Laboratory terms and conditions

COMPLIANCE & CONFIDENTIALITY
GenoSUR is a CLIA Certified independent diagnostic laboratory located in Miami, Florida. We perform diagnostic services consistent with all applicable standard practices, laws and regulations. GenoSUR and its employees or agents, shall not use (except in the course of the services provided herein), in any form or manner, and shall not disclose, in whole or in part, to any other party, confidential information provided by the Client or any patient of any Client.

COMMUNICATIONS All
Clinical matters are to be discussed among the clinician, head nurse practitioner or the professional that sampled the Client’s patent, and GenoSUR’s on site Medical Technologist who may be reached at:

Cindy Briones - Mobile - (786) 658 4744. cindy.briones@genosur.com

SPECIMEN CUSTODY AND DELIVERY:
All biological samples (specimens) must be transported and delivered to GenoSUR in a transport container (box) that is clearly labeled as an “INACTIVATED Nasopharyngeal Specimen” Each biological sample must be placed in a secondary container (i.e. zipper bag) within the transport container . All vials must be sprayed with 70% ethanol, or 70% isopropanol, then dried prior to being placed in the secondary container. Transport Protocol: 1) The Client shall prepare a statement of how many specimens are in each container, which must be signed by the individual person who prepared the container. GenoSUR will notify the Client if the number of specimens delivered differ from the number of specimens noted on the container. 2) The Client shall contact the GenoSUR laboratory 20 minutes before arriving at the diagnostic location to arrange the specimen delivery. Hours of operation for sample reception:

Monday through Friday: 10 am - 6:30 pm
Saturday: 2:30 pm -6:30 pm
(305) 503-7746, (305) 851-7632, (305) 859-0422.

SAMPLE REJECTION
Biological samples received by GenoSUR may be rejected due to any one of the following:

  • Insufficient specimen volume
  • Altered sample volume (less or more than 1 mL)
  • Commingled or possibly contaminated specimens that may affect results of testing procedures Inappropriate specimen type
  • Mislabeled specimen
  • Lack of unique identifiers on the vial with the specimen or the requisition form such:
    • Label does not contain patient’s full name and date of birth
    • Requisition form information does not match the information in the sample
    • Requisition form submitted without specimen sample
    • Specimen submitted without a requisition form
    • More than one vial identifier
  • Failure to adhere to the transport protocols
  • Requisition form is not signed or incomplete

In cases where the vial can be associated with a sample ID, but it is not properly labeled, we will report the result and the vial ID, yet no patient information will be included in the report.

DIAGNOSTIC RESULTS
GenoSUR has the following processing times:

  • Monday through Friday:11 am and 3 pm
  • Saturday: 3 pm

 

Samples received prior to GenoSUR’s daily processing times will be processed and reported no more than four hours. In the event a biological sample must be reanalyzed, GenoSUR will conduct the reanalysis and it will be reanalyzed the same day and will report the diagnostic results the following morning before 9am. GenoSUR will not be held responsible for any diagnostic reporting delays if and when a biological sample must be reanalyzed.

GenoSUR’s SARS-CoV-2 rRT-PCR is a molecular test that detects the presence of SARS-CoV-2 RNA, when samples are analysed there are 4 potential outcomes.

  • POSITIVE result, which means that SARS-CoV-2 RNA has been detected on the patient’s sample,
  • NEGATIVE result, which means that SARS-CoV-2 has not been detected,
  • INCONCLUSIVE result, which means that it cannot be ruled out that SARS-CoV-2 is present in the sample.
  • INVALID, which is a sample rejection that occurs after analysis and generated by insufficient sample in the vial.

 

Both INCONCLUSIVE result and INVALID sample are informed only after the sample is reanalysed and the outcome is the same twice, if the outcome is an INVALID sample or an INCONCLUSIVE result, the patient must be sampled again for a new analysis. Patients with INCONCLUSIVE results should quarantine until they retest and obtain a NEGATIVE result, they are to be treated as presumptive positives.

SERVICE EXCEPTIONS: GenoSUR shall be excused from delivering diagnostic results in the timeframe described herein in the event the delay in diagnostic testing arises out of causes beyond GenoSUR’s control and without the fault or negligence of GenoSUR. Such events include, but are not limited to, fires, floods, epidemics, strikes, freight embargo, acts of God or public enemy/terrorism, or any acts of any government in either its soveright or contractrual capacity.

igned by: