Medical Laboratory Services

Description

This is a Request For Proposals (RFP) used when County expenditure will be more than $150,000 for the initial term of the resulting contract. PRE-PROPOSAL CONFERENCE: There will not be a pre-proposal conference for this sourcing event. INTRODUCTION AND BACKGROUND: The Multnomah County Health Department (MCHD) is seeking a supplier from whom it may purchase medical laboratory services that fall outside the scope of internal services at the MCHD laboratory.  This includes but is not limited to the following clinics:  Communicable Disease/ Occupational Health (CD/OHO) Tuberculosis (TBC) Sexually Transmitted Disease (STD) Harm Reduction (HRC) Primary Care (8) Student Health (9) Corrections Health (3) Central Laboratory (1)  Major Service components include:  Provide laboratory testing services  Provide specimen pickup services  Provide laboratory consultation services for the interpretation of laboratory results  Provide test results and reports to MCHD Central Lab & providers Provide STAT Lab services to MCHD Central Lab & providers in the event of STAT and/or critical results 24 hours a day, 7 days a week. Provide support services and all related supplies  Provide interface connectivity and backup connectivity in the event of a power outage for EHR (Electronic Health Record)  Provide interface testing, maintenance, updates and problem resolution. Provide patient support services.   Provide primary and secondary billing services including Medicare, Medicaid and other third party payors.  Provide Laboratory Directorship services and oversight of all MCHD CLIA certificates.   Note: Multnomah County reserves the right to continue to send medical diagnostic testing samples to the Oregon State laboratory and other reference laboratories for testing if it is in the best interest of Multnomah County and the population served.  INTRODUCTION AND PROGRAM HISTORY Multnomah County operates federally funded clinics that provide services for the citizens of Multnomah County. These services are provided under a Health Resources and Services Administration (HRSA) Bureau of Primary Care Federally Qualified Health Center (FQHC) grant.  MCHD has 7 Primary Care Health Centers, 9 School Based Health Centers, 3 Corrections Health Clinics, an HIV clinic, a Communicable Disease/Occupational Health Clinic, a Tuberculosis Clinic, a Sexually Transmitted Disease Clinic and a Harm Reduction Clinic. In the fiscal year 2018, MCHD performed approximately 100,000 internal lab tests and ordered an estimated 250,000 laboratory tests. The Supplier must have adequate capacity to accommodate this volume of laboratory testing from multiple clinic sites within MCHD. MCHD is Joint Commission accredited and provides patient centered care using the Medical Home model.  GOALS, VALUES AND OTHER IMPORTANT CONSIDERATIONS The goal of seeking external laboratory services is to continue to provide a high quality, comprehensive and cost effective services for MCHD patients.  MCHD currently uses the EpicCare electronic health record (EHR) provided by Oregon Community Health Information Network (OCHIN). The medical laboratory services supplier must be able to provide a real time electronic order and result interface with this EHR. The orders and results interface must be HL7 compliant and be compatible with the EHR provider.  TARGET POPULATION SERVED MCHD provides care to underserved, low income and uninsured residents of Multnomah County. In fiscal year 2018, MCHD had an estimated 191,726 visits which included approximately 246,00 external laboratory tests. See Multnomah County Health Department Fiscal Year 2018 (FY18) Visits by Payor Mix, Attachment 3, for details.  GEOGRAPHIC BORDERS/LIMITATIONS & SERVICE AREAS Supplier must be able to provide services to all MCHD Health Center locations (which are subject to change) listed below:  Central Laboratory 619 NW 6th Ave, 8th Floor, Portland, OR 97209   HIV Health Services Center 619 NW 6th Ave, 3rd Floor, Portland, OR 97209  Communicable Disease/Occupational Health/ Tuberculosis Clinic 619 NW 6th Ave, 2nd Floor, Portland, OR 97209  Sexually Transmitted Disease Clinic 619 NW 6th Ave, 2nd Floor, Portland, OR 97209  East County Health Center 600 NE 8th St., #300 Gresham, OR 97030  La Clinica de Buena Salud 6736 NE Killingsworth St., Portland, OR 97218  Mid County Health Center 12710 SE Division, Portland, OR 97236  Northeast Health Center 5329 NE MLK Jr. Blvd Portland, OR 97218  North Portland Health Center 9000 N Lombard St., Portland, OR 97203  Rockwood Health Center 2020 SE 182nd Ave., Portland, OR 97233  Southeast Health Center 3653 SE 34th Ave., Portland, OR 97202  Harm Reduction Clinic 12425 NE Glisan Street, Portland, OR 97230   Cleveland High School 3400 SE 26th Ave Portland, OR 97212  David Douglas High School 1034 SE 130th Ave., Portland, OR 97233   Franklin High School 5405 SE Woodward St Portland, OR 97206     Jefferson High School 5210 N Kerby St Portland, OR 97212   Madison High School at Marshall 3905 SE 91st Ave, Portland, OR 97266  Parkrose High School 12003 NE Shaver St Portland, OR 97220 Reynolds High School 1698 SW Cherry Park Rd., Troutdale, OR 97060  Roosevelt High School 6941 N Central St Portland, OR 97203  Multnomah County Juvenile Detention Center 1401 NE 68th Ave., Portland, OR 97213  Multnomah County Detention Center 1120 SW 3rd Ave 4th Floor, Portland, OR 97204 Multnomah County Inverness Jail 11540 NE Inverness Dr., Portland, OR 97220  CURRENT SERVICES/SOLUTION: Not applicable to this sourcing event.  