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[Accreditation of medical laboratories].

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the official acceptance of ISO 15189 the clauses of this harmonized guideline fulfill the requirements of the new international standard as well. Accreditation of medical laboratories in Hungary may not only facilitate quality improvement of laboratory services, but also the development of a quality-based purchasing and reimbursement policy of the health insurance fund.

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Accreditation and certification.

In Italy the debate has focused on three different assessment systems: accreditamento autorizzativo (regulatory accreditation), accreditamento di eccellenza (excellence accreditation), and certification. Regulatory accreditation verifies the conformance to a set of quality standards that entitle an organisation to the status of belonging to the NHS. Excellence accreditation attempts to maintain incremental improvement of the quality of services. Certification is a means by which an independent third party declares that a determined product or process conforms to the ISO 9000 set of standards; the main objective of certification is to increase the "credibility" of a company on the market in order to orient and at the same time assure customers. Certification loses meaning in a regulated market, as the Italian NHS, in which there is a distinction between the consumer and the paying body. Regulatory accreditation should be deeply rooted in regional planning; the recognition of accredited organisations should be the result of a demonstrated capacity to co-operate in achieving the goals of regional planning and not of conformance to organisational standards. Regional experiences of regulating accreditation show a high level of contamination between systems for quality assessment. The large number of standards proposed seemed to be redundant with respect to the aims that should be pursued by a regulating accreditation system. The furthering of quality in the NHS requires a complex system of quality assessment within which a plurality of subjects, each with different interests, work together to determine the final result by each one setting up procedures consistent with its own particular problems: the institutions set up regulatory accreditation and the professions develop excellence accreditation in their individual professional associations. What is important is to establish relationships across the various levels so as to give the whole system cohesion and consistency. (Int J Artif Organs

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Implementing a national hospital accreditation program: the Zambian experience.

OBJECTIVES: This study describes the development of the Zambia Hospital Accreditation Program from 1997 to 2000. Ten major milestones are presented and discussed, as are challenges to the program. DESIGN: Data were collected through a review of written documents, interviews with major stakeholders, hospital visits, and discussions with implementers. MAIN OUTCOME MEASURES: Zambia has successfully developed hospital standards that are relevant and potentially achievable by its hospitals. Half of Zambia's 79 hospitals have received educational surveys, and 12 have also received the full accreditation survey. Significant improvement in compliance with standards occurred in overall scores, and in seven out of 13 functional areas. However, the program has stalled due to lack of sufficient funds, lack of legal standing for the Zambia Health Accreditation Council, difficulties in retaining qualified surveyors, and indecision on how to handle accreditation results. In addition, serious resource constraints in hospitals and the need for ongoing facilitation have hindered their full participation in the program. It is estimated that the program costs about 10000 dollars US per hospital to complete the cycle. CONCLUSIONS: Having a developing country sustain an accreditation program requires dedicated funds, government and donor commitment, continual adaptation, ongoing technical assistance to hospitals, and a functioning accreditation body. In Zambia, the accrediting Council was stymied by a heavy workload, lack of legitimacy and budget authority, and the government's indecision on incentives and feedback. Long delays arose between accreditation surveys and feedback of written results. Zambia has now begun to include some accreditation standards in performance audits and is considering decentralizing survey functions.

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The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines.

PURPOSE: To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation. DESIGN/METHODOLOGY/APPROACH: Interventional "before-after" study in 51 units (38 surgical and 13 anaesthetic) in nine hospitals participating in a RCT in the greater Copenhagen area; 27 of the units also underwent international accreditation. FINDINGS: The proportion of units with guidelines increased from 24/51 (47 percent) units before to 38/51 (75 percent) units after the trial. Among the 27 units without guidelines before the trial, significantly more accredited units compared to non-accredited units had a guideline after the trial (9/10 (90 percent) compared to 5/17 (29 percent). The quality of the systematic development scale and the clinical scales improved significantly after the trial in both accredited units (both p < 0.001) and in non-accredited units (both p < 0.02). The improvement of the systematic development scale was significantly higher in accredited than in non-accredited units (p < 0.01). ORIGINALITY/VALUE: The combination of conducting both the DIPOM Trial and international accreditation led to a significant improvement of both dissemination and quality of guidelines on perioperative diabetic care.

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[Towards an accreditation system for the Dutch hospitals].

