Quality Management of Apheresis Personnel

In: McLeod BC, Price TH, Weinstein R, eds. Apheresis: Principles and Practice, 2nd Edition Bethesda, MD: AABB Press, 2003 Quality Management of Apheresis Personnel 32 Quality Management of Apheresis Personnel WANDA B. KOETZ, RN, HP(ASCP) IT IS OFTEN SAID THAT AN ORganization is only as good as the people who do the work. The provision of apheresis services is no different. In apheresis donor collections, hematopoietic progenitor cell (HPC) collections, therapeutic apheresis procedures, or any combination of these activities, success depends on having well-trained staff performing clearly described tasks. This chapter looks at some of the issues involved in staffing and directing an apheresis unit from a quality management perspective. WandaB.Koetz,RN,HP(ASCP),PrincipalAssociate, American Red Cross, Arlington, Virginia Assessment Background Providing apheresis services is an expensive and complex undertaking that requires careful assessment of the institutional or community needs for such services. Such an assessment will provide answers to the questions: What types of services are needed at what frequency? and Do we have the resources and expertise to provide the needed services? Because different services may require different numbers of staff and different skill levels on the part of each employee, this will determine the type of employee resources needed. For example, performing therapeutic procedures requires knowledge 681

Apheresis: Principles and Practice and skills in patient assessment, management of fluid and electrolyte balances, vascular access, and administration of medications, as well as familiarity with operating and troubleshooting the apheresis instrument and ancillary equipment. Performing donor collection procedures, on the other hand, requires knowledge and skills in donor assessment and treatment of donor reactions and injuries, as well as familiarity with apheresis instrument operation and troubleshooting. Requirements When decisions have been made regarding the types of apheresis services to be offered, employee requirements federal, state, and local 1 must be assessed carefully. There are specific licensing requirements for physicians, nurses, and technologists who are practicing as professionals in an apheresis service; these requirements may vary from state to state. Many states also have Nurse Practice Acts that may affect apheresis services. For example, many state Nurse Practice Acts forbid the administration of intravenous medication by anyone other than a Registered Nurse (RN), thus significantly limiting the use of unlicensed staff for such services as therapeutic apheresis and HPC collections. Until recently, California law required all phlebotomies for donor collections to be performed by RNs. The Occupational Safety and Health Administration and the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) regulations discussed in Chapter 30 should also be reviewed carefully. The humanresourcesstaffinanorganizationorinstitution should assist in this assessment of laws and requirements. Job descriptions should then be developed and should reflect employment requirements by job title. As emphasized in Chapter 30, the Food and Drug Administration (FDA) is the branch of the federal government responsible for licensing and inspecting blood collection facilities. The Code of Federal Regulations (CFR), which is published yearly by the federal government, outlines federal requirements concerning the activities of blood collection facilities, of which apheresis donor collection facilities are a subset. The CFR does not specify the qualifications of employees; rather, it states that there be a qualified, trained individual to be the responsible head and that those involved in collecting processing, testing and distributing blood products be sufficient in number and adequately trained. 2 It is up to agencies providing apheresis services to define in their policies and procedures how they will meet CFR requirements pertaining to employees. The American Association of Blood Banks (AABB) does not regulate blood collection activities, but it has published voluntary standards for member blood banks and transfusion services to follow. The AABB Standards for Blood Banks and Transfusion Services states that the blood bank or transfusion service shall have a medical director who is a licensed physician and qualified by training and/or experience. 3(p1) In addition, the blood bank or transfusion service shall have a process to ensure the employment of an adequate number of qualified (by education, training, and/or experience) individuals. Personnel performing critical tasks shall be qualified on the basis of appropriate education, training, and/or experience. 3(p4) The American Society for Apheresis (ASFA) has published voluntary guidelines for therapeutic apheresis facilities. These guidelines state that each TA [Therapeutic Apheresis] Service should be led by a licensed physician, qualified by training and/or by experience, who will be called the Director and that the remainder of the TA Service staff should consist of medical per- 682

Quality Management of Apheresis Personnel sonnel qualified to perform TA procedures. 4 In addition to the previously described requirements, organizational contracts with individual hospitals may include specific requirements for staff who perform apheresis services. Handling Inspections Compliance with personnel requirements inthecfrcanbeafocusoffdainspections for problems and deficiencies. To avoid citations for deficiencies, all personnel files must be current and complete. An inspector may ask to see an employee s job description, job qualifications, and regular periodic competency determinations. Each file must also contain supporting documentation that the employee has been properly trained and updated on procedural changes as necessary, and has maintained current licensure status when working in a professional capacity (eg, RN). Employee Categories and Roles Physicians Medical directors of donor collection facilities should be licensed physicians who have knowledge and experience in hematology and transfusion medicine. These physicians must also be familiar with blood banking principles, appropriate FDA regulations, AABB standards, current good manufacturing practice (cgmp) requirements, and employee safety regulations. According to the CFR, 2 although the responsible head is not required to be a physician, that individual is responsible for: 1. Monitoring compliance with all requirements in the CFR for manufacturing blood components. 2. Representing the facility in all matters to the Center for Biologics Evaluation and Research. 3. Enforcing discipline and performance of assigned functions by employees engaged in manufacturing blood products. 4. Training employees in manufacturing methods and their knowledge of the appropriate sections of the CFR. According to AABB Standards, 3(p1-2) the medical director: 1. Has responsibility and authority for all medical and technical policies, processes, and procedures, including those that pertain to laboratory personnel and test performance, and for the consultative and support services that relate to the care and safety of donors and/or transfusion recipients. 2. Approves all medical and technical policies, processes, and procedures. For physicians who will be in charge of therapeutic apheresis services, the following guidelines have been established by ASFA as recommended requirements for medical directors: 1. Knowledge of immunology, of transfusion medicine, and of the principles of apheresis separation and its effects on the body after removal or exchange. 2. Familiarity with various apheresis instruments currently in use. 3. Knowledge of diseases treated by therapeutic apheresis and the clinical indications for it. 4. Expertise in the planning and performance of all modalities of apheresis therapy. 5. Expertise in the management of adverse effects of therapeutic apheresis. 6. Expertise in the logistical, financial, and personnel management of the therapeutic apheresis service. According to ASFA guidelines, therapeutic apheresis service medical directors are responsible for: 1. Medical and technical policies and procedures. 683

Apheresis: Principles and Practice 2. Support services related to the safety of patients, including compliance with the published guidelines. 3. Assurance of the safety and adequacy of the place of treatment. 4. Selection, maintenance, and proper use of apheresis devices and other equipment and materials used for therapeutic apheresis. 5. Assuranceofadequatetrainingandperformance of members of the therapeutic apheresis service staff. Technical Staff Under the medical director s supervision, the technical staff members of an apheresis program collect apheresis components and perform therapeutic apheresis and HPC collection procedures. The technical staff in any apheresis unit ordinarily evaluate donor eligibility, obtain consent, establish vascular access, perform the procedures, cares for donors and/or patients, and perform maintenance and quality control of supplies and equipment used during apheresis procedures. At a management level, some members of the technical staff may supervise the daily operations of the unit; interact with physicians and other medical professionals; write procedures; train apheresis staff; and enforce compliance with applicable procedures, standards, and requirements. The technical staff can consist of RNs, medical technologists (MTs), licensed practical nurses (LPNs), medical technicians, trained phlebotomists, those with a bachelor s degree in a science such as biology, or some combination of these categories. Historically, centers that perform therapeutic apheresis or HPC procedures have tended to rely on RNs or MTs. In centers performing apheresis donor collections only, individualswithlessformaleducation,suchaslpns, medical technicians, or trained phlebotomists, have worked successfully. For centers offering a combination of services, a mixture of all levels has worked well. Wright 5 has detailed the differences in educational background, technical skills, and work experience for the various types of technical staff employed in the therapeutic apheresis service. She suggests that the education and training of the