The Texas Newborn Screening (NBS) Program is the largest testing volume NBS program in the world. In 2010, we received 762,360 specimens, which is about 63,500 per month or 2,516 per work day. Operating six days a week, each specimen is tested for 28 disorders by measuring over 35 separate analytes. This equates to over 25,000,000 measurements each year, not including retest and repeat assays. Despite the staggering testing volume, screening the children of Texas is a labor of love for the NBS staff. This issue highlights how the NBS Laboratory is working on this vital screening program.
I was fortunate to play a role in the Texas Newborn Screening Performance Measures Project (TNSPMP), which was launched to improve health outcomes for children who are diagnosed with a NBS disorder. As I worked on the TNSPMP website, consulted on document formatting, and helped at meetings, I could not help but be impressed with the dedication and passion of the project team. This enthusiasm continued throughout the multi-year project. Now this important work continues with the launch of the Public Health Performance Measures Project (PHPMP). This project will expand on the work of the TNSPMP.
Our remote laboratories are implementing a new and innovative blood test for tuberculosis infection. You can also read part three of the “Laboratory History” series, which highlights the rapid growth needed to meet the changing needs of the citizens of Texas and our commitment to continual improvement in the work that we do.
by Jimi Ripley-Black
Improving Health Outcomes for Children: Texas Newborn Screening Performance Measures Project
Providing rapid care and ongoing treatment of a child with a Newborn Screening (NBS) disorder is critical for optimum outcomes. Given the size of Texas, the mobility of families, and inaccurate contact information, it is sometimes challenging to follow up on out-of-range screen results. The Texas Newborn Screening Performance Measures Project (TNSPMP) was launched to address this challenge and improve health outcomes for children diagnosed with a NBS disorder.
Focused on developing evidence-based performance measures in pre- and post-analytical aspects of the Texas NBS Program, the TNSPMP was made possible in 2007 by an award from Centers for Disease Control and Prevention (CDC). The three-year grant was titled “Evidence-Based Laboratory Medicine: Quality/Performance Measure Evaluation.”
- Year 1 - Identify deficiencies (“gaps”) in pre- and post-analytical phases of the Texas Newborn Screening System.
- Year 2 – Develop and identify evidence-based performance measures and determine their effectiveness.
- Year 3 – Pilot the measures and document specific interventions for which there is likelihood of effectiveness in improving performance/quality in areas with noted deficiencies.
In year one, two teams were established: an external stakeholder team to assist in directing project activities and efforts, and an integrated DSHS project team composed of staff from the NBS Laboratory and Follow-up Programs. The external stakeholder team included:
- Representatives from birthing facilities
- Primary care physicians
- Pediatric subspecialists
- Medical societies and associations
- Insurance carriers
- State and federal funding agencies
- NBS programs from other states
- Subject matter experts
Assessments were performed on the Texas NBS System using results from the National Newborn Screening and Genetics Resource Center (NNSGRC) 2005 review of the Texas NBS Program, the NNSGRC Program Evaluation and Assessment Scheme (PEAS), and stakeholder input.
In year two, performance measures were developed that could be used at the program and system levels. The team investigated existing measures in the NBS community, reviewed literature to identify evidence-based performance measures, and began selection of the performance measures to be piloted. Twenty-one key performance measures were selected, based on potential impact and feasibility of implementation in a six month pilot project.
In year three, the 21 key performance measures were piloted for effectiveness in improving outcomes for infants with a NBS disorder. Report formats were developed in three categories of performance measures: pre-analytical universal, post-analytical universal, and disorder-specific. The reports measure critical points in the screening process including time from specimen collection to receipt in the laboratory, from an abnormal laboratory result to physician notification, and from physician notification to intervention and treatment for the child. The monthly reports, for each healthcare provider, have been automated and will soon be made available for online access.
Key lessons learned were:
- Program evaluation is essential to improvement.
- Strong evidence is hard to find in NBS.
- Performance measures must be carefully defined, understood, and consistently reported.
The final goal of the project was to brainstorm, identify, and investigate interventions for potential solutions to close the gaps and break down barriers in the NBS System. TNSPMP team members and stakeholders worked together and proposed a list of both traditional and unconventional methods to improve the system. Education has always been a part of the NBS Program, however the need for ongoing and effective education throughout the system has been challenging. Recommendations included utilizing social media to reach a wider audience of consumers and professionals and routinely providing targeted training on newborn screening to those seeking professions in health care (e.g. medical students, physician assistants, nursing students, etc.)
