St Croix Cancer Specialists

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Revisit 08/28/2025 I. New Findings. Based on review of the laboratory's procedure, monthly checklist, and Beckman Coulter DxH 520 patient analyzer printouts, the laboratory failed to follow their own written procedure for reviewing 41 of 41 flagged patient results from the DxH 520 analyzer in 07/2025. Findings included: 1. The laboratory's "Standard Operating Procedure: Complete Blood Count (CBC) Procedure" (submitted 06/26/2025 as part of Allegation of Compliance) stated, "Review the results for Flags, codes and messages. All flagged results will be reviewed by the provider of record for the day and/or the laboratory director to determine if reflex testing with manual microscopy or additional testing is necessary per the laboratory's Standard Operating Procedure (SOP). Testing personnel will keep all analyzer print outs of patient results to be reviewed by the lab director monthly during the end of month lab review." 2. Review of the "Lab Monthly Check List" for 07/2025 did not include the laboratory director's signature and date. The checklist included, "ALL Flag / codes / Message - reviewed/signed by provider or lab director? YES / NO." The box was checked, but "YES / NO" was not selected and 41 patient results with flags/codes/messages did not include documentation of being reviewed /signed by a provider or lab director, as required. 3. Review of Beckman Coulter DxH 520 patient analyzer printouts included the following flags and messages without documentation of review (sampling from the 41 flagged results) from 07/2025: 07/02 /2025 at 8:53 AM - H&H Check Failed 0703/2025 at 11:04 AM - PLT1: Debris 07/7 /2025 at 1:08 PM - Suspect Diff 07/8/2025 at 2:36 PM - PLT1: Debris 07/10/2025 at 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 -- 2:23 PM - Abnormal Diff, Suspect Diff, NE/EO Overlap 07/14/2025 at 1:44 PM - Abnormal Diff, Cellular Interference, NE/LY Overlap, Suspect Diff, LY/MO Overlap, BA interference 07/15/2025 at 2:53 PM - PLT1: Debris 07/17/2025 at 12:55 PM - Abnormal Diff, Suspect Diff, LY/MO Overlap 07/18/2025 at 10:06 AM - Suspect Diff 07/21/2025 at 10:57 AM - PLT3: PLT/RBC Overlap 07/22/2025 at 9:23 AM - Abnormal Diff, Suspect Diff, NE/EO Overlap 07/24/2025 at 2:55 PM Abnormal Diff, Suspect Diff, NE/EO Overlap 07/28/2025 at 10:22 AM - Abnormal Diff, Suspect Diff, MO/NE Overlap 07/29/2025 at 10:14 AM - PLT3: PLT/RBC Overlap 07/30 /2025 at 8:37 AM - Suspect Diff 07/31/2025 at 9:12 AM - PLT1: Debris Refer to D5411 for manufacturer's instructions for flagged results. 43831 II. Based on review of the complete blood cell count (CBC) procedures, review of the attestation documentation, and interviews, the laboratory personnel failed to follow the procedure. Findings include: 1. Review of the procedure titled "DxH 500 Reagent SOP" approved by the laboratory director (LD) on 6/24/2025, showed "If at least 2 out of 3 control results are within the acceptable ranges you are ready to analyze patient samples." 2. Review of the attestation documentation signed on 6/13/2025 by the LD showed, "We will not report patient results when control material does not meet the required acceptable ranges. We will formulate an SOP regarding documentation of

Summary Statement of Deficiencies D0000 A Centers for Medicare & Medicaid Services (CMS) New York CLIA Branch Location federal surveyor conducted an announced CLIA recertification survey at Delgiacco Medical LLC DBA St. Croix Cancer Specialists on March 22, 2023. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following deficiencies was found during the announced routine CLIA recertification survey performed on March 22, 2023. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter D520 quality control (QC), calibration and temperature records and interview with testing personnel (TP) #1, the laboratory failed to retain at least two years of QC, calibration and temperature records for the Beckman Coulter D520 from March 2021 to March 2023. Findings Include: 1. On the day of survey, March 22, 2023, TP #1 could not provide QC or calibration records for the Beckman Coulter D520 performed from March 2021 to September 2022. 2. TP #1 could not provide temperature records from March 19, 2021 to September 23, 2021. 3. TP #1 confirmed the findings above on March 22, 2023 around 11:45 am. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. 