ITB016334_LDC008_Contract.pdf

STATE OF OHIO

DEPARTMENT OF ADMINISTRATIVE SERVICES

GENERAL SERVICES DIVISION

OFFICE OF PROCUREMENT SERVICES

4200 SURFACE ROAD, COLUMBUS, OH 43228-1395

MANDATORY USE CONTRACT FOR: HUMAN DIAGNOSTIC LABORATORY SERVICES

CONTRACT No.: ITB016334

CONTRACT ID: 16334

EFFECTIVE DATES: 12/1/2023 to 10/31/2027

SUPPLIER: Laboratory Corporation of America Holdings

The Department of Administrative Services has accepted bids submitted in response to Invitation to Bid No. SRC0000011659. The evaluation of the bid response(s) has been completed. The bidder(s) listed herein have been determined to be the lowest responsive and responsible bidder(s) and have been awarded a contract for the items(s) listed. The respective bid response, including the Instructions to Bidders and Standard Terms and Conditions, special contract terms & conditions, any bid addenda, specifications, pricing schedules and any attachments incorporated by reference and accepted by DAS become a part of this Requirements Contract.

This Requirements Contract is effective beginning and ending on the dates noted above unless, prior to the expiration date, the Contract is renewed, terminated or cancelled in accordance with the Contract Terms and Conditions.

CONTRACT RENEWAL. This Contract may be renewed after the ending date of the Contract solely at the discretion of the Contracting Agency for a period of one month. Any further renewals will be by mutual agreement between the Contractor and the Contracting Agency for any number of times and for any period of time. The cumulative time of all mutual renewals may not exceed 10/31/31 unless the Contracting Agency determines that additional renewal is necessary.

This Requirements Contract is available to Ohio Department of Youth Services, Ohio Department of Mental Health and Addiction Services and Ohio Department of Rehabilitation and Corrections, as applicable.

Agencies are eligible to make purchases of the listed supplies and/or services in any amount and at any time as determined by the agency. The State makes no representation or guarantee that agencies will purchase the volume of supplies and/or services as advertised in the Invitation to Bid.

This Requirements Contract and any Amendments thereto are available from the OhioBuys public portal at the following address:

https://supplier-emarketplace.ohio.gov/page.aspx/en/usr/login?ReturnUrl=%2fpage.aspx%2fen%2fbuy%2fhomepage

Signed: _____________________________________________________________________

Kathleen C. Madden, Director Date

1 - SPECIFICATIONS AND REQUIREMENTS

1.1. SCOPE:

The State seeks a contractor to provide Human Diagnostic Laboratory Testing Services to include Phlebotomy and Routine Courier pick-up for the Ohio Department of Rehabilitation and Correction (DRC), the Ohio Department of Youth Services (DYS) and the Ohio Department of Mental Health and Addiction Services

(DMHAS).

The State’s desire is to continue our standard of quality services through a contract awarded to a single contractor which covers all of the agencies’ facilities. By these efforts, the State desires to maintain or improve the overall quality of the contracted services and reduce the State’s administrative and personnel costs.

1.2. CONTRACTOR PRICING REQUIREMENTS

1.2.1. The Core Services Price Schedule contains a listing of tests and estimated quantities performed annually.

Prices for all services, unless otherwise noted, shall be priced based on standard laboratory Cost per Reportable (CPR) test prices.

1.2.2. Phlebotomist Services Schedule is pricing for phlebotomist services at a per draw rate.

1.2.3. Emergency After Hours (STAT) is pricing for additional services required outside of normal business hours.

This will be billed as a single charge per occurrence. Each facility will establish normal business hours with the contractor.

1.2.4. Discount Off List.

1.2.4.1. Discount off List Price for Additional Test will apply for any laboratory test services not listed in Core

Service Price Schedule. The Contractor shall provide a current listing of other tests available along with a current price list. Indicate the percentage (%) discount from list price or fee schedule that will apply.

1.3. Billing

1.3.1. Each month the Contractor must submit a single detailed invoice, subtotaled by facility to each Agency.

1.4. Additional Requirements

1.4.1. The awarded Contractor shall remove all waste from each facility generated by this service.

1.4.2. The State reserves the right to modify or delete facility locations, detailed in Facility Site Supplement, with a thirty (30) day notice to the Contractor, without additional cost or expense to the State by the Contractor.

