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BASHORE ET AL., ACC/SCA&I CLINICAL EXPERT CONSENSUS DOCUMENT ON CATHETERIZATION LABORATORY STANDARDS
JACC VOL. 37, NO. 8, JUNE 2001:2170-214

American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards

A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents

VI. PERSONNEL ISSUES AND LABORATORY DESIGN

A certain critical mass of personnel is required to safely perform cardiac catheterization. The following is an outline of pertinent personnel requirements, roles, and obligations.

A. Attending Physician

The attending physician is the physician in charge of the procedure. The attending physician is considered the primary operator for the procedure. He or she is a credentialed physician, experienced in all aspects of the performance of the procedure, including preprocedural and postprocedural care of the patient.

B. Teaching Attending Physician

A teaching attending physician meets the requirements of an attending physician in a program instructing graduate physicians in the performance of the procedure and transmission of information to the trainee physician(s). A teaching attending physician must be present for all critical aspects of the cardiac catheterization procedure.

C. Secondary Operators

Secondary operators are additional attending physicians or physician extenders who assist the primary attending physician. These physicians may fulfill the requirements for an attending physician but are not in charge of the procedure at hand and are not considered the primary operator. They should not take credit for the case for the purpose of fulfilling minimum performance volume requirements.

D. Laboratory Director

The laboratory director should be a physician with the experience and leadership qualities needed to control the laboratory environment (69). The director is charged with the responsibility for policy development, quality control, and fiscal administration. Depending on the type of laboratory and type of patients studied, the director may be an adult cardiologist or a pediatric cardiologist and may have special interests such as in interventional cardiology or electrophysiology. The director should be board certified and thoroughly trained in cardiac radiographic imaging and radiation protection. The director must be proficient in performing procedures specific to the laboratory and must be a skilled administrator supportive of the needs of the departments served. The director’s qualifications should include at least 5 years of catheterization experience and recognized skill in the laboratory. Preferably, he or she should be board certified in interventional cardiology if interventional procedures are performed in the laboratory.

The duties and responsibilities of the director are multiple and wide-ranging and demand strong management skills. The director shall set criteria for granting privileges to physicians and then review and make recommendations about applications for those privileges. The director must periodically review physicians' performance, make recommendations for renewal of laboratory privileges, review performance of nonprofessional staff, and provide necessary training to personnel. The director shall establish and monitor quality control, including morbidity and mortality. Other responsibilities include control of patient scheduling, procurement and maintenance of equipment and supplies, budget preparation and monitoring, organization of regular conferences for laboratory personnel, and regular reports on laboratory activity. The director shall maintain communication and cooperation among laboratory staff, clinicians, and the hospital administration to ensure that the patient is best served. The director must designate a substitute who will act in his or her absence.

E. Operating Physicians

As suggested in several recent documents (2,70-73), all physicians credentialed to operate in the laboratory must have proper training. This includes those classified as the attending physician of record and those functioning as teaching attending or secondary operators. This training may be in adult or pediatric cardiology. Clinical training in one of these fields should fulfill requirements for that specialty board. The physician must also be trained in emergency care and radiation physics and be certified as competent by the program director of his or her training institution. A laboratory physician should be a fully accredited member of the hospital staff and ideally be specialty certified or at least board eligible. A physician who would provide only laboratory service without being a full member of the hospital staff should not be granted laboratory privileges. He or she must participate in the laboratory’s QA program, including peer review. Physicians performing interventional procedures should be board eligible or certified in interventional cardiology.

F. Cardiovascular Trainee (Fellow)

The primary role of the cardiovascular trainee is to learn cardiac catheterization procedures. The trainee also provides preprocedural care, procedural performance, and postprocedural care. In so doing, trainees obtain the critical knowledge and skills to become qualified attending physicians. Trainees may perform all functions of the procedure as the primary operator, but only under the direct supervision of a credentialed physician who assumes responsibility for the procedural results. The use of house staff not directly engaged in a formal cardiovascular training program is inappropriate. Table 12 outlines the current recommendations for training and maintaining proficiency in invasive skills. All trainees should receive at least 4 months of training and participate in 100 procedures (level I). For diagnostic catheterization skills, trainees should perform 300 procedures, with 200 as the primary operator (level II). For interventional catheterization skills at level III, trainees are required to perform 250 interventional procedures as the primary operator (74).

G. Use of Physician Extenders (Physician’s Assistants and Nurse Practitioners)

Increasingly “physician extenders” (e.g., physician’s assistants and nurse practitioners) are being used clinically as secondary operators. It should be recognized that extenders should never be primary operators. The physician extender should be proficient in both the technical and cognitive aspects of cardiac catheterization, including (1) preprocedural evaluation, (2) indications, (3) cardiac physiology and pathophysiology, (4) emergency cardiac care, (5) radiation safety, and (6) application of diagnostic catheterization data regarding the procedure, according to the standards established by the Society for Cardiac Angiography and Intervention (SCA&I), American College of Cardiology (ACC), and American Heart Association (AHA) (5,75,76).

Although there has been some controversy about whether physician extenders are qualified to perform cardiac catheterization and coronary angiography as primary operators in lieu of physicians (75), it is the position of the Committee that nonphysicians should not perform catheterization as primary operators (76). The primary operating physician must be in the catheterization suite during the procedure when secondary operators are performing the procedure. The primary physician operator must always be immediately present to direct the physician extender and provide all clinical decision making.

Specially trained nurses may assist attending physicians in much the same role as physician’s assistants in the performance of procedures. They may be able to assist in place of cardiovascular trainees, but they require greater supervision during all aspects of the procedure. Specialized experience in both clinical care and cardiovascular procedures is required.

