Chap accreditation process and its relationship

chap accreditation process and its relationship

The Accredited in Public Relations (APR) credential is valuable to those available on the National PRSA site and the North Florida chapter offers scholarships. Chapter 3 - The aged care standards and accreditation agency. but assessing the quality of care particularly in relation to Standard 3: Resident Lifestyle.[]. Though not complex, the accreditation process does take time. for Healthcare ( ACHC) and the Community Health Accreditation Program (CHAP) both require.

This pool is limited, however, and it would be unrealistic to expect a new accreditation organization to manage more than one or two site visits per week, on average, during its first year.

It would take even longer to accredit the institutions surveyed in in the most recent and extensive survey of IRB operations Bell et al. Most institutions have more than one IRB, so the number of IRBs registered is much larger than the number of potential applicant institutions.

chap accreditation process and its relationship

Page 53 Share Cite Suggested Citation: Repeat Accreditation Accreditation is not permanent. The models of accreditation reviewed by the Lewin Group in involved accreditation terms of 3 to 5 years. The NCQA program plans a 3-year accreditation cycle. The process for reapplication might or might not differ from that for initial accreditation.

It is likely that accredited organizations with few untoward events would face a more abbreviated process, but this is likely to be decided in light of experience.

chap accreditation process and its relationship

Accreditation of HRPPPs should be pursued as one promising approach to improving the human participant protection system. The first step is implementation of pilot programs to test standards, establish accreditation processes, and build confidence in accreditation organizations.

This effort should be evaluated for its impact on protecting the rights and interests of participants in 3 to 5 years. Accreditation as a mark of excellence—of achievement well beyond regulatory compliance—might offer an HRPPP a competitive advantage over nonaccredited competitors in seeking support from sponsors or access to participants, researchers, or students. That is, NIH or other funding review committees might look more favorably on research proposals from accredited institutions than on those from nonaccredited ones, those recruiting participants might advertise accreditation as a hallmark of quality and safety, or private drug and device firms might preferentially site clinical trials that they sponsor at accredited research institutions or have them reviewed by accredited IRBs.

Page 54 Share Cite Suggested Citation: The process of preparing for accreditation would force institutions to attend to their HRPPPs, and that attention would necessarily entail education about the importance of protection of human participants in research. It might offer HRPPPs located within research institutions, both public and private, a potent argument when asking their administrative supervisors for additional resources. This is a major role played by accreditation of academic units within a university and is used as a tool to effect changes in, for example, library services, curricula, and services.

Accreditation could not serve these ends, however, until it became widely accepted as a mark of excellence. Any accreditation program seeking to establish its value on the basis of these terms would first need to achieve broad recognition as a credible program.

All previous accreditation programs faced a similar dilemma when they were initiated, and some have succeeded in attaining credibility, but others have not. Both OHRP and FDA have signaled that they might consider accreditation by a nongovernmental accreditation organization presumptive evidence of compliance with regulations.

In the case of research institutions under OHRP oversight, accreditation could serve as a partial substitute for the assurance and compliance functions, reducing FDA and OHRP scrutiny of accredited organizations allowing them to concentrate their scrutiny on nonaccredited organizations. However, before the usefulness of this approach can be assessed in the case of HRPPP accreditation, an accreditation program s will need to be much further along in its development.

The regulatory enforcement model is also worth considering, particularly as a starting point. It might be wise to start, as NCQA apparently proposes to do under its contract with the VA, with a focus on innovative or more effective means of evaluating regulatory compliance before moving on to a program that raises standards above the regulatory minimum.

This approach could, however, have the effect of inundating HRPPPs with further paperwork if additional requirements are imposed on current ones. If the goal is to shift from a focus on such paper compliance to a focus on more meaningful performance measures, 7 Some accreditation programs fail to take root and flourish. An AMA physician certification program was announced with great fanfare in latebut AMA discontinued the program in April because it had not been widely adopted.

