To, 12/04/2014 Dr. Anil Kumar, CMO(AK) Room No.506 ‘D’ Wing, 5th Floor, Nirman Bhawan, New Delhi-110018 Subject: The comments, suggestions, objections, including deletions /additions required in the draft minimum standards for various categories of Clinical Establishments for implementation of the Clinical Establishments Act ****** Respected Sir, With the reference to the notification published on website (http://clinicalestablishments.nic.in/cms/Home.aspx/ http://clinicalestablishments.nic.in/En/1070- draft-minimum-standards.aspx/ http://clinicalestablishments.nic.in/WriteReadData/493.pdf), We on behalf of Members of Karnataka State Physiotherapy Federation®, forwarding our comments, suggestions, objections, including deletions /additions required in the draft minimum standards for various categories of Clinical Establishments for implementation of the Clinical Establishments Act. We are glad and proud that National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, Government of India in consultation with various stakeholders has prepared drafts for minimum standards for various categories of Clinical Establishments for implementation of the Clinical Establishments Act has been enacted by the Central Government 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 provided by them.   We on behalf of Karnataka State Physiotherapy Federation giving prior apology to bring to your notice that in Clinical Establishment Act it is expedient in the public interest to promote quality health care and monitor by law the running of Clinical Establishments in all States by stipulating minimum standards for quality of service in keeping with the principles of ethics. The drafts were with many errors and certain clauses in the draft may be due an inadvertent error crept while preparing draft that contradicting the state clinical establishment acts. Page 1 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org We have provided our opinion for the following minimum standards Clinical Establishment Act drafts: 1. Clinical Establishment Act Standard for Physiotherapy Centre Standard No. CEA/Physiotherapy Centre- 023.{ Physiotherapy Center} 2. linical Establishment Act Standard for Hospital (level 1) Standard No – CEA/Hospital 001.{ Hospital (Level 1) } 3. Clinical Establishment Act Standard for Hospital (level 2) Standard No.CEA/Hospital- 002. {Hospital(Level 2)} 4. Clinical Establishment Act Standard for Hospital (level 3) Standard No.CEA/Hospital- 003. {Hospital(Level 3)} 5. Clinical Establishment Act Standard for Clinic / Polyclinic only Consultation Standard No.CEA/Clinic- 008 { Polyclinic Only Consultation} 6. Clinical Establishment Act Standard for Clinic / Polyclinic with Dispensary Standard No.CEA/Clinic- 009 { Polyclinic With Dispensary 7. Clinical Establishment Act Standard for Clinic / Polyclinic with Observation / Short Stay Standard No.CEA/Clinic- 010 { Polyclinic With Observation} 8. Clinical Establishment Act Standard for Clinic / Polyclinic with Diagnostic Support Services : Standard No.CEA/Clinic- 011}{Polyclinic With Diagnostic Support} 9. Clinical Establishment Act Standard for Wellness Centre Standard No.CEA/Wellness Centre- 017.{ Allied Health Executive/ Allied Health Wellness Center} 10. Clinical Establishment Act Standard for Wellness Centre- Executive Health Check up Standard No. CEA/Wellness Centre- 018. 11. Clinical Establishment Act Standard for Mobile Clinic with Procedures in Local / Regional Anesthesia. Standard No. CEA/Mobile Clinic with Procedures in Local/ Regional Anaesthesia- 016 {Mobile Clinic Only Consultation/ Mobile Clinic With Procedure} ***** Page 2 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org COMMENTS, SUGGESTIONS, OBJECTIONS, INCLUDING DELETIONS /ADDITIONS REQUIRED IN THE DRAFT: Clinical Establishment Act Standard for Physiotherapy Centre Standard No. CEA/Physiotherapy Centre- 023. {Physiotherapy Center} Ref to: Clauses 1. 1. Definition “A physiotherapy centre is a paraclinical establishment providing, physical therapy services by a physiotherapist to patients with a recent prescription or referral from a licensed medical doctor (physician/surgeon). After three weeks or earlier if indicated a review and re- prescription from the treating medical doctor is required for continuing physical therapy services.” Comments: The entire definition has to be deleted and new definition need to be framed. The entire definition contradicts and violates the state clinical establishment acts definition on Physiotherapy Establishments as stated that “Physiotherapy establishment means an establishment where massaging, electrotherapy, hydrotherapy, remedial gymnastic or similar