H. Nursing Personnel

The type and number of nursing personnel required in the catheterization laboratory depend on the laboratory caseload and mix and may include nurse practitioners, registered nurses, licensed vocational or practical nurses, or nursing assistants. In most laboratories, the nursing supervisor is a registered nurse. This nurse must be familiar with the overall function of the laboratory, help set the tone of patient surroundings, and influence the efficiency and safety of procedures. The registered nurse may also directly participate in observation and nursing care of the patient during catheterization and be ready to respond to any emergency. The nursing supervisor should be in charge of the preprocedure and postprocedure holding areas.

The background of a catheterization laboratory nurse should include critical-care experience, knowledge of cardiovascular medications, ability to start an IV infusion, and experience in sterile techniques. Experience with vascular catheter instrumentation, especially with identification, cleaning, sterilization, and storage, is necessary. Knowledge of vascular catheter materials and the proper size correlations for catheters, guidewires, and adapters is important, as is experience in the manipulation of manifolds, injection of contrast, and changing of guidewires and catheters. The catheterization laboratory nurse must have a thorough understanding of the flushing of catheters and prevention of clots or air emboli.

A licensed practical nurse with the proper background and experience may have duties similar to those of the registered nurse. However, a licensed practical nurse should not supervise laboratory nursing. In some laboratories, an appropriately trained nursing assistant may be responsible for some duties. The nursing assistant may be a cardiopulmonary technician who is familiar with procedures in associated disciplines and is thereby able to function in the dual capacity of cardiopulmonary technician and nursing assistant.

I. Non-Nursing Personnel

Several kinds of technical knowledge are required in the cardiac catheterization laboratory, although any 1 person may not possess all the different types of technical expertise. At least 1 technologist, who may or may not be a certified radiological technologist, should be skilled in radiographic and angiographic imaging principles and techniques. This technologist should be experienced in the proper performance of x-ray generators, cine pulse systems, image intensification, automatic film-processing equipment (if used), pressure injection systems, video systems, and cine cameras. He or she, in cooperation with electronic and radiological service engineers, should be responsible for routine care and maintenance of the radiological equipment. A basic ability to troubleshoot this equipment is advantageous. This technologist, in cooperation with a radiation physicist, should monitor radiation safety techniques for both the patient and laboratory personnel. Immediate availability of a radiological engineer in the event of equipment failure is highly desirable.

Laboratory technologists should be skilled in managing blood samples and performing blood gas measurements and calculations. They should be qualified to monitor and record electrocardiographic and hemodynamic data and have enough skill and experience in interpreting these data to report significant changes immediately to the physician responsible for the patient. During any single procedure, the monitoring technician or nurse must have no responsibility other than monitoring and observing patient status. Training should include skills in patient observation and preparation for assistance in acute cardiac care, including resuscitation and related therapeutic efforts.

In laboratories in which cinefilm is still used, at least 1 technologist should be skilled as a darkroom technician, because the quality of images recorded on film is heavily dependent on darkroom technique. This person must be trained in photographic processing and the operation of automatic film processors and must be familiar with the characteristics of film and chemicals used for cardiovascular procedures. Skills should be acquired in the techniques of day-to-day calibration and maintenance of automatic processors and the use of sensitometric/densitometric equipment and data. These skills, plus skills in digital image acquisition, storage, transfer, and processing are necessary for the technologist to ensure high quality of the diagnostic images. As laboratories move to a cineless environment, a technician with computer skills is very valuable for handling film transfer methods and archival storage devices and equipment necessary to maintain the digital libraries and produce compact discs or other transfer media when needed. As all-digital laboratories become the norm over the next few years, the role of the darkroom technician will evolve into that of a digital archive technician. This will undoubtedly require retraining and a new set of skills unlike those needed in film development. Knowledge of x-ray systems, acquisition of digital images, and handling of the resultant digital information will remain important adjunct skills.

J. Staffing Patterns

An invasive cardiologist must be present in the laboratory during each procedure and must be responsible for the outcome. To maintain effective and safe laboratory operation, each basic support function should be performed by adequately trained personnel who constantly maintain their skills and credentials. There should be adequate cross training among laboratory staff so that personnel can rotate responsibilities and provide 24-hour coverage of essential team functions. Complex studies, especially those of children and acutely unstable patients, require personnel with special training to deal with the particular requirements of these procedures. Frequently, the presence of a second physician is important for optimal care in many such difficult cases.

K. Cardiopulmonary Resuscitation

All members of the catheterization team—physicians, nurses, and technologists—should complete a course in basic CPR. Certification in advance cardiac life support is also strongly urged for all members of the cardiac catheterization team. Yearly recertification is recommended.

L. Suggested Space Requirements

Table 13 outlines some suggested minimum room sizes for the cardiac catheterization laboratory. It should be obvious that these recommendations are only suggestions and that space for development and access to newer technology will require modification. For instance, cinefilm and record storage is gradually being replaced by computer review stations and computer archival and retrieval areas. Many physicians review digital angiographic results immediately after the procedure in the control room, and this capability means that control room space should be expanded to accommodate this activity. Database requirements also require appropriate space for computers, not only for data entry but also for compilation of the results and preparation of the final catheterization report. Because most diagnostic cardiac catheterization procedures have moved to the outpatient environment, appropriate check-in, patient waiting, and holding rooms have become necessary for any cardiac catheterization suite. In some situations these areas are shared with other areas of the hospital, such as ambulatory surgery or radiology; in others, these areas are occupied solely by the cardiac catheterization laboratory.

Room heights are commensurate to room-need requirements. Procedure rooms require a minimum height of 9 feet, 10 inches. Heights of the control room and most other rooms are generally 8 feet.


©2001 by the American College of Cardiology and
Society for Cardiac Angiography and Interventions

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