ARFQ WEH2500000008 Specifications Laboratory Director Services.docx

Laboratory Director Services

ARFQ WEH2500000008

SPECIFICATIONS

1. PURPOSE AND SCOPE: The West Virginia Office of Shared Administration, Purchasing Division is soliciting bids on behalf of the Department of Health Facilities (DHF), Welch Community Hospital (WCH) to establish an open-end service contract to supply staffing of specialty services in the areas of Laboratory Director to in-house laboratory.

NOTE: This request is covered in part or in whole by federal funds. All bidders will be required to acknowledge and adhere to the attached Provisions Required for Federally Funded Procurements.

NOTE: The DoHS OSA has developed an EEOP Utilization Report and it is available at:

https://dhhr.wv.gov/office-of-drug-controlpolicy/news/Documents/EEO%20Uitlization%20Report%20Completed%20Form%201-29-21-final-PDF%20review%20for%20approval%20to%20submit%20%283%29.pdf

NOTE: The Health Insurance Portability and Accountability Act of 1996 (hereafter, HIPAA) Business Associate Addendum (“Addendum”) is made a part of the Agreement by and between the West Virginia Department of Health Facilities (DHF), Bureau for Office of Health Facilities (OHF), Welch Community Hospital (Agency), and Business Associate (Vendor) and is effective as of the date of execution of the Addendum.

2. DEFINITIONS: The terms listed below shall have the meanings assigned to them below. Additional definitions can be found in Section 2 of the General Terms and Conditions.

2.1 “Contract Services” means physician services contract for specialty services in the areas of Laboratory Director services to in-house laboratory as more fully described in these specifications.

2.2 “Pricing Page” means the pages contained WV OASIS or attached hereto as Exhibit A, upon which Vendor should list its proposed price for the Contract Services.

2.3 “Solicitation” means the official notice of an opportunity to supply the State with goods or services that is published by the Purchasing Division.

3. QUALIFICATIONS: VENDOR, or Vendor’s staff if requirements are inherently limited to individuals rather than corporate entities, shall have the following minimum qualification

3.1. Vendor shall provide physicians who are qualified, professional, competent, duly licensed, in the State of West Virginia.

3.2. Vendor’s physicians will have a background check done by the Vendor.

3.3. The Vendor will ensure that appropriate releases are signed by the physician to release the background checks to the Hospital.

4. MANDATORY REQUIREMENTS:

4.1 Mandatory Contract Services Requirements and Deliverables: Contract Services must meet or exceed the mandatory requirements listed below.

4.1

4.1.1 Laboratory Director Services Qualifications:

4.1.1.1 The laboratory director must be qualified to manage and direct the laboratory Department.

4.1.1.2 The laboratory director must be a Doctor of Medicine or Doctor of Osteopathy licensed to practice medicine or osteopathy in the State of West Virginia; OR

4.1.1.3 The laboratory director must be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; OR

4.1.1.4 The Laboratory director must have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); OR

4.1.1.5 The laboratory director must have at least 2 years of experience directing or supervising high complexity testing; OR

4.1.1.6 Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS; OR

4.1.1.7 The laboratory director prior to February 24,2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have the following:

4.1.1.7.1 Two years of laboratory training or experience, or both.

4.1.1.7.2 Two years of laboratory experience directing or supervising high complexity testing.

4.1.1.8 The laboratory director must have previously qualified as a laboratory director; or

4.1.1.9 On or prior to February 28, 1992, must be qualified under State law to direct a laboratory in the State of West Virginia.

4.1.2 Lab Director Responsibilities

4.1.2.1 The laboratory director is responsible for the overall operation and administration of the laboratory department

4.1.2.2 The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel.

4.1.2.3 The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.

4.1.2.4 Each individual may direct no more than five laboratories.

4.1.2.5 The laboratory director must:

4.1.2.5.1 Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing.

4.1.2.5.2 Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards.

4.1.2.5.3 Ensure the following:

4.1.2.5.3.1 The test methodologies selected have the capability of providing the quality of results required for patient care.

4.1.2.5.3.2 Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.

4.1.2.5.3.3 Laboratory personnel are performing the test methods as required for accurate and reliable results.

4.1.2.5.4 Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and the following:

4.1.2.5.4.1 The proficiency testing samples are tested as required.

4.1.2.5.4.2 The results are returned within the timeframes established by the proficiency testing program.

4.1.2.5.4.3 All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action.

4.1.2.5.4.4 An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory.

4.1.2.5.5 Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.

4.1.2.5.6 Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.

4.1.2.5.7 Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly.

4.1.2.5.8 Ensure that reports of test results include pertinent information required for interpretation.

4.1.2.5.9 Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.

4.1.2.5.10 Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test.

4.1.2.5.11 Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.

4.1.2.5.12 Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.

4.1.2.5.13 Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.

4.1.2.5.14 Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the pre-analytic, analytic, and post-analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.

4.1.2.6 Invoice to Hospital:

4.1.2.6.1 Vendor must complete one (1) full month of service before invoicing Agency.

4.1.2.6.2 The Vendor shall submit invoices, in arrears, by the 15th of each month, to the Agency at the address on the face of the purchase order labeled “Invoice To” pursuant to the terms of the contract. The invoices must be in a form approved by the Department and must include a monthly activity log. Vendor will be responsible for payment of all subcontracts, staff, and any other support staff contracted to provide services.

