The Laboratorian - Volume 1, Issue 4

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The Laboratorian - Volume 1, Issue 4
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May 2010 - Volume 1, Issue 4

Article Index

- NBS Cystic Fibrosis
- Clinical Chemistry
- South TX Laboratory

Editorial

On April 12, 2010, the DSHS Laboratory implemented a pilot project for a state wide courier service designed to increase the speed and efficiency of specimen delivery from Medicaid providers across Texas to the laboratory in Austin. The implementation of the courier service has had a difficult road, from being an unsuccessful exceptional item requested in 2007 to its funding in 2010. Susan Neill, PhD, the Laboratory Director, never gave up on the creation of this unique program, and with the help of Susan Tanksley, PhD, Biochemistry and Genetics Branch Manager, continued to look for funding opportunities. In February of this year the Laboratory was awarded approximately 2.6 million dollars a year for fiscal years 2010 through 2013 to implement a state wide courier service. The funding came to us as part of the FREW Medical and Dental Initiatives, Texas Health Steps Laboratory Improvements Project.

There are many advantages to establishing a state wide courier service for specimens collected from Medicaid patients, including:

- Reducing the total time from specimen collection to results reporting, which will allow faster interventions for children with potential medical problems. Specimens will be received within 24 hours of pick up.

- Reducing the number of specimens that are rejected for being too old to test upon receipt in the laboratory. This will ensure that more children are screened in a timely manner, reducing stress and hardship on parents and clients.

- Reducing the differences in timeliness of care due to different shipping methods.

- Streamlining packaging and shipping procedures and eliminating the cost to providers will encourage participation in the Texas Health Steps Program (THSteps).

- Implementing a package tracking system to help ensure specimen receipt.

During fiscal year 2010, the pilot project will include 230 sites, which represent 60 percent of all THSteps and NBS specimens submitted to the Laboratory, scheduled for regular pick-ups. The 230 sites were determined based upon their location in the state, the number of THSteps and Newborn Screening (NBS) specimens that they routinely submit to the Laboratory (Measured by the daily average of total specimens submitted from January to September 2009), and the number of THSteps and NBS specimens that were rejected because they were too old to test upon arrival in the Laboratory.

In the next several months, we will be evaluating the courier pilot program, establishing performance measures, and sending out surveys to measure customer satisfaction with the service. The program will be expanded, as funding allows, by initiating “Will Call” requests for specimen pick-up for those providers who do not require regularly scheduled pick ups. We will also be looking for additional funding opportunities that will allow us to expand the program even further and sustain it for the long term.

There are a number of people in the Laboratory who have worked hard to ensure the successful implementation of this pilot project. I want to publicly thank them for their contributions. They are: Dr. Susan Neill, Dr. Eldridge Hutcheson, Dr. Susan Tanksley, Catherine von Alt, Jan Adversario, Susan Hoffpauir, Lisa Chappell, Walter Douglass, Kathleen Adams, Dawni Allen, Yan Xu, John Holcomb, Dorothy Breeden, Anabel Granado, and Monica Cypress.

by Sherry Clay, Director, Quality Assurance Unit


Did you know?

The administration offices of the Health Department stayed in the Capitol from 1903 until 1933.

The Pure Food Commission was established in 1906, but it did not come under the Health Department umbrella until 1921.


Newborn Screening for Cystic Fibrosis Begins in Texas

DNA Analysis team members load Cystic Fibrosis samples for analysis

On December 1, 2009, the Newborn Screening Program at the Texas Department of State Health Services added screening for Cystic Fibrosis to the newborn screening panel, fulfilling a promise to the 400,000 children born in Texas each year. Early diagnosis of cystic fibrosis is a difficult and emotional issue for affected families, but countless studies have shown that early diagnosis in infants is associated with increased life expectancy, reduced incidences of hospitalization, decreased mortality rates, improved nutrition, and better overall development. Through the cooperation of the Newborn Screening Program (NBS) and the entire Department of State Health Services (DSHS) community, Texas can now offer these positive benefits to its youngest citizens.

Cystic fibrosis (CF) is a complex and life limiting recessive genetic disorder caused by mutations in the cystic fibrosis gene called the transmembrane conductance regulator (CFTR). This gene is located on chromosome 7 and ensures the production of CFTR protein, which is responsible for the movement of chloride ions through cell membranes and influences the regulation of other intercellular pathways. The hundreds of mutations associated with CF, and the subsequent deregulation of cellular ion transport, disrupt major functions in multiple organs, including the exocrine pancreas, lungs, sweat glands, and intestines. In the lungs, CF prompts an endless cycle of impaired mucociliary clearance, bronchial obstruction, inflammation, and infection. In the digestive tract, CF disrupts the production and release of pancreatic enzymes, triggers the malabsorption of fats and critical fat-soluble vitamins, and alters intestinal motility.

