Root-cause investigation
Five required elements: instrument logs, reagent lot records, calibration/QC history, personnel competency files, and a narrative identifying the most consistent cause — all present, or the pack does not release.
The most rigorous CLIA PT failure remediation pack a laboratory can receive.
PTGuard assembles a documentation-complete root-cause investigation and corrective action plan — every regulatory element, every required record cross-reference, the personnel competency review, and the inspection-readiness dossier — checked against the letter of 42 CFR Part 493 Subpart H before a credentialed CLIA Technical Consultant releases it.
Every subsection of 42 CFR Part 493 Subpart HFive regulatory elements, gate-checkedInstrument logs · reagent lots · QC records · personnel filesCLIA Technical Consultant release on every pack5-business-day SLA
Why packs fail
A single missing element can suspend patient testing for six months.
A laboratory's CLIA proficiency testing failure is only as remediated as the corrective action plan behind it. Miss one of the five required root-cause elements, skip a required record cross-reference, mis-time the 60-day window for re-enrollment, or fail to document personnel competency — and the lab can face a CMS suspension, cessation of patient testing for the failed analyte, and concurrent Medicare payment cancellation.
Most labs run this by hand, from memory, once or twice a year. The regulation has not been read end-to-end since the last time it mattered. That is exactly where completeness gaps hide.
PTGuard exists to close that gap with a single, exhaustive standard applied identically to every file.
2 of 3
unsatisfactory events triggers 'unsuccessful' performance and mandatory suspension
The benchmark
Measured against the letter of the regulation — subsection by subsection.
We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 42 CFR Part 493 Subpart H. These are the provisions each pack is held to.
Corrective action plan (CAP)
Specific, monitorable corrective actions with deadlines and responsible parties, designed to survive CMS or state-agency review.
Personnel competency review
Documented review of the testing personnel involved, including retraining or reassignment if the root cause is a competency gap.
Re-enrollment timeline
The next PT event enrollment is verified to occur within the required window, with two consecutive successful events needed before patient testing may resume.
Record retention
All remediation documents are organized and indexed for the mandatory two-year retention period, with an inspection-ready dossier.
Public notification compliance
If the failure results in suspension, the lab's public notice obligations under CMS rules are drafted and included.
How a pack is built
Intake to specialist release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A credentialed CLIA Technical Consultant signs every release. That order is never reversed.
01
PT Failure Gap Scan
Upload the PT score report, instrument logs, QC records, and personnel files. We return a free completeness read: which regulatory elements and records you already have, and which are missing.
02
Evidence & record cross-reference
As your authorized clerical agent, we cross-reference the failed analyte against instrument logs, reagent lots, calibration/QC history, and personnel competency files, building a corroborated evidence log.
03
Grounded drafting
The root-cause narrative and CAP are drafted from your validated data and the 42 CFR Part 493 Subpart H rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
All five root-cause elements are present; the CAP is specific and monitorable; personnel review is documented; re-enrollment timeline is verified; record retention is indexed. Any failure blocks release.
05
Specialist release
A CLIA Technical Consultant or General Supervisor-qualified reviewer reviews the exception queue and signs the release. High-complexity or multi-analyte failures route to a senior reviewer first.
06
Delivery
You receive the pack: root-cause investigation, CAP, personnel competency review, evidence log, re-enrollment timeline, and inspection-ready dossier — ready for the lab to submit or retain.
The bar we hold
Rigor you can measure.
100%
CLIA Technical Consultant-released
No pack ships without a credentialed human signature.
5 days
Standard SLA
From complete intake to released pack.
<1%
Critical-defect target
Tracked against a gold-standard pack library.
4
Record-source cross-references
Instrument logs · reagent lots · QC records · personnel files, every applicable file.
Why PTGuard
Built to be the most thorough option a laboratory has.
Documentation-complete, by design
The deliverable is completeness itself — every regulatory element and record cross-reference accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run record cross-references as your clerical agent. We never contact CMS, give legal advice, or conduct the remediation on your behalf.
Engagement
Flat fee, per released pack. No hourly billing, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
- A free PT Failure Gap Scan before you commit — see exactly what is missing.
- One flat fee per released Remediation & Compliance Pack; disclosed pass-through record retrieval fees.
- Optional fixed-fee senior reviewer for high-complexity or multi-analyte failures.
- Optional Monitoring Subscription for ongoing PT event tracking and pre-event readiness checks.
FAQ
Questions, answered precisely.
Is PTGuard a law firm?
No. PTGuard, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. CLIA Technical Consultant review is available and recommended for high-complexity or multi-analyte failures.
Do you contact CMS or the PT program on our behalf?
Never. PTGuard is not a regulatory representative and does not contact CMS or any PT program. The laboratory remains the entity responsible for submitting all corrective action plans and communicating with regulators.
What makes a pack 'complete'?
Completeness is defined by the regulation: the five root-cause elements present, the CAP specific and monitorable, personnel competency reviewed, re-enrollment timeline verified, and record retention indexed. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to a specialist-released pack. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through record retrieval costs. No hourly billing and no percentage of any recovered amount or sale proceeds.
See what's missing before it costs you patient testing.
Start with a free PT Failure Gap Scan. Send your PT score report and supporting records and we'll return a completeness read against every subsection of 42 CFR Part 493 Subpart H.
Documentation-completeness service · not legal advice · the laboratory submits every notice.