Part 3 - Professional Services
Chapter 21 - Medical Imaging Program
- Purpose. This chapter establishes the policy, procedures, and regulations pertaining to the delivery of diagnostic medical imaging services administered by the Indian Health Service (IHS). This chapter ensures that IHS beneficiaries receive high-quality diagnostic imaging services.
- Scope. Commonly used in-house diagnostic modalities in the IHS include x-ray, ultrasound, mammography, and computerized axial tomography. Some diagnostic imaging services contracted out to non-IHS facilities not covered by this chapter include nuclear medicine, magnetic resonance imaging (MRI), and other diagnostic imaging services.
- Authority. The regulations and standards of the following organizations are reference throughout this chapter:
- Centers for Medicare and Medicaid Services (CMS)
- American College of Radiology (ACR)
- Accreditation Association for Ambulatory Health Care, Inc. (AAAHC)
- Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
- Policy. All medical imaging services shall meet or exceed JCAHO, AAAHC, ACR, CMS, and/or applicable State standards and regulations.
- Certified Component or Equipment. Electronic products certified by the manufacturer to be in compliance with applicable standards described in 21 Code of Federal Regulations (CFR) Subchapter I, Subpart J, "Regulations for the Administration and Enforcement of the Radiation Control for Health and Safety Act of 1968."
- Entrance Skin Exposure. The amount of radiation delivered at the skin surface.
- Federal Drug Administration. The Federal Drug Administration (FDA) is a vast organization of 15 offices, including the Office of Regulatory Affairs, the National Center for Toxicological Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine. The administration has 9,000 employees who monitor and process $1 trillion worth of products each year.
- Licensing and Certification. Licensing and certification are part of the process whereby a State government or non-governmental agency or association grants recognition to whomever meets certain predetermined qualifications.
- Mammography Technologist. A registered radiologic technologist who meets the requirements of the "FDA Mammography Quality Standards Act" (MQSA).
- Medical Imaging. The creation of human anatomy images by radiography, sonography, nuclear medicine, computerized tomography (CT), and MRI. Medical imaging is used to aid in the diagnosis and treatment of disease, trauma, or other abnormality.
- Occupational Radiation Dose Report. A clear and legible record of each employee's radiation exposure history.
- Organ Dose. The distribution of an absorbed dose in a patient depends on the amount of incident radiation, the location and direction of the incident beam, and the attenuation of the beam in the body. Calculating patient organ doses is difficult based on these factors. This difficulty is one reason the FDA has chosen to use the "free-in-air," patient entrance skin exposure (ESE) measurement in its Nationwide Evaluation of X-ray Trends (NEXT) studies.
- Phantom. A device that absorbs and scatters x-rays in approximately the same way as tissues of the body do. A body phantom is used to take ESE measurements.
- Quality Assurance. The portion of the Radiation Protection Survey that monitors or audits image processing and its effects on radiation exposure and medical imaging program (MIP) quality assurance (QA).
- Quality Assurance Program. A program comprised of facility-based activities to improve the MIP.
- Radiation Protection Surveyor. An individual who has successfully completed the certification requirements detailed in the Indian Health Service Federal Facility Diagnostic X-ray Survey Procedure Manual and who may perform unassisted radiological health and safety surveys.
- Radiation Protection Surveyor In-Training. An individual who has successfully completed the IHS FDA radiation training but has not received certification. Radiological health and safety surveys performed by a radiation protection surveyor in-training require the review and approval of a radiation protection surveyor before distribution.
- Radiographer or Radiologic Technologist. An individual who has successfully completed a course of study in the arts and science of radiologic technology in a program accredited by the Joint Review Committee on Education in Radiologic Technology (JRCERT) and who is board certified by the American Registry of Radiologic Technologists (ARRT). Radiographers are distinguished from personnel such as x-ray machine operators whose use of diagnostic procedures is limited to a few specific body sites and/or standard procedures. The personnel designated as x-ray machine operators are clinical professionals occasionally called upon to assist in diagnostic radiology examinations. A radiographer is licensed to perform or may be called upon to perform a comprehensive scope of diagnostic imaging procedures employing equipment that emits ionizing radiation. A radiographer is delegated or exercises responsibility for the operation of radiation-generating equipment, the shielding of patient and staff from unnecessary radiation, the appropriate exposure of radiographs, or other procedures that contribute to any significant extent to the site or dosage of ionizing radiation to which a patient is exposed.
- Radiologist. A licensed physician who has successfully completed a residency in radiology.
- Radiology Technician. An individual who has successfully completed less than a 2-year course in radiologic technology and has gained his/her experience through more than 6 months of on-the-job training.
- Significant Deficiencies. All findings that may contribute to unnecessary radiation exposure to patients or staff, or create unsafe working conditions.