Early detection of cystic fibrosis through newborn screening can provide critical time for dietary and respiratory intervention prior to the infant becoming symptomatic. Though no cure for CF exists, currently available treatments improve the overall quality of life. These treatments have also increased the median life-expectancy from 32 years in 2000 to 37 years in 2008.

Demographically, CF is one of the most common genetic disorders in Caucasians, with an incidence of roughly 1 in 2500-3300 live births. The disease also has a fairly high incidence among Hispanics with 1 in 4,000 to 1 in 8,000 live births being affected. For African-American and Asian-American populations, the incidence rates are approximately 1 in 15,000 and 1 in 32,000, respectively. Overall about 30,000 people in the United States and 70,000 people worldwide have been diagnosed with CF.

The high incidence rate for cystic fibrosis, as well as its significant carrier frequency, (non-Hispanic Caucasians: 1 in 25 to 30 individuals) encouraged the development of population based screening. In 2001, the American College of Medical Genetics (ACMG), with the American College of Obstetricians and Gynecologists (ACOG), issued physician guidelines recommending screening for 25 CFTR mutations and six reflex tests. In 2004, the screening panel was revised to include 23 CFTR mutations and two reflex tests. The table below highlights the 23 mutations recommended by the ACMG. This list included ΔF508, a deletion of the amino acid phenlyalanine at codon 508, which is the most common cystic fibrosis mutation—occurring in 66 percent of patients.

Table of the 23 CFTR mutations and two reflex tests

At the DSHS, newborn screening for cystic fibrosis is a two-tiered screening process. Universally, all screening programs for cystic fibrosis rely on the detection of immunoreactive trypsinogen (IRT). Trypsinogen is produced in the pancreas and is a precursor for the enzyme trypsin. High IRT concentrations have demonstrated a loose positive correlation with CF because the condition prevents the secretion of trypsinogen from the pancreas to the intestines, which leads to elevated blood IRT levels. All live births in Texas require a first newborn screen within

the first 24 to 48 hours. Initial IRT screening on all of these thousands of specimens is completed by the IRT team. For infants with a high IRT concentration on the initial screen, the second newborn screen—submitted at one to two weeks of life—will determine if further testing is required.

If the second newborn screen also shows a high IRT concentration, the specimen will be sent to the Newborn DNA Analysis Laboratory for second tier testing. The Newborn DNA Analysis group uses a proprietary signal amplification method that utilizes pre-labeled

An Endocrine team member evaluates a test plate prior to loading for IRT analysis
microfluidic cards to efficiently screen for 40 CFTR mutations, including the recommended 23 ACMG mutations.

The addition of cystic fibrosis screening required countless hours of work by the laboratory, case management, and information technology staff. Extensive validation of the laboratory tests was conducted on the modified computer system to ensure that all results and processes for CF are accurate.

Following positive IRT and DNA mutational analysis screening results, information is forwarded to DSHS Case Management. Case management contacts consulting physicians and submitters regarding the CF screening findings and recommends follow-up care and additional testing. The sweat test, which will be performed at an accredited CF Care Center in Texas, is the gold standard for diagnosing cystic fibrosis and those results, along with the information provided by DSHS, will be used to determine a final diagnostic outcome and a possible treatment plan for the infant. Spread throughout the state, the CF Care Centers provide a multidisciplinary approach to treat each patient and critical medical support throughout a patient’s lifetime. Click here for additional information about the CF Care Centers in Texas and throughout the United States.

Through the joint efforts of CF Care Center teams, primary care physicians, and now the DSHS NBS program, a diagnosis of cystic fibrosis can be determined before an infant begins to experience symptoms. The screening process in place at the DSHS is expected to provide early detection for 82-94 new cystic fibrosis patients each year. Even though there is currently no cure for cystic fibrosis, early supportive treatments and interventions improve the patient’s quality of life. Further information and supporting resources can be found at on the Cystic Fibrosis Foundation website and the National Heart and Lung Blood Institute Diseases and Conditions Index on Cystic Fibrosis.