The development of the Netherlands system for accreditation of hospitals started in 1989 in the Pilotproject Accreditation (PACE). This resulted in the establishment of the Netherlands Institute for Accreditation of Hospitals (NAIH) early 1999, by the Dutch Association of Hospitals, the Dutch Association of University Hospitals, the Dutch Organisation of Medical Specialists and the PACE foundation. Dutch hospitals may request (voluntary) for an accredition for their whole organisation or for parts of it, independent of the used quality system. An accreditation assesses whether organizational requirements are available for quality assurance. Accreditation is not primarily aimed to account for organizational quality, but rather to find points for improvement. The survey is carried out by peers: experts from other Dutch hospitals. The frame of reference used in accreditation is composed of 35 departmentwise standards and a hospitalwide standard 'Quality system'. All standards are developed by people in Dutch hospitals. NIAH can accept certificates for parts of the hospital (e.g. laboratoria) issues by organisations. The system is complementary to the 'visitities' which are organized by the medical specialist societies in the Netherlands. From 1996-1998 trial accreditations were carried out in 19 Dutch hospitals. These showed that the accreditation system has an added value for Dutch hospitals.

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Report on the European Association of Echocardiography accreditations in echocardiography: December 2003-September 2006.

AIMS: The European Association of Echocardiography (EAE) launched its Accreditation scheme in echocardiography in December 2003. Currently there are accreditations in Adult Transthoracic Echocardiography and Transesophageal Echocardiography and an Accreditation in Echocardiography for Congenital Disease will be launched in December 2006. METHODS AND RESULTS: Over the past 3years 350 applicants have undertaken the written exams and 157 applicants have completed the process and achieved accreditation. This report summarises the accreditation process, the details of the numbers of applicants and their progress through the Accreditation scheme. This report also provides data about the performance of the written exam, its reliability and the effectiveness of the questions and data about the reproducibility of the log book marking system. CONCLUSION: Taken together this report provides evidence that the EAE Accreditation schemes have been effective in establishing a standard for echocardiographic practice and an accreditation that is effectively organised, reliable, robust and successful.

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Accreditation: a "voluntary" regulatory requirement.

Hospitals and ambulatory surgery centers may choose to voluntarily apply for accreditation from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or the American Association for the Accreditation of Ambulatory Surgical Facilities (AAAASF) as appropriate. The facilities must comply with written standards regarding the environment of care, the provision of care, and the quality of care. Regular surveys of the organization's performance by the accrediting agency are intended to ensure the quality of care provided to the patients entrusted to our care. The accreditation process certifies to the health care community and the community-at-large that the facilities meet nationally accepted standards through a recognized accreditation program. Perianesthesia nurses should have an understanding of the regulatory agencies that influence daily patient care. This article provides an overview of the 3 accrediting bodies: JCAHO, AAAHC, and AAAASF. These agencies are committed to improving safety by providing standards of care, survey evaluations, and professional consultative and educational services, and they have an important role in our health care environments.

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Quality measurement for health systems: accreditation and report cards.

Efforts to measure the quality of care provided by health systems, including the accreditation processes used by the National Committee for Quality Assurance (NCQA) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and three report card systems-NCQA's Health Plan Employer Data and Information Set (HEDIS), JCAHO's requirements for performance data (Oryx), and a consumer-oriented system of performance measures created by the Foundation for Accountability (FACCT)-are described. NCQA reviews and accredits all types of health maintenance organizations, as well as point-of-service health plans and certain physician-hospital organizations. NCQA accreditation survey teams consist primarily of physicians. The fee for the process-oriented survey depends on the size and complexity of the plan. HEDIS was created to standardize the way in which health plans calculate and report information about their performance, thereby enabling comparisons among plans. NCQA is including more outcome measures as HEDIS is revised. Several HEDIS measures relate to medication use. In the future, health plans will be required to submit HEDIS data as part of the NCQA survey process. JCAHO's accreditation program for health care networks began in 1994. Survey teams and fees depend on the size and complexity of the network. A survey covers the central office, all hospitals, and selected components (excluding those that are accredited by other bodies recognized by JCAHO), and practitioners' offices. NCQA and JCAHO have no pharmacy-specific accreditation standards, but pharmacy information may be requested by the surveyors. In 1997 JCAHO began phasing in requirements for performance data as part of its accreditation process; networks must begin collecting data for at least 10 measures from five approved systems. FACCT performance measures are based on patients' health care experiences and outcomes; FACCT hopes these measures will be adopted by NCQA, JCAHO, and others. As health care purchasers and consumers increasingly demand evidence of quality, pharmacists will have ample opportunity to improve health outcomes.

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Quality oversight: why are rural hospitals less likely to be JCAHO accredited?

