Effective Quality Assurance Program Research Articles

Product Liability: Beyond Loss Control–An Argument for Quality Assurance

Companies should be diligent in examining the relationship of product liability claims and effective quality assurance programs. A review of the literature suggests there are many writings about the mechanics of a product liability case, but very little hard evidence to suggest that companies are saving money because of implemented quality initiatives. While liability in this arena is usually borne by an injury that is due to a defect in either design, manufacturing, or marketing materials, suits are generally filed under three broad categories: negligence, breach of warranty, or strict tort liability. Properly implemented quality assurance initiatives will serve a company by tracking all aspects of the operation, from design to packaging, in order to determine where waste and defects are occurring. The courts are looking for this documentation, as well as how negative discoveries are handled in a company's quality management system. Since the courts are looking beyond a simple defect to determine a company's methodology for handling problems, effective quality systems must exist to demonstrate the exercise of due diligence. They also serve as documentation controllers that disallow “smoking guns” (internal or external communiqué) from becoming financial liabilities.

TH-A-M100F-01: QA for Imaging Systems Used for Planning (CT, PET, MR)

Imaging for radiation therapy treatment planning has different goals than diagnostic imaging. Quality assurance (QA) of imaging devices (CT, PET, MR) which are used for radiation therapy imaging will therefore have different or additional goals compared to QA for diagnostic imaging purposes. Use of PET and MR imaging in radiation therapy is constantly increasing and reliable performance of these imaging modalities is important to avoid potentially significant errors. Quality assurance for CT scanners used for radiation therapy scanning is relatively well established and defined. This process remains to be adequately defined for PET and MR scanners that are used for treatment planning. Evaluation of image quality of CT, PET, and MR scanners is generally adequately addressed by procedures which were established for diagnostic imaging. Design of QA protocols for radiation therapy scanning should be founded on procedures which are used for diagnostic imaging. Evaluation of mechanical accuracy and image spatial integrity is unfortunately not a major concern in diagnostic imaging and these parameters are often not sufficiently addressed in diagnostic QA protocols. All three imaging modalities have multiple potential sources of spatial and geometric errors and understanding of these parameters is necessary for design of an effective quality assurance program. The design of QA programs for these devices will be affected by the location of individual scanner and distribution of its utilization for diagnostic and radiation therapy imaging. Scanners which have dual purpose (diagnostic and treatment planning imaging) should have a QA program designed jointly by diagnostic and radiation therapy physicists to ensure that the program meets the needs of both groups. The quality assurance for these imaging modalities in the radiation therapy goes beyond the QA of the scanners and should include evaluation of implementation of images in the treatment planning process. This should include evaluation of data transfer, image registration, potential degradation in image quality, image distortions, and evaluation of process for delineation of tumor and normal structure volumes. MR and PET images can contain biologically active regions which may not correlate with any readily visible anatomic features. Correct identification and use of these regions in the treatment planning process should be a major concern of the QA program. This lecture will provide an outline and description of QA program for CT, PET, and MR scanners used in radiation therapy. The fundamental goals of such program will be described and information which can be used for establishment institution specific QA programs will be provided. Educational Objectives: 1. Describe goals of QA programs for CT, PET, and MR scanners used for radiation therapy imaging. 2. Describe QA process for individual imaging devices. 3. Describe a concerns for verification of correct implementation of these imaging modalities in the treatment planning process.

A study to establish reasonable action limits for patient‐specific quality assurance in intensity‐modulated radiation therapy

An effective patient quality assurance (QA) program for intensity‐modulated radiation therapy (IMRT) requires accurate and realistic plan acceptance criteria—that is, action limits. Based on dose measurements performed with a commercially available two‐dimensional (2D) diode array, we analyzed 747 fluence maps resulting from a routine patient QA program for IMRT plans. The fluence maps were calculated by three different commercially available (ADAC, CMS, Eclipse) treatment planning systems (TPSs) and were delivered using 6‐MV X‐ray beams produced by linear accelerators. To establish reasonably achievable and clinically acceptable limits for the dose deviations, the agreement between the measured and calculated fluence maps was evaluated in terms of percent dose error (PDE) for a few points and percent of passing points (PPP) for the isodose distribution. The analysis was conducted for each TPS used in the study (365 ADAC, 162 CMS, 220 Eclipse), for multiple treatment sites (prostate, pelvis, head and neck, spine, rectum, anus, lung, brain), at the normalization point for 3% percentage difference (%Diff) and 3‐mm distance to agreement (DTA) criteria. We investigated the treatment‐site dependency of PPP and PDE. The results show that, at 3% and 3‐mm criteria, a 95% PPP and 3% PDE can be achieved for prostate treatments and a 90% PPP and 5% PDE are attainable for any treatment site.PACS Numbers: 87.53Dq, 87.53Tf, 87.53Xd, 87.56Fc

