Quality assurance in radiology from the viewpoint of the specialists and the supervisory authorities]

Quality assurance for diagnostic imaging equipment has been successful so far. In the old Federal Republic of Germany, inspection of the existing equipment in diagnostic radiology in being completed. The estimated number of uninspected units is relatively small. All detected shortcomings have been repaired in the meantime, and very few faults have been detected in newly installed equipment. Of the status obtained following inspection and repair is to be maintained, however, more effective methods must be implemented. There is no doubt that everybody involved in quality assurance programs, including the experts and supervisory authorities, is actively working on improving the results.     

Expanding the scope of practice for radiology managers: radiation safety duties

In addition to financial responsibilities and patient care duties, many medical facilities also expect radiology department managers to wear "safety" hats and complete fundamental quality control/quality assurance, conduct routine safety surveillance in the department, and to meet regulatory demands in the workplace. All managers influence continuous quality improvement initiatives, from effective utilization of resource and staffing allocations, to efficacy of patient scheduling tactics. It is critically important to understand continuous quality improvement (CQI) and its relationship with the radiology manager, specifically quality assurance/quality control in routine work, as these are the fundamentals of institutional safety, including radiation safety. When an institution applies for a registration for radiation-producing devices or a license for the use of radioactive materials, the permit granting body has specific requirements, policies and procedures that must be satisfied in order to be granted a permit and to maintain it continuously. In the 32 U.S. Agreement states, which are states that have radiation safety programs equivalent to the Nuclear Regulatory Commission programs, individual facilities apply for permits through the local governing body of radiation protection. Other states are directly licensed by the Nuclear Regulatory Commission and associated regulatory entities. These regulatory agencies grant permits, set conditions for use in accordance with state and federal laws, monitor and enforce radiation safety activities, and audit facilities for compliance with their regulations. Every radiology department and associated areas of radiation use are subject to inspection and enforcement policies in order to ensure safety of equipment and personnel. In today's business practice, department managers or chief technologists may actively participate in the duties associated with institutional radiation safety, especially in smaller institutions, while other facilities may assign the duties and title of "radiation safety officer" to a radiologist or other management, per the requirements of regulatory agencies in that state. Radiation safety in a medical setting can be delineated into two main categories--equipment and personnel requirements--each having very specific guidelines. The literature fails to adequately address the blatant link between radiology department managers and radiation safety duties. The breadth and depth of this relationship is of utmost concern and warrants deeper insight as the demands of the regulatory agencies increase with the new advances in technology, procedures and treatments associated with radiation-producing devices and radioactive materials.     

Quality assurance in x-ray diagnosis as specified in DIN 6868

Regular quality control and safety assurance in diagnostic radiological systems are included in the new radiation protection regulations. The monitoring program for both the equipment and the film processor can enable the user to recognize loss of quality early. Variables in the film processing unit can be differentiated from faults in the X-ray equipment more easily, including its use. The cost and time spent in setting up a safety assurance program are justified by the increase in quality.     

1998 MQSA (Mammography Quality Standards Act) final rule released. American College of Radiology

In October 1997, the Food and Drug Administration (FDA) released the final regulations for implementing the Mammography Quality Standards Act (MQSA). Briefly, the final rule establishes experience requirements for medical physicists and radiologic technologists and clarifies equipment standards. The Interim Rules, issued in late 1993 and amended in 1994, now apply. Final regulations become effective April 1999, with certain equipment regulations becoming effective in October 2002. Changes in experience and continuing education requirements for medical physicists and radiologic technologists parallel requirements in the interim rule. The FDA shifted the majority of quality assurance requirements for equipment to the quality assurance section of the regulations, and will treat them as performance standards. Under the final rule, each facility is required to have a system to ensure that mammogram exam results are communicated to patients in a timely manner. Under the interim regulations, mammography facility personnel must continue to participate in medical education programs in mammography to acquire five CME/CEU per year.     

