Summary:
Summary Statement of Deficiencies 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 review of the laboratory's procedure manuals and interview with testing personnel, the laboratory failed to establish and follow written policies and procedures for monitoring, assessing, and correcting problems identified as required in general laboratory systems. Findings: 1. Review of the binder titled "Policy and Procedure Manual" found no written policy, procedure, or documentation for the monitoring and assessment of general laboratory systems, which includes confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing evaluation. 2. Interview with Testing Personnel #1 (TP1) on 4/25/2019 at approximately 1255 confirmed that there is no written policy for performing quality assessment of the general laboratory systems components. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. 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 3 -- Based on review of the laboratory's procedure manuals and interview with testing personnel, the laboratory failed to establish and follow written policies and procedures for monitoring, assessing, and correcting problems identified in the preanalytic system, as required. Findings: 1. Review of the binder titled "Policy and Procedure Manual" found no written policy, procedure, or documentation for the monitoring and assessment of the preanalytic system, which includes the following: test request and specimen submission, handling, and referral. 2. Interview with Testing Personnel #1 (TP1) on 4/25/2019 at approximately 1255 confirmed that there is no written policy for performing quality assessment of the preanalytic system. 3. Per TP1, preanalytic checks are done on a monthly basis. TP1 was unable to provide documentation of these monthly checks. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manuals and interview with testing personnel, the laboratory failed to establish and follow written policies and procedures for monitoring, assessing, and correcting problems identified in analytic systems, as required. Findings: 1. Review of the binder titled "Policy and Procedure Manual" found no written policy, procedure, or documentation for the monitoring and assessment of the analytic system, which includes the following: procedure manual, test systems/equipment/supplies, establishment and verification of performance specifications, maintenance and function checks, calibration and calibration verification procedures, control procedures, comparison of test results,