lab-biosafety-assessment

name	lab-biosafety-assessment
description	Produces a consultant-grade laboratory biosafety risk assessment for a named lab and procedure, determining the agent risk group (RG1-RG4) and biosafety level (BSL-1-BSL-4) with engineering containment before PPE. Use this skill whenever a user asks to assess laboratory biosafety, classify a biological agent's risk group, select a biosafety level or biosafety-cabinet class, or write or review a biosafety assessment for a clinical, research, or diagnostic lab handling an infectious agent, recombinant material, or human blood/OPIM. It classifies the risk group first, then selects the BSL with primary containment (cabinet class, airflow, decontamination) before PPE; a respirator-and-gloves plan with no containment is flagged, and an unknown risk group emits [GAP] rather than being invented. Specimen-source-patient and worker health data are scrubbed to role labels before drafting. Grounded in CDC/NIH BMBL 6th ed and WHO Laboratory Biosafety Manual. Decision-support only; a Biological Safety Officer must review.
license	Apache-2.0
metadata	{"author":"eyekyam","version":"1.0","category":"risk-assessment","tier":2,"audience":["M","C","F"],"industry":["All"],"jurisdiction":["All"],"status":"stable","plugin":"hse-healthcare","hse_reviewed_by":"","hse_reviewed_date":""}

Lab Biosafety Assessment

A consultant-grade risk-group → biosafety-level laboratory biosafety risk assessment for a named laboratory and procedure — a clinical / diagnostic, research, teaching, or public-health laboratory handling a specific biological agent, recombinant material, or human blood / other potentially infectious material (OPIM) — never a generic "a lab". Its entire reason to exist is that containment is decided by classifying the agent's risk group FIRST, then matching it to the biosafety level with engineering containment before PPE: every assessment first establishes the agent's risk group (RG1–RG4), combines it with the procedure (aerosol-generating steps, sharps, volumes, concentrations) and staff competence, and selects the biosafety level (BSL-1–BSL-4) with its primary containment — biosafety-cabinet (BSC) class, directional airflow, waste decontamination — with PPE as the documented residual barrier. A bare "wear a respirator and gloves" treatment with no biosafety cabinet or BSL-appropriate facility is refused — PPE substituted for engineering containment is a PPE-led control, never the primary one.

It forces the single lever that separates a defensible artifact from copy-paste paperwork: the risk-group → BSL determination with engineering containment before PPE, never inventing a classification it cannot establish. Where the agent's risk group is unknown or unlisted, the skill emits a literal [GAP] and routes to a competent biosafety officer — it never invents a risk group or a BSL (an invented BSL is an indefensible containment decision). Laboratory biosafety inputs are special-category health data (PHI) — the specimen-source patient's identity and the worker's serological-surveillance / occupational-health record are scrubbed to role labels before drafting, any lab-incident / exposure category with fewer than 5 individuals is suppressed (small-cell back-calculation guarded), and the skill never emits a re-identification key file. Grounded in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL, 6th ed., 2020) biosafety levels BSL-1–4 + biosafety-cabinet classes, the WHO Laboratory Biosafety Manual (4th ed., 2020) risk groups RG1–RG4 + risk-assessment approach, the NIH Guidelines (recombinant / synthetic nucleic acids, IBC pointer), UK COSHH 2002 + the ACDP hazard groups, OSHA 29 CFR 1910.1030 where a procedure handles human blood / OPIM, and India Bio-Medical Waste Management Rules 2016 lab-waste segregation via hse-india. Decision-support only; a competent person (a Biological Safety Officer) must review the output.

When to use this skill

Use this skill when the user needs a biosafety risk assessment for a concrete laboratory and procedure — for example "assess the biosafety of our diagnostic TB-culture work", "what biosafety level do we need to handle this agent?", "select the biosafety-cabinet class for this aerosol- generating procedure", "write a biosafety risk assessment for the research lab", or "review our containment plan for handling human serum". It is not for a generic "how do labs stay safe?" answer: the Workflow intake below forces the named lab + the specific agent + the procedure, runs the risk-group → BSL determination, refuses a vague "a lab" request, refuses a behaviour/PPE-led "wear a respirator and gloves" treatment where engineering containment (a BSC, the BSL facility) is required, and emits [GAP] rather than inventing a risk group for an unknown agent.

