The algorithm that reflexes HPV testing off the PAP Test (LAB1230097) when the “HPV Reflex” option is selected during PAP ordering will no longer include pregnancy status as a criterion for reflexing on LSIL patients. Prior to this update, if HPV Reflex was selected, a PAP Diagnosis of LSIL on patients 25 and older would only reflex HPV testing if the patient was non-pregnant. Starting 11/6/2024, if HPV Reflex was selected, a PAP Diagnosis of LSIL on patients 25 and older will reflex HPV testing regardless of pregnancy status. This update aligns with current ASCCP Risk-Based Management Consensus guidelines.
Cytology
New Test: HPV High Risk Screen with HPV Genotype Reflex
Effective August 26, 2024, Corewell Health Laboratories West will be updating their High-Risk HPV testing. The new assay will be performed on the Abbott Alinity m at Corewell Health Reference Laboratory West, Grand Rapids. Testing will now automatically include HPV Genotype results whenever HPV is detected. There will no longer be a separate charge to the patient for HPV Genotype testing.
There will also be an expanded number of High-Risk HPV Genotypes reported:
- HPV Genotype 16
- HPV Genotype 18
- HPV Genotype 45
- HPV Genotype 31/33/52/58
- HPV Genotype 35/39/51/56/59/66/68
The new assay is FDA approved for Primary screening in addition to co-testing.
Post hysterectomy vaginal specimens will still be a send out test (LAB1230722).
Safety of our patient and quality of care are of utmost importance. For this reason we require specimens sent to the Spectrum Health Cytology Laboratory be labeled with at least two patient identifiers, (i.e., patient legal name, birth date and MRN.) We will no longer return to the collection site, unlabeled, mislabeled specimens lacking two patient identifiers or specimen containers with multiple different patient labels. These specimens will be discarded and repeat collection will be necessary.
Procedures to verify correct labeling of patient specimens at the time of collection are recommended. Specimen containers should not be pre-labeled. Variation of the “time-out” procedure used in the hospital and surgical center setting is an excellent way of confirming that the specimen is correctly labeled. This can easily be achieved by having the patient verify his or her name and birth date, by reading the label placed on the specimen container at the time the specimen is collected. This “time out” should occur before the specimen leaves the examination or treatment room.
It is our mission to provide the best and safest care we can to our patients. We know that physicians and other practitioners are required to see patients more efficiently and at times with less than adequate time allowed. Following a “time out” procedure and not pre-labeling specimen containers will prevent errors that may lead to diagnoses being assigned to wrong patients, hence, unnecessary procedures and lack of follow-up for the appropriate patient.
Spectrum Health Laboratory strives to ensure that all marketing of laboratory services is honest, straightforward, fully informative and non-deceptive. The Spectrum Health’s Code of Conduct dictates that quality laboratory practices are followed and laboratory marketing activities must meet all government laws and regulations.