Burzynski Clinic

Summary Statement of Deficiencies D0000 A recertified onsite survey was completed on 07/14/2025. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 the direct observation of the surveyor, review of manufacturer's packages and package insert, the laboratory's temperature log, random review of the laboratory's temperature logs from June 2024 to August 2024 and May 2025 to June 2025, patient results, and confirmed in an interview, the laboratory failed to store 3 of 3 i-STAT materials according to manufacturer's instructions for 25 of 153 days reviewed on i- STAT analyzer (SN: 416390). The findings were: 1. The surveyor's direct observation on 7/17/2025 at 12:15 pm in the IV room, the refrigerator revealed storing i-STAT CHEM8+ cartridges and 2 levels of i-STAT Tricontrols. i-STAT CHEM8+ Cartridges Lot#: H25048 Exp.2025-08-16 i-STAT TriControl 1 Lot#: 301179 Exp. 2025-11-30 i- STAT TriControl 3 Lot#: 321179 Exp. 2025-11-30 2. Further review of i-STAT Tricontrol packages revealed the temperature requirement was from 2-8C (35-46F). 3. Review the manufacturer's package insert titled i-STAT CHEM8+ Cartridges (Rev. 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 -- Date: 06-Nov-2020 Art: 765859-01 Rev. B) under Storage Conditions revealed "Refrigeration at 2-8C (35-46F) until expiration date." 4. Random review of the laboratory's temperature logs from June 2024 to August 2024 and May 2025 to June 2025 revealed 25 of 153 days reviewed were out of the temperature ranges according to the manufacturer's instructions. 06/12/2024 8.4C 06/13/2024 8.6C 06/18/2024 8.6C 06/19/2024 8.2C 06/20/2024 8.2C 06/24/2024 8.9C 06/26/2024 8.6C 07/03/2024 8.9C 07/17/2024 8.9C 08/01/2024 8.1C 08/12/2024 8.5C 05/29/2025 9.9C 05/30/2025 10.1 C 05/31/2025 9.9C 06/02/2025 10.2C 06/04/2025 8.2C 06/05/2025 8.2C 06/06/2025 8.3C 06/07/2025 8.2C 06/09/2025 8.2C 06/10/2025 8.1C 06/11/2025 8.1C 06/14/2025 8.1C 06/17/2025 8.2C 06/24/2025 8.1C 5. Review of the laboratory's patient results for the above dates revealed the laboratory performed 10 tests on i-STAT analyzer. 06 /12/2024 MRN#: 27391 06/12/2024 MRN#: 27397 06/18/2024 MRN#: 27391 06/18 /2024 MRN#: 26886 06/18/2024 MRN#: 27400 06/20/2024 MRN#: 27391 06/20 /2024 MRN#: 27400 06/26/2024 MRN#: 27400 06/24/2024 MRN#: 27391 06/24 /2025 MRN#: 27400 6. An interview on 07/17/2025 at 12:30 pm in the lab, the technical consultant (indicated on the CMS 209 form) confirmed the above findings. **This is a repeated deficiency** Key: C=Celsius F=Fahrenheit CMS=Center for Medicare and Medicaid Services D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209 form, the personnel's competency assessment records, and confirmed in an interview, the technical consultant failed to evaluate and document at least twice of competency assessments during the first year for 1 of 6 TP performing moderate complexity testing. The findings were: 1. Review of the laboratory's CMS 209 form, Laboratory Personnel Report (CLIA), signed by the laboratory on 07/13/2025, revealed the laboratory identified 6 TP performing moderate complexity testing. 2. Review of the laboratory's competency assessment records revealed the technical consultant failed to evaluate and document at least twice of competency assessments during the first year for 1 of 6 TP performing moderate complexity testing. TP#5 Hired date: 08/01/2023 Missing 1st annual competency assessment. 3. An interview on 07/17/2025 at 11:30 am in the lab, the technical consultant (indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services TP=Testing personnel D6061 CLINICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1419(c) (c) Ensure that reports of test results include pertinent information required for specific patient interpretation; and This STANDARD is not met as evidenced by: Based on the review of the laboratory's validation records for DxH 520 hematology analyzer, random review of the patient CBC fianl reports, and confirmed in an interview, the clinical consultant failed to ensure the correct reference ranges were on -- 2 of 3 -- the CBC patient final reports for 7 of 7 patients reviewed. The findings were: 1. Review the laboratory's validation records for Beckman Coulter DxH 520 hematology analyzer (SN:BG010034) , signed by the laboratory director on 12/12/2023, revealed DxH 520 reference ranges were verified as follows. WBC 3.71-10.67 x 10^3 ul RBC 3.87-5.68 x 10^6 ul HGB 12.00-16.75 g/dl Platelet 150.5-366.8 x 10^3 uL 2. An interview on 07/17/2025 at 12:45 pm in the lab, the technical consultant (indicated on the CMS 209 form) confirmed 4 direct measured analytes were WBC, RBC, HGB, and Platelets on DxH 520. All other analytes were calculated based on those 4 analytes. 