Rapid Screening False-Positive in Diagnostic Testing: No Section 336 IPC Without Gross Negligence; No Vicarious Criminal Liability by Designation
1. Introduction
Case: Manisha singh v. The State of Telangana
Court: Telangana High Court
Date: 05-08-2026
Coram: The Honourable Sri Justice N. Tukaramji
Proceeding: Criminal Petition under Section 482 CrPC seeking quashing of C.C. No. 8530 of 2022 arising from Crime No. 291 of 2022, Osmania University Police Station
Offence alleged: Section 336 IPC (rash or negligent act endangering human life or personal safety)
The petitioners (Accused Nos. 1 to 4) were associated with a diagnostic centre where the de facto complainant’s pre-surgical profile included an
HBsAg (Rapid Test) reported as “Reactive.” The complainant alleged that this report caused severe mental trauma, depression, suicidal thoughts,
and increased apprehended surgical costs. A subsequent HBsAg test at another hospital returned “Non-Reactive.” When confronted, the diagnostic centre
later tested the retained sample through CMIA and again found “Non-Reactive.”
The prosecution theory was that issuing a “Reactive” rapid screening report without confirmatory testing amounted to negligence that endangered life/personal safety,
thereby attracting Section 336 IPC. The central legal issue before the High Court was whether the allegations and charge-sheet materials, even if taken at face value,
met the high threshold of criminal rashness/gross negligence required under Section 336 IPC—particularly in the context of medical/diagnostic services.
2. Summary of the Judgment
- The High Court held that not every negligent act is criminal; Section 336 IPC requires gross, culpable negligence or recklessness endangering life/personal safety.
- A discrepancy between a rapid screening test and a confirmatory test, by itself, does not establish criminal negligence.
- The expert opinion relied on by police stated a preferred protocol (confirm reactive rapid tests by CMIA/CLIA/ELISA, preferably on repeat sample), but did not conclude that issuing the initial report was necessarily grossly negligent or reckless.
- The report’s disclaimer (screening test not the sole criterion; confirmatory testing required) undermined an inference of criminal culpability.
- Criminal proceedings were also unsustainable because the charge-sheet did not attribute specific overt acts to each petitioner; implication based mainly on official positions is impermissible absent a statute creating vicarious liability.
- Applying quashment principles, the Court found the case fell within categories where, even accepting allegations as true, no offence is made out; continuation would be an abuse of process.
Result: Proceedings in C.C. No. 8530 of 2022 were quashed as against Accused Nos. 1 to 4.
3. Analysis
3.1 Precedents Cited
This precedent formed the judgment’s backbone on criminal liability for medical professionals. The High Court relied on three core propositions:
- Criminal vs. civil negligence: criminal liability requires negligence of a very high degree—“gross” negligence akin to recklessness.
- Protection against indiscriminate prosecution: careless criminal process against medical professionals harms public interest by chilling bona fide practice.
- Need for competent medical opinion: investigation should ordinarily be supported by an independent, competent opinion applying accepted standards (linked to the Bolam principle).
In the present case, the High Court used Jacob Mathew to reject the prosecution’s attempt to criminalise an alleged protocol lapse in diagnostic reporting
(rapid screening reported “Reactive” without confirmatory testing first), finding it fell far short of “gross” negligence.
(b) Bolam v. Friern Hospital Management Committee, (1957) 1 WLR 582
Cited via Jacob Mathew, the “Bolam Test” represents the benchmark of professional reasonableness: whether the conduct aligns with a practice accepted as proper by
a responsible body of professionals skilled in that art. The High Court’s reasoning reflects a Bolam-type approach—recognising that rapid screening tests have known
limitations (false positives), and that disagreement or discrepancy does not itself show culpable deviation amounting to criminality.
This case was used to reinforce that negligence cannot be inferred merely because:
- another professional might have followed a different approach, or
- the outcome turned adverse, or
- there exists a difference in professional opinion.
The High Court’s application is clear: a later “Non-Reactive” result does not automatically convert an earlier “Reactive” screening result into criminal negligence.
The High Court drew from the Supreme Court’s reiteration that medical negligence requires proof of failure to exercise the skill, care, and competence expected of a
reasonably competent professional in that field. Importantly, an adverse outcome alone is not proof of negligence—still less criminal negligence. This supported the
conclusion that even if the complainant suffered distress, criminal liability under Section 336 IPC could not be presumed without gross recklessness endangering life/personal safety.
This precedent guided the High Court’s exercise of Section 482 CrPC powers. The Court invoked the Bhajan Lal categories to hold that:
- even if allegations are accepted entirely, they do not constitute the offence alleged, and
- continuing the prosecution would amount to abuse of process.
The quashment was therefore framed not as an evaluation of trial evidence, but as a threshold legal assessment of whether the charge-sheet narrative satisfies
Section 336 IPC at all.
3.2 Legal Reasoning
(i) The statutory threshold under Section 336 IPC
The Court emphasised that Section 336 IPC is not triggered by every mistake or lapse. It requires an act done “so rashly or negligently as to endanger human life or the
personal safety of others.” The judgment articulates the settled principle that criminal negligence is qualitatively different from civil negligence:
it must be gross, culpable, and showing utter disregard for life and safety.
(ii) Diagnostic discrepancy ≠ criminal culpability
The prosecution’s case hinged on the discrepancy between:
- HBsAg rapid screening report: “Reactive,” and
- subsequent testing (including CMIA): “Non-Reactive.”
