Business Accent

Regulation in Healthcare: Improved Care Delivery or Just Documentation?

Accepting a regulator signifies acceptance of authority to assess, probe, question and recommend changes in processes and practices across all operations

"Over the years, Joint Commission accreditation has become synonymous with 'quality and safety in care delivery'" - Ravi Mariwalla

We can relate to the regulatory environment by virtue of familiarity with everyday reported instances of control. Here in India, the financial markets are controlled by SEBI, banks by the RBI, and telecom companies by TRAI. More recently the National Accreditation Board of Hospitals and Healthcare (NABH) was created. It is charged with the functions of monitoring and accrediting providers to encourage development of safety and quality in healthcare facilities across India.

Regulation is control, assessment and monitoring of the players that constitute the industry. Accepting a regulator signifies acceptance of authority to assess, probe, question and recommend changes in processes and practices across all operations. Regulators are duty bound to provide a rationale as well as best practices and also a roadmap for improvement. Accreditation bodies add a dimension to regulation- they act as a public approval of practices and certifying safe/ efficient practices.

The Joint Commission

In the USA, the much feared and agonised- over regulator and accreditation body for hospitals is the Joint Commission (formerly called the JCAHO). Over the years, the Joint Commission has come to be the sole accrediting agency (barring a few - 40 hospitals that have a DNV accreditation) that has tremendous influence over a hospitals operations and acceptability.

I have never ceased to be surprised at how much work has been done and though there obviously are shortcomings, an immense body of knowledge and a methodology for objective evaluation and comparison has evolved over time. The granularity of approach and depth of understanding as well as articulation is truly amazing. The Joint Commission evaluates and accredits more than 16,000 healthcare organisations and programmes in the United States. An independent, not-for-profit organisation, The Joint Commission is the nation's predominant standards-setting and accrediting body in healthcare. Since 1951, The Joint Commission has maintained state-of-the-art standards that focus on improving the quality and safety of care provided by healthcare organisations. The Joint Commission's comprehensive process evaluates an organisation's compliance with these standards and other accreditation or certification requirements. Joint Commission accreditation and certification is recognised nationwide as a symbol of quality that reflects an organisation's commitment to meeting certain performance standards. To earn and maintain The Joint Commission's Gold Seal of Approval, an organisation must undergo an on-site survey by a Joint Commission (JC) survey team at least every three years.

This brief list can be misleading because within these areas the JC, through 'elements of performance' covers every conceivable area and function in a hospital at an amazing level of detail. Whether it is any aspect of care delivery, transfer, medication administration, facility planning, management, leadership, disaster preparedness and many more. Over a 1,000 focus areas are adjudged by a group of inspectors empowered to assess the hospital during an inspection.

Over the years, the demand for a Joint Commission accreditation has grown immensely. It has become synonymous with 'quality and safety in care delivery'. Every reader must realise therefore that these standards are only a starting point.

The Patient Safety Continuum

We have a continuum of patient safety (as shown in the figure below):

Liability, Regulatory Oversight, Selection, Payment, Prioritisation, Process operation and management (Identification of best in class), applied research. This covers the evolution of US healthcare with respect to patient safety.

The first interventions (Liability, Regulatory Oversight) work to make professionals accountable. Interventions to the right are applications that focus on learning :the feedback of performance data to clinicians as well as redesign of care processes by hospitals based on analysis of data collected in near-miss and adverse event reporting systems. Falling between these are applications intending to encourage care providers to strive for excellence by rewarding those who achieve the highest levels of performance.

Performance: Thresholds

Let us focus now on the two graphs below. These demarcate the acceptable vs unacceptable levels of performance. Note also how the threshold is set allowing a large area of acceptable performance and effectively weeding out only an extreme poor performance level.

This effectively shows that performance variation is permitted or tolerated across many different levels.

Now focus on the second graph where we note an active selection. We notice that quality is more closely defined as acceptable only if it falls within a defined limit.

The point I am trying to make is this: regulatory compliance is tolerance of a large area of performance permitting variation. A closely defined quality / performance level restricts variation and completely moves the threshold leading to a quantum shift. This closely resembles our situation today: performance and quality are loosely defined and literally everything is acceptable (for instance mortality and morbidity based indicators versus appropriateness, process and outcome indicators).

The JC and Second Graph

Going back to the Joint Commission storyline: While the burden of complying with the JC requirements is great, all efforts to succeed in gaining accreditation after all help you qualify as 'not part of the failing group'.

Hospitals and staff would go into a tizzy three months before an inspection was due. All kinds of adjustments (some even verging on the ridiculous) were made to comply with JC requirements. Experts and consultants were called in to advice and to help the departments prepare. It was a great show. Once the accreditation was conferred the hospital slipped back into old ways of functioning and worse, the strain of complying made staff go into a 'relax mode' that made service levels reach a low, until they recovered.

Administrators as well as the media, experts and observers became particularly critical of the JC approach when the Institute of Medicine publications ( as recently as the year 2000 and onwards) brought to the fore the 'lack of safety' and the 'likelihood of harm during treatment' in healthcare institutions. The question asked was, "After hospitals making this extraordinary effort to comply (with JC standards), is there any real (and measurable) correlation between improvement and accreditation?"

The JC responded to this criticism with alacrity. It came up with two different ways out of this dilemma.

