Terms of Use and License Agreement

Phoenix Compliance Shop, a d/b/a of Phoenix Laboratory Consulting, LLC

Effective 6 August 2026 · Version 1.3

1. Who we are

Phoenix Compliance Shop is a trade name of Phoenix Laboratory Consulting, LLC, a Kentucky limited liability company ("Phoenix," "we," "us"). Our registered address and contact details are available on request. You can reach us at bronwynr@phoenixlabconsulting.com.

These Terms govern (a) your use of this website and (b) your use of any product you license from us. By using this site or a Phoenix product, you agree to them.

2. How purchases work, and whose terms apply

We sell through FastSpring, which acts as our authorized reseller and Merchant of Record. When you buy a Phoenix product, FastSpring is the seller of record for that transaction. FastSpring's terms and conditions govern the payment transaction itself, including billing, tax, and payment disputes. FastSpring appears on your card or bank statement, not Phoenix.

These Terms govern your license to use the content you receive. The two documents do different jobs and both apply.

Some laboratories buy by invoice or purchase order rather than by card. Where an order is invoiced, the invoice identifies the seller for that transaction. These Terms govern your license either way.

Our Refund Policy describes how refunds are handled. Our Privacy Policy describes how personal information is handled.

3. The products these Terms cover

These Terms cover two products. Each is defined here and referred to by that name for the rest of this document.

"The System" means the NYSDOH CLEP Compliance System: a documentation and implementation resource consisting of a written manual, a spreadsheet workbook, and a library of forms and templates. It is a structured reference and planning framework for laboratories preparing for New York State Department of Health Clinical Laboratory Evaluation Program licensure, test approval, and survey readiness.

It is a set of documents. It is not software, not a medical device, not a laboratory developed test, and not a service.

"The Finder" means the PGx Control Finder: a hosted web tool that maps pharmacogenetic validation targets to publicly available Coriell reference materials, packs a selected panel into the fewest samples that cover it, and exports the result to a spreadsheet. It is described in full in Section 6.

Sections 4 and 5 apply only to the System. Section 6 applies only to the Finder. Sections 1 to 3 and 7 to 18 apply to both.

4. License grant — one laboratory facility

Subject to these Terms and to payment in full, we grant you a non-exclusive, non-transferable, perpetual license to use the NYSDOH CLEP Compliance System at one laboratory facility.

Each purchase authorizes use at one laboratory facility, identified by its CLIA license number or NYSDOH Permanent Facility Identifier (PFI). Where a facility does not yet hold a PFI, the license binds to one named physical laboratory location and converts to that location's PFI on issuance. Multi-site systems, parent corporations, and affiliated laboratories require separate licenses unless otherwise agreed in writing.

Within that one facility, you may:

• install, store, print, and distribute copies to your own personnel, without limit on the number of individuals or copies;
• adapt, edit, rename, and incorporate the content into your own quality management system documents, policies, and procedures;
• use the resulting adapted documents in your own operations, submissions, and inspections indefinitely.

Adapted documents survive. Documents you have genuinely incorporated into your own quality system remain yours to use even if this license later terminates. You do not have to withdraw your own QMS on our account.

5. What you may not do with the System

You may not:

1. use the System at, or share it with, any laboratory facility other than the licensed facility identified by the CLIA license or PFI under which it was purchased;
2. deploy, apply, or reuse the System in consulting, advisory, or contract-director engagements for third parties (this requires the separate Consultant Deployment license — contact us);
3. resell, sublicense, rent, lend, publish, or otherwise distribute the System or any substantial part of it;
4. post the System to any repository, drive, intranet, or platform accessible to people outside the licensed facility;
5. remove, obscure, or alter any copyright notice, watermark, or order stamp;
6. use the System, in whole or in part, as training data for, or as input to, any machine-learning or artificial-intelligence system.

If you direct more than one facility, purchase one license per facility or contact us for a multi-site quote.

6. PGx Control Finder — license, tokens, and data

6.1 What the Finder is, and what it is not

The Finder is a hosted web tool. It maps pharmacogenetic validation targets to publicly available Coriell reference materials, runs a set-cover optimizer that packs a selected panel into the fewest samples that cover it — including distinct CYP2D6 deletion, duplication, and hybrid or tandem controls — and produces a spreadsheet export containing a Coriell shopping list and an expected-results table.