- Sonographer. An individual who has specialized training and skills in producing ultrasound images and is eligible for national certification as an American Registered Diagnostic Medical Sonographer (ARDMS).
- Trained X-ray Machine Operator. An individual who is a minimally trained operator of radiographic equipment and meets the training requirements of Public Law (P.L.) 97-35, “Consumer-Patient Radiation Health and Safety Act” of 1981.
- Ultrasound Technician. An individual who has specialized training in producing ultrasound images and is not certified by ARDMS.
- X-rays (gamma-radiation). A form of electromagnetic ionizing radiation with the physical characteristics of photons generated from the electron shells of atoms. X-rays are useful in medical imaging because their energy and quantity are controlled.
3-21.2 PROGRAM ADMINISTRATION
The IHS is organized into three major administrative levels: Headquarters, Area Office, and service unit. A line of authority exists from the Director, IHS to Area Director to the service unit’s Chief Executive Officer (CEO). The Area and Headquarters staff shall be responsible for providing consultation to and evaluation of the medical imaging services at the service units. A technical and consultative relationship exists among the medical imaging staff at each level.
- Director, MIP. The Director, MIP, is responsible to the Director, IHS, through the Director, Office of Clinical and Preventive Services, for coordinating and advising on activities relating to the provision of medical imaging services. The Director, MIP:
- develops goals and objectives for improving the delivery of medical imaging services throughout the IHS;
- develops and implements IHS-wide medical imaging policies, procedures, and standards;
- identifies and develops resource opportunities required for the delivery of services, including the coordination of national recruitment activities and continuing staff development;
- provides consultation to Tribal programs on delivery of diagnostic imaging services;
- maintains liaison with national medical imaging organizations;
- remains current in the knowledge, skills, and methods of diagnostic imaging to assist with the improvement of the health status of the IHS beneficiaries;
- recommends staffing guidelines and equipment requirements for new medical imaging departments based on projected workloads; and
- conducts Area MIP reviews.
- Chief Executive Officer. The CEO administers the service unit MIP to ensure high-quality diagnostic imaging services are provided to IHS beneficiaries.
- Medical Imaging Personnel. Service unit medical imaging personnel provide medical imaging services and are the principal advisors to the service unit Clinical Director and the CEO. The responsibilities of the service unit medical imaging staff include:
- providing diagnostic imaging services to patients of the service unit within the framework of Headquarters and Area policies;
- ensuring that service unit diagnostic imaging services meet and maintain FDA, JCAHO, ACR, AAAHC, and CMS standards; and
- participating actively in service unit risk management activities, which include:
- identifying general areas of potential risk in the clinical aspects of patient care and safety;
- developing criteria for identifying specific cases with potential risk in the clinical aspects of patient care and safety;
- correcting problems in the clinical aspects of patient care and safety identified by risk management activities; and
- designing programs to reduce risk in the clinical aspects of patient care and safety.
3-21.3 MEDICAL IMAGING SERVICE QUALIFICATIONS AND TRAINING
- Personnel Staffing Qualifications.
- Medical imaging services provided by the IHS shall be provided by qualified, licensed, and/or certified physicians and/or diagnostic medical imaging technologists complying with the credentialing standards in 42 CFR, Part 75.
- Only personnel meeting the requirements of the “Presidential Directive on Radiation Protection Guidance,” P.L. 97-35, and the applicable JCAHO, AAAHC, ACR, or CMS medical imaging standards shall be permitted to operate IHS x-ray equipment.
- Personal Services Contractors. Personal services contractors shall be required to follow IHS hiring policy qualifications by having an active State or national license in good standing prior to being assigned to an IHS facility.
- Training The IHS MIP encourages the support of training and continuing education at all program levels. Radiologic technologists licensed by ARRT are required to maintain national certification and licensure. Continuing education is for acquiring new skills or techniques and updating knowledge related to current trends in clinical diagnostic imaging practice. Training programs, including in-service workshops and Area or regional refresher courses, may be established by the Areas or through the Director, MIP. All radiographers, technologists, technicians, and sonographers are encouraged to participate in training activities to keep abreast of developments in the field of diagnostic imaging.
- Professional Affiliations. Medical imaging personnel have the responsibility to participate in the advancement of their respective professions. They should participate in national and local professional organizations. They should develop professional collegial relationships both within and outside the IHS and assist in training American Indian and Alaska Native (AI/AN) students, where applicable.
3-21.4 FACILITIES PLANNING AND CONSTRUCTION.
The IHS Health Systems Planning (HSP) is used for space allocation criteria for new health care facilities, including medical imaging departments. The IHS standards of medical imaging practice dictate some construction criteria, i.e., adequate number of radiographic rooms, space for automated electronic image or film processing and necessary equipment, and a separate inpatient medical imaging patient waiting area. For more specific information regarding diagnostic imaging department construction and space allocation criteria, see the IHS HSP document.
