ESBD_File_328856_RFP 515-23-0003 Laboratory Services.doc

RFP 515-23-0003 Laboratory Services

STATE OF TEXAS

TEXAS STATE BOARD OF PHARMACY

REQUEST FOR PROPOSAL NO. 515-23-0003

LABORATORY SERVICES

Reference: RFP 515-23-0003

CLASS: 962 ITEM: 22

Posting Date: 07/12/2023

RESPONSE DEADLINE: 08/11/2023 @4:00 PM CT

SUBMIT RESPONSES to Texas State Board of Pharmacy online Procurement Portal: https://pharmacytexas.bonfirehub.com/portal/

Submissions by other methods will not be accepted. Minimum system requirements: Microsoft Edge, Google Chrome, Safari, or Mozilla Firefox. Javascript and browser cookies must be enabled.

Respondents should contact Bonfire at Support@GoBonfire.com for technical questions related to submissions or visit Bonfire’s help forum at https://vendorsupport.gobonfire.com/hc/en-us

Submission materials should be prepared in the file formats listed under Requested Information for this opportunity in the Bonfire Portal. The maximum upload file size is 1000 MB. Documents should not be embedded within uploaded files, as the embedded files will not be accessible or evaluated.

ORGANIZATION NAME

ADDRESS

TAX ID/VENDOR IDENTIFICATION NUMBER

The vendor’s authorized agent must sign below. By signing this document, the respondent acknowledges that all information contained in the document is true and correct and that respondent agrees to comply with all terms and conditions. Failure to sign will disqualify this bid. By signing this bid, respondent certifies that if a Texas address is shown as the address of the respondent, respondent qualifies as a Texas Bidder as defined in Section 2155.444(c) of the Texas Government Code.

Signature Title

Date

TABLE OF CONTENTS

1.0 INTRODUCTION

1.1 General Information

1.2 Purpose

1.3 Statutory Basis

1.4 Definitions

1.5 Term of Contract

1.6 Change Process

1.7 Cancellation

1.8 Order of Precedence

1.9 Agency contact

1.10 Schedule

2.0 STATEMENT OF WORK-GENERAL ELEMENTS

2.1 Proposal requirements

2.2 Performance Requirements

2.3 Contract Inspections

2.4 Invoicing and Payment

3. 0 STATEMENT OF WORK-EVALUATED ELEMENTS

3.1 Pricing

3.2 Testing Standards

3.3 Experience and Qualifications

3.4 Quality Assurance

3.5 Methods

3.6 References and Vendor Performance

3.7 Evaluation

4.0 Submission and Contract Requirements

4.1 Submissions

4.2 Cost of Submissions

4.3 Public Information

4.4 Questions

4.5 HUB Subcontracting

4.6 Insurance Requirements

4.7 Certification and Prohibited Contracts

1.0 INTRODUCTION

1.1 General Information

The Texas State Board of Pharmacy (TSBP) strives to protect the public health of the citizens of Texas, by licensing pharmacies and facilitating the regulation of the practice of pharmacy in accordance with the highest standards of quality pharmaceutical care. This is accomplished by assuring that compounded preparations not only meet safety, quality, and environmental control requirements but also are compliant with established standards and regulations.

The United States Pharmacopeia (USP) has developed widely recognized quality guidelines in which established procedures, conditions, and other requirements are intended to prevent patient harm resulting from compounding subpar sterile preparations.

In accordance with sections 556.051(a)(3) and 556.053(a)(3) of the Texas Occupations Code and to effectively regulate and meaningfully monitor quality deficiencies in the sterile compounding process, TSBP seeks to identify a certified laboratory for sampling and analytical services.

Sampling Services. By observing a product specific quantitative sampling recommendation provided by the contracted laboratory, TSBP inspectors will collect sterile compounding samples from Texas licensed resident (Class A-S, B and CS) sterile compounding pharmacies. Contracted vendors conducting inspections on TSBP’s behalf will collect samples of sterile compounds from Texas licensed non-resident pharmacies (Class E-S) that ship sterile products into the state of Texas.

Analytical Services. After collection, samples will be sent to the contracted laboratory for analysis of potency, sterility, the presence of pyrogens, or fungus using USP methodologies. The specific USP method of analysis performed on each sample will be determined by the nature of the sterile compounding business conducted by the pharmacy.

The anticipated laboratory contract described in this Request for Proposals (RFP) will require adherence to a rigorous quality assurance/quality control (QA/QC) protocol and consistent and regular communication with TSBP regarding associated contractual requirements.

1.2 Purpose

The Texas State Board of Pharmacy (TSBP) is seeking competitive sealed proposals to establish a contract for analysis of compounded pharmaceuticals as outlined in this Request for Proposal.

1.3 Statutory Basis

Authority to post and award this solicitation is delegated to TSBP by the Comptroller of Public Accounts.

