UA_Contract_Letters_of_Inquiry.pdf

California Department of Corrections and Rehabilitation Bid Number C5612218-D Response to Letters of Inquiry Rebid 1

Statewide Urinalysis Testing Services (Drug Interdiction) IFB C5612218-D; Rebid 1

Response to Letters of Inquiry

Question 1: Please confirm the Contractor is only expected to pick up the specimens from the facilities listed in Exhibit G, and is not expected to perform the actual specimen collection from the donor.

Response 1: Correct.

Question 2: Please confirm all drug testing (both screens and confirmations) will be done in the contractor’s certified laboratory.

Response 2: Correct.

Question 3: Page 6 of the IFB requests the Contractor’s Published Price List. If a bidder does not have a published price list and considers its pricing to be confidential and proprietary, what is the expectation here?

Drug test pricing is typically based on the volume of samples received from a customer, in addition to other considerations.

Response 3: This requirement has been removed.

Question 4: What is the historical quantity of specimens submitted by each location in Exhibit G?

Response 4: Don’t have data broken down by location by statewide in 2023-24 all locations averaging 2800 tests per month.

Question 5: Please confirm the DVBE and SB subcontracting is not mandatory for a non-small business.

Response 5: Not mandatory. See Page 11 of IFB - DISABLED VETERAN BUSINESS ENTERPRISE (DVBE) PROGRAM. See Page 13 of IFB - NON-SMALL BUSINESS PREFERENCE REQUEST.

Question 6: In regard to the 15% preference for local businesses (TACPA), is the CDCR’s current vendor claiming this preference?

Response 6: Please submit your request to CDCR’s Public Records Portal at www.cdcr.ca.gov/pra .

Question 7: Please describe the populations being tested under this contract.

Response 7: California Department of Corrections inmate population.

Question 8: What are the objectives of your drug testing program?

Response 8: Testing the inmate population for rehabilitation purposes.

Question 9: Will minor variations from the cutoffs listed in Exhibit A-1 be acceptable to CDCR?

Response 9: No.

Question 10: Per page 21 of the pdf, Collection Requirements, D.1, please confirm that specimens will not need to be shipped overnight. This requirement states that specimens should be delivered to the laboratory within 7 days.

Response 10: Does not need to be shipped overnight and seven day shipping is fine.

http://www.cdcr.ca.gov/pra

Response to Letters of Inquiry Rebid 1

Question 11: Also, per D.1. on page 21, “All specimen analyses are to be completed and reported electronically to the contributing facility site location within 48 hours of receipt of specimen, excluding holidays, Saturdays, and Sundays.” Is this requirement for both screening tests and confirmation testing of presumptive positives? Please confirm that this requirement applies to negative screening results, not confirmed positive results.

Response 11: The results of the test should be provided 48 hours after the receipt of delivery of specimen to the lab. Per D.1. on page 21, “All specimen analyses are to be completed and reported electronically to the contributing facility site location within 48 hours of receipt of specimen, excluding holidays, Saturdays, and Sundays.”

Question 12: In the Scope section, under F, Specimen Containers, this section asks for 6 items to be included on the pre-printed labels, per the bullet list. However, the items listed in the bullets are not the same data that is represented in the sample label that is provided underneath. Please clarify the minimum data expected on the pre-printed labels.

Response 12: Unit Identification number=account number; Participant’s identification number=CDCR number

The label will need the below information.

Question 13: Also, in regard to Specimen Containers and labeling under F. on page 22, is a specimen seal that contains a bar code matching the specimen to the Chain of Custody sufficient for the CDCR?

Response 13: Yes. This would be in lieu of the detailed label requirements provided on page 22. The COC with the matching bar code would contain additional detailed information.

Question 14: Please describe what data is expected for the List Date field under F. on page 22.

Response 14: Date the lab tested the sample.

Question 15: Please confirm that a licensed or Ph.D. toxicologist is acceptable for the medical review process outlined on page 5, Item L, of the Scope of Services/page 24 of the IFB.

Response 15: That is acceptable.

