CHLAMYDIA/GONORRHEA SPECIMEN COLLECTION DEVICE … 2018 BLOG UPDATE.pdf · Entamoeba histolytica CPT Code: 87505 Soft Code: ENPAR Sample: ... Shiga-like toxin-producing E. coli (STEC)

Page 1

TE

ST

BU

LLE

TIN

February 2018

Dear Healthcare Provider,The information contained here may be very important to your practice. Please take a moment to review this document.

CHLAMYDIA/GONORRHEA SPECIMEN COLLECTION DEVICE CHANGE EFFECTIVE 2/15/18PCL Alverno is moving to a new PCR testing platform for Chlamydia and Gonorrhea testing. Please review page 2 for details on the new multi-collection specimen kit, which will replace the four different collection devices utilized previously, depending on specimen type.

MOLECULAR ENTERIC PATHOGEN PANELS START 3/1/2018Beginning March 1, 2018, PCL Alverno will offer two molecular platforms that will provide flexibility to the Healthcare Provider ordering testing. Please review pages 3 to 6.

REMINDER: REFLEX CRITERIA FOR URINE CULTURES CHANGED IN JANUARY!Alverno has recently updated its criteria for urine culture reflex testing from >5 WBCs to >10 WBCs. Effective January, all urinalysis ordered with a urine culture reflex do so based upon the new criteria.

EGFR BY PCR – PLASMA SPECIMEN FOR LIQUID BIOPSYPlease review page 7 for information on a non-invasive supplement to biopsy analysis for identifying non-small cell lung cancers that may benefit from treatment with epidermal growth factor receptor-tyrosine kinase or anaplastic lymphoma kinase inhibitors.

WELCOME NEW CLIENTS! We would like to welcome all new Healthcare Providers who joined our team in January!

Find Us on Facebook, LinkedIn and Google Plus!

2434 Interstate Plaza Drive, Hammond, IN 46324toll free 800.937.5521 · phone 219.989.3700 · fax 219.989.3900

www.PCLAlverno.com

Chlamydia / GonorrheaSpecimen Collection Update

Single Collection Device February 15, 2018

On February 15th, PCL Alverno will move the Chlamydia and Gonorrhea by PCR testing to a new platform. This move will greatly simplify the collection device protocol. Currently the collection device is dependent upon the source of the specimen. This requires the stocking of four different collection kits. The new test has a single multi-Collect™ Specimen Collection Kit that can be used for all specimen types except PAP ThinPrep® samples.



www.PCLAlverno.com Page 2

Test Summary Utilization

Guidelines

Ordering Information:

Category Item Number Item Description

Molecular 176526 Chlamydia/Gonorrhea by PCR Kit

Specimen Types for CT/NG Collection Kit: Female Male

Endocervical swab Urethral swab

Physician or Self-Collected Vaginal Swab Urine

Urine Rectal SwabRectal Swab

Alternative Specimen: PAP ThinPrep (do not add to multi-Collect vial) Specimen Stability:• In Collection Kit Room Temp / Refrigerated – 14 Days• ThinPrep Solution Room Temp – 30 Days Cause for Rejection: • Urine samples above or below the Min/Max window. • Vaginal or Urethral collections without swab in transport tube. • Leaking transport tubes.

***Disposal of unused BD collection Devices***Please box any remaining BD collection devices and return to PCL Alverno via courier after February 15th.

Molecular Enteric Pathogen Panels

March 1, 2018

Beginning March 1, PCL Alverno will begin offering molecular detection of gastrointestinal organisms.

Acute diarrheal syndromes are usually self-limiting, but may be complicated by dehydration, vomiting and fever. Rapid multiplex panel detection of the most common agents of enteric infections directly from stool specimens is sensitive, specific and provides same-day results.

Molecular testing is a rapid alternative to conventional culture technique. Results should be used in conjunction with clinical observation. A negative result cannot rule out the presence of PCR inhibitors in a patient specimen or target concentrations below the level of detection. Due to the high sensitivity of PCR testing, false positives can occur if nonviable organisms are present. Therefore, PCR testing of enteric pathogens is not intended for monitoring treatment.

PCL Alverno has two molecular platforms that will provide flexibility in ordering. The BD Max provides targeted testing with smaller panels while the BioFire provides a large panel for more critically ill patient populations. Please see the utilization guidelines and platform testing details on the following pages.





Guidelines





Guidelines

UTILIZATION GUIDELINE:GI Panel Ordering Guidelines

BD Max Enteric Panels

Patient History BD Max Panel>7 days OR immunocompromised OR recent travel ENPAR: Enteric Parasite Panel

Community acquired; otherwise healthy ENTBS: Basic Bacterial Panel

Child or elderly in closed population (daycare/school/LTC) ENTEX: Extended Bacterial Panel

Patient history positive for RISK Factors:• Pork or shellfish consumption• Recent travel to high-risk region• Recreation in water-based setting• Consider seasonality of pathogens

ENTEX: Extended Bacterial Panel

BioFire FilmArray®

The new BioFire GI Panel offers simultaneous detection and identification of multiple gastrointestinal viral, parasitic, and bacterial nucleic acid targets in stool samples obtained from individuals suspected of gastrointestinal tract infections.