processes are usually carried on, for the purpose of treatment of diseases or of infirmity or for improvement of health or for the purpose of relaxation or for any other purpose whatsoever” Reference: State Establishment acts:- 1. Clauses 1 sub clause (o) in Karnataka Private Medical Establishments Act, 2007 /The Karnataka Private Medical Establishments (amendment) act, 2012 ; 2. Clauses 2 sub clause (j) in The Andhra Pradesh Private Medical Care Establishments (Registration and Regulation) Act, 2002; 3. Clauses 2 sub clause (j) in The Arunachal Pradesh Health and Establishment Act, 2002; 4. Clauses 2 sub clause (b) in The Orissa Clinical Establishments (Control and Regulation) Act, 1990; 5. Clauses 2 sub clause (e) in The Tripura Clinical Establishment Act, 1976; 6. Clauses 2 sub clause (l) The West Bengal Clinical Establishments Act, 1950; 7. Clauses 2 sub clause (f) in The Jammu and Kashmir Nursing Homes and Clinical Establishments (registration and licensing) act, 1963. The definition is about to amend in 8. Madhya Pradesh Clinical Rules, 1973 / Madhya Pradesh Upcharya Griha Tatha Rajupchar Sanbabdu Sthapama Adhiniyam, 1973; 9. The Punjab State Nursing Home Registration Act, 1991; 10. Bombay Nursing Homes Registration Act, 1949; 11. Delhi Nursing Homes Registration Act, 1953; 12. Orissa Clinical Establishment (Control and Regulation) Act, 1991; 13. Manipur Nursing Home and Clinics Registration Act, 1992; 14. Sikkim Clinical Establishments, Act 1995; 15. Nagaland Health Care Establishments Act, 1997; 16. Tamilnadu private clinical establishment Act 1997, 17. The Kerala Clinical Establishments Bill, 2013. Objections on: Page 3 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org a. The use of the word “Physiotherapy Centre” b. The use of the word “paraclinical establishment” c. The statement “physical therapy services by a physiotherapist to patients with a recent prescription or referral from a licensed medical doctor (physician/surgeon)” d. The statement “after three weeks or earlier if indicated a review and re-prescription from the treating medical doctor is required for continuing physical therapy services.” The proposed definition on Physiotherapy Centre may lead to confusion to follow under exciting state clinical establishment acts as per (the clause 8. Legal/statutory Requirements- subclause 8.1. Every application must be accompanied with the documents confirming compliance with local regulations and law) the Clinical Establishment Act Standard for Physiotherapy Centre Standard No. CEA/Physiotherapy Centre- 023. Explanation: a. The state establishment acts used the term “Physiotherapy establishment” to define not as “Physiotherapy Centre”. In some state acts to define it is also mentioned the term “Physiotherapy Clinic”. Therefore in the proposed minimum standards draft it is necessary to change the term ‘Physiotherapy Centre” to “Physiotherapy Establishment” by considering the state Clinical establishment acts that seems appropriate. b. The word “paraclinical” (in case if used as paramedical) not related to Physiotherapy profession or Physiotherapy establishment. Professional Practice of Physiotherapy involves direct involvement with the patients. The paraclinical means “Relating to the branches of medicine, especially the laboratory sciences that provide a service for patients without direct involvement in care.” Ref: from Oxford Dictionary. Therefore Physiotherapy cannot practice without direct involvement with the patient. c. To Practice Physiotherapy there is no requirement of referral system. Physiotherapists operate as independent practitioners– the term practitioner encompasses all roles that a Physiotherapist may assume such as patient/client care, management, research, policy maker, educator, and consultant, as well as members of health service provider teams, and are subject to the ethical principles of World Confederation of Physical Therapy (WCPT). They are able to act as first contact practitioners, and patients/clients may seek direct services without referral from another health care professional. ( Ref: www.wcpt.org) Physiotherapy profession and Education is developed from Diploma to doctorate programs in various Universities in India recognized by University Grant Commission. The Diploma program has been stopped, the Bachelor degree in Physiotherapy is considered as primary degree to practice Physiotherapy in India. No University Physiotherapy course curriculum states that the Physiotherapy has to be practiced under referral system. More over for multidisplinary approach in rehabilitation of patient, a referral system is necessary and it has been followed by all health