FUNDING MCHD has a budget of approximately $307,015,929 per year from a mixture of federal, state and local funding for all geographic area services. The current allocation policy provides a base allocation plus additional funds allocated on a formula basis. The formula directs funds to service areas with greater needs, taking into account multiple factors such as:  1. 60+ population in the district; 2. Ethnic population in district; 3. Income level e.g. poverty rate; 4. Frailty (age and mobility related); 5. Service authorization to patients based on risk; and 6. Grandparents parenting children.  Additional weight is given to populations who are living below poverty and those who constitute minority populations. The source of data for the allocation policy and formula is from the Census Bureau. Funding of the work described in this RFP is not guaranteed, and may be granted on an as needed basis. Fluctuations in funding year to year should be expected. Multnomah County cannot assure that any particular level of work will be assigned and the contract will permit Multnomah County to add or remove work as necessary depending on availability of funding SOLUTION REQUIREMENTS/SCOPE OF WORK Supplier shall be an established firm continuously engaged in the business of providing accredited reference laboratory services in compliance with the requirements of the Clinical Laboratory Improvement Amendment (CLIA). Supplier shall have current reference laboratory accreditation evidenced by its ability to meet or exceed all accreditation requirements and standards as developed and imposed by one or more CLIA-approved accrediting organizations such as the Joint Commission or the Commission or the College of American Pathologists. Supplier shall have an established quality assurance program that ensures that the Supplier will preserve its accreditation during the term of the Contract by maintaining and continually improving its standards of performance in order to continue to meet or exceed applicable accreditation standards for testing services. Supplier shall be enrolled in an approved proficiency testing (PT) program for each test performed for which PT is available. Where PT is not available, selected Supplier shall be able to demonstrate a biannual verification of accuracy program that satisfies CLIA requirements. If the Supplier requires software and/or hardware installed on Multnomah County workstations, servers, and/or network, then a successful solution will accommodate the following system considerations: Accommodate the Microsoft Windows desktop environment and operate within Multnomah County's Information Technology Framework If hosted at Multnomah County, be architected using a shared and/or virtualized server environment. Services under this contract shall consist of the following: 1. Medical Laboratory Testing: Provide laboratory testing services. See Attachment 4, Cost Worksheet, for the types of tests Multnomah County has ordered in the past and may order under this contract. Other tests that are not on the list may be ordered as needed. Attachment 4 does not need to be completed or returned in this stage of the sourcing event (RFP). 2. Laboratory Consultation Services: Laboratory consultation services including genetics, toxicology, HIV, microbiology and any other consultation services as needed to aid providers with test result interpretation. 3. Reporting: Provide quarterly reports to MCHD Lab and clinic staff detailing the description and cost of each test, or any other reports on demand. Provide monthly reports of tests ordered by each clinic site for tests paid for by MCHD and those paid for by insurance as well as total MCHD tests ordered and total cost. Additional reports may be requested as needed. Required Reports Test Utilization Report Frequency: Monthly Data to include: Patient Last Name, First Name and Middle Initial, Patient Medical Record Number, Test Name, Test Number, Test volume, Charge billed to primary insurance, Charge billed to secondary insurance, Charge billed to Patient, and Total Test Volume for each Test Type. Hemoglobin A1c Frequency: Quarterly Data to include: Patient Last