ACHIEVEMENTS

                              MANUFACTURING RECORD:

Solomon Park is the manufacturer of record for the following sera:  

NIST standard reference materials:

• SRM 1951a for cholesterol
• SRM 1951b for cholesterol
• SRM 967 for creatinine
• SRM 967a for creatinine

CDC Testing Programs:

• Cholesterol Reference Method Laboratory Network (CRMLN) Certification Materials (since 1989)
• Lipid Research Clinic (LRC) Controls (since 1991)
• Lipid Standardization Program (LSP) External Control Program (since 1999)

Cholesterol Certification Materials:

• Certification serum for manufacturers (since 1989)
• Certification serum for medical test sites (since 1989)
• ReLabs serum for external testing (since 1989)

SERUM PREPARATION 

Serum for the NIST and CDC materials and programs are prepared according to Clinical and Laboratory Standards Institute document C37-A (which can be obtained from the CLSI at www.clsi.org telephone 610-688-0100 or FAX 610-688-0700).


Solomon Park prepares and ships certification and ReLabs materials for the Northwest Lipid Reference Laboratory to approximately 100 laboratories on a quarterly basis. These materials are produced from fresh, never-frozen serum that must be manufactured and distributed on a strict time schedule. The lipid levels are stringently controlled by the CDC and the materials must be collected, processed, assayed, and shipped to participating laboratories within a 24-hour period. The assays are performed on the fresh serum in the participating laboratories within 48 to 96 hours of collection. Target values are set at the NWLRL. Laboratories interested in participating in this program should contact the Northwest Lipid Research Laboratory at http://depts.washington.edu/nwlrl/relabs.html telephone (206) 685-3332 or FAX (206) 685-3279

Serum and plasma for other pooled materials are routinely collected according to CLSI document C37-A and frozen on the day of collection and held at –70o until either shipped in bulk or thawed and aliquoted for these pools. The bulk and aliquoted serum pools can be either unfiltered or filtered through 0.22 micron filters. Plasma pools cannot be 0.22 micron filtered.



PERFORMANCE RECORD

Performances Licenses and Certifications:

Cholesterol Certification:
Solomon Park Research Laboratories participates in and has successfully passed without interruption since 1989 the CDC sponsored biannual Cholesterol Certification Program monitored by the Northwest Lipid Research Laboratory.

ReLabs Program:
The Laboratory participates in the Reference Lipid Analysis Basic Survey (ReLabs) program sponsored by Northwest Lipid Research Laboratories and has successfully passed all testing since 1989.

Proficiency Testing Programs:
Solomon Park Research Laboratories has been enrolled in external proficiency testing for lipids and glucose from the College of American Pathologists and the American Proficiency Institute and has successfully passed all challenges since 1989.

HIV Proficiency Testing:
Solomon Park Research Laboratories participates in the voluntary CDC Model Performance Evaluation Program (MPEP) sponsored proficiency testing program for HIV testing and has successfully passed all challenges since 2001

Medical Test Site:
The laboratory is a medical test site registered in the State of Washington and has successfully passed all inspections.

FDA Approved blood draw center:
Solomon Park Research Laboratories is an FDA registered blood draw center and has successfully passed all inspections by this agency since 1990