TH‐A‐224A‐01: QA for Imaging Systems Used for Planning (CT, PET, MR)

Imaging for radiation therapy treatment planning has different goals than diagnostic imaging. Quality assurance (QA) of imaging devices (CT, PET, MR) which are used for radiation therapy imaging will therefore have different or additional goals compared to QA for diagnostic imaging purposes. Use of PET and MR imaging in radiation therapy is constantly increasing and reliable performance of these imaging modalities is important to avoid potentially significant errors.Quality assurance for CT scanners used for radiation therapy scanning is relatively well established and defined. This process remains to be adequately defined for PET and MR scanners that are used for treatment planning. Evaluation of image quality of CT, PET, and MR scanners is generally adequately addressed by procedures which were established for diagnostic imaging. Design of QA protocols for radiation therapy scanning should be founded on procedures which are used for diagnostic imaging. Evaluation of mechanical accuracy and image spatial integrity is unfortunately not a major concern in diagnostic imaging and these parameters are often not sufficiently addressed in diagnostic QA protocols. All three imaging modalities have multiple potential sources of spatial and geometric errors and understanding of these parameters is necessary for design of an effective quality assurance program. The design of QA programs for these devices will be affected by the location of individual scanner and distribution of its utilization for diagnostic and radiation therapy imaging. Scanners which have dual purpose (diagnostic and treatment planning imaging) should have a QA program designed jointly by diagnostic and radiation therapy physicists to ensure that the program meets the needs of both groups.The quality assurance for these imaging modalities in the radiation therapy goes beyond the QA of the scanners and should include evaluation of implementation of images in the treatment planning process. This should include evaluation of data transfer, image registration, potential degradation in image quality, image distortions, and evaluation of process for delineation of tumor and normal structure volumes. MR and PET images can contain biologically active regions which may not correlate with any readily visible anatomic features. Correct identification and use of these regions in the treatment planning process should be a major concern of the QA program.This lecture will provide an outline and description of QA program for CT, PET, and MR scanners used in radiation therapy. The fundamental goals of such program will be described and information which can be used for establishment institution specific QA programs will be provided.Educational Objectives:1. Describe goals of QA programs for CT, PET, and MR scanners used for radiation therapy imaging.2. Describe QA process for individual imaging devices.3. Describe a concerns for verification of correct implementation of these imaging modalities in the treatment planning process.

The importance of a successful Quality Assurance (QA) program from a research manager's perspective.

One responsibility of an EPA research manager is to ensure that data from research projects are acquired, processed, and reported in accordance with Quality Assurance (QA) requirements established by the Agency. To meet this responsibility, the research manager should understand Agency QA requirements, require an appropriate, effective Quality Assurance program to ensure that data are of known and acceptable quality for the intended use of the data, and provide support, guidance, and oversight to principal investigators in meeting QA requirements. In addition, the effectiveness of the QA effort can be enhanced if the research manager 1) ensures that principal investigators and other managers are aware that QA is viewed as an essential, integrated component of the research programs; 2) provides adequate resources (people and money) to support an effective Quality Assurance program; 3) encourages cooperative, productive interactions between researchers and Quality Assurance professionals; and 4) maintains oversight so that issues that have the potential for adversely affecting research and Quality Assurance objectives can be negotiated and corrected quickly. This presentation will discuss the Air Pollution Prevention and Control Division's Quality Assurance program and the approaches used to meet Quality Assurance requirements in the Division. The presentation will be a technical manager's perspective of the Division's requirements for and approach to Quality Assurance in its research programs. The presentation will include the design of the QA Team, the roles of members of the QA Team, training and technical aids provided by the QA Team to promote understanding of and adherence to Agency QA requirements, the interactions of the QA Team members with principal investigators, and examples of effective conflict resolution.

