Attachment B - Scope of Work - Pages 1-4.pdf

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Attached to
Referral Lab Testing for CLSH-LDH
Solicitation number
3000026810
Issued by
East Baton Rouge Parish, Baton Rouge City, Louisiana

About this file

This Scope of Work document outlines the referral laboratory testing services required by the state of Louisiana for CLSH-LDH (Clinically Significant Low-Level Discrepancies in LDH testing). The document establishes the technical and operational requirements for the selected vendor to provide comprehensive laboratory testing services, including specimen receipt and processing, test methodology implementation, quality assurance protocols, and result reporting to referring healthcare facilities. The scope defines specific performance standards for turnaround times, accuracy rates, and compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations and Louisiana state laboratory licensing requirements.

The vendor selected under this contract must demonstrate current CLIA certification, maintain proficiency in the specified testing methodologies, and establish quality control procedures that meet or exceed industry standards. The contractor is responsible for maintaining detailed documentation of all testing procedures, maintaining secure chain-of-custody protocols for specimens, and providing regular quality assurance reports to the state. The contract requires the vendor to establish communication protocols with referring laboratories and healthcare providers, implement corrective action procedures for any testing discrepancies, and maintain confidentiality of all patient information in compliance with HIPAA regulations. Additional requirements include staff training documentation, equipment maintenance records, and participation in proficiency testing programs as mandated by regulatory authorities.

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Attachment B – Scope of Work

RFx #3000026810 Contract Title: Referral Lab Testing for CLSH-LDH

Referral Lab Testing for Central LA-Pineville

Laboratory Testing Services, As Needed for Central LA-Pineville Hospital, Herein Referred to As Pineville.

Located At: 6250 Esler Field Road, Pineville, LA 71361

The contractor will provide laboratory services to residents in Pineville. The contractor will perform all laboratory tests requested by attending physicians for which the contractor has facilities or arrange for specimen referral to a certified reference laboratory for those tests that cannot be performed by the contractor.

Services To Include All of The Following:

Specimen Transport Specimens shall not be processed in any manner of transport other than that necessary to preserve specimens.

Equipment & Supplies Contractor shall provide all equipment, software, supplies, forms, etc., necessary for the collection, labeling, and transporting of lab specimens for the period of this contract.

Contractor is to provide an adequate supply of urine cups with sealing lids that allow for identification labels. Urine tubes and a suction needle are also to be supplied for the transfer of urine to tubes, as needed.

All replacement supplies requested by Pineville are to be delivered within forty-eight hours of request.

Contractor will supply Pineville with a computer, printer, and modem capable of receiving test results through a secure, direct connection to the contractor’s system. This secure connection shall be independent of Pineville’s computer network. While online access to lab services is expected, the contractor-provided computer must also be capable of serving as an alternative backup service onsite with daily backups, onsite data storage, and the ability to order and receive lab results.

Pick-Up Requirements The contractor shall provide for pickup of our Routine lab specimens once daily, Monday through Friday, 8:00 AM until 4:00 PM, excluding the following major holidays: New Year’s Day, Memorial Day, 4th of July, Labor Day, Thanksgiving Day, a n d Christmas Day. Other holidays may be excluded from the required pickup at the discretion of PINEVILLE. The contractor pickup for Same Day labs shall be no more than one hour from the time of the call for Same Day pickup.

Contractor pickup for After Hours Same Day requests is preferred. If the contractor cannot provide pickup service for After Hours Same Day requests, PINEVILLE reserves the right to serve this part of the service from the contract and purchase from another source.

After Hours Same Day Drop Off Location Contractor must provide an After-Hours Same Day drop-off location that is located within 45 minutes of Pineville.

Pineville will provide for collection of non-blood specimens and blood specimens.

Designated Pineville personnel will be trained to collect routine, same-day, after-hours same-day, and unscheduled blood specimens, if needed. Pineville will ensure that specimens are adequately labeled and stabilized. Pineville will be responsible for After Hours Same Day delivery to a location agreed upon by both parties. Pineville will also ensure that the laboratory request forms are filled out properly, accurately, and completely, and will complete the accurate billing information upon submission of the requisition.

