SOW_MRO_Services_final.pdf

STATEMENT OF WORK

MEDICAL REVIEW OFFICER

SERVICES

BACKGROUND:

The Regional Transportation District (RTD) is seeking a qualified Medical Review Officer (MRO or “Contractor”) to provide MRO services according to Department of Transportation (DOT) regulations 49 CFR part 40 the (“DOT MRO Guidelines”), FTA regulations 49 CFR part 655, FRA regulations 49 CFR part 219 and FMSC regulations 49 CFR part 391, Subpart E, as updated from time to time (collectively, the “MRO Regulations”).

The MRO must be a licensed physician (Doctor of Medicine or Osteopathy), must be certified to perform MRO services and otherwise qualified in accordance with the MRO Regulations.

The contract period will be for five (5) years, unless terminated earlier in accordance with the terms and conditions of the Contract.

MINIMUM KNOWLEDGE REQUIREMENTS:

The MRO must be knowledgeable regarding the MRO Regulations and all other applicable laws and regulations and must keep current on any updates or changes to these regulations and materials.

1. The MRO must be knowledgeable and have clinical experience in controlled substance abuse disorders including detailed knowledge of alternative medical explanations for laboratory confirmed drug test results.

2. The MRO is required to have the appropriate medical training to interpret and evaluate laboratory confirmed positive test results and knowledge of alternative medical explanations for laboratory confirmed test results.

3. The MRO must be knowledgeable about issues relating to adulterated and substituted specimens as well as the possible medical causes of specimens having an invalid result.

QUALIFICATION TRAINING:

1. The MRO must be certified through qualified training that provides instruction on the following subjects:

a. Collection procedures for urine specimens

b. Chain of custody, reporting, and record keeping

c. Interpretation of drug and validity tests results

d. The role and responsibilities of the MRO in the DOT drug testing program

e. The interaction with other participants in the program [Designated Employer Representative (DER), Substance Abuse Professional (SAP)].

f. Provisions of DOT and FTA rules that apply to RTD, including changes and updates to the MRO Regulations, DOT agency rules, guidance, interpretations, and policies affecting the performance of MRO functions, as well as issues that MRO’s confront in carrying out their duties under the MRO Regulations and applicable DOT agency rules.

2. The MRO must satisfactorily complete an examination administered by a nationally recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of DOT-mandated drug tests. The examination must comprehensively cover all the elements of qualification training listed in §40.121 of 49 CFR part 40.

CONTINUING EDUCATION:

During each three-year period from the date on which the MRO satisfactorily completes the examination required under §40.121 of 49 CFR part 40, the MRO must complete continuing education consisting of at least 12 professional development hours relevant to performing MRO functions.

1. This continuing education must include material concerning new technologies, interpretations, recent guidance, rule changes, and other information about developments in MRO practice, pertaining to the DOT program, since the time The MRO met the qualification training requirements of the above noted section.

2. The MRO’s continuing education activities must include assessment tools to assist the MRO in determining whether you have adequately learned the material.

3. The MRO must maintain this documentation showing that the MRO currently meet all requirements of §40.121.

4. The MRO must provide any license renewals to RTD demonstrating their continued qualification to serve as an MRO.

RESPONSIBILITIES:

The MRO’s responsibilities include:

1. Acting as an independent and impartial “gatekeeper” and advocate for accuracy and integrity of the drug testing process.

2. Providing a quality assurance review of the drug testing process for the specimens under your purview. This includes, but is not limited to:

a. Ensuring the review of the control custody form (CCF) on all specimen collections for the purposes of determining whether there is a problem that may cause a test to be cancelled.

b. Providing feedback to RTD, collection sites and laboratories regarding performance issues when necessary.

c. Reporting to and consulting with the Office of Drug and Alcohol Policy and Compliance (ODAPC) or a relevant DOT agency when MRO wish DOT assistance in resolving any program issue.

d. MRO must determine whether there is a legitimate medical explanation for confirmed positive, adulterated, substituted, and invalid drug tests results from the laboratory.

e. MRO must act to investigate and correct problems where possible and notify appropriate parties (e.g., HHS, DOT, RTD, service agents) where assistance is needed, (e.g., cancelled or problematic tests, incorrect results, problems with blind specimens).

f. MRO must ensure the timely flow of test results and other information to

RTD.

g. MRO must protect the confidentiality of the drug testing information.

f. MRO must perform all your functions according to DOT regulations.

VERIFICATION PROCESS

As the MRO, you must review negative test results and laboratory confirmed non-negative drug test results and reconfirmed results according to 49 CFR Part 40 Subpart G and H.

If the copy of the documentation provided to the MRO by the collector or laboratory appears unclear, the MRO must request that the collector or laboratory send the MRO a legible copy the same day that the result is reported from the laboratory. There must be an in-house process to ensure that the delay in reporting any result to RTD shall not be due to the delay of paperwork.

The MRO is responsible for reporting the drug test results to the RTD Substance Abuse/Office Services Manager/Supervisor via secure website. Negative results shall be posted on the MRO’s secure website the same day they are received from the laboratory. Secure website should also make available the CCF for viewing.

All verified positive test results, results requiring an immediate collection under direct observation, adulterated or substituted specimen results, results requiring reconfirmation, and other refusals to test shall also be reported to the RTD Substance Abuse/Office Services Manager/Supervisor the same day the MRO determines the result.

Safety cautions will be communicated by encrypted email to DAP@rtd-denver.com.

mailto:DAP@rtd-denver.com

RECORD KEEPING

The transmitting of test results to RTD shall be in a confidential electronic manner.

You must transmit to the DER on the same day the MRO verifies the result.

Direct telephone contact with the DER is the preferred method of immediate reporting.

Follow up your phone call with appropriate documentation see (§40.163 of 49 CFR part 40).

The MRO’s report that you transmit to RTD must contain all information required by §40.463 of 49 CFR part 40.

The MRO must personally review at least 5 percent of all CCFs reviewed by MRO’s staff on a quarterly basis, including all results that required a corrective action.

REPLACEMENT STAFF:

A replacement MRO shall be provided during vacation or time off. The MRO shall provide a regular and emergency telephone number.

OTHER RESPONSIBILITIES:

MRO services must provide single point of contact via email and telephone for billing issues and single point of contact for drug result related issues.

MRO services must provide PIN accessible results via telephone as required by §40.167(b)(2) of 49 CFR part 40.

MRO Services must provide non-Federal results verbally when requested.

Affidavits of correction sent to the MRO will be forwarded by the MRO to the lab.

MRO services must provide multiple secure electronic means to transmit CCFs from the employer to the MRO.

BILLING:

Invoices will be provided by the 5th of the following month in two separate documents:

1) document that includes the total charges; 2) in a separate file a list of the specimen IDs, names, etc. that were tested during the billing period in Microsoft Excel, or similar sortable electronic non-proprietary format. This information will be made available through the contractor’s electronic portal or through some other secure means.

See Section 2.4, Invoicing of the Statement of Contract Cost (Form of the Contract) for invoice requirements.

Need cost of the following:

1. Verification of specimens – Oral and Urine (unless same price)

2. Confirmatory testing of a split specimen