The Finder is an informational and planning tool. It is not software you install, not a medical device, not in vitro diagnostic software, not a laboratory developed test, and not a service engagement. It does not analyze your specimens, produce a patient result, or perform any part of a validation.

We do not supply DNA, cell lines, or any physical reference material. The Finder tells you which publicly available materials exist and which combination covers your panel. You obtain the materials themselves from the Coriell Institute for Medical Research or another repository, on that repository's own terms and at your own cost.

A free preview covering a small warfarin panel is available with no purchase and no sign-up. It is offered as-is, and we may change or withdraw it at any time.

6.2 License grant — the purchasing organization

Subject to these Terms and to payment in full, we grant you a non-exclusive, non-transferable, perpetual license to use the Finder, and the exports you generate from it, for the internal purposes of the laboratory or organization that purchased the license.

Unlike the System, the Finder is not licensed per facility. It is licensed to the purchaser. Your license key identifies your order. It must not be shared with, sold to, or used by anyone outside your organization.

Within your organization you may:

• generate exports and use them to select, purchase, and document reference materials;
• copy, print, and circulate your exports internally, without limit on the number of individuals or copies;
• incorporate the contents of your exports into your own validation plans, validation summaries, standard operating procedures, quality records, and submissions to accrediting bodies and regulators — including NYSDOH, CAP, and CMS.

Your validation records survive. Exports and derived records that you have genuinely incorporated into your own quality system remain yours to keep and use indefinitely, even if this license later terminates. A validation record that might have to be withdrawn later is worth nothing to you or to your inspector, so it does not have to be.

6.3 What you may not do with the Finder

You may not:

1. share, publish, sell, or otherwise disclose your license key, or permit its use by anyone outside your organization;
2. use the Finder, or exports from it, to provide a service to third parties — including consulting, contract-director, or validation-design services for other laboratories (contact us for separate terms);
3. resell, redistribute, or republish exports, in whole or in substantial part, as a product, dataset, tool, or service of your own;
4. use automated means to scrape, harvest, bulk-download, or systematically extract the Finder's database or any part of it;
5. reverse engineer, or attempt to reconstruct, the curated database, the target-to-control mapping, the platform panel definitions, or the optimizer;
6. use the Finder, its database, or any export as training data for, or as input to, any machine-learning or artificial-intelligence system;
7. attempt to circumvent the token mechanism, generate or forge license keys, or interfere with the operation of the service.

6.4 Export tokens

Export tokens are the unit of purchase. A purchase credits export tokens to a single license key in the quantity stated in the product name and on your receipt. If you order more than one unit, all tokens are credited to that one key rather than split across several.

• One token unlocks one bounded export — one platform preset, or one gene.
• Tokens do not expire. There is no time limit, subscription, or renewal.
• Tokens are tied to the license key issued for your order, and to the purchaser. They cannot be transferred, split across keys, resold, pooled with another purchase, or reassigned to a different organization.
• Re-exporting a unit you have already exported is free. Re-generating a preset or gene you have already unlocked does not consume a token, and is unlimited for as long as the service is available.
• The gap view is free for a platform you have already exported. You paid for that platform's data; the gap view is a filtered view of it and does not consume a token.
• A token is spent when the export is generated, and a spent token is non-refundable. Refunds are governed by our Refund Policy: an order is refundable in full within 14 days of purchase if no token has been used, and is not refundable once any token has been used.
• Tokens have no cash value. They are not credit, currency, or a stored-value instrument, and they cannot be exchanged for money or for any other product.
• If an order is refunded or charged back, the license key issued for it is disabled and any tokens remaining on it are void.

6.5 Availability of the service

The Finder is a hosted service. We do not guarantee uninterrupted availability, and we may modify, suspend, or discontinue it or any part of it. Because tokens do not expire, export what you have paid for rather than leaving tokens unspent indefinitely, and keep your own copy of every export you rely on.

If we permanently discontinue the Finder, unspent tokens cannot be redeemed, and your remedy is limited as set out in Section 14. Exports you have already generated remain yours under Section 6.2.

6.6 Research use — and no clinical use

The Finder is for research and laboratory-planning use only. It is not for use in diagnostic procedures. No output of the Finder may be used to diagnose, treat, or manage a patient, or to generate or report a patient result.