employees be used to establish performance standards, that the standards be reviewed periodically, and that changes be made as necessary. The following discussion identifies the different types of technical staff participating in apheresis and examines their unique contributions to apheresis services. Registered Nurses The education of nurses includes human anatomy and physiology, basic concepts of human disease, and practical training in patient care. An RN s skills and qualifications usually include patient/donor physical assessment, expertise in interpersonal relationships, interview skills, first aid, training in cardiopulmonary resuscitation, and a license to administer medications and fluids under a physician s prescription. Local and state requirements may dictate that certain tasks be performed by or under the supervision of an RN. These requirements should be kept in mind when decisions are being made about whether nurses are a necessary part of the staffing matrix for a particular apheresis unit. Background and experience in hemodialysis can be especially beneficial when nurses new to the field of apheresis are being hired. Medical Technologists Because the education of medical technologists emphasizes laboratory concepts, the contribution of these individuals to the apheresis unit can include knowledge of hematology and blood banking, experience in instrumentation and equipment quality 684

Quality Management of Apheresis Personnel control, skill in problem-solving, and attention to detail. CLIA regulations must be assessed to determine if any tasks to be performed by apheresis staff require the educational background and certification of medical technologists. 1 Other Technical Staff Experienced medical technicians, LPNs, emergency medical technicians, and others with some technical/medical training bring some of the clinical and technical skills of RNs and MTs, but their limitations must be recognized. Individual state Nurse Practice Acts will determine at what level LPNs can function compared with RNs. Many centers use staff at this level because they can perform many, but certainly not all, of the same dutiesbutatalowersalarythanthatofan RN or MT. Employees with a 4-year degree in one of the sciences such as biology can be trained successfully to operate apheresis instruments and to care for donors and patients. They possess good decision-making skills and can use their knowledge of science to better understand the concepts of anatomy and physiology, disease processes, and disease treatment. Trained phlebotomists have also been used in donor collection facilities, usually at a lower salary. However, phlebotomists are generally not required to have the strong skills in decision-making that are expected in an employee with a degree. For phlebotomists, procedural training may need to be repeated more frequently. Supervision of these individuals may also require more time and involvement. Nontechnical staff Donor Recruiters and Schedulers The success of any donor collection facility depends on the people who recruit new donors into the program, schedule their donation appointments, and assist in donor recognition activities. These people need to demonstrate excellent communication skills along with an ability to generate enthusiasm about the program in potential donors. Extensive education may not be required to perform these tasks successfully, but a basic knowledge of the process of apheresis donations and of the requirements that donors must meet is critical to offer clear explanations to donors and answer their questions. Other Nontechnical Staff Whether the apheresis unit operates independently or as a department within a larger organization, certain ancillary functions must be provided to ensure that the unit meets regulatory and legal requirements. One function is legal counsel, which might be required for such activities as the development and review of contracts or informed consent documents. In addition, a lawyer might be necessary during negotiations with employees, particularly if the employee group is part of a union. Larger organizations often have regulatory affairs staff. These individuals are responsible for keeping abreast of the regulations established by federal and state governments and for interpreting those regulations for the organization. They may also function as the liaison between the government and the organization. As emphasized in Chapter 31, no organization is complete today without a quality assurance program. If it is large enough, the organization may have dedicated quality assurance staff. If not, systems must be in placetoensurethataqualityassuranceprogram is carried out by the regular staff. The quality assurance staff are part of the organization s quality system, which consists of the organizational structure, responsibilities, policies, processes, procedures, and re- 685

