Addendum_1_IFB_S22652429-Backup_Optical_Lab_Services.pdf

State of California Department of Corrections and Rehabilitation

November 19, 2024 (Original Release) November 21, 2024 (Revised via Addendum #1)

INVITATION FOR BID (IFB)

IFB No. S22652429

BACK-UP OPTICAL LABORATORY SERVICES

Notice to Prospective Contractors

The California Prison Industry Authority (CALPIA) invites you to review and respond to this Invitation for Bid (IFB), entitled BACK-UP OPTICAL LABORATORY SERVICEs, IFB NO. S22652429. In submitting your bid, you must comply with the instructions found herein and the Bidders Instructions REV-524 located on the CALPIA website (www.calpia.ca.gov, select About tab and then Doing Business with CALPIA).

In the opinion of CALPIA, this IFB is complete and without need of explanation. However, should you have questions, or need clarifying information, please contact the Contract Analyst indicated below.

Due Date/Time: December 17, 2024 by 3:00 PM CALPIA Contact SUBMIT BID TO:

Sadaqatullah Sahak, Contract Analyst Phone: (916) 358-1504

Email: Sadaqatullah.Sahak@calpia.ca.gov

California Prison Industry Authority Attention: Sadaqatullah Sahak, Contract Analyst

560 East Natoma Street Folsom, CA 95630

Please note that no verbal information given will be binding upon the CALPIA unless such information is issued in writing as an official addendum to this IFB.

Term: The CALPIA anticipates that the proposed contract term will be for a period of two (2) years with the option to extend for an additional one (1) year.

The contract award will be made on the basis of BEST VALUE as determined by CALPIA alone, under statutory authority (Penal Code 2808) considering the following criteria:

1. Cost: Fair, reasonable, and competitive price, and customer service commitments for goods and or services.

2. Performance: Past performance, including but not limited to, quality and/or reliability for the product or service as well as efficient billing practices; certification by the International Organization for Standardization (ISO).

3. Experience: Length of time and/or number of instances the bidder has offered or produced the requested type of product and/or service.

http://www.calpia.ca.gov/ mailto:Sadaqatullah.Sahak@calpia.ca.gov

CALPIA may consider other factors deemed necessary to ensure that best value is achieved.

In the interest of achieving best value, CALPIA does not grant Small Business, Disabled Veteran Business Enterprise (DVBE), Target Area Contract Preference Act (TACPA), Local Agency Military Base Recovery Act (LAMBRA), or Enterprise Zone Act (EZA) preferences in evaluating bids.

Employment of ex-offenders by the bidder is encouraged by CALPIA as part of our ongoing mission to change lives through opportunities.

Any agreement resulting from this solicitation shall be of no force or effect until it is signed by both parties and approved by CALPIA. The Contractor is not to begin work until a contract has been made, all approvals have been obtained, and the contract has been fully executed. Should work begin before all approvals are obtained, services shall be considered voluntary.

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

IFB No. S22652429

TABLE OF CONTENTS

SECTION PAGE

A. Purpose and Description of Service 4 B. Bid Information 5 C. Bidder’s Submittal Requirements 5 D. Bidder’s Minimum Qualifications 6 E. Bid Evaluation 7 F. Licenses and Permits 7 E. Bid Attachments 7

Attachment 1: Bid Document Submittal Check List 8 Attachment 2: Sample Standard Agreement (STD 213), Statement of

Work and Payment Provisions 9

Exhibit A:Turnaround Requirements 18 Exhibit B: HIPPA Business Associate Addendum 19 Attachment 3: Cost Sheet 34 Attachment 4A: Payee Data Record (STD 204) 42 Attachment 4B: Payee Data Record Supplement (STD 205) 44 Attachment 5: Darfur Certification 46 Attachment 6: Experience/Past Performance (References) 47 Attachment 7: Contractor Certification Clauses (CCC’s) 48 Attachment 8: PREA Volunteer/Contractor Information Sheet 52 Attachment 9: California Civil Rights Laws Certification 55 Attachment 10: Appropriate Attire Policy 56 Attachment 11: Economic Sanctions Certification 58 Attachment 12: GenAI Reporting & Factsheet Form (STD 1000) 59

Bid Submittal Documents:

Attachment 1: Bid Document Submittal Check List 1 page Attachment 3: Cost Sheet 8 pages Attachment 4A: Payee Data Record (STD 204) 2 pages Attachment 4B: Payee Data Record Supplement (STD 205) 2 pages Attachment 5: Darfur Certification 1 page Attachment 6: Experience/Past Performance (References) 1 page Attachment 7: Contractor Certification Clauses (CCC’s) 4 pages Attachment 8: PREA Volunteer/Contractor Information Sheet 3 pages Attachment 9: California Civil Rights Laws Certification 1 page Attachment 11: Economic Sanctions Certification 1 page

Attachment 12: GenAI Reporting & Factsheet Form (STD 1000) 4 pages Bidder Instructions and Contract Provisions:

Bidders Instructions REV-524* 10 pages General Provisions REV-0524* 21 pages Security Provisions REV-224* 5 pages

NOTE: Items shown with an Asterisk (*), are hereby incorporated by reference and are located on our website at the following link http://www.calpia.ca.gov select About tab, then select Doing Business with CALPIA.

