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EMR Integration for Outreach Success

 

March 15, 2012

In a mad dash to qualify for the HITECH Act electronic medical records adoption incentives, physician electronic medical record (EMR) usage has surged. Clinical laboratories must be agile and responsive in developing and implementing connectivity strategies to interface with hundreds of individual EMRs and electronic health record (EHR) software products or risk losing providers and market share. Labs need the right technology in place to seamlessly integrate EMRs and EHRs into their existing processes to remain competitive. Labs can set themselves apart by providing connectivity solutions that allow providers to stay on top of critical patient health and medical record data and enable them to meet the meaningful use requirements for incentive payments available for electronic medical record adoption. 
With a robust, reliable and unlimited integration platform, regional, anatomical pathology, molecular, specialty and hospital-based outreach labs can be more responsive to EMR interface requests to solidify provider relationships and lock in new and repeat client business. Labs that have a viable and easily implementable strategy have a better chance to compete and be successful in this demanding market. Both providers and labs are motivated to get on the EMR bandwagon. Providers are aware of the need to provide electronic results to qualify for Stage 1 meaningful use stimulus incentives. Stages 2 and 3 have even tougher requirements that encompass computerized and integrated provider ordering (CPOE) along with structured results reporting. 

The difficulty labs face is that each EHR and laboratory information system (LIS) has its own interface requirements. Adding to this is the reality that providers, who typically use multiple labs on a regular basis, are unable to support the connectivity needed on their end, as they don't maintain dedicated IT staff. In addition, it is difficult for these providers to afford the connectivity fees that EMR vendors are setting. Without being connected, they are not eligible for the incentive payments. 

Lab Data at the Center of Care 
There is no denying that clinical laboratory test data is essential in medical care decision making with up to 70% of medical decisions based on laboratory results.1 Laboratory data is needed for every aspect of care, from screenings, diagnosis and treatment protocols to effective follow-up care. 

An obvious solution is for labs to make one connection from their LIS to a connectivity hub which can distribute data to an unlimited number of EMRs and support provider direct order entry. Making this connectivity available to providers is an efficient and cost effective option to maximize EMR usefulness and meet meaningful use criteria. However, as obvious as this solution is, it is not initially simple for labs to achieve. 
Interface Alternatives In addition to EMR integration, there are ongoing government-based HIT initiatives spanning the care continuum that also require connectivity for data sharing and have labs rethinking their existing point-to-point interfaces. Local HIEs and RHIOs, which have the capacity to manage and store data electronically, often assist healthcare providers with healthcare IT adoption and require the same patient data being transmitted between the labs and the EMRs and rely on an interoperability platform to connect multiple HIT systems. Having one feed to get the information from the lab to the EMR, RHIO or HIE is the most efficient way to go.

 

Labs that offer EMR connectivity find themselves supporting multiple interfaces to meet EMR integration demands. The HHS Certified Product List contains more than 400 ambulatory EHR products and labs need to accommodate these systems and the diverse functionality they offer.

 

Most small to midsized labs do not have deep IT resources or qualified internal technical expertise for interface programming and implementation. Labs are unable to absorb the steep cost (average interface engine cost $200K+) associated with building, implementing and maintaining the complex point-to-point interface engines needed to serve multiple EMR vendors and HIEs. Once built, specially trained and certified IT staff is needed to properly implement and operate these engines, even the open source offerings, and provide reliable interfaces which can be required 24/7. Implementation alone often requires a deep team of IT specialists that most labs cannot supply. Home grown systems are usually not scalable or portable and may not be able to keep up with EMR interface demand causing the lab to lose clients and negatively impact outreach growth.

 

In dealing with these issues, lab managers have recognized that existing legacy point-to-point interfaces are no longer a viable operating strategy for the long term. Successful labs have realized that developing and supporting IT solutions are not their area of expertise and have engaged connectivity and integration specialists for cost effective, reliable interface solutions. A vendor-neutral partnership strategy establishes a collaborative environment in which product solutions and operating platforms from EMR/EHR to LIS and HIE/RHIO can coexist within a small technology footprint, minimizing ongoing maintenance and IT personnel requirements. Working with available lab IT resources, the strategic partner provides domain expertise, hands-on experience and the manpower needed for every phase of the EMR integration process.