The Texas Pharmacy Act prohibits a pharmacy located in another state from dispensing prescription drugs to Texas residents unless the pharmacy holds a Non-Resident Pharmacy license issued by TSBP. The Texas Pharmacy Act grants TSBP the authority to conduct random inspections of Non-Resident Pharmacies that compound sterile preparations. The Texas Pharmacy Act also prohibits TSBP from issuing a Pharmacy license to an out-of-state pharmacy compounding sterile preparations, unless the pharmacy has first undergone an inspection to ensure the pharmacy meets the safety standards and other requirements set forth by TSBP rules.

1.4 Definitions

TSBP -

Texas State Board of Pharmacy

Fiscal Year - September 1 to August 31

Respondent - Any individual, partnership, corporation or other legal entity submitting a timely proposal in response to this RFP.

RFP -

Request for Proposals

State - State of Texas

Portal, Bid Portal-Online portal for submission of proposals

Bonfire Interactive-contracted host for Procurement Portal Bid Table - A template on the portal for proposers to enter pricing information.

Questionnaire - A template on the portal for proposers to fill out and submit as part of their proposal package.

Contract Inspector-Entity qualified to perform inspections of sterile compounding pharmacies located outside of Texas.

Out-of-State Pharmacy-A pharmacy located outside of Texas that is required to have a Texas license to do business in Texas, including the shipment of compounded preparations into Texas and directly to either Texas residents or Texas resident practitioners for office use. The term includes a non-resident pharmacy.

CSP – Compounded sterile preparation.

HPLC – High Performance Liquid Chromatograph

GC -Gas Chromatography

MS – Mass spectroscopy

USP – United States Pharmacopeia

EP – European Pharmacopeia

JP – Japanese Pharmacopeia

ACS – American Chemical Society

1.5 Term of Contract

A contract, if any, will be effective upon signing by the Texas State Board of Pharmacy (TSBP) and any vendor awarded by the evaluation process. The contractor will be eligible to provide services for an initial period of one year from date of award to August 31, 2024, with three (3) optional one-year renewals at TSBP’s discretion.

1.6 Change Process

Changes to any contract arising from this RFP must be in writing and coordinated through the TSBP’s designated contract administrator prior to the change. The agency point-of-contact for contract administration is TSBP Purchaser, David Hardy, CTCD/CTCM. TSBP may appoint a new contract manager at our sole discretion. Upon agreement of both parties, except as noted below, a formal amendment will be issued.

1.7 Cancellation

TSBP reserves the right to cancel any contract resulting from this solicitation if in the opinion of the TSBP the contractor is not performing analytical tests to adequately ensure that pharmacies are complying with the standards set forth in Texas Administrative Code Title 22, Part 15, Chapter 291, Subchapter G, Rule 291.133. Such cancellation will be in writing and will take effect immediately.

1.8 Order of Precedence

In the event of conflicts or inconsistencies between this contract and its exhibits or attachments, such conflicts or inconsistencies shall be resolved by reference to the documents in the following order of priority: Signed Contract (or Notice of Award), Attachments to the Contract (or Notice of Award), Request for Proposals, and Respondent’s Response to Request for Proposals.

1.9 Agency contact

The point-of-contact for this RFP is:

David Hardy, CTCD/CTCM 1801 Congress Ave., Ste. 13.100 Austin, TX 78701 Phone: 512-305-8023 Fax: 512-305-8075 E-mail: david.hardy@pharmacy.texas.gov

All questions are to be directed to the agency point-of-contact. Upon publication of this RFP, besides written inquiries as described in Section 3.4 Questions, employees and representatives of TSBP will not answer any questions or otherwise discuss the contents of the RFP with any potential provider or their representatives. If a potential provider fails to observe this restriction, that provider’s response to this RFP may be disqualified.

1.10 Schedule

This schedule of events is subject to change by the TSBP. In the event of a change, notice will be posted on the ESBD and bid portal, https://pharmacytexas.bonfirehub.com/portal/78169.

2.0 STATEMENT OF WORK-GENERAL ELEMENTS

2.1 Proposal requirements: Respondents’ responses must indicate how the respondent meets or exceeds the following specifications.

2.1.1 The contractor shall provide analysis of drug products, including compounded sterile and non-sterile compounded preparations (CSPs) for the TSBP, in accordance with the provisions and requirements stated herein. See Section 3.1 for the estimated quantities of work ordered directly by TSBP and performed on samples collected from non-resident sterile compounding pharmacies by Contract Inspectors (see Section 2.3).

2.1.2 The contractor shall conduct analytical testing for the following, as requested by the TSBP, and shall provide written results to the TSBP. The TSBP may request pharmaceutical testing other than those listed below as needed.

a. Sterility

b. Contamination by Pyrogens or Endotoxins

c. Potency

Other testing would include out of specification (OOS) investigation of potency and sterility, identifying contamination down to the genus and species of the organism, and retesting method suitability pursuant to the USP 71 testing.

Additional fees for these extra pharmaceutical testing would apply.