The quality of health care for adults with developmental disabilities.

The purpose of this study was to determine the health status of adults with developmental disabilities residing in community settings and the quality of the preventive, medical, dental, and psychiatric services they receive. Data were collected on a sample of 353 adults residing in Los Angeles, California, in 1997. Historical data were obtained from study subjects or caregivers, physical and dental examinations were performed, blood was drawn for analysis, and a psychiatrist reviewed medical records for reports of psychiatric diagnoses and consultations. Health markers, such as rates of obesity, and laboratory test results of routine screening panels including blood cell counts, hemoglobin, and hematocrits; blood concentrations of liver enzymes and other enzymes, cholesterol, and tryglycerides; and urinalyses were within normal limits for an adult population. However, preventive services were notably lacking, especially for individuals living at home. Fewer than half of the study subjects had received influenza vaccine; only a third of those living alone or with family or friends had received this vaccination. Chart audits revealed that about a third received psychotropic medications, but only 24% of these individuals had psychiatric consultations noted in their record. Further, 36% of this medicated group received psychotropic drugs without any identifiable diagnosis, and simultaneous receipt of two or more antipsychotics was not uncommon. Given that the U.S. health care system fails to ensure the provision of preventive services for all people, including the developmentally disabled, a systematic overhaul is necessary to establish an effective quality assurance program that will provide preventive medical, dental, and psychiatric services for people with developmental disabilities.

Intensity modulation using multileaf collimators: current status

Intensity-modulated radiation therapy (IMRT) extends the capability of 3D conformal methods (3D-CRT). Studies show that these methods can clinically reduce complications and can allow a larger safety margin for dose escalation. The ultimate goal is improved survival and improved quality of life. IMRT methods typically require more fields, or segments, and more monitor units for a given dose, as compared to conventional CRT methods. Because of this, some multileaf collimator (MLC) parameters take on more importance. A review of current standard MLC configurations are discussed, along with the concept of integral dose. An effective quality assurance (QA) program for IMRT involves more than dose modeling of the MLC. Integrity of data flowing from 3D radiograph databases to treatment planning to delivery sequencing files to verify-and-record function is required. End users need to be aware of differences in commercial availability vs. in-house developments for configuring a system. Great strides have been made in streamlining the whole process. This is evidenced by the first major symposium on community-based IMRT. Research continues to improve accuracy and productivity.

Never audit alone--the case for audit teams.

On-site audits, conducted by technical and quality assurance (QA) experts at the data-gathering location, are the core of an effective QA program. However, inadequate resources for such audits are the bane of a QA program and, frequently, the proposed solution is to send only one auditor to the study site. There are several reasons why audits should be performed by more than one person: 1. Audits of EPA projects frequently involve hazardous chemicals or other environmental hazards. They also often involve working after normal work hours in remote locations with dangerous equipment. It is unsafe to work alone under such conditions. 2. Skills: Many of EPA's projects are multidisciplinary, involving multiple measurements systems, several environmental media, and complex automated data collection and analysis systems. It is unlikely that one auditor would have the requisite skills to assess all of these operations. 3. Separateness: Two auditors can provide two (sometimes differing) perspectives on problems encountered during an audit. Two auditors can provide complementary expertise and work experience. Two auditors can provide twice the surveillance power. 4. Support: The operations that need to be assessed are sometimes in different parts of a site, requiring two auditing devices or considerable commuting time. Also, auditors are occasionally diverted by managers wishing to show their best efforts rather than the whole operation; if two auditors are on-site, one can interview managers while the other talks with technical staff. If there is a dispute, one auditor can support the other in verifying observations. 5. Savings: Although sending one auditor is perceived to be a cost-saving measure, it may be more economical to send two auditors. Time on site (lodging, food) is decreased, more of the project is assessed in one visit, less pre-audit training is required, and report preparation is accelerated. In summary, sending more than one auditor on a field audit is smarter, safer and more effective, and can be less expensive in the long run.