Question 16: Is it acceptable for the CDCR/DAI to retrieve invoices from the Contractor's billing portal after the 1st of the month versus having the invoice emailed or mailed?

Response 16: It’s possible but email will probably be best.

Acct#/Name: ________________________________ Collection Date: ______________________________ CDCR#: _______________ Reason______________ Last Name: __________________________________ First Name: __________________________________ List Date: ______ / _____ / _______

Response to Letters of Inquiry Rebid 1

Question 17: Please confirm that bidders will be able to bill at an hourly rate for expert witness testimonies.

Response 17: CDCR will pay for travel expenses and per diem, but the vendor will not be able to charge hourly rate for expert witness testimonies. (please include this time in your quote in the cost per test).

Question 18: Does the CDCR anticipate that any remote testimony will be required, in addition to the four in-person testimonies (per Q on page 26 of the IFB pdf)?

Response 18: No.

Question 19: How many testimonies have been required historically, per year?

Response 19: Four per year.

Question 20: Please confirm fingerprinting is not required if Contractor is not performing specimen collections and is only picking up specimens at the facilities.

Response 20: That is correct.

Question 21: On pages 49 – 50 of the IFB pdf, Items 44 and 45 refer to security regulations for access to CDCR facilities. Do these regulations apply to courier services that are picking up specimens from the facilities?

Response 21: Yes.

Question 22: There is a Business Associate Agreement (BAA) included in the IFB. Because toxicology laboratories are considered Covered Entities under the Health Insurance Portability and Accountability Act (HIPAA), a lab does not have the legal status of a business associate under federal regulations. As a Covered Entity as defined by HIPAA, we are required to fully comply with HIPAA Rules and not just the sections to which a business associate is subject, including the HIPAA privacy and security notification rules. With that said, will your laboratory testing vendor be required to sign the BAA?

Response 22: The BAA will remain a part of the final contract.

Question 23: Who is the incumbent, current provider of the services?

Response 23: San Diego Reference Lab.

Question 24: What is the County currently paying for the services?

Response 24: CA. $6-$10K per month.

Question 25: Is the current contract available to view?

Response 25: To view records, please submit a request for records to CDCR’s Public Records Portal at www.cdcr.ca.gov/pra.

Question 26: If the officers are collecting all samples, will this licensing requirement still be applicable?

California Department of Health Services Laboratory Field Services (LFS) license.

Response 26: Yes, the licensing is still applicable.

Response to Letters of Inquiry Rebid 1

Question 27: Regarding Bid # C5612218-D, in Exhibit A, Section D. Collection Requirements, are collections not required for the bids? It states collections, but pick-ups in parenthesis.

Response 27: Weekly collections are required, and these can be done through the mail or can be picked up form facilities.

Question 28: Who is the incumbent provider for the requested services?

Response 28: San Diego Reference Lab.

Question 29: What is the CDCR currently paying for the requested services?

Response 29: $6-10K per month.

Question 30: Please provide a copy of the existing contract used for these services.

Response 30: Please submit your request for records to CDCR’s Public Records Portal at www.cdcr.ca.gov/pra.

Question 31: What were the actual volumes per line item for the requested services?

Response 31: Please submit your request for records to CDCR’s Public Records Portal at www.cdcr.ca.gov/pra.

Question 32: What is the CDCR's estimated positivity rate (by drug, if possible)?

Response 32: Unknown.

Question 33: Can the CDCR clarify what population this testing is for (e.g. Adult, Juvenile, both, which programs)?

Response 33: Adult Programs only.

Question 34: Is any portion of the requested services for clinical purposes?

Response 34: These services as requested are mandatory tests completed as a result of a guilty finding on a rules violation report for a drug related offense.

Question 35: Can the CDCR clarify if it is currently using an instant device for its primary screen?

Response 35: No, CDCR does not test urine samples only physical narcotics/controlled substances.

Question 36: Is the CDCR interested in receiving pricing for both instant devices and lab-based testing options for its primary screening method, or only interested in lab-based testing?

Response 36: Can include both.

