College Recovery Llc

Summary Statement of Deficiencies D0000 The survey conducted on October 19, 2021 found the laboratory in compliance with 42 CFR part 493 Requirements for Laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material and interview with the Testing Personnel (TP), the laboratory had expired QC material for Toxicology tests run on the AMS Liasys 450 from 7/24/21 to the date of the survey. The findings include: 1. Reagents were expired as follows: a. AMS Ecstasy Control 1 & 2 Lot 206081 expired 7/24/21 b. AMS Opiate Control 1& 2 Lot 196111 expired 8/9 /21 2. Approximately 30 patients per week were run and reported. 3. The TP confirmed on 10/19/21 at 1:50 am that the laboratory used expired QC. 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 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 -- 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: -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing records and interview with the Testing Personnel (TP), the laboratory failed to evaluate coded results obtained for Urine Drug proficiency testing event performed with the American Proficiency Institute. The findings include: 1. The laboratory did not evaluate 'Not Graded' grade achived for event 3 of 2016 sample #s UAD 05 and 06. 2. The TP confirmed on 11/15 /18 at 1:00 pm that the laboratory failed to evaluate coded results. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Reports (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that Urine Drug tests FR had accurate 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 -- information from 2/21/17 to the date of survey. The finding includes: 1. The laboratory reported units of measurements with qualitative urine drug results. 2. The laboratory did not report cut-off values for urine drug tests. 3. The TP confirmed on 11 /15/18 at 12:45 pm that the FR did not include accurate information. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of Final Reports (FR) and interview with the Testing Personnel (TP), the laboratory failed to report Reference Range (RR) for all Urine Drug tests from 2/21/17 to the date of survey. The TP confirmed on 11/15/18 at 1:15 pm that RR was not on the FR. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require