C HA P T E R

1Introduction to Quality

Management

K E Y T E R M S

actionaggregate data

indicatorappropriateness of carebenchmarkingbrainstormingconcurrent datacontinuity of carecost of qualitycritical pathcustomerDeficit Reduction Act

effectiveness of careefficacy of careefficiency of careexpectationFMEAfocus groupFOCUS-PDCAHIPAAindicatorsinputMammography Quality

Standards Reauthorization Act

outputprocessquality assessmentquality assurancequality controlquality improvement teamSafe Medical Devices ActSix Sigmasentinel event indicatorsupplierSWOT analysissystem

O B J E C T I V E S

At the completion of this chapter the reader should be able to do the following:• Identify the need for quality management in diagnostic

imaging• Discuss the impact of government regulation and

The Joint Commission accreditation on qualitymanagement

• Explain the differences between quality assurance,quality control, and quality management

• Identify the five steps of a process• List the various tools of group dynamics• Explain TJC 10-step monitoring and evaluation process

and cycle for improving performance

O U T L I N E

History of QualityManagement inRadiology 3Governmental Action 3The Joint Commission 5

Quality Assurance 6Quality Control 6Continuous QualityImprovement 7

Process ImprovementThrough ContinuousQuality Improvement 7Key QualityCharacteristics 8Key Process Variables 8

Problem Identificationand Analysis 8Group Dynamics 8

Specific Quality ManagementQuality ImprovementProcesses 10TJC 10-Step Process 10TJC Cycle for ImprovingPerformance 12

Other Quality Management/Quality ImprovementModels 14

Summary 16

1

Diagnostic imaging is a multistep process by whichinformation concerning patient anatomy and physiologyis gathered and displayed with the use of modern tech-nology. Unfortunately, numerous sources of variability,in both human factors and equipment factors, can pro-duce subquality images if not properly controlled. Thiscan result in repeat exposures that increase both patientdose and department cost and possibly decrease theaccuracy of image interpretation. This in turn can resultin decreased customer satisfaction (customers being phy-sicians, vendors, insurance companies, employees, andpatients) that ultimately costs the healthcare providerlost business and revenue. The purpose of a qualitymanagement program is to control or minimize thesevariables as much as possible. In a diagnostic imagingdepartment, these variables include equipment; imagereceptor; processing; viewing conditions; and compe-tency of the technologist, support staff, and the observeror interpreter.

When discussing the quality of particular goods orservices (or in our case, the quality of patient care andthe diagnostic images that we produce), one must keepin mind the three levels on which quality is determined:

1. Expected quality. This is the level of quality of theproduct or service that is expected by the customerand may be influenced by outside factors such asprior word of mouth from friends and relatives.A diagnostic imaging professional would likely havethe least amount of impact on this level of qualitybecause it is present before the patient comes intothe imaging department.

2. Perceived quality. This is the customer’s perception ofthe product or service. It is based on the customer’sperception of the product or service and is highly sub-jective and more difficult to measure quantitatively.For patients undergoing diagnostic imaging, their expe-rience (such as how long they had to wait or how theywere treated) during the procedures greatly influencestheir perception of quality. Therefore how well animaging professional performs his or her respectiveresponsibilities will have the greatest impact on thislevel of quality. Because perceived quality is often whatbrings patients back to a hospital or imaging center, itcan be more important than the actual quality.

3. Actual quality. This level of quality uses statisticaldata to measure outcomes and considers all factorsthat can influence the final outcome (e.g., the qualityof the image, accuracy of diagnosis, timeliness ofreport to primary physician). It also can comparethe quality of the product or service with that of acompetitor.

Since the early 1980s, healthcare delivery in theUnited States has undergone dramatic changes that haveaffected diagnostic imaging departments and their abil-ity to provide quality care. These changes include thefollowing:

• Advances in technology, equipment, and procedures.The digitization of radiography, along with expensivetechnologies such as magnetic resonance imaging(MRI), spiral computed tomography (CT), electronbeam tomography, positron emission tomography(PET), digital radiography and fluoroscopy, and singlephoton emission computed tomography (SPECT), hasincreased the cost of equipment acquisition, installa-tion, and maintenance.

• Legislation and government regulations. Legislationsuch as the Safe Medical Devices Act (SMDA) of1990, the Mammography Quality Standards Act(MQSA) of 1992, and the Mammography QualityStandards Reauthorization Act (MQSRA) of 1998has increased the responsibility of diagnostic imagingdepartment managers and staff to document properequipment operation and procedures. This is in addi-tion to requirements from the Occupational Safetyand Health Administration (OSHA), the Environ-mental Protection Agency (EPA), and the Food andDrug Administration (FDA) that affect matters rang-ing from blood-borne pathogens to disposal of pro-cessing chemicals.

• The Joint Commission Accreditation Procedures.The accreditation procedures of The Joint Commis-sion (TJC) have gone from the philosophy of qualityassurance (QA) to one of total quality management(TQM) (explained in more detail later in thischapter).

• Corporate buyouts and mergers. Since 1980, morethan 1000 hospitals have closed in the United States.Many others have been purchased by “for profit”healthcare organizations or have merged to condensecosts or reduce competition, or both.