Name, First Name and Middle Initial, Patient Medical Record Number, Date of Service, Ordering Provider, Accession Number, Requisition Number, Patient Medical Record Number, Lab Reference Number, Result Name, Result Number and Abnormal Flag. Hep C Frequency: Quarterly Data to include: Patient Last Name, First Name and Middle Initial, Patient Medical Record Number, Date of Service, Ordering Provider, Accession Number, Requisition Number, Lab Reference Number, Result Name, Result Number, Signal to Cut Off and Abnormal Flag. HIV - RNA Quantitative and Genotype Frequency: Quarterly Data to include:  Patient Last Name, First Name and Middle Initial, Patient Medical Record Number, Date of Service, Ordering Provider, Accession Number, Requisition Number, Lab Reference Number, Result Name, Result Number and Abnormal Flag. Glucose tolerance tests Frequency: Quarterly Data to include: Patient Last Name, First Name and Middle Initial, Patient Medical Record Number, Date of Service, Ordering Provider, Accession Number, Requisition Number, Lab Reference Number, Result Name, Result Number and Abnormal Flag. Abnormal PAP Frequency: Monthly Data to include: Patient Last Name, First Name and Middle Initial, Patient Medical Record Number, Date of Service, Ordering Provider, Accession Number, Requisition Number, Lab Reference Number, Result Name (ASCH, ASCUS, LSIL, HSIC, HPV Genotype), Abnormal flag. 4. Immediate Test Results: Provide immediate test results to MCHD lab and providers in the event of STAT and/or critical results 24 hours a day, 7 days a week. 5. STAT services: Provide specimen pick-up, delivery and result within a 4-hour time period. Provide result notification as specified above. 6. MCHD Staff Training, Support Services and Related Supplies: Provide MCHD staff training materials on specimen collection requirements. Provide all supplies needed for blood collection, tissue collection, urine collection, other miscellaneous specimen supplies and any required forms. Provide centrifuges that are maintained by the supplier in compliance with all regulations to process blood samples. Provide end user training such as on the use of supplier’s electronic or web-based interfaces for results, test history etc. General application design, screen navigation, toolbar use Data entry, updates, modifications, edits Lab processing Billing adjustments Individual user customization for personal preferences Ordering and receiving supplies Provide System Administration Training, such as; Knowledge transfer of schema, system configuration and set-up Operations and maintenance systems programming training Running ad-hoc reports Ongoing maintenance and support Provide training for MCHD technical support staff Provide phone support to resolve specimen issues and/or ordering issues, e.g. QNS (Quantity Not Sufficient), missing specimen, wrong specimen type, and wrong order placed Provide phone support for inquiries regarding testing options or delayed/ missing test results Provide phone and internet support for specimen collection, type,  processing and transport questions. 8. Medical Laboratory Reference Testing: Provide MCHD with the ability to reference medical laboratory tests to another reference laboratory when a test is not available on the suppliers test menu or if it is not available as a STAT priority through the supplier. Coordinate and support the transport of these specimens to a secondary reference laboratory and the reporting of results. 9. Connectivity: Provide resources to work with EHR provider technical staff to include the following: Test code compendium Technical staff to configure the interface (including the setup, creation, maintenance of a bi-directional lab interface through the EHR provider). Technical staff to map specific data elements. Technical staff to execute an extensive test plan for the orders and results interface. Interface testing performed in a dedicated test environment outside of production. Immediate notification of updates, modification or service disruption in interface capability. Periodic interface testing to ensure functionality. Regular updates to the test code compendium. Bi-directional interface for placing and receiving orders electronically Interface to manage patient sliding fee schedules based on Federal Poverty Limit guidelines and ensure patients are billed appropriately for out-of-pocket costs. Interface to handle rule based billing PDF Technology embedded into the HL7 data file Send LOINC codes via HL7 with results. HL7 version needs to be compatible with Electronic Health Record (EHR) supplier HL7 compatibility (as of Oct 2019) Outgoing 2.3 Incoming 2.5.1 Supplier to provide test environment along with production environment Supplier to provide responsive troubleshooting (interface errors, etc) Supplier to work with Multnomah County to reduce errors such as