“Guidelines for Pathology Laboratories in Goa”
As Drafted By the Goa Medical Council
Preamble:
It has been observed for some time now, that pathology laboratories are
operating without any controls, supervision or checks. The matter has
come before the Supreme Court in numerous cases, and figured in various
complaints of negligence, prompting the Goa Medical Council to take suo
motto action to rectify the problem.
The Goa Medical Council, at its meeting on the 7thFebruary 2014, has
produced guidelines for pathology laboratories in the state of Goa. These
guidelines are the result of a series of meetings of a committee of the
Council specially appointed for the purpose. This Committee was chaired
by Dr. Dhanesh T. Volvoikar, Vice President, Goa Medical Council with the
following members:-
Dr. Rajendra M. Tamba - Chairman, Disciplinary Committee, Goa Medical
Council
Dr. R. G. Wiseman Pinto – Professor & HOD, Department of Pathology, Goa
Medical College, Bambolim Goa.
Dr. Suresh Mandrekar– Assistant Professor, Department of Pathology, Goa
Medical College, Bambolim Goa.
Dr. Govind G. Kamat– Special Invitee/ Member, Goa Medical Council
Dr. Babita Angle– Special Invitee, Practitioner Pathologists
Director, Directorate of Health Services
President, Indian Medical Association
President, The General Practitioners Association
The Committee met on 23-08-2012, 09-10-2012 & 21-06-2013. Relevant
stakeholders such as representatives of practicing pathologists in Goa, the
D.H.S. Director, the Dean, Goa Medical College were also consulted. These
guidelines have now been presented to the government for formal
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ratification, and as per the decision of the Council taken at its meeting on
the 7thFebruary, will come into effect immediately.
Guidelines for InvestigationLaboratoriesin the State of Goa asapproved by
Goa Medical Council
I) For the purpose of these guidelines “Laboratory” means a clinical
establishment which deals with collection, processing and analysis of
various specimens namely blood, urine, stool, sputum, semen, body
fluids – i.e. CSF, Pleural, Pericardial, ascitic/ peritoneal etc., tissue and
other types of biopsy and cytology specimens.
II) DEFINITIONS:
a)Registered Medical Practitioner (R.M.P.): means Registered Medical
Practitioner who has medical qualification (i.e. MBBS or equivalent) as included
in the Schedule of Indian Medical Council Act, 1956 and registered with Medical
Council of India/State Medical Council.
b) Laboratory: as defined in I.
c) Post graduate degree/diploma holder in any branch of Laboratory medicine:
are doctors registered with MCI/State Medical Council with recognized
postgraduate degree/diploma in any branch of laboratory medicine namely
Pathology, Pathology & Bacteriology, Microbiology, Biochemistry, Clinical
Haematology,Clinical Pathology, Laboratory medicine(or equivalent).
d) M.C.I.: Medical Council of India.
III) Forthe purpose of regulations, the laboratories may be sub-divided as
follows:
a) Standalone laboratories.
b) Laboratories attached to Hospitals and Nursing homes.
c) Physicians’ office side lab.
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d) Labs/ Centers conducting fitness check for overseas
recruitments,for factory workers, occupational health services
etc.
e) Collection Centers
f) Laboratory in Govt.Institutions:
IV) Requisite qualifications and experience to run a pathology
laboratory in the State of Goa and authorization to sign laboratory
reports.
a) For Standalone laboratoriesi.e. laboratories which are run
independently and are not apart of any nursing home/ hospital.
R. M. P. with:
1. Post-Graduate degree/ diploma in any branch of
laboratory medicine from a recognized University.
2. Failing above (iv/a/1) report can be signed by
registered medical practitioner. (Refer Para. V for
details)
b) For Laboratories attached to Hospitals and Nursing Homes.
R. M. P. with:
1. Post graduate degree/ diploma in any branch of
laboratory medicine namely Pathology, Pathology and
Bacteriology, Microbiology, Biochemistry, Clinical
Pathology, Laboratory Medicine from a recognized
University.
2. Failing above (iv/b/1), report can be signed by
registered medical practitioner. (Refer Para. V for
details)
3. For Emergency services like Blood gases, Electrolyte
etc. done at odd hours (outside office hours), basic
doctor with MBBS or equivalent should be the signatory
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for reports (Registered Medical Practitioner). This
report should be ratified by in charge authorized doctor
of that laboratory next day.
c) Physician’s office side labs which deals with routine basic tests
& which are being used for their own clinical practice shall be the
responsibility of the concerned physician(Registered Medical
Practitioner) who shall be duly registered with the Medical Council, to
run a lab and sign report.
d) For Labs/ Centers conducting fitness check for overseas
recruitments, for factory workers, occupational health services
etc.1) R. M. P. with Post graduate degree/diploma or recognized
certificate course like AFIH which deals with investigation, examination
and certification for above mentioned purpose and curriculum of said
courses include lab investigation.
e) Collection Centers:
1. Independent collection centers dealing with collection
of patients samples should have trained technical
personal who shall work under the supervision of
Registered Medical Practitioner.