 

Providing a virtual integration platform utilizing a "hub and spoke" structure that requires only a single interface to a lab's LIS reduces implementation time, effort and cost and enables a lab to connect with every EMR in their provider community. A dedicated connectivity vendor facilitates lab order processing, reduces EMR implementation time and cost and provides a reliable connection between its LIS and the vast array of EMRs they have to accommodate. The vendor also provides consistent and top-notch support and maintenance, freeing lab IT personnel to focus on core functions and other IT challenges such as the ICD-10 and HIPAA ASC X 12 version 5010 transitions.

Open letter from Otsuka America Pharmaceutical, Inc to consumers regarding PMA Application

 

March 15, 2012

Dear Valued Customer,

On February 22, 2012, the FDA approved our Premarket Approval (PMA) Application for the BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and the Pediatric Urea Hydrolysis Rate Calculation - Application (pUHR CA) to aid in the initial diagnosis and post-treatment monitoring of H. pylori infection use in children ages 3 to 17 years old. This letter clarifies our position on marketing this product following the pediatric approval.

The PMA approval allows BreathTek UBT Kit use in conjunction with both the UBiT ® IR300 Infrared Spectrophotometer (UBiT-IR300) and the web-based pUHR-CA. It is necessary for our customers to understand that the pUHR-CA must be used to calculate the Urea Hydrolysis Rate (UHR) to obtain pediatric test results and the pUHR-CA can only use the DOB obtained from the UBiT-IR300. The DOB result cannot be used to determine the H. pylori infection status in children, even though it is used for adult test results.

At this time, OAPI is not commercially promoting the use of BreathTek UBT Kit for use in children or allowing access to the web-based pUHR-CA. We believe it may be confusing to our customers when laboratories may have both the UBiT-IR300 and POCone, yet we only have PMA approval for using the UBiT-IR300 for the analysis of pediatric breath samples. Furthermore, OAPI is committed to ensuring that our customers use the products appropriately; we do not want to encourage or inadvertently enable use of the_TJBiT-IR300 without the pUHR-CA or use the P0Cone for analysis of pediatric breath samples.

To support the PMA approval for the pediatric indication, two multi-center clinical studies were conducted to demonstrate the safety and effectiveness of the BreathTek UBT Kit in children. The study breath samples were analyzed only on the UBiT-IR300 and there is no clinical data available to support analysis of pediatric breath samples with the POCone. The FDA has requested additional data to demonstrate that the POCone produces similar results as the UBiT-IR300 in analyzing breath samples from children when used in conjunction with both the BreathTek UBT Kit and the pUHR-CA.

QIAGEN Welcomes change of a major U.S. guideline to recommend HPV testing as part of cervical cancer screening

 

March 15, 2012

Today welcomed a significant change to a national guideline in the United States that underscored the benefits of its digene HPV Test as part of cervical cancer screening protection in combination with traditional cytology (Pap test).

The final report of the U.S. Preventive Services Task Force (USPSTF) issued a "Grade A" recommendation in favor of co-testing women age 30 to 65 every five years with HPV (human papillomavirus) and Pap tests as the preferred alternative to a Pap test alone on a three-year basis. This was a reversal from a draft proposal issued in October 2011 with a "Grade I" recommendation stating that the benefits of HPV testing needed to be reviewed through further testing.

In addition, the report cited QIAGEN's digene HPV Test as being "commonly used" for HPV testing, noting that "although alternative HPV detection methods are emerging, the clinical comparability and implications of these methods are not completely understood."

QIAGEN further welcomed the reaffirmation of prior cervical cancer screening guidelines issued by other U.S. organizations including the American Cancer Society, the American Society of Colposcopy and Cervical Pathology (ASCCP) and the American Society for Clinical Pathology. These guidelines state that testing with both Pap and HPV tests is preferable to Pap testing alone. The guidelines were issued in advance of the biennial ASCCP meeting in San Francisco.

"The key to reducing the burden of cervical cancer is to improve screening, and the clear views of these organizations is for women in the relevant age groups to receive co-testing with cytology and HPV testing," said Dr. Ellen E. Sheets, Chief Medical Officer of QIAGEN. "Co-testing has been demonstrated to be more effective than Pap tests alone based on data showing that QIAGEN's HPV DNA test is more accurate than cytology alone. These guidelines reaffirm our commitment to continue working with physicians and other healthcare providers to encourage co-testing to give women and their physicians an early warning of the threat of cervical cancer. We are convinced that these guidelines will help drive the momentum to shift toward co-testing in the U.S. and further reduce the often-fatal burden of cervical cancer."