1.4.3. All contracted staff shall abide by terms of this contract.

1.5. SERVICES

1.5.1. Human Diagnostic Laboratory Services.

1.5.1.1. Services shall include timely pick-up and delivery of specimens at each ordering facility.

1.5.1.1.1. Facilities will be available for specimen pick up Monday through Friday excluding eleven (11) state holidays.

1.5.1.1.2. Each ordering facility will establish pickup and drop off times with the Contractor.

1.5.1.1.3. Pickup and delivery of each order will be included in the test unit price.

1.5.1.2. The Contractor is to provide test analysis within 24 hours after receipt of sample.

1.5.1.3. The Bidder must have policies and procedures in place when a sample is lost or otherwise mishandled by staff or a courier. The Bidder must submit a copy of their current policy and procedures with its bid.

If the Bidder’s policies and procedures are not provided with the bid submission the Bidder will have five

(5) calendar days in which to provide them once they have been requested by the Office of Procurement Services. Failure to provide them within five (5) calendar days may deem the submitted bid not responsive.

1.5.1.4. The Contractor shall provide all necessary supplies and equipment to perform all services. This includes but not limited to:

1.5.1.4.1. Furnishing and delivery of all supplies for specimen collection, including any administration supplies, transportation material and centrifuges.

1.5.1.4.2. Provide, supply and maintain printers, or other electronic reporting equipment, at each facility for the daily transmission of lab results.

1.5.1.4.3. Provide pre-printed lab requisition forms for the using facilities or emergency situations, as well as order forms for supplies, and a toll-free number for ordering maintenance of equipment.

1.5.1.5. The Contractor shall have back up procedures to deliver reports in a timely manner by other means, such as hard copies delivered when specimens are picked up, should the primary method for reporting fail.

1.5.1.6. The Contractor may be called upon to provide consulting and phlebotomy training as needed at no additional charge.

1.5.1.7. DRC / DYS Assigned Phlebotomist duties shall include, but not limited to the following:

1.5.1.7.1. Perform care consistent with the scope of licensure/certification and in accordance with agency facility policies and procedures.

1.5.1.7.2. Perform draws in morning sessions to accommodate fasted inmate-patients or at times established by the agency for each facility.

1.5.1.7.3. Follow established agency departmental policies and procedures.

1.5.1.7.4. Perform venipunctures and finger-sticks using standard equipment to include vacutainer tubes and sleeves, tourniquets, blood culture, syringes and butterfly needles.

1.5.1.7.5. Collect and centrifuge specimens from patients for laboratory testing.

1.5.1.7.6. Maintain inventory of supplies, stock supplies and hand trays.

1.5.1.7.7. Follow institution written standard procedure, or follow standard phlebotomy practice for positive patient identification.

1.5.1.7.8. Other duties as required including assisting Nurses, Physicians, and/or laboratory personnel in obtaining blood from “hard to draw patients” and maintain appropriate records of specimens drawn in the DRC Electronic Health Record (EHR) system and other record keeping methods.

1.5.1.8. Contractor will provide bi-directional interface, at contractor’s expense, to DRC’s Electronic Health Record (EHR), as well as provide secure on-line access for staff to obtain lab testing results electronically.

1.5.1.9. DYS/DMHAS does not have an EHR system. In the event that DYS or DMHAS implements an Electronic Health Record for their facilities, the contractor must supply an interface according to requirements of Sections 1.5.1.8, 1.5.1.10 and 1.5.1.11.

1.5.1.10. Contractor will provide bi-directional interface, at contractors expense, to DYS/DMHAS Electronic Health Record (EHR), Avatar (Netsmart), as well as provide secure on-line access for staff to obtain lab testing results electronically, pre Agency implementation.

1.5.1.11. Contractor, at contractor’s expense, shall provide the necessary programming, testing, training, etc.

resources to develop, test, and implement the listed interfaces listed in 1.5.1.8 and 1.5.1.9. Testing shall include both unit testing of each lab order, resulting, and charging for each facility implemented, as well as the execution of regression test scripts as part of integrated testing. Implementation shall include any needed data conversions.

