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EDITORIAL
Year : 2019  |  Volume : 13  |  Issue : 2  |  Page : 53-57

Clinical Establishments Act, 2010: Improving clinical standards or proscribing physiotherapy


Department of Physiotherapy, Punjabi University, Patiala, Punjab, India

Date of Submission12-Dec-2019
Date of Acceptance16-Dec-2019
Date of Web Publication30-Dec-2019

Correspondence Address:
Editor in Chief Akhoury Gourang Kumar Sinha
Department of Physiotherapy, Punjabi University, Patiala, Punjab
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/PJIAP.PJIAP_34_19

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How to cite this article:
Sinha AG. Clinical Establishments Act, 2010: Improving clinical standards or proscribing physiotherapy. Physiother - J Indian Assoc Physiother 2019;13:53-7

How to cite this URL:
Sinha AG. Clinical Establishments Act, 2010: Improving clinical standards or proscribing physiotherapy. Physiother - J Indian Assoc Physiother [serial online] 2019 [cited 2020 May 28];13:53-7. Available from: http://www.pjiap.org/text.asp?2019/13/2/53/274288



Utilization of health and rehabilitation services in India is a complex phenomenon influenced by several factors. A poor referral system that does not fully utilize the expertise available within the system is one of the main factors that influence the access to rehab services in India in addition to availability and affordability of services.[1] A person with existing or eminent locomotor disability requires a variety of services such as physiotherapy, occupational therapy, speech therapy, and orthotic, prosthetic, vocational, and psychosocial rehabilitation. However, they do not always receive these services. According to the World Bank, foremost services received by people with locomotor disability in India are medication (86%) and physiotherapy (44%).[1]

Most of the doctors are not trained for rehabilitation of persons with disabilities, they often try to treat their disabilities even when medical or surgical interventions are not required. In the process, most critical period of six years of life is lost which is most important period to train and rehabilitate the child with disability to utilize the residual capacity of the impaired organs. Consequently, it is too late for such children to respond to the rehabilitation therapies even by most qualified and skilled rehabilitation professionals like Physiotherapists etc.” Observes the Deputy chief commissioners of disability in a letter addressed to presidents of MCI and IMA way back in 2007[2] and issued a warning to initiate action under Section 59 of the Persons with Disabilities Act, 1995 against the doctors for not referring the children with disability to the rehab professionals well in time.

In light of these observations, it should have been the effort of the Government of India to make efforts for facilitating the access of physiotherapy to millions of patients. However, rules notified in 2012 under the Clinical Establishments Act (CEA) seem to do exactly the opposite.[3] Unfortunately, the Draft Rules for Third Amendment 2019[4] has not done anything to reverse the regressive rules that indirectly seek to proscribe physiotherapy clinics across the country.

CEA came into existence in 2010 to provide for registration and regulation of all clinical establishments in the country with a view to prescribe the minimum standards of facilities and services.[3] The objectives of this act are to establish digital registry of Clinical Establishments at National, State, and District level, to prevent quackery by unqualified practitioners by introducing a mandatory registration system, and to improve the quality of health care through standardization of health-care facilities by prescribing minimum standards of facilities and services for all categories of health-care establishments (except teaching hospitals) and ensuring compliance of other conditions of registration such as compliance to standard treatment guidelines, stabilization of emergency medical condition, and display of range of rates to be charged.

The act is applicable to all kinds of clinical establishments from public and private sectors of all recognized systems of medicine including single-doctor clinics. The only exception is establishments run by the armed forces. The first set rules were notified in 2012. On July 17, 2019, the Health Ministry placed the draft notification on Clinical Establishments (Central Government) Third Amendment Rules, prescribing “minimum standards for 8 general and 35 specialty categories of allopathy clinical establishment and all seven systems of AYUSH clinical establishment in public domain for comments/suggestions.” For each category of clinical establishment, it provides definition, scope, infrastructure, equipment/instruments, furniture and fixtures, human resource, support service, legal/statutory requirements, record maintenance, and reporting process. The clinical establishment of physiotherapy, dietetics, and integrated counseling center is included under the general category of allopathy clinical establishment.

Under this act, there are three distinct authorities, i.e., central council, state councils, and district registration authority. The mandate of central council is to frame scheme for classification of clinical establishment and develop minimal standards and undertake their periodic review through a consultative process. State councils are designed to implement the rules, and the task of registration of clinical establishment is vested with district registration authority which comprises district collector as chairman and district medical officer as convener and three other members including senior superintendent of police, a senior level officer of local self-government, and a representative of professional medical association.[4]

After the enactment of this act, no person shall run any clinical establishment without registration. Further, the clinical establishment must follow the prescribed minimal standard of facilities and services. Any contravention of the rules would invite monetary penalties that range from rupees 10,000 to 50 lakhs depending on the nature of contraventions. If a professional is found working in unregistered clinical establishment, he/she is also liable for punishment up to 25,000 rupees. The central government has the power to amend the rules regarding determination of standards and classification of clinical establishment and minimal standards of facilities. However, such amendments must be ratified by both houses of parliament. In India, health is a state subject; therefore, every state has to adopt this act. As of now, CEA has been adopted in 14 states and union territories, including Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, Assam, Jharkhand, Rajasthan, Uttar Pradesh, Bihar, and Uttarakhand.

