Karen M. Byrne, Ernest G. Frank, Lauren A. Gedman, Julie R. Ivey, They’re Here! How to Prepare Your Blood Bank for Inspection, Laboratory Medicine, Volume 46, Issue 1, Winter 2015, Pages e2–e6, https://doi.org/10.1309/LMIGNO604GBVAMGM
Navbar Search Filter Mobile Enter search term Search Navbar Search Filter Enter search term SearchThe importance of an inspection ready blood bank cannot be overemphasized. Various agencies perform inspections to ensure that facilities are compliant with federal and state regulations, as well as with standards defined by professional organizations. Inspections may strike fear into the staff members of the organizations being inspected. When a laboratory is in a state of constant readiness, such anxiety is likely to be lessened. Facilities may differ in structure and size and yet be held to the same standards. This article discusses the who, when, and why of laboratory safety inspections. We share helpful information gathered from various resources, including interviews with a quality assurance specialist, a blood bank manager, and an assessor, to help facilities work towards an inspection ready state.
If a clinical laboratory is performing tests on specimens derived from humans to provide information for the diagnosis, prevention, treatment and assessment of disease, the laboratory is subjected to the tenets of the Clinical Laboratory Improvement Amendments (CLIA). When a laboratory performs a clinical test, the test method is categorized into 3 levels of complexity: waived, moderate, and high. The more complicated the test, the more stringent the requirements. 1 CLIA establishes quality standards and stipulates that laboratories performing CLIA regulated tests are to be certified by the Secretary of the United States (US) Department of Health and Human Services (DHHS). CLIA standards are applied nationwide to all health care providers that render clinical testing services, regardless of whether Medicare claims are filed by a given institution.
Successful participation in an approved proficiency testing program is a condition for CLIA certification. CMS has granted deeming authority to several accrediting agencies, such as the AABB (formerly known as the American Association of Blood Banks) and the College of American Pathologists (CAP). This means that the inspection processes of these organizations will evaluate compliance with CLIA quality standards. AABB and CAP have similar fundamental goals in setting standards and upholding practices to ensure the safety of patients and donors regarding traditional transfusion medicine and cellular therapies ( Table 1 and Table 2). 4– 6
Agencies That Perform Inspections a
Agencies That Perform Inspections a
Inspection Details for Agencies
Inspection Details for Agencies
When reading about inspections, the various terms used may be confusing. Is an audit or assessment the same thing as an inspection? Will a checklist or an assessment tool be used? What assessment method will the assessor use? Table 3 lists several terms and definitions. Although the agencies use individual terminology, those terms are often used interchangeably. 6–9
Terms Used in Inspections
Terms Used in Inspections
We gathered practical advice from 3 individuals: a quality assurance (QA) specialist, a blood bank manager, and an assessor. We asked each of them, “How would you suggest getting the blood bank inspection ready?” Additional position specific questions were asked to tap into the areas of expertise among those individuals ( Table 4).
Questions Asked to Gather Practical Information to Prepare the Blood Bank for Inspection
Questions Asked to Gather Practical Information to Prepare the Blood Bank for Inspection
The common responses given by those we interviewed reflect recommendations shared by multiple interviewees. One such recommendation was to locate, review, and complete the reference guide that the inspector will use. For example, if the facility is preparing for an AABB assessment, the Assessment Tool provided by the AABB Accreditation Program should be used to evaluate the facility internally. 9 Scheduling these internal audits as a fixed yearly task helps to guarantee their completion. This process may be performed by the internal QA department and/or appointed personnel. After the completion of the internal audit process, the results should be reviewed and findings addressed. Findings on the audit report may lead to additional investigation and possible procedural changes to bring the facility into compliance with a given set of standards. This process serves the purposes of ensuring compliance and ensuring safety, competency, and adherence to standard operating procedures (SOPs).
The second common response was that the physical appearance of a facility is very important: first impressions are critical. The facility should be clean, organized for efficiency, and free of safety violations. Periodically surveying the laboratory can help to maintain a clutter free environment and to identify areas that need attention. All equipment should be clearly identified and have acceptable and readily available calibration records. SOPs should be standardized, reviewed annually, and easily accessible to staff. Procedures should be managed in a controlled manner and should be managed carefully through manual or electronic methods.
The attitudes of the staff are just as important as the appearance of the laboratory. Employees may have a more positive outlook towards the inspection process if they feel well prepared. This may be achieved through employee involvement in the internal audit process and through discussions about appropriate responses to questions posed by the inspector. Remind your employees that it is always proper practice to refer to the SOPs. A facility should have an SOP that addresses how to handle inspections. Items addressed in the SOP include which agencies may inspect the facility, who is notified when an inspector arrives, who chaperones the inspector, and how the staff should interact with inspectors. An external inspection should be less stressful when undertaken by a trained and competent workforce that has been involved with internal preparation processes.
