Variability in healthcare delivery has led to inconsistent outcomes in the United States. In 1966, Donabedian1 published a sentinel article that proposed measuring the quality of health care through the examination of its structure, processes, and outcomes, setting into motion multiple movements to address quality improvement and patient safety. The healthcare industry has broadened its approach to improve patient care by following quality improvement processes initiated by other industries. One major example is that of aviation,2 which uses a collaborative approach to improve safety. The Institute of Medicine's report “To Err Is Human: Building a Safer Health System”3 stated that up to 98,000 Americans die each year as a direct result of medical errors. In addition to morbidity and mortality, medical errors cost as much as US $29 billion annually. The Institute of Medicine recognized that this level of healthcare delivery–related patient harm is unacceptable in the United States. In response, agencies and professional societies develop and implement evidence-based guidelines to promote best practices and reduce errors in medical care.
A core concept of quality improvement is the measurement of relevant outcomes, including the evaluation of outliers and the iterative refinement of contributing processes. Although many countries and groups, including the United Kingdom,4 Australia,5 the European Union,6 and Canada7 have quality improvement guidelines and measures in place for colposcopy, there are no recognized standards in the United States. To achieve these goals for colposcopy, the American Society for Colposcopy and Cervical Pathology (ASCCP) organized the ASCCP Colposcopy Standards Committee, which represented multiple disciplines (including physicians, advanced practice providers, and researchers in the disciplines of obstetrics and gynecology, family medicine, gynecologic oncology, preventive medicine, and pathology) all involved in cervical cancer screening, diagnosis, and prevention. The Standards Committee initiated a process to develop comprehensive, evidence-based recommendations to address colposcopy quality, documentation, and practice. The quality improvement working group was charged with developing guidelines for quality assurance to serve as a starting point for developing quality improvement programs in the United States.
Recognizing the limitations of current colposcopy approaches in the United States, the ASCCP, in collaboration with investigators from the US National Cancer Institute, set out to review evidence and develop recommendations for US colposcopy practice. The ASCCP leadership formed a steering committee, who selected additional working group members with expertise in colposcopy and guideline development.
MATERIALS AND METHODS
In developing quality indicators, the Quality Improvement Working Group performed a systematic review of existing major society and national guidelines.8 The completed systematic review was supplemented with input from the steering committee to develop a list of proposed US quality measures and guidelines. The list of proposed US quality measures was refined through successive iterative discussions by the working group members in collaboration with the other working groups of the ASCCP Colposcopy Standards Committee. Because of the paucity of evidence and the volume of potential measures, a Delphi style method9 augmented with group conference calls was used to derive specific proposed quality indicators for the United States. Guiding principles were created by the working group to inform the key values in guideline development (see Table 1). Specific quality indicators were chosen based on the guiding principles, availability of necessary informatics infrastructure, and anticipated ability of US clinical practice settings to implement the required changes. The working group considered all of the indicators in the identified international guidelines (enumerated in the companion systematic review) as well as recommendations of the other working groups.10 When there was no evidence to support a recommendation and international guidelines varied, criteria were selected based on expert opinion. In general, the working group began with consideration of the varying international recommendations but was not limited to them. Expert opinion was used most frequently to determine follow-up time intervals.
The output of the working group was regularly reviewed by the steering committee for appropriateness and direction. After multiple cycles of revision, draft quality indicators were proposed by the working group based on the abstracted evidence and expert consensus. The recommendations were presented to the steering committee in October 2016 and reviewed for content and consistency. Revisions were presented to all working group members for discussion and further revision in January 2017, and a vote among working group members was held shortly after. Sixty-seven percent affirmative votes were required for approval of individual recommendations. All recommendations were approved at the first vote, and most were approved unanimously with only minor comments. After further editing and notification of stakeholder professional organizations, recommendations were posted on the ASCCP Web site for public comments between March 13 and 22, 2017, which resulted in additional modifications in response to the comments. Finally, recommendations were presented at the International Federation for Cervical Pathology and Colposcopy's 16th World Congress in Orlando, Florida, on April 5, 2017, followed by a plenary discussion. Final revisions were made by the steering committee based on comments received at this meeting. Colposcopy terminology defined by the ASCCP Colposcopy Standards Committee for the United States was used for reporting quality indicators.