2.1.3 The contractor must have the capability to conduct potency testing using the equipment listed below. Mass-spectroscopy variants of HPLC and GC are acceptable, but not required. As approved by the TSBP, the contractor may conduct potency testing using the equipment listed by the contractor on the attached Pricing Page. If during the term of the contract, the contractor obtains additional equipment to conduct potency testing, other than the equipment specified below or on the Pricing Page, the contractor shall notify the TSBP of such and the price per potency test utilizing such equipment. The TSBP reserves the right to amend the contract to include the provision of potency testing utilizing such equipment.

a. High Performance Liquid Chromatograph (HPLC)

b. High Performance Liquid Chromatography + Mass Spectrometry (HPLC-MS)

c. Gas Chromatography (GC)

d. Gas Chromatography + Mass Spectrometry (GC-MS)

e. Ultra-Violet/Visible Spectrometer

f. Titration Assay

Contractor shall inspect and calibrate equipment appropriately and if equipment is inoperable they will notify TSBP in writing within 24 hours of determination of inoperability.

2.1.4 The contractor shall complete all services and deliver the results to the TSBP no later than fourteen (14) days from the date that the sample submitted for testing is received by the contractor with the exception of sterility testing. Sterility tests may take up to 18 days to complete due to turbidity and microbial identification for failed sterility tests. In addition, the 14-day limit does not include method development and validation if such is required. TSBP may not pay invoices for results that are not completed in the required time-frame.

2.1.5 The contractor must follow the highest-quality standards for performance, as outlined in the applicable procedural guidelines provided in or by any of the following:

a. Food and Drug Administration (FDA) guidance documents (i.e., Current Good Manufacturing Practices (cGMP)/Good Laboratory Practices (GLP), Analytical Procedures and Methods Validation for Drugs and Biologics)

b. Drug Enforcement Administration (DEA);

c. The International Organization for Standardization (e.g., ISO 17025:2017); and

d. the United States Pharmacopeia/National Formulary (USP/NF) (e.g., USP General Chapter <71>, USP General Chapter <1163>)

2.1.6 The contractor’s work must be defendable in a court hearing. The contractor must maintain and provide to the state agency, upon request, the chain of custody used during the testing of each drug product throughout the process. The contractor must provide expert testimony on the chain of custody, testing methods, and results, if needed. TSBP’s legal counsel will review reports, but the contractor is responsible for ensuring the work is defensible.

2.1.7 Unless otherwise specified herein, the contractor shall furnish all materials, labor, facilities, equipment, and supplies necessary to perform the services required herein.

2.1.8 The contractor shall not subcontract any of the services to another individual or business unless the contractor has obtained prior written approval by the TSBP.

2.1.9 The contractor shall perform all services to the sole satisfaction of the TSBP. In the event of a dispute, refer to section 13 of the Terms and Conditions.

2.2 Performance Requirements: The contractor shall provide the TSBP with analysis of drug products, including compounded sterile and non-sterile preparations, and components used in compounding, including finished and unfinished products, in accordance with the following:

2.2.1 The contractor shall provide appropriate documentation, including TSBP required forms, for shipping and chain of custody of samples submitted for testing.

2.2.2 The TSBP shall collect and ship the samples to the contractor with a request for specific testing to be performed. The contractor shall determine the correct sample size of the drug product to be collected when requested by the TSBP.

2.2.3 Once the sample is received, the contractor shall determine if established reference test methods (e.g. USP, EP, JP, ACS, etc.,) are available for sterility and potency. The contractor will be required to provide pricing for method development for sterility testing and potency testing as outlined in Section 3.1. Any costs involving method development shall be discussed with TSBP prior to proceeding as follows:

a. For sterility testing, if an established reference test method is available, the contractor shall perform the test using such method. Cost must reflect pricing specified in Section 3.1.

b. For potency testing, if an established test method is available, the contractor will notify the agency of the equipment type to be used for testing (e.g. HPLC, GC, etc.) and receive approval from the agency before proceeding with the test. Cost must reflect pricing specified in Section 5.2.

c. If an established reference test method is not available, either for sterility or potency, the contractor shall notify the TSBP and receive approval before developing and validating a new test method. All costs for testing using a newly developed method must reflect pricing specified in Section 3.1.

d. See Section 2.2.6 for ownership of methods developed under this contract.

2.2.4 If the TSBP does not approve the testing, the contractor shall destroy the drug sample and the contractor shall not conduct any testing. If testing is not approved, the denial of testing will be documented in TSBP records. There will be no payment to contractor unless services are rendered.