Other helpful tips for inspection preparedness included gathering information about the most common citations reported by the agencies. This information may be available on the Web site of the agency in question and/or addressed in an educational audioconference. 10 Make it a practice to review all past results of external audits and to confirm that all nonconformities have been addressed. Finally, never forget that the blood banking community is a rich source of information. If your organization discovers that one of its processes needs improvement, other blood banks may be willing to share their improvement strategies with your organization. Further, AABB offers to its members a Commendable Practices Library that provides examples of exceptional and novel ways to meet standards. Health care providers don’t need to reinvent the wheel and certainly don’t need to do it alone.
The QA specialist emphasized that a formal QA program is not only required but essential. 8 All staff must be trained in its application, and the facility must document that internal audits of the quality systems have been scheduled and completed. 9 Areas of weakness identified through error reports and complaints, as well as input from management, may be used to determine the scope and depth of the internal audits. QA employees and/or other departmental employees who have auditing experience may perform these audits. A systematic process should be followed: audit scheduled, audit performed, report written and appropriate management personnel must review the written results of the audit report. These reports are effective tools to confirm positive practices and to correct nonconformities. Involving staff in this process builds a sense of teamwork among various departments and diminishes the possible adversarial role of the auditors.
Two functions of the QA specialist are to guide and to act as an interpreter between the blood bank employees and the inspector. This intermediary function is necessary because terms or phrases used internally may not be consistent with those used by inspectors, and vice versa.
Because voluntary laboratory accreditations are expensive, the executive management team should assess the benefits offered by the accrediting agency beyond mere accreditation. For instance, some agencies provide materials that can be used for continuing education and for inspection preparation.
The facility that this blood bank manager oversees is inspected biannually by 3 different agencies, including the AABB, CAP, and FDA, as well as being part of the hospital assessment carried out by The Joint Commission. Review of current regulations, standards, and guidelines; completion of reference guides; continuous training; and adherence to procedures help laboratories to maintain a state of readiness for inspection. Documents such as the AABB crosswalk document that details the intersection between current AABB standards and the CAP checklist are useful tools to help quickly determine regulatory overlap.
CAP inspections for Transfusion Services can be completed in conjunction with AABB assessments. The AABB assessor uses the AABB audit tool and the CAP checklist during the inspection. If a facility uses these guidelines as part of its readiness plan, the inspection targets should not be a surprise. When external inspectors identify nonconformities, a correction plan must be completed by the facility and submitted within the designated period. If process changes have been implemented or procedures updated, an internal follow up assessment should be conducted at specific intervals to ensure compliance.
When addressing questions regarding document management, this blood bank manager handles procedures and forms using an online document control system. This system allows users access to only the most current and approved documents.
Professionalism and a welcoming attitude on the part of the facility staff and the inspector immediately set the tone for a productive assessment. Skilled inspectors are trained and are competent to conduct useful and meaningful inspections free of personal bias. The inspectors use the AABB assessment tool to confirm compliance to AABB standards, and the tracer method can be used to systematically evaluate the operations performed at a facility. Asking open ended questions helps inspectors to understand the processes of a given facility and to gauge the level of understanding and compliance of the staff. The inspection is an opportunity for the inspector and the facility staff to learn, with the ultimate goal of ensuring that the facility is providing the highest quality products and services, in accordance with federal guidelines and regulatory standards, in an efficient and effective manner.
Many agencies function to ensure that facilities are in compliance with regulations and standards. The agencies in question publish those regulations and standards. Many agencies also share reference guides that inspectors use when conducting inspections. By reviewing and completing the reference guidelines on a routine basis, a facility can remain in a state of inspection readiness. In addition, confirming that past nonconformities have been addressed and maintaining awareness of hot topics of inspection are useful ways to prepare. Regulatory agencies may share these findings on their Web sites, through audioconferences, and at professional meetings. The main focus of the inspection process is education; one should remember to take criticism constructively. The ultimate reason for inspection is to confirm adherence to standards which ensures product quality and patient and donor safety. By using the information provided in this article, “The inspectors are here!” can become a welcomed announcement.
We thank Heather McGann, MS, MT(ASCP)SBB CM (LifeBridge Health, Baltimore, MD) and J. Wade Atkins, MS, MT(ASCP)SBB and Traci Page, MT(ASCP)SBB CM (both from the Department of Transfusion Medicine, Clinical Center, National Institutes of Health [NIH], Bethesda, MD), for their willingness to be interviewed. We also thank Willy A. Flegel, MD, and Sherry L. Sheldon, MT(ASCP)SBB, for reviewing the manuscript and providing helpful suggestions.
The views expressed do not necessarily represent the view of the National Institutes of Health, the Department of Health and Human Services, or the U.S. Federal Government.