There is a large rural-urban disparity in the proportion of hospitals that are accredited by the Joint Commission on the Accreditation of Health Care Organizations (JCAHO). Several factors can influence whether a hospital participates in the accreditation process. A few of those factors include the hospital's size, case mix and ownership. However, even after controlling for many of these factors, hospitals in the most rural locations are less likely to be accredited by the JCAHO than urban hospitals. A survey was conducted to explore why rural hospitals are not participating in the accreditation process. Survey results show that the largest factor contributing to rural hospital deterrence to seeking accreditation is cost. Without accreditation by the JCAHO and compliance with their movement into performance measurement, quality monitoring of rural hospitals will fall further behind that of urban hospitals. Policy initiatives that make accreditation more financially feasible should be considered.

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Medicare program; granting and withdrawal of deeming authority to national accreditation organizations--HCFA. Final rule.

This rule implements section 1865(a) of the Social Security Act, as amended by sections 2345 and 2346 of the Deficit Reduction Act of 1984 and section 6019 of the Omnibus Budget Reconciliation Act of 1989. The amendments expand the types of providers and suppliers of services that we may consider to meet conditions of participation or certification, nursing home requirements, or conditions for coverage by virtue of their accreditation by a national accreditation program; these providers and suppliers are also subject to validation surveys. The rule also extends confidentiality to accreditation surveys, other than home health agency surveys, done by accreditation programs in addition to the Joint Commission on Accreditation of Healthcare Organizations, except that we may disclose survey and related information to the extent that such information relates to an enforcement action we take on the basis of accreditation survey findings. The rule also provides for: the release to, and use by, HCFA of all accreditation surveys and other relevant information even if a provider or supplier is not subject to a validation survey; the removing of deemed status of a facility based on a validation survey, an accreditation survey, or other information related to either; and appeal procedures for denied or withdrawn approval.

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Point of care testing: regulation and accreditation.

OBJECTIVE: To provide an overview of point of care testing (POCT) regulatory and accrediting agencies and their requirements. DATA SOURCES: Current literature and the author's experience. DATA SYNTHESIS: To develop and successfully run a POCT program that meets the federally mandated standards evaluated by accrediting agencies with Health Care Financing Administration (HCFA) status, requires that participants are aware of CLIA '88 requirements. Joint Commission on Accreditation of Healthcare Organizations (JCAHO), College of American Pathologists (CAP) and Commission on Office Laboratory Accreditation (CQLA) are the 3 principal organizations currently inspecting and accrediting POCT programs. They have included all CLIA '88 requirements on their inspection checklists. This paper covers requirements of JCAHO and CAP. In order to successfully meet the accreditation requirements of HFCA and their deeming agencies, JCAHO and CAP, these issues must be addressed: direction and supervision of the program, procedures performed, proficiency testing, quality assurance, quality control, procedure manuals, specimen handling, results reporting, reagents, calibration and standards, instrument selection and maintenance, personnel training and competence, and safety. CONCLUSION: CLIA '88 states that all testing is site neutral, therefore the same regulations apply regardless of where the test is performed. All POCT programs must apply for a CLIA certificate and choose an appropriate accreditation agency for their needs. All accreditation agencies must follow the requirements listed in the federal register; some agencies are more stringent than others.

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An update on the accreditation of graduate education in ophthalmology. The Residency Review Committee for Ophthalmology.

Educational standards for residency training in ophthalmology are established by a nine-member committee whose members represent the American Academy of Ophthalmology, the American Medical Association, and the American Board of Ophthalmology. Residency programs are reviewed to see that they meet these standards and are accredited if they do. Over the past 11 years, the accreditation status of a total of 445 programs was reviewed: 19 programs lost accreditation (nine withdrew voluntarily), 52 programs were placed on probation or were continued on probation, 310 programs were granted full accreditation or continued accreditation, and 15 of 20 applicants were granted provisional accreditation. During this time, the Residency Review Committee for Ophthalmology on two occasions modified the "Special Requirements for Residency Training in Ophthalmology." In addition, an appeals process was instituted by the Accreditation Council for Graduate Medical Education to give program directors the opportunity to appeal adverse accreditation decisions. There is evidence that this system has had an overall beneficial effect on residency training in ophthalmology in the United States.

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The American College of Nurse-Midwives' dream becomes reality: The Division of Accreditation.

Recognized continuously by the US Department of Education since 1982 as a specialized accrediting agency, the American College of Nurse-Midwives' Division of Accreditation (DOA) accredits not only nurse-midwifery education programs at the postbaccalaureate or higher academic level as certificate and graduate programs for registered nurses (RNs), but also precertification programs for professional midwives from other countries who are licensed as RNs in the United States. The DOA also accredits midwifery education programs for non-nurses at the postbaccalaureate or higher academic level as certificate and graduate programs, and precertification programs for professional midwives from other countries. The accreditation process is a voluntary activity involving both nurse-midwifery and/or midwifery education programs and the DOA. Present plans include another expansion of recognition: to become an institutional accreditation agency for independent and proprietary schools and to continue as a programmatic accrediting agency. Since its inception, the accreditation process has been viewed as a positive development in nurse-midwifery education.