2.2.5 Once a testing method is validated, it will be considered an established reference test method for future use.

2.2.6 Test methods developed pursuant to this contract are the exclusive property of TSBP. All right, title and interest in and to said property shall vest in TSBP upon creation and shall be deemed to be a work for hire and made in the course of the services rendered pursuant to this contract. To the extent that title to any such work may not, by operation of law, vest in TSBP, or such work may not be considered a work made for hire, all rights, title and interest therein are hereby irrevocably assigned to TSBP. TSBP shall have the right to obtain and to hold in its name any and all patents, copyrights, registrations or such other protection as may be appropriate to the subject matter, and any extensions and renewals thereof. The contractor must give TSBP and/or the State of Texas, as well as any person designated by TSBP and/or the State of Texas, all assistance required to perfect the rights defined herein without any charge or expense beyond those amounts payable to the contractor for the services rendered under this contract.

2.2.7 Once the results are known, the contractor shall provide written results along with the testing method used to the TSBP. The results of the testing should be submitted to the TSBP on the designated point-of-contact for contract management. A copy of the validation study must be provided to the TSBP for all contractor-validated testing methods.

2.2.8 The contractor must maintain any unused test sample for 180 days after notification of the test results has been sent to the TSBP. After this time, the contractor may destroy any unused test sample unless notified by the TSBP to return it to the TSBP.

2.2.9 If requested by the TSBP, the contractor shall provide an expert witness for use in any legal proceeding as required. The expert witness testimony may include defense of the test results and the testing method used.

a. The contractor shall appear before the TSBP, the State Office of Administrative Hearings, or other court of competent jurisdiction for the purpose of providing testimony in any hearing and/or litigation involving the testing results and testing methods used.

b. The contractor shall assist the TSBP’s legal counsel in the preparation of discovery questions or examination questions in any hearing and/or litigation involving the professional(s) as a result of the investigative services and the contractor’s findings.

2.2.10 The contractor shall be accessible to the TSBP via telephone during normal business hours. TSBP’s regular business hours are 8 a.m. to 5 p.m. Central Daylight Time or Central Standard Time Monday through Friday.

2.2.11 The contractor will provide training at TSBP headquarters in Austin or through live webinar. Training will include a presentation of visual materials, steps, processes specific to laboratory procedures that the inspector is required to complete in order to submit samples for processing by the contractor. Training shall include a question and answer (Q & A) session following the presentation. All materials for the training will be provided by the contractor which shall include policy and procedures and supplemental written materials which provide the inspectors the information necessary in processing the samples with the said contractor. The contractor will be expected to present the training on sampling procedures on a date set by TSBP, followed by a separate training session for inspectors of in-state (resident) pharmacies on a date set by TSBP. The contractor shall be available to provide updated training at the request of TSBP.

If the vendor changes their processes in regards to sample collection, the vendor will notify TSBP of the change within one business day. The vendor will provide training to TSBP staff to acquaint them with the changes. Such training may be conducted by webinar or other remote training at TSBP’s discretion.

2.2.12 The contractor must provide parameters, limits, and acceptable ranges per USP on potency, endotoxin, and sterility testing for application of the testing for TSBP. Testing is to meet the same standards as set forth in Section 2.1.5.

2.2.13 The contractor must provide a description of testing methods used for sterility testing per USP 71 with applicable supporting documents for each method of type of equipment. If the contractor develops new testing methods or acquires new testing equipment the vendor must provide TSBP with updated descriptions and supporting documents for the new methods. Documentation may include peer-reviewed research articles, trade journal publications, manufacturer’s product information, primary sources, results of vendor-conducted tests, and similar items.

2.2.14 The contractor shall perform any other related activities as assigned by the TSBP.

2.3 Contract Inspections: In addition to samples collected by TSBP staff, the contractor will test samples collected from non-resident sterile compounding pharmacies by Contract Inspectors. The number of non-resident pharmacies inspected is typically between 65 and 75 annually. Each non-resident pharmacy can be expected to provide samples for sterility, endotoxin, and potency testing. No quantities are guaranteed.

2.3.1 The contractor will be the sole provider of Laboratory Services to vendors qualified as Out of State Contract Inspectors. The same statement of work contained in this RFP shall apply to all work performed under this clause.

The current Contract Inspection vendors and their associates are listed on the TSBP website:

https://www.pharmacy.texas.gov/Class-E-Non-Resident-Pharmacy-Inspectors.asp

2.3.2 Pricing for work performed under this requirement is to match pricing offered in response to this RFP (see Section 3.1 for pricing tables).

2.3.3 TSBP is not responsible for payment for work performed on behalf of Contract Inspectors. Costs of drug samples and analysis, including shipping, are to be borne by the non-resident pharmacy providing the samples for inspection. All arrangements for invoicing and payment is the responsibility of the contractor and the non-resident pharmacy.

2.3.4 The contractor must provide reports on a regular basis to allow TSBP to evaluate the cost of testing performed for the contract inspection program.

The contractor must forward productivity reports to TSBP on a monthly basis. These reports must contain the following items:

The number and type(s) of tests performed for the contract inspection program during the reporting period.

The cost of the testing performed for the contract inspection program during the reporting period.

Other information as determined by TSBP.

See Attachment C, Productivity Report, for the report format. This form is subject to modification by TSBP.