Question 37: Approximately how many "flawed specimens" did the CDCR submit in the past year?

Response 37: Tested around 30,000 samples.

Question 38: Can the CDCR define what drugs make up the requested "full drug panel"?

Response 38: Please see Exhibit A-1, page 1, first table.

Response to Letters of Inquiry Rebid 1

Question 39: Is the CDCR interested in bundled pricing (e.g. cost to screen + confirm all positive drugs) or would the CDCR accept pricing for confirmations separate from screens?

Response 39: CDCR is interested in a price per test, and we need to screen and confirm results, so we need the bundled pricing.

Question 40: Can the CDCR confirm that it will accept FedEx or USPS to perform specimen collections (pick-ups) from all facility site locations?

Response 40: CDCR can confirm.

Question 41: On page 22 of the bid, the CDCR outlines barcoding requirements for specimen collection. In order to reduce operational workload and potential errors, will the CDCR allow for electronic specimen collection (i.e. test requisition using a desktop or mobile device), which would include barcoding on the specimen security seal and/or label?

Response 41: No, using a desktop or mobile device will not always be possible.

Question 42: On page 23 of the bid, the CDCR states that copies of proficiency testing results "any outside proficiency testing in which it participates" shall be made available to the State. Please verify that this is in reference to certificates of participation rather than proficiency test result data.

Response 42: That’s correct.

Question 43: On page 24 of the bid, the CDCR outlines requirements for a Medication Review process. Is the CDCR's current provider including this review automatically on results reports or is this a process only performed upon request?

Response 43: Only performed on request.

Question 44: Would the CDCR allow for a toxicologist to provide consultations upon request for the purposes of the Medication Review process?

Response 44: Not sure if necessary, CDCR employs pharmacists and doctors on site.

Question 45: Would the CDCR consider quality control requirements in alignment with CLIA as opposed to defining a specific minimum quality control percentage per batch?

Response 45: No.

Question 46: To our knowledge, no specimen container is labeled as "leak-proof." Please confirm that specimen containers meant for urine transportation are acceptable without this labeling.

Response 46: “leak-poof” is not required for the label.

Question 47: Would the CDCR allow for an Ethanol (alcohol) screen at 0.04 g/dL instead of 0.025 g/dL?

Response 47: No.

Response to Letters of Inquiry Rebid 1

Question 48: On page 7 of the bid, the CDCR states that it "does not accept alternate contract language from a prospective Contractor." Can the CDCR clarify whether all requests for modifications must be submitted during this Q&A period?

Response 48: Correct.

Question 49: Would the CDCR consider any requests for modification submitted in a Vendor's bid response, to be negotiated at a later date?

Response 49: No.

Question 50: Would the CDCR consider the removing of the Business Associates Agreement as part of this contract? Per OCR/HHS, a BAA is not required when we are providing testing outside the clinical context.

For example, when laboratory-based drug testing is conducted to produce evidence of compliance with a court-imposed sentence, or to determine eligibility for parole or probation, or to determine suitability for hiring, drug testing laboratories do not “qualify” as a “HIPAA business associate” as that term is defined in 45 C.F.R. § 160.103, and a BAA would not be applicable.

Response 50: The BAA will remain a part of the final contract.

Question 51: Would the CDCR consider making the Right to Terminate clause mutual so that it reads: "Either party may terminate immediately upon written notice in the event of a substantial failure to perform/material breach that remains uncured 30 days following receipt of notice of such failure/breach. Either party is permitted to terminate without cause upon at least 30 days’ written notice to the other party."

Response 51: No. Please see Exhibit D, Number 2, page 2 & 3.

Question 52: Copy of the current, most updated version of the contract pricing for the services currently being solicited in the Statewide Urinalysis Testing Services BID NUMBER C5612218-D.

Response 52: Please submit your request to CDCR’s Public Records Portal at www.cdcr.ca.gov/pra.

Question 53: Where did the projected volume numbers come from and how were they determined?

Response 53: The numbers were determined by the volume of tests in 2023-2024 and with an anticipated increase of tests in the future fiscal years.