Attachment B - Specifications - Pages 1-8.docx

Attachment B - Specifications Drug Abuse Screening for Acadiana Area Human Services District

(AAHSD)

RFx #3000025331

PART I. ADMINISTRATIVE INFORMATION

1.0 Definitions:

A. Mandatory Requirements - The terms shall or must denote mandatory requirements.

B. Permissible Action - The terms should and may denote an advisory or permissible action.

C. Contractor - The term Contractor refers to the successful responder of the Invitation To Bid (ITB); (Vendor to whom this contract has been awarded).

D. Agency - Any department, commission, council, board, office, bureau, committee, institution, agency, government, corporation, or other establishment of this state authorized to participate in any contract resulting from this Invitation To Bid (ITB).

E. State - The State of Louisiana.

F. Donor - Any person identified as a client by the Acadiana Area Human Services District as subject to drug testing.

G. Medical Review Officer (MRO) - A licensed physician responsible for receiving laboratory results generated by employer or testing entity’s drug testing program who has knowledge of substance abuse disorders and has appropriate medical training to interpret and evaluate an individual’s positive test result together with his medical history and any other relevant biomedical information.

H. Drug - Any chemical substance that either produces physical, mental or emotional change in the user, or one that is capable of altering the mood, perception, pain level, or judgment of the individual consuming it.

I. Illegal/Designer Drug - Any drug (a) which is not legally obtainable or (b) which is legally obtainable but has not been legally obtained. The term includes prescribed drugs not legally obtained and prescribed drugs not being used for prescribed purposes.

J. Legal Drug - Any prescribed drug or over-the-counter drug or medication which has been legally obtained and is being used for the purpose for which it was prescribed or manufactured.

K. Prescribed Drug - Any substance for which a prescription has been written by a licensed medical practitioner for consumption by the individual for whom it is written or ordered.

L. Prohibited Drug - Any of the following substances specified in Schedule I or Schedule II of the Controlled Substances Act, 21, U.S.C., 801,802 (19031 & 1987 Cum. P.P.): marijuana, cocaine, opiates, amphetamines, and phencyclidine (PCP).

M. Controlled Drugs - Those drugs or chemical substances placed on a schedule or in special categories to prevent, curtail or limit their distribution and manufacture as defined by the Controlled Substance Act of 1970, as amended.

N. SAMHSA - Substance Abuse and Mental Health Services Administration within the U. S. Department of Health and Human Services (formerly NIDA).

O. CAP-FUDT - College of American Pathologists Forensic Urine Drug Testing P. User Agency - Agency which orders drug testing (Acadiana Area Human Services District).

1.1 Confidentiality:

The awarded bidder acknowledges that, in the performance of its obligations under the terms of this bid, the Contractor and/or subcontractors may have access to information which the State has identified as confidential. Both the Contractor and any subcontractors and each of their employees assigned to the work or participating in the project or reviewing any information related to the project are hereby notified that this information should be kept confidential and that their employees should use prudence and due diligence in the use of this information, subject to the provisions of L.A.-R.S. 47:1508. In all cases, the Louisiana laws concerning confidentiality of information must be observed, as well as the Federal Regulations regarding confidentiality 45 CFR, Parts 160 and 164, as well as 42 CFR, Part 2 Additionally, under no circumstances without prior express written approval, is the Contractor and/or subcontractors to discuss and/or release information to the media concerning this project.

PART II. SCOPE OF SERVICES

2.0 GENERAL REQUIREMENTS:

A. All activities performed under the contract shall be in compliance with the laws of the State of Louisiana in accordance with the Federal Department of Human Health and Human Services/ Substance Abuse and Mental Health Services Administration (DHHS/SAMHSA) Guidelines.

B. The bid responses shall be a firm fixed price per drug test that includes all costs associated with supplies required for specimen collection, initial screening, and confirmation of all positives, as well as the Medical Review Officer (MRO) functions. The price will also include all supplies and costs of specimen shipping and storage.

In short, the firm fixed price per test shall include all costs associated with the scope of service, including the provision relating to expert witness testimony requesting such services. Rejected specimens that are unreported after 3 working days in the laboratory will be handled at no charge.

C. The Bidder must obtain Certified Substance Abuse Program Administration (C-SAPA) certification (WWW.SAPACC.ORG) no later than 6 months after the date of contract implantation.

D. The Successful Contractor must maintain all required certifications during the entire contract period.

2.1 BILLING:

The Contractor shall handle all financial arrangements for services under the contract and bill Medicare/Medicaid and accept assignment for full payment of these charges. All private-pay patient charges will be billed to the client, and indigent clients will be billed to Acadiana facilities. The Contractor will bill back to Acadiana facilities all charges necessary, according to the contract, when indicated on the lab requisition as a client bill (i.e., Medicare skilled or hospital patient).

Acadiana facilities will provide accurate billing information upon submission of the lab requisition form.