Apheresis: Principles and Practice sources that are established by executive management to achieve quality. 3(p106) Human resource experts are a final element of desirable support staff. No organization can hire staff and manage operations successfully without knowledge in the area of human resource management. With expertise in employment requirements and legal issues surrounding employment, human resource experts can provide input into developing clear and concise job descriptions, establishing salary ranges, and developing a work performance review program. In addition, they can assist in progressive disciplinary actions that meet all legal requirements, thereby helping to protect the organization from employment litigation. Training Management of Individuals If one of the key components of quality management and quality improvement is the staff performing the procedure, then a key component of staff performance is training. To do the job and do it well, staff must be trained to perform the appropriate tasks correctly. A good training program consists of written objectives, written training plans that are consistent with the unit s standard operating procedures (SOPs), and tests or assessments to verify the effectiveness of training. 6 SOP training should include training in the actual steps of the procedure, the rationale for performing the steps in a particular order, and the consequences that can occur if the process is not followed. 7 For all employees, records must be maintained thatdocumentthetypeoftrainingprovided, the methods used for training, and the methods used to assess the employee s competency to perform independently. Systems must be in place to ensure that the employee s ongoing training in procedural changes is documented. According to Callery, The generally accepted industry standard for preparing employees to perform job skills is that of competency-based training. 8 This means that the training is designed to reflect the job responsibilities and is measured by direct observation of performance. Callery identifies four components of competency-based training: outcome-based learning objectives, identified content, specific methods of instruction, and a structure for evaluating learning and readiness for the job. 8 She describes in detail how to write objectives that are specific, measurable, and observable,aswellashowtodevelopthe content, methods of instruction, and methods for evaluation. Specific training needs may vary, depending on job descriptions. Training for medical directors of donor collection facilities should include hematology, transfusion medicine, cgmp regulations, and working knowledge of the facility s SOPs, of appropriate FDA requirements and AABB standards, and of requirements for employee safety. Medical directors involved in therapeutic apheresis procedures should have the qualifications listed previously in this chapter. They must also be able to determine the suitability of blood and components for transfusion. Training should cover the SOPs, as well as the operational details of the apheresis unit, and should provide a basic knowledge of the particular apheresis equipment used. For technical staff, training in such basics as physiology, diseases, physical assessment, fluid and electrolyte balances, and interpersonal skills should be provided in addition to procedure-based training. Certification and Credentialing Currently, the only certification available in the apheresis specialty is the hemapheresis practitioner (HP) designation offered by the American Society for Clinical Pathology 686

Quality Management of Apheresis Personnel (ASCP), the leading organization providing certifications in the area of laboratory medicine. The HP certification is available to apheresis professionals who satisfy the requirements established by ASCP. 9 To be eligible, a candidate must meet one of the following background requirements: 1. An RN with a current state or provincial license and 3 years of full-time experience in hemapheresis within the last 10 years under the direction of a medical director. 2. An MT, technologist in blood banking (BB), or specialist in blood banking (SBB) certification and 3 years of fulltime experience in hemapheresis within the last 10 years under the direction of a medical director. 3. A baccalaureate degree from an accredited college or university with 24 semester hours of biology and chemistry, and 5 years of full-time experience in hemapheresis within the last 10 years under the direction of a medical director. Additional requirements for full-time work experience must be in six of the following eight areas: donor procedures, therapeutic procedures, donor selection, fluid balance, quality assurance procedures, management of adverse reactions, clinical assessment, and vascular access. Experience with either donor procedures or therapeutic procedures must be included. An eligible candidate may obtain a registration form by contacting the ASCP Board of Registry. Once the completed form has been submitted and eligibility verified, the candidate may take the examination by computer at any one of a number of test centers across the country by calling and making an appointment. Test scores are sent by mail within 10 working days after the examination. Currently no regulatory agency has required HP certification for staff employed in anapheresisunit.thedecisiontodosois left to individual facilities, but consideration should be given to certification for at least the supervisor of a therapeutic apheresis service. Competency Testing Staff performing apheresis procedures should be observed and assessed regularly to confirm their competency to perform the procedures. 