1.5.1.12. Contractor must perform tests that can be configured as custom profiles per using agency’s requests.

1.5.1.13. Laboratory testing will include:

1.5.1.13.1. Chemistry.

1.5.1.13.1.1. Routine

1.5.1.13.1.2. Special Chemistry

1.5.1.13.1.3. Urine Chemistry

1.5.1.13.1.4. TDM’s

1.5.1.13.2. Toxicology: 12 Panel Drug screen with GC/MS confirmation on requested positives.

1.5.1.13.3. Serology.

1.5.1.13.4. Microbiology.

1.5.1.13.4.1. SARS Cov-2 PCR Test /Nucleic Acid Amplification Test (NAAT)

1.5.1.13.5. Immunology.

1.5.1.13.6. Hematology.

1.5.1.13.7. Molecular Testing.

1.5.1.13.7.1. HIV Viral Loads.

1.5.1.13.7.2. Hepatitis C Viral Loads.

1.5.1.13.7.3. CT/NG.

1.5.1.13.8. Urinalysis.

1.5.1.13.9. Cytopathology.

1.5.1.13.10. Surgical Pathology.

1.5.1.13.11. Dermatopathology.

1.5.1.13.12. Flow Cytometry.

1.5.1.13.13. Quantiferon - TB tests.

1.5.1.14. The Contractor shall supply a listing of test services and explanatory guide for in-house testing and send-out routine testing (both clinical and anatomic). The listing shall be an alphabetical listing of procedures with corresponding test codes. The listing shall include profile/panel breakdowns, methodologies, reference ranges and panic/critical values. The listing shall be distributed in sufficient quantities to meet the need of the facilities. Any update to the listing shall be communicated and distributed in a timely manner to all facility locations.

1.5.1.15. The Contractor shall have procedures for reporting ‘panic’ or very abnormal test results that exceed predefined criteria. All abnormal test results must be shared with the Agency as soon as possible after verification of test results.

1.5.1.16. The Contractor shall notify the appropriate facility when an unacceptable routine clinical or anatomic specimen is received. Notification shall be made within 24 hours of discovery of the unacceptable nature of the routine specimen.

1.5.1.17. The Contractor, when requested by the State, will be required to supply a copy of their routine specimen retention schedule for storing all specimen types including whole blood, pathology specimens, urines, serum, plasma, fluids etc.

1.5.1.18. The Contractor shall repeat testing upon request. When facility personnel believe that reported results do not correlate with the clinical status of the patient, the Contractor shall repeat the specimen testing within twenty four (24) hours of request at no further charge to the State. If repeat testing does not resolve the conflict, the Contractor shall submit the specimen to a mutually agreeable “outside” facility at the State’s expense.

1.5.1.19. Laboratory specimens must be evaluated with written/transmitted reports prepared and submitted to the ordering facility within twenty four (24) hours after Contractor acknowledged receipt of specimen, with the exception of cultures and other tests, which may require more than twenty four (24) hours of analysis in accordance with standard laboratory procedures.

1.5.1.20. The Contractor shall provide toll free customer phone service and timely responses to questions and concerns. The using facilities require that a service representative visit each facility upon request to assess service and address any questions / concerns.

1.5.1.21. The Contractor’s Laboratory Director and designated personnel shall provide consultation regarding receipt, performance results, and methodological/clinical interpretation of laboratory test results.

1.5.1.22. Reflex HPV testing shall be performed on gynecological cytology specimens only upon request.

1.5.1.23. Histology/Cytology correlation should be performed monthly and in case of a discrepancy, a letter must be sent to the facility with a follow up request correlation analysis.

1.5.1.24. The Bidder shall establish and utilize a comprehensive Quality Control Plan and a Quality Improvement Plan. The Bidder must provide a current copy of both Plans with its bid submission. If the Bidder’s Quality Control and Quality Improvement Plans are not provided with the bid submission the Bidder will have five (5) calendar days in to provide them after being requested by the State. Failure to provide the plans within five (5) calendar days may deem the submitted bid not responsive.

1.5.1.24.1. The Plan shall include, but not limited to:

1.5.1.24.1.1. Activities to be monitored, frequency of monitoring, samples of forms to be used in monitoring, title/level and qualifications of personnel performing monitoring functions.

1.5.1.24.1.2. Ensure the services, deliverables, and requirements defined in the contract are being provided at or above the level of quality agreed upon by the State and the bidder.

