Cancer Marker Test: Calcutta High Court Holds Accuhealth Solutions Liable For Negligence & Lack Of Expertise

The bench held that the diagnostic centre did not possess the necessary capability to perform the test independently and had instead outsourced it to AI Diagnostics.

The High Court has directed that all matters concerning the licensing and operations of the diagnostic centre be referred to and adjudicated by the Chief Medical Officer of Health.

Brief Facts:

The matter pertained to an order issued by the West Bengal Clinical Establishment Regulatory Commission which mandated the immediate closure of a diagnostic centre. The Commission, primarily relying on expert opinions and a complaint from the patient's son, directed the Chief Medical Officer of Health to suspend the centre's license. The centre contended that discrepancies in the Complainant's report do not justify such severe actions. It argued that the Commission failed to obtain expert opinion and denied the Petitioner the opportunity to cross-examine crucial witnesses.

In response, the Commission pointed to admissions by the diagnostic centre regarding procedural lapses and the misuse of digital signatures. It argued that these actions jeopardized patient safety and justified the Commission's order under Section 38(1)(iii) of the West Bengal Clinical Establishments (Registration, Regulation and Transparency) Act, 2017. It contended that the Commission's regulatory role empowers it to safeguard patient interests.

Observations by the High Court:

The High Court noted that the diagnostic centre lacked the necessary expertise to conduct the crucial cancer marker test for the patient, who is a survivor of thyroid cancer. Following a total thyroidectomy at Tata Medical Centre, the accuracy of this test was critical to assess whether the cancer had recurred.

Initially, the bench noted that the diagnostic centre erroneously performed an undesired test for Anti Thyroglobulin Antibody. Upon objection, they re-collected the blood sample and submitted a second report, which the treating doctor at Tata Medical Center found to be vastly inconsistent with their findings.

Further complicating matters, it was revealed that the diagnostic centre lacked the capability to conduct the test itself and outsourced it to AI Diagnostics. The resultant report was mistakenly reproduced on the centre's letterhead, including the digital signature of Dr. Roy Chowdhury, without actual verification by a qualified practitioner.

The High Court held that this sequence of events strongly suggested a pattern of negligence, lack of expertise, and potential deceit on the part of the diagnostic centre. The High Court found that the Commission acted appropriately in referring the matter to the Chief Medical Officer of Health for further investigation and regulatory action as per statutory provisions.

The bench held:

“This entire procedure, prima facie, indicates carelessness, lack of expertise, negligence and an element of deceit. The patient's party complained that the lab had drawn the blood sample twice from the patient. The fact that the test was done by another laboratory and a report was prepared on the letter head of the petitioner indicates that there was lack of truthfulness and transparency. There is no evidence that the test report had been signed at all by a practising doctor, which is the mandate of law. If the digital signature of Dr. Atreyee Roy Chowdhury was incorporated by mistake, it was for the diagnostic centre to prove that another doctor had actually prepared and signed the report. Such evidence was not before the Commission. Neither is such evidence before this Court.”

The High Court set aside the Commission's directive for the immediate closure of the diagnostic centre. Instead, it directed that all matters pertaining to the centre's licensing and operations be adjudicated by the Chief Medical Officer of Health. Until a decision is made regarding the suspension, cancellation, or any other regulatory action, the diagnostic centre shall remain non-operational.

Case Title: Accuhealth Solutions Private Limited Versus The State of West Bengal & Ors.

Case Number: W.P.A. No. 16283 of 2024

Advocate for the Petitioner: Mr. Biswaroop Bhattacharyya, Mr. Aniruddha Chatterjee, Mr. Sumitava Chakraborty, Mr. Aditya Mondal, Ms. Bratati Pramanick

Advocate for the Respondent: Mr. Samrat Sen, ld. Sr. Advoate, Mr. Avik Ghatak ...for the Petitioner. ...for the Regulatory Commission. Mr. Sirsanya Bandyopadhyay ...for the State-respondents. Mr. Shibaji Kumar Das ...for the Respondent No.5.

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