2.4 Invoicing and Payment

2.4.1 The contractor shall submit, within one month of performance of a test, an itemized invoice to show and indicate the type of test that was used. Additionally, if the drug product was tested for potency, the contractor shall indicate the equipment that was utilized to test the drug product. The contractor shall submit the itemized invoices to the address stated on page one.

2.4.2 Payment

a. For each type of test actually provided, the contractor shall be paid the applicable price per test, as specified on the Pricing Page.

b. For each development and validation of non-established reference test method, the contractor shall be paid in accordance with the price per hour specified on the Pricing Page. However, the contractor shall not be paid more than the guaranteed total price quoted by the contractor.

c. For each hour for expert witness services actually provided, the contractor shall be paid the price per hour, as specified on the Pricing Page.

2.4.3 Other than payments specified above, no other payments or reimbursements shall be made to the contractor from TSBP for any reason whatsoever.

2.4.4 Out-of-state compounding pharmacies are responsible for the costs of sampling required for inspections. Pricing for out-of-state analysis is to be the same as pricing provided to TSBP under this RFP.

3. 0 STATEMENT OF WORK-EVALUATED ELEMENTS

3.1 Pricing

3.1.1 Respondents must be able to perform the following types of tests and services:

a. Sterility tests

b. Pyrogen or Endotoxin tests

c. Fungal tests

d. Potency-High Performance Liquid Chromatograph tests

e. Potency-Titration Assay test

f. Develop Sterility Method Suitability

g. Potency-Gas Chromatograph tests

h. Potency-Ultra-Violet/Visible Spectrometer tests

i. Develop and Validate Non-established Reference Test Methods

j. Expert Witness Services

3.1.2 Drug Testing-Evaluated Pricing The respondent shall provide prices for each of the following on the Laboratory Services bid table BT-47NY in the portal. The respondent shall provide firm fixed prices. All costs associated with providing the required services shall be included in the stated prices. Any costs not defined in this pricing table will be considered exceptions to the RFP and must be clearly noted in the submitted proposal.

The following tests are required. The evaluation quantities are found on bid table BT-47NY. Prices are to be entered on the bid table ONLY. The evaluation quantities are estimates only for a one-year period. No quantities are guaranteed.

Sterility Test

Pyrogen or Endotoxin Test

Fungal Test

Potency-High Performance Liquid Chromatograph Test

Potency-Titration Assay test

Develop Sterility Method Suitability

3.1.3 Testing and Services-Non-Evaluated Pricing. The respondent shall provide prices for each of the following on Bid Table BT-14GM. Prices are to be entered on the bid table ONLY. The respondent shall provide firm fixed prices. All costs associated with providing the required services shall be included in the stated prices. Prices offered under Section 3.1.3 are for contingent use and considered a part of the contract but are not calculated as part of evaluation scoring.

Sterility test-antibiotic

Potency-Gas Chromatograph Test

Potency-Ultra-Violet/Visible Spectrometer Test

Develop and Validate Non-established Reference Test Method

Expert Witness Services*

*Travel expenses for expert witnesses may be reimbursed by the TSBP.

3.1.4 Renewal Pricing

Respondents shall indicate what price escalation, if any, they wish to take during the four optional renewal periods on Bid Table BT-69EN. Price escalations are to be entered on the bid table ONLY. Respondents are limited to an increase of no more than 7.0% of the previous contract period’s pricing. Respond with a number from 0 to 7.

Optional Renewal 1 (9/1/2024 to 8/31/2025)

Optional Renewal 2 (9/1/2025 to 8/31/2026)

Optional Renewal 3 (9/1/2026 to 8/31/2027)

3.1.5 Additional testing capability. TSBP reserves the option to order additional types of testing as needed to fulfill the agency’s mission. Proposers may list up to 10 additional services they can provide, with associated prices in questionnaire Q-68CF. Description and prices are to be entered on the questionnaire ONLY. Such prices will not be considered for evaluation purposes

Respondents shall list any additional testing they are able to perform below, with pricing for reference purposes. Prices are to be firm, fixed prices and are considered a part of the contract.

3.1.6 Responses to Sections 3.1.1 and 3.1.4 will be scored for evaluation purposes.

3.2 TESTING STANDARDS

3.2.1 The proposer must provide detailed information in the form of charts and tables with regard to the following:

a. representative sample sizes (i.e., quantities of finished compounded preparations [articles]) needed from the pharmacy to perform a sterility test and assess the sterility of batch preparation of both compounded sterile preparations and compounded non-sterile preparations in accordance with the USP/NF;

b. representative sample sizes (i.e., quantities of finished compounded preparations [articles]) needed from the pharmacy to perform a potency test and assess the potency of batch preparation of both compounded sterile preparations and compounded non-sterile preparations in accordance with the USP/NF;

c. representative sample sizes (i.e., quantities of finished compounded preparations [articles]) needed from the pharmacy to perform a test to detect the presence of pyrogens and/or endotoxins of both compounded sterile preparations and compounded non-sterile preparations in accordance with the USP/NF;

d. Provide detailed information regarding the approach for HPLC method development for both compounded sterile preparations and compounded non-sterile preparations;

e. Provide detailed information regarding the commercial source, characteristics, and routine maintenance, storage, and calibration of the HPLC columns.

f. Provide detailed information regarding the procedures used in the dedication of HPLC columns in the analysis of a specific sample type, and the subsequent testing of sample types of the same active ingredient, including a description of how a specific HPLC column can be used and billed amongst a series of pharmacy accounts in need of testing an identical sample type.