The scope of practice of physiotherapy center includes electrotherapy, exercise therapy, mechanotherapy, hydrotherapy, and manual therapy. The center is required to display the name of center along with name and registration number of a physiotherapist, fee structure, timing, and services provided within the facility. The center should have at least one support staff to cater to the service needs of the patients. It shall be mandatory to keep copies of all records and statistics for at least 3 or 5 years. The center must provide a floor area of approximately 600 sq ft. Minimum qualification for physiotherapists working in the center shall be Bachelor of Physiotherapy from recognized university or Diploma in Physiotherapy awarded till 1991 from recognized university. The rules also provide a list for electrotherapy and exercise therapy equipment that must be available in the center.[5]

The definition of physiotherapy centers in this act has instilled fears in the mind of physiotherapists who have been running their physiotherapy clinics for so many years without a hitch. They perceive this act as an assault on their livelihood. According to CEA Standards for Physiotherapy Centre, “A physiotherapy centre is an allied Health care establishmentproviding, physical therapy services by a physiotherapist to patients with a recent prescription orreferral from a licensed medical doctor (physician or surgeon). Depending on the disease condition a review and re-prescription by a treating medical doctor is required for continuing physiotherapy services.”

It implies that before availing physiotherapy, a patient should not only have referral of a licensed medical doctor (physician surgeon) but also the prescription for physiotherapy and that prescription should be renewed every 3 weeks if one wants to continue the plan of care.

Such tortuous definition of physiotherapy center shall have far-reaching clinical and societal implications. In the first instance, it provides a blanket authority to all licensed medical doctors (Allopathy, Homeopathy, Unani, Siddha, Yoga, and Ayurveda) for prescribing and reviewing physiotherapy management of all types of patients without bearing in mind as to whether these doctors have the competency to do so.

The study of physiotherapy is not the part of the curriculum of the undergraduate courses of the allopathic, homeopathic, and ayurvedic system of medicine, and it is beyond the expertise of the holders of these degrees to chalk out the physiotherapy treatment. Leaving the responsibility to direct the physiotherapy to this group will amount to put millions requiring physiotherapy at the whims and fancy of a group which is grossly ignorant about the importance and use of physiotherapy.

In such a situation, the medical doctor would struggle to generate a prescription of physiotherapy using the limited knowledge and would run the risk of inviting provision of the Consumer Protection Act for a wrong prescription and finally will land up in neither issuing any prescription nor referring the patient for physiotherapy. As a result, millions of patients requiring physiotherapy services will be compelled to suffer indefinitely or will be forced to go to the unqualified persons which this bill intends to weed out.

Shortage of medical professionals in the rural areas of India is a well-recorded fact. Therefore, millions of patients leaving in the far-flung areas will not receive physiotherapy treatment because there will be nobody to issue the prescriptions. As a result, the preventable impairments will be allowed to become permanent and all the wisdom, knowledge, and skill of the practitioner of the tread, i.e., physiotherapists will be pronounced illegal.

Orthopedicians have been prescribing the physiotherapy treatment since ages. Their role in deciding an overall multidisciplinary treatment program of an orthopedic patient can be understandable. However, they are not competent to decide about the physiotherapy prescription in neurological, gynecological, and cardiopulmonary cases where the application of physiotherapy is increasingly becoming common. Physiatrists are another group of medical doctors who desire that each and every case must pass through them even when it adds nothings to the care of patients. There are hardly 500 physiatrists in the country, and in many states, there is no physiatrist. In this situation, the inclusion of the phrases such as recent prescription, review, and represcription from the treating medical doctor in the definition of physiotherapy will not improve the quality of health care; rather, it will a retrograde step that would take the care of millions of victims of existing and imminent locomotor disability 50 years back.

This definition infringes upon the patient autonomy and snatches away the right of self-referral from millions of patients that provides them the opportunity to seek the remedy of their ailment as per choice. Currently, there is no law in the country that prohibits the administration of physiotherapy if a patient so desires. The actual delivery of physiotherapy services in hospitals and clinics is governed by convention and expertise of the professional of providing physiotherapy service. Some 70 years ago in the years of inception, it was common to see a medical doctor (orthopedicians and physiatrists) heading the physiotherapy unit and generating the physiotherapy prescription for the benefit of physiotherapy staff employed in the unit. Over time with the advancement of instrumentations as well as the knowledge and skills of physiotherapists, the trend shifted toward the medical doctors referring the patients for physiotherapy. Physiotherapists then decided on the basis of examination and experience about the methods of therapy. Some hospitals follow the practice of generating line of treatment after detailed case discussion among the medical doctors, physiotherapists, and other professionals such as occupation therapists and speech therapists.