3-21.5 DIAGNOSTIC X-RAY RADIATION PROTECTION
- Purpose. To establish responsibilities and procedures for diagnostic x-ray radiation protection at IHS facilities using medical and dental x-ray units.
- To reduce radiation exposure to patients to the minimum consistent with clinical requirements. This includes reducing excessive radiation by reducing retake rates and unnecessary examinations (e.g., routine employment physicals and pre-operative chest x-ray exams without clinical indications). All IHS MIPs are encouraged to use patient dose guidelines published by the FDA Center for Devices and Radiological Devices (CDRD), and/or the Conference of Radiation Control Program Directors (CRCPD).
- To ensure the AI/AN people receive quality radiology service that produces the maximum diagnostic information while minimizing patient radiation exposure.
- To reduce radiation exposure to medical, dental, and ancillary personnel to a level as low as reasonably achievable (ALARA) and lower than the occupational, absorbed, and effective dose limits established by the National Council on Radiation Protection and Measurements (NCRP) and the Occupational Safety and Health Administration (OSHA).
- To ensure radiation protection equipment (e.g., lead shields or patient restraining devices) are used during diagnostic imaging procedures and are maintained in good repair.
- To ensure only certified equipment and components are used for medical imaging examinations. Such equipment shall be selected based on its appropriateness to the medical imaging needs of the population served by the facility and in consultation with the Biomedical Engineering program.
- To inform P.L. 93-638 contractors of consultative services available from IHS MIP and biomedical engineering programs.
- Radiation Protection Technical Consultant. The IHS Institutional Environmental Health Program Manager, or his/her designee, shall be the IHS Radiation Protection Technical Consultant on radiation hazards. The IHS Radiation Protection Technical Consultant shall:
- Ensure that radiation protection surveys are conducted in accordance with the methods and frequencies described in the IHS Diagnostic X-ray Radiation Protection Survey Procedures Manual and the FDA CDRH Radiological Survey Procedures Manual.
- Ensure the Indian Health Service Survey Procedures Manual is reviewed and updated biennially.
- Coordinate a personnel monitoring system in accordance with the United States Public Health Service Indian Health Service Radiation Personnel Monitoring Program Instruction Manual.
- Develop and implement an Agency-wide policy for a training and certification program of IHS radiation protection surveyors.
- Radiation Protection Surveyor. The Area Institutional Environmental Health Specialist or designee shall be a certified radiation protection surveyor or a radiation protection surveyor in-training under supervision of a certified radiation protection surveyor. The radiation protection surveyor shall be the technical consultant on radiation hazards for the CEO or P.L. 93-638 program director. The radiation protection surveyor shall:
- Review and recommend necessary operational practices (in consultation with the MIP and/or radiologist) to ensure that employee and patient exposure meet ALARA guidelines.
- Provide radiation protection training for operators of diagnostic radiographic equipment, when requested.
- Review personnel monitoring exposure reports.
- Conduct radiological health and safety surveys of stationary and mobile medical radiographic equipment at each IHS facility once every two years and IHS dental radiographic equipment every three years. This frequency will be followed provided that a preventative maintenance contract is in place or no significant deficiencies were identified in the previous survey. Annual radiological health and safety surveys should be conducted if either one of the above conditions is missing or inadequate.
- A radiological health and safety survey may be required after the replacement of any certified components.
- Mammography units will be surveyed in accordance with MQSA requirements by a certified health physicist.
- Radiological health and safety surveys shall be conducted using the most current version of the IHS Diagnostic X-ray Radiation Protection Survey Procedures Manual and the Center for Devices and Radiological Health Use Control Manual, and/or other references, as necessary. All significant deficiencies shall be reported to the radiologist, radiographer, or radiologic technologist before leaving the facility.
- The original report of the radiological health and safety survey will be forwarded to the CEO for inclusion in the departmental equipment log books.
- Copies of the report will be given to the Area Associate Director, Office of Environmental Health and Engineering (OEHE).
- Copies of the radiological health and safety surveys shall be maintained by the radiation protection surveyor.
- The final report shall be delivered to the facility within 30 days.
- In cooperation with the local facility Radiation Safety Officer (RSO), investigate instances of excessive/abnormal exposure, (quarterly dose exceeding 600 mRem), as defined by the United States Public Health Service Indian Health Service Radiation Personnel Monitoring Program Instruction Manual. This is to determine the cause and recommend measures to prevent recurrence. The Area Associate Director, OEHE, and the Director, MIP, shall be informed of excessive occupational exposures and recommendations.
- Conduct or arrange for radiation protection review of plans for new or remodeled radiology departments. The review shall be coordinated with the Area Chief Medical Officer (CMO), the Area Biomedical Engineering program, and Headquarters counterparts. Plans for the remodeling of radiological facilities should include a shielding design by a licensed physicist.