1.5.1.24.1.3. Ensure that professional staff rendering services under the contract have the necessary prerequisites.

1.5.1.24.1.4. Identifying and preventing deficiencies in the quality of service before the level of performance becomes unacceptable.

1.5.1.24.1.5. Taking any corrective action, if needed, including a commitment to provide to the using agency upon request a record of all inspections, the corrective action taken, the time the problem is first identified, a clear description of the problem, and the time elapsed between identification and completed corrective action.

1.5.1.24.1.6. Monthly monitoring of treatment indicators.

1.5.1.24.1.7. Performing Problem Specimen Monthly report for the using agencies and reporting problems to the institutions if problems would be greater than 5.0%.

1.5.1.24.1.8. Performing statistical analysis of timing for critical and STAT calls monthly and reporting of corrective actions if timing exceeds acceptable limits.

1.5.1.24.1.9. All statistical data shall be reported to the using agency monthly. The using agency may request any structured data to be presented to the department for review.

1.5.2. Emergency After Hours Testing (STAT) will require pick up and performance of laboratory testing outside of the routine pick up of samples. All conditions of Section 1.5.1 Human Diagnostic Laboratory Services apply with the addition of:

1.5.2.1. STAT Testing may be requested on any day, at any time twenty four (24) hours a day by any facility.

1.5.2.2. STAT Testing samples must be collected by the Contractor within thirty (30) minutes of initial contact from the requesting facility.

1.5.2.3. STAT Testing from call to test result must be no longer than four (4) hours for all institutions except for Franklin Medical Center (FMC). FMC requires a STAT turnaround time not to exceed two (2) hours. The turnaround time will be from the Agency STAT request to the Contractor providing STAT test results.

1.5.2.4. STAT lab requesting will include the following:

1.5.2.4.1. PT/INR, APTT

1.5.2.4.2. BMP, Glucose, BUN, Creatinine, Sodium, Potassium, Chloride, CO2 and Calcium.

1.5.2.4.3. Misc. Chemistry Tests:

1.5.2.4.3.1. Amylase

1.5.2.4.3.2. Lipase

1.5.2.4.3.3. Total Bilirubin

1.5.2.4.3.4. Magnesium

1.5.2.4.3.5. Phosphorous

1.5.2.4.4. CBC or any of its components

1.5.2.4.5. Therapeutic Drugs

1.5.2.4.5.1. Digoxin

1.5.2.4.5.2. Phenytoin

1.5.2.4.5.3. Gentamicin

1.5.2.4.5.4. Vancomycin

1.5.2.4.5.5. Tobromycin

1.5.2.4.5.6. Valproic Acid

1.5.2.4.5.7. Carbamazepine

1.5.2.4.5.8. Lithium

1.5.2.4.5.9. Theophylline

1.5.2.4.5.10. Phenobarbital

1.5.2.4.6. D-Dimer, BNP

1.5.2.4.7. Urinalysis

1.5.2.4.8. Any additional testing requested by the ordering facility.

1.5.2.5. After hours pick up and the cost of the STAT testing must be priced as a single per patient event.

2 - STANDARD TERMS AND CONDITIONS

State of Ohio Standard Terms and Conditions (revised 10/18/22) will apply to this Contract.

3 - CONTRACT SPECIFIC TERMS AND CONDITIONS

3.1. AMENDMENT TO CONTRACT TERMS AND CONDITIONS

The following Amendments to the Contract Terms and Conditions do hereby become part hereof. In the event that an amendment conflicts with the Contract Terms and Conditions, the Amendment will prevail.

3.2. - ORDER OF PRIORITY

The order of priority of the Contract will be the following: 1.) Specifications and Requirements; 2) Contract Specific Terms and Conditions; 3) Standard Terms and Conditions.

3.3. - LICENSE

Each bidder must supply all necessary documentation for all State and Federal Licenses to include copies of current CLIA (Clinical Laboratory Improvement Act) license and current CAP (College of American Pathologist) Accreditation in good standing and maintain for the duration of this contract. All subcontractors and independent laboratories must be properly https://procure.ohio.gov/static/pdf/About_Procurement/Procurement_Policies/Standard_T_C_10_15_22.pdf licensed. Failure of contractor’s subcontractors and independent laboratories to maintain compliance will be the responsibility of the contractor.