Table 2 presents the ASCCP Colposcopy Standards Committee's quality indicator recommendations. All of these indicators fall into the process category of the Donabedian model. Each indicator is presented along with a brief rationale for its inclusion and a summary of other organizations that are already using it. A total of 11 quality indicators were chosen. Both minimum and comprehensive standards are presented for most indicators. The minimum value represents the lowest performance measure that the working group determined was acceptable for a provider or colposcopy unit. The comprehensive goal was felt to be reasonably attainable and an appropriate measure for a quality colposcopy provider or unit. Instructions for determining numerators and denominators for calculating the measure are included. There are no specific minimum denominator values specified.
Colposcopy has been performed in the United States for decades without formal standards. This is at odds with many other parts of the world, where standards for colposcopy are widely implemented, measured, and enforced by professional societies and payors.8 A number of forces at work will promise to make maintenance of colposcopy skills notably more difficult in the future, because procedure volume drops and difficulty increases. Procedure volume has already started to fall with the implementation of the 2012 American Cancer Society / American Society for Clinical Pathology Screening Guidelines,11 which increased the testing intervals and consequently decreased the number of abnormal tests. At the University of Alabama, average monthly colposcopy volume dropped to nearly one third of its peak from 2010 to 2015.20 With increased uptake of human papillomavirus (HPV) vaccination, numbers of abnormal screening tests will decline further. Predictive values of cytology for cervical intraepithelial neoplasia 3+ already seem to be dropping in vaccinated populations.21 Lesions associated with HPV 16 are typically more acetowhite and easier to visualize.22 Because vaccination will prevent many of these infections, lesions from the remaining HPV types will be harder to visualize at colposcopy. The ASCCP Colposcopy Standards Working Group 3 found that 32% of respondents to the ASCCP survey indicated that they did fewer than 6 colposcopies per month.23 In the setting of lower volumes of harder to perform procedures, training new providers and maintaining proficiency of existing providers will be more challenging and quality measurement will be much more important.
Maintaining quality is further challenged by the varied practice settings in which colposcopy is currently performed and the geographically and socioeconomically diverse population of women undergoing the procedure. In developing the standards, we defined a set that would be applicable across practice settings, including public and private clinics, low or high volume, and insured and uninsured patients. These factors were particularly relevant to setting thresholds for follow-up, which needed to encompass both easy-to-reach patients with resources for follow-up testing and potentially difficult-to-reach uninsured populations in public settings and rural communities.
The proposed minimum and comprehensive quality measures for colposcopic practice can be divided into 2 general categories. The first has to do with the documentation of minimum elements of a technically complete and clinically well-performed colposcopic evaluation. At a minimum, these must include documentation of the visualization (or not) of the cervix. Additional documentation of the entire squamocolumnar junction, the presence (or absence) and location of acetowhite lesion(s), as well as whether biopsies were performed and how many must also be included. These standards should be achievable by any type of provider with any patient population in any practice setting. Efforts to incorporate these elements into templates in the electronic medical record (when available) should facilitate clinicians' ability to meet these standards.
The second category sets minimum standards for patient follow-up in the setting of the management of cervical disease. The expectation is for documented attempts at contacting a patient with high-grade cervical cancer screening within 4 weeks of reported results and to be scheduled for evaluation within 4 weeks of that contact. Likewise, women with suspected invasive disease on laboratory report or referral should have contact attempted within 2 weeks and evaluation scheduled within 2 weeks of that contact. Similar to many of the quality improving standards from other countries, the working group put a differential in the urgency of follow-up based on cytology results to allow clinics with high volumes to prioritize more severe cases. We based our goals mostly on the New Zealand recommendations, but the British, the Canadians, and others have a similar differential in follow-up scheduling.4,7,13 This should help not unduly burden high-volume safety net clinics while still increasing and measuring the quality being delivered. The guideline group appreciated that achieving these targets would be profoundly affected by the adherence of the patient population and the resources of the provider and practice setting; it accounted for this by focusing on the process of patient contact and evaluation rather than on the events. In this instance, time intervals were determined by the risk of underlying invasive cancer and the natural course of HPV disease rather than the particulars of the range of practice settings.
The guidelines group did not set minimum numbers of procedures to review in assessing adherence with the quality measures. The guidelines groups appreciated that some units and providers may have sophisticated electronic medical records allowing global review of all colposcopy procedures performed. Other practices may still use paper charts or have electronic medical records that do not allow summary review, requiring individual records review to determine adherence with quality measures. In this setting, review of a minimum of approximately 30 procedures is likely adequate. The group was also not specific about whether the measures should be applied to individual providers or entire units. It was felt that the measures could be calculated either way depending on the organization of the practice or unit. The working group also did not make recommendations about frequency with which the indicators should be reviewed. For stable practices with minimal staff turnover, intervals of 1 to 3 years may be reasonable. For new practices or practices undergoing staff or provider changes, more frequent assessments may be required.