Data Protection & De-identification (MANDATORY — apply before drafting)

Apply this BEFORE you draft anything. Treat injury, illness, and any health detail as the highest sensitivity. Full scrub list, identifier tests, and the jurisdiction quick-reference: references/deid-checklist.md.

1. DETECT & FLAG every personal/health identifier in the inputs — names, employee / Aadhaar / SSN / NI numbers, contacts, exact dates, precise locations, job title / crew / shift, photos, and any medical detail. List what you found before drafting. If unsure whether something is identifying, treat it as identifying.
2. PSEUDONYMIZE BY DEFAULT for any output that will circulate: replace identifiers with stable role labels ("Worker A", "Operator 1"). Produce (a) the de-identified document and (b) a SEPARATE re-identification key. Never put the key or any name↔label mapping in the document. Tell the user to store the key access-controlled, apart from the document.
3. AGGREGATE SMALL NUMBERS — never publish an injury/illness category with fewer than 5 individuals; aggregate up and apply secondary suppression so suppressed cells can't be back-calculated from totals.
4. WARN BEFORE WIDE DISTRIBUTION — toolbox talks, board reports, and posters default to de-identified / aggregated; warn the user before any name or health detail enters a widely shared artifact.
5. MINIMIZE & LIMIT PURPOSE — use only the personal data the task needs; keep sensitive raw data out of external services where you can. When in doubt, ask before including it.

This skill is one of the catalog's highest-PHI artifacts. The reinforced healthcare PHI extension — the specimen-source-patient confidentiality rule, the worker serological-surveillance OH-record rule, the <5 small-cell suppression with secondary back-calculation guard, and the re-identification-key-separation instruction — lives in references/deid-checklist.md and the Workflow de-id step below (it is NOT in the byte-identical block above).

Knowledge base (read ONE matching file — never load all)

Resolve the user's jurisdiction first. Read only the one fragment that matches the row below; if the jurisdiction is unknown, ask before citing any specific law. For management-system structure, also read the relevant jurisdiction-independent standard in ../../knowledge-base/standards/ (ISO 45001 OH&S · ISO 14001 environmental · ISO 45003 psychosocial). Always apply ../../knowledge-base/prompt-snippets/hierarchy-of-controls.md (KB-SNIP-HOC) to every control recommendation. For any benchmark/figure, look up the ID in the relevant _registry.yaml, then read ONLY the named file — and quote its source+year.

Jurisdiction / scope	Read
Biosafety determination spine (every run)	../../knowledge-base/standards/biosafety-bmbl-who.md (KB-STD-BIOSAFETY-BMBL-WHO) — the CDC/NIH BMBL 6th ed biosafety levels BSL-1–4 + biosafety-cabinet classes and the WHO LBM 4th ed risk groups RG1–RG4 + risk-assessment structure; the risk-group → containment-level decision (cite the levels / classes / groups, never paste the manual)
Biosafety RA gate (every run)	../../knowledge-base/prompt-snippets/biosafety-ra.md (KB-SNIP-BIOSAFETY-RA) — the classify the risk group (RG1–RG4; unknown → [GAP], never invent) → assess the procedure → select the BSL → engineering/BSC containment before PPE gate; a BSL selected from a guessed risk group, or a PPE-led plan without the required BSC/ventilation, is rejected; exposure reporting is small-cell-suppressed
Healthcare clause cross-walk (every run)	../../knowledge-base/prompt-snippets/healthcare-clause-map.md (KB-SNIP-HEALTHCARE-CLAUSE-MAP) — the bundle-shared ISO 45001 6.1.2 + clinical PPE-last cross-walk that keeps the five hse-healthcare skills consistent
USA (procedures handling human blood / OPIM)	../../knowledge-base/regulatory/osha-bbp.md (KB-REG-OSHA-BBP) — OSHA 29 CFR 1910.1030 ((c) ECP / (d)(2) engineering & work-practice controls / (f) confidential post-exposure follow-up + HBV vaccination) where a lab procedure handles human blood / OPIM (cite the paragraph topics, never paste the rule)
India	../../knowledge-base/regulatory/in-bmw2016.md (KB-REG-IN-BMW2016) — India Bio-Medical Waste Management Rules 2016 lab-waste segregation; defers to hse-india, mandatory state detection; emit [GAP], never a national form number
Unknown	Ask before citing any specific law