HPV is the primary cause of cervical cancer. QIAGEN's digene HPV Test uses the proven hybrid capture (HC2) technology that is the basis for the most clinically validated threshold detection method for high-risk HPV and is the market-leader for HPV testing. QIAGEN has worked closely with physicians and laboratories to encourage co-testing with cytology and the digene HPV Test.

The digene HPV Test is the market-leading FDA-approved molecular test for HPV screening based on annual sales. It is considered the "gold standard" in terms of performance and validation, supported by clinical data in independent, peer-reviewed publications involving more than 1 million women. More than 80 million digene HPV Tests have been delivered worldwide since its market introduction in 1997.

The unique HC2 technology employed in the digene HPV Test has demonstrated significant benefits— most importantly superior clinical sensitivity in identifying women with HPV infections that place them at high risk for cervical cancer. Based on publicly available data, QIAGEN believes that no other test has been able to match the power of the digene HPV Test to detect infections that put women at risk for cervical cancer. The digene HPV Test is indicated both for co-testing with cytology to screen women age 30 and older as well as to determine the need for colposcopy/biopsy referral for women with borderline abnormal cytology results (ASC-US).

"The digene HPV Test with its proven clinical threshold, focuses on telling clinicians whether each patient is relevantly infected with one or more of 13 high-risk strains of HPV," Dr. Sheets said. "If the patient has a high-risk HPV infection, clinical guidelines call for follow-up care that is essentially the same regardless of which particular strain is detected."

The value of molecular HPV testing is increasingly recognized in treatment guidelines around the world. Many countries have established or are evaluating co-testing, primary screening with HPV alone, or reflex HPV testing as a cornerstone of cervical cancer prevention programs, based on QIAGEN's digene HPV Test data. With about 500,000 new cases and 300,000 related deaths annually around the world, cervical cancer is the second most frequent cancer in women. Early detection has been proven to reduce the burden of this disease, as cervical cancer can be effectively treated if found in its early stages.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of December 31, 2011, QIAGEN employed approximately 3,900 people in over 35 locations worldwide.

Lenco Diagnostic Laboratories Inc. Is pleased to announce the addition of ImmunoCAP® Specific IgE assays to our test menu

 

September 15, 2010

Allergy and diseases caused or complicated by allergy, such as asthma, or diseases with symptoms which mimic allergy, are among the most widespread and costly health problems in the world.

Lenco Diagnostic Laboratories, Inv. provides allergy testing that is safe, simple, and accurate with groundbreaking technology with the latest generation of automated allergy diagnostic systems.

Detection of immunoglobulin E (IgE) antibodies and determination of specific allergens allow for better outcomes and increased quality of life for allergy patients. To be reliable, the testing system used to detect allergy must be standardized. Phadia allergy test systems, along with all their components, are standardized against World Health Organization reference preparations for reproducible, reliable results. Phadia, a global leader in allergy diagnostics research and development since 1974, offers advanced automated instrumentation to process the ImmunoCAP® technology-based test kits for allergy, and inflammation markers for asthma and anaphylaxis. The ImmunoCAP® instrument provides innovative software and hardware solutions that meet laboratory automation and throughput requirements.

ImmunoCAP® Specific IgE assays are the first to be FDA cleared for the quantitative measurement of specific IgE. The most significant features of ImmunoCAP technology are extensive quality control measures, excellent allergen and reagent source materials, and calibration to WHO reference preparations. In addition, the structural design of ImmunoCAP® allows for automation and thorough elimination of unbound nonspecific material in the reaction complex, resulting in highly reproducible, accurate, and quantitative results.

Lenco Labs is proud to add the ImmunoCAP® Specific IgE assays to our already extensive test menu. As always, we strive to render the upmost in patient care, and we feel that working with companies like Phadia enable us to achieve that goal.

Allergen Test Requisition

August 30, 2010

Lenco Diagnostic Laboratory, Inc. would like to take this time to thank you for choosing us as your clinical reference laboratory. The purpose of this letter is to enable us to process your patient's specimens in the most timely and accurate manner possible.