3.2.2 The proposer must provide a detailed explanation and/or schematic diagram of the quantity determination (i.e., quantity of CSP articles to be submitted by pharmacy), receiving and preliminary processing steps, pre-preparation procedures, analysis procedures, including the column type (i.e., normal phase, ion exchange, etc.) and dimensions, solvents used, detector type, and data reporting of the following examples of CSP samples:

a. Cefazolin 2 gram dissolved in 50 ml Normal Saline (0.9% Sodium Chloride) minibag (e.g. “IV Piggy Back [IVPB]);

b. Diphenhydramine 50 mg dissolved in 50 ml D5W (Dextrose in Water) minibag (e.g. “IV Piggy Back [IVPB]);

c. Normal Saline (0.9% Sodium Chloride) 10 ml syringe;

d. Vancomycin 1 gram dissolved in 250 ml Normal Saline (0.9% Sodium Chloride) solution bag;

e. Testosterone 100 mg sterile pellet;

f. Sterile antibiotic solutions for inhalation (e.g., Gentamicin / Sodium Bicarbonate nebules);

g. Bupivacaine HCl 20mg/ml sterile solution for intrathecal/epidural injection 10 ml syringes;

h. Thiamine 400mg/ml injection, 5 ml vial;

i. Methylcobalamin 15000 mcg/ml injection, 20 ml vial;

j. Baclofen 4 mg/ml in Saline (0.9% Sodium Chloride), 20 ml syringe; and

k. Multi-Ingredient Compounded Sterile Preparations (e.g.,Trimix [Papaverine/Phentolamine/Alprostadil] 20 mg/1 mg /10mcg / ml, 2 ml in a 5 ml vial).

Responses to Section 3.2 will be scored for evaluation purposes.

3.3 EXPERIENCE AND QUALIFICATIONS

3.3.1 Experience: Respondents must provide demonstrated experience in providing analysis of drug products, including compounded sterile and non-sterile preparations. It is preferred that respondents have a minimum of five years of experience in laboratory analysis for compounded preparations. Respondents shall provide the number of years of experience in laboratory analysis below:

RESPONDENT NAME:

YEARS EXPERIENCE:

3.3.2 Respondents shall separately list all experience working for federal, state, or local government.

3.3.3 Respondents shall include, at a minimum, the following in response to this specification:

a. Laboratory certifications or accreditations (e.g ISO, A2LA, etc.).

b. Scientific credentials of staff chemists.

3.3.4 The contractor shall provide copies of all previous inspections conducted by the Food and Drug Administration, or any other accreditation body for laboratories (e.g., American Association for Laboratory Accreditation [A2LA], ANSI-ASQ National Accreditation Board [ANAB], International Accreditation Service, Inc [IAS], National Voluntary Laboratory Accreditation Program [NVLAP], Perry Johnson Laboratory Accreditation, Inc. [PJLA], AIHA’s Laboratory Accreditation Programs, Laboratory Accreditation Bureau [L-A-B], AIHA’s Laboratory Accreditation Program, American Society of Crime Laboratory Directors / Laboratory Accreditation Board [ASCLD/LAB], etc.) for the previous five years to the state agency and within 30 days of any inspection conducted during the term of the contract.

3.3.5 Responses to Section 3.3 will be scored for evaluation purposes.

3.4 QUALITY ASSURANCE

Compounding pharmacies are required to provide samples for testing if available. Samples have to be collected by an inspector in person. This imposes burdens of time and cost on TSBP and compounding pharmacies. In the event a sample is not tested correctly, it is extremely difficult to collect another sample for re-testing. Therefore, TSBP expects the contractor to make every effort to avoid errors in analysis.

3.4.1 Respondents must provide their most recent quality audit. Respondents must indicate how often they perform quality audits. The contractor will be expected to provide a copy of any quality audit performed subsequent to award of the contract.

3.4.2 TSBP shall have the right to make site visits to any contractor for the purpose of assessing vendor work processes in regard to work under this contract. Respondents must provide pictures, photos, or blueprints of their laboratory setting in response to this RFP.

3.4.3 In the event of a testing error, the contractor will be required to provide a written report to identify how the error occurred and to establish a means to prevent repetition of the same or similar errors. TSBP may request pictures, photos, or blueprints that will clarify the nature of the error.