misordered tests, incorrect specimen type, sample stability, result reporting, and specimen turnaround time. Supplier use of Provider Master File based on NPI and not UPN Supplier to provide test rollup for cascading labs Supplier to provide On-line capability to obtain results in the event of EHR service interruption For New Tests, Test Changes and Discontinued tests Supplier will provide the following to Multnomah County and our EHR provider: Test Name Test Code CPT Specimen Requirements Rejection Criteria Instructions Transport Temperature Specimen Stability Set-Up/Analytic Time Reference Range Units of Measure Methodology Assay Category Performing Site Effective Date 10. Specimen Pick-Up Service: Provide transportation of specimens in appropriate conditions (refrigeration/frozen/room temperature) from MCHD central lab and all other locations. 11. Patient Services Support: Provide Patient Service centers for referral procedures. 12. Billing services: A. Supplier is to bill the patients’ primary and secondary insurance before billing Multnomah County Health Department (MCHD) B. Before invoicing MCHD the balance for any denied claims by third party payers, Supplier shall make reasonable efforts to correct any claim errors and omissions and re-invoice the responsible payer with a corrected claim. C. Payments received from Medicaid and Medicare constitute payment in full. D. Supplier shall consult Multnomah County as needed to obtain sufficient information to perform and ensure accurate billing. E. Multnomah County will qualify self-pay patients in accordance with the Federal Poverty Guidelines from the U.S. Department of Health and Human Services. For patients screened for self-pay status for the first time, or who are reapplying subsequent to their initial qualification, and whose documentation has not yet been approved by Multnomah County, Multnomah County will provide the approved tier level below within 30 days. F. For those patients whom the Multnomah County has qualified as self-pay, Multnomah County will provide an appropriate third party billing mnemonic code (INDIG) and list the tier specific to the patient’s FPL level and the Supplier shall charge the patients using the following sliding fee discount provided by the Multnomah County: Tier 1: 0-100% pay 0.00 Tier 2: 101-133% receive 75% discount Tier 3: 134-167% receive 50% discount Tier 4:    168-200% receive 25% discount Tier 5:    >201% No Discount G. Supplier shall be paid for the work on the following basis: Upon receipt of a correct itemized monthly invoice for services performed, with properly invoiced prices that do not exceed the prices set forth in the current fee schedule provided at the beginning of the contract and any amendments.  All invoices must include the following: Supplier Number Patient Last Name, First Name, Middle Initial Patient Medical Record Number Date of service Lab Reference Number Test Name Unit cost of test Primary payer’s name, payment and adjustment (include per line item code) Secondary payer’s name, payment and adjustment FPL applied Balance Due Invoices shall be sent electronically to the following:: Multnomah County Health Department - Accounts Payable unit:  hdap@multco.us. Multnomah County Health Department Laboratory Manager 619 NW 6th Ave  Floor 8 Portland, OR  97209 Payment terms shall be net Forty-Five days provided the work described in the invoice has been performed in accordance with the terms of the contract. All final billings affecting contract payments must be received within forty-five (45) days after the end of the contract period. H. All refunds issued back to Multnomah County by the Supplier , shall include the following: Supplier Number Patient Last Name, First Name, Middle Initial Patient Medical Record Number Date of Service Lab Reference Number Test Name Reason for refund I. Any additional expenses will require prior approval in writing from Multnomah County. 13. Laboratory Directorship services: Provide Laboratory Directorship for three (3) or more CLIA licenses and ensure compliance with all CLIA regulations. Provide technical oversight of all MCHD laboratories and additional laboratory sites as needed. Ensure quality performance of all aspects of testing conducted within the limitations of the clinical laboratory license. Ensure Laboratories are operating in safe environmental conditions Approve all laboratory procedures and ensure all approved procedures are available to laboratory staff. Ensure MCHD employs a sufficient number of employees with appropriate education/training to cover the workload. Ensure lab staff competencies and proficiencies are conducted in accordance with all applicable rules and regulations. In coordination with the Lab Manager and Pharmacy and Lab Services director, write the job descriptions and expectations for the Lab Manager, Lab Operations Supervisor, Medical Technologists and Medical Laboratory Technician. Appropriately delegate additional responsibilities to the Laboratory Manager as needed and ensure delegated tasks are performed properly. Ensure Lab Manager and Operations Supervisor provides on-site supervision as required for high complexity testing personnel qualified under 493.1489 (4). 