by Nicole Kroutter


Clinical Chemistry and the Texas Health Steps Program

The Texas Department of State Health Service (DSHS) Clinical Chemistry Laboratory performs laboratory testing in support of several health programs, including Title V Maternal and Child Health, which involves family planning, prenatal, and children’s medical and dental care, and the Childhood Lead Poisoning Prevention Program (CLPPP), which monitors blood lead levels for children tested for blood lead poisoning/intoxication in the state of Texas. The majority of specimens tested by Clinical Chemistry, however, are from children who qualify for Medicaid and the Texas Health Steps

Texas Health Steps Logo

Program (THSteps). THSteps is Texas Medicaid’s comprehensive preventive child health service plan for individuals from birth through 20 years of age, providing medical, dental, and case management services as well as periodic screening for vision, hearing, development, mental health, and tuberculosis. Additionally, the program works to provide critical immunizations for all of its participants. The Clinical Chemistry Laboratory performs testing for a majority of the specimens associated with THSteps medical check-ups and coordinates directly with medical providers participating in the program to provide quality care for all patients.

THSteps medical services are provided by medical providers located throughout the State of Texas. These providers, who see the patient and perform preventative and medically necessary screenings and assessments, are enrolled through Texas Medicaid & Healthcare Partnership (TMHP). Medical providers utilize the THSteps medical check-ups periodicity schedule to determine when laboratory screenings need to be performed for each patient. Collected specimens are submitted directly from the providers’ offices and clinics, through the United States Postal Service or a courier service, to the DSHS Clinical Chemistry Laboratory, as required by the THSteps program.

Laboratory Services provided by the Clinical Chemistry Laboratory
and associated disorders

Clinical Chemistry Test

Detected Disorder

Total Hemoglobin

Anemia

Hemoglobin Type

Sickling disorders or other pathogenic hemoglobinopathies

Blood Lead

Lead poisoning

Glucose

Diabetes

Cholesterol / Lipid Profile

Coronary artery disease

RPR

Syphilis infection

Specimens received by the Laboratory and are tested within one to two days of receipt and must meet pre-analytical quality requirements. When the specimen arrives at the Clinical Chemistry Laboratory for testing, it must also meet certain analytical quality requirements. For example, the specimen may not be clotted. Because both hemoglobin and lead are located in the red blood cells, when a specimen is clotted, it ties up hemoglobin and lead within the clots, leading to a falsely low value for these tests. Therefore, an anticoagulated, homogeneous whole blood specimen is required for testing.

One of the biggest challenges faced with laboratory specimens for THSteps testing is the number of specimens received that are unsatisfactory for testing. These specimens cannot be processed when they do not meet pre-analytical and analytical criteria and, therefore, are rejected with the appropriate statement to inform the medical provider of why the specimen was unsatisfactory for testing. To maintain quality testing standards, in 2004 the DSHS Laboratory implemented more stringent acceptance criteria. The changes initially led to an increase in unsatisfactory specimens. The transition period was difficult for medical providers, patients and their parents/legal guardians, and the DSHS Laboratory. Medical providers are obligated to recollect specimens from patients after receiving reports of rejected specimens, which is a burden for both these young patients and their healthcare providers. In order to minimize the volume of unsatisfactory specimens, educating providers about the laboratory’s requirements has become a major focus in the Clinical Chemistry Laboratory. For example, telephone consultations can provide helpful tips on collection techniques to meet the correct fill volume or the correct method for shipping specimens. Providers are also contacted by fax or telephone in order to obtain missing information, such as date of collection or which test is being requested. Training is provided in conjunction with regional provider relations staff for the THSteps program. The training is done on site in each region; medical providers in that region are invited to a central location for in-depth training on how to successfully submit specimens to the DSHS Laboratory. Additionally, a variety of tools are provided to assist with meeting requirements and minimizing unsatisfactory specimens.

By providing preventive and medically necessary health care for a population that may not otherwise receive any care, the THSteps Program is an important service for many residents of Texas. These services might not be possible without the Clinical Chemistry Laboratory. The staff of the Clinical Chemistry Laboratory not only performs the necessary tests, they also provide outreach and support to the entire Texas Health Steps community—assuring the health and medical safety of all Texans.

by Monica Cepress


South Texas Laboratory

A laboratorian processes tuberculosis samples under a fume hood

The Department of State Health Services (DSHS) South Texas Laboratory, located in Harlingen, Texas is one of three laboratories in the DSHS Laboratory Services Section. The mission of the South Texas Laboratory (STL) is to provide outpatient and public health testing for Rio Grande State Center, the Cameron and Hidalgo County health departments, Region 11 tuberculosis clinics, and various other facilities. STL is also a Laboratory Response Network (LRN) reference laboratory—responsible for training sentinel laboratories in eight counties in South Texas.

STL has gone through several transformations since it was established in 1956.