- Conduct or arrange for surveys of new or remodeled facilities for shielding design using current NCRP criteria or other industry accepted reference in the absence of current NCRP criteria.
- Check patient ESE.
- The ESE will be measured at the time of conducted surveys and after acceptance testing of newly installed/renovated imaging systems.
- The ESE evaluation shall address commonly used imaging systems, such as automatic exposure control and/or manual techniques using CDRH or equivalent radiological phantoms. Standard radiographic examinations, such as, A/P (anterior/posterior) abdomen (23 cm), A/P lumbar spine (23 cm), P/A chest (23 cm), P/A pediatric chest (12.5 cm), and dental intraoral (Bitewing), should be evaluated.
- The functioning parameters of x-ray generating equipment, image processing, and technique factors should be considered during this evaluation.
- Any radiographic examinations with ESE measurements that exceed by more than 20 percent the values of the current patient exposure and dose guide in the most recent Conference of Radiation Control Program Directors report shall be evaluated to determine the cause.
- Recommendations will be made to reduce the ESE in consultation with the facility radiologist and lead radiology technologist. Records of ESE measurements shall be included in the radiation protection survey reports.
- Chief Executive Officer. The CEO shall be responsible for the safe operation of medical and dental facilities utilizing radiographic equipment and compliance with the recommendations of the NCRP, Federal, and other national standards/guidelines. The CEO:
- designates the local RSO;
- ensures that personnel using medical imaging equipment will be knowledgeable of departmental policies and procedures, including radiation protection practices;
- ensures training is provided to diagnostic x-ray equipment operators on radiation protection;
- ensures personnel monitoring devices are issued and used in accordance with the current United States Public Health Service Indian Health Service Radiation Personnel Monitoring Program Instruction Manual; and
- ensures that the occupational radiation dose report containing the occupational exposures to ionizing radiation is included in the employee health medical record as defined by the OSHA.
- Radiation Safety Officer. The RSO is appointed by the CEO and is qualified by training and experience to conduct the activities listed below. The local RSO:
- reviews medical imaging and dental departmental policies and procedures to ensure adherence to applicable standards and guidelines;
- develops radiation safety policies and procedures in cooperation with the directors of the medical imaging and dental programs;
- is responsible for training mobile radiographic unit operators; and
- is responsible for the annual evaluation of lead aprons and shields used to protect patients and staff.
3-21.6 PROGRAM OPERATION
- Radiographic Procedures. Radiographic procedures shall be performed by radiographers and radiologic technologists with appropriate credentials to perform these activities, except as limited by the requirements of this chapter.
- Only providers privileged by the facility to order diagnostic imaging procedures will be allowed to do so.
- Dental x-ray examinations shall be ordered by a Doctor of Dental Surgery or a Doctor of Dental Medicine.
- Ultrasound Procedures. Ultrasound procedures shall be performed by sonographers, radiologists, radiologic technologists, and/or physicians trained to meet the minimum qualifications set forth in this chapter.
- Medical imaging departments performing mammographies shall meet all the requirements of the MQSA.
- Only radiologists who meet the requirements of MQSA are permitted to interpret mammography studies.
- Only medical physicists who meet the requirements of the MQSA are permitted to conduct medical physicist surveys of mammography facilities.
- Contracting for Mobile Diagnostic Imaging Service. Contracting for mobile diagnostic imaging services should be considered when it would result in cost savings for the Government compared to developing an in-house service requiring the purchase of equipment and the hiring or training of technologists to operate the equipment.
3-21.7 REDUCING EXPOSURE
- General X-ray Procedures. Only persons required for the radiographic procedure shall be permitted in the room during an exposure. All such persons shall be properly shielded and protected. Only the patient's body part to be x-rayed shall be in the useful beam.
- Annual inspection/testing of leaded aprons/gloves shall be performed.
- No persons occupationally exposed to radiation shall routinely hold patients during exposures, nor shall any one person be regularly used for this service.
- Each medical facility shall establish a policy on the use of patient restraints during radiographic procedures.
- The policy shall state that restraints and positioning devices shall be used in preference to requiring the use of personnel to hold the patient.
- Parents and relatives should not be used to hold infants and small children during x-ray procedures, except in an emergency; and then such persons shall use protective devices.
- Each facility shall establish a fetal protection policy that conforms with the current issuance of the NCRP publication #116, "Limitation of Exposure to Ionizing Radiation." The fetal protection policy shall ensure that occupational exposure levels for female employees of child-bearing age are within the NCRP guidelines.
- Patient Preparation.
- Thorough patient preparation, including patient measurements, shall precede any radiographic exposure to optimize the radiographic technique and reduce the need for retakes.