Analysis of the status of X-ray diagnosis in Ghana

In Ghana's healthcare system there are about 4200 people to each physician. The annual frequency of X-ray examinations during the period 1990 to 1996 ranges from six to 11 per thousand population. Chest radiograph examinations account for 46.5% of the annual frequency. The survey revealed that there are no established acceptance testing procedures for newly installed X-ray equipment. Neither institutional level performance checks following major repairs of faulty equipment, nor routine checks at regular intervals to ensure self-consistency of equipment performance are conducted. The results of the film retake analysis undertaken indicates a need for quality assurance programmes to be taken seriously to avert considerable cost and high patient doses. Radiographers and X-ray-technical officers who physically perform X-ray examinations should receive adequate training in the selection of procedures so as to ensure that doses to patients are as low as reasonably practicable in order to achieve the desired diagnostic objective.     

Experiences in the testing of standard data on roentgen diagnostic equipment

The TUV (German Standards Control Body) are performing inspections of standard characteristics of different devices for medical diagnostic radiology used in medical consulting as well as in hospitals. The inspections are carried out according to the recommendations of the German rule "Richtlinien über die Aufzeichnungen nach # 29 der R?ntgenverordnung-R?V" (i.e. guide line on recording according to # 29 R?V). In addition the surface dose is measured, which is a characteristic of an x-ray equipment and the knowledge of which is helpful when estimating the patient's radiation exposure. The latter inspections are performed for different modes of operation. In this paper the inspection procedure as well as the results of the inspections of radioscopy and of radiography equipment are presented and discussed. These inspections may be regarded as a part of a general performance test aimed at quality assurance in medical diagnostic radiology. The results show a wide statistical variation of several inspected parameters (e.g. film exposure, exposure rate of the image intensifier). The possible causes of this variation are presented. A further result of the inspections is the fact that in many cases some components of the complete imaging system are unrecognisedly defective. For this reason the inspection records contain-if necessary-recommendations for the improvement of the quality of the image and radiation protection.     

The role of the forensic pathologist in quality assurance and safety of patient care

During this past half century, there has been remarkable increase in the role of forensic pathologists and medical examiners in the determination of cause and manner of deaths in health care facilities and investigations of quality of patient care. Autopsy data are an essential part of this quality assurance (QA) program in patient care, especially in trauma centers' QA programs. Forensic pathologists participate in evaluating appropriateness of patient care where death occurs during or following therapeutic and diagnostic procedures. Continuous quality improvement programs now extend into data sharing in child and elder abuse, monitoring of defective medical devices and consumer products which contributed to deaths. In recent years, forensic pathologists are increasingly requested directly by family members to conduct private autopsies to provide independent opinions as to quality of patient care. Thus forensic pathologists are contributing expertise to an ever widening circle of influence in prevention of unnecessary deaths with quality assurance programs and peer review processes.     

Constancy check of beam quality in conventional diagnostic X-ray equipment.

A tandem ionization chamber was developed for quality control programs of X-ray equipment used in conventional radiography and mammography. A methodology for the use of the tandem chamber in the constancy check of diagnostic X-ray beam qualities was established. The application at a medical X-ray imaging facility of this established methodology is presented. The use of the tandem chamber in the constancy check of diagnostic X-ray beam qualities is a useful method to control the performance of the X-ray equipment.     

Quality control and diagnostic reference levels in intraoral dental radiographic facilities

OBJECTIVES: A quality control program in intraoral radiographic equipment was conducted aiming to verify compliance with the latest legal requirements and to measure radiation dose in order to contribute to the establishment of appropriate diagnostic reference levels. METHODS: This study was performed in 191 intraoral radiographic facilities in Northern Greece. The quality control program included visual inspection of the unit, registration of its characteristics, measurement and calculation of several radiological parameters, including entrance surface dose, and overall compliance with legislation requirements. RESULTS: Most units (61.8%) were found to perform within their corresponding specifications. Exposure timer accuracy was the parameter that the dental units showed the poorest performance. Inadequate beam filtration was found in almost half of the older 50 kVp units. Entrance surface dose showed significant discrepancies, varying from 0.30 mGy to 16.09 mGy with a third quartile value of 3.37 mGy. CONCLUSIONS: A diagnostic reference level of 3.5 mGy is considered to be a realistic value for all intraoral equipment currently operating in Greece. However, for newly installed units, a value of 2.8 mGy is considered to be more appropriate.     