JCAHO implemented an accreditation program for managed care in but stopped inuntil a new managed care accreditation program was put in place in BNA,; Dimmitt, Page 55 Share Cite Suggested Citation: Again, it is important to look carefully at what value accreditation adds to the regulatory program that already exists and whether this added value justifies the added costs financial and personnel of such a program.

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A voluntary national accreditation system, however, could decrease the burden currently experienced by regulators, allowing them to refocus their efforts where they are most needed, and it could also increase flexibility for entities attempting regulatory compliance. An independent accreditation organization s could more readily modify and improve its standards than federal agencies carrying out mandatory programs. Federal agencies attempting to modify their regulatory approach are less flexible because they must follow formal rule-making procedures to do so.

It took a decade to reach agreement on the federal Common Rule, and at least three agencies that conduct research with human participants did not adopt the rule, 8 leaving all agencies loathe to reopen the process used to modify the regulations. The current need for multiagency concurrence is a tremendous barrier, and so short-term improvements are more likely to come from other approaches, such as nongovernmental accreditation, that do not require major regulatory overhaul.

The need to shift from paper compliance to measures that more meaningfully prevent unnecessary risks, promote sound scientific design, and ensure autonomous choice has been a consensus direction for improvement since regulations were first implemented.

The call for better measures was articulated by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and 8 OPRR noted three agencies that appeared to sponsor research with human participants but that were not signatories to the Common Rule: This topic is beyond the scope of this committee's first report but will likely be taken up in its subsequent report.

Page 56 Share Cite Suggested Citation: Establish a Nongovernmental Accreditation Organization s.

chap accreditation process and its relationship

Organizations formulating accreditation standards and carrying out the accreditation process should be independent, nongovernmental organizations. These organizations should include within their programmatic leaderships the perspective of the relevant stakeholders in the applicant HRPPP community i. As discussed above, one of the chief virtues of a nongovernmental accreditation system is that it can evolve over time without requiring new federal regulations at each step.

The operations of organizations seeking accreditation will also evolve. The parallel evolution of accreditation standards and HRPPP operations should be an iterative process, with the formulation of standards efficiently informed by knowledge acquired in the accreditation process. The formulation of standards, the conduct of accreditation site visits, and external evaluation must therefore be intimately linked and appropriately responsive to feedback. Organizations formulating standards and conducting the accreditation process should be national in scope; be familiar with the operations of institutions that apply for accreditation; and incorporate the perspectives of research participants within their programmatic leaderships.

Page 57 Share Cite Suggested Citation: Accreditation bodies for HRPPPs will require input from academic health centers, organizations representing research sponsors, nongovernmental research organizations, private firms developing products and services tested in studies with humans, participants, IRB members and staff from both academic and nonacademic institutions, research administrators in both academic and nonacademic institutions, and individuals from a range of research fields appropriate to the intended range of applicant institutions.

In most cases, an accreditation process could be used as an indirect means to improvement; however, further actions would be needed in parallel with the establishment of an accreditation process.

chap accreditation process and its relationship

The committee expects to come back to many of these topics in its second report and has discussed how to integrate some elements not currently emphasized into the accreditation process.

The discussion below includes some suggestions to that effect. Accreditation is not a short-term fix. It must be viewed as one element of a long-term strategy. The VA-NCQA accreditation program will operate in a relatively circumscribed system, but it will take several years to implement the system and several more to evaluate it. Before a program could be granted deemed status it would need to be given time to develop and mature. Turning over regulatory authority to an untested program would be very risky, reinforcing the need for pilot testing as a first step.

Chapter 3 - The aged care standards and accreditation agency

Identifying, Investigating, and Sanctioning Violations Accreditation cannot totally replace federal regulation. Accreditation is rarely effective in dealing with bad actors—those who intentionally flout or ignore requirements.

