIENCY TESTING PROVIDER: American Proficiency Institute SODIUM: Year 2022 1st Event 40% Year 2022 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/16/22, the laboratory has not successfully performed proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY: PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY - WBC, RBC, Hemoglobin, Hematocrit, Platelets, WBC Differential: Year 2021 3rd Event 0% Year 2022 1st Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure 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 -- of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2123 HEMATOLOGY CFR(s): 493.851(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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/16/22, the laboratory has not successfully performed proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY: PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY - WBC, RBC, Hemoglobin, Hematocrit, Platelets, WBC Differential: Year 2021 3rd Event 0% Year 2022 1st Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2131 HEMATOLOGY CFR(s): 493.851(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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/16/22, the laboratory has not successfully performed proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY: PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY - WBC, RBC, Hemoglobin, Hematocrit, Platelets, WBC Differential: Year 2021 3rd Event 0% Year 2022 1st Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 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 review of the Vitros 350 chemistry calibration records from 10/25/17 through 9/5/19 and interview with lab manager/testing personnel #1 at 3:00 pm on the day of survey, 9/5/19, the laboratory failed to perform calibration on chemistry analytes every 6 months or with each lot number change, which ever comes first, as required in the manufacturer's instructions. Findings include: 1. Review of the Vitros 350 Operator's manual indicated that the manufacturer's requirements for calibration are with each lot number change and every 6 months. 2. Interview with lab manager /testing personnel #1 confirmed calibrations were performed with each change of lot number throughout the year. 3. Review of the Vitros 350 calibration records revealed that at least one calibration interval for each of the following analytes exceeded the every 6 month requirement: Alkaline Phosphatase- calibrated on 12/14/17, 3/11/19 ALT - calibrated on 11/21/17, 3/11/19 AST - calibrated on 10/9/17, 11/21/18, 6/25/19 Bu (Unconjugated Bilirubin)- calibrated on 8/17/17, 1/30/19 Bc (Conjugated Bilirubin) - calibrated on 8/17/17, 1/30/19 BUN- calibrated on 12/27/17, 2/13/19 Calcium - calibrated on 11/22/17, 12/4/18, 6/6/18, 7/1/19 Chloride - calibrated on 10 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 -- /11/17, 8/30/18, 7/1/19 Creatinine - calibrated on 11/22/17, 2/28/19 Carbon Dioxide - calibrated on 11/29/17, 3/4/19, Glucose - calibrated on 12/6/17, 3/18/19 Magnesium - calibrated on 11/14/17, 7/17/19 Sodium - calibrated on 11/8/17, 7/2/18, 11/21/18, 7/1 /19 Total Bilirubin - calibrated on 11/1/17, 6/21/18 Total Protein - calibrated on 11/16 /17, 11/13/18 Urine Protein - calibrated on 10/4/17, 8/30/18, 9/16/19 D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of chemistry calibration records from the last survey on 10/25/17 through 9/5/19, the day of the current survey, and confirmation with laboratory manager/testing personnel #1 at 2:30 pm on 9/5/19, the laboratory failed to perform calibration verifications on the Ortho Vitros 350 chemistry analyzer every 6 months for Sodium (Na), Potassium (K) and Chloride (Cl). Findings include: 1. Review of the Vitros 350 Calibrator materials revealed that the calibrators for Na, K, and Cl only have 2 levels. 2. Calibration Verification is required every 6 months for assays calibrated with less than 3 calibrators--the three calibrators must extend throughout the reportable range of the assay. 3. Review of Vitros 350 chemistry calibration records revealed that a calibration verification was not performed on Na, K, and Cl every 6 months. A calibration verification had not been performed since the last survey on 10/25/17. 4. Interview with laboratory manager/testing personnel #1 at 2:30 pm on 9/5/19 confirmed that Na, K, and Cl calibration verifications had not been performed on the Vitros 350 chemistry analyzer since 10/25/17. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 3/29/2018, the laboratory has not successfully participated in proficiency testing for ALBUMIN, TOTAL BILIRUBIN and TSH. Findings include: PROFICIENCY TESTING PROVIDER: American Proficiency Institute Our records indicate the following proficiency testing scores for your laboratory for ALBUMIN: Year 2017 2nd Event 0% Year 2018 1st Event 60% Our records indicate the following proficiency testing scores for your laboratory for TOTAL BILIRUBIN: Year 2017 2nd Event 0% Year 2018 1st Event 40% Our records indicate the following proficiency testing scores for your 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 2 -- for TSH: Year 2017 2nd Event 0% Year 2018 1st Event 20% Scores less than 80% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 3/29/2018, the laboratory has not successfully participated in proficiency testing for ALBUMIN and TOTAL BILIRUBIN. Findings include: PROFICIENCY TESTING PROVIDER: American Proficiency Institute Our records indicate the following proficiency testing scores for your laboratory for ALBUMIN: Year 2017 2nd Event 0% Year 2018 1st Event 60% Our records indicate the following proficiency testing scores for your laboratory for TOTAL BILIRUBIN: Year 2017 2nd Event 0% Year 2018 1st Event 40% D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 3/29/2018, the laboratory has not successfully participated in proficiency testing for TSH. Findings include: PROFICIENCY TESTING PROVIDER: American Proficiency Institute Our records indicate the following proficiency testing scores for your laboratory for TSH: Year 2017 2nd Event 0% Year 2018 1st Event 20% -- 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 3/26/2018, the laboratory has not successfully participated in proficiency testing for Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Sodium and Blood Urea Nitrogen (BUN). Findings include: Our records indicate the following proficiency testing scores for your laboratory for Alanine Aminotransferase (ALT), Aspartate Aminotranferase (AST), Sodium and Blood Urea Nitrogen (BUN). PROFICIENCY TESTING PROVIDER: American Proficiency Institute ALT AST Sodium BUN 2017 - 2nd 0 % 0% 0% 0% 2017 - 3rd 60% 60% 60% 40% 2018 - 1st 20% 60% 20% 40% Scores less 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 -- than 80% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 3/26/2018, the laboratory has not successfully participated in proficiency testing for Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Sodium and Blood Urea Nitrogen (BUN). Findings include: Our records indicate the following proficiency testing scores for your laboratory for Alanine Aminotransferase (ALT), Aspartate Aminotranferase (AST), Sodium and Blood Urea Nitrogen (BUN). PROFICIENCY TESTING PROVIDER: American Proficiency Institute ALT AST Sodium BUN 2017 - 2nd 0 % 0% 0% 0% 2017 - 3rd 60% 60% 60% 40% 2018 - 1st 20% 60% 20% 40% Scores less than 80% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: This Condition is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 3/26/2018, the laboratory director has not provided overall management and direction in accordance with 493.1407 of this subpart. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 3/26/2018, the laboratory director has failed to ensure the proficiency testing samples were tested as required under subpart H of this part. -- 3 of 3 --