- Patients instructed in the proper methods of breathing for radiographic examinations could avoid motion during radiographic procedures.
- Reducing Exposure to the Patient. (applicable to mobile diagnostic x-ray units)
- Patients shall be x-rayed only when clinically indicated.
- Patient exposure shall be kept at the minimum consistent with clinical objectives.
- Patient exposure should be minimized through the use of the optimum or fixed kilovoltage (KVP) technique, proper collimation, appropriate film/screen combinations, and patient shielding.
- "Patient Exposure and Dose Guides," published by the CRCPD, shall be used to compare with measured patient ESE.
- Current, accurate manual and automatic (photo-timed) techniques shall be available and used in each radiographic room and procedure.
- Only clinically indicated administrative radiographic examinations shall be performed.
- The useful beam should be collimated to the smallest area necessary to obtain the diagnostic information needed.
- Appropriate and effective shielding for critical organs (e.g., breast, gonads, and thyroid) shall be used on patients during selected medical x-ray examinations. Shadow shields, lead aprons, waist aprons, and breast shields shall be used on all patients where such shielding will not interfere with the visualization of the diagnostic area (such as scoliosis examinations).
- Factors to consider for the need of the patient shall include the following:
- The clinical objectives of the radiographic examination shall not be compromised.
- Specifically for female clients with reproductive potential, the gonads shall not be within the primary x-ray beam area, or within close proximity (i.e., 5 cm) to the beam edge of an adjacent primary beam exposure area, despite proper beam limitation.
- Excluded examinations would include, but not be limited to, abdomen, pelvis, hips, and barium enema studies.
- Pregnancy. Medical imaging departments shall establish and implement a program to identify women between the ages of 12 and 50 who may be pregnant. The following information should be obtained by the referring physician or practitioner and recorded on the x-ray requisition form:
- What is the date of the last menstrual period? If this date is more than 10 days before the date of the examination, the question at 3-21.7D(2) shall be asked.
- Is there a possibility of pregnancy? If YES, it is recommended that the examination be rescheduled to within 10 days after the patient's next menstrual period or there should be further investigation into the possibility of pregnancy. If NO, the question at 3-21.5D(3) shall be asked.
- How is the client certain she is not pregnant? The answer given should be included on the x-ray requisition.
- Standard medical imaging examinations should be postponed, if possible, when pregnancy is confirmed or suspected. When the clinical evaluation by the referring physician or practitioner indicates the diagnostic imaging procedure is medically necessary (i.e., a positive finding as a result of the procedure could be more beneficial for the patient than the exposure to radiation), the referring physician or practitioner shall acknowledge the medical necessity of the procedure due to a life-threatening situation and proceed with a modified or limited x-ray examination.
3-21.8 EQUIPMENT PROCEDURES
- Radiographic Film Storage. Radiographic film should be stored according to the manufacturer's specifications. Outdated film or film exposed to heat or radiation should not be used. Defective film should not be stored with new film stock. Film should not be stored for more than 6 months without refrigeration. Unexposed x-ray film shall not be stored in or near a controlled area without proper shielding.
- Procedures Applicable to Fluoroscopic Units. Fluoroscopic procedures shall be performed only by properly trained physicians with appropriate privileges granted by the service unit governing body. Each registered radiology technologist (RTR) who uses fluoroscopy shall have written authorization from the Chief Radiologist and/or Clinical Director. The authorization shall describe the situations when fluoroscopy may be used. The authorization statement shall be on file in the facility administration office and radiology/medical imaging department.
- Fluoroscopy procedures shall be performed only with image intensifying systems or equivalent digital technology.
- All personnel present in the radiation area shall use appropriate protective devices (i.e., lead-lined aprons or wheeled partitions) when radiation exposures are generated.
- Replacement systems shall be equipped with automatic brightness controls.
- The hands of the fluoroscopist shall not be placed in the useful beam unless the beam is attenuated by the patient and a protective glove of at least one-quarter millimeter lead or its equivalent is worn.
- Procedures Applicable to Mobile and Fixed Above Table Radiographic Units.
- The exposure switch on mobile units shall be arranged so that the operator may stand at least 2 meters from the patient, the x-ray tube, and the useful beam. The operator shall be positioned at least 2 meters from the radiographic equipment and shall wear a protective apron or stand behind a suitable shield.
- Mobile equipment shall be used only for examinations where it is impractical or hazardous to the patient's physical condition to transfer the patient to the permanent radiographic installation.
- The service unit RSO shall ensure that the operators of mobile equipment understand the proper use and limitations of the equipment to avoid needless exposure of the patient or other people in the vicinity.
- The exposure switch on fixed radiographic units, except for those used in conjunction with "spot-film" devices in fluoroscopy, shall be arranged so that the operator cannot conveniently operate the switch outside a shielded area.
