Yacht Haven Family Practice

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) CLIA federal surveyor conducted an announced CLIA recertification survey at Yacht Haven Family Practice on June 13, 2023. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following deficiency was found during the announced routine CLIA recertification survey performed on June 13, 2023. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the laboratory failed to maintain a copy of a laboratory procedure for at least two years after the procedure was discontinued. Findings include: 1. Interview with the laboratory director on 06/13/2023 at 12:00 PM, confirmed the laboratory discontinued Complete Blood Count (CBC) testing performed on the Horiba ABX Micros 60 on 06/10/2022. 2. Record review on 06/13/2023 revealed the laboratory failed to maintain a copy of the CBC procedure after the procedure was discontinued. 3. Interview with the laboratory director on 06/13/2023 at 12:10 PM confirmed the findings indicated above. 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 D2128 HEMATOLOGY CFR(s): 493.851(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 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 proficiency testing results and laboratory director interview, the laboratory failed to take and document remedial action for proficiency testing (PT) failures for 5 of 16 test analytes reviewed on the AAFP 2021-A testing event for Hematology. Findings include: 1) Review of the AAFP 2021-A shows the following PT failures: a) Sample HD5- Lymphocyte in percent- result submitted- 1.2. PT evaluation- Fail b) Sample HD2- Monocyte/Mixed in percent- result submitted- 0.5. PT evaluation- Fail c) Sample HD2- Red Blood Cell Count- result submitted- 2.23. PT evaluation- Fail d) Sample HD2- Hemoglobin- result submitted- 6.5. PT evaluation- Fail e) Sample HD2- Hematocrit- result submitted- 16.7. PT evaluation- Fail 2) Surveyor requested remedial and or

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on interview with technical consultant and review of quality control records, the laboratory failed to perform external control procedures for the urine pregnancy test, using Icon25 test system, since the discontinuance of the use of serum sample in 2018. 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 interview with the technical consultant at around 11:30 am and review of Proficiency testing records, the laboratory failed to participate in 3rd event of 2017 for 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 -- the hematology specialty. The laboratory was unable to recover documentation of participation during the recovery time after natural disasters that hit St. Thomas USVI. -- 2 of 2 --