Respondents must provide their current quality assurance plan, including all details relevant to sample handling, analysis, and reporting. The contractor is required to provide a current copy of their quality assurance plan whenever it is updated. The burden falls upon the vendor to notify TSBP when their quality assurance plan is updated.

Responses must include training documentation of the staff scientists, problem solving methods, and standard operating procedures.

Responses to Section 3.4 will be scored for evaluation purposes.

3.5 METHODS

Respondents must provide a list of methods developed for the analysis of pharmaceuticals that can be applied to this contract.

Responses to Section 3.5 will be scored for evaluation purposes.

3.6 REFERENCES AND VENDOR PERFORMANCE

3.6.1 References: Respondents must provide at least three (3) references. References must be current or previous customers of the respondent and have been users of the respondent’s forms system. References are scored pass/fail.

References may expect to be contacted after proposals are opened, but before negotiations for award.

List references separately and include the following:

Agency or Entity

Date(s) of Services Provided

Name of Contact: Telephone Number of Contact

Email Address of Contact

3.6.2 Vendor Performance: A Respondent’s past performance will be measured based upon pass/fail criteria, in compliance with applicable provisions of §2155.074, 2155.075, 2156.007, 2157.003, and 2157.125, Gov't Code. Respondents may fail this selection criterion for any of the following conditions:

a. A score of less than C in the current Vendor Performance System,

b. An Unsatisfactory rating in the old Vendor Performance System,

c. Currently under a Corrective Action Plan through the CPA,

d. Having repeated negative Vendor Performance Reports for the same reason,

e. Having purchase orders that have been cancelled in the previous 12 months for non-performance (i.e. late delivery, etc.).

Contractor performance information is located on the CPA web site at:

http://www.window.state.tx.us/procurement/prog/vendor_performance/

3.6.3 TSBP has the right to review any vendor performance reports from other government entities, based on Respondents’ having worked with those entities. The same conditions shall apply for evaluation of vendor performance outside of Texas.

3.7 EVALUATION

3.7.1 Best Value: The TSBP intends to award one contract to the responsive respondent whose proposal offers the best value to the State.

3.7.2 Proposal Evaluation: Proposals will be evaluated on the following:

Sections 3.2, 3.3, 3.4, and 3.5 will be scored for evaluation purposes. The scores assigned to those sections will be totaled and calculated as 60% of the overall score. Pricing, Section 3.1, including renewal costs will be at 40% of the total score.

Quality

Pricing

4.0 Submission and Contract Requirements

4.1 Submissions

Responses must be submitted through TSBP’s online bid portal at: https://pharmacytexas.bonfirehub.com/portal/ Bidders are required to register with Bonfire eSourcing. Respondents should contact Bonfire at Support@GoBonfire.com for technical questions related to submissions or visit Bonfire’s help forum at https://vendorsupport.gobonfire.com/hc/en-us Submissions may be amended, but only before the Submission Deadline. Proponents wishing to amend their proposals may amend before the Submission Deadline directly on the e-Procurement Portal.

Submissions by other methods will not be accepted. Minimum system requirements: Microsoft Edge, Google Chrome, Safari, or Mozilla Firefox. Javascript and browser cookies must be enabled. Submission materials should be prepared in the file formats listed under Requested Information for this opportunity in the Bonfire Portal. The maximum upload file size is 1000 MB. Documents should not be embedded within uploaded files, as the embedded files will not be accessible or evaluated.

RESPONSES MUST BE RECEIVED BY 08/11/2023 4:00 PM CENTRAL TIME.

4.2 Cost of Submissions

The cost of preparing and submitting any response is solely that of the respondent. TSBP will not reimburse directly or indirectly respondents for any cost of responding to this RFP.

4.3 Public Information

TSBP will comply with the Texas Public Information Act (Chapter 552, Gov't Code) as interpreted by judicial opinions and opinions of the Attorney General of the State of Texas. Information, documentation, and other material in connection with this solicitation or any resulting contract may be subject to public disclosure pursuant to the Texas Public Information Act. TSBP will notify the respondent of any request for information that is marked as confidential, and the respondent will have an opportunity to submit written justification to support the request for confidentiality to the Attorney General of the State of Texas.

Proprietary and confidential information must be clearly marked. If the response includes proprietary or confidential information, the respondent must include one (1) redacted copy in the bid portal. The redacted copy must have all proprietary or confidential information redacted.

4.4 Questions

Any person wishing to obtain clarifying information about this Request for Proposals may contact:

David Hardy, CTCD/CTCM david.hardy@pharmacy.texas.gov

FAX: 512-305-8075

(Written documentation of all interaction is required. Email is preferred.)

OR:

Questions may be submitted through TSBP’s online bid portal at https://pharmacytexas.bonfirehub.com/portal/. Use of the portal requires registration with Bonfire.