Spirometry in Primary Care Practice: The Importance of Quality Assurance and the Impact of Spirometry Workshops

To determine the quality of spirometry performed in primary care practice and to assess the impact of formal training. Randomized, controlled prospective interventional study. Primary care practice, Auckland City, New Zealand. Thirty randomly selected primary care practices randomized to "trained" or "usual" groups. One doctor and one practice nurse were nominated to participate from each practice. "Trained" was defined as participation in an "initial" spirometry workshop at week 0 and a "maintenance of standards" workshop at week 12. "Usual" was defined as no formal training until week 12, when participants they attended the same "initial" workshop provided for the trained group. The study duration was 16 weeks. Each practice was provided with a spirometer to be used at their clinical discretion. Spirometry data were uploaded weekly and analyzed using American Thoracic Society (ATS) criteria for acceptability and reproducibility. The workshops were assessed objectively with practical and written assessments, confirming a significant training effect. However, analysis of spirometry performed in clinical practice by the trained practitioners revealed three acceptable blows in only 18.9% of patient tests. In comparison, 5.1% of patient tests performed by the usual practitioners had three acceptable blows (p<0.0001). Only 13.5% of patient tests in the trained group and 3.4% in the usual group (p<0.0001) satisfied full acceptability and reproducibility criteria. However, 33.1% and 12.5% of patient tests in the trained and usual groups, respectively (p<0.0001), achieved at least two acceptable blows, the minimum requirement. Nonacceptability was largely ascribable to failure to satisfy end-of-test criteria; a blow of at least 6 s. Visual inspection of the results of these blows as registered on the spirometer for the presence of a plateau on the volume-time curve suggests that < 15% were acceptable. Although a significant training effect was demonstrated, the quality of the spirometry performed in clinical practice did not generally satisfy full ATS criteria for acceptability and reproducibility. Further study would be required to determine the clinical impact. However, the ATS guidelines allow for the use of data from unacceptable or nonreproducible maneuvers at the discretion of the interpreter. Since most of the failures were end-of-test related, the FEV1 levels are likely to be valid. Our results serve to emphasize the importance of effective training and quality assurance programs to the provision of successful spirometry in primary care practice.

A method for evaluating health care providers' decision making: the Provider Decision Process Assessment Instrument.

Valid and reliable assessment of the clinical decision-making process is essential for the evaluation of decision aiding methods and effective quality assurance programs. The Provider Decision Process Assessment Instrument is a 12-item questionnaire that measures a health care provider's degree of comfort with a medical decision. Its measurement properties were studied in two general internal medicine practices. Reliability, measured using Cronbach's alpha, was 0.90 (95% Cl = 0.87 to 0.92). Construct validity was also high, with expected negative correlations ranging from -0.53 to -0.67. The instrument also satisfied standard criteria for item homogeneity and was readily completed by clinicians. These results suggest that the Provider Decision Process Assessment Instrument will prove to be a valuable tool for assessing medical decision making in busy clinical settings.

Points to Consider When Implementing a Clinical Quality Assurance Program

Implementation of an effective quality assurance (QA) program for good clinical practices (GCPs) requires a full understanding of applicable regulations and an upper management commitment to provide training for personnel and to modify company procedures as deficiencies are discovered. This paper will address differences in the approach depending on the limits set by the scope of the clinical program and the extent of transferred obligations to outside vendors. Global clinical programs introduce country-specific differences that must be effectively addressed. The effectiveness of QA programs for GCPs is dependent on the degree of understanding upper management has of these differences and its commitment to a team approach to effective resolution. Three scenarios are presented.

Electron-beam processing for sterilization

High-powered, 10-MeV linear accelerators offer advantages for sterilization of medical products. A highly effective quality assurance program must be in place to ensure the appropriate dose is delivered to each product unit and that all required documentation is produced. The key elements of such a program are establishing the routine processing window for each product, maintaining process control and demonstrating compliance.