Monitoring, investigation, and enforcement are necessary to augment an accreditation system, and under the current regulatory framework these will remain functions of OHRP and the FDA. Some of the most conspicuous cases in the past two decades—Martin Cline's gene transfer experiments in Israel and Italy Thompson, and the death of Jesse Gelsinger in gene transfer experiments at the University of Pennsylvania infor example 12 —appear to be attributable to the conduct of principal investigators and their collaborators or to institutional decisions unrelated to the IRB, so it is not clear how accreditation of an HRPPP could prevent such cases.

prsacentralcalif | ACCREDITATION

An accreditation body should not be expected to be the original source responsible for uncovering violations or the main body responsible for investigating or sanctioning them. Accreditation could, over time, reduce the likelihood that violations would occur as a result of changes in norms and behaviors. Accreditation could, moreover, be withdrawn or made probationary on the basis of the disclosure of infractions at an accredited institution. Reports of infractions would surely increase scrutiny by an accreditation body.

An accreditation organization could also be used as part of the strategy to bring an institution back into compliance with federal regulations after infractions were detected and investigated. Therefore, accreditation is relevant to the problem of bad actors, but 12 InMartin Cline administered recombinant DNA with the hope of effecting gene transfer in two patients with thalassemia, one in Israel and one in Italy.

His IRB had not approved his protocol and, indeed, rejected it just days after Cline conducted the experiments. The IRB had reviewed the protocol several times and had enlisted external expert reviewers who uniformly judged the experiment premature. Cline also deliberately misled a review panel in Israel and his collaborator in Italy, who identified the patient who was treated.

The experiments had no known adverse health consequences for the patients, and after an NIH investigation, Cline had several grants terminated and was barred from seeking NIH funds for 4 years; he also resigned from his division chairmanship at the University of California at Los Angeles.

IRB action in connection with this protocol was not at fault in the infractions. IRB action was similarly a relatively minor concern in the death of Jesse Gelsinger.

CHAP Accreditation and Home Health Care Licensure

The benchmark of care, which would be fully costed, could be used as the tool to determine the funding that the government provided for care.

Those minimum staffing levels need to be flexible so that they can be adjusted for the particular care plans and circumstances of each facility. But underlying that there has to be a stage when government says: A key component would be the establishment of an aged care benefit schedule to modernise government care subsidies and to deliver appropriate support to the frail elderly.

It is linked to the benchmark. There needs to be a commitment of funding to ensure appropriate staffing levels are in place for facilities, depending on their size, and the resident profile. The benchmark of care needs to take into account all aspects of a person's needs: Under the benchmark of care approach, what we would be saying is that there are certain dependency levels and clinical groupings of care need for residents.

Chapter 3 - The aged care standards and accreditation agency – Parliament of Australia

When you have a group of residents that are in a similar care cohort or casemix, then you really need a mix of staff to meet that care need for that particular casemix of residents. Many submissions argued for the introduction of a benchmark of care or a quality of care compact that links resident outcomes, staffing levels and skills mix. The Committee believes, however, that such a system would need to be sufficiently flexible to take into account the changing needs of residents. The benchmark of care that is developed needs to be flexible so as to accommodate the changing needs of residents.

Access to medical and allied health workers 3. The Australian Society for Geriatric Medicine ASGM noted 'older people in residential care facilities are significantly disadvantaged and have poor access to both basic medical care and specialist medical care'.

In addition, there are few geriatricians who consider residential care their area of particular interest in geriatric practice. The ASGM noted that 'the best models of care focus on a multidisciplinary approach to care, with allied health, nursing and medical practitioners working together.

That does not happen in this country in residential care'. The Accreditation Standards state that residents be referred 'to appropriate health specialists in accordance with the resident's needs and preferences' Standard 2. The Australian Physiotherapy Association APA expressed concerns that the Agency places insufficient emphasis on ensuring the presence of preventive programs and that therapy is properly provided in facilities.

