Detailed specifications of work to be performed under this solicitation are as follows: 1. The Contractor shall fill the requirements set forth by CLIA and Joint Commission regulations for Moderate Complexity Testing. The Contractor shall fill the required position of Laboratory Director (LD) and Clinical Consultant (CC). The Contractor shall meet the qualifications of these positions as defined in the CLIA Required Personnel Qualifications. 2. The Contractor will review and sign as approving the following manuals: a. Performance Improvement b. Lab guidelines c. Lab general policies and procedures d. Point of Care e. Fire Safety f. Laboratory test procedures g. Quality control procedures h. Schuyler user manual 3. The Contractor shall not serve as Director of more than five (5) laboratories to include Clinical Laboratory Improvement Amendments (CLIA) certificates for non-waived and Provider Performed Microscopy (PPM) certificates. 4. The Contractor shall schedule with the Contract Monitor, monthly on-site visits. The Contractor shall be available to meet with accreditation inspectors and will review, make any recommendations and sign as approving the following areas: a. CAP surveys b. Linearity studies and calibrations c. Quality Control including but not limited to the following areas of the Laboratory: 1. Endocrinology 2. Chemistry 3. Immunology 4. Hematology 5. Urinalysis 6. Point of Care Testing 7. Toxicology d. DHHC Laboratory policies and procedures
