Cd Laboratories, Inc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Associates of Bioanalyst (AAB) proficiency testing (PT) program, the laboratory failed to successfully participate in the AAB PT program for bacteriology testing, in which the laboratory is certified under CLIA. (Refer to D2028) D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Associates of Bioanalyst (AAB) proficiency testing (PT) program, the laboratory failed to successfully participate in the AAB PT program for bacteriology testing, in which the laboratory is certified under CLIA. The following analyte was noted as failed in the 1st and 2nd event 2020. Findings: 1. American Association of Bioanalysts 2020 2nd event Bacteriology 0% 2. American Association of Bioanalysts 2020 1st event Bacteriology 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Associates of Bioanalyst (AAB) proficiency testing (PT) program, the laboratory director failed to ensure that the laboratory successfully participate in the AAB PT program for bacteriology testing, in which the laboratory is certified under CLIA. (Refer to D2028) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory 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) 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 the proficiency testing (PT) results and interview with the quality assurance manager, the laboratory did not investigate and correct problems associated with a PT failure. Findings: 1. The laboratory PT records for Q1 Gram Stain shows a score of 80%. The records showed that there was no documented investigation of the failure of the gram stain. 5. During the survey on 11/29/18 at 5:30 PM the quality assurance manager confirmed that there was no investigation of the PT failures. D2116 TOXICOLOGY CFR(s): 493.845(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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) results and interview with the quality assurance manager, the laboratory did not investigate and correct problems associated with a PT failure. Findings: 1. Review of the PT results for Q1 Chemistry 2018 showed that the laboratory did not investigate and correct problems associated with an unsatisfactory PT result. 2. The laboratory's PT records show a score of 100% for Entailing. Review of the actual results show that sample number 3 was recorded as 6.6 with an acceptable reference range of 7.5-12.6. Sample number 4 was recorded as 11 with an acceptable reference range of 3.5-5.8. 3. The laboratory's PT records show a score of 100% for Lithium. Review of the actual results show that sample number 4 was recorded as 2.1 with an acceptable reference range of 0.5-1.1. 4. The results were coded with a # sign. The # code lists the following comment- "This method was not graded due to an insufficient number of peer respondents. No appropriate default grouping was available. The listed range should provide a reasonable guide to your performance. However, exercise caution in evaluating your results." 5. During the survey on 11/29/18 at 5:30 PM the quality assurance manager confirmed that there was no investigation of the PT failures. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: I. Based on quality control (QC) record review and interview with the laboratory staff, the laboratory did not retain chemistry QC records for at least 2 years. Findings: 1. A review of chemistry QC from July to November, 2018 showed that QC was rarely out of range. During an interview at 11:45 AM, the testing person stated that "QC is reviewed weekly" and that they "don't keep bad QC because it skews the averages." The testing person stated that they delete the out of range QC and only save the "good" QC. 2. The testing person stated that the DXI 600 chemistry analyzer does not print out the QC when run and that the analyzer does not save QC data older than 90 days. 3. During an interview on 11/29/18 at 11:45 AM, the laboratory staff confirmed that the laboratory did not retain chemistry QC records for at least 2 years. II. Based on quality control (QC) record review and interview with the laboratory staff, the laboratory did not retain urinalysis QC records for at least 2 years. Finding: 1. A review of urinalysis QC from January to October, 2018 showed that there was no out of range QC or