14. Quality Supplier to: Provide proactive notifications of test delays and recalls Provide test results immediately for those designated as STAT Notify and work with Multnomah County when samples are lost Work with Multnomah County in continuous quality improvement efforts 15. Privacy Supplier to: Comply with all requirements of Multnomah County’s standard Business Associate Agreement (BAA) without modification (see attached BAA) Maintain system security to protect patient health information as required by HIPAA (please also refer to BAA attachment in the Buyers Attachment section) Ensure policies are in place with subcontractors to protect patient health information as required by HIPAA 16. Conversion Considerations If Multnomah County awards to a new Supplier, the transition will involve Multnomah County, EHR provider, the current Supplier and the new Supplier. It is important that the new Supplier work with Multnomah County, EHR provider, and the current Supplier to ensure a smooth transition from the current supplier to the new supplier. This will include developing and implementing a transition plan without service interruption. A new Supplier should have prior experience with successfully transitioning Patients, similar in size and complexity to Multnomah County. 17. Implementation Services In addition to the requirements listed above, Multnomah County is seeking implementation services.  This may include providing customization, design, coding, and testing of new software/interfaces/reports.  Implementation support, which includes business process analysis, system configuration, as well as end-user training, go-live, and post go-live support. If hardware/software installation is involved, this includes assistance with that installation and configuration. 18. Security Considerations This sourcing event will assess the security considerations listed below.  Suppliers may be required to complete an IT Security Assessment as part of this sourcing event. Information security or privacy certifications Asset Management Governance Supply Chain Risk Management Identity Management, Authentication and Access Control Human Resource Security Data Security System Acquisition, Development and Maintenance Physical and Environmental Security Information Protection Processes and Procedure Protective Technology Security Continuous Monitoring Information Security Incident Management Privacy 19. Technology Considerations This sourcing event will assess the technology considerations listed below. System Architecture Current Hardware Compatibility Current Technical Environment Compatibility Support and Maintenance EHR compatibility with EPIC PRE-AWARD RISK ASSESSMENT Successful proposers whose contract award includes federal funding (as identified by a Catalog of Federal Domestic Assistance number) will be subject to a Pre-Award Risk Assessment (which includes an evaluation of financial stability, quality of financial /management systems, experience with federal funds, reports and findings from audits) completed by Multnomah County (if one has not been submitted in the last year) prior to the issuance of a contract. Contractors who fail to submit the required documents will not be eligible for a contract from the County. MINIMUM PROPOSAL SUBMITTAL REQUIREMENTS Timely submission of responsive, responsible offers is the only minimum requirement for this sourcing event. FISCAL REQUIREMENTS AND REPORTING The program office will negotiate reporting requirements with the selected Supplier during contract negotiations. PERFORMANCE MEASURES/PERFORMANCE CONTRACTING Final performance measures will be negotiated between MCHD and the selected Supplier. Typical performance measures may include:  • Receiving test results and reports within a designated timeframe as specified in the contract.  • Continuity of care during normal business hours and after hours.  • Communicating to MCHD in cases of STAT and critical findings  • Connectivity and Interface performance • Sustainable business practices. CONTRACT NEGOTIATION The County will initiate contract negotiations with the responsive and responsible Supplier with the highest scoring proposal. Multnomah County may, at its option, elect to negotiate general contract terms and conditions, services, pricing, implementation schedules, and such other terms as the County determines are in the County’s best interest. If negotiations fail to result in a contract, the County reserves the right to terminate the negotiations and initiate contract negotiations with the next highest scoring responsive and responsible Supplier. This process may continue until a contract agreement is reached.  