6 Assessment is usually made after the initial training and annually thereafter. Documentation of these assessments must be maintained in the individual employee s file. In conjunction with periodic competency testing, an employee s job performance is also documented by means of a performance review or performance appraisal system. This regular written assessment is a result of ongoing review and observation by the supervisor. The performance review is based on the specific job tasks outlined in the job description and assesses the employee s ability to perform each of the identified job tasks successfully. It is often used as a basis for promotion or salary increases. 10 Continuing Education Staff should be encouraged and provided opportunities to attend continuing education seminars on topics in apheresis and related fields. In many states, continuing education is mandatory for the renewal of licenses for RNs. Management of the Apheresis Unit Once a staffing pattern has been determined and the staff are trained adequately and proven competent to perform their specific tasks, it remains necessary to manage the unit on a daily basis to accomplish the goals and fulfill the purposes of the organization. This is not an easy task, however, as there is no one right formula that will work 687

Apheresis: Principles and Practice Table 32-1. Key Factors Influencing Apheresis Units Type of apheresis procedures performed (donor collections, therapeutic procedures, hematopoietic progenitor cell collections) Qualifications and skill levels of staff Total number of procedures of each type to be performed daily/monthly/yearly Size and commitment of donor base Hours and days of operation Additional services offered/components collected HLA-matched components Platelet crossmatched components Granulocyte components Autologous apheresis Red Blood Cell components Miscellaneous issues Distance from facility to clients Distance from collection facility to processing and testing locations equally well in all apheresis units. Even in large corporate networks such as Blood Systems,Inc.andtheAmericanRedCross,what works well in one area of the country does not necessarily work well in others. Table 32-1 identifies some of the key factors that will determine how best to manage an apheresis unit. It is hoped that the needs for apheresis services in a community have been assessed carefully before a unit is opened. Once the unit is operating, mechanisms should be in place to evaluate the program periodically and implement the changes that are needed to meet the changing demands of the institution or community. 10-12 Many decisions about who performs what tasks are determined to some extent by the type of staff hired. Those roles and responsibilities may change daily, depending on the activities and needs of a particular day. However, mechanisms must be in place to ensure adequate coverage so that staff members are not expected to perform tasks for which they have not been trained and tested adequately. The balance between ensuring adequate coverage and avoiding overstaffing becomes difficult to achieve in these days of limited resources. The job of supervisor or group leader is usually assigned to a person who has a higher level of education as well as advanced technical and management skills. (For purposes of this chapter, the terms management and supervision are used synonymously.) Table 32-2 summarizes the responsibilities of an apheresis supervisor as well as the tasks that may be reasonably divided among various nonsupervisory staff members. The levels of performance and responsibility for tasks listed in the second column may be influenced by state requirements regarding various tasks. Many apheresis activities can be performed by non- RN, non-mt staff, but written procedures must be comprehensive and must clearly delineate responsibilities and limits. Donor Centers Procedural load requirements depend in part on the types of instruments. With automated apheresis instruments, it is possible for a single person to be responsible for two or more donors with the appropriate ancillary support to ensure that donor safety is never at risk. The optimal approach to scheduling donors has been a topic of considerable debate. The type and length of procedures to be performed should be taken into consideration when determining the interval between donations for each instrument. Perhaps there is no single best way, and each center must choose the method that works 688