What that does and does not mean, stated plainly. The Finder is intended to help a laboratory plan and document the validation of a pharmacogenetic assay: using an export to decide which reference materials to purchase, and to record what results you expect from them, is the intended use. What the Finder cannot do is stand in for your validation. Selecting a control from the Finder is not evidence that the control performs on your platform, and an export is not a validation. You must run the material on your own assay and evaluate the result yourself.

Your laboratory director remains solely responsible for the design, execution, acceptance criteria, and defensibility of your validation, and for everything you submit to an accrediting body or a regulator.

6.7 Data provenance and accuracy

The Finder's database is compiled from third-party public sources. In particular:

• 1000 Genomes Project / IGSR. Genotypes are derived from 1000 Genomes Project data made available by the International Genome Sample Resource (IGSR) at EMBL-EBI. That data is openly available without access or use restrictions, but IGSR states that it cannot guarantee the data is accurate for any purpose, that rights claimed in different pieces of the data vary, and that those rights may change over time.
• GeT-RM. Consensus genotype and diplotype assignments — including the CYP2D6 structural spine of deletions, duplications, hybrids, and tandems — are drawn from published characterization studies of the Genetic Testing Reference Materials Coordination Program (GeT-RM), a Centers for Disease Control and Prevention program run collaboratively with the Coriell Institute for Medical Research and the wider genetic testing community. Those publications remain the property of their publishers.
• Coriell. Sample identifiers, panel membership, and ancestry annotations refer to materials distributed by the Coriell Institute for Medical Research. Coriell distributes those materials on its own terms, and availability is a matter between you and Coriell.

We do not own, control, produce, or independently confirm any of that source data, and we make no representation about it. Star-allele definitions, consensus genotypes, and sample availability all change. PharmVar allele definitions are revised; a sample's published assignment can be updated, corrected, or withdrawn after the study that characterized it; and a repository can retire a line.

Verify any control that matters against primary sources before you rely on it. Confirm the current genotype or diplotype assignment, confirm the sample is still available, and confirm that the variants you care about are actually interrogated by your platform. An expected-results table generated by the Finder is a starting point for your validation, not a reference standard.

What we do claim as our own is the curation, the mapping of validation targets to controls, the platform panel definitions, the CYP2D6 structural set, the optimizer, the export design, and the selection and arrangement of the database as a whole. See Section 12.

7. No guarantee of approval

Nothing we sell is a guarantee, warranty, or assurance of any regulatory outcome.

Purchasing and using the System does not guarantee that your laboratory will obtain or retain a NYSDOH CLEP permit, that any test approval or modification submission will be approved, that any inspection or survey will be passed, or that any deficiency will be avoided. Purchasing and using the Finder does not guarantee that a validation will be accepted, that a control set will be considered adequate by any inspector or assessor, or that any assay will pass validation. Regulatory outcomes depend on your laboratory's own facts, personnel, practices, and evidence, and on decisions made solely by the New York State Department of Health or the relevant accrediting body.

8. Not professional, legal, or clinical advice

The System and the Finder are structured reference resources. Neither is legal advice, regulatory advice, clinical advice, or a consulting engagement, and using either does not create a consultant-client or any other professional relationship between you and Phoenix or Bronwyn Ramey.

Regulatory requirements change, and so do allele definitions and reference-material characterizations. You are responsible for verifying all requirements against the current primary sources published by the New York State Department of Health and any other applicable authority, and for verifying reference-material data against its current primary sources. Your laboratory director remains solely responsible for your laboratory's compliance, for the accuracy of anything you submit, and for all decisions made in reliance on either product.

9. No support is included

The Single-Laboratory License is a deliverable-only product. It includes no support, no consultation, no review of your documents, no assistance with submissions, and no training. We are not obliged to answer questions about the System's content or about your laboratory's situation.

The Finder is sold as a tool, not as a service relationship. It includes no consulting, no review of your validation design or data, no interpretation of results, and no assistance with submissions. We will make reasonable efforts to resolve problems that are ours — an order that did not fulfil, a license key that does not work, an export that will not generate — if you email us with your order reference. That is the limit of what is included.

If you want hands-on help, the Implementation Bundle and Consultant Deployment tiers include consulting support and are quoted separately at phoenixlabconsulting.com.

10. Updates and versions

The System is licensed in the version delivered to you, identified by its version date. We are under no obligation to provide updates, revisions, or notice of regulatory change. If we later offer an update program, it will be a separate paid product.