This iteration of the ASCCP Colposcopy Standards Committee and its working groups did not assess or address types and uses of particular colposcopy instruments or colposcopes. We only assessed the colposcopy procedures and documentation, not screening tests or treatments. It is expected that these will be addressed by future committees.
There were no patients or patient advocates in the working group. It is anticipated that when providers and clinics develop or continue to develop their quality improvement program, there will be patients and/or patient advocates involved in the process as recommended by quality groups such as the Agency for Healthcare Research and Quality.24
For the purposes of these quality indicators, follow-up could be either with the original provider or with a provider who can continue providing care at the same or a more advanced level. The goal is to make sure that patients get appropriate continuity of care. This could be with the original provider who performed testing, a partner within a practice, or with other providers who provide services that the original provider does not.
The working group examined the question of how many quality indicators adopt. In the United States, quality improvement program is often carried out in the form of continuous quality improvement, which is a process that continually assesses, improves, reassesses, and further adjusts the system (Plan, Do, Study, Act or PDSA cycles) to produce a steady and constant flow of improvement to the system. High-yield, high-impact quality measures are often first chosen to focus considerable resources to devote to improving outcomes. The working group decided to assume this paradigm and selected 11 measures as a starting point for quality improvement for colposcopy. This contrasts with some national society programs where comprehensive programs with numerous quality indicators are employed. To produce a limited list of desirable indicators that would be feasible to implement in clinical settings not currently practicing quality improvement, it was necessary to exclude some potentially useful international measures. These guidelines are intended to be a starting point, especially for those clinical settings without a strong clinical quality improvement focus. The authors anticipate that because infrastructure is developed and practices and healthcare systems become more adept at conducting colposcopy quality improvement activities, additional helpful indicators will be added.
Other national and society guidelines included a number of standards that we chose not to include. The United States does not have any national data repository for cytology or histologic findings, so we did not include any indicators that required a national registry. The United States also does not have a unique patient identifier for its citizens, so any indicators that require cross-linking of results across healthcare systems were also not included. Because of the high mobility of the US population, indicators that require repetitive cytology or histology data points over time to determine long-term treatment and colposcopist outcomes were not included. Because information systems continue to develop in the United States, future efforts may be able to reasonably include such quality indicators as have already been implemented in other countries, particularly the United Kingdom and Australia.
Although we included measures of time to first contact for women with High-grade squamous intraepithelial lesion and cancer, we did not define what should constitute adequate attempts to make contact. Systems to ensure pending tests are tracked and patients notified of results have been described.25 Multiple efforts should be undertaken and documented in the medical record, as discussed in a 1997 guideline from the ASCCP Practice Committee; secure electronic messaging may be a component of contemporary systems for patient notification.26
We also did not specifically address issues related to colposcopy training. In the United States, training is not regulated by the government and there is no certification. Standards in many other countries do include training.8 These standards generally stipulate that all clinicians who perform colposcopic examinations should have completed a formal colposcopic training program conducted by expert trained personnel whose clinical competence and teaching abilities are well documented. This training typically included objective demonstration of core knowledge of the evaluation and management of HPV-related neoplasia and related lower genital tract disease, as well as the demonstration of clinical skills and competence based on a practical preceptored experience. This training generally occurred under the direct supervision of a competent colposcopist preceptor and should be evidence based and include at a minimum the following 4 core components: diagnoses and management, therapeutic modalities, documentation, and maintenance of competence. We did not include training requirements in our standards. In the United States, training in the traditional settings of residency, informal proctoring, or through courses put on by major societies has been considered adequate in the past, although structured curricula have been proposed and variably adopted.27,28 Because procedural volume decreases, this is likely to change, and future iterations of these guidelines may incorporate training and maintenance of certification requirements.
We view these indicators as the first step of a set of measures that will evolve and anticipate that ASCCP will monitor them and refine them over time. During the implementation, we anticipate that some measures, particularly documentation requirements, will be easy to comply with and over time no longer reflect quality. Because electronic medical records mature, it may become easier to monitor a broader array of indicators and tie them to outcomes on a larger scale.
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