- Doors leading into radiographic procedure rooms shall be closed during procedures, and an outside-the-room indicator light/sign shall be visible when the room is in use.
- A mobile medical x-ray unit shall not be used as the sole radiographic system at an IHS facility except under extenuating circumstances. These circumstances shall be reviewed and approved by the Area CMO and the Director, MIP, prior to the start of such an arrangement.
- Sufficient clinical information shall be provided on all x-ray exam requests to ensure the correct clinical area of interest is radiographed and to focus the interpretive efforts of the radiologist.
- Shielding and Equipment. Before rearranging existing x-ray equipment, installing new x-ray equipment, renovating, or constructing new facilities to house x-ray equipment at any installation, the proposed changes should be reviewed by the Area Institutional Environmental Health Specialist or his/her designee. The plans should also be reviewed by the Director, MIP. The review should include input from the Area CMO and biomedical engineering program. Construction of new facilities or renovations to house x-ray equipment shall receive prior approval from Headquarters as specified in the HSP process. Shielding plans designed by a qualified physicist should be included in the renovation or new facility construction documents.
- Maintenance of X-ray Equipment.
- Radiographic equipment shall receive preventive maintenance and calibration in accordance with Part 5, Chapter 14, "Biomedical Engineering," Indian Health Manual (IHM).
- Each film processing area shall be appropriately ventilated with at least 10 exhaust air exchanges per hour and maintain a negative air pressure relationship with adjacent areas.
- The film loading bench and counter top shall be clear and free of dust or moisture.
- Cassettes and screens shall be cleaned in accordance with the manufacturer's instructions at least every 6 months or more often when indicated to remove blood, bodily fluids, etc.
- Each facility with an automatic film processor shall have a preventative maintenance program that consists of written policies and procedures for the operation and maintenance of the automatic film processor and silver recovery program.
- Automatic film processors shall be operated, cleaned, and serviced according to the manufacturer's recommendations.
- An equipment maintenance log and the date corrections were completed shall be maintained in the biomedical or medical imaging department.
- Maintenance, cleaning schedules, and other related mammography activities shall be conducted at the frequency required by the MQSA.
3-21.9 PATIENT, CLIENT, OR CUSTOMER CONSIDERATION
The patient has the right to considerate and respectful care, including consideration of the psycho-social, spiritual, and cultural variables that influence perceptions of illness. The patient has the right to accept or deny the medical imaging examination, and the decision shall be honored.
The patient has the right to make health care decisions, including the right to accept or refuse medical imaging procedures or treatment, to the extent permitted by law. The patient shall be informed of the medical consequences of such refusal. The right of the patient to deny the medical imaging examination may be overridden by the designated representative or surrogate power of attorney, i.e., decision maker participating in the consideration of issues that arise in the care of the patient. The medical imaging staff members could decide to proceed with the examination without direct permission from the patient based on ethical considerations. A notation in the patient's medical chart shall state that the patient's designated representative granted permission for the patient to have the procedure performed against the wishes of the patient.
It is the right of the patient's guardian, next of kin, or legally authorized responsible person to exercise, to the extent of the law, the rights delineated on behalf of the patient if the patient is incapable of understanding the proposed treatment or procedure, is unable to communicate their wishes regarding treatment, or is a minor.
Following the explanation of a procedure, the patient has the right to request a technologist or chaperon of the same sex to be present during the examination. Every effort shall be made to honor the client's request. Examples: genital urinary exams, mammography, barium enema, etc.
- Video Tape Examinations or Procedures. The use of photographic imaging equipment shall not be permitted during an examination or procedure without the patient’s written informed consent.
- Static Picture of the Unborn Fetus. A static picture of the unborn fetus produced from the ultrasound imaging equipment may be taken and given to the expecting mother.
- Tele-Radiography. Images sent electronically via tele-radiography shall comply with the Health Insurance Portability and Accountability Act (HIPAA) guidelines and American College of Radiology recommendations for image quality and interpretation.
3-21.10 QUALITY CONTROL
- Comprehensive Radiological QC Program. A comprehensive radiological QC program shall be conducted in all IHS facilities containing x-ray equipment. The Medical Imaging Department supervisor(s) shall ensure that elements 3-21.11E and F are properly conducted and documented.
- Equipment QC Manual. Each service unit medical imaging service shall maintain a complete “Quality Control Manual” (QCM) for all medical imaging equipment in use. The QC technologist shall be accountable for presenting a current QCM during a JCAHO, AAAHC, or CMS accreditation review. (The QCM shall contain all the information required by Section 3-21.4.) The QCM will contain:
- documentation for each type of equipment;
- reports/dates of QC tests; and
- information for machines generating diagnostic medical images, i.e., x-ray machines, fluoroscopes, mammography, ultrasound, CT, and MRI.