Although the project is officially over, an enormous benefit gained through the TNSPMP has been the development of strong relationships with system stakeholders. Many of the stakeholders are now members of the legislatively appointed Newborn Screening Advisory Committee. The new Committee members bring a deep understanding of the systems strengths as well as weaknesses. As strong advocates for improving the program, they are instrumental in providing guidance as the Texas NBS Program prepares for the addition of new disorders to the screening panel.
by Jimi Ripley-Black
The DSHS Laboratory decided to expand on the Texas Newborn Screening Performance Project (TNSPMP) by applying some of the pre-analytical measures identified by the TNSPMP to another area of the Laboratory.
The Blood Lead Screening Laboratory, in collaboration with the Childhood Lead Poisoning Prevention Program (CLPPP), applied for a grant though the Association of Public Health Laboratories (APHL) entitled “Innovations in Quality Public Health Laboratory Practice.” Funding was awarded to the DSHS Laboratory in November 2010, and the Public Health Performance Measures Project (PHPMP) was formed.
With a focus on pre-analytical processes in blood lead screening, the purpose of PHPMP is to establish evidence-based performance measures for healthcare providers submitting specimens for analysis as well as state laboratory employees logging and preparing specimens for testing. Examples of specific areas of focus include completeness of test requests, specimen quality, and timely transport to the state laboratory. Internally, assessments include appropriate specimen log-in entry and specimen preparation. Project Manager Cheryl Burcham* stressed that although PHPMP focuses on blood lead screening, the team decided to keep “public health” in the project’s name to allow flexibility and to keep it open for future expansion.
The scope of PHPMP includes, but is not limited to, the validation of specific performance measures in data collection and specimen submission for facilities, the submission of satisfactory blood lead specimens, and the supply of timely, ongoing feedback to submitters regarding their performance. More specifically, the goals of the PHPMP are to:
- Establish the PHPMP as a formal project within the DSHS.
- Perform and document a systematic review of existing evidence and seek input from local stakeholders in identifying evidence-based gaps in pre-analytical phases of the Blood Lead Screening Program.
- Identify, define or develop performance measures to assess and document gaps in the pre-analytical phases of Lead Screening.
- Validate select performance measures and prepare evaluation reports documenting all aspects of the process and suggested interventions.
The project team for PHPMP is composed of members from various areas within the Laboratory, including the Texas Health Steps Check-In Team, Special Chemistry Team, Container Preparation Group, Hemoglobinopathy Team, Demographic Entry Team, and Laboratory Reporting Team. Due to the short, eight-month time frame, the team wasted no time in organizing and getting the project started.
As part of PHPMP, the project team mapped the existing workflow processes of each laboratory area involved in blood lead screening. Burcham noted that mapping workflow (or creating an “as-is” process analysis) is a traditional aspect of project management which enables a project team to review workflow processes on detailed levels as well as “at a view of 30,000 feet.” A total of 19 blood lead screening workflow process
|maps were created. From this, the project team identified 15 gaps and barriers, which they used to lay the foundation of the work for the PHPMP.
The project team selected the top five issues identified through process mapping and will focus on these in future continuous quality improvement projects:
- Decentralized customer service
- Redundancy in several processes
- Difficult or time-consuming processes
- Internal delays in testing
- Conflicting directions and instructions
Because one of the requirements of the grant is that the project must be evidence-based, the project team completed a literature review pertaining to the project goals. As suggested by literature, the project team reviewed and revamped the Clinical Chemistry report cards for submitters. Specifically, the team has discussed the design and format, content, distribution methods, and possibility of automatically generating the report cards. Plans are also underway in the Container Preparation Group to use barcode scanning mechanisms to significantly enhance workflows.
On June 5-8, 2011, a representative of the project team attended the APHL Annual Meeting in Omaha, Nebraska to provide updates on the project and present a poster for display at the event.
*Cheryl Burcham’s last day at the DSHS Laboratory was on May 5, 2011.
by Jan Adversario
Texas Women’s Health Laboratory (WHL) and South Texas Laboratory (STL) are offering the T-SPOT.TB test through August 14, 2011. T-Spot.TB is a new, highly accurate TB blood test for tuberculosis infection.
|Tuberculosis (TB) is an infectious disease caused by the bacterium Mycobacterium tuberculosis. TB was once the leading cause of death in the United States, but it can now be successfully treated if discovered in time. Microscopic droplets suspended in the air pass the TB organism from person to person. Infection can occur when an uninfected person comes in contact with someone who has active tuberculosis.