Infection control in the department of nuclear medicine

Concern about the spread of infections in the hospital setting has prompted regulatory agencies to mandate infection control standards. Each hospital department is required to have written policies and procedures which describe measures to prevent and control the spread of nosocomial infections (hospital acquired infections), along with quality assurance programs to assure that procedures are followed. The Department of Nuclear Medicine, as other departments, should have procedures which address special precautions for the prevention of nosocomial infections. This article will focus on a new approach to prevent nosocomial infections, guidelines for handling patients and contaminated equipment, and the importance of quality assurance activities to monitor compliance to established standards. An opening discussion on the routes of transmission, and factors necessary for transmission of infection, will serve as a review to assist with understanding the concept for handling the hospitalized patient in a Nuclear Medicine setting.     

Continuing reject-repeat film analysis program

A continuing image quality assurance and control program has been employed in the Department for over 9 years. One of the tools used in assessing quality has been reject-repeat analyses performed 9 times. The reject rate dropped from 15% in 1980-1981 to 8.4% in 1982. After moving to a new department with new film processing systems and, in part, new diagnostic equipment, the rejection rate increased to 13.2%. New and renewed procedures such as increased control and adjustment of technical equipment (in particular the automatic daylight film processing systems), information and education, decreased the rejection rates to 9.2 and 6.6% on 2 analysis occasions in 1987, and to 6.4% in 1988. Image quality assurance and control have to be continuous activities if they are to yield favourable and economically justifiable results.     

The importance of education and training in reducing patient doses

Education and training in radiological protection of patients is an important part of a quality assurance program and it is recognised that the knowledge in radiation protection helps prescriber to a correct indication to procedures and practitioner to design and conduct an optimised examination. In the European Union, the international recommendations have been translated in the European Directive 97/43/Euratom asking proper education and training for professionals involved in medical exposures, both for diagnosis and therapy. International and European guidelines, together with guidelines proposed by international and national bodies and associations, are helping institutions to set up education and training programs. Several experiences and research projects have demonstrated the impact on reduction of patient doses when a quality assurance and training program in radiation protection has been conducted.     

Implementing quality assurance in roentgen diagnosis in accordance with the new roentgen ordinance

Image quality and radiation protection can be optimised by means of quality assurance testing in accordance with the new Federal German regulations governing the handling of x-ray equipment (functional testing and control of constancy of performance). The x-ray films of patients are examined according to quality criteria relating to the organs of which x-ray films are produced; the diagnostic pointers obtained from these x-ray films enable on-target counselling, taking into consideration the technical guidelines on the taking of x-ray films to produce best possible results.     

Automatic film processing: analysis of 9 years of observations.

A survey method known as the sensitometric technique for the evaluation of processing (STEP) has been used to monitor processing speed of over 2,000 automatic film processors in hospitals, private offices, and mammography facilities since 1981. Analysis of data obtained through this program revealed underprocessing at 33% (76 of 231) of observed hospitals in 1987, 7% (13 of 179) of mammography facilities in 1988, and 42% (101 of 241) of private practices in 1989. Underprocessing at mammography facilities decreased from 18% (25 of 139) in 1985, which was contrary to the trend in hospitals. The consequence of underprocessing is higher radiation exposure and a degradation in film contrast. Evaluation of automatic film processors is a necessary part of any comprehensive evaluation of a diagnostic radiography facility. The STEP procedure was designed only as a field survey test; to ensure optimal conditions for obtainment of diagnostic quality radiographs, facilities should perform quality assurance evaluations of their processing equipment and verify that processing recommendations of manufacturers are being followed.     

A novel quality assurance method in a university teaching paediatric radiology department

Primary diagnostic equipment in a paediatric radiology department must perform at optimal levels at all times. The Children's Hospital Radiology Department in Winnipeg, Canada, has developed an impartial means of reporting radiographic image quality. The main objectives of this study programme were two-fold. First, to monitor diagnostic X-ray equipment performance, and second, to improve the resultant image quality as a means of implementing the fundamental concepts of continuous quality improvement. Reading radiologists completed a quality assurance (QA) card when they identified a radiographic image quality problem. The cards were subsequently collected by the clinical instructor who then informed, in confidence, the radiographers of the written comments or concerns. QA cards have been conspicuously installed in the paediatric radiology reading room since the middle of 1993. Since its inception, equipment malfunction has been monitored and indicators for improving image quality developed. This component of the QA programme has shown itself to be a successful means of communicating with radiographers in maintaining superior image quality.     