3. Random review of the laboratory's CBC patient final reports performed on DxH 520 revealed 7 of 7 patient final report direct measured analytes reference ranges were different from the reference ranges obtained from validation records. CBC performed date: 01/22/2024 MRN#: 27301 Reference ranges on the report: WBC 3.77- 11.03 x 10^3 ul RBC 3.83-5.06 x 10^6 ul HGB 11.59-15.11 g/dl Platelet 169.1-368.3 x 10^3 uL CBC performed date: 06/03/2024 MRN#: 26884 Reference ranges on the report: WBC 3.77-11.03 x 10^3 ul RBC 3.83-5.06 x 10^6 ul HGB 11.59-15.11 g/dl Platelet 169.1-368.3 x 10^3 uL CBC performed date: 06/02/2025 MRN#: 27579 Reference ranges on the report: WBC 3.53-9.52 x 10^3 ul RBC 4.33-5.72 x 10^6 ul HGB 12.55-16.99 g/dl Platelet 146.5-351.5 x 10^3 uL CBC performed date: 06/04 /2025 MRN#: 27539 Reference ranges on the report: WBC 3.53-9.52 x 10^3 ul RBC 4.33-5.72 x 10^6 ul HGB 12.55-16.99 g/dl Platelet 146.5-351.5 x 10^3 uL CBC performed date: 06/09/2025 MRN#: 27595 Reference ranges on the report: WBC 3.77- 11.03 x 10^3 ul RBC 3.83-5.06 x 10^6 ul HGB 11.59-15.11 g/dl Platelet 169.1-368.3 x 10^3 uL CBC performed date: 06/23/2025 MRN#: 27607 Reference ranges on the report: WBC 3.77-11.03 x 10^3 ul RBC 3.83-5.06 x 10^6 ul HGB 11.59-15.11 g/dl Platelet 169.1-368.3 x 10^3 uL CBC performed date: 07/01/2025 MRN#: 27555 Reference ranges on the report: WBC 3.53-9.52 x 10^3 ul RBC 4.33-5.72 x 10^6 ul HGB 12.55-16.99 g/dl Platelet 146.5-351.5 x 10^3 uL 4. An interview on 07/17/2025 at 2:05 pm in the lab, the technical consultant (indicated on the CMS 209 form) confirmed the above findings. Key: CBC=Complete Blood Count WBC=White blood cell RBC=Red blood cell HGB=Hemoglobin CMS=Center of Medicare and Medicaid Services -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records for 2021, 2022 and 2023, laboratory's policies/procedures and staff interview, the laboratory failed to retain all PT documents for 1 of 10 PT events reviewed as per laboratory's protocols. Findings included: 1. Review of laboratory's PT records for 2021, 2022 and 2023 revealed the following 1 of 10 reviewed PT events did not have documentation of signed attestation statement or review of PT performance evaluation: American Proficiency Institute 2022 Chemistry - Core - 2nd Event 2. Review of laboratory's "Proficiency Testing Policy" (last revised 12/07/2021) revealed: "The proficiency report is to be signed by testing personnel, secondary reviewer and the Lab Director. This form is to be placed with instrument printouts, or copies of worksheets, and maintained in the laboratory for at least two years." 3. In an interview on 06/29/2023 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- at 1405 hours in the patient treatment room number three, the laboratory's Technical Consultant (as indicated on submitted form CMS 209) confirmed the above documents could not be located for review. Key: CMS - Centers for Medicare and Medicaid D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records for 2021, 2022 and 2023, laboratory's policies/procedures and staff interview, the laboratory failed to document

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 proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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 review of the CMS database and verified with the 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 3 -- records, the laboratory failed to successfully participate in a proficiency testing program for the analyte Sodium (NA). Refer to 2096. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records from 2021 and 2022, the laboratory failed to achieve satisfactory performance for the analyte Sodium (NA) for two of three testing events in 2021 and 2022, resulting in unsuccessful performance for Sodium. Findings include: 1. Review of the CMS database revealed the laboratory received unsatisfactory scores (less than 80%) for NA in 2021 and 2022. 2021 3rd event - 0% 2022 2nd event - 40% 2. Review of the API results from 2021 and 2022 confrimed the laboratory received the above scores for Sodium. 2021 API Chemistry 3rd event 0% (failure to participate) 2022 API Chemistry 2nd event 40% CH-06 - lab result 147 mmol/L (acceptable range 150-159) CH-07 - lab result 117 mmol/L (acceptable range 118-127) CH-10 - lab result 147 mmol/L (acceptable range 148-157) 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the analyte Sodium. Refer to 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 proficiency testing results it was revealed that the -- 2 of 3 -- laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 3 of 3 --