South Texas Laboratory Timeline

Year

Event

1956

Texas Department of Health hospital and Tuberculosis Laboratory founded.

1976

The Laboratory, which served as both the local health department laboratory and the regional Texas Department of Health Laboratory, is relocated to Harlingen, Texas.

1991 The South Texas Hospital Laboratory, which provides inpatient, outpatient, and public health testing for South Texas Hospital and the Lower Rio Grande Valley, is officially created.
2000 South Texas Hospital discontinued its in-patient services in August 2000 and changed its name to South Texas Health Care System; consequently, the laboratory’s name was changed to South Texas Health Care System Laboratory.
2004 Texas Department of Health became the Department of State Health Services. South Texas Health Care System Laboratory was merged with the DSHS in Austin as a branch of the Laboratory Services Section and took the current name of South Texas Laboratory.

STL provides testing in several laboratory areas, including clinical, microbiology, mycobacteriology (tuberculosis testing and susceptibilities), public health bacteriology and serology, water bacteriology, and emergency preparedness. STL also serves as a reference laboratory for other public health core functions and as a training facility for Medical Technology students from the University of Texas-Pan American and Medical Laboratory Technology students from the University of Texas at Brownsville/Texas Southmost College.

Laboratorians processing water samplesA laboratorian processes Clinical Chemistry samples

The Clinical Department of STL is the main testing laboratory for the Outpatient Clinic of Rio Grande State Center (RGSC). Testing consists of Clinical Chemistry, Special Chemistry, Hematology, Immunology, and Urinalysis; the laboratory outsources any necessary special clinical tests. This type of laboratory testing is a critical component of patient care with approximately 70 percent of all medical treatment decisions influenced by laboratory tests. The medical technologists in the Clinical Department perform testing for RGSC outpatients and health departments throughout Region 11 counties in south Texas. Wellness testing for the lower Rio Grande Valley and RGSC employees and their families is also performed in the Clinical Department.

Tuberculosis testing is performed by the Mycobacteriology Department for the four county Rio Grande Valley area hospitals, DHS-Immigration and Customs Enforcement detention centers, Region 11 clinics, and Region 11 Bi-National Program. This program was established to join efforts with Mexico on a bi-national level to control and eliminate tuberculosis. The Mycobacteriology Department helps train laboratories on both sides of the US/Mexico border.

Testing for syphilis using the RPR (Rapid Plasma Reagin) card and TPPA (Treponema pallidum particle agglutination) confirmatory test is performed by the Public Health Bacteriology and Serology Department. Gen-Probe DNA testing for chlamydia and gonorrhea is also performed. These services are provided for Cameron and Hidalgo County Health Departments, Valley AIDS Council, RGSC, and regional clinics.

The Water Bacteriology performs total coliform and E. coli testing in public water systems in Cameron, Hidalgo, Starr, and Willacy counties for the Texas Commission on Environmental Quality (TCEQ).  Water testing is also performed for bottled and vended water companies and individual wells.

Emergency Preparedness, the newest section of STL, was established following the 2001 United States Anthrax events. This section is responsible for responding to public health emergencies, including food outbreaks and health threats such as bioterrorism. Testing encompasses Bacillus anthracis, Yersinia pestis, Francisella tularensis, Brucella spp, and pandemic influenza.The Emergency Preparedness

Bioterrorism training

laboratory serves eight counties, local hospitals, and reference laboratories.

STL fulfilled its role in the LRN by serving as one of the primary testing facilities during the H1N1 flu outbreak of 2009. The laboratory also trains personnel in local facilities, such as hospital laboratories, on how to respond to possible exposure to unknown biological and chemical agents.

With its diverse subspecialties, STL spans the spectrum of laboratory science—from urinalysis testing to bioterrorism threats and employee wellness to the safety of public water systems—taking care of Texas residents in the Rio Grande Valley.

by Corrine Trevino


Note: External links to other sites are intended to be informational and do not have the endorsement of the Texas Department of State Health Services. These sites may not be accessible to people with disabilities.

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THE LABORATORIAN
October 2010, Volume One, Issue Four
(Publication #E14-13156)
Published by DSHS Laboratory Services Section
PO Box 149347, MC 1947
Austin, TX 78714

512 458 7318
888 963 7111, ext 7318 Toll Free
email The Laboratorian

 

LABORATORY DIRECTOR
Susan U. Neill, PhD
512 458 7318
email Susan

NEWSLETTER EDITOR
Jimi Ripley-Black
512 458 7318, ext 6505
email Jimi

Last updated April 06, 2011