• Methods of reimbursement for services rendered.The previous method of “fee for service” reimburse-ment of healthcare expenses is rapidly being replacedby managed care plans such as health maintenanceorganizations (HMOs) and point of service planssuch as preferred provider organizations (PPOs).The lower rate of reimbursement from these planshas reduced the operating budgets of many diagnos-tic imaging departments. In addition, many insurersare now employing radiology benefits managementcompanies (RBMs) to determine the necessity ofvarious diagnostic imaging orders.

These changes have made a quality management pro-gram essential to the operation and survival of a diag-nostic imaging department. The cost of such aprogram in the form of personnel time and test equip-ment is more than offset by the savings from lowerrepeat rates, less equipment downtime, film and chemi-cal savings in nondigital departments, greater depart-ment efficiency, and increased customer satisfactionbecause waiting time can be reduced. When assessingthe effectiveness of a quality management program,

2 CHAPTER 1 Introduction to Quality Management

one must consider the cost of quality. This is defined asthe expense of not doing things right the first time. Indiagnostic imaging departments, this could be consider-able because the result could lead to lost business atthe very least or the injury or death of a patient at thevery worst.

HISTORY OF QUALITY MANAGEMENTIN RADIOLOGY

One of the earliest known methods of evaluating thequality of clinical healthcare by assessing patient out-comes was carried out by Florence Nightingale in the1860s. She was one of the first to use a systematicapproach to collecting and analyzing mortality rates inhospitals. The origins of modern quality managementcan be traced back to the early 1900s, to the work ofan industrial engineer named Frederick Winslow Taylor.Taylor is considered the “Father of Scientific Manage-ment” because of his philosophy that the planning func-tion and the execution stage be separate and thatnumerous individuals be assigned specific tasks withinthe production process to minimize the complexity ofthe task. With complexity minimized, the hope was tomaximize efficiency because, theoretically, fewer mis-takes would occur. Job tasks were broken down intosimple, separate steps that could be performed overand over again (i.e., assembly lines). Only specific per-sons were assigned the task of quality control inspec-tion. This philosophy was common practice, both inAmerican industry and in healthcare settings (includingdiagnostic radiology), until the 1980s.

During the 1980s, the concept of quality improve-ment began to gradually replace the concept of scientificmanagement. This concept is credited to W. EdwardsDeming and Joseph Juran, who used the qualityimprovement philosophy to revitalize the economy ofJapan after World War II. This concept combines qualitycontrol with an overall management philosophy thatgives input to all persons involved in the process of cre-ating the specific good(s) or service(s). This concept isdiscussed in further detail later in this chapter. Manydiagnostic imaging departments have been systemati-cally monitoring their equipment and procedures (qual-ity control) since the 1930s, independent of anygovernment regulation or accreditation agency. Themain motivations were to save money and increase effi-ciency and quality of care. Since then, governmentalaction and policies mandated by the TJC have all butrequired that an extensive quality management programbe implemented by diagnostic imaging departments.

Governmental Action

The federal government’s first step toward requiringthat diagnostic imaging departments implement qualitymanagement programs came in 1968 with the Radiation

Control for Health and Safety Act. This law required theU.S. Department of Health, Education, and Welfare(now called Health and Human Services) to developand administer standards that would reduce humanexposure to radiation from electronic products. TheBureau of Radiological Health (BRH) (now called theNational Center for Devices and Radiological Health)was given the responsibility for implementing this act.The BRH set forth regulatory action, beginning in1974, with several amendments to control the manufac-ture and installation of medical and dental diagnosticequipment to reduce the production of useless radiation.These regulations are contained in the document Title21 of the Code of Federal Regulations Part 1020(21 CFR 1020). Title 21 refers to the FDA. In 1978 theBRH published the “Recommendations for QualityAssurance Programs in Diagnostic Radiology Facilities.”The Joint Commission, along with most state publichealth agencies, has adopted these recommendationsinto its various policies governing diagnostic imagingdepartments.

In 1981 the Consumer-Patient Radiation Health andSafety Act addressed issues such as unnecessary repeatexaminations, quality assurance techniques, referral cri-teria, radiation exposure, and unnecessary mass screen-ing programs. It also established minimum standardsfor accreditation of educational programs in the radio-logic sciences and for the certification of radiographicequipment operators. This law motivated many statesto enact licensure laws for radiologic technologists.However, there is no legal penalty for noncompliancecontained within the law and eight states, plus the Dis-trict of Columbia, currently have no minimum educa-tional or certification criteria for healthcare workerswho perform radiologic procedures. As of the writingof this edition, the eight states are Alabama, Alaska,Georgia, Idaho, Missouri, North Carolina, Oklahoma,and South Dakota. The states of Michigan and Nevadalicense mammographers but not radiographers, whileWisconsin does not license radiographers but doesrequire American Registry of Radiologic Technologistscertification. In September 2000, the Consumer Assur-ance of Radiologic Excellence (CARE) Act was firstintroduced in Congress by Rep. Rick Lazio (R-NY) asH.R. 5624. In 2006, the CARE bill was retitled the Con-sistency, Accuracy, Responsibility and Excellence inMedical Imaging and Radiation Therapy Bill becausemany of the imaging disciplines included in the CARElegislation are not directly related to radiology. TheCARE Act mandates educational and training require-ments for all technologists performing imaging proce-dures (thereby mandating the standards contained inthe Consumer-Patient Radiation Health and Safety Actof 1981). In addition to improving the quality of carenationwide, enacting the CARE Act also would saveconsiderable money each year. According to the Radi-ologic Society of North America (RSNA) journal,

3CHAPTER 1 Introduction to Quality Management