Medical Council action against doctors- UP orders statewide crackdown on pathology labs, doctors over diagnostic report manipulation
Lucknow: The Uttar Pradesh Government has ordered a statewide crackdown on pathology labs, diagnostic centres, doctors, and collection agents to prevent the alleged physical and financial exploitation of patients through deliberate manipulation of investigation reports in collusion between private pathology laboratories and doctors.
In a recent directive, the Director General of Medical and Health Services, Dr. Pawan Kumar Arun, has issued directions to all Chief Medical Officers (CMOs) across the State to launch a special inspection drive within 30 days covering all pathology laboratories, diagnostic centres and collection centres operating in their respective districts. Further, the Government has directed that strict action be taken against those found guilty during the investigation.
Recently, concerns were raised alleging that pathology lab reports were being manipulated in collusion with private doctors, resulting in unnecessary treatment and physical and financial hardships for the patients.
During the discussion held on this matter with the Principal Secretary, Medical Health and Family Welfare Department, Government of Uttar Pradesh, the issue was taken extremely seriously.
In its order, the Director General of Medical and Health Services reiterated that public health is of the highest priority of the government and clarified that "zero tolerance" will be adopted towards such fraudulent and malicious activities.
In compliance with the instructions given during the discussion with the Principal Secretary, the Director General of Medical and Health Services has issued the following directions to the CMOs:
Immediate Investigation into the matter:
The Director has directed all CMOs across the State to immediately identify such pathology labs in view of news reports published in newspapers. It has also been directed to set up an investigation committee under the chairmanship of the Additional Chief Medical Officer, comprising a senior pathologist from a government hospital/medical college and the nodal officer for Clinical Establishment registration as mandatory members.
This panel shall immediately take possession of and secure the sample registers, report registers, original data and printouts from machines/analysers, billing records and records of payments made to collection agents of the concerned laboratories to prevent any tampering with the evidence.
It has been directed that the investigation shall clearly establish the registration status of the laboratory, the actual presence of a qualified pathologist, the qualifications of the person signing the reports, and the identities of the doctors at whose request the reports were manipulated.
The order mentions that if during the investigation, prima facie evidence of unregistered operations, absence of a qualified pathologist or manipulation of reports is found, the laboratory's registration shall be immediately suspended and the laboratory sealed as per rules. An FIR shall also be registered. Further, the CMOs have been directed that the investigation report, containing clear findings and determination of the responsibility of those found guilty, along with details of the action taken, shall be submitted to the undersigned within seven days.
Special Inspection Drive Across the State:
The Director has asked the CMOs to ensure conducting a special inspection drive covering all pathology laboratories, diagnostic centres and collection centres operating in their respective districts within 30 days. The order also includes a prescribed format under which the inspections shall be carried out.
It has been mentioned in the order that such inspection team shall mandatorily include the Additional/Deputy Chief Medical Officer and a pathologist, and videography of the inspection shall also be conducted. The Director has ordered an immediate shutdown of unregistered laboratories, laboratories operating without a qualified pathologist, or those being operated by unauthorised persons.
Govt Directive for Pathology Laboratories:
The order includes general instructions for all pathology laboratories that require mandatory compliance. The Director has mentioned that all CMOs shall issue the following general instructions in writing to all laboratories in their respective districts:
(i) Every laboratory requires valid registration under the Clinical Establishments (Registration and Regulation) Act, 2010 and the relevant rules/government orders, and the registration certificate, name, qualifications and registration number of the qualified pathologist shall be displayed prominently in the laboratory.
(ii) The labs shall also have to ensure that every investigation report is verified and signed only by a qualified and registered pathologist (MD/DNB/DCP Pathology or equivalent qualification in the relevant subject) and the name, qualifications, and registration number of the pathologist are mentioned on the report. The Government has strictly prohibited issuance of reports or scanned or pre-signed letterheads in the absence of the pathologist.
(iii) Further, the CMOs shall ensure that independent operation of a laboratory or issuance of reports by a pharmacist, laboratory technician or any other unqualified person shall be strictly prohibited.
(iv) The labs will have to ensure that the investigation reports are fully consistent with the original results generated by the machine/analyser and any handwritten or manual alteration of the original results shall be prohibited. The labs will have to ensure that the original machine data/printouts shall be preserved for a minimum period of 01 year and produced during inspections.
(v) Where the results show extremely abnormal values, the same sample shall have to be retested to confirm the result and a record of the same shall have to be maintained.
(vi) Every sample shall be assigned a unique identification number, and the sample register must mandatorily contain the name of the patient and referring doctor, time of sample collection along with the details of the collection agent/centre.