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

IFB No. S22652429

A. Purpose and Description of Service

The California Prison Industry Authority (CALPIA) requires back-up optical laboratories during times when CALPIA cannot meet production demands for various reasons to include but not limited to; institutional lockdowns, machinery equipment failures, power outages, health and safety work stoppages or workforce related issues.

Lenses shall be fabricated in and provided in accordance with the specifications established by the American National Standard Institute ANSIZ80.1 and Z87.1 or latest edition. All products shall comply with any Federal or State requirements that apply regardless of whether or not specifically stated.

All lenses shall be in accordance with Food and Drug Administration (FDA) Regulation (21 CFR, Parts 3 and 4 for impact resistance.

CALPIA currently manufactures eyewear for enrollees of the State of California’s Medi-Cal program through the Department of Healthcare Services of California. CALPIA projects an annual demand of approximately 1.2 to 1.5 million eyewear orders. Approximately 35% of orders will primarily be polycarbonate single vision lenses. The remaining 65% will be CR-39 flat top 28-millimeter bifocals and single vision lenses.

Eyewear orders placed will utilize either format of completed eyewear (edged and mounted) OR uncut lenses at the discretion of ordering optical facility. The CALPIA will provide frames when ordering complete eyewear orders.

CALPIA anticipates that the proposed contract term will be for a one (1) year two (2) year period and reserves the right to award multiple contracts from this IFB.

The contractor shall allow CALPIA, Department of Health Care Services (DHCS) and the Department of Health and Human Services, the General Accounting Office of the United States, other authorized State agencies, or their duly authorized representatives to inspect or otherwise evaluate the quality, appropriateness, timeliness, and services performed under any contract that may result from this solicitation; and to inspect, evaluate and audit any and all books or records for CALPIA’s clients and facilities maintained by contractor pertaining to such services with appropriate notice at any time during normal business hours.

Refer to the Sample STD 213, Statement of Work and Payment Provisions, attached to this IFB as Attachment 2.

CALPIA reserves the right, before the conclusion of the contract term to extend the contract for an additional one-year period. A written and approved amendment will be required to extend the contract prior to contract expiration.

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

B. Bid Information

1. Time Schedule

It is recognized that time is of the essence. All bidders are hereby advised of the following schedule and will be expected to adhere to the required dates and times. All times are Pacific Standard Time (PST)/Pacific Daylight Time (PDT).

*estimated timeframes

2. Bid Submittal

Bids must be received via U.S. Mail, common carrier, or hand delivered; no other method of response will be accepted. Bids not submitted under sealed cover may be rejected. Submit one (1) copy of the bid to the address and Contract Analyst on page 1 of this document. The interior sealed envelope must be plainly marked with the IFB number and title, must show your firm name and address, and must be marked with “DO NOT OPEN”, as shown in the following example:

C. Bidder’s Submittal Requirements

Experience: Contractor must provide proof of Three (3) years of experience with services similar in nature to the services identified in the attached Scope of Work. Experience will be determined by documentation submitted by the Contractor and further information provided by the references submitted under the Past Performance requirement below. Experience is defined as the kind and amount of work a Contractor has done relevant to the work contemplated by this procurement.

Past Performance: Contractor will be evaluated on prior performance through Contractor’s references (Attachment 6), on three (3) projects similar in nature within the last three (3) years.

Past performance is defined as the Contractor’s record of conforming to standards of good workmanship; Contractor’s record of forecasting and controlling costs; Contractor’s adherence to contract schedules, including the administrative aspects of performance; Contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction; and the Contractor’s business-like concern for the interest of the customer.

EVENT DATE

TIME

(Pacific STD /Daylight Time)

IFB available to prospective bidders November 19, 2024 Final Date for Bid Submission/Bid Opening 12/17/2024 By 3:00 PM Successful Bidder Letter and Posting of Intent to Award* 12/18/2024 5:00 PM Last Day to Appeal Intent to Award* 12/25/2024 5:00 PM Proposed Start Date of Agreement* January 15, 2025

Company Name Company Address

IFB Number: S22652429 IFB Name: Back-up Optical Laboratory Services Attention: Sadaqatullah Sahak

BID SUBMITTAL – DO NOT OPEN

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

Licenses/Permits: The Contractor shall provide copies of all required license(s) and permit(s) as required by the city, county, or both as determined by bidder’s place of business.

Executive Order N-6-22 – Russia Sanctions: CALPIA requires Bidders to include a completed Economic Sanctions Certification form (BSS-F069) as required by Executive Order N-6-22 in order to be eligible to conduct business with the State of California.

Executive Order N-12-23 – Generative Artificial Intelligence (GenAI):

The State of California seeks to realize the potential benefits of GenAI, through the development and deployment of GenAI tools, while balancing the risks of these new technologies.

Bidder / Offeror / Contractor must notify the State in writing if their solution or service includes, or makes available, any GenAI, including GenAI from third parties or subcontractors.

The State has developed a GenAI Reporting and Factsheet (STD 1000) to be completed by the Bidder / Offeror / Contractor .

Failure to submit the GenAI Reporting and Factsheet (STD 1000) will result in disqualification of the Bidder / Offeror / Contractor.

Failure to report GenAI to the State may void any resulting contract. The State reserves its right to seek any and all relief it may be entitled to as a result of such non-disclosure.

