Global Diagnostic Labs, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) survey was completed on September 9, 2020. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records and an interview with the Laboratory Director (LD), the laboratory failed to enroll in a CMS-approved proficiency test (PT) program or peer review as required by Clinical Laboratory Improvement Amendments (CLIA) for the specialty of General Immunology from October 2018 through September 2020. The findings include: 1. Review of laboratory PT records revealed the laboratory was not enrolled in a PT program or peer review for the specialty of General Immunology from October 2018 through September 2020. 2. The laboratory did not have any PT records or peer views for their allergen assay. 3. The Laboratory Director confirmed on 09/09/2020 at 10:30 AM in the conference room, that the facility was not enrolled in a CMS- approved PT program or peer review for the specialty of General Immunology. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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: Based on surveyor review of laboratory records and interview with the laboratory supervisor, the laboratory failed to retain quality control, proficiency test, and maintenance records from October 2018 through September 2020. The findings include: 1. The laboratory had no records of their proficiency test or peer review data for their allergen assay. 2. The laboratory was unable to provide quality control data for all test performed in the laboratory.. 3. The laboratory was unable to provide maintenance records for all laboratory equipment. 4. An interview with the Laboratory Director in the conference room on 09/09/2020, at 11:30 AM, confirmed that the laboratory did not maintain quality control, proficiency test, and maintenance records for October 2018 through September 2020. 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: A review of the personnel records and interview with the testing personnel (TP), determined that the laboratory failed to establish a written policy that assess employee competency for their allergen assay performed in the laboratory from their allergen test assay. The findings include: 1. The laboratory failed to have a written policy and procedure to assess competency based on the position responsibilities on an initial, semi-annual, and annual bases. 2. An annual competency assessment was not performed for any of the staff from October 2018 through September 2020 for their allergen assay. 3. An interview with the Laboratory Director in the conference room on September 9, 2020, at 11:30 AM, confirmed that the laboratory did not have a written policy for assessing employee competency for the test performed in the laboratory. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Laboratory Director, the laboratory failed to establish a written quality assessment (QA) to -- 2 of 6 -- monitor, assess, and correct problems in the general laboratory system for quality assessment. The laboratory did not have a written quality assessment policy that encompasses all facets of the laboratory's technical and non-technical functions. 1. The laboratory failed to have a QA that assess patient confidentially, specimen integrity and identification, complaint,

Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on September 25, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 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: 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 -- Based on hematology calibration review and staff interview, the laboratory failed to perform instrument calibrations every six months as required. Findings include: 1. Beckman Coulter AcT5 Diff (hematology analyzer) calibration document review revealed the laboratory did not perform required instrument calibration between 10/24 /17 and 9/10/18. 2. An interview with Staff #2 (CMS 209) on 9/25/18 in a conference room at approximately 3:00 p.m. confirmed the aforementioned hematology analyzer calibration was not performed. 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 reference laboratory test report review and staff interview, the laboratory failed to properly identify the reference laboratory performing patient testing. Findings include: 1. Reference laboratory test report review revealed the report did not contain the name, address, or laboratory director (LD) of the reference laboratory where the test was performed. 2. The reference laboratory report contained the name, address, and LD of the survey facility only. 3. An interview with Staff #4 (CMS 209) on 9/25/2018 at approximately 3:00 p.m. in a conference room confirmed the reference laboratory report did not contain the name or address of the reference laboratory nor the name of the reference laboratory LD. -- 2 of 2 --