Quality assurance and morbidity and mortality conference

Many surgeons assert that Morbidity and Mortality (M & M) conference in itself assures an effective quality assurance (QA) program. Recent emphasis on QA in other sectors has resulted in other processes for evaluating quality of care. The goals of QA programs are to identify adverse patient care events, relate these to specific physicians and use this information to improve patient care, and for credentialing and privileging physicians. Our aim was to determine the role of surgical M & M conference in a QA program which also includes occurrence screening, wound infection surveillance, and surgical case review. The weekly M & M conference is a discussion of identified complications and deaths submitted voluntarily by surgeons. During a 2-year period 5755 procedures were associated with 255 complications and 82 deaths. Only 74% of events identified by occurrence screening, 35% of cases identified by surgical case review, and 54% of wound infections had been submitted to M & M conference. Seventy-four percent of surgical residents and 33% of staff surgeons were present at M & M conference when their complications were discussed. Level of care (I, accepted practice; II, may have managed differently; and III, would have managed differently) was assessed for each complication at M & M conference and by peer review of the medical record for occurrence screening. The assignment of level of care was similar by either process (I = 49, II = 11, III = 2, at M & M vs I = 44, II = 16, III = 2, r = 0.7405, P < 0.005). M & M conference remains an important component of an overall QA program but does not meet all of the goals. There is excellent agreement between level of care assigned at M & M conference compared to peer review of the medical record. However, many adverse events identified via other processes are not reported at M & M conference. In our experience, physicians are often not present when their complications are discussed.

A Program for Quality Assurance of Computerized Treatment Planning Systems

Quality Assurance (QA) on computerized treatment planning systems is currently an area that requires considerable attention. To meet this objective a simple yet effective quality assurance program has been developed and implemented at the Cross Cancer Institute.

Policies and quality assurance in the pharmaceutical industry.

The pharmaceutical industry is engaged in a critical undertaking of research, development, and marketing of drugs to patients. In this complex process there are a number of important steps involving corporate policies that require adherence by top management and personnel. The clinical trials, especially phase I—where drugs are first introduced into man, is one of these key steps that requires careful ethical consideration. The generic problem of varied conflict of interest among the personnel and departments can be the main contributing factor to decline in faith and confidence in the industry. It is argued in this paper than an effective and comprehensive quality assurance program that depends on internal and external review process and augumented by periodic externally conducted data audit is essential for corporations in developing and marketing safe and effective drugs. External quality assurance programs and data audit can make recommendations to management to avoid conflict of interests. The compre...

Excellence in Ambulatory Care: A Practical Guide to Developing Effective Quality Assurance Programs

Excellence in Ambulatory Care: A Practical Guide to Developing Effective Quality Assurance Programs

Quality in ambulatory care: the two minute demonstration.

When asked to produce convincing evidence of quality, 281 ambulatory healthcare professionals suggested 98 different components of an ambulatory program. Obviously no overwhelming majority exists, nor is there a clear focus on what constitutes quality in the ambulatory setting. This demonstrates and highlights both the diversity of ambulatory care and the difficulty of defining quality in the ambulatory environment. We all feel that we know what quality is and that we provide quality care in our organizations. Quality is high priority, yet when asked for the most important demonstrator of quality, ambulatory care professionals gave 98 different answers. Based upon the Pareto diagram's top five categories as shown in Figure One, we can put together a composite definition. This composite would present the combined judgment of nearly 80% of the 281 seminar attendees. Quality ambulatory health care--meets the expectations (pleases) the patients, is enhanced and demonstrated by an effective quality assurance program, is the achievement of desired outcomes for patients, is dependent upon the excellence of the provider staff, and is enabled by an accurate, timely, and complete medical record system. The message for those of us in ambulatory care is that the process of working toward the definition of quality may be just as important as the actual definition of quality. A consensus on a definition of quality in the ambulatory setting is unlikely as there is too much diversity. It is important that each of our ambulatory centers should set out to determine its own definition of quality. The process itself is useful because it will help us to focus on the dimensions of quality. (ABSTRACT TRUNCATED AT 250 WORDS)

Excellence in Ambulatory Care: A Practical Guide to Developing Effective Quality Assurance Programs

Excellence in Ambulatory Care: A Practical Guide to Developing Effective Quality Assurance Programs

Book Review Excellence in Ambulatory Care: A practical guide to developing effective quality assurance programs By Dale S. Benson and Peyton G. Townes. 296 pp. San Francisco, Jossey-Bass, 1990. $33.95.

Book Review Excellence in Ambulatory Care: A practical guide to developing effective quality assurance programs By Dale S. Benson and Peyton G. Townes. 296 pp. San Francisco, Jossey-Bass, 1990. $33.95.

Effective Quality Assurance

An effective quality assurance program is an integral part of laboratory operations. Its primary goal is to assist in the planning and documentation of studies as well as helping to generate trustworthy reports. An effective program is based on a cooperative attitude, support by management, professional respect, known and communicated requirements, and a system to generate data with integrity.