James Haines Md & William Belcastro Md

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 record review and interview with the technical Consultant (TC) and Laboratory Director (LD) the laboratory failed to ensure proficiency testing (PT) was rotated amongst all testing personnel (TP) in the specialty of Hematology. Findings include: 1. Record review on 4/11/2024 of the laboratory's 2022 and 2023 American Proficiency Institute (API) Hematology/Coagulation PT records revealed, one of three TP (TP3) did not run PT samples in 2022 or 2023. 2. Record review on 4/11/2024 of the laboratory's 2022 and 2023 competency assessment records for TP3, revealed: a. The section referring to PT performance was checked off as completed. b. The form was signed as complete by the TC. 3. Staff interview on 4/11/2024 at 3:00 PM with the TC and LD confirmed TP3 did not participate in PT in 2022 and 2023, yet it was marked as completed on TP3's 2022 and 2023 competency form. TC also confirmed TP3 did not run an internal blind or previously analyzed specimen in 2022 and 2023. 4. The laboratory performs 6,534 tests annually in the specialty of Hematology. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) Chemistry Core Proficiency Testing (PT) records and interview with the technical consultant (TC) and Laboratory Director (LD) the laboratory failed to attain an overall testing event score of at least 80 percent leading to unsatisfactory performance in the specialty of Chemistry. Findings include: 1. Record review on 4/11/2024 of the laboratory's 2022, 2023 and 2024 to date API Chemistry Core PT records revealed: a. 2022 Event 3 - The laboratory received a score of 20% for the regulated analyte Cholesterol Total. The laboratory only repeated results and did not investigate or employ

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the James Haines, MD & William Belcastro, MD laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 record review and interview, the laboratory failed to perform calibration verification as appropriate as evidenced by the following: Envoy 500 chemistry 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 -- analyzer: a) A review of quality control records for calendar years 2020, and 2021 was performed. The review revealed that calibration verifications of at least 3 points were not performed once every six months for all twenty one (21) of twenty one (21) routine chemistry analytes performed on the analyzer. Calibration verification documentation showed that calibration verifications had only been performed once on 12/30/20 for the two year time period reviewed. b) The designated technical consultant (refer to D6033) interviewed on 1/26/22 at 9:50 AM confirmed that calibration verifications of at least 3 points had not been performed at least once every six months for the twenty one (21) analytes performed on the analyzer. . D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on document review and interview the laboratory failed to have a individual qualified under 493.1411 - Technical Consultant Qualifications to fulfill the duties and responsibilities as evidenced by the following: On the day of the survey a review of the CLIA personnel listing revealed that the designated technical consultant did not have the requisite educational experience to qualify for the position. Interview with the designated technical consultant on 1/26/22 at 10:20 AM revealed that she did not have a bachelors degree in a chemical, physical, or biological science. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on observation, record review and interview, a qualified technical consultant failed to maintain documentation to verify the competency evaluation of the staff through review of quality control records as evidenced by the following: Quality Control: a) During the time of the survey a request was made to review cumulative quality control records for calendar years 2020 and 2021. It was observed on 1/26/22 at 10:16 AM that the designated technical consultant (refer to D6033) was printing out cumulative quality control data from the laboratory's information system. When asked if there was documentation of quality control reviews the designated technical consultant replied that she only reviews the quality control data on the screen and that the reviews were not documented. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the James Haines, MD & William Belcastro, MD laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify at least twice annually procedures it performs that are not included in subpart I of this part as evidenced by the following: a) A review of calendar years 2018 and 2019 (six testing events) proficiency testing records revealed that the laboratory had received an unacceptable score of zero (0)% for C-reactive protein for the first testing event of 2018 and a score of fifty (50)% for C-reactive protein for the second testing event of 2018. b) Based on the two unacceptable scores the laboratory had not demonstrated twice annual accuracy for the C-reactive protein analyte. c) The technical consultant interviewed on 12/6/19 at 9:20 AM was asked whether any other procedures were performed to verify the accuracy of C-reactive protein test results. She confirmed that no other procedures had been put into place to verify the accuracy of C-reactive protein test results twice annually. 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 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 --