伽玛刀质量保证的日常程序化管理

目的为保证伽玛刀放射外科治疗的精确性和安全性，按照国内、外标准制定了一系列质量保证程序。方法此质量保证程序涉及有关设备和治疗操作两方面内容，并规定了各项措施的检测频率和允许误差范围。结果剂量率输出的误差为0～0．3％（〈3％），机械等中心精度0．26～0．31mm（〈0．5mm），其他各项检测结果均在允许误差范围内。结论质量保证的日常程序化管理可有效地保证伽玛刀放射外科治疗的精确性和安全性。     

NRC inspections: risk-informed and performance-based

In 2002, the U.S. Nuclear Regulatory Commission (NRC) revised its regulations governing the use of byproduct materials for medical purposes (10 CFR Part 35). These changes were the result of a detailed, 4-year examination of the issues surrounding the medical use program of the NRC and are stated in the latest revision to its medical policy statement, published in the Federal Register on August 3, 2000. As part of an overall program for revising its regulatory framework for medical use, the NRC revised its medical policy statement in keeping with the goal of focusing regulation on those medical procedures that pose the highest risk and structuring the regulations to be risk-informed. NRC inspection procedures were also revised to focus on high-risk activities through a performance-based approach, that is, through observations and interviews with licensee personnel performing NRC-regulated tasks. The purpose of this article is to inform the radiation worker (nuclear medicine technologist or authorized user physician) of the revised focus of the medical use program of the NRC and inspection procedures relative to nuclear medicine-licensed activities. After reading this article, the radiation worker should be able to describe the concept of risk-informed, performance-based regulations and inspections, identify areas of high-risk activities in the nuclear medicine laboratory, and describe techniques used by the NRC inspector to determine the licensee's compliance with the regulations.     

2018—2021年南疆地区医疗机构放射诊断工作场所防护检测情况及结果分析

目的分析南疆地区基层医疗机构医用X射线诊断设备工作场所X射线防护情况及问题, 并提出相应措施和建议。方法按照国家医用辐射防护监测项目方案和放射卫生相关标准要求, 选取放射诊疗机构的医用X射线诊断设备进行工作场所的防护检测, 并对结果进行统计分析。结果 2018—2021年, 共检测南疆4个地区15家放射诊疗机构, 开展工作场所防护检测84次, 合格率98.8%, 与内地包括东中部地区一致。结论对于南疆地区放射诊疗机构医用辐射防护现状, 建议加强放射诊疗设备监督管理工作, 提高新疆地区本地医用辐射防护监测技术队伍检测能力, 提高南疆地区放射卫生工作水平。     

The final rule: what administrators must know by April 28.

On April 28, 1999, the Final Rule of the Mammography Quality Standards Act (MQSA) goes into effect. The Final Rule remains basically the same, with the addition of a few new specifications and modifications. The Quality Standards are divided into two parts. To obtain and maintain compliance with the standards, facilities must be most familiar with sections 900.10 through 900.12 in Subpart B. A policy on reinstatement, added to the section on requirements for certification, outlines the conditions facilities must meet to have their certification reinstated. The requirements for mammography personnel, equipment and general quality assurance standards are listed in section 900.12, (a) through (j). A new requirement is that mammography technologists must have 40 hours of direct instruction, eight of which must include training in each modality they will use to perform examinations. All mammography personnel must have a minimum of eight hours training before working independently in a new modality. The Final Rule makes it clear that mammography facilities are responsible for communicating test results to patients. Under the Final Rule, responsibility for a facility's quality assurance program now belongs to the lead-interpreting physician, a position facilities are now required to have. Facility cleanliness and infection control standards have been added to the section on QA requirements. The Final Rule establishes that facilities must establish and implement an infection control program, as well as a documented procedure for resolving consumer complaints.