The Court held that discrepancy alone cannot found criminal liability. At most, it may call for professional scrutiny, further clinical correlation, or civil/consumer remedies.
This reasoning is particularly important for diagnostics, where screening tools can carry known false-positive rates, and where confirmatory testing is part of clinical workflows.
(iii) The “expert opinion” relied on by the prosecution was protocol-advisory, not culpability-finding
The Superintendent, Gandhi Hospital opined that a reactive rapid HBsAg should ordinarily be confirmed by another method (CMIA/CLIA/ELISA), preferably on a repeat sample,
before issuing a final report. The High Court treated this as an articulation of good laboratory protocol, but not as a conclusion that issuing the screening result
was necessarily “wrong,” nor that it constituted gross negligence.
Critically, the Court read the opinion as describing what should “ordinarily” be done—not as establishing criminality for not doing so in every case.
(iv) The disclaimer on the report undermined criminal inference
The Court gave weight to the report’s disclaimer that the rapid test is not the sole diagnostic criterion and that confirmatory testing/clinical correlation is necessary.
This supported the Court’s conclusion that the petitioners’ conduct lacked the hallmark of Section 336 culpability—namely, a reckless disregard endangering life/personal safety.
(v) Personal criminal liability cannot be based on job titles
The judgment highlights a structural weakness in the charge-sheet: petitioner Nos. 2 to 4 were managers/operations functionaries and petitioner No. 1 a consultant
microbiologist, yet the prosecution failed to specify which individual did what (who tested, who validated, who authorised issuance, who decided to release without confirmation).
The Court reaffirmed that criminal liability is personal, and absent a statutory framework for vicarious liability, a person cannot be prosecuted simply because
they occupy a managerial or supervisory position.
(vi) Section 482 CrPC: preventing abuse of process
Having found that the charge-sheet materials did not disclose the essential ingredients of Section 336 IPC, the Court treated the continuation of proceedings as an abuse of process
and used inherent powers to quash—consistent with Bhajan Lal.
3.3 Impact
(a) On criminalisation of diagnostic/medical lapses
The decision strengthens a clear boundary: alleged protocol deviations in diagnostics—especially involving screening tests with known false-positive possibilities—will not readily
cross into Section 336 IPC unless the facts show gross recklessness that truly endangers life/personal safety.
(b) On investigative standards in medical/diagnostic prosecutions
By anchoring analysis in Jacob Mathew, the judgment signals that police must not treat advisory protocol notes as sufficient to allege criminal negligence.
Investigations must meaningfully address whether conduct meets the “gross negligence” threshold, and whether expert material truly supports criminal culpability (not merely ideal practice).
(c) On managerial prosecutions in healthcare organisations
The Court’s insistence on specific overt acts and rejection of designation-based implication is likely to influence future cases involving hospitals, laboratories, and corporate medical entities.
Prosecutors may need to:
- identify the actual signatory/validator of reports,
- trace decision-making responsibility for release/communication of results, and
- plead and support individual knowledge/participation, rather than arraying senior staff as accused by default.
(d) On choice of remedy: civil/consumer vs criminal
The judgment channels such disputes toward civil law or consumer protection frameworks for “deficiency in service,” reserving criminal law for truly egregious cases.
This is consistent with the Supreme Court’s concern about the chilling effect of criminal prosecutions on medical services.
4. Complex Concepts Simplified
4.1 Section 336 IPC
It punishes a rash/negligent act that endangers human life or personal safety. The key is the seriousness of the negligence:
ordinary carelessness may be civilly actionable, but criminal liability requires gross negligence/recklessness.
4.2 Civil negligence vs criminal negligence
- Civil negligence: failure to take reasonable care, typically leading to compensation/damages.
- Criminal negligence: a much higher degree—conduct so careless it is treated as culpable wrongdoing (recklessness/gross disregard for safety).
4.3 Section 482 CrPC (inherent powers of High Court)
A High Court can quash criminal proceedings to prevent abuse of process or to secure justice—especially when allegations, even if accepted as true, do not amount to any offence.
4.4 The “Bolam Test”
A professional is generally not negligent if their conduct aligns with a practice accepted as proper by a responsible body of professionals in that field.
It accommodates professional judgment and rejects hindsight-based criminalisation of imperfect outcomes.
4.5 Rapid screening vs confirmatory tests (HBsAg context)
A rapid test is commonly used for screening and may have false positives. Confirmatory methods (e.g., CMIA/CLIA/ELISA) are typically more specific.
The judgment treated confirmatory testing as an advisable protocol step, but not a basis—without more—for branding the initial screening report as criminally negligent.
5. Conclusion
The Telangana High Court’s decision lays down a practical and protective rule for criminal law’s interface with diagnostic medicine:
a discrepant screening report and an alleged failure to confirm by a second method may indicate a matter for civil/consumer adjudication, but does not, without proof of gross recklessness, satisfy Section 336 IPC.
The Court further reinforced that criminal prosecution must be individualised; managerial or supervisory titles cannot substitute for specific allegations of participation and culpable conduct.
In the broader legal landscape, the judgment extends the Supreme Court’s medical-negligence safeguards (notably Jacob Mathew v. State of Punjab, (2005) 6 SCC 1)
into the domain of diagnostic laboratories, helping ensure that criminal process is reserved for truly culpable conduct rather than being used as a tool to litigate professional dissatisfaction or distressing outcomes.