care professional. When patient with self referral consult Physiotherapist, a Physiotherapist have an ability to make decision through his examination skills, if necessary refers patient to another health professional who could be a Physician/Surgeon, or Super specialist or Ayurveda, Homoeopathy, Unani, Naturopathy practitioners etc, similarly these professionals also refers Page 4 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org patients to Physiotherapy when needed. As Physiotherapy is an Independent fraternity, it has its own role in rehabilitation of patient without any referral system or supervision. d. A licensed medical doctor (physician/surgeon) who are not trained in physiotherapy then in what capacity they can plan, execute or modify physiotherapy treatment or expecting that physiotherapist should follow their commands in relation to physiotherapy treatment. In such case if physiotherapy treatment is followed on referral based, the effective treatment required for the patient might be limited by physiotherapist. This will harm the patient by incomplete/ injustice treatment required to be given by the Physiotherapist affecting ethical practice. During the course curriculum of medical course, some contents might have included about Physiotherapy, however a graduated medical student may be unaware about physiotherapy subjects and independent physiotherapy practice. Even they learn physiotherapy treatments; legally they are not allowed to do supervise and prescribe the Physiotherapy treatment. They are prohibited to do so by laws of exciting State Physiotherapy councils in India. As per Maharashtra State Occupational and Physiotherapy Council, (MHACT II OF 2004) and also “The Delhi State Council for Physiotherapy and Occupational Therapy” only a registered Physiotherapist of state council has right to plan, modify, execute and terminate Physiotherapy treatment in respective states. Other than registered physiotherapist no one is allowed to plan, modify, dictate and execute physiotherapy treatment. If any other health care professional is planning, modifying or dictating physiotherapy treatment to a physiotherapist then it is recorded as malpractice and it is a punishable offence; the action will be taken on such members under penalty section provisions of Maharashtra state OT PT council act and Delhi state PT OT Council. States like Delhi, Maharashtra, and Tamilnadu have independent councils to regulate physiotherapy profession in their states. Gujarat State assembly already passed the Gujarat Physiotherapy council Bill 2010 and is in process for constitution of council. Karnataka State Physiotherapists submitted a sample copy on constitution of “Karnataka State Physiotherapy Council bill” to Government of Karnataka. Similarly in states such as Rajasthan, West Bengal, Bihar, and Kerala had proposed for state Council. Already the Bill for the Establishment of Central Physiotherapy Council of India is under process in Rajaya Sabha that remains status quo. (Reference: 1. Standing Committee Report Summary: The Paramedical and Physiotherapy Central Councils Bill, 2007 dated January 15th 2009. Reference:2. Legislative Brief: The Paramedical and Physiotherapy Central Councils Bill, 2007, dated June 27th 2008. http://www.prsindia.org) At present the Physiotherapy education, practice and services are regularized by state physiotherapy councils in three major states of country i.e. Delhi, Maharashtra, Tamilnadu. Gujarat State assembly already passed the Gujarat Physiotherapy council Bill 2010. I would like to bring to your kind notice that “The Delhi State Council for Physiotherapy & Occupational Therapy” (NO.F.-17 (75)/ 99—MED/ DHS), Maharashtra State Council for Occupational & Physiotherapy” (II OF 2004), Tamilnadu State Council for Physiotherapy” (G.O. (MS) NO.338 TN) already awarded independent status to physiotherapy profession. Prognosis (including plan of care/intervention) begins with determining the need for care/intervention and normally leads to the development of a plan of care/intervention, including Page 5 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org measurable outcome goals negotiated in collaboration with the patient/client, family or care giver. Alternatively it may lead to referral to another agency or health professional in cases which are inappropriate for Physiotherapy. Physiotherapist follows inter-disciplinary approach in rehabilitation of patient. During practice Physiotherapist by themselves whenever necessary take opinion by other professionals based on referral system. Hence the duration of treatment cannot limit and even some cases after three weeks or