Over the time, independent physiotherapy departments, where patients directly go to physiotherapists for consultation and treatment, became a common occurrence. During the late 90s and in the first two decades of a new millennium, the country has witnessed a quantum leap in the number of physiotherapy educational institutes – each running their own physiotherapy clinics and providing independent physiotherapy services. The graduates and postgraduates passed out from these institutes have opened clinics in the areas where physiotherapy had not reached in all these years. This has benefited the society and also provided self-employments to thousands of youths. Early access to physiotherapy is known to reduce the consumption of analgesics and nonsteroidal anti-inflammatory drugs. Given the increasing patient reluctance to consume these drugs in the light of their side effects, these physiotherapy clinics have found greater social acceptance. So far, there has not been a single report of negligence and patient mismanagement from any of these centers. In these independent physiotherapy clinics, physiotherapists, if required, refer the patient to other medical experts. A case in point is the practice of sports physiotherapy where physiotherapist remains the only available health-care professional at the time of training and injury. Sports physiotherapists not only diagnose the patient but also provide the necessary treatment and when required refer the patients to other health professionals and later on work in close coordination with them to facilitate the early return of players to the sports ground. However, with enactment of CEA rules, all these practices would become illegal and punishable.

The evolution of physiotherapy practice in India is similar to what has happened in other countries. In Australia, physiotherapists acquired the right of first-contact practitioners way back in 1976.[6] Two years later in 1978, the UK also conferred the same rights to physiotherapists and in 2005 also provided to rights of extended practice which allowed a physiotherapist to prescribe certain types of medicine.[7] In 1997, the Health Professions Council of South Africa observed that it was legally and ethically acceptable for a patient to approach a physiotherapist for treatment without a referral from another health-care practitioner.[6] During 2006, the Netherlands provided direct access to physiotherapy.[6] The studies appeared in the literature provide evidence for positive influence of these practices on patient care.[8],[9],[10],[11] It is to be noted that a significant number of practicing physiotherapists in the UK, Australia, Canada, and the USA are Indians who have acquired physiotherapy education in India.

The definition of physiotherapy center provided in the CEA rules is very different from the definition of dietetics center. The dietetics center is defined as a clinical establishment providing consultation to outpatients or inpatients by dietician (s) or clinical nutritionist (s). It is difficult to figure out as to why should a physiotherapy center not be defined as a clinical establishment providing treatment or consultation to outpatients and inpatients by physiotherapist (s)?

It appears that phrases such as referral from medical doctors, review, and represcription after 3 weeks or earlier are included in the definition just with the single-minded aim of benefiting a group of medical practitioners who by hook or crook want to maintain their hegemonic control over physiotherapy. This convoluted definition of physiotherapy center would complicate the registration process as many district authorities may demand the name and consent of associate doctors and would deny registration on flimsy grounds.

Three weeks' time for reevaluation is also arbitrary and beyond comprehension. Not all conditions managed by physiotherapy require review of medical doctors after every 3 weeks. Movement disorders due to brain or spinal cord injury, cerebral palsy, and systemic arthropathies require unaltered physiotherapy treatment for many months or even for years not only for functional restoration but also for maintenance of the existing situation. On the other hand, in many cases, physiotherapy treatment is changed as frequently as on a daily basis. Till now, these alterations have been decided by the physiotherapists considering all the aspects of patient care.

With the CEA rules, this practice will be rendered illegal. Every time for the alteration of the treatment, the patient will have to visit a medical doctor before initiating the required physiotherapy. Indian health services operated in fee for service mode, and therefore, the medical doctor will not see the patient for free. This is bound to increase the cost of care and out-of-pocket expenses. It will also put greater financial burden to the government and private hospitals also as they will first have to appoint a medical doctor for issuing the direction for the use of physiotherapy methods before making arrangements to provide the physiotherapy services.

It appears that rules for standards of physiotherapy have been drafted without any consultation with physiotherapy. This becomes evident when one looks at the manual therapy portion of the scope of practice. In physiotherapy literature, the term manual therapy refers to passive procedure such a massage, soft-tissue manipulation, joint mobilization, and manipulations carried out by the physiotherapist. However, CEA 2010 rules describe manual therapy as a means to deliver primary service in health education and health promotion and to deliver health care services of physiotherapy and rehabilitative nature [sic]. Further, the proposed mandatory requirements of equipment for exercise therapy and electrotherapy are rudimentary and do not take in account the need of realistic practice. After all, why should it be necessary for a clinic offering physiotherapy services to children with cerebral palsy or paraplegia/quadriplegia to keep short-wave diathermy? The space requirement of minimum 600 sq ft is also not practical and if enforced strictly would lead to closure of hundreds of physiotherapy clinics situated in the metros and other cities of India.