A person exposed to TB may never get sick, instead developing a latent TB infection, which is not contagious. The person does not show any signs or symptoms of being sick because their immune system controls the infection. Latent TB may develop into active TB if the immune system becomes weakened. A person with active TB disease is sick and shows signs and symptoms of disease (e.g., persistent cough, weight loss). People with active TB are infectious and can spread the TB bacterium to others.
There are two types of tests that screen for TB infection: the tuberculin skin test (TST or PPD) and interferon gamma release assays (IGRAs) such as the QuantiFERON-TB test and the T-SPOT.TB test. The tuberculin skin test has been around for over 100 years. The T-SPOT.TB test received approval from the FDA in July 2008 and the third generation QuantiFERON-TB Gold In-tube (QFT-GIT) was approved by the FDA in October 2007. The FDA has approved both QFT-GIT and T-Spot.TB as in vitro diagnostic aids for detection of M. tuberculosis infection. The T-Spot.TB test is backed by the clinical evidence of over 200 peer-reviewed publications, and it demonstrated sensitivity and specificity exceeding 95 percent in FDA pivotal trials.¹ IGRAs are unaffected by BCG vaccination and have become widely utilized in detection of latent TB infection in hundreds of hospitals, medical practices, universities, and public health facilities throughout the United States. The QFT-GIT test has been routinely performed at the DSHS Laboratory in Austin since April 2009, when it was approved for implementation.
The T-SPOT.TB test is based on a patented enzyme-linked immunospot (ELISpot) technology that detects the patient’s immune response to T cells that have been stimulated by Mycobacterium tuberculosis antigens. This indirect test for M. tuberculosis infection, including disease, is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations.
The benefits of the T-SPOT.TB test are:
- Accuracy: Highly sensitive and specific
- Reliable in the immunosuppressed¹
- Does not cross react with the BCG vaccine and most common non-tuberculosis mycobacteria¹
- Requires just one visit in contrast to the TST or PPD
- Simple, easy blood collection; utilizes a standard green top lithium or sodium heparin tube
The T-SPOT.TB test can be used for all at-risk groups, such as TB suspects, TB contacts immunosuppressed patients (e.g. HIV-infected persons, patients undergoing TNF-blocker therapy), foreign-born individuals, and healthcare workers.
In June, the Centers for Disease Control and Prevention (CDC) released updated guidelines for using IGRAs. These new guidelines (MMWR 2010: 59/RR-5) state that the T-SPOT.TB test may now be used in place of a TST in all situations in which the CDC recommends tuberculin skin testing as an aid in diagnosing M. tuberculosis infection. The new guidelines also recommend that an IGRA, such as the T-SPOT.TB or QFT-GIT tests, are preferred for testing persons who have received BCG and for testing persons from groups that historically have low rates of returning to have TSTs read.
The American Medical Association has assigned a unique CPT® code, 86481, for this test.
The collection process is simple; a standard lithium or sodium heparin (green top) tube is used to collect the blood sample. Collect two tubes for an immunosuppressed patient. The blood sample should be maintained at room temperature until transported to the laboratory. Blood samples can be collected Monday through Thursday Friday. The samples must be delivered to the laboratory on the day of collection. The lab must be notified in advance. Results will be reported within 36-48 hours of receipt the sample.
A qualitative (positive, negative, borderline, or invalid) result will be reported. Borderline and invalid results should be repeated with a new sample.
For questions about the T-SPOT.TB test, call WHL at 210-531-4596 (Toll Free 888-440-5002); for questions about the QuantiFERON-TB test, call the Austin Laboratory at 512-776-7760 or 7514 (Toll free 888-963-7111).
¹ The T-SPOT.TB Package Insert
T-SPOT is a registered trademark of Oxford Immunotec Ltd.
CPT is a registered trademark of the American Medical Association.
Laboratory History: Growing and Improving Specimen Testing
Growth and improvement have been constant throughout the history of the Laboratory. The organizational structure has changed markedly as we adapt to meet the needs of the citizens of Texas, but our commitment to improving testing techniques and response times remains the same.