4.1.2.6.3 The Vendor will bill the facility an hourly rate for services provided not to exceed 24 hours per day.

4.1.2.6.4 The Vendor will complete the billing for all Emergency Department professional fees

4.1.2.6.5 State law forbids payment of invoices prior to receipt of services. The Department reserves the right to reject any or all invoices for which proper documentation has not been provided. Vendor will be notified of deficiencies within fifteen (15) days of receipt of the invoice.

4.1.2.6.6 Purchasing Card Acceptance: The State of West Virginia currently utilizes a VISA purchasing card program which is issued through a bank. The successful Vendor must accept the State of West Virginia VISA purchasing card for payment of all orders placed by any state Agency as a condition of award.

4.1.2.6.7 The Vendor will invoice monthly and will provide detailed documentation supporting the invoiced amount.

4.1.2.6.8 Agency and Vendor shall determine the format of the invoice form. Agency reserves the right to modify the invoice format at any time if additional information is required.

4.1.2.7 Access & Confidentiality:

4.1.2.6.9 The Vendor, its employees and agents shall have access to private and confidential data maintained by the Hospital to the extent required for Vendor to carry out the duties and responsibilities defined in the contract. The Vendor agrees to maintain confidentiality and security of the data made available.

4.1.2.6.10 The Vendor shall indemnify and hold harmless the State and Agency against any and all claims, brought by any party, attributed to actions of breach of confidentiality by Vendor, subcontractors, or individuals permitted access by Vendor, including legal fees and disbursement paid or incurred to enforce the provision of the contract.

4.1.2.6.11 The Vendor shall accept responsibility for providing adequate supervision and training to its agents and employees to ensure that confidentiality is maintained. No private or confidential data maintained or used during the contract period shall be disseminated except as authorized by statute either during the contract period or thereafter.

4.1.2.6.12 News Release: News releases or other publicity pertaining to the services to be provided under this contract shall not be made without prior approval by DHF.

4.1.2.7 Debarment and Suspension: Vendor certifies that no entity, Agency, subcontractor or person associated with the Vendor is currently debarred or suspended by any state or the Federal government.

5. CONTRACT AWARD:

5.1 Contract Award: The Contract is intended to provide Agency with a purchase price for the Contract Services. The Contract will be awarded to the Vendor that provides the Contract Services meeting the required specifications for the Lowest Grand Total Cost for Healthcare Provider Services as shown on the Pricing Page.

5.2 Pricing Page: Vendor should complete the Pricing Page by entering pricing for requested item. Vendor should complete the Pricing Page in full as failure to complete the Pricing Page in its entirety may result in Vendor’s bid being disqualified. The Vendor should type or electronically enter the information into the Pricing Pages through WV OASIS, if available, or as an electronic document.

6. PERFORMANCE: Vendor and Agency shall agree upon a schedule for performance of Contract Services and Contract Services Deliverables, unless such a schedule is already included herein by Agency. In the event that this Contract is designated as an open-end contract, Vendor shall perform in accordance with the release orders that may be issued against this Contract.

7. PAYMENT: Agency shall pay pricing as indicated within bid proposal as shown on the Pricing Pages, for all Contract Services performed and accepted under this Contract. The Vendor shall accept payment in accordance with the payment procedures of the State of West Virginia.

8. TRAVEL: The Vendor shall be responsible for all mileage and travel costs, including travel time, associated with performance of this Contract. Any anticipated mileage or travel costs may be included in the flat fee or hourly rate listed on Vendor’s bid, but such costs will not be paid by the Agency separately.

9. FACILITIES ACCESS: Performance of Contract Services may require access cards and/or keys to gain entrance to the Agency’s facilities. If access cards and/or keys are required:

9.1. The Vendor must identify principal service personnel which will be issued access cards and/or keys to perform service.

9.2. The Vendor will be responsible for controlling cards and keys and will pay replacement fee, if the cards or keys become lost or stolen.

9.3. The Vendor shall notify the Agency immediately of any lost, stolen, or missing card or key.

9.4. Anyone performing under this Contract will be subject to Agency’s security protocol and procedures.

9.5. The Vendor shall inform all staff of the Agency’s security protocol and procedures.

10. VENDOR DEFAULT:

10.1. The following shall be considered a Vendor default under this Contract.

10.1.1. Failure to perform Contract Services in accordance with the requirements contained herein.

10.1.2. Failure to comply with other specifications and requirements contained herein.

10.1.3. Failure to comply with any laws, rules, and ordinances applicable to the Contract Services provided under this Contract.

10.1.4. Failure to remedy deficient performance upon request.

10.2. The following remedies shall be available to the Agency upon default.

10.2.1. Immediate cancellation of the Contract.

10.2.2. Immediate cancellation of one or more release orders issued under this contract

10.2.3. Any other remedies available in law or equity.

11. MISCELLANEOUS:

11.1. Contract Manager: During its performance of this Contract, Vendor must designate and maintain a primary contract manager responsible for overseeing Vendor’s responsibilities under this Contract. The Contract manager must be available during normal business hours to address any customer service or other issues related to this Contract. Vendor should list its Contract manager and his or her contact information below.

Contract Manager: ______________________ Telephone Number: ________________________ Fax Number: ______________________________ Email Address: ____________________________

Revised 08/15/24