- Equipment Techniques Guide for X-ray Exposures. Each medical facility medical imaging staff shall prepare a techniques guide for x-ray exposures for each x-ray machine. The guide shall be based on patients' body habitus. The guide shall be updated when equipment is repaired, re-calibrated, or reformatted. The date of the equipment update shall be placed on the upper right-hand or left-hand comer of the guide.
- Film Reject Analysis. Departmental film reject analysis shall be performed to evaluate continuous quality improvement of patient care, operating cost, departmental efficiency, and reason for rejects (i.e., over-exposure, under-exposure, positioning, motion, technical errors, QC testing, processor clean-up, and waste).
- Film Based Imaging Systems. Routine automatic film processor testing shall be performed for medical and dental processors. Periodic monitoring of dental processors using the dental radiographic normalizing and monitoring device should be performed. Medical x-ray film processors should be tested daily for temperature, base plus fog, contrast, and speed. The following items apply to medical x-ray film processor testing:
- A box of film shall be designated and used for QC testing.
- A crossover procedure shall be conducted when a new box of film (with a different emulsion batch number) is used.
- Safelight testing shall be done using the CDRH protocol or equivalent.
- Fog testing shall be done at least annually or when a problem is suspected.
- Screens shall be checked visually for defects, and film/screen contact testing shall take place every 6 months.
- Cassettes shall be numbered as a means of accurately documenting QC testing.
- New or replacement grids should be examined for damage prior to use.
- Digital (Electronic) Imaging Systems.
- Image processing QC will be conducted as recommended by the manufacturer and other industry-accepted standards.
- Manufacturer-provided phantom image (QC test tool) testing shall be conducted as recommended by the imaging system manufacturer.
- Monitors and work stations shall be checked for QC purposes as recommended by the manufacture and other industry-accepted standards.
- Grids shall be used on all body parts that exceed 10 cm thickness.
- Imaging plates shall be cleaned in accordance with the imaging system manufacturer's recommendation.
- Performance Improvement. Radiology/medical imaging departments shall have a written performance improvement (PI) plan designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. The service unit shall implement this plan as part of the PI program.
The PI written plan shall describe the program’s objectives, organization, scope, and mechanisms for overseeing the effectiveness of monitoring, evaluating, and problem-solving activities. Indicators of dysfunction shall be documented and appropriate action taken to correct. If dysfunction is found, the issue shall be highlighted in subsequent searches. At a minimum, there should be a PI indicator for the radiographer (i.e., repeat rates), medical staff (i.e., essential agreement of initial impression with the radiologist’s interpretation) and the radiologist (i.e., peer review).
- Medical Imaging Records. Medical imaging records shall be identified, numbered, filed, safeguarded, maintained, and disposed of according to the following criteria:
- Records Retention and Disposal. Records retention and disposal shall be in accordance with the Part 5, Chapter 15, "Records Management Program," IHM.
- Patient Identification. Standard input of data throughout IHS facilities shall follow a specific pattern, such as: last name, first name, NO space between names; and use of CAPITAL letters for the full name. Also, L shall be used for left and R for right.
- Diagnostic Films. Diagnostic films shall be identified by:
- the patient's name
- his/her facility registration number,
- the medical facility's name, and
- the date of the examination.
- Film Folder Identification. The patient's last name, first name, middle initial, and facility identification number shall be recorded on the film jacket.
- Medical Imaging Locator Cards. A hard copy of a medical imaging locator card or an electronically retrievable examination record shall be made easily available for each patient. The information contained should consist of the name of the patient, the facility registration number, the date, and the type of examination.
- Resource Patient Management System Radiology Package. The Resource Patient Management System (RPMS) radiology package is recommended for implementation at service units. The use of the radiology RPMS software will improve recordkeeping, billing, and the tracking of information. Daily QC activities may be performed for examination status review for accuracy and accountability.
- Release of Films. The release of imaging films, including electronic images, shall be in compliance with the Privacy Act and HIPAA.
- Records Disposition Schedule. The IHS Records Disposition Schedule (RDS) (see IHM Section 5-15.4A) is the central, key source of information for effective records management activities within your office. The RDS identifies and describes records created and used in the operations and functions of the IHS and provides disposition authorities and instructions. Most radiology records disposition authorities and instructions can be found in the RDS Schedule 3, Section 6, "Laboratory Services (including Radiology)." You may obtain a copy of the IHS RDS by contacting your respective Area records management officer or the Agency records management officer.
- Electronic Equipment. Electronic equipment should be stored both on-site and at a remote location so that a back-up copy is available in compliance with HIPAA requirements. The record copy of "paperless" or "filmless" electronic medical imaging records cannot be destroyed until the Archivist of the United States has approved a disposition for IHS electronic medical imaging records. Storage requirements for on-site electronic imaging records shall be assessed by the facility medical staff to ensure the adequate on-site availability of prior imaging studies.