earlier if indicated a review and re-prescription from the treating medical doctor is not required for continuing physical therapy services The Various Universities providing degree in Physiotherapy in India mentioned about Physiotherapist professional practice involves as below: Physiotherapy is concerned with identifying and maximising quality of life and movement potential within the spheres of promotion, prevention, treatment/intervention, habilitation and rehabilitation. This encompasses physical, psychological, emotional, and social well being. Physiotherapy involves the interaction between Physiotherapist, patients/clients, other health professionals, families, care givers, and communities in a process where movement potential is assessed and goals are agreed upon, using knowledge and skills unique to Physiotherapists. Physiotherapists are qualified and professionally required to: • Undertake a comprehensive examination/assessment/evaluation of the patient/client or needs of a client group • Formulate a diagnosis, prognosis, and plan • Provide consultation within their expertise and determine when patients/clients need to be referred to another healthcare professional • Implement a Physiotherapist intervention/treatment programme • Determine the outcomes of any interventions/treatments • Make recommendations for self management The Physiotherapist’s has extensive knowledge about body, its movement needs and has potential to determining strategies for diagnosis and intervention. The practice settings will vary according to whether the Physiotherapy is concerned with health promotion, prevention, treatment/intervention, habilitation or rehabilitation. The Physiotherapy profession is advanced in its health delivery systems. The WHO defined and awarded same status to physiotherapy Professionals as “Physiotherapists assess, plan and implement rehabilitative programs that improve or restore human motor functions, maximize movement ability, relieve pain syndromes, and treat or prevent physical challenges associated with injuries, diseases and other impairments. They apply a broad range of physical therapies and techniques such as movement, ultrasound, heating, laser and other techniques. They may develop and implement programmes for screening and prevention of common physical ailments and disorders.” The World Health Organization (WHO) has classified physiotherapists as an independent health professional i.e. (ISCO CODE: 2264) on the International Standard Classification of Health Workers (ISCO’s) and paramedical professionals has classified in a separate entity (ISCO code 2240). (Reference -WHO: http://www.who.int/hrh/statistics/Health_workers_classification.pdf ) Page 6 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org According to ISCO’s : Physiotherapists and related associate professionals treat disorders of bones, muscles and parts of the circulatory or the nervous system by manipulative methods, and ultrasound, heating, laser or similar techniques, or apply physiotherapy and related therapies as part of the treatment for the physically disabled, mentally ill or unbalanced. There tasks include - (a) Advising communities and individuals on correct body postures, for work or otherwise, to avoid injuries and strain and to strengthen muscles; (b) Conducting examinations to make diagnoses of disorders of bones, muscles and parts of the circulatory or the nervous system to determine proper treatment or refer to Medical doctors, if necessary; (c) Treating disorders of bones, muscles and parts of the circulatory or the nervous system by manipulative methods, and the use of ultrasound, heating, laser or similar techniques; (d) Massaging client or patient to improve circulation, sooth or stimulate nerves, facilitate elimination of waste matter, stretch contracted tendons and produce other therapeutic effects; (e) Examining body deformities and disorders to determine and write specifications for artificial limbs or other appliances, helping to fit them and explaining their use; (f) Applying physiotherapy and related techniques as part of the treatment of the mentally ill or unbalanced; (g) Performing related tasks; (h) Supervising other workers. (Reference WHO: http://www.ilo.org/public/english/bureau/stat/isco/isco88/3226.htm ) World Confederation of Physical Therapy (WCPT) states that Physical therapists are qualified and professionally required to: - undertake a comprehensive examination/assessment of the patient/client or needs of a client group - evaluate the findings from the examination/assessment to make clinical judgments regarding patients/clients - formulate a diagnosis, prognosis and plan - provide consultation within their expertise and determine when patients/clients need to be referred to another healthcare professional - implement a physical therapist intervention/treatment programme - determine the outcomes of any interventions/treatments - make recommendations for self-management. (Reference: http://www.wcpt.org/what-is-physical-therapy) Delhi Council for Physiotherapy & Occupational Therapy Act 1997 : defines “Physiotherapy means physiotherapeutic system of medicine which includes examination, treatment, advice and instructions to any persons preparatory to or for the purpose of or in connection with movement dysfunction, bodily malfunction, physical disorder, disability, healing and pain from trauma and disease, physical and mental conditions using physical agents including exercise, mobilization, manipulation, mechanical and electrotherapy, activity and devices or diagnosis, treatment and prevention.” (Reference: http://delhiassembly.nic.in/aspfile/billspassed/141997.htm ) Maharashtra State Occupational therapy & Physiotherapy Council, Mumbai (MH ACT II of 2001): "Physiotherapy means a branch of modern medical science which includes examination, Page 7 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org assessment, interpretation, physical diagnosis, planning and execution of treatment and advice to any person for the purpose of preventing, correcting, alleviating and limiting dysfunction, acute and chronic bodily malfunction including life saving measures via chest physiotherapy in the intensive care units, curing physical disorders or disability, promoting physical fitness, facilitating healing and pain relief and treatment of physical and psychosomatic disorders through modulating physiological and physical response using physical agents, activities and devices including exercise, mobilization, manipulations, therapeutic ultrasound, electrical and thermal agents and electrotherapy for diagnosis , treatment and prevention.” (Reference: http://www.msotptcouncil.com/OTPTActs.aspx) Government of India- Quality Council of India, Survey Report & Recommendations of Clinical Establishments: Physiotherapy Definition: The treatment of disease, bodily defects, or bodily weaknesses by physical remedies, as massage, special exercises, etc., rather than by drugs. (Reference: http://clinicalestablishments.nic.in/WriteReadData/384.pdf Page11 ) Therefore, Physiotherapy is not a Paramedical or Paraclinical profession/ practice/ Establishment; it’s an independent health profession. Deletions: Deletion of entire definition is necessary. Suggestions: Recommended definition: “Physiotherapy Establishment” means (i). a facility or premises for the purpose of carrying out the practice of physiotherapy by whatever name called that offers physiotherapy services requiring physiotherapy diagnosis and treatment established and administered or maintained by any person or body of persons , whether incorporated or not; or (ii). A place established as an independent entity or a part of an establishment referred to in sub-clause (i) in connection with physiotherapy diagnosis and treatment established and administered or maintained by any person or body of persons , whether incorporated or not; or and shall include a clinical establishment owned, controlled or managed by A. The government or a department of the government B. A trust, whether public or private C. A corporation (including a society) registered under a Central, Provincial or state Act, whether or not owned by the Government; D. A local authority; and E. A single Physiotherapist, but does not include the clinical establishment owned, controlled or managed by armed forces. Explanation – for the purpose of this clause “ Armed Forces” means the forces constituted under the Army Act, 1950, the Air Force Act, 1950 and the Navy Act, 1957; Physiotherapy practice/ Services are provided by a qualified physiotherapist involves but not limited to in performing assessment, examination, interpretation, diagnosis, planning, and implementing rehabilitative programs that improve or restore human motor functions, maximize movement ability, relieve pain syndromes, prevent and treat physical challenges associated with injuries, diseases and other impairments using broad range of physical therapies and techniques, Page 8 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org but not limited to exercises, mobilization, manipulation, mechanical and electrotherapy modalities, activities and devices. Ref to :- Clauses 2: Sub clause 2.1 -These set of common minimum standards framed shall be applicable to stand alone physiotherapy centre with one or more physiotherapy