For questions regarding registration or technical support, contact Bonfire at Support@GoBonfire.com for technical questions related to submissions or visit Bonfire’s help forum at https://vendorsupport.gobonfire.com/hc/en-us Questions concerning this RFP must be in writing and submitted no later than 07/17/2023 at 3:00 PM CT. The TSBP’s official response to questions received by this deadline is expected to be posted as an addendum to the solicitation on the ESBD and the agency’s bid portal.

Respondents should note that the Official Response to Questions may contain information modifying the terms and conditions of the RFP, revising or amending the RFP and/or documents attached to the RFP. It is the responsibility of interested parties to periodically check the portal for updates to the procurement prior to submitting a response. The Respondent’s failure to check the portal will in no way release the selected vendor from “addenda or additional information” resulting in additional costs to meet the requirements of the RFP.

4.5 HUB Subcontracting

Respondents must complete and sign Attachment B, HUB Subcontracting plan. It is the policy of the Texas State Board of Pharmacy to promote and encourage contracting subcontracting opportunities for State of Texas certified Historically Underutilized Businesses (HUBs) in all contracts in compliance with Texas Government Code, Statute 2161.001-253. Respondents are encouraged to become HUB certified. State of Texas HUB applications may be found at:

https://comptroller.texas.gov/purchasing/vendor/hub/ Definitions for State of Texas HUB certifiable businesses can be found in Texas Administrative Code Title 34 Part 1, Subchapter B, Chapter §20.12 under the Comptroller of Public Accounts Procurement and Support Services (TPASS) program and HUB Rules.

4.6 INSURANCE REQUIREMENTS

Contractor will provide TSBP with current certificates of insurance or other proof acceptable to TSBP of the following insurance coverage: Standard Workers Compensation Insurance, covering all personnel who will provide services under this Contract and listing all states covered therein with limits at a minimum of $1,000,000.00 and Commercial General Liability Insurance, personal injury and advertising injury with, at a minimum, the following limits: $1,000,000 minimum each occurrence; $2,000,000 per general aggregate. Privacy and Network Security Insurance coverage is required with the following limits: Privacy Liability $3,000,000.00 per occurrence, Data Breach and Notification Expenses $2,000,000.00 per occurrence, and Network Security Liability $1,000,000.00 per occurrence.

Contractor represents and warrants that all of the above coverage is with “A” rating from A.M. Best, and authorized to provide the corresponding coverage. Contractor also represents and warrants that all policies contain endorsements prohibiting cancellation except upon at least thirty (30) days prior written notice to TSBP. Contractor represents and warrants that it shall maintain the above insurance coverage during the term of this contract and shall provide TSBP with an executed copy of the policies immediately upon request. Sole proprietors must indicate they relevant coverage they carry.

Proposers must respond on questionnaire Q-49HR found on the bid portal. Certificates of insurance may be submitted with proposal.

4.7 CERTIFICATION AND PROHIBITED CONTRACTS

Proposers must certify that they are not ineligible for an award of contract under the following prohibited conditions. Proposers must respond on questionnaire Q-29FG found on the bid portal.

4.7.1 Pursuant to Section 2271.002 of the Texas Government Code, Respondent certifies that either (i) it meets an exemption criteria under Section 2271.002; or (ii) it does not boycott Israel and will not boycott Israel during the term of the contract resulting from this solicitation. Respondent shall state any facts that make it exempt from the boycott certification in its Response.

4.7.2 CONTRACTS WITH COMPANIES ENGAGED IN BUSINESS WITH IRAN, SUDAN, OR FOREIGN TERRORIST ORGANIZATION PROHIBITED. A governmental entity may not enter into a governmental contract with a company that is identified on a list prepared and maintained under Section 806.051, 807.051, or 2252.153.

Relevant lists can be located at:

https://comptroller.texas.gov/purchasing/publications/divestment.php

4.7.3 Respondent represents and warrants that it will comply with the requirements of Section 2054.5192 of the Texas Government Code relating to cybersecurity training and required verification of completion of the training program.

4.7.4 Respondent certifies that for contracts for services, Respondent shall utilize the U.S. Department of Homeland Security’s E-Verify system during the term of the contract to determine the eligibility of:

1. all persons employed by Respondent to perform duties within Texas; and

2. all persons, including subcontractors, assigned by Respondent to perform work pursuant the contract within the United States of America.

4.7.5 Under Section 2155.0061 of the Texas Government Code, the Respondent certifies that the individual or business entity named in this Response or contract is not ineligible to receive the specified contract and acknowledges that this contract may be terminated and payment withheld if this certification is inaccurate.

4.7.6 Respondent represents and warrants that the contract is not a taxpayer resource transaction prohibited by Section 2272.003 of the Texas Government Code and that payments made by Agency to Respondent and Respondent’s receipt of appropriated funds under the contract are not prohibited by Article IX, Section 6.25 of the General Appropriations Act.

Under Texas Government Code § 2252.908 any vendor awarded a contract under RFP 515-21-0004 may be required to submit a disclosure of interested parties via form 1295. This form may be found online at: https://www.ethics.state.tx.us/filinginfo/1295/.