The Finder is a live service, and it works the other way round. Its database, target list, platform presets, optimizer, and export format may change at any time and without notice as source data and vendor panels are revised. An export reflects the data as it stood at the moment you generated it, and a later re-export may not return the same samples. Retain your own copy of every export you rely on. We are under no obligation to preserve any prior state of the database, to reproduce an earlier export, or to notify you of changes.

11. Delivery and access

The System is delivered as electronic downloads through FastSpring immediately after payment clears. The manual is stamped with the purchaser's name and order reference on download. You are responsible for downloading and retaining your own copies of the files within the download window shown at checkout, and for maintaining your own backups.

The Finder is delivered as a license key, not as a file. Your key is emailed to you and shown on your receipt. Access is through the Finder page at phoenixlabconsulting.com; there is nothing to install and nothing to download except the exports you generate. Keep your key. It is the only credential attached to your tokens, and re-issuing it requires your order reference.

12. Intellectual property

The System, the Finder, and all content in them are the intellectual property of Phoenix Laboratory Consulting, LLC and are protected by copyright. Nothing in these Terms transfers ownership. All rights not expressly granted in Section 4 or Section 6 are reserved.

Third-party and government materials. The System includes documents published by the New York State Department of Health and other authorities, reproduced for your convenience. The Finder incorporates genomic and reference-material data from the sources named in Section 6.7. Those documents and datasets remain the property of their respective publishers and owners, we claim no ownership of them, and your use of them is subject to any terms their publishers apply. Our copyright covers our own manual, workbook, forms, and templates; our own curation, target-to-control mapping, panel definitions, optimizer, and export design; and the selection, arrangement, and organization of each product as a whole.

13. Warranty disclaimer

The System and the Finder are provided "AS IS" and "AS AVAILABLE," without warranty of any kind. To the fullest extent permitted by law, we disclaim all warranties, express or implied, including implied warranties of merchantability, fitness for a particular purpose, accuracy, completeness, currency, and non-infringement. We do not warrant that either product is error-free, or that it reflects the most current regulatory requirements.

In addition, and without limiting the above, we do not warrant that the Finder's database is accurate, complete, or current; that any control it identifies is correctly characterized, still available, or suitable for your platform; or that the service will be available without interruption.

14. Limitation of liability

To the fullest extent permitted by law, our total aggregate liability arising out of or relating to the System, the Finder, or these Terms will not exceed the amount you actually paid for the license or tokens in question.

We will not be liable for any indirect, incidental, special, consequential, exemplary, or punitive damages, or for lost profits, lost revenue, lost data, business interruption, regulatory penalties, denial or revocation of a permit or approval, inspection or assessment findings, remediation costs, the cost of reference materials or reagents purchased, or the cost of repeated, delayed, or failed validation work, even if we have been advised of the possibility of such damages.

Some jurisdictions do not allow certain exclusions or limitations, in which case the above applies to the maximum extent permitted.

15. Termination

Your license terminates automatically if you materially breach these Terms, in particular Section 5 or Section 6.3. On termination you must stop using the affected product and destroy all copies, and any license key issued to you may be disabled.

Two things are carved out and you keep them: documents you have genuinely incorporated into your own quality system under Section 4, and exports and derived validation records you have genuinely incorporated into your own quality system under Section 6.2.

Sections 7, 8, 12, 13, 14, and 16 survive termination, as do Sections 6.6 and 6.7.

16. Governing law and venue

These Terms are governed by the laws of the Commonwealth of Kentucky, without regard to its conflict-of-laws rules. Any dispute will be brought exclusively in the state or federal courts located in Jefferson County, Kentucky, and you consent to their jurisdiction.

17. General

These Terms, together with our Refund Policy and Privacy Policy, are the entire agreement between you and Phoenix regarding the System and the Finder, and supersede any prior discussion. If any provision is held unenforceable, the rest remains in effect. Our failure to enforce a provision is not a waiver of it. You may not assign this license without our written consent.

We may update these Terms. The version in force for your purchase is the version published on the date of your order. Material changes will be reflected in the version number and effective date above.

18. Contact

Phoenix Laboratory Consulting, LLC d/b/a Phoenix Compliance Shop bronwynr@phoenixlabconsulting.com phoenixlabconsulting.com · phoenixcomplianceshop.com