Off Contract_DHS_Quality Management Platform_1.11.2024_Approved Media Lab 01.12.2024.pdf

Arizona State Public Health Laboratory

Melissa Spencer/Monique Harris melissa.spencer@azdhs.gov/monique.harri

QA Manager/Procurement Supervisor 480-417-3469/480-521-2703

Quality Management Platform for clinical laboratories. Customizable and integrated system that includes policies & procedures management, safety training, continuing education and professional development for laboratory professionals as well as quality improvement tools to manage, track and trend nonconforming events and corrective actions. All data must be sufficiently secure to meet Health Insurance Portability and Accountability Act of 1996 (HIPAA), and State of Arizona privacy laws. In addition, the vendor must be RAMP certified.

CTR046099 - Software Value Added Reseller SHI INTERNATIONAL CORP

MediaLab Solutions, LLC PO Box 847635 Boston, MA 02284-7635

Authorization request

5 years ~$6600 per year. $33,000.00 for 5 years.

- The state contract(s) designated as mandatory pursuant to A.A.C. R2-7-A301(B) does not/do not meet the need

The Arizona State Public Health Laboratory (ASPHL) Bureau Chief has set a goal for all sections of the laboratory to transition to utilizing one quality management system because this will lead to cost savings and increase efficiencies. PO0000545091 for $1385.00 was created on October 04, 2019. In 2019, MediaLab was utilized off-contract to build the majority of the laboratory's federally mandated safety orientation and refresher training program. MediaLab's capability to create laboratory-authored instruction utilizing both visual and auditory elements has been critical to ensuring that the laboratory meets the federal requirement for safety training to be facility-specific. The MediaLab platform has been utilized at ASPHL for three years as the primary quality management program for most of the clinical sections of the lab. More than 700 of the laboratory's forms and procedures have already been uploaded to MediaLab. In addition to the document and training components, several laboratory sections transitioned earlier this year from the paper-based system of creating and tracking nonconforming events and corrective actions to the custom-built, all-electronic system in MediaLab. Thousands of man-hours have been spent on building these quality systems in Media Lab in order to streamline and automate these processes. Since 2019, the Agency has spent $18,930.31 off contract. This NPTQ is to cover $33,000 over a five (5) year period to ensure that this embedded system continues to be operatable.

- Not practicable to quote (A.A.C. R2-7-D301(4))

The state requested a quote from state-contracted suppliers. CDW Government Inc.(ADSPO17-149774 and CTR060021) did not respond to the request. A quote was received from one supplier under CTR046099 - Software Value Added Reseller SHI INTERNATIONAL CORP (iPassport Software by Genial). However, the state-contracted supplier confirmed on November 07, 2023, that they are not RAMP Certified. Procurement confirmed with the Agency’s technology department that RAMP certification is a requirement for this type of service. Media Lab has been a RAMP certified supplier since March 15, 2021. Additionally, the services offered by the state contractor were not comparable. The training component was not provided. MediaLab provides it. The price quoted by MediaLab is fair and reasonable. A quote was received from SHI on March 12, 2023 for iPassport. The annual cost is more than $15,500. iPassport is not customizable, does not provide a training module, and the price quoted was for a limited number of concurrent users (twenty). In contrast, MediaLab's annual cost is less than 50% of iPassport's cost per year, has more than 200 built-in continuing education courses for laboratory professionals as well as modules for creating quality improvement processes and training specific to our laboratory. In addition, the number of concurrent users in MediaLab is not limited. It is equal to the number of user subscriptions. To promote the continuity of the embedded process and provide a RAMP Certified supplier that meets the program's current needs, a determination has been made to request approval for an off-contract purchase through MediaLab. MediaLab does not have a minority business entity approved status. MediaLab is advantageous for the state because it is a cost effective, comprehensive and critical program for maintaining compliance with regulatory and laboratory accreditation requirements Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Clinical Laboratory Improvement Amendments of 1988 (CLIA), U.S. Environmental Protection Agency (EPA), and International Organization for Standardization (ISO).

12/19/2023

As the agency has made a good-faith effort to obtain comparable services via the Statewide contracts, but the current vendor, who is already established and integrated into the agency's processes, does not work with software Resellers, I recommend approval of this Off-Contract request.