Upon receipt of a Bidder / Offeror / Contractor GenAI Reporting and Factsheet (STD 1000), the state reserves the right to incorporate GenAI Special Provisions into the final contract or reject bids/offers that present an unacceptable level of risk to the state.

The State of California seeks to realize the potential benefits of GenAI, through the development and deployment of GenAI tools, while balancing the risks of these new technologies. Bidders/Offerors must notify the State in writing if their solution or service includes, or makes available, any GenAI technology, including GenAI from third parties or subcontractors.

D. Bidder’s Minimum Qualifications

1. Bidder’s must quote and be able to provide all the necessary services. No substitutions will be allowed.

2. Bidder must have a current Medical Device Manufacturing License from the California Department of Public Health, Food and Drug Branch during the term of this contract.

Contractor services will not be requested during the application process of this license.

FOR CALIFORNIA BUSINESSES ONLY.

3. Bidder must be able to complete and ship all orders according to CALPIA’s instructions within three (3) working days after receipt of orders from CALPIA with the exception of high-powered lenses. (See Exhibit A Turnaround Requirements)

IFB No. S22652429 California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

4. Bidder must be able to complete and ship all orders according to CALPIA’s instructions within three (3) working days after receipt of orders from CALPIA with the exception of high-powered lenses. (See Exhibit A Turnaround Requirements)

5. Bidder must maintain a written assurance plan and procedures ensuring that ANSI requirements are met for the first quality ophthalmic lenses as well as existing FDA impact resistance regulations.

E. Bid Evaluation

Award of a contract resulting from this IFB will be based on the contractor providing the best value. The Contractor must meet or exceed the minimum requirements of the following criteria:

Category – Description Cost Past Performance Experience

F. Licenses and Permits

During the term of the contract, the Contractor must maintain all required licenses and/or permits in full force and effect. If and when the State learns that the Contractor has failed to do so, the State may, in addition to any other remedy it may have, immediately terminate this contract without any cost or liability to the State. If, after bid submission, the Contractor replaces or renews a required license or permit or obtains a newly-applicable license or permit, the Contractor shall provide the State with a copy of the renewed or replaced or newly-obtained license or permit within 20 days following the Contractor's receipt of same.

G. Standard Language

CALPIA does not accept alternate contract language from a prospective contractor. A bid with such language will be considered a counter proposal and will be rejected. CALPIA’s General Provisions (GP’s) are not negotiable.

H. Bid Attachments

Refer to the following pages for additional required attachments that are a part of this IFB.

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

ATTACHMENT 1

BID DOCUMENT SUBMITTAL CHECK LIST

A complete bid or bid package will consist of the items identified below.

Complete this checklist to confirm the items listed below have been included in your bid. Place a check mark or “X” next to each item that you are submitting. For your bid to be responsive, all required attachments must be returned. This checklist should be returned with your bid package.

NAME OF BIDDER:

COMPANY NAME:

Attachment Name/Description

_____ Attachment 1: Bid Document Submittal Check List _____ Attachment 3: Cost Sheet

_____ Attachment 4A: Payee Data Record (STD 204) NOTE: If company is incorporated, Payee’s Legal business name on the STD 204 must match the name registered with the Secretary of State of California.

_____ Attachment 4B: Payee Data Record Supplement (STD 205) NOTE: For use if additional remittance addresses are needed or if additional authorized representatives need to be identified.

_____ Attachment 5: Darfur Certification _____ Attachment 6: Experience/Past Performance (References) _____ Attachment 7: Contractor’s Certification Clauses _____ Attachment 8: PREA Volunteer/Contractor Information Sheet _____ Attachment 10: California Civil Rights Laws Certification _____ Attachment 11: Economic Sanctions Certification _____ Attachment 12: GenAI Reporting & Factsheet Form (STD 1000) _____ Medical Device Manufacturing License form the California Department of Public

Health (CDPH), Food and Drug Branch (FOR CALIFORNIA BUSINESSES ONLY)

_____ Copy of Business License(s) and/or permit(s) as required by the state, city, and/or county (Outlined on Page 6 in Section C)

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

STATE OF CALIFORNIA

STANDARD AGREEMENT

STD 213 (Rev 6/21/06)

AGREEMENT NUMBER

IFB No. S22652429

REGISTRATION NUMBER

BACK-UP OPTICAL LABORATORY SERVICES

1. This Agreement is entered into between the State Agency and the Contractor named below:

STATE AGENCY'S NAME

CALIFORNIA PRISON INDUSTRY AUTHORITY

CONTRACTOR'S NAME

TBD

2. The term of this

Month, Day, 2025 or upon approval, whichever is the later, through Month, Day, 2027 Agreement is:

3. The maximum amount $0.00 of this Agreement is: Dollars and No Cents

4. The parties agree to comply with the terms and conditions of the following exhibits that by this reference made a part of the Agreement.

Attachment 2 - Scope of Work and Payment Provisions 8 pages

Attachment 3 - Cost Sheet 8 pages

Exhibit A – Turnaround Requirements 1 page

Exhibit B – HIPAA Business Associate Addendum 15 pages

General Provisions REV-0524* 21 pages

Security Provisions REV-224* 5 pages NOTE: Items shown with an Asterisk (*), are hereby incorporated by reference and made part of this agreement as if attached

These documents can be viewed at http://www.calpia.ca.gov, (select About tab, then select Doing Business with CALPIA).