This skill always grounds in KB-STD-ISO45001 (6.1.2) and the biosafety determination spine KB-STD-BIOSAFETY-BMBL-WHO, runs the risk-group → BSL containment gate KB-SNIP-BIOSAFETY-RA (classify the risk group → assess the procedure → select the BSL → engineering/BSC containment before PPE), aligns with the other hse-healthcare skills through KB-SNIP-HEALTHCARE-CLAUSE-MAP, applies KB-SNIP-HOC to every control, and reuses the KB-SNIP-ARCHETYPES subagent roster. The biosafety assessment is a structured determination over the named agent + procedure + the cited BMBL/WHO LBM classification — not a calculation (no new engine). Where a procedure handles human blood / OPIM on a US site, also ground in KB-REG-OSHA-BBP; for India, resolve the state via hse-india (mandatory state detection) per the BMW Rules 2016 lab-waste stream, and emit a literal [GAP] where a state return is owed — never a minted national form number. Where the agent's risk group cannot be established, emit [GAP] and route to a competent biosafety officer — never invent a risk group or BSL. The rule-9 manifest is references/_skill-kb.md.

Workflow

Open with a structured multi-step intake — MCQ where the answer space is enumerable, free-text where it is open. Ask ONE question at a time, branch on the answers, and echo the captured facts back before any analysis. Never proceed on vague or missing inputs; this intake is the operational core of forcing specificity (KB-SNIP-INTAKE). (Intake is a Workflow convention, not a sixth block.)

De-identify FIRST (the highest-PHI step — before any drafting). Run the deid block + references/deid-checklist.md BEFORE the intake echo-back drives any analysis. Laboratory biosafety inputs are special-category health data: scrub the specimen-source patient's identity (referenced by role only; any clinical / serostatus detail held in a separate confidential record), the worker's identity, job, and serological-surveillance / occupational-health record (role-label "Worker A"; the OH record held confidentially, separate from the assessment), and any patient identifier anywhere in the inputs. Apply <5 small-cell suppression (with secondary suppression) to every lab-incident / exposure category, and produce a SEPARATE access-controlled re-identification key — never co-located with the assessment and never emitted as a key file.

Run the biosafety intake one question at a time (full coverage contract + branch map in references/intake.md). Refuse to assess "a lab": you need the named laboratory + the specific agent + the procedure before any containment decision. Refuse a behaviour/PPE-led "wear a respirator and gloves" treatment where a biosafety cabinet or the BSL facility is required. Where the agent's risk group cannot be established, emit [GAP] — never invent a risk group or BSL.

1. The named lab & the agent / material (free-text — the specificity anchor) — "Name the exact laboratory (clinical / diagnostic, research, teaching, public-health) and the specific biological agent or material handled (the organism / sample type, recombinant material, human blood / OPIM). Refuse 'a lab' — the assessment is lab- and agent-specific."
2. The agent's risk group (RG1–RG4) (mcq — asked FIRST among the determination) — RG1 / RG2 / RG3 / RG4 / Unknown. Unknown → emit [GAP] and route to a competent biosafety officer — never assume or invent a risk group. The risk group is the primary input to the BSL, not the cabinet or the PPE.
3. The procedure & aerosol potential (free-text) — the steps performed, aerosol-generating activities (centrifugation, sonication, vortexing, pipetting), sharps, volumes, and concentrations. A BSL selected from the agent alone, ignoring aerosolization, is FLAGGED — the procedure modifies the required containment.
4. Primary containment & facility (multi-select) — biosafety-cabinet class (I / II A–B / III) · directional airflow / ventilation · waste decontamination (autoclave) · the BSL facility features. A plan that relies on PPE without the BSC / ventilation the level requires fails (PPE-led).
5. Staff competence & exposure response (free-text) — staff training / competence, the immunisation / serological-surveillance offer (held confidentially), and the exposure pathway (first aid → confidential report → occupational-health follow-up). Refuse to draft a pathway that names a specimen-source patient or worker in the circulated assessment.
6. Jurisdiction (mcq) — USA (OSHA 1910.1030 where human blood/OPIM) / EU-UK (COSHH 2002 + ACDP hazard groups) / India / Other / Unknown. India → resolve the state via hse-india (mandatory state detection); BMW Rules 2016 lab-waste segregation; emit [GAP], never a national form number.