The Contractor shall be required to enroll or contract with all Managed Care Organizations (MCOs) that are contracted with the Louisiana Department of Health’s (LDH) Healthy Louisiana Program and with the Louisiana Department of Health-Office of Behavioral Health’s (LDH-OBH) behavioral health partnership Contractor, Magellan. Billing for all Medicaid recipients who are enrolled as members of one of the MCOs or whose care is coordinated and covered by Magellan must be submitted to the MCO or Magellan for consideration and payment in accordance with the authorization and billing requirements of the MCO or Magellan. The Contractor will be responsible for billing Medicare patients and legacy Medicaid patients that are not covered by Magellan or one of the MCOs.

2.2 SERVICES:

The Contractor must:

A. Provide all supplies necessary for collection and transportation of specimens from the listed Acadiana Area Human Services District (AAHSD) clinic locations to the laboratory testing site.

The Contractor shall provide a urine collection kit that meets federal specifications. This collection kit must contain easy-to-follow instructions, a 200 ml container, a 45 ml shatterproof specimen tube, temperature indicator, unique internal and external tamper-proof seals, volume indicator, and absorbent packet to prevent leaks in transport. Kits shall be shipped to the AAHSD clinics at the addresses provided.

Specimen collection will be performed at the AAHSD clinics and transported to the Contractor at their expense. All necessary supplies required to transport the specimens shall be provided by the Contractor.

The Contractor shall provide pre-printed custody and control forms and tamper-evident seals with the Agency information to simplify completion.

The Contractor shall provide the User Agency access to a single individual on the Contractor's staff who has the authority to resolve problems that may arise at the collection sites and with related matters.

B. Provide method of transportation of specimens from the collection site AAHSD to the Contractor’s Substance Abuse and Mental Health Services Administration (SAMHSA) certified laboratory.

All necessary supplies required to transport the specimens shall be provided by the Contractor. The Contractor must ensure that the sample reaches the testing laboratory timely in order to accommodate the required 48 hour reporting of results. The Contractor must be able to document the integrity of the transportation process.

C. Maintain Substance Abuse and Mental Health Services Administration (SAMHSA) certified laboratory(ies) or College of American Pathologists – Forensic Drug Testing (CAP-FDT) accreditation to conduct all testing as required by this program.

Initial Testing/Screening: The initial testing shall use an immunoassay which meets the requirements of the Food and Drug Administration (FDA) for commercial distribution.

Generally, AAHSD requires initial testing for the following classes of drugs:

Ng/ml

Confirmatory Tests: Specimens identified as positive on the initial test shall be confirmed using gas chromatography/mass spectrometry (GC/MS) techniques. The costs associated with donor-requested gas chromatography/mass spectrometry (GC/MS) confirmatory tests will be at the expense of the donor, as per the AAHSD procedure noted below.

Quantitative gas chromatography/mass spectrometry (GC/MS) confirmation at the following cutoff values shall be used for the following drugs:

Phencyclidine…………………………………………………………………………………….25

Cannabinoids (Marijuana Metabolites)…………………………………………………………..15 (Delta-9-tetrahydrocannabinol-9-carboxylic acid)

Synthetic Cannabis……………………………………………………………………………

Cocaine Metabolites…………………………………………………………………………….100 (Benzoyl Ecgonine)

Opiate Metabolites Oxycodone, Hydrocodone, Hydromorphone, Oxymorphone, Codeine, Morphine…….300

Amphetamines Amphetamine…………………………………………………………………………...250 Methamphetamine………………………………………………………………………250 (Specimen must also contain amphetamine at a concentration > 200 ng/ml)

Barbiturates…………………………………………………………………………………

Benzodiazepines…………………………………………………………………………………80

Methadone………………………………………………………………………………………200

Note: However, additional drug tests can be requested. Detection levels and list of analytes are subject to adjustments when required by applicable government regulations, guidelines, or AAHSD.

AAHSD provides for the confirmation of urine drug screen results upon request from recipients of AAHSD services. The procedure is as follows:

1. If a client requests confirmation of a positive urine screen, the client is to provide the AAHSD facility with a money order to cover the cost of the Gas Chromatography/Mass Spectrometry (GC/MS). The “pay to the order of” portion of the money order should be made out to AAHSD.

2. A procedure to protect the security of the money order should be implemented in each facility. The Contractor’s invoices will list the individual(s) tested, thereby assisting facilities in tracking this information. It is suggested that when a facility receives an invoice from the Contractor, the facility makes a copy of the invoice, marks the confirmations that are being paid with client money orders, and forwards the copy of the invoice along with the money orders made out to the Contractor for payment. For the remaining confirmations, the facility must follow the procedures outlined for processing any other State contract item.

The Contractor will also assay each specimen for signs of possible adulteration. Specimen adulteration assays will include, but are not limited to, the following:

Creatinine Nitrites Specific Gravity pH Chromate The User Agency will note on the chain of custody form if any confirmatory tests are to be performed on a specific donor’s sample.

The laboratory shall have a quality assurance program which encompasses all aspects of the testing process: specimen acquisition, chain of custody, security, and reporting of results, in addition to the screening and confirmation of analytical procedures. Quality control procedures will be designed, implemented, and reviewed to monitor the conduct of each step of the process.

