The Commissioner of Health & Family Welfare, Telangana, Hyderabad in the reference has stated that Government of India under NHM has sanctioned an amount of Rs. 1035.75 lakhs for the “Free Diagnostics Initiative” in the state. Diagnostics are an integral part of the health care system and provide information needed by service providers to make informed decisions about care provision related to prevention, screening, detection, treatment and management. Limited availability and access to quality laboratory and radiology services are among the major challenges contributing to delayed or inappropriate responses to disease control and patient management. This also results in continued reliance on empirical patient care or irrational diagnostic prescription, practices that waste scarce resources.
2. The Government of India released operational guidelines which lay out the key features of the “Free Diagnostic Services Initiative” suggesting a minimal set of essential diagnostics to be available at different levels of public facilities across the states to reduce variability in coverage and unequal access. These guidelines also provide broad guidance on features of alternative delivery models through which diagnostics can be made available including financing modalities and monitoring mechanisms. The guidelines also provide a flexible framework, for states to adapt to their context, based on the availability of appropriate skilled staff and epidemiological and disease profile. These guidelines are expected to assist states to roll-out/scale up the initiative to ensure that access to free diagnostics is met in full measure. Objectives of the “Free Diagnostics Service Initiative” are:
i. ensure the availability of a minimum set of diagnostics appropriate to the level of care
ii. reduce high out of pocket expenditure incurred by patients for diagnostics
iii. Enable initiation and continuation of appropriate treatment based on accurate diagnosis.
iv. Use of appropriate diagnostics to screen patients for a set of chronic conditions so as to enable secondary prevention measures.
v. Improve overall quality of healthcare and patients experience as a result of availability of comprehensive healthcare in public health facilities.
Salient features of the Free Diagnostics Service Initiative are:
i. The free Diagnostics Service initiative would be rolled out under the National Health Mission, in order to build on and leverage existing institutional structures that are already in place under the Mission and
facilitate immediate roll out.
ii. to begin with, a set of free essential diagnostic services at each facility level has been identified which would be provided free of cost in an assured mode.
iii. the tests encompass haematology, serology, bio-chemistry, clinical pathology, microbiology, radiology, and cardiology. However, states are free to add to the list based on epidemiological considerations and
available financial resources.
iv. the initiative aims at the provision of a package of quality essential diagnostic services free of cost in all public health facilities. such diagnostic tests (specific for each level of health facility) are to be provided through a strengthened public health system that provides comprehensive primary and secondary care diagnostic services to patients, from the sub-center to the level of the district hospitals.
v. for each level of care- the primary health care centre (inclusive of community outreach) the Mobile Medical Units, the Block PHC or CHC and the District Hospital, a minimum range of diagnostics would be
vi. the list of diagnostics is based on a combination of common epidemiological considerations, availability of skilled workforce, and those essential to maximise health outcomes within the available resource envelope. the scheme would be synergized with existing packages to avoid duplication.
vii. the technology for diagnostic services is based on emerging diagnostic methods that are innovative, low cost and those for which competencies can be built relatively easily.
viii. the quantity of consumables and human resources required would depend on the case load for each test at each facility.
ix. High volume and low cost tests not requiring highly skilled manpower should preferably be undertaken within public health facilities. However high cost, technologically demanding and lower frequency
diagnostic services could be outsourced as a way of gap filling, with adequate checks and balances as safeguards to prevent abuse.
x. An alternate model for laboratory diagnostics services where the public health facility is unable to manage this, is the Hub and spoke Model. Under this model, the samples are collected at peripheral facilities/collection centres (including Mobile Medical Units) and safely transported to a central laboratory which will act as the Hub. the Hub can be a District Hospital Lab/Medical College/or a public laboratory set up for the purpose or a Private Laboratory, with results reported to the originating facility on the same day. this will help in maintaining quality as well as management of manpower and logistics in supply of reagents and consumables.
xi. if a private laboratory is chosen as a hub, or even for some select tests, appropriate Public Private Partnerships (PPP) would also be established with predetermined and transparent procedures. the templates for a model contract to be used for partnerships with private diagnostic facilities.
xii. Human resources required for greater access to diagnostics requires appropriate state level planning – not only to increase the numbers generated from educational institutions, but also in recruitment policies
and terms of service. Where contracting- in is a feasible option, the services of specialists, such as like radiologists, pathologists, microbiologists etc can be contracted in.