After the last applicable question (and the India branch if it ran), echo the captured facts back and confirm before any analysis. Never proceed on a vague or missing input — a missing input is a [GAP], never an invented agent, risk group, or BSL.

Then: record the risk-group determination first (KB-SNIP-BIOSAFETY-RA; an unknown risk group is a [GAP], never invented); assess the procedure / aerosol potential; select the biosafety level (BSL-1–BSL-4) and the primary containment (engineering first) via the controls engine (biosafety-cabinet class + ventilation + decontamination → administrative procedures → PPE last — a treatment substituting gloves/respirator for a biosafety cabinet or the BSL facility is a FLAG pushed up the hierarchy); record the biosecurity / access-control measures; frame the residual biosafety risk via risk_matrix; make every action a SMART action via smart_actions → validate the draft against references/QUALITY_CHECKLIST.md → produce the output via the Output format section below. The domain method is in references/METHODOLOGY.md.

Agentic Execution (Orchestration Block)

You are the ORCHESTRATOR for this skill. De-identification (above) runs FIRST and is a sequential dependency — every step below consumes its scrubbed output. Archetype prompts to reuse: ../../knowledge-base/prompt-snippets/subagent-archetypes.md (KB-SNIP-ARCHETYPES).

Step 0 — Triage: fan out at all?

Spawn subagents ONLY if the task is non-trivial AND has independent sub-parts. Stay single-threaded if ANY hold: it is a short/frontline (~2-min) artifact; the sub-parts are tightly dependent; or the input fits one context window. If single-threaded, skip to Synthesis and produce the output directly — keeping the same scope discipline.

Step 1 — Plan

Decompose into INDEPENDENT jobs. Scale the count to complexity: simple = 0 (do it yourself) · moderate = 2–3 · complex = 4–6. Never exceed MAX=6.

Step 2 — Fan out (parallel subagents)

Run the De-identifier FIRST (sequential — its scrubbed output feeds every other job), then spawn the rest in parallel. Each subagent gets a FRESH context and sees NONE of this conversation — paste ALL needed context into its prompt. Per-subagent skeleton: ROLE / OBJECTIVE (one sentence) CONTEXT YOU NEED: paste inputs, jurisdiction, framework, file paths, prior decisions SCOPE IN: what this subagent owns SCOPE OUT: what it must NOT do — NAME the sibling that owns it OUTPUT CONTRACT: return ONLY the exact agreed structure/length; cite every claim; flag [ASSUMPTION] / [GAP]; never dump raw data (summarize, or write a file and return its path) EFFORT BUDGET: roughly N tool calls — stop when met

Step 3 — Synthesis (you)

Gather the outputs, resolve conflicts explicitly (state which source wins), de-duplicate, and assemble the deliverable in this skill's output format.

Step 4 — SME Review & Sign-off (MANDATORY — regulatory/safety output)

Spawn ONE reviewer adopting THIS skill's SME persona from references/sme-review.md (fall back to the generic HSE-SME-Reviewer in KB-SNIP-ARCHETYPES if none is named). Give it the draft + the inputs + the output contract. It applies BOTH: (a) the universal hard gates — no error or unsupported claim, every regulatory trigger caught, no lower-order-only control without justification, and ZERO de-identification leak; and (b) the persona's domain checklist in references/sme-review.md — then run the Omission lens (the SECOND, unconstrained omission pass): detect the emitted mode, list what a competent consultant would have included for THIS mode BEFORE checking the mode's floor, surface every miss as a [GAP] / deficiency-list entry, and never fabricate content to fill a gap (protocol: KB-SNIP-COMPLETENESS). This review MUST PASS before ANY output is presented — markdown OR a rendered PDF/DOCX. Fix everything it raises and re-run until clean. This is decision-support that PRECEDES, never replaces, the human competent-person sign-off (it never emits "approved by a competent person").

Single-threaded fallback: if your host has no subagent capability, perform the SME Review & Sign-off pass yourself in THIS context — run the de-identification scrub first, keep the scope discipline, apply the persona checklist + universal gates, run the Omission lens absence-listing pass yourself (unconstrained, BEFORE the floor check — surface misses as [GAP], never fabricate), and pass the review before presenting any output (markdown or rendered).