Statewide Procurement Manager

1/10/2024

Eric Bell

5 years from contract start

Jessica Klein Deputy SPA

1/11/2024

- Request Authorized Pursuant to to A.A.C. R2-7-A301(B) https://azadoagov.na1.echosign.com/verifier?tx=CBJCHBCAABAAkcu9_I4VMFb3zrEewuloHSwH0mO01-10

1/11/24, 3:36 PM State of Arizona Mail - Fwd: 3rd Request: Off Contract Procurement Authorization for AZ State Public Health Lab https://mail.google.com/mail/u/0/?ik=37e42f68fc&view=pt&search=all&permthid=thread-f:1787727207525489369&simpl=msg-f:1787727207525489369 1/5

Rowan Bittner <rowan.bittner@azdoa.gov>

Fwd: 3rd Request: Off Contract Procurement Authorization for AZ State Public Health Lab 1 message

Eric Bell <eric.bell@azdoa.gov> Wed, Jan 10, 2024 at 10:57 AM To: SPOCompliance - ADOA <SPOCompliance@azdoa.gov> Cc: Monique Harris <monique.harris@azdhs.gov>

Hello SPO Compliance, Please see the attached Off-Contract request.

Respectfully, Eric

---------- Forwarded message --------- From: Eric Bell <eric.bell@azdoa.gov> Date: Wed, Jan 10, 2024 at 10:34 AM Subject: Re: 3rd Request: Off Contract Procurement Authorization for AZ State Public Health Lab To: Monique Harris <monique.harris@azdhs.gov> Cc: Jim Atkins <james.atkins@azdoa.gov>, Michael Hillebrand <michael.hillebrand@azdoa.gov>, Larry Woo <larry.woo@azdoa.gov>, Jessica Klein <jessica.klein@azdoa.gov>, Gina Castner-Corwin <gina.corwin@azdhs.gov>

Thanks Monique. I think all the boxes are now checked. I'll give this my recommendation for approval and send it to SPO Compliance for final approval. (Yes, there's another approval, but usually goes fast).

Respectfully, Eric

On Wed, Jan 10, 2024 at 9:53 AM Monique Harris <monique.harris@azdhs.gov> wrote:

Good Morning Eric, Thank you for getting back to me. I've included my responses to your questions below.

Is Quality Management Platform purely a Cloud Software Application? Yes, this is a cloud software application.

From MediaLab: Yes, we are 100% cloud-based.

Is MediaLab Solutions refusing to sell their solution through a Reseller, such as SHI or CDW? Correct. Media Lab stated in July 2023: “Regretfully, we do not work with 3rd party vendors to sell our products. We prefer to work direct with customers for quoting and contracting which provides the best pricing as well.”

It looks like you may have asked SHI for an alternative solution (was iPassport the solution quoted by SHI?) We have been working with SHI since April 2023 on getting an alternative solution. In the end, SHI was able to get Genial added to their contract. Genial sales iPassport, which is a comparable product to Media Lab. However, per the ADHS technology department, this product must have RAMP certification. Genial confirmed in November 2023 that they had selected the internationally recognized certifications of ISO 9001, IS) 27001, and Cyber Essentials instead of FEDRAMP certification. This is not acceptable per the ADHS technology department. The product must be RAMP certified. In November 2023, the ADHS technology department confirmed that Media Lab is FEDRAMP certified, so they do not need to be AZRAMP certified. The FEDRAMP certification is acceptable.

Please let me know if you have any further questions.

Thank you, Monique Harris, CPPB, MSL Procurement Supervisor Arizona Department of Health Services 150 N. 18th Avenues, Suite 530, Phoenix, AZ 85007 Direct: 480-521-2703 Email: Monique.Harris@azdhs.gov mailto:eric.bell@azdoa.gov mailto:monique.harris@azdhs.gov mailto:james.atkins@azdoa.gov mailto:michael.hillebrand@azdoa.gov mailto:larry.woo@azdoa.gov mailto:jessica.klein@azdoa.gov mailto:gina.corwin@azdhs.gov mailto:monique.harris@azdhs.gov mailto:Monique.Harris@azdhs.gov