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In the past four (4) years COLTCO has built many new POL’s and Reference Laboratories. The sizes range from a single-practitioner to multi-specialty clinics to reference laboratories performing testing on 500-600 patients per day.

Our services include everything required to open a new laboratory...from the planning of the layout to the recommendations for instrument acquisition, the generation of custom policy & procedure manuals, the training of your personnel and, finally, the standing of the initial survey with your personnel and the surveyor(s) to ensure that everything goes well.

After the survey process has ended, many of our clients have requested that we be retained with a Technical Consulting Agreement which ensures the client of frequent visits and maintained compliance within their laboratory. These agreements include on-site inspections, review of all documents, the production of any new documentation, and the documented training of your personnel.

COLTCO guarantees all work performed. If you are cited for anything which we have prepared for you and trained your staff, we will fix it, to include any required documentation and/or training at no charge.

PRE-SURVEY evaluations have become necessary due to the recent changes in the laws which govern clinical laboratories. Depending on the size of your facility, the pre-survey routinely takes 3-8 hours. During this period, all manuals, forms, instrument printouts, personnel files, QA, QC, Proficiency Testing, Preventative Maintenance, and Billing Procedures are thoroughly reviewed for content and compliance. In addition, all OSHA and OIG mandates and recommendations are reviewed.

POST-SURVEY review of SOD’s (Statement of Deficiencies) and other Federal and State documents delineating any problems or deficiencies for which you have been cited is quickly followed by recommended ‘actions’ and reasonable dates of completion to be returned in a timely manner to the surveying entity.

These recommended actions depending on the depth and breadth of the citations received may include but are not limited to:
  • new policies & procedures (with appropriate documented logs)
  • new training or retraining with testing personnel sign-off
  • the documented purchase of equipment and/or outside services (i.e. Preventative Maintenance contract with an accredited outside vendor)
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1581 E. Downing Street • Simi Valley, California 93065
(805) 577.8320 • FAX (805) 577.6605 • E-mail: coltco@coltco.com
Edd E. Epstein, MS, MT[ASCP], REHS • President