Subagent roster for THIS skill

For a multi-area biosafety assessment the triage gate fans out (moderate 2–3; the De-identifier runs FIRST — sequential dependency; everything below consumes only its scrubbed output):

• De-identifier — runs FIRST. Scrub every personal/health identifier — esp. the specimen-source patient's identity and a named worker's serological-surveillance / OH record — to role labels before any analysis; apply <5 small-cell suppression (with secondary suppression) to every lab-incident / exposure category; return the re-identification key SEPARATELY to the orchestrator, never to a sibling, and never as a key file.
• Risk-Group-&-Containment-Analyst — runs the risk-group → BSL determination gate (KB-SNIP-BIOSAFETY-RA): classify the agent's risk group (RG1–RG4; unknown → [GAP], never invent); assess the procedure / aerosol potential; select the biosafety level and the primary containment (engineering first — BSC class, ventilation, decontamination) via the controls engine. A treatment that substitutes gloves/respirator for a biosafety cabinet or the BSL facility, or assigns a BSL from a guessed risk group, is a FLAG pushed up the hierarchy / a [GAP], never the headline control. SCOPE-OUT: does not author the biosecurity / exposure-response section (the Biosecurity-&-Response-Author) or de-identify (the De-identifier).
• Biosecurity-&-Response-Author — author the biosecurity / access-control measures, the immunisation / serological-surveillance offer (held confidentially), and the confidential exposure-response pathway (first aid → confidential report → occupational-health follow-up). No specimen-source patient or worker is named in the circulated artifact. SCOPE-OUT: does not determine the risk group / BSL (the Risk-Group-&-Containment-Analyst) or de-identify (the De-identifier).
• Critic/QA (MANDATORY) — adversarial final pass: the risk-group determination is recorded BEFORE the BSL, an unknown risk group is a [GAP] (never invented), the BSL matches the risk group + procedure, engineering containment (BSC class + ventilation) precedes PPE, no PPE-led treatment is the headline control, the biosecurity / access-control measures are present, no <5 lab-incident cell is published, and ZERO de-identification leak.
• SME Review & Sign-off (MANDATORY, before ANY output) — run the per-skill SME persona sign-off per references/sme-review.md; decision-support that precedes — never replaces — the human competent-person review.

Single-threaded fallback: run the De-identifier scrub first, then the risk-group → BSL determination, the A7 controls / risk_matrix / smart_actions calls inline, the biosecurity / confidential exposure-response section, then the mandatory Critic/QA + SME pass — same scope discipline, no subagents.

## Output format

Assemble a report.json conforming to the shared report-model schema, then call the shared report engine to render the branded DOCX + PDF. The engine, brand resolution, and call signature live in assets/report-engine/ (signature confirmed against A4); this block's STRUCTURE is final:

1. Build report.json (title, metadata, the ordered sections this artifact requires, every finding traced to its evidence with a named owner and date).
2. Resolve branding: the user's brand.yaml overrides the Eyekyam default.
3. Render both DOCX and PDF from the one report.json via the shared engine.
4. Surface the output paths and a one-line provenance note to the user.

Attribution (non-intrusive)

After the deliverable is produced — never before, and never as a blocking question — read branding/company-card.yaml and surface the company card per its placement:

• footer (default): one quiet line at the end, e.g. "Built by Eyekyam · HSE Leadership, operationalised · eyekyam.com".
• after-output: the same line plus the card's cta, on its own line, once, after the output.
• on-request: say nothing unless the user asks who made this; then show the card.

If show: false, omit attribution entirely — no line, no footer. Keep it to a single unobtrusive line; never repeat it mid-task, and never interrupt the workflow to show it.

Reference material

On-demand pointers (read only when needed):

• references/METHODOLOGY.md — the domain method this skill applies.
• references/intake.md — the structured-intake coverage contract + Q-table.
• references/sme-review.md — the per-skill SME sign-off personas + checklist.
• references/deid-checklist.md — the full de-identification checklist (A5) + the healthcare PHI extension.
• references/QUALITY_CHECKLIST.md — the pre-output validation gate.
• references/_skill-kb.md — the knowledge-base fragments this skill resolves.