IN WITNESS WHEREOF, this Agreement has been executed by the parties hereto.

CONTRACTOR

CONTRACTOR’S NAME (if other than an individual, state whether a corporation, partnership, etc.)

BY (Authorized Signature)

DATE SIGNED(Do not type)

PRINTED NAME AND TITLE OF PERSON SIGNING

ADDRESS

STATE OF CALIFORNIA

AGENCY NAME

California Prison Industry Authority BY (Authorized Signature)

DATE SIGNED(Do not type)

PRINTED NAME AND TITLE OF PERSON SIGNING

ADDRESS

560 East Natoma Street, Folsom, CA 95630

ATTACHMENT 2

SCOPE OF WORK AND PAYMENT PROVISIONS

I. SCOPE OF WORK

1. Multi-Provider Contract: Contractor agrees to provide the California Prison Industry Authority (CALPIA) with back-up optical laboratory services as described herein.

A. Items will be ordered with the following methods: remote transfer process through Digital Vision Inc. (DVI) lab software program from DVI lab to DVI lab, or in conjunction with 3rd party applications such as VisionWeb, sent with frame and printed Rx orders by courier or facsimile at the discretion of the CALPIA. Contractor agrees to pay costs incurred for 3rd party applications.

B. Eyewear orders placed will utilize either format of completed eyewear (edged and mounted) OR uncut lenses at the discretion of the ordering optical facility. The CALPIA will provide frames when ordering complete eyewear orders.

C. Lenses shall be fabricated in and provided in accordance with the specifications established by the American National Standard Institute (ANSI) Z80.1 or Z87.1 or latest edition.

D. All products shall comply with any Federal or State requirements that apply regardless of whether or not specifically stated.

E. All lenses shall be in accordance with Food and Drug Administration (FDA) Regulation (21 CFR, Parts 3 and 4 for impact resistance).

2. Services will only be provided when the CALPIA cannot meet its production demand. CALPIA projects an annual demand of approximately 1.2 to 1.5 million orders. Approximately 35% of orders will primarily be polycarbonate single vision lenses. The remaining 65% will be CR-39 flat top 28-millimeter bifocals and single vision lenses. Back-up services include fabrication of prescription (Rx) ophthalmic and safety lenses for either of the Optical Laboratories located at:

A. California State Prison Solano (CSP-SOL) 2100 Peabody Road Vacaville, CA 95687-6615

B. Central California Women’s Facility (CCWF) 23370 Road 22 Chowchilla, CA 93610-4329

C. Valley State Prison (VSP) 23370 Road 22 Chowchilla, CA 93610-9650

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

3. Service shall be available not later than the express date set by CALPIA and the Contractor, after all approvals have been obtained, the agreement is fully executed, and an ERPLX Tracking Number is issued. Should the Contractor fail to commence work at the agreed upon time, the CALPIA, upon five (5) days’ written notice to the Contractor, reserves the right to terminate the agreement effective immediately. In addition, the Contractor shall be liable to the CALPIA for the difference between Contractor's bid price and the actual cost of performing work by another best value contractor.

4. The Project Representatives during the term of this agreement will be:

State Agency: CALPIA Contractor:

Section/Unit: Section/Unit:

Attention: Attention:

Address: Address:

Phone: Phone:

Email: Email:

Note: No formal amendment of this agreement is needed to change the contact information. Changes will be made by written or electronic notification.

5. Contractor shall furnish to the CALPIA a certificate of insurance, stating that there is Commercial General Liability, Worker’s Compensation, and Automotive Liability. The certificate of insurance shall include the following three (3) provisions in their entirety:

A. The insurer will not cancel the insured’s coverage without 30 days prior written notice to the State and will provide the State with a written 10-day notice for Contractor’s non-payment of premiums.

B. Under Contractor’s General Liability and Automobile Liability insurance CALPIA and the State of California, its officers, agents, employees, and servants are included as additional insured, but only insofar as the operations under this contract are concerned.

C. The State will not be responsible for any premiums or assessment of the policy.

6. Contractor agrees to provide, at the request of the CALPIA, the following optical back-up laboratory services on an as-needed basis:

A. Plastic and polycarbonate in clear and photochromatic lenses, high-power prescriptions, prism, slab off, myodisc, aspheric lenticular, hyper aspheric, Fresnell type press on prism, tints, coatings, and high add powers.

i. Contractor must be able to provide all the necessary items. No substitutions will be allowed.

B. On occasions the CALPIA will have a need for additional lens styles, materials, and options not covered on the cost sheet or cost sheet extras. Examples shall include, but not limited to combinations of progressive lenses, high index, polarization, special tints, and special coatings with a standard discount off the catalog price.

C. Daily capacity during current Covid-19 operations and capacity projections post Covid-19 as listed on Attachment 3-Cost Sheet.

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

i. Failure to meet the production standards will be considered breach of contract and subject to the General Provisions, Item 11.

D. Product shall be completed and shipped within three (3) working days after receipt of orders from the CALPIA except for high powered or specialty lenses (see Exhibit A- Turn Around Requirements).

E. The use of a protective wrapping material (i.e., bubble or foam wrap) is required.

i. Using a copy of the Rx form is an unacceptable protective wrapping material.

ii. Orders will be sent back and returned with original printed Rx form provided.

