Ideal Option Pllc

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 record review and interview with the laboratory director the morning of the survey, the laboratory did not have documentation showing that the clinical consultant had a competency check performed for duties assigned. Findings: 1. The laboratory did not have written documentation showing that the clinical consultant had a competency check performed during the previous year; and 2. This was confirmed during interview with the laboratory director. 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 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: A. Based on record review, the laboratory did not have the laboratory director review and approve verification studies for pH and buprenorphine precision studies. The precision study worksheets for these two analytes included a place to document the laboratory director review and approval of the study results and the "accepted by" line on the worksheet was not filled in. B. Based on record review, the laboratory did not have the laboratory director review and approve verification studies for pH and creatinine method validation studies. The method validation study worksheets for these two analytes included a place to document the laboratory director review and approval of the study results and the "accepted by" line on the worksheet was not filled in. D5783