The definition of physiotherapy center and the scope of practice in CEA reflect a complete coordination within the ministry of health and family welfare. During 2015–2016, the allied health section of ministry constituted a task force to formulate the model curriculum of physiotherapy course along with 12 priority professional streams grouped under allied health professionals. This model curriculum of physiotherapy[12] recognizes that physiotherapists practice independently of other health-care/service providers and also within multidisciplinary rehabilitation/habilitation programs to prevent, gain, maintain, or restore optimal function and quality of life in individuals with loss and disorders of movement. The aims of the recommended curriculum, which the ministry wants to implement across the country, are to train students to work as independent physiotherapists or in conjunction with a multidisciplinary team to diagnose and treat movement disorders as per red and yellow flags. However, with this strange definition, all these efforts of shall be rendered meaningless.

Nonetheless, the overall intensions of this act appear good. A country, where the private medical sector remains the primary source of health care for 60% of households and out-of-pocket private payments make up 75% of the total expenditure on health care,[13] no doubt requires a statutory mechanism for registration of clinical establishment and enforcement of minimal standard of care. However, this requirement must not be misused to formulate rules that threaten to strangulate a profession.



 
  References Top

1.
World Bank. People with Disabilities in India: From Commitments to Outcomes. Washington, DC: World Bank; 2009.  Back to cited text no. 1
    
2.
Office of Chief Commissioners for Person with Disability Ministry of Social Justice and Empowerment. Handling of Children with Disability and Referral. Available from: https://www.mciindia.org/CMS/wp-content/uploads/2017/10/Circular-disabled-children.pdf. [Last accessed on 2019 Dec 12].  Back to cited text no. 2
    
3.
Clinical Establishment Act; 2010. Available from: http://clinicalestablishments.gov.in/cms/Home.aspx. [Last accessed on 2019 Dec 12].  Back to cited text no. 3
    
4.
Operating Guidelines for Clinical Establishment Act; 2010. Available from: http://clinicalestablishments.gov.in/WriteReadData/597.pdf. [Last accessed on 2019 Dec 12].  Back to cited text no. 4
    
5.
Draft Notification on Clinical Establishment (Central Government) Third Amendments Rules; 2019. Available from: https://mohfw.gov.in/newshighlights/draft-notification-clinical-establishment-central government-third-amendment-rules. [Last accessed on 2019 Dec 12].  Back to cited text no. 5
    
6.
Kruger J. Patient referral and the physiotherapist: Three decades later. J Physiother 2010;56:217-8.  Back to cited text no. 6
    
7.
Chartered Society of Physiotherapists. CSP History. Available from https://www.csp.org.uk/about-csp/who-we-are/our-history/csp-history. [Last accessed on 2019 Dec 12].  Back to cited text no. 7
    
8.
Goodwin RW, Hendrick PA. Physiotherapy as a first point of contact in general practice: A solution to a growing problem? Prim Health Care Res Dev 2016;17:489-502.  Back to cited text no. 8
    
9.
Holdsworth LK, Webster VS, McFadyen AK. Physiotherapists' and general practitioners' views of self referral and physiotherapy scope of practice: Results from a national trial. Physiotherapy 2008;94:236-43.  Back to cited text no. 9
    
10.
Bishop A, Ogollah RO, Jowett S, Kigozi J, Tooth S, Protheroe J, et al. STEMS pilot trial: A pilot cluster randomised controlled trial to investigate the addition of patient direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain. BMJ Open 2017;7:e012987.  Back to cited text no. 10
    
11.
Hackett GI, Hudson MF, Wylie JB, Jackson AD, Small KM, Harrison P, et al. Evaluation of the efficacy and acceptability to patients of a physiotherapist working in a health centre. Br Med J (Clin Res Ed) 1987;294:24-6.  Back to cited text no. 11
    
12.
Ministry of Health and Family Welfare. Allied health section 2015-16. In: Model Curriculum Hand Book Physiotherapy. Ministry of Health and Family Welfare. Available from https://www.mohfw.gov.in/sites/default/files/5632211456985633_0.pdf. [Last accessed on 2019 Dec12].  Back to cited text no. 12
    
13.
Mahal A, Karan A, Engelgau M. The economic implications of non-communicable diseases for India. In: Health, Nutrition and Population (HNP) Discussion Paper. Washington, DC: World Bank; 2010.  Back to cited text no. 13
    




 

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