2. All collection centers should be under registered
medical practitioner and his/her degree certificate,
registration with medical council and other certificates as
per land of law has to be displayed in the premises.
3. Registered Medical practitioner under whose name
these centers are working will be fully responsible for all
the affairs of the collection centre.
f) In Government Institutions:
i) Medical Colleges:
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1) Registered Medical Practitioner with post graduate
degree/diploma in Laboratory Medicine.
4. In Emergency situation and after office hours:
Registered Medical Practitioner. (Refer Para V) This
doctor can be Resident doctor/ Houseman, etc.The
report should be ratified by in charge authorized doctor
of that laboratory next day.
ii)District Hospital:
1) Registered medical practitioner with post graduate
degree/diploma in any branch of Laboratory Medicine.
2) Failing above (iv/f/i/1) Registered Medical Practitioner.
(Refer Para V)
3) In emergency situations Registered Medical
Practitioner in absence of Post graduate
degree/diploma holder in Laboratory Medicine.
iii) Peripheral Hospitals/ Health Centers like Primary Health Center/Urban Health
Center/ Rural Health Centre/ Rural Medical Dispensary/Mobile Clinic/Sub Center/
Sub District Hospitals/ other Govt. Health Centers or small Hospitals. The report
should be ratified by in charge authorized doctor of that laboratory next day.
1) Minimum Registered Medical Practitioner.
V) REQUISITE KNOWLEDGE AND EXPERTISE FOR SIGNING REPORT:
Signatory for any of the Laboratory reports has to be minimum
Registered Medical Practitioner who has registered qualification as
included in the schedule of MCI Act 1956, i.e. MBBS or equivalent.
Those doctors who do not have any of the post graduate qualification
in Laboratory Medicine but their undergraduate curriculum has covered
all basic investigation can sign Laboratory report within the level of
his/her competence and should have full knowledge of the
investigation carried out and will be fully responsible for same. These
signatory with a basic degree like MBBS or equivalent qualification
recognized by MCI as per MCI Act 1956, should restrict themselves in
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signing basic laboratory report and as far as possible should not sign
highly specialized reports like histopathology etc. which require expert
person with appropriate training and post graduate qualification in
concern subject. A basic graduate doctor who takes responsibility of
signing this report can get their knowledge and expertise updated with
refresher courses or refresher training in larger laboratory run by a
qualified post graduates like pathologist.
Specialized investigations like histopathology, blood culture etc.
should be signed by postgraduate degree/diploma in concerned
specialty like pathology, microbiology, Biochemistry, Clinical
Hematology etc. who has requisite training, knowledge & required
qualification about the concern subject and curriculum of that particular
post graduate qualification and covers corresponding investigation.
VI) Requisite for complete authentic report.
1) Every report has to be signed by authorized doctor as stated in
Para IV & V.
2) Report must have complete Name of signing doctor, his/her
qualification, Registration Number of Medical Council along with
other information like date, address, and Email address if
available. License Number from Govt. authority as per the law of
land should be displayed on the report.
Input/Reference:
1) MCI vide letter No MCI/211(2) (51) 2011 Ethical 64036 dated
11/8/11 regarding guidelines for running the individual lab has
stated as under:- Pathology laboratory can only be opened by
trained Registered Medical Practitioner, who has registered
qualification as included in the schedule of Indian Medical Council
Act 1956.
Pathology laboratories as such do not come under the
preview of MCI, however the pathological report has to be signed
by the registered doctor.
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3) As per discussion in the meetings of committee appointed by Goa
Medical Council to frame these guidelines.
4) As per discussions in executivecommittee meetingof this council.
CAUTION FOR R. M. P’s WHO TREAT PATIENTS BASED ON LAB
REPORT:
Clinicians should not treat patients based on unauthorized report. They
will be fully liable for their act and disciplinary action can be taken as
per Goa Medical Council Act.
Reports signed by Laboratory technicians are unauthorized report
and cannot be used in modern medical practice to treat patients.
Authorized and authentic report is one which will full form all the criteria
laid down in this guideline.
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