Testing should be limited to:

• Severe illness (profuse watery diarrhea, signs of hypovolemia, passage of ≥3 unformed stools per 24 hours, severe abdominal pain, need for hospitalization)

• Inflammatory diarrhea (bloody diarrhea, small volume mucous stools, fever)

• High-risk host (age ≥70 years, cardiac disease, immunocompromising condition, inflammatory bowel disease, pregnancy)

• Symptoms lasting more than 7 days

• Hospitalization ≤3 days with no history of antibiotic treatment (one order per admission)

• Public health concerns (diarrheal illness in food handlers, healthcare workers, and day care facility personnel/attendees)

For more information on diagnosis of acute diarrheal infections in adults, refer to the following:1. The American College of Gastroenterology algorithm for diagnosis, treatment, and prevention of acute diarrheal infections in adults:

https://gi.org/guideline/diagnosis-treatment-and-prevention-of-acute-diarrheal-infections-in-adults/2. “Approach to the adult with acute diarrhea in resource-rich settings.” Wanke, MD, Christine A.: https://www.uptodate.com/contents/

approach-to-the-adult-with-acute-diarrhea-in-resource-rich-settings

The BD Max has FDA approval for a basic bacterial panel, an extended bacterial panel and a parasite panel. This allows for selective ordering for cost-effective diagnostic testing.

BD Max Basic Bacterial PanelSalmonella spp. Shigella spps. / Enteroinvasive E. coli (EIEC)

Campylobacter spp. (jejuni and coli) Shiga toxins DNA (toxins 1 and 2)

CPT Code: 87505 Soft Code: ENTBS

Sample: Fresh stool in Cary Blair Medium Transportation: Room Temp

BD Max Extended Bacterial PanelSalmonella spp. Shigella spps. / Enteroinvasive E. coli (EIEC)

Campylobacter spp. (jejuni and coli) Shiga toxins DNA (toxins 1 and 2)

Plesiomonas shigelloides Enterotoxigenic E. coli (ETEC)

Vibrio spp. (vulnificus, parahaemolyticus and cholerae) Yersinia enterocolitica

CPT Code: 87506 Soft Code: ENTEX


BD Max Parasite PanelGiardia lamblia Cryptosporidium (hominis and parvum)

Entamoeba histolytica

CPT Code: 87505 Soft Code: ENPAR

Sample: Fresh stool in 10% Formalin Transportation: Room Temp





Guidelines





Guidelines

The BioFire FilmArray® Panel is an extensive panel with multiple bacterial, parasitic and viral targets. Please follow the utilization guideline provided when considering the BioFire GI Panel.

BioFire FilmArrayBACTERIAL PARASITES

Campylobacter (jejuni, coli, upsaliensis) Cryptosporidium

Clostridium difficile (toxin A/B) Cyclospora cayetanensis

Plesiomonas shigelloides Entamoeba histolytica

Salmonella spp. Giardia lamblia

Yersinia enterocolitica

Vibrio spp. (parahaemolyticus, vulnificus, cholerae)

Vibrio cholerae (species specific call out) VIRUSES

DIARRHEAGENIC E. COLI / SHIGELLA Adenovirus F40/41

Enteroaggregative E. coli (EAEC) Astrovirus

Enteropathogenic E. coli (EPEC) Norovirus GI / GII

Enterotoxigenic E. coli (ETEC) lt/st Rotavirus A

Shiga-like toxin-producing E. coli (STEC) stx1 / stx2 Sapovirus (I, II, IV & V)

Shigella/Enteroinvasive E. coli (EIEC)

E. coli O157 (serogroup specific call out)

CPT Code: 87507 Soft Code: BFGI





Guidelines

EGFR by PCR Plasma Specimen for Liquid Biopsy

February 15, 2018

Clinical UseA non-invasive supplement to biopsy analysis. For use in identifying non-small cell lung cancers that may benefit from treatment with epidermal growth factor receptor-tyrosine kinase or anaplastic lymphoma kinase inhibitors.

Clinical BackgroundNon-small cell lung carcinoma (NSCLC) accounts for 75%-80% of all lung cancers. Patients with advanced NSCLC may not be healthy enough for a tissue biopsy, or might only be able to undergo limited tissue procedures, like a Fine Needle Aspirate (FNA) or Core Needle Biopsy (CNB) for diagnosis.

After first-line TKI therapy, it is preferable to use a new tumor specimen for EGFR analysis which would require another invasive tissue biopsy procedure. The key benefits of testing with plasma is that it involves a non-invasive procedure for collecting specimen from the patient and can be collected as frequently as needed without putting patients at risk. Patients who are negative for EGFR mutations by this test should be reflexed to tissue biopsy for testing.

EGFR-targeted therapies have been approved by the FDA for use in treating patients with NSCLC who previously failed to respond to traditional chemotherapy. Efficacy of EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, is confined to patients with tumors demonstrating EGFR mutations, particularly in exons 19 and 21. This assay detects 42 mutations in exons 18, 19, 20 and 21 including the T790M resistant mutation.

Specimen Requirements:

Specimen: K2 EDTA Plasma. Centrifuge to separate from cells within 4 hours.

Stability: 2-8°C, 72 hours

Cause for Rejection: Serum

Method: Real-Time Polymerase Chain Reaction (PCR)

Turnaround Time: Testing is batched once a week

CPT code:* 81235

SOFT code: EGFRM

*CPT codes provided are for informational purposes only. Questions regarding coding should be directed to the payor.

Documents

CHLAMYDIA/GONORRHEA SPECIMEN COLLECTION DEVICE … 2018 BLOG UPDATE.pdf · Entamoeba histolytica CPT Code: 87505 Soft Code: ENPAR Sample: ... Shiga-like toxin-producing E. coli (STEC)