We have been receiving a number of specimens at the laboratory that do not have the proper amount of blood for the quantity of allergen tests ordered. We require 2ml serum from a spun barrier tube for any group of up to 6 allergens, 0.5 ml for each additional allergen. Also, please do not exceed 32 tests per form. If you require additional testing for allergens for a particular patient, please use another requisition for these tests.

If you need to receive the Allergen Test Requisition forms, please contact our Client Service Department at 718-232-1515, Ext 1. This updated Allergen Test Requisition was designed with our clients in mind. This requisition contains the most common allergens requested by our physician clients. We have also attached a flyer listing some of our standard Allergen Profiles for your use. Of course, we will also custom design a test panel for you containing any particular tests that you desire.

Clinical Laboratory Update

June 17, 2010

Lenco Diagnostic Laboratory, Inc. is pleased to announce the following panel has been added for your convenience.

  • Sexually Transmitted Disease (STD) Panel #3125
    • RPR
    • Herpes Simplex Virus (HSV) I & II
    • HIV I & II
    • GC/CHLAM
    • Hep A Antibody
    • Hep B Surface Antigen
    • Hep B Surface Antibody
    • Hep B Core Antibody
    • Hep C Antibody
    • Specimen Requirements: 2 SST, 1 Urine

This panel was created in response to commonly requested tests. As always, we can custom design test panels to suit your requirements.

Clinical Laboratory Alert

August 30, 2010

Lenco Diagnostic Laboratory, Inc. would like to take this time to thank you for choosing us as your clinical reference laboratory. The purpose of this letter is to enable us to process your patient's specimens in the most timely and accurate manner possible.

Expired Tubes, Containers, and other Clinical Supplies with expiration dates

Lenco Diagnostic Laboratory Inc. is committed to the highest quality of clinical laboratory testing available. To accomplish this, it is imperative that all specimens submitted to the laboratory for testing is sent in the proper, unexpired container for the test ordered. If a specimen is sent in either an incorrect container, or one that has an expired date, the requested testing will not be performed. This ensures that the most accurate test results for your patients will be generated.

In conjunction with New York State law, we will gladly provide you with any approved collection devices and containers at no charge. For a complete list of approved supplies, please contact our Client Service department at the number above.

Histology turn-around time

August 30, 2010

PROTOCOL: Turn-around time for the histology specimens.

PROCEDURE:

  1. Specimens received after 5:00 pm will be accessioned in Novo Path system the next day.
  2. Grossing and overnight processing in Sacura VIP-300 Tissue Processor of the specimens will be done the same day as the accessioning of the specimens.
  3. Histology slides will be available for diagnosis the day after accessioning.

The following exceptions are:

  1. Fatty specimens - That require extra formalin fixation prior to processing [Except Friday]
  2. Bones and nails - That require at least overnight decalcification to soften them.

*** NOTE: The following is the standard turn-around-time for histology specimens. Please keep in mind that this is a guideline, individual result times may vary. Typical turn-around-time is 4-5 business days, not including weekends and holidays.

Collection Day

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Results Released

Friday

Friday

Monday

Monday

Wednesday

Wednesday

Histology specimens must be accompanied by a completed requisition. Requisitions must be completely filled out in order to process the specimen. The following are of particular importance:

  • Specimen number
  • Number of pieces
  • Type of tissue
  • Date of processing and date of final diagnosis
  • Comment
  • Signature

Clinical Laboratory Update

June 17, 2010

Lenco Diagnostic Laboratory, Inc. is pleased to announce the following assays are now performed in-house. This significantly improves efficiency and turnaround time.