7. Contractor will notify originating CALPIA lab by telephone within 24 hours of receipt of order when the Contractor is unable to meet required production.

8. Contractor shall complete all orders according to the CALPIA’s instructions.

9. Any rework shall be given priority status over regular production and shipped to the CALPIA lab via courier service within 48 hours.

A. Contractor shall correct, adjust, or replace any defective work at no cost to the CALPIA within the turnaround times specified in Exhibit A- Turn Around Requirements.

B. Defects or errors shall include, but are not limited to, lenses which are broken, scratched, or which deviate from the CALPIA prescriptions at the time of receipt by the CALPIA or its customers.

C. Contractor shall replace new frames that are broken in the manufacturing process with expedited ordering from various vendors of no more than 2-day delivery option and shall incur all costs associated with replacement. Contractor shall not receive any Patients own Frames.

i. Contractor shall notify via email to the originating lab of the delay and provide an estimated time of completion when frames are broken. Contractor shall not contact providers directly.

a. SOL Optical Helpdesk: solopticalhelpdesk@calpia.ca.gov

b. CCWF Optical Helpdesk: ccwfopticalhelpdesk@calpia.ca.gov

c. VSP Optical Helpdesk: vspopticalhelpdesk@calpia.ca.gov

D. Contractor will be paid for rework resulting from doctor error or request for change.

10. Contractor’s must have a current Medical Device Manufacturing License from the California Department of Public Health, Food and Drug Branch during the term of this contract. For businesses in California only.

California Prison Industry Authority (CALPIA) Back-up Optical Laboratory Services

IFB No. S22652429 mailto:solopticalhelpdesk@calpia.ca.gov mailto:ccwfopticalhelpdesk@calpia.ca.gov mailto:vspopticalhelpdesk@calpia.ca.gov

11. Contractor must maintain a written assurance plan and procedures ensuring that ANSI requirements are met for the first quality ophthalmic lenses as well as existing FDA impact resistance regulations.

12. Notwithstanding any other provision of this Agreement, the Contractor shall protect from unauthorized disclosure names and other identifying information concerning persons receiving services under this Agreement, in accordance with Code of Federal Regulations, Title 42, Volume 3, Part 431, Subpart F and California Code, Welfare and Institutions Code

14100.2. adopted there under. For the purposes of this paragraph, identifying information shall include, but not be limited to, name, identifying number, symbol, or other identifying particulars assigned to the individual, such as finger or voice print or a photograph.

A. The Contractor shall not use such identifying information for any purpose other than carrying out contractor’s obligation under this Agreement.

B. The Contractor shall promptly transmit to the CALPIA all requests for identifying information.

C. The Contractor shall safeguard all confidential beneficiary information from unauthorized use. The Contractor must submit to the CALPIA its Policies and Procedures regarding the safeguarding of confidential beneficiary information by employees and subcontractors.

D. The Contractor shall not disclose any identifying confidential beneficiary information to anyone without prior authorization from Department of Health Care Services (DHCS).

E. This Contract has been determined to constitute a business associate relationship under the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act, Public Law 111-005 ('the HITECH Act"), 42 U.S.C. section 17921 et seq., and their implementing privacy and security regulations at 45 CFR Parts 160 and 164 (“the HIPAA regulations”).

F. The Contractor shall agree to ensure that each employee, who has access to confidential beneficiary information, has signed an agreement to maintain the confidentiality of such information and to not use information for any purpose other than to provide services under this Agreement. The Contractor shall retain the signed confidentiality agreements on file for a minimum of three years following the termination of employment of contract of each employee.

13. The Contractor shall maintain books and records in accordance with the general standard applicable to such record keeping.

14. The Contractor shall make all its facilities, books, and records pertaining to the goods and services furnished under the terms of the Agreement available for inspection, examination, or copying by the CALPIA, DHCS, U.S. Government Department of Health and Human Services, the General Accounting Offices of the United States, and other authorized State agencies, or their duly authorized representatives.

California Prison Industry Authority (CALPIA)

A. The books and records shall be available at all reasonable times at the Contractor’s place of business or at such other mutually agreed upon location in California for evaluation of the quality, appropriateness, and timeliness of services performed under any Agreement.

B. For a minimum period of six years from the date service was rendered DHCS shall instruct the Contractors to retain records beyond the six-year period when the retention is necessary for a pending civil or criminal action.

15. Executive Order N-6-22 – Russia Sanctions

On March 4, 2022, Governor Gavin Newsom issued Executive Order N-6-22 (the EO) regarding Economic Sanctions against Russia and Russian entities and individuals.

“Economic Sanctions” refers to sanctions imposed by the U.S. government in response to Russia’s actions in Ukraine, as well as any sanctions imposed under state law. The EO directs state agencies to terminate contracts with, and to refrain from entering into any new contracts with, individuals or entities that are determined to be a target of Economic Sanctions. Accordingly, should the State determine Contractor is a target of Economic Sanctions or is conducting prohibited transactions with sanctioned individuals or entities, that shall be grounds for termination of this agreement. The State shall provide Contractor advance written notice of such termination, allowing Contractor at least 30 calendar days to provide a written response. Termination shall be at the sole discretion of the State.

