Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) complaint survey was completed on July 2, 2019. 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: D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's policies and procedures, and interview with the blood bank supervisor, the laboratory failed to report blood bank occurrences for distributed blood or blood products as required by the Food and Drug Administration (FDA). The findings include: 1. The facility did not follow their Error Management policy 705-011 for reporting blood bank errors, variances, and accidents to the FDA. Policy guideline states "crossmatch unit tag or label had incorrect or missing information.". The laboratory did not report on 5/5/19 that a crossmatch unit tag was missing information and the sample had identification errors. 2. The blood bank supervisor confirmed on 7/2/19, at 11:00 AM, in the conference room, that the laboratory was not reporting all blood bank errors, variances, and accidents for blood and blood products. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the 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 -- laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of the Immunohematology records, patient records, and interviews with the laboratory's blood bank supervisor and laboratory director, the laboratory failed to meet applicable requirements in specialty of Immunohematology. (Refer to D5553) D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's polices and procedures and interview with the blood bank supervisor, the laboratory failed to address and document problems that occurred when a breakdown in communication arose between the nursing staff and the laboratory for emergency release of blood. The findings include: 1. The laboratory's protocol for emergency release of blood indicates that the laboratory must have a "statement signed by the requesting physician indicating that the clinical situation was sufficiently urgent enough to require the emergency release of blood". 2. The nursing staff's protocol indicates that only a verbal order to the blood bank for the emergency release of blood is required. 3. The laboratory's protocol conflicts with the nursing staff's protocol for the authorization request for the emergency release of blood for a verbal or written confirmation. The conflicting protocols for the authorization of emergency blood release confirms a breakdown in communication between the nursing and laboratory departments. 4. The blood bank supervisor confirmed on 7/2/19, at 11:00 AM in the conference room, that the laboratory's protocol for emergency release conflicts with the nursing staff's protocol for emergency release. 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 surveyor review of laboratory personnel records and interview with the blood bank supervisor (BBS), it was determined that the laboratory failed to assess employee competency for the blood bank supervisor for the specialty of Immunohematology. The findings include: 1. The laboratory had no record of a competency assessment for the BBS for the 2017 and 2018 for the specialty of Immunohematology. 2. A supervisory performance assessment was performed for the BBS in 2018 but did not encompass laboratory testing competency for Immunohematology. 3. The BBS confirmed on 07/01/19, at 11:30 AM, in the -- 2 of 4 -- conference room, that a competency assessment was performed by the Technical Supervisor but she did not have access to those records. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of