Response 1:

One obvious way was to make the survey based evaluation unannounced. Today, a hospital can only choose which days in a year the survey team should not land up at the hospital for an un-announced survey. It was hoped that this would result in continuous readiness and continuous compliance across the hospital. To an extent this has been a success.

Response 2:

The other step the JC took was even more remarkable though it only marks a new beginning.

Introduced in February 1997, the Joint Commission's ORYX initiative integrates outcomes and other performance measurement data into the accreditation process. ORYX measurement requirements are intended to support Joint Commission accredited organisations in their quality improvement efforts. Performance measures are essential to the credibility of any modern evaluation activity for health care organisations. They supplement and help guide the standards-based survey process by providing a more targeted basis for the regular accreditation survey, for continuously monitoring actual performance, and for guiding and stimulating continuous improvement in health care organisations. Beginning in July 2002, hospitals began collecting core measure data. Hospitals were required to select at least 2 measure sets respecting populations served by the HCO. Public reporting of core measure data was initiated as part of the Joint Commission's Quality Report in July 2004.

These measure sets identified the most critical areas of medicine and are known as the 'core measure sets'-SCIP or the Surgical Care Improvement Plan, Acute Myocardial Infarction, Heart failure , Pneumonia, Pregnancy related, Hospital Outpatient measures, Children's Asthma Care and In-patient Psychiatric services.

These measures are eventually reported merely as a numerator divided by a denominator. The fraction the hospital reports as a measure or metric result is the compliance or no. of patients for whom the compliance happened and was documented divided by the total no. of patients in that population. For instance, the number of patients (with AMI) with Beta Blockers prescriptions at discharge divided by the total number of AMI patients the hospital served in a quarter.

The beauty of these 109 odd measures is that the JC has very clear directives regarding the populations to be included, guidelines for exclusion criteria (ex: patients below 18 for AMI). In fact, each of them is accompanied with an Algorithm. Not only that, many of them are risk adjusted( which means that to make a population of treated patient comparable they have to be normalized or the severity of disease , co morbid conditions ( HF with diabetes and asthma) have to be accounted for before they can be compared.

Milestones in Uncharted Territory

What we as members of the Indian healthcare industry should note is:

1. The evolution(from static standards compliance to extend to dynamic performance measurement ) has been remarkably rapid.
2. Absolutely innovative application of PM methodology probably for the first time in an industry famous for variation and lack of standardisation in practice .
3. Mind numbing clarity and unambiguous definition, documentation and articulation.
4. Applied across a staggering no. of units and a heightened compliance level or Standard application( exact replication) across diverse set ups, geographies, owners, types of centers.

Please try and imagine the kind of focus and organisational depth required to achieve this. Also try and understand how well the whole initiative was thought through at the beginning for it to be implemented so well.

It also shows how far the USA has progressed in applying performance management techniques and pioneering these initiatives in healthcare —a sector that accounts for over $1.3 trillion and about 21 per cent of their GDP. The remarkable feature is that the Joint Commission really had no precedent or parallel which it could emulate. Nor was there an implementation of vision in this direction anywhere amongst healthcare organisations.

The phenomenal success of this effort arises from:

• The Institute of Medicine highlighting lacunae in the system and quantifying the magnitude of the problem.
• The consumer activism & high level of patient awareness in the US.
• The development of Consumer Directed Health Plans (CDHP).
• The maturity of the US Health system (they have already been through several evolutionary stages: Liability: Managed Care: CDHP: Health saving accounts).
• Social pressure being inadequate, it is effectively coupled with federal mandates.

NABH- An Indian Endeavour

NABH is an institutional member of the International Society for Quality in Health Care (ISQUA). ISQUA is an international body which grants approval to Accreditation Bodies in the area of healthcare as mark of equivalence of accreditation programme of member countries.

So far hospital standards of only 11 countries viz. Australia, Canada, Egypt, Hong Kong, Ireland, Japan, Jordan, Kyrgyz Republic, South Africa, Taiwan, United Kingdom were accredited by ISQua.

So far only 27 hospitals have received the accreditation status by the board. Several of the big names amongst Indian Hospitals are missing from that list. The fact is that this is a tiny fraction of the over 16,000 hospitals in the country. As a gold standard for processes, safety and quality in the delivery of healthcare services we do not compare.

As is obvious a comparison with the JC would be unfair. We are only just making a beginning. If we were really concerned, there would be Government mandates similar to those in Banking/ SEBI/ Pharmaceuticals and Telecom.

It seems like our priorities center around 'patient access to medical care' in rural areas (a process focus, safety and quality and comparative reporting hardly measure up in comparison) .

I do feel regulation in healthcare is not the responsibility of the central Government alone (Ministry of Health), but that a measure of public activism is critical in order to raise the stakes and create traction to articulate and implement a new standard of care. The smaller organised hospitals should be taken up on priority and then nursing homes which form the bulk of care givers must be the focus. Experts from different hospitals must sit together and define a roadmap to take these efforts forward. This is crucial for a good beginning. Refer to the none National Patient Safety Goals of the JC which help focus improvement efforts.

The writer is Manager- Consulting Healthcare- Provider practice COGNIZANT TECHNOLOGY SOLUTIONS
MEPZ- Chennai ravimariwalla@yahoo.com