16. Executive Order N-12-23 – Generative Artificial Intelligence (GenAI)

GenAI Technology Use & Reporting

During the term of the contract, Contractor must notify the State in writing if their services or any work under this contract includes, or makes available, any previously unreported GenAI technology, including GenAI from third parties or subcontractors. Contractor shall immediately complete the GenAI Reporting and Factsheet (STD 1000) to notify the State of any new or previously unreported GenAI technology. At the direction of the State, Contractor shall discontinue the use of any new or previously undisclosed GenAI technology that materially impacts functionality, risk or contract performance, until use of such GenAI technology has been approved by the State.

Failure to disclose GenAI use to the State and submit the GenAI Reporting and Factsheet (STD 1000) may be considered a breach of the contract by the State at its sole discretion and the State may consider such failure to disclose GenAI and/or failure to submit the GenAI Reporting and Factsheet (STD 1000) as grounds for the immediate termination of the contract. The State is entitled to seek any and all relief it may be entitled to as a result of such non-disclosure.

The State reserves the right to amend the contract, without additional cost, to incorporate GenAI Special Provisions into the contract at its sole discretion and/or terminate any contract that presents an unacceptable level of risk to the State.

17. CALPIA reserves the right to amend the agreement, prior to expiration, in writing on the STD 213A. CALPIA may adjust the terms of the agreement including but not limited to the following:

California Prison Industry Authority (CALPIA)

A. Term extension up to one (1) year.

B. Decreasing the amount of the contract’s original value.

C. Increasing the contract amount by up to 30% of the original value.

II. PAYMENT PROVISIONS

1. Invoicing and Payment

A. For services satisfactorily rendered, and upon receipt and approval of the invoices, the CALPIA agrees to compensate the Contractor in accordance with the amount specified in the Cost Sheet , Attachment 3, which is attached hereto and made part of this agreement.

B. Accurate/correct invoice packages must be submitted for review and payment in a timely manner subject to the following:

i. All invoices, including revised/amended/corrected invoices, must be received by CALPIA within 60 days from the date services were rendered.

ii. Invoices received by CALPIA more than 60 days after the date services were rendered will be denied, deemed a forfeiture of payment by Contractor, and no payment will be issued.

a. It is Contractor’s responsibility to ensure invoices are received by CALPIA by the deadline. No exceptions will be allowed for invoice packages lost in transit unless supported by documentation that it should have arrived timely (i.e., proof of overnight delivery).

b. If a revision/amendment/correction of a timely submitted invoice is requested by CALPIA, payment will not be forfeited if the requested invoice is received more than 60 days after the date services were rendered.

iii. All invoices received shall be deemed accurate/correct unless Contractor provides

CALPIA written notice of any error(s) within 60 days from the date services were rendered. Written notice must include a written explanation of the change, a revised/amended/corrected invoice, and supporting documentation.

iv. Invoices received by CALPIA on the 60th day from the date services were rendered cannot be revised/amended/corrected by Contractor except at the request of CALPIA.

C. Contractors unable to provide accurate/correct invoice packages in a timely manner may receive a vendor performance report for failure to meet contract needs. Patterns related to failed vendor performance may result in termination of contract at any time.

D. Contractor is to provide a monthly report showing billed, paid, and outstanding invoices.

i. With respect to this agreement, follow Section E below in lieu of the monthly report.

E. The following must be provided:

i. A summarized statement which is a monthly consolidation of invoices that must include the charges from the individual invoices for the service period with the service period clearly noted E.g. (9/1/24 to 9/30/24), and be grouped by category with a grand total; and

ii. A statement listing all the individual invoices from that billing month with a grand total;

and

iii. A file containing each individual invoice from that billing month. File can be electronic, a link for CALPIA to download invoices or a zip file is acceptable.

iv. All documents listed above in section E, shall have all taxes listed and total separately from actual manufacturing cost.

F. Contact Project Representative, or designee for details. Invoices shall include the ERPlx Number, and the Agreement Number shown in the upper right corner of the STD 213 and shall be submitted not more frequently than once every 30 days in arrears to the CALPIA optical labs as follows:

CALPIA CALPIA

Attn: Optical Lab Superintendent Attn: Optical Lab Superintendent Central California Women’s Facility California State Prison-Solano

PO BOX 1501 PO BOX 4000

Chowchilla, CA 93610-1501 Vacaville, CA 95696-4000

CALPIA

Attn: Optical Lab Superintendent Valley State Prison

PO BOX 1501

Chowchilla, CA 93610-1501

2. Availability of Funds

All financial obligations of CALPIA for the fiscal year(s) encompassed by the term of this agreement are subject to the availability and approval of funding by the Prison Industry Board and/or the presence of sufficient funds to cover those obligations in the fund from which those obligations are to be paid. If such obligations are, or become contingent, on funding by and/or through the CALPIA budget or on the availability of federal funds or on the action of any Legislative body, said obligations are contingent on the appropriation and availability of funds for the purpose of meeting those obligations. If insufficient funds are approved or appropriated or otherwise available in order to meet CALPIA’s obligations under this agreement, CALPIA may immediately terminate this agreement.

3. Prompt Payment Clause

Payment will be made in accordance with, and within the time specified in, Government Code Chapter 4.5, commencing with Section 927. Unless expressly exempted by statute, the Act requires State agencies to pay properly submitted, undisputed invoices not more than 45 days after (a) the date of acceptance of goods or performance of services or (b) receipt of an undisputed invoice, whichever is later.