The laboratory shall provide all services and testing in such a manner that all results and reports shall be developed so as to maximize the likelihood that they will be admissible evidence in any administrative or civil judicial proceeding. The laboratory shall provide personnel deemed necessary by the User Agency to establish this admissibility. All testing will be of forensic quality. Litigation package shall be provided at no cost.

The use of an electronic, web-based chain-of-custody program and the use of an electronic, web-based reporting system are preferred.

Within the first 60 days of the contract, the Contractor shall conduct a staff training at no cost to AAHSD. The training will cover collection, testing, reporting, web-based features, results interpretation, and general troubleshooting. Additionally, at no cost, at least yearly, the Contractor will visit each of the five AAHSD clinics to provide on-site consultation and review.

D. The Contractor must contract with an independent Medical Review Officer(s) (MRO) who is a licensed physician, responsible for receiving laboratory results generated by the drug- testing laboratory that has knowledge of substance abuse disorders and has appropriate medical training to interpret and evaluate a donor’s positive test result together with her/his medical history and any other relevant biomedical information.

The MRO shall be certified by one or more of the three recognized MRO authorities. These are the American Association of Medical Review Officers, the American Society of Addiction Medicine, or the American College of Occupational and Environmental Medicine.

The MRO shall not be an employee or agent of or have any financial interest in the laboratory for which the MRO is reviewing the drug testing results. Additionally, the MRO shall not derive any financial benefit by having an agency use a specific drug-testing laboratory or have any agreement with the laboratory that may be construed as a potential conflict of interest.

The Contractor’s laboratory shall report all test results to the AAHSD Clinic as follows:

(1) Initial reporting of negative results will be transmitted or available electronically to the AAHSD Clinic within 48 hours after the receipt of a proper specimen at the testing laboratory, with no mitigating circumstances.

(2) Initial reporting of positive results (or those specimens requiring re-testing) will be transmitted or available electronically to the MRO/AAHSD Clinic within 72 hours after receipt of a proper specimen at the testing laboratory, with no mitigating circumstances.

(3) Electronic reporting and availability of results will be in a manner designed to protect confidentiality and will be subject to any applicable Federal or State regulations.

(4) The report shall identify the drugs/metabolites tested for, concentration of drugs/metabolites detected, whether positive or negative, the requisition (billing) number, the donor’s identification number, and the laboratory specimen identification number. The report shall also indicate the date of specimen collection, the date received by the laboratory, and the date and time reported.

(5) The Contractor’s laboratory will maintain all test records in confidence, as required by applicable Federal and State regulations.

The Medical Review Officer (MRO) will:

(1) Receive, collate, and reconcile all preliminary positive test reports (electronic and hard-copy) and necessary supporting documentation.

(2) The MRO or appropriate Contractor personnel will be available upon subpoena to testify in administrative hearings or court proceedings and must be available to provide expert testimony by deposition for any administrative hearing or court proceeding. MRO services shall be included in the scope of services.

(3) Provide a statewide statistical summary of program utilization and results on a quarterly and as-needed basis.

E. Bill the individual User Agencies monthly for those tests ordered by their entity.

The fee for drug testing services shall be all-inclusive, including provisions of expert witness testimony by the MRO or Contractor personnel.

All collection efforts for accounts receivable will be handled directly with the appropriate User Agency.

F. Provide the following additional services as part of the contract at no additional cost:

(1) Separate customized pre-printed, uniquely-numbered chain of custody forms for each employing entity;

(2) Specimen collection and transportation supplies (including wide-mouth bottles for specimen collections from female donors);

(3) Retention of specimens in accordance with Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines;

(4) Consultation and expert witness testimony by the Contractor’s staff, including laboratory and collection facility staff;

(5) Order retesting of donors where the specimen is rejected by the laboratory due to improper collection or transportation;

(6) Monthly statistical and activity reports to the User Agencies; web-based reporting is preferred.

(7) Random selection service for each User Agency on a monthly, quarterly, or on an as-needed basis. The fee for this service shall be included in the drug testing costs.

Pick-Up Locations for Urine Screens

Crowley Behavioral Health Clinic 1822 West 2nd Street Crowley, LA 70526 Phone: 337-788-7511 Fax: 337-788-7588

New Iberia Behavioral Health Clinic 611 West Admiral Doyle Drive New Iberia, LA 70560 Phone: 337-373-0002 Fax: 337-373-0129

Opelousas Behavioral Health Clinic 220 South Market Street Opelousas, LA 70570 Phone: 337-948-0226 Fax: 337-948-0399 Nancy Bourque – Clinic Manager

Tyler Behavioral Health Clinic 302 Dulles Drive Lafayette, LA 70506 Phone: 337-262-5870 Fax: 337-262-4178

Ville Platte Behavioral Health Clinic 312 Court Street Ville Platte, LA 70586 Phone: 337-363-5525 Fax: 337-363-1567