(vii) The labs will have to ensure regular calibration of machines, internal quality control and participation in the External Quality Assessment Scheme (EQAS) and maintenance of records. The laboratories shall be encouraged to obtain NABL accreditation.
(viii) The labs will submit a list of all collection centres/collection agents associated with the laboratory to the office of the Chief Medical Officer. There will be a strict prohibition of payment of commission, cuts, gifts, or any other inducement to any doctor, collection agent, or other person in exchange for referring patients.
(ix) All the labs shall display their rate list for investigations, issue receipts for every payment, and prominently display the complaint helpline number of the Chief Medical Officer's office and details of the Jan Sunwai (IGRS) portal.
(x) If the labs violate these instructions, strict legal action shall be taken under the prevailing laws and rules, along with suspension/cancellation of the laboratory's registration.
Instructions for Doctors, Private Hospitals and Nursing Homes:
The CMOs shall issue the following instructions to doctors, private hospitals and nursing homes:
(i) Doctors shall not demand or accept commission, cuts, gifts or any other benefit from any laboratory in exchange for referring patients, as this will be regarded as professional misconduct under Regulation 6.4 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, and the prevailing regulations of the National Medical Commission.
(ii) Any doctor shall be held guilty of criminal conspiracy if found pressuring a laboratory to alter a report or making such a demand.
(iii) Before admitting a patient or initiating serious treatment based on severely abnormal results such as platelet count, creatinine, TLC, etc., confirmation shall be obtained, if possible, by conducting a repeat investigation at another registered lab and it shall also be mentioned in the case sheet.
(iv) All CMOs shall conduct surprise audits of records of patients admitted to private hospitals/nursing homes, particularly during the dengue and other infectious disease seasons, and have suspicious reports verified by government laboratories.
(v) Disciplinary action, along with criminal proceedings, shall be initiated under the Uttar Pradesh Government Servants (Discipline and Appeal) Rules, 1999 if a government doctor is found involved.
Measures to ensure continuous monitoring and verification mechanism:
The Government has directed that every month, the CMO shall secretly send samples to selected laboratories on a surprise basis and arrange parallel testing of the same samples at government/NABL- accredited laboratories and compare the results. In case of significant discrepancies, immediate action shall be taken.
Further, it has been directed that complaints received through the Jan Sunwai portal, helpline, newspapers or social media shall be taken up suo motu, investigated and resolved within seven days.
The order also mentioned that a nodal officer shall be appointed at the district level for this purpose and their name and telephone number shall be publicised widely.
Govt Action Against Guilty Doctors, Laboratories:
The order also specified what action shall be taken against the guilty doctors, laboratories, and collection agents.
(i) In case of pathology labs, the action could involve suspension/cancellation of registration, sealing of the laboratory, imposition of penalties under the Clinical Establishments Act, 2010 and the relevant rules, and registration of an FIR under the relevant provisions of the Bharatiya Nyaya Sanhita, 2023 (such as Section 318 – Cheating, Section 336 – Forgery, Section 340 – Using forged documents as genuine, Section 61 – Criminal conspiracy, etc.). If the laboratory is empanelled under Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana or any other government scheme, a recommendation shall be sent to SACHIS, Uttar Pradesh, for termination of its empanelment.
(ii) The private doctors involved in this could face registration of an FIR. Further, the matter shall be referred to the Uttar Pradesh Medical Council for suspension/cancellation of the doctor's registration. Action shall also be taken to suspend/cancel the registration of the concerned private hospital/nursing home.
(iii) If a government doctor is found involved in such activities, they could face suspension and departmental disciplinary proceedings, along with initiation of criminal proceedings. The matter shall also be referred to UPMC.
(iv) The collection centre, if found guilty, shall be shut down and an FIR shall be registered against the concerned person.
(v) Unqualified operators such as pharmacists shall face registration of an FIR and the matter shall be referred to the Uttar Pradesh Pharmacy Council for necessary action regarding their registration.
(vi) The order also mentioned that if any laxity, negligence or protection being extended to the guilty is brought to notice at any level in the implementation of these instructions, personal responsibility shall be fixed upon the concerned Chief Medical Officer and members of the inspection team, and strict disciplinary action shall also be taken against them.
(vii) The CMO, Lucknow has been directed to submit the investigation report concerning the specific case within a week.
(viii) Further, all CMOs have been directed to mandatorily submit the report of the special inspection drive in the prescribed format with 30 days. Thereafter, monthly compliance reports shall be submitted to the undersigned by the 5th of every month.
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