Texas 1943-1957. The State Health Department had been located on the east end of the third floor in the Austin Capitol Building since 1903. In 1933, it was moved to the Land Office Building at Eleventh and Brazos. In 1943, while Dr. George W. Cox was State Health Officer, a new health department building was erected, adjoining the Laboratory building at Fifth and Trinity. In 1945, an additional story was constructed, giving the health department four stories of space and the Laboratory three. The crowded conditions of the Laboratory were greatly relieved. Safer quarters were provided where risk of laboratory-acquired infections could be minimized and where contamination of vaccines and other manufactured biologicals was less likely. The neighboring small buildings, which had grown up over the years, continued to be devoted mainly to Laboratory services. One large two-story building was rented for a warehouse and shipping department at 303 East 5th Street. Later, while Dr. Henry Holle was State Health Officer, additional space was rented nearby with the expansion of activities.
Between 1933 and 1946, Laboratory personnel increased from 13 to 76. Twenty-four "regional" laboratories had been activated.
At the end of 1945, Dr. S.W. Bohls left the Laboratory to enter private laboratory practice, and Dr. J.V. Irons became director. Dr. Irons had joined the department as Chief Bacteriologist in 1933 and had been serving in several capacities, more recently as Associate Director. He began Laboratory tests in virology shortly after his employment.
Both Bohls and Irons were particularly interested in the Laboratory taking full advantage of the opportunities for Laboratory and field research, and their leadership enabled the Laboratory to make important contributions to knowledge of the Laboratory methodology and epidemiology of several infectious and zoonotic diseases. Tick-borne relapsing fever had been discovered near Austin in 1928; previously this disease was known to occur only in Africa. Beginning in 1938, the Laboratory pioneered in development of technology for large-scale production and distribution of smallpox vaccine made in embryonated eggs. The cattle industry was much relieved that Q fever did not to pose an important economic problem. Some of the numerous investigations and publications from this period attracted considerable attention, particularly on turkey ornithosis, which for a few years threatened to ruin the turkey industry.
Local Laboratories. In 1935, the United States Surgeon General began a campaign to eradicate syphilis by a nationwide effort at diagnosis and treatment supported by massive federal funds. The ten-year program was barely initiated and had few notable successes, except for steps toward the standardization of serological procedures, when this country was drawn into the Second World War. With the threat of conflict, induction of young men had already started, and this was dramatically increased in December 1941.
At that time, every inductee received a serological test for syphilis and treatment, if necessary, before starting duty in the military. Most of the specimens in Texas came into the Central Laboratory. Up to 3,000 specimens per day were being tested with the Kline Test, and all specimens received further study with the Kolmer and the Kahn. However, the delay in shipping specimens across the state resulted in a significant number of hemolyzed and anticomplementary specimens, necessitating the retesting of patients and delay in his processing. Consequently, a cry arose for testing to be provided closer to the induction centers and nearer to the treatment centers where the drip-method with arsenicals was employed.
With this impetus, Dr. Bohls used federal funds from the Syphilis Eradication Program to establish fifteen regional laboratories. Beginning in 1942, regional laboratories were located in Abilene, Corpus Christi, Dallas, El Paso, Fort Worth, Houston, Midland, Mineral Wells, Port Neches, San Antonio, San Benito, Texarkana, Tyler, Waco, and Wichita Falls. In a two-year period, the 15 laboratories were activated as part of the statewide network, some of them being newly established and others incorporated into the system after having existed for some time as city-operated facilities. In time, other regional laboratories were added as a result of the proximinty to military bases, because of local interest, in support of food industry need, or to provide sanitation quality checks at transportation centers. Most of the equipment, supplies, and personnel were provided from federal funds in support of the Syphilis Eradication Program. Local governments provided the building space and utilities.
Texas 1958-Present. Although major advancements were made in the control of syphilis, federal support for the program waned. The state correspondingly altered its level of support to the local health departments with laboratories, gradually reducing its funding share from 75 precent to 25 percent, and then to no more than $50,000 annually, and finally to no formula at all, just an indeterminate amount of material. In response, local governments picked up a larger portion of the Laboratory's cost or withdrew support entirely and closed their Laboratory. By 1970, this left 24 laboratories in Amarillo, Lubbock, Midland, El Paso, San Angelo, Sweetwater, Abilene, Wichita Falls, Greenville, Dallas, Fort Worth, Paris, Texarkana, Tyler, Waco, Bryan, Port Arthur, Houston, LaMarque, San Antonio, Laredo, San Benito, Corpus Christi, and Brownwood. In 1972, the San Benito Laboratory was closed, and its functions were moved to the Harlingen State Chest Hospital Laboratory, leaving a 1980 level of 23 local, affiliated laboratories and one state regional Laboratory.