Accreditation Standards: The services to be performed under this contract shall meet standards required by The Joint Commission (TJC), Center for Medicaid & Medicare Services (CLIA) and College of American Pathologist (CAP) or other accrediting or certifying organizations, as appropriate.

The Contractor shall provide copies of current Ohio licenses, with no restrictions or limitations, with the bid submission. If the licenses are not provided with the bid submission the bidder will have five (5) calendar days in which to provide them once they have been requested by the Office of Procurement Services. Failure to provide them within seven (7) calendar days may deem your bid not responsive.

The Contractor must maintain all licenses throughout the term of this contract and any renewals. At the request of a State Agency, a copy shall be provided within five (5) calendar days. Failure to maintain and provide copies of license(s) when requested may result in cancellation of the Contract.

3.4 – FIXED PRICE WITH ECONOMIC ADJUSTMENT

The contract prices(s) will remain firm for the first twelve (12) months duration of the contract. Thereafter, the Contractor may submit a request to increase their price(s) to be effective thirty (30) calendar days after acceptance by DAS. No price adjustment will be permitted prior to the effective date of the increase received by the Contractor from its suppliers, or on purchase orders that are already being processed, or on purchase orders that have been filled and are awaiting shipment. If the Contractor receives orders requiring quarterly delivery, the increase will apply to all deliveries made after the effective date of the price increase.

The price increase must be supported by a general price increase in the cost, due to increases in the cost of raw materials, labor, freight, Workers' Compensation and/or Unemployment Insurance, etc. Detailed documentation, to include a comparison list of the contract items and proposed price increases, must be submitted to support the requested increase.

Supportive documentation should include, but is not limited to copies of the old and the current price lists or similar documents which indicate the original base cost of the product to the Contractor and the corresponding increase, and/or copies of correspondence sent by the Contractor's supplier on the supplier's letterhead, which contain the above price information and explains the source of the increase in such areas as raw materials, freight, fuel or labor, etc.

Should there be a decrease in the cost of the finished product due to a general decline in the market or some other factor, the Contractor is responsible to notify DAS immediately. The price decrease adjustment will be incorporated into the contract and will be effective on all purchase orders issued after the effective date of the decrease. If the price decrease is a temporary decrease, such should be noted on the invoice. In the event that the temporary decrease is revoked, the contract pricing will be returned to the pricing in effect prior to the temporary decrease. For quarterly deliveries, any decrease will be applied to deliveries made after the effective date of the decrease. Failure to comply with this provision will be considered as a default and will be subject to the “Suspension/Termination” and the “Contract Remedies” sections of the “Standard Contract Terms and Conditions”.

The Discount Off List will be a firm fixed percentage for the term of the contract. Failure of the bidder to furnish the Discount Off List as part of their bid response may deem the bidder not responsive. If the Discount Off List is not provided with the bid submission the bidder will have seven calendar days in which to provide them once they have been requested by the Office of Procurement Services. Failure to provide them within seven calendar days may deem the bid not responsive.

3.5 – HIPAA

As a condition of receiving a contract from the State, the Contractor, and any subcontractor(s), will be required to comply with 42 U.S.C. Sections 1320d through 1320d-8, and to implement regulations at 45 C.F.R. Section 164.502 (e) and 164.504 (e) [relating to privacy] and 164.308 and 164.314 [relating to security] regarding disclosure and safeguarding of protected health information under the Health Insurance Portability and Accountability Act (HIPAA) of 1996, as amended by the American Recovery and Reinvestment Act of 2009. Contractor and any subcontractor(s) may be required to enter into the Agency Business Associate Agreement.

4 - INVITATION TO BID INSTRUCTIONS

Instructions, Terms and Conditions for Bidding that apply to the solicitation.

5 - SPECIAL INSTRUCTIONS TO BIDDERS

5.1 - CONTRACT AWARD

The contract will be awarded to the lowest responsive and responsible bidder by low lot total. Low lot total will be determined by multiplying the unit cost by the estimated usage listed in the bid and then adding each of the totals together to arrive at a total for all items. Failure to bid all items may result in the bidder being deemed not responsive.

5.2 - EVALUATION

Bids will be evaluated in accordance with Article I-15 of the “Instructions to Bidders”. In addition, the state will multiply the estimated usage by submitted unit cost and then add each of the totals together to arrive at the total cost.

