Beach Care Pllc

Summary Statement of Deficiencies D0000 An onsite complaint visit, #2020003843 was conducted on 06/23/20 at Beach Care PLLC. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on CLIA records reviewe and interview, the laboratory failed to notify to the proficiency testing Agency that the laboratory was not testing before the due date to submit the proficiency testing results for 1 out of 1 event for Routine Chemistry (3rd event 2019). Findings include: Record review revealed the laboratory was enrolled in proficiency testing with American Academy of Family Physician. Review of CLIA Casper report 096 CLIA Application and Summary revealed a score of 0% for Arterial blood pH (PH Blood Gas), Partial pressure Oxygen (PO2), Partial pressure Carbon dioxide (PCO2), Chloride (CL), Creatine Kinase Total, Creatine Kinase (CK) Iso, Creatine, Glucose, Potassium (K), Serum Sodium(NA), Blood Urea Nitrogen (BUN) and an overall score of 0 % for Routine Chemistry for the 3rd event of 2019. During an interview on 6/23/2020 at 2:30 PM, the owner confirmed that the laboratory failed to notify to the proficiency testing agency that the laboratory was not testing within the timeframe for the event of reference. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a 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 -- 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 CLIA records review and interview, the laboratory failed to notify to the proficiency testing Agency that the laboratory was not testing before the due date to submit proficiency testing records for 1 out of 1 event for Hematology (3rd event 2019). Findings include: Record review revealed the laboratory was enrolled in proficiency testing with American Academy of Family Physician. Review of CLIA Casper report 096 CLIA Application and Summary revealed a score of 0% for platelet and an overall score of 0 % for the Hematology 3rd event of 2019. During an interview on 6/23/2020 at 2:30 PM, the owner confirmed that the laboratory failed to notify to the proficiency testing agency that the laboratory was not testing within the timeframe for the event of reference. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial certification survey conducted at Beach Care LLC; on 8/12/2019 found that the laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview with Technical Consultant (TC), it was found that the instrument verification for Istat and Abaxis Piccolo analyzers was incomplete. Findings include: Record review of performance verification revealed that: - For Istat analyzer, for Cardiac markers, there was no documentation of the accuracy and precision evaluation. - For Abaxis Piccolo analyzer performance, for Comprehensive Metabolic Panel, there was no documentation of the accuracy and precision evaluation. During an interview on 8/12/19 at 11:30 AM, the TC acknowledged that there was no validation for the equipment of above-reference. 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 --