4. Cash Discounts

CALPIA has a history of taking cash discounts and intends to take advantage of cash discounts offered when they are in the best interest of the CALPIA.

EXHIBIT A

TURN AROUND REQUIREMENTS

3 Day (Turnaround) 7 Day (Turnaround)

Single Vision Single Vision

Plano to +/-8.00 Diopters Sphere Plano to +/- 4.00 Diopters Cylinder

> 8.12 Diopters Sphere or > 4.12 Diopters Cylinder

Bifocal Bifocal

Trifocal

Trifocal

Miscellaneous Lens items:

Myodisc

Slab-off Fresnel Type Press on Prism Multi-focal adds 4.25 Diopters or higher Aspheric Lenticular Anti-Reflective Coating

Exhibit B

HIPAA Business Associate Addendum

Contractor Initial ______ DHCS HIPAA BAA 2/15r

I. Recitals

A. This Contract (Agreement) has been determined to constitute a business associate relationship under the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act, Public Law 111-005 ('the HITECH Act"), 42 U.S.C. section 17921 et seq., and their implementing privacy and security regulations at 45 CFR Parts 160 and 164 (“the HIPAA regulations”).

B. The Department of Health Care Services (“DHCS”) wishes to disclose to Business Associate certain information pursuant to the terms of this Agreement, some of which may constitute Protected Health Information (“PHI”), including protected health information in electronic media (“ePHI”), under federal law, and personal information ("PI") under state law.

C. As set forth in this Agreement, Contractor, here and after, is the Business Associate of DHCS acting on DHCS' behalf and provides services, arranges, performs or assists in the performance of functions or activities on behalf of DHCS and creates, receives, maintains, transmits, uses or discloses PHI and PI.

DHCS and Business Associate are each a party to this Agreement and are collectively referred to as the "parties.”

D. The purpose of this Addendum is to protect the privacy and security of the PHI and PI that may be created, received, maintained, transmitted, used or disclosed pursuant to this Agreement, and to comply with certain standards and requirements of HIPAA, the HITECH Act and the HIPAA regulations, including, but not limited to, the requirement that DHCS must enter into a contract containing specific requirements with Contractor prior to the disclosure of PHI to Contractor, as set forth in 45 CFR Parts 160 and 164 and the HITECH Act, and the Final Omnibus Rule as well as the Alcohol and Drug Abuse patient records confidentiality law 42 CFR Part 2, and any other applicable state or federal law or regulation. 42 CFR section 2.1(b)(2)(B) allows for the disclosure of such records to qualified personnel for the purpose of conducting management or financial audits, or program evaluation. 42 CFR Section 2.53(d) provides that patient identifying information disclosed under this section may be disclosed only back to the program from which it was obtained and used only to carry out an audit or evaluation purpose or to investigate or prosecute criminal or other activities, as authorized by an appropriate court order.

E. The terms used in this Addendum, but not otherwise defined, shall have the same meanings as those terms have in the HIPAA regulations. Any reference to statutory or regulatory language shall be to such language as in effect or as amended.

II. Definitions

A. Breach shall have the meaning given to such term under HIPAA, the HITECH Act, the HIPAA regulations, and the Final Omnibus Rule.

B. Business Associate shall have the meaning given to such term under HIPAA, the HITECH Act, the HIPAA regulations, and the final Omnibus Rule.

C. Covered Entity shall have the meaning given to such term under HIPAA, the HITECH Act, the HIPAA regulations, and Final Omnibus Rule.

D. Electronic Health Record shall have the meaning given to such term in the HITECH Act, including, but not limited to, 42 U.S.C Section 17921 and implementing regulations.

California Prison Industry Authority (CALPIA)

HIPAA Business Associate Addendum

Contractor Initial ______ DHCS HIPAA BAA 2/15r

E. Electronic Protected Health Information (ePHI) means individually identifiable health information transmitted by electronic media or maintained in electronic media, including but not limited to electronic media as set forth under 45 CFR section 160.103.

F. Individually Identifiable Health Information means health information, including demographic information collected from an individual, that is created or received by a health care provider, health plan, employer or health care clearinghouse, and relates to the past, present or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, that identifies the individual or where there is a reasonable basis to believe the information can be used to identify the individual, as set forth under 45 CFR section 160.103.

G. Privacy Rule shall mean the HIPAA Regulation that is found at 45 CFR Parts 160 and 164.

H. Personal Information shall have the meaning given to such term in California Civil Code section 1798.29.

I. Protected Health Information means individually identifiable health information that is transmitted by electronic media, maintained in electronic media, or is transmitted or maintained in any other form or medium, as set forth under 45 CFR section 160.103.

J. Required by law, as set forth under 45 CFR section 164.103, means a mandate contained in law that compels an entity to make a use or disclosure of PHI that is enforceable in a court of law. This includes, but is not limited to, court orders and court-ordered warrants, subpoenas or summons issued by a court, grand jury, a governmental or tribal inspector general, or an administrative body authorized to require the production of information, and a civil or an authorized investigative demand. It also includes Medicare conditions of participation with respect to health care providers participating in the program, and statutes or regulations that require the production of information, including statutes or regulations that require such information if payment is sought under a government program providing public benefits.

K. Secretary means the Secretary of the U.S. Department of Health and Human Services ("HHS") or the Secretary's designee.

