5190-0 final~1.docx

SOLE-SOURCE DETERMINATION MEMO

FOR SUPPLIES AND SERVICES

DHS Office of Contracts & Procurement

Estimated total contract value: $150,000.00 (five-year projection); Sole Source Determination Request is for up to Five (5) years, with an option to extend for an additional Five (5) years and increase funding by commensurate amount as needed.

Description of goods or services: The College of American Pathologists (CAP) Laboratory Preparedness Exercise (LPX), Bi-Annual (April & October) Proficiency Testing (PT)/Educational Challenge Exercises, general accreditation and ongoing and regular participation in Proficiency Testing programs.

1. Background: This sole source justification applies to the purchase of:

1. The OSPHL has been accredited by the CAP for more than 20 years. The CAP’s Laboratory Accreditation provides the OSPHL with the most rigorous evaluation to maintain Clinical Laboratory Improvement Amendments1 (CLIA) eligibility. The CAP accreditation provides laboratory consumers with an added assurance of high-quality testing, increasing the standing of the laboratory in the scientific and medical community.

2. Laboratory certification requirements include participation in a proficiency program for each testing service offered (See 42 CFR 493.803).

3. The CAP LPX proficiency program/challenge exercise is the only commercially available and recognized program approved in the United States which offers proficiency challenges twice a year for biothreat organisms and other clinically relevant emerging pathogens that may be encountered in hospitals, or clinical or veterinary laboratories, and that meets the requirements and other desirable attributes determind by the OSPHL. These proficiency kits align with current clinical and veterinary laboratory practices and reflect the majority of significant laboratory tests needed to presumptively identify biothreat organisms, and which are in alignment with the current American Society of Microbiology (ASM) Sentinel Clinical Level Laboratory Guidelines for Agents of Bioterrorism and Other Emerging Pathogens.

The OSPHL purchases the CAP LPX for distribution to qualified Sentinel2 Laboratories in Oregon annually.

The OSPHL purchases the CAP LPX using the Federal Cooperative Agreement Public Health Emergency Preparedness (PHEP) grant funding to meet the PHEP requirements of insuring sentinel laboratory preparedness and competence in biothreat agent presumptive identification testing and notification to public health authorities. This specialized testing and promp notification to public health is a critical exercise in communicable disease surveillance in Oregon. Laboratories will have various requirements from their various accreditation bodies (e.g., CAP, CLIA, Joint Commission, etc.), including those for laboratory preparedness, testing proficiency, safety, and other areas of laboratory practices, and the CAP LPX provides direct assistance for meeting some of these requirements. The CAP is able to mail LPX kits twice a year directly to pre-determined, approved, and qualified sentinel laboratories, and provides evaluations after each bi-annual exercise for future competency assessment. The CAP LPX evaluations include participating laboratory-specific results as well as national aggregate result comparisons, and reports are prepared by nationally recognized subject matter experts. The OSPHL relies heavily on the CAP LPX to meet a PHEP requirement of assessing sentinel laboratory competence for properly identifying agents of bioterrorism and prompt notification to public health for statewide and national preparedness measures.

2. Prospective contractor/vendor:

DBA:

Protests are due by 3:00 PM within seven calendar days after the first date the notice is posted on OregonBuys. Protests must be sent via mail, fax, email, or hand carried to the following address: Protests via telephone will not be accepted.

Oregon Department of Human Services/Oregon Health Authority

Office of Contracts and Procurement

Agency reserves the right to purchase additional goods, services to include on-call maintenance, preventative maintenance, repair (unless available on DAS price agreement), or training.

3. Written findings of fact (market research):

The findings below must include factual information supporting the determination that meet the sole source requirement in statute.

Pursuant to ORS 279B.075, Agency must conduct market research that supports the assertion that there is only one source that can provide the goods or services. Market research includes utilization of the internet, trade journals, agency vendor lists, professional organizations, studies, catalogs/industrial periodicals, vendor sources, yellow pages, etc.

Agency must select at least one of the findings and prepare the determination as it specifically relates to the good or service being procured. More than one finding can be addressed. The findings are as follows:

|X| Pursuant to ORS 279B.075 (2)(a): Provide findings supporting the determination that the efficient utilization of existing goods requires the acquisition of compatible goods or services from only one source.

Switching to an alternative accreditation would increase the burden to staff and will decrease the OSPHL clinical and professional reputation, even if a lower cost vendor is identified. Using one Proficiency Testing provider for most of the required analytes provides greater efficiency for the testing staff at the OSPHL. Additionally, the CAP provides the specific PT’s required by the OSPHL. The CAP organizes the shipping calendar so that shipments are staggered and do not all arrive at the testing laboratory during the same timeframe. Proficiency Testing specimens must be tested and reported within a specific amount of time after receipt, making staff unavailable to perform patient specimen testing.

The CAP LPX proficiency program is the only program approved (as required by 42 CFR 493) in the United State which offers proficiency challenges for the specialized biothreat agent tests (potential bioterrorism organisms) OSPHL performs, and for bacteriology tests conducted in clinical or veterinary LRN sentinel laboratories for biothreat organisms and other significant emerging pathogens. The other approved proficiency testing (PT) programs are designed to serve the physician office and small hospital laboratory. These programs do not regularly offer proficiency in specialized testing, such as high complexity microbiology testing that would be needed by qualified sentinel laboratories to detect biothreat organisms. The bi-annual CAP LPX kits can be mailed directly to participating laboratories and provide exercise summary evaluation reports for individual participating laboratories as well as national aggregate data to aid in laboratory preparedness competency assessment determinations. The CAP LPX is designed to measure proficiency and is in alignment with current guidelines from the American Society for Microbiology (ASM) and the CDC for laboratory bioterrorism identification and prompt notification to public health to assess disease surveillance systems. The Wisconsin State Laboratory of Hygiene (WSLH) offers a similar Proficiency Test menu comparable to those offered by CAP, including a bi-annual laboratory bioterrorism preparedness exercise (BPE), however the WSLH BPE is not able to provide national aggregate data used for comparable and diverse competency assessment purposes.

and |X| Pursuant to ORS 279B.075 (2)(d): Any other findings that support the conclusion that the goods or services are available from only one source.

Proficiency Testing enrollment and successful participation is required to be compliant to federal and state laws, and to ensure the CAP accreditation and CLIA certification in order to provide quality laboratory testing to protect the health and welfare of the people of the State of Oregon. Year after year top hospitals choose to partner with the CAP as the most rigorous choice for accreditation, strengthening each laboratory’s ability to deliver high-quality service to ensure best patient care possible (per US News and World Report, US News Best Hospitals, web page January 2020 and IBM Watson, 100 Top Hospitals web page, July 2019).

APPROVED:

By:

Kirk N. Rhoades or acting DPO

1 Additional information about CLIA can be found at: https://www.cms.gov/Regulations- and-Guidance/Legislation/CLIA

2 Definition of Sentinel Laboratory can be found at: https://asm.org/Articles/Policy/Laboratory-Response-Network-LRN-Sentinel-Level-C