Multnomah County reserves the right to score the acceptance of its standard contract terms and conditions as a part of this sourcing event. CONTRACT AWARD County is seeking to award one contract through this sourcing event.  Award, as determined by the County, will be made to the responsible Supplier whose Proposal the County determines is most advantageous to the County based on the evaluation process and evaluation factors described in this sourcing event.  Multnomah County strongly encourages the participation of Minority-Owned, Women-Owned, and Emerging Small Businesses and Organizations in providing these services. CONTRACT TERM The contract term will be negotiated at time of contract award and will be dependent upon the product and/or services provided. The Negotiated contract term will be in compliance with all public procurement laws and Multnomah County PCRB public contracting rules. COMPENSATION AND METHOD OF PAYMENT Compensation method for implementation services and hardware: deliverables-based payments upon acceptance with a not to exceed cap. Compensation method for ongoing services, software maintenance and support or subscriptions, etc. will be subject to negotiation once the County has selected a Supplier. COOPERATIVE PURCHASING Other public agencies may establish contracts or price agreements directly with the awarded Supplier under the terms, conditions and prices of the original contract Pursuant to ORS 279A.215 and agreement by the selected Supplier to extend the terms, conditions and prices of the original contract. INSURANCE REQUIREMENTS The Supplier awarded a Contract as a result of this sourcing event will be required to provide at a minimum the insurance outlined in the table below. The type of insurance required will depend on the type of services and or products provided under the contract which will be negotiated during the contract process. Type of Insurance Per Occurrence Aggregate Professional Liability $1,000,000 $2,000,000 Commercial General Liability $1,000,000 $2,000,000 Cyber Liability (only if Software as a Service) $5,000,000 $10,000,000 Workers Compensation Required  MULTI-STAGE SOURCING EVENT SUMMARY Multnomah County will follow a multi-stage sourcing event that incorporates the following potential steps in the Multco Marketplace Supplier Portal: Panel Questionnaire Solution and Supplier Research (Unscored) Autoscored Supplier Qualification based on Solution Requirements Scripted Remote Demo Autoscored Written Proposal Panel Questionnaire Written Proposal Oral Evaluation Pricing Evaluation Best and Final Offer (BAFO) The purpose of a multistage process is to identify and adjust the competitive range between proposed solutions based on the evaluation of each stage with the goal of identifying the most advantageous solution at the conclusion of the process.  The first stage for this Sourcing Event will be an auto-scored Supplier Qualfication based on Solution Requirements.  The follow-on stages will be determined based on the results of the first stage. Multnomah County reserves its right, at its sole discretion, to modify, adjust, re-order, repeat, re-schedule or cancel individual steps by written notification to all affected parties.  Multnomah County may, at its sole discretion, make an award at such time as the most advantageous solution for the County has been identified through this competitive process. EVALUATION PROCESS AND CRITERIA Proposed solutions will be evaluated using a combination of auto-scoring and scoring by an evaluation panel depending on the stage.  Scores of each stage will be added together for a total score for all stages excluding BAFO.  If the County uses an optional BAFO process, prior scores will be considered but a new score will be determined based on evaluation of Best and Final Offers. Multnomah County is seeking a solution and/or services that meets or exceeds its identified requirements based on the judgment of the evaluators and the score of the supplier’s offer determined by this process, at a cost that is deemed by evaluators to be reasonable, responsible and optimal for purchase with public dollars. DETERMINATION OF COMPETITIVE RANGE Multnomah County will determine Competitive Range based on a natural break in scores for those proposers that are determined to be closely competitive and have a reasonable chance to be the Most Advantageous Proposer.  At the conclusion of each stage, all proposers will be receive notification of which Proposers have been determined to comprise Competitive Range.  Proposers determined to be within the Competitive Range will continue to the next stage.

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