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 quality assessment (QA) records and interview with testing personnel (TP) #1, the laboratory failed to retain at least two years of QA records for March 2021 to March 2023. Findings Include: 1. On the day of survey, March 22, 2023, TP #1 could not provide QA records from monthly QA reviews performed from March 2021 to December 2022. 2. TP #1 confirmed the finding above on March 22, 2023 around 9:45 am. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory room and refrigerator temperature records and interview with testing personnel (TP) #1, the laboratory failed to define storage conditions (reference ranges) to monitor the Beckman Coulter D520 reagents stored at ambient room temperature and in a refrigerator from March 2021 to March 2023. Finding Include: 1. On the day of survey, March 22, 2023, review of the laboratory refrigerator and ambient room temperature records revealed, the laboratory did not define temperature reference ranges to monitor Beckman Coulter D520 reagents stored at ambient room temperature and refrigerator temperature from March 2021 to March 2023. 2. TP#1 confirmed the laboratory did not have defined the reference ranges for reagents stored at ambient room and refrigerator temperatures on March 22, 2023 around 11: 00 am. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of refrigerator and laboratory room thermometer records and interview with testing personnel (TP) #1, the laboratory failed to establish and perform functions checks on two of two thermometers used to monitor laboratory refrigerator and room temperatures from March 2021 to March 2023. Finding Include: 1. On the day of survey, March 22, 2023, a tour of the laboratory revealed, two Fridge - Freezer thermometers were in use to monitor the -- 2 of 4 -- temperatures for a mini refrigerator storing Beckman Coulter D520 reagents and ambient room temperature from March 2021 to March 2023. 2. TP#1 could not provide an established maintenance protocol that ensures the functionally of the thermometers on a periodic basis. 3. The laboratory was unable to provide documentation of maintenance/ function check performed on the two thermometer in use from March 2021 to March 2023. 4. TP#1 confirmed the findings above on March 22, 2023 around 11: 10 am. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of a sampling of laboratory test reports and interview with TP#1, the failed to indicate which one of the two laboratory locations where the complete blood count tests were performed from March 2021 to March 2023. Finding Include: 1. The top of the laboratory test reports state: - St. Thomas & St. Croix Cancer Specialist - St. Thomas Cancer Specialist 9150 Estate Thomas, Suite 230 St. Thomas VI 00802 - St. Croix Cancer Specialist 6048 Estate Castle Coakley Christainsted, VI 00820 2. On the day of survey, March 22, 2023, review of a sampling of test reports (five of five) revealed, the test report did not state which one of the two labs (St. Thomas or St. Croix) the CBC test was performed March 2021 to March 2023. 3. TP# 1 confirmed the findings above on March 22, 2023 around 11:00 am. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records and interview with testing personnel (TP) #1, the technical consultant (TC) failed to document training performed for four of four new testing personnel hired since 2021. Findings Include: 1. On the day of survey, March 22, 2023, TP#1 could not provided training records for four of four new testing personnel not listed on the CMS 209 from the last recertification survey perfom on March 19, 2021. 2. TP#1 confirmed the finding above on March 22, 2023 around 10:00 am. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) -- 3 of 4 -- (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of competency assessment (CA) records and interview with testing personnel (TP) #1, the technical consultant (TC) failed to evaluate the competency of all TP in 2022. Findings Include: 1. On the day of survey, March 22, 2023, review of three of four testing personnel CA records revealed: - TP#2 circled for May 2022, evaluated 17, May 2022 but not completed until May 10, 2023. - TP#3 circled for May 2022, evaluated 23, May 2023 but completed May 23, 2022. - TP#1 circled for May 2022, evaluated 17, May 2023 and completed May 23,2023. - TP#1 circled for September 2022, evaluated 09, September 2023 and completed September 08,2023. - TP#3 circled for September 2022, evaluated 19, September 2023 and completed September 19,2023. 2. TP#1 confirmed the findings above on March 22, 2023 around 10:00 am. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competency assessment (CA) records, review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview with TP#1, the technical consultant (TC) failed to document blind testing/ PT performance for two of threeTP in 2022. Finding Include: 1. The laboratory Procedure manual and Quality Assessment Plan states, "Personnel competency assessment will be conducted three times a year on the same schedule as our PT ". 2. On the day of survey, March 22, 2023 review of three TP competency records revealed, all three testing personnel were evaluated and dated for the blind testing/ PT performance for CBC testing on the hematology analyzer. 3. Review of MLE records revealed TP#1 was the only testing personnel attesting to the performance of PT since Event 2 of 2022. 4. TP#1 could not provide documentation showing the performance of blind testing for TP#2 and TP#3. 5. TP#1 confirmed the findings above on March 22,2023 around 10:45 am. -- 4 of 4 --

Summary Statement of Deficiencies D0000 . An unannounced CLIA off-site proficiency testing (PT) desk review for Delgiacco Medical was conducted on November 4, 2022 by a federal surveyor from the Centers for Medicare and Medicaid Services, CLIA New York Operation Branch. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. . 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 an off-site review of the CASPER 0153D report (Unsuccessful proficiency testing report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing (PT) organization Medical Laboratory Evaluation (MLE),the laboratory failed to achieve satisfactory 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 -- performance of at least 80% for two out of three (first and third) consecutive MLE PT events for the analyte Hemoglobin (HGB) which is in the specialty of Hematology in 2022. Findings include: Please refer to D2130. . 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 an off-site review of the CASPER 0153D report (Unsuccessful proficiency testing (PT) report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to achieve satisfactory performance of at least 80% for two out of three (first and third) consecutive MLE PT events for the analyte Hemoglobin (HGB) which is in the specialty of Hematology in 2022. Findings Include: 1. Based on an offsite PT desk review performed on November 4, 2022, around 12:30 pm and review of the CASPER 0153D, 0155D, and MLE proficiency testing evaluation reports, the laboratory failed to achieve satisfactory scores for the following two out of three consecutive events in 2022: a. Analyte: 0795 HGB: i. MLE 2022 - 1st event - 0%. ii. MLE 2022 - 3rd event - 40%. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing (PT) desk review for Delgiacco Medical was conducted on July 19, 2022 by a federal surveyor from the Centers for Medicare and Medicaid Services, CLIA New York Operation Branch. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. 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 an off-site review of the CASPER 0153D report (Unsuccessful proficiency testing report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing (PT) organization Medical Laboratory Evaluation (MLE), the laboratory failed to achieve satisfactory 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 -- performance of at least 80% for two out of three consecutive events for the analyte Hematocrit (HCT) which is in the specialty of Hematology for the first and second testing events in 2022. Findings include: Please refer to: - D2130 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 an off-site review of the CASPER 0153D report (Unsuccessful proficiency testing (PT) report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to achieve satisfactory performance of atleast 80% for two out of three consecutive events for the analyte Hematocrit (HCT) which is in the specialty of Hematology for the first and second testing events in 2022. Findings Include: 1. Based on an offsite PT desk review performed on July 19, 2022 at 11:00 am and review of the CASPER 0153D, 0155D, and MLE proficiency testing evaluation reports, the laboratory failed to achieve satisfactory scores for the following two out of three consecutive events in 2022: a. Analyte: 0785 HCT: i. MLE 2022 - 1st event - 0%. ii. MLE 2022 - 2nd event - 60%. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of documentation and confirmation by the laboratory director, the laboratory failed to follow its polices and procedures for assessing the competency of three of four testing personnel responsible for patient testing using the Coulter AcT 5 hematology analyzer. 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 --