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The costs of pursuing accreditation for methadone treatment sites: results from a national study.

The use of accreditation has been widespread among medical care providers, but accreditation is relatively new to the drug abuse treatment field. This study presents estimates of the costs of pursuing accreditation for methadone treatment sites. Data are from 102 methadone treatment sites that underwent accreditation as part of the Center for Substance Abuse Treatment's evaluation of the Opioid Treatment Program Accreditation Project. The analysis represents the most comprehensive analysis of the costs of pursuing accreditation by a health care provider. Importantly, it is the first analysis of the costs of pursuing accreditation by drug treatment providers. Policy makers and drug treatment providers can use this analysis to plan the labor requirements and costs of future accreditation initiatives.

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Performance reporting: alignment with accreditation.

This paper reviews the strong relationship of performance measurement and reporting with the Canadian Council on Health Services Accreditation (CCHSA) accreditation program and consistency with the direction of ongoing development. The CCHSA authors discuss the issue of public reporting of the accreditation results, the impact of public reporting on accreditation, aligning accreditation with the public reporting requirements, the measurement framework, quality improvement results and reporting and the linkage of accreditation with accountability. As public reporting gains momentum, the accreditation program must align to enable this while protecting the fundamental integrity and value of the program. Participating in the accreditation program clearly demonstrates the organization's commitment to accountability.

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The accreditation of ultrasound practices: impact on compliance with minimum performance guidelines.

OBJECTIVE: To determine the effectiveness of the American Institute of Ultrasound in Medicine (AIUM) accreditation program in improving compliance with standards and guidelines for the performance of obstetric and gynecologic ultrasound examinations. METHODS: Scores of case studies of accreditation applications were compared with their respective scores at the time of reaccreditation 3 years later. To account for the element of time, scores of applications that recently completed first-time accreditation were also compared as a control group. RESULTS: Individual obstetric case studies, as well as the average of all obstetric and gynecologic case studies, showed highly significant improvement with the reaccreditation application when compared with the initial accreditation application 3 years earlier (all P <.001). The proportion of practices successfully meeting obstetric and gynecologic AIUM accreditation requirements improved significantly with reaccreditation (obstetric, 57.3% for accreditation compared with 86.6% for reaccreditation; gynecologic, 60% for accreditation compared with 91.9% for reaccreditation; P <.001). Furthermore, reaccreditation scores were significantly higher than scores of recent first-time applications for obstetric case studies as well as scores of the average of obstetric and gynecologic case studies (all P <.05). CONCLUSIONS: Our study confirms that practices that sought and received ultrasound accreditation were able to improve the scores of case studies and compliance with published minimum standards and guidelines for the performance of obstetric and gynecologic ultrasound examinations when reevaluated 3 years after the initial application scores. This improvement should translate into an enhancement of the quality of ultrasound practice.

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HMOs serving rural areas: experiences with HMO accreditation and HEDIS reporting.

This article explores the reasons why two groups of health maintenance organizations (HMOs) that serve rural areas have chosen to apply or not to apply for National Committee for Quality Assurance (NCQA) accreditation, and their future plans regarding accreditation. It also describes the challenges faced by HMOs serving rural areas in meeting NCQA accreditation standards and collecting Health Plan Employer Data and Information Set (HEDIS) data. A number of accredited HMOs cited positive benefits of the accreditation process, and most HMOs plan to apply or reapply for accreditation in the near future. Several HMOs identified challenges with accreditation standards, and the majority reported difficulty collecting some HEDIS measures. The HMOs identified a number of accreditation and HEDIS issues that are more problematic in rural areas.

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Overview of the laboratory accreditation programme of the College of American Pathologists.

Although Saudi medical laboratories have developed enormously over the past 25 years, the absence of a national body for medical laboratory accreditation has meant the number of accredited laboratories (seven) remains low. Of these, five are accredited by the College of American Pathologists' Laboratory Accreditation Program (LAP)--the 'gold standard' of laboratory accreditation. It requires successful performance in the College of American Pathologists' proficiency testing programme as well as passing on-site inspections carried out by practising laboratory technicians, after which the laboratory is accredited for a 2-year period. This article gives an insight into the current situation of laboratory accreditation in Saudi Arabia and an updated overview of the process involved in obtaining laboratory accreditation from the College of American Pathologists.

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