5.3 - DESCRIPTIVE LITERATURE

The Bidder may be required to submit descriptive literature of the supplies or services being offered. If requested, the literature will be used in the evaluation process to determine the lowest responsive and responsible bidder. If not provided as part of the bid response, the Bidder must provide said literature within seven (7) calendar days after request/notification by the Office of Procurement Services to do so. Failure of the bidder to furnish descriptive literature either as part of their bid response or within the time specified herein will deem the bidder not responsive.

5.4 - SUPPLEMENT S RESPONSE – STATE INFORMATION SECURITY AND PRIVACY REQUIREMENTS, STATE DATA

HANDLING REQUIREMENTS

Bidders must include a completed copy of Supplement S with their bid. Bidders must follow the process instructions contained in the supplement when preparing their response. When responding, Bidders should note the redaction process that is described in section 5.5. Failure of a Bidder to submit a fully completed Supplement S response with their bid response may cause the submitted bid to be deemed not responsive.

5.5 - SUPPLEMENT S REDACTION PROCESS

If a Bidder includes in its Supplement S response confidential, proprietary, or trade secret information, it must also submit a complete redacted version of its Supplement S response in accordance with Confidential, Proprietary or Trade Secret Information that follows. Bidders shall only redact (black out) language that is exempt from disclosure pursuant to Ohio Public Records Act. Bidders must also submit an itemized list of each redaction with the corresponding statutory exemption from disclosure. The redacted version(s) must be submitted as an electronic copy in a searchable PDF format and submitted with the bid. Redacted versions should be indicated as redacted in the file name. The redacted version, as submitted, will be available for inspection and released in response to public records requests. If a redacted version is not submitted, the original submission of the include with the bid will be provided in response to public records requests.

5.6 - SUPPLEMENT A RESPONSE – STATE IT POLICY, STANDARD and SERVICE REQUIREMENTS

Bidders must include a fully completed copy of Supplement A with their bid. Bidders must follow the process instructions contained in the supplement when preparing their response. When responding, Bidders should note the redaction process that is described in section 5.7. Failure of a Bidder to submit a fully completed Supplement A response with their bid response may cause the submitted bid to be deemed not responsive.

5.7 - SUPPLEMENT A REDACTION PROCESS

If a Bidder includes in its Supplement A response confidential, proprietary, or trade secret information, it must also submit a complete redacted version of its Supplement A response in accordance with Confidential, Proprietary or Trade Secret Information that follows. Bidders shall only redact (black out) language that is exempt from disclosure pursuant to Ohio Public https://procure.ohio.gov/pdf/OhioBuys_ITB_Instructions_to_Bidders_030921.pdf

Records Act. Bidders must also submit an itemized list of each redaction with the corresponding statutory exemption from disclosure. The redacted version(s) must be submitted as an electronic copy in a searchable PDF format and submitted with the bid. Redacted versions should be indicated as redacted in the file name. The redacted version, as submitted, will be available for inspection and released in response to public records requests. If a redacted version is not submitted, the original submission of the include with the bid will be provided in response to public records requests.

5.8 – SITE VISIT

Prior to submitting their solicitation response, the supplier should visit the locations in the solicitation in order to survey the facility(s) and to become familiar with the requirements of the solicitation. The supplier must contact each facility to schedule an appointment. To schedule an appointment, refer to the Facility Site Supplement for locations and contact information.

5.9 - REFERENCES

To be considered responsive, the bidder must, at the time of bid submission, be an established business with all required licenses, bonds, facilities, equipment and trained personnel necessary to perform the work in this bid. Each bidder is to submit, with its bid, a listing of three (3) references documenting experience in providing Human Diagnostic Laboratory Services, in accordance with state and federal standards and guidelines, within the previous five (5) years. Also, in its bid, the bidder must demonstrate it has provided, within the last five (5) years, similar services to other customers of similar size and scope of work. Name, address, telephone number and contact person for each reference and prior customer must be included. If not included as part of their bid response, the bidder will be required to provide the references within five (5) calendar days after notification. Failure to provide the references within the stated time period will result in the bidder being deemed not responsive.

5.10 – DELIVERY

Services will be performed as set forth in the Contract. The location of performance will be noted on the purchase order issued by the participating agency.