xiii. some level of multi skilling of existing staff, (ANM/MPW) especially at the level of the Health and Wellness Centres and Primary Health care centres may be required given that the requisite human resources may not be immediately available across such a large number of facilities at these levels.
xiv. Quality Assurance for diagnostics would include standard operating Procedures for conducting tests and appropriate Bio-safety procedures, effective monitoring systems, and mechanisms to ensure maintenance of
high cost equipment. A system of periodic calibration of all laboratory equipment needs to be ensured. In states, where Biomedical Maintenance programme is operational under PPP/outsourcing mode, responsibility for such calibration services should be the obligation of the maintenance service provider.
xv. All laboratories in district hospitals would be encouraged to achieve NABL accreditation. However, laboratories that act as a Hub must necessarily obtain NABL accreditation within 3 years from the date of declaration of such laboratories as a Hub. A system of regular sample cross-checking of diagnostic results with identified reference laboratories such as the All India institute of Medical sciences (AIIMs) or Christian Medical College (CMC), Vellore etc. would be established.
xvi. The measures for promoting rational use of medicines shall also apply to rational use of diagnostics, for preventing misuse and wastage. The MoHFW will develop standard operating Protocols to provide guidance on
appropriate diagnostic tools to be used in specific conditions to prevent misuse and waste. Critical gaps in infrastructure and skills could be met through the following mechanisms :
a. in all SCs, PHCs, CHCs, SDHs and DHs, the state government should put in place adequate medical equipment infrastructure to perform tests that are of low cost and high volume. However, until such time and in such facilities where the medical equipment, Human Resource or infrastructure for performing prescribed tests does not exist, outsourcing mechanisms could be used. In such cases, the private service provider shall arrange for sample collection of all samples once daily from PHC, CHCs/SDHs and twice daily at DH, ensure safe transport, analysis and timely reporting of results. Outsourcing of testing of samples for high cost low volume tests to private laboratories could be part of this arrangement.
b. for radiology investigations, identification of technological pathways and setting up of systems for capturing, transmission and reporting of tests that could be digitized, should be attempted where in house expertise is not available. This would facilitate capturing of images at public facilities and transfer images to specialists in
public or private sector for diagnosis through its based solutions and electronic reporting.
c. Where contracting- in of human resources, is a feasible option, services of specialists, such as like radiologists, pathologists, microbiologists etc can be contracted in.
3. In a nut shell under this initiative the following types of facilities (SC/PHC/CHC/AH/DH) have to be identified in which the diagnostic services have to be provided through PPP mode (the private partner to be selected after competitive bidding).
i. Facilities where trained HR is available to perform tests, but without equipment
ii. Facilities where equipment is available but HR is not available
iii. Facilities where both HR and Equipment are not available
iv. Scope for providing Tele-Radiology, Ultra-sonography and CT Scan Services
4. The Commissioner of Health & Family Welfare & Managing Director, NHM has therefore requested to constitute a committee to develop the model for outsourcing of Diagnostic Services in PPP mode by taking into consideration the model guidelines developed by the NHM, Govt. Of India.
5. Government after careful examination of the matter hereby constitute a Committee to develop the model for outsourcing of Diagnostic Services in PPP mode by taking into consideration the model guidelines developed by the NHM, Govt. of India with the following members:-
i. Principal Secretary to Government (HM&FW)… Chairperson
ii. The Commissioner, H&FW and MD(NHM) …… Member & Convenor
iii. Managing Director, TSMSIDC ……. Member
iv. Commissioner, TVVP …… Member
v. Director of PH&FW …… Member
vi. Dr.Jitender Sarma, Senior Consultant, NHSRC, New Delhi (Representative of GoI)…….. Member
6. The committee shall to a) validate the data of available manpower and diagnostic facilities in all health facilities up to district level b) work out the modalities for provision of free diagnostic services in PPP mode (c) prepare the draft expression of interest for consideration of the Government. The committee shall submit its report within a period of 15 days.
7. The Commissioner of Health and Family Welfare, Telangana, Hyderabad, shall take necessary action in the matter accordingly
G.O.RT.No. 828 Dated: 29/12/2015 Read :- From the Commissioner of Health & Family Welfare and MD, NHM, Hyderabad Lr. No.100/SPMU/FDS/CIO/2015, dt.26/10/2015