More formal arrangements were set up, beginning in 1979. The department introduced affiliation agreements that specified the degree of departmental support and the types of tests that would be supported. Using these written agreements as a guide, the department then attempted to obtain significant increases in funding at the legislative session in 1981. The effort failed. For the next decade, support of local laboratories remaind at 1979 levels. In 1982, agreements became contracts, and the provisions were included in subparagraphs in the contracts between the department and the local public health departments. The term for local laboratories had, by 1990, changed from "regional" to "affiliated" to "contract" laboratories. Their numbers dropped to 22 with the closing of the Brownwood Laboratory in 1983.
In 1988, significant federal laws and regulations came into existence that would gradually change the status of local health laboratories. Until July, 1988, government operated laboratories were exempt from the provisions of Medicare regulations. After passage, any government laboratory that recovered costs from Medicare was required to meet certification requirements. Within two months the regulation was expanded to include any Laboratory that charged a fee for service. Finally, the Clinical Laboratory Improvement Amendments of 1988 were passed in October, requiring certification of any Laboratory that tested human specimens.
The Laboratory Services Section continues to accept the responsibility for the improvement in techniques throughout the Laboratory and has improved testing methods and shortened reporting times. It leads the way in the addition of services that meet the challenges of the quickly changing field of laboratory science.
The Texas Legislature passed a bill in 1965 charging legacy agency Texas Department of Health (now the Department of State Health Services) with the responsibility of designing a program to combat mental retardation in children suffering from phenylketonuria. This was the beginning of the Newborn Screening (NBS) Program, which has grown to become the largest of its kind in the world. Since the establishment of the program, tests for other disorders, including hypothyroidism, galactosemia, biotinidase, sickle cell anemia, and congenital adrenal hyperplasia, have been added to the Newborn Screening panel. With the addition of Cystic Fibrosis screening in December 2009, the NBS Laboratory now tests every infant born in Texas for 28 disorders. Staff members have also served in leadership roles on national and international committees formulating guidance materials for newborn screening. As the largest testing volume NBS program in the world, the Texas NBS Program continues to fulfill its role in averting and reducing the burden of disease by providing early detection, patient follow-up, and reduced economic hardship.
The Environmental Sciences Division provides testing services to monitor environmental quality, drinking water, and consumer product safety. They identify lead contamination sources, test for shellfish safety, and assess levels of environmental pollution components such as pesticides and PCBs.
The Rabies-Arbovirus Section adapted a procedure to type animal rabies virus isolates in 1989, using monoclonal antibodies to monitor the spread of the disease across the state. PCR is now used to further differentiate among rabies virus strains.
In 1995, the Microbiological Investigation Section was one of four US state health laboratories chosen to perform pulsed-field gel electrophoresis (PFGE) of Escherichia coli O157:H7. PFGE is used to examine strain relatedness of E. coli and other foodborne pathogens. The Tuberculosis section has developed a rapid presumptive positive identification method utilizing high performance liquid chromatography for Mycobacterium tuberculosis. The Medical Serology Branch developed a polymerase chain reaction (PCR) procedure to detect Borrelia lonestarii from ticks is 1998. B. lonestarii may be the causative agent of Lyme disease in Texas.
The 74th Texas Legislature authorized construction of a new Laboratory, parking garage, and office facility. Completed in 2002, the building has allowed the Laboratory to continue to improve health and wellbeing in Texas.
As the largest testing volume Public Health Laboratory in the United States, the Laboratory Services Section performs a wide range of tests. It remains at the forefront of technology, providing state-of-the-art services through development of new tests, adaptation of available tests, and collaboration with other public health agencies. A list of services provided can be found in the Laboratory's Manual of Reference Services.
This article is the third installment of a three-part series on the history of the DSHS Laboratory. Click here to view part one and here to view part two.
In April 2010, Renee Beckham joined the Emergency Preparedness Branch at the DSHS Laboratory. Renee quickly excelled as a Training Specialist. In March 2011, she was selected both as employee of the month for the DSHS laboratory and as the Association of Public Health Laboratories (APHL) State Training Coordinator for Texas.
As part of the Emergency Preparedness Branch team, Renee works closely with the Laboratory Response Network (LRN). The LRN is a national network of over 150 local, state, and federal public health laboratories that perform food testing, veterinary diagnostic and environmental testing. This network encompasses both bioterrorism and chemical terrorism preparedness and consists of three tiers of laboratories. National laboratories