The APA noted that some aged care facilities that advertise a comprehensive physiotherapy service do not employ sufficient physiotherapists to provide this service. The Society argued that psychologists have little current role in aged care despite the effectiveness of psychological interventions in these situations. The Accreditation Standards require that residents' 'oral and dental health is maintained' Standard 2. The Aged Care Lobby Group noted that 'oral care is often lacking and as a follow-on These include selection of management options, prescribing decisions, administration and use of pharmaceuticals and the lack of ongoing review and follow-up of residents.

The Australian Pharmaceutical Advisory Council's Guidelines for Medication Management in Residential Aged Care Facilities provide guidelines about improving the quality use of medicines in aged care facilities. It was suggested that, while the facilities pick up on those guidelines as part of the accreditation process, 'there are very major gaps The Australian Society for Geriatric Medicine noted that: The problem of polypharmacy and drug use is a very serious and significant one in residential care facilities, and in part it comes from the ignorance and skill mix of those who provide care.

The answer to behavioural problems in patients with dementia, for example, is not to give them antipsychotic medications but to put in pace appropriate behavioural and environmental strategies. The Centre for Research into Aged Care Services conducted a study into a comparison of two types of medication administration systems, particularly in terms of the time and resources involved in the two systems.

One was the traditional dosette box and the other was the computerised sachet. The study found that with the computerised delivery system 'there were fewer errors, there was more confidence with the people dispensing the medications and they were able to move away from the big trolley and all that stuff that takes up time'. Poor nutrition can lead to a range of health problems. The Accreditation Standards merely require that residents receive 'adequate nourishment and hydration' Standard 2.

Most people never see fresh fruit in a nursing home unless it is brought by relatives. For elderly people, and for us all, food is a celebration and we hang our day on what we are going to have That is one of the real pleasures that most aged care facilities do not provide. This supplement to be funded by the Commonwealth — and be similar to other supplements under the Aged Care Act — would provide a dedicated funding allocation towards transport support for people living in aged care facilities.

Fronditha Care noted that: The current regulatory framework Currently the number of elderly from CALD backgrounds is 20 per cent of the population aged 65 years and over. This is projected to increase to 23 percent, or almost a quarter of the aged population 65 years and over, by One witness cited the example of elderly Greek-speaking women in their mids who speak very little English: They are in a mainstream nursing home for 24 hours a day, days of the year If you do not have the language and if you do not share a common sense of history, values, music or food The decision to engage a translator rests with the local State manager and will be based on information collected regarding the dominant cultures and languages used in the service.

It may also be appropriate to discuss the need for a translator with the provider at the service. The Agency noted that 'it is not practical' for it to provide a translator for every cultural group or language group in a particular service.

Cultural diversity needs to be effectively addressed across all the Standards, as all are relevant in meeting the full range of individual care and health needs of CALD residents. Specific expected outcomes need to be introduced relating to the language and communication needs of CALD residents.

Agency auditors should be trained in cultural competency in aged care service provision. The Agency should develop and utilise standard cultural competence assessment tools. Cultural factors, language and ethnicity is included in the attributes identified for quality assessor registers. The Agency also maintains its own list of staff who speak a language other than English. Some witnesses called for the construction of more Indigenous-specific aged care facilities in areas of large Aboriginal populations or the construction of specific wings in local nursing homes in other areas.

There are only two Indigenous-specific residential care facilities in NSW.

One witness noted that: We have a lot of people out west [of NSW] who want — who need — to go into residential care and just cannot access to it, because it means leaving their homes, their regions and their families. Aboriginal communities and Aboriginal people do not particularly want residential care anyway, but when we get to the point where we need it, we would like to be able to have something that is culturally appropriate, that is close by and that has Aboriginal workers providing that care.

Aboriginal staff actually address a lot more issues than just carrying out their required duties — it entails the emotional care of our elders, which no non-Aboriginal person with any amount of cultural awareness can address. There are also our historical conversations, if you like — some of our elders with dementia go back to things that happened in the past.

Aboriginal people are much more empathetic Conclusion — how effective are the Accreditation Standards? The Committee believes that the Accreditation Standards are too generalised to effectively measure care outcomes.