practioners and physiotherapy sections attached to hospitals or polyclinic. Comments: The scope of physiotherapy is not limited to as per the clauses 2 of subclause 2.1. Therefore deletion and reformation of the Clauses 2 Subclause 2.1 is necessary. Objections on: a. The statement “minimum standards framed shall be applicable to stand alone physiotherapy centre with one or more physiotherapy practioners” b. The statement “physiotherapy sections attached to hospitals or polyclinic.” Explanation: The scope of Physiotherapy services are extended but not limited to: Physiotherapy is an essential part of the health and community/welfare services delivery system. Physiotherapists practice independently of other health care/service providers and also within interdisciplinary rehabilitation/habilitation programmes to prevent, gain, maintain or restore optimal function and quality of life in individuals with loss and disorders of movement etc. Physiotherapists are guided by their own code of ethical principles. Thus, they may be concerned with any of the following purposes: • promoting the health and well being of individuals and the general public/society, emphasising the importance of physical activity and exercise • preventing impairments, activity limitations, participatory restrictions and disabilities in individuals at risk of altered movement behaviours due to health or medically related factors, socio-economic stressors, environmental factors and lifestyle factors • providing interventions/treatment to restore integrity of body systems essential to movement, maximise function and recuperation, minimise incapacity, and enhance the quality of life, independent living and workability in individuals and groups of individuals with altered movement behaviours resulting from impairments, activity limitations, participatory restrictions and disabilities • modifying environmental, home and work access and barriers to ensure full participation in one’s normal and expected social roles. Physiotherapists may also contribute to the development of local, national and international health policies and public health strategies. Physiotherapy is delivered in a variety of settings which allow it to achieve its purpose. Prevention, health promotion, treatment/intervention, habilitation and rehabilitation take place in multiple settings that may include, but are not confined to, the following: Page 9 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org • community based rehabilitation programmes • community settings including primary health care centres, individual homes, and field settings • education and research centres • fitness clubs, health clubs, gymnasia and spas • hospices • hospitals –Primary, Secondary and Tertiary care • nursing homes • occupational health centres • out-patient clinics • Physiotherapist private offices, practices, clinics • prisons • public settings (e.g., shopping malls) for health promotion • rehabilitation centres, residential homes, old age homes, and day care centres etc. • schools, including pre-schools and special schools • senior citizen centres • sports centres/clubs • workplaces/companies/industries • domiciliary physiotherapy • governmental and non-governmental rehabilitation/ disability organisations etc. Therefore, Physiotherapy sections are not limited to either alone physiotherapy centre or attached to hospitals or polyclinic. Suggestions: Recommended statements for scope of Physiotherapy: Scope of Physiotherapy included in minimum standards act shall applicable to all kinds of setup where Physiotherapy services are provided: In reference to Physiotherapy Course Curriculum from Various Universities in India: Physiotherapy includes the following but not limited to (cid:57) Initial Examination/Assessment, Evaluation, Diagnosis, and Prognosis (cid:57) Plan of Care/Interventions/Treatments (cid:57) Interventions/Treatment (cid:57) Re-examination/Evaluation of Progress (cid:57) Discharge/Discontinuation of Intervention/Treatment Physiotherapy assessment may includes but not limited to : (cid:57) Subjective - chief complaints, history taking, history of present illness personal, past and present medical and socioeconomic history, informed consent, Pain assessment, Intensity, character, aggravating and relieving factors of various signs and symptoms. (cid:57) Objective examination includes observation, palpation, inspection, examination, special test and investigations. (cid:57) Subjects and objective Examination includes in various areas of assessment includes but not limited to : Page 10 of 26 Karnataka State Physiotherapy Federation ® website: https://www.karnatakaphysio.org