- Equipment inventory records shall be maintained until equipment replacement occurs.
- Equipment maintenance and repair records shall be maintained until equipment is replaced.
- Film - Unexposed, Exposed, Surplus, Storage, and Silver Recovery. Unexposed and exposed diagnostic films shall be stored, safeguarded, and handled as follows.
- Silver Recovery. All films declared as surplus shall be recycled for silver recovery. Silver recovery should also be performed on used film-processing chemistry prior to disposal.
- Silver Collection. Silver collection shall be in accordance with IHS policy. All IHS facilities shall dispose all chemistry (i.e., developer, fixer, and films containing silver) in the most cost-effective manner for the Government and in accordance with Federal, State, and local regulations.
- Storing and Safeguarding of Exposed Films Following Radiologist Interpretation. Diagnostic films shall be placed in secure storage at the service unit. Proper atmospheric conditions shall be maintained to prevent film deterioration.
- Unexpected. Unexposed films shall be stored in accordance with the manufacturer's recommendations.
- Safety Other Than Radiation. Refer to specific Area Office or service unit guidelines as they pertain to safety in accordance with OSHA and the National Fire Protection Agency.
3-21.11 REQUIRED REPORTS
- Workload Reports. Where required by the service unit, workload reports shall indicate units of total diagnostic examinations completed by specific sections, i.e., x-ray, mammography, CT, MRI, and ultrasound. The report should include the number of patient visits and percentage of repeated diagnostic exposures. The Director, Medical Imaging Department, or the lead technologist shall submit the report to the CEO of the facility as required by the facility's administrative staff and to the Area Institutional Environmental Health Officer.
- Radiological Health and Safety Survey Reports. Radiological health and safety survey reports are completed at the frequency required by Section 3-21.5C(2)d and (2)e of this chapter. The Radiation Protection Surveyor will complete the report and send it to the CEO with a copy to the Area Associate Director, OEHE.
- Personnel Dosimetry Reports. Employees with the potential for radiation exposure as defined in the United States Public Health Service Indian Health Service Radiation Personnel Monitoring Program Instruction Manual shall wear personnel radiation monitoring devices. The local RSO shall maintain the records from the monitoring devices. The local RSO shall provide monthly or quarterly readings to the department supervisor. The supervisor shall inform each individual named on the report of the readings of their exposure reported by the local RSO. If an occupational exposure has occurred within the past year, the supervisor shall conduct a review with each employee to discuss their total radiation exposure. The employees shall initial the report indicating their review and understanding of the data contained within the annual report. The employees' annual radiation exposure report shall be maintained by the facility throughout the employment of the person plus 30 years.
- Contingency Status Reports. The IHS hospitals pay a fee to JCAHO to be surveyed for accreditation. The JCAHO survey team requires the hospital to submit documents for review prior to an in-depth, on-site review of the hospital's facility, staff, and process-of-care provision. Depending on the survey team's findings, a hospital may be fully accredited, accredited with contingencies, or not accredited. Accreditation without contingency means that a hospital will not be required to undergo the procedure again for 3 years, while contingencies may shorten that time span or require the hospital to demonstrate, through written reports, progress on the contingencies during the 3-year period.
3-21.12 MANAGEMENT CONTROL
- Medical Imaging Program Review. The MIP review shall be conducted at the discretion of the Director, MIP, and/or upon request of the Area Director or his/her designee. The Director, MIP, or a review team shall review the policies and procedures to:
- assess the Area PI Plan;
- review implementation of that plan;
- define and help resolve special concerns or needs of the program staff;
- identify successful projects and practices deserving dissemination;
- share the latest information on program development, planning, policies, staff opportunities, etc.; and
- determine compliance with elements of this IHM chapter.
- Program Review of Diagnostic Imaging Departments. The Area Director or his or her designee may request the Director, MIP, to conduct a program review of specific service units within his/her scope of responsibility. A report of the program review shall be submitted to the Area Director, Area Associate Director, OEHE, and the CEO within a timely manner following the review process.
- The CEO/program director shall ensure all corrective measures are implemented expeditiously.
- A record of corrections shall be maintained in the facility.
- Copies of the survey report and corrective records shall be available for the JCAHO/AAAHC/CMS surveyor upon request.
- The survey report shall be submitted to the local safety committee for follow-up and corrective action.
- A process should be implemented to address continual deficiencies (such as forwarding reports to the governing body for follow-up action).
- Area Diagnostic Imaging Program Review. A program review may be requested for each Area Diagnostic Imaging Program; its performance is directed by Section 3-21.2A(8) and further described in the IHM, Part 5 , Chapter 16, "Management Control Systems."
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