  • Test 1740: Free Testosterone – 1 ml serum
    • Reference Range for: Free Testosterone
      Male age 1 – 9 0 - 0.6
      Male age 10 -18 0.6 – 159
      Male age 19 up 47 – 244
      Female age 1 -9 0 – 0.6
      Female age 10 – 18 1 – 5
      Female age 19 up 0.6 – 6.8
  • Test 1735: Sex Hormone Binding Globulin (SHBG) – 1 ml serum
    • Reference Range for: SHBG
      Male age 1 – 3 42 - 156
      Male age 4 - 6 39 - 146
      Male age 7 - 9 38 - 114
      Male age 10 - 12 32 - 93
      Male age 13 - 15 13 - 63
      Male age 16 -18 11 – 54
      Male age 19 up 13 - 71
      Female age 1 - 3 51 - 158
      Female age 4 - 6 48 - 142
      Female age 7 - 9 31 - 103
      Female age 10 - 12 20 - 100
      Female age 13 - 15 17 - 77
      Female age 16 - 18 9 - 75
      Female age 19 up 18 - 114
  • Test 1745: Prostatic Acid Phosphatase (PAP) – 1 ml serum
    • Reference Range for: PAP

This panel was created in response to commonly requested tests. As always, we can custom design test panels to suit your requirements.

Specimen Handling

June 17, 2010

Common Specimen Collection/Handling Errors

  • Improper labeling. Unlabeled or mislabeled specimens will not be tested
  • Incomplete or missing requisition form.
  • Failure to provide sufficient quantity of specimen for testing (QNS).
  • Using the wrong container or tube type.
  • Collecting the specimen at the wrong time (e.g. peak drug level collected just prior to dosing).
  • Failure to adequately tighten specimen container lids, resulting in leakage and/or specimen contamination.
  • Hemolysis, caused by:
    • using needles smaller than 20- or 21-gauge
    • leaving wet alcohol on the skin during venipuncture
    • removing the needle from the vein prior to complete filling of the tube, resulting in cell damage due to a rush of air into the tube
    • filling the tube too slowly, often due to improper (too shallow) entry into the vein
  • Clotting of anticoagulant tubes caused by improper/inadequate mixing.
  • Failure to store samples properly for delivery to laboratory.

Proper Tube Order When Collecting Blood

To ensure the most accurate test results, vacutainer tubes should be filled in the following order:

  1. Blood Culture/Sterile Tubes
  2. Blue (Coagulation Tube- Sodium Citrate)
  3. Red or Yellow (Serum Tube with or without Clot Activator, with or without Gel)
  4. Green (Heparin Tube) Light Green (Heparin Tube with Gel Separator)
  5. Lavender/Purple or Pink (EDTA)
  6. Grey (Fluoride Tube)

Centrifuge Procedures

Please follow these instructions when using the Barrier Tube or the SST tube with Clot Activator in order to obtain the most accurate test results:

  1. Collect blood specimen using the usual venipuncture technique. Fill tube completely.
  2. Gently invert barrier tube five times to mix clot activator with blood.
  3. Allow blood to clot for 30 minutes.
  4. Centrifuge at High Speed for 15 minutes.
  5. Remove from centrifuge. Barrier will have formed, separating cells from serum. All of the separation gel should have moved from the bottom of the tube to form a barrier layer.
  6. The sample is now ready to be transported to the laboratory. Do not remove stopper.

VAP Cholesterol Test

August 30, 2010

VAP Technology VAP Cholesterol Test - A comprehensive lipoprotein analysis to improve patient diagnosis and treatment. The VAP cholesterol test provides a more comprehensive coronary heart disease (CHD) Risk assessment than the conventional lipoprotein profile. The VAP cholesterol test measures all primary and secondary by the NCEP ATP III* guidelines. Direct measurements are provided for total cholesterol, LDL, HDL, VLDL, and cholesterol subclasses.

In a single test profile additional lipoprotein information is provided to assist physicians to develop patient-specific treatment initiatives. Lipoprotein response to treatment can vary; the additional information provided by the VAP cholesterol test, when medically indicated, can be helpful in selecting the most appropriate therapy, including choice of drugs and the intensity of risk-reduction therapy.

*The VAP cholesterol test includes all serum lipids that define the targets of therapy recommended by ATP III:

  • LDL cholesterol-Primary Target
  • HDL cholesterol
  • Total VLDL cholesterol
  • Triglycerides
  • Lipoprotein (a) cholesterol
  • Remnant lipoproteins
  • Intermediate-density lipoprotein (IDL) cholesterol
  • VLDL3 (small dense) cholesterol
  • VLDL 1+2 (large buoyant) cholesterol
  • LDL particle density pattern (small dense vs large buoyant)
  • HDL Subfractions: HDL2 (large buoyant, more protective) and HDL3 (small dense, less protective) and reports the total cholesterol/HDL cholesterol ratio.
VAP Test

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