Reporting Of Test Results The contractor must contact Pineville by telephone upon completion of Routine and Same Day requests. Same Day reports should take no more than 6 hours from time of pickup/drop off to call back of the results. When the test analysis is complete, the Reference Laboratory personnel or contracted hospital lab personnel will notify Pineville by computer printer, by phone, or fax.

Routine tests shall typically be reported within twenty- four hours of receipt of the specimen by the testing facility. Specialty tests shall typically be reported within seventy-two hours of receipt of the specimen by the Testing facility.

Lab results shall be made available to the Pineville computer furnished by a contractor with secure online viewing within twenty-four hours, and the contractor shall fax when necessary or requested. Labs shall be available via a secure online site as well as available in a format compatible with EMR/EHR systems for most providers (HL-7).

Training Contractor will provide periodic in-service training sessions with qualified personnel to update Pineville’s personnel in test ordering procedures, specimen collection, etc.

associated with this contract.

Contractor Licensing Requirements Laboratory shall be licensed to perform medical laboratory analysis under the provisions of the Clinical Laboratories Improvement Act of 1967 (42 U.S.C. 263A). Laboratories for this contract must be currently licensed and maintain their license throughout the contract period.

Laboratories must have an accreditation certificate from the College of American Pathologists (CAP). The laboratory must have been accredited for at least the previous ten years and must maintain accreditation throughout the contract period.

*Legible copies of the CLIA license and CAP accreditation certificate will need to be provided within three business days of the bid opening date, if not included in the bid packet.

Contractor shall also be licensed with a Board Certified (Anatomic and Clinical) Pathologist to review all results and be available for consultation on laboratory results or clinical problems.

Outside Testing In the event that the tests are not performed in the contractor’s own laboratory and are sent to an outside lab(s), there will be no additional referral charge. The certification and licensing requirements for the outside lab(s) are the same as those specified for the contract laboratory.

Billing The contractor shall handle all financial arrangements for services under this agreement and bill Medicare/Medicaid and accept assignment for full payment of these charges. All private pay patient charges will be billed to Pineville. The contractor will bill back to Pineville all charges necessary, according to the price sheet, when indicated on the lab requisition as client bill (i.e., Medicare skilled or hospital patient).

Pineville will provide accurate billing information upon submission of the lab requisition form. Contractors are required to enroll or contract with all managed care organizations (MCOs) that are contracted with the Department of Health’s (LDH) Healthy Louisiana Program and with LDH-OBH’s behavioral health partnership contractor, Magellan. Billing for all Medicaid recipients that are enrolled as members of one of the MCO’s 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 managed care organizations (MCOs).

Right To Audit The State Legislative auditor, federal auditors, and the internal auditors of the Department of Health, the Division of Administration, or others designated by the DOA, shall have the option to audit all accounts directly pertaining to the contract for a period of five years after contract acceptance or as required by applicable State and Federal Law. Records shall be made available during normal working hours for this purpose.

Record Retention Upon the written request of the Secretary of the Department of Health or the Comptroller General or any of their duly authorized representatives, the Contractor’s laboratory shall make available to the Secretary those contracts, books, documents, and records necessary to verify the nature and extent of costs of providing these services. Such an inspection shall be available up to four years after the rendering of such services. If the

Contractor’s laboratories carry out any of the duties of this agreement through a subcontract with a value of $10,000 or more over a twelve-month period, the Contractor’s laboratory agrees to include this requirement in any such subcontract. This section is included pursuant to and governed by the requirements of Public Law 96-499 of the Social Security Act, and Regulations promulgated thereunder.

Confidentiality Of Test Results The contractor agrees that test results constitute privileged medical information, and such results are subject to applicable L o u i s i a n a and federal laws and regulations governing the same. Any breach of confidentiality by the contractor, its agents, or employees may be cause for immediate contract cancellation. (A breach of this confidentiality clause voids the required thirty days written notice of cancellation listed in the invitation to bid –instructions to bidders #23)

It is understood that this policy of confidentiality is forever binding, even after the contractor's association with Pineville has terminated.

It is understood that failure to abide by this policy of confidentiality could also result in litigation against the contractor.

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