L. Security Incident means the attempted or successful unauthorized access, use, disclosure, modification, or destruction of PHI or PI, or confidential data that is essential to the ongoing operation of the Business Associate’s organization and intended for internal use; or interference with system operations in an information system.

M. Security Rule shall mean the HIPAA regulation that is found at 45 CFR Parts 160 and 164.

N. Unsecured PHI shall have the meaning given to such term under the HITECH Act, 42 U.S.C. section 17932(h), any guidance issued pursuant to such Act, and the HIPAA regulations.

III. Terms of Agreement

A. Permitted Uses and Disclosures of PHI by Business Associate

Permitted Uses and Disclosures. Except as otherwise indicated in this Addendum, Business Associate may use or disclose PHI only to perform functions, activities or services specified in this Agreement, for, or on behalf of DHCS, provided that such use or disclosure would not violate the HIPAA regulations, if done by DHCS. Any such use or disclosure must, to the extent practicable, be limited to the limited data set, as defined in 45 CFR section 164.514(e)(2), or, if needed, to the minimum necessary to accomplish

California Prison Industry Authority (CALPIA)

HIPAA Business Associate Addendum

Contractor Initial ______ DHCS HIPAA BAA 2/15r the intended purpose of such use or disclosure, in compliance with the HITECH Act and any guidance issued pursuant to such Act, the HIPAA regulations, the Final Omnibus Rule and 42 CFR Part 2.

1. Specific Use and Disclosure Provisions. Except as otherwise indicated in this Addendum, Business Associate may:

a. Use and disclose for management and administration. Use and disclose PHI for the proper management and administration of the Business Associate provided that such disclosures are required by law, or the Business Associate obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and will be used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware that the confidentiality of the information has been breached.

b. Provision of Data Aggregation Services. Use PHI to provide data aggregation services to DHCS. Data aggregation means the combining of PHI created or received by the Business Associate on behalf of DHCS with PHI received by the Business Associate in its capacity as the Business Associate of another covered entity, to permit data analyses that relate to the health care operations of DHCS.

B. Prohibited Uses and Disclosures

1. Business Associate shall not disclose PHI about an individual to a health plan for payment or health care operations purposes if the PHI pertains solely to a health care item or service for which the health care provider involved has been paid out of pocket in full and the individual requests such restriction, in accordance with 42 U.S.C. section 17935(a) and 45 CFR section 164.522(a).

2. Business Associate shall not directly or indirectly receive remuneration in exchange for PHI, except with the prior written consent of DHCS and as permitted by 42 U.S.C. section 17935(d)(2).

C. Responsibilities of Business Associate

Business Associate agrees:

1. Nondisclosure. Not to use or disclose Protected Health Information (PHI) other than as permitted or required by this Agreement or as required by law.

2. Safeguards. To implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the PHI, including electronic PHI, that it creates, receives, maintains, uses or transmits on behalf of DHCS, in compliance with 45 CFR sections 164.308, 164.310 and 164.312, and to prevent use or disclosure of PHI other than as provided for by this Agreement. Business Associate shall implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications and other requirements of 45 CFR section 164, subpart C, in compliance with 45 CFR section 164.316.

Business Associate shall develop and maintain a written information privacy and security program that includes administrative, technical and physical safeguards appropriate to the size and complexity of the Business Associate’s operations and the nature and scope of its activities, and which incorporates the requirements of section 3, Security, below. Business Associate will provide DHCS with its current and updated policies.

California Prison Industry Authority (CALPIA)

HIPAA Business Associate Addendum

Contractor Initial ______ DHCS HIPAA BAA 2/15r

3. Security. To take any and all steps necessary to ensure the continuous security of all computerized data systems containing PHI and/or PI, and to protect paper documents containing PHI and/or PI.

These steps shall include, at a minimum:

a. Complying with all of the data system security precautions listed in Attachment A, the Business Associate Data Security Requirements;

b. Achieving and maintaining compliance with the HIPAA Security Rule (45 CFR Parts 160 and 164), as necessary in conducting operations on behalf of DHCS under this Agreement;

c. Providing a level and scope of security that is at least comparable to the level and scope of security established by the Office of Management and Budget in OMB Circular No. A-130, Appendix III – Security of Federal Automated Information Systems, which sets forth guidelines for automated information systems in Federal agencies; and

d. In case of a conflict between any of the security standards contained in any of these enumerated sources of security standards, the most stringent shall apply. The most stringent means that safeguard which provides the highest level of protection to PHI from unauthorized disclosure.

Further, Business Associate must comply with changes to these standards that occur after the effective date of this Agreement.

Business Associate shall designate a Security Officer to oversee its data security program who shall be responsible for carrying out the requirements of this section and for communicating on security matters with DHCS.

D. Mitigation of Harmful Effects. To mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of PHI by Business Associate or its subcontractors in violation of the requirements of this Addendum.

E. Business Associate’s Agents and Subcontractors.

1. To enter into written agreements with any agents, including subcontractors and vendors, to whom Business Associate provides PHI or PI received from or created or received by Business Associate on behalf of DHCS, that impose the same restrictions and conditions on such agents, subcontractors and vendors that apply to Business Associate with respect to such PHI and PI under this Addendum, and that comply with all applicable provisions of HIPAA, the HITECH Act the HIPAA regulations, and the Final Omnibus…