Quality Management of Apheresis Personnel Table 32-2. Tasks in an Apheresis Unit Supervisor Staff Interviewing, selecting, and training staff Assessing staff performance Appraising staff performance Implementing new policies and procedures Writing new procedures and revising current procedures Investigating errors and accidents and determining corrective action Scheduling staff and assignments Monitoring component and equipment quality control Monitoring and tracking instrument validation Coordinating apheresis services with other departments Coordinating apheresis services with hospitals and physicians Functioning as staff person when needed Donor collection facilities Conducting donor registration, interview, and assessment Performing phlebotomy Performing apheresis collection procedures Mixing and administering anticoagulants and fluids Assessing and treating donor reactions and injuries Providing postdonation care Troubleshooting apheresis instrument problems Calibrating equipment Therapeutic services Assessing patient condition Performing patient chart review Performing therapeutic apheresis procedures Administering medications and/or blood components Handling patient emergencies Troubleshooting apheresis instrument problems Calibrating equipment well in its own specific context. Any successful approach, however, must address the following issues regarding donor preference: Aretheretimesavailablebeforeorafterthe potential donor s usual work hours? Are weekend appointment times available? Is theschedulingsystemflexibleenoughtoallow for seasonal and holiday-associated fluctuations in donor availability? Is the donor center convenient to most donors? Are satellite facilities a possibility? To ensure the success of an apheresis program, methods should be in place to assess the responses to these questions and their impact on the program. Management should also assess productivity and efficiency of individual staff, including recruiters. This information is critical in determining the financial aspects of apheresis services and ensuring that operations are managed in an effective manner. Therapeutic Apheresis Services Scheduling and staffing for therapeutic apheresis can be even more challenging. Initial therapeutic procedures are often per- 689

Apheresis: Principles and Practice formed on an emergency basis, usually within 24 hours of notification. The frequency and duration of subsequent treatments are difficult to predict, as they will depend on the disease being treated and the patient s response to successive treatments. Instruments may need to be moved to multiple locations. Periods when there are more procedures requested than staff can perform may alternate with periods when staff have no procedures to perform. Cross-training of therapeutic staff to donor apheresis or whole blood collections can make more efficient use of staff during times of low demand for therapeutic procedures. Independent therapeutic apheresis services may consider cross-training staff to perform dialysis procedures if both services are offered by the facility. Multiple Services Scheduling is probably most complex in those centers where the same staff are cross-trained to perform donor collections as well as therapeutic procedures. When demand exceeds staffing capacity, therapeutic procedures for cases with well-documented need will usually take priority over donor procedures. Part of the rationale is that there is no substitute therapy for patients who need therapeutic apheresis, while needed blood components can be obtained from units of Whole Blood rather than donor apheresis. Summary The operation of an apheresis unit depends on the quality of staff performing the work. With careful attention to selecting the appropriate people, providing comprehensive training that is well documented, and managing the unit in an effective manner that meets all appropriate requirements and regulations, apheresis units can meet the needs of the community successfully. References 1. Davis B. Governmental regulations. In: Karni KR, Viskochil KR, Amos PA, eds. Clinical laboratory management A guide for clinical laboratory scientists. Boston: Little, Brown, 1982:497-516. 2. Code of federal regulations. 21 CFR 600-799. Washington, DC: US Government Printing Office, 2002 (revised annually). 3. Fridey JL, ed. Standards for blood banks and transfusion services. 22nd ed. Bethesda, MD: American Association of Blood Banks, 2003. 4. American Society for Apheresis, Standards and Education Committee. Organizational guidelines for therapeutic apheresis facilities. J Clin Apheresis 1996;11:42-5. 5. Wright SK. Standards for personnel performing hemapheresis therapies. In: Mac- Pherson JL, Kasprisin DO, eds. Therapeutic hemapheresis. Boca Raton, FL: CRC Press, Inc., 1985:103-19. 6. Abruzzese RA. Nursing staff development. Garden City, NY: Mosby-Year Book, 1992: 203-14, 249-69. 7. Motscham TL, Moore SB. Error detection and reduction in blood banking. Clin Lab Med 1996;16:961-73. 8. Callery MF. Employee selection and training. In Kasprisin CA, Laird-Fryer B, eds. Blood donor collection practices. Bethesda, MD: American Association of Blood Banks, 1993:41-68. 9. Board of Registry. 2002 procedures for examination and certification. Chicago, IL: American Society for Clinical Pathology, 2002. 10. Silver GA. Introduction to management. St. Paul, MN: West Publishing Company, 1981: 80-97, 266-89. 11. Hodgetts RM. Management fundamentals. Hinsdale, IL: Dryden Press, 1981:48-65, 258-77. 12. Sisk HL, Williams JC. Management and organization. 4th ed. Cincinnati: South-Western Publishing Co., 1981:61-82, 127-47. 690