Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of procedures manuals and proficiency testing (PT) records and interview with the technical supervisor (TS); the individual testing the samples and the laboratory director did not sign the attestation statement. Findings include: 1. Review of PT records revealed that testing personnel and laboratory director or designee did not sign the PT statement attesting that PT samples were tested in the same manner as patient specimens for the 1st, 2nd, and 3rd PT events of 2018. 2. During survey date 01/29/2019 at 10:30 AM, the TS confirmed the surveyor's findings. 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 review of laboratory policies, procedures, personnel records and interview with the laboratory director (LD); the laboratory failed to establish written policies and procedures to assess employees' competency assessments. Findings include: 1. Review of laboratory policies and procedures revealed that there were no laboratory's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- process for assessing the competency of personnel or documentation to show that competency assessments were performed on the following personnel: a. Laboratory Director b. Clinical Consultant c. Technical Supervisor/Technical Consultant d. General Supervisor 2. During survey date at 3:00 PM on 01/29/19, the LD confirmed the surveyor's findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory policies, procedures, personnel records and interview with the laboratory director; the laboratory failed to have a director who provides overall management in accordance with 493.1445 of this subpart. Findings include: 1. The laboratory failed to establish and maintained a quality control program that assures quality of laboratory services provided and to identify failures in quality as they occur. See D6093. 2. The laboratory director failed to ensure that testing personnel were qualified and competent to perform all laboratory services provided. See D6102 and D6103. 3. The laboratory director failed to ensure that an approved procedures manual was available to all testing personnel. See D6106. 4. The laboratory director failed to assign personnel to their positions (titles) held in the laboratory, as well as assign which tests each individual is authorized to perform. See D6107. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review laboratory policies, procedures, quality control (QC) records and interview with the technical supervisor; the laboratory director failed to ensure that the quality control programs are established and maintained to identify failures in quality as they occur. Findings include: 1. Review of the laboratory's policies and procedures revealed that the laboratory's control procedures did not include the following: a. Type of control (e.g., manufacturer or in-house, electronic); b. Identity (e.g., normal, abnormal, level I, II, patient or a control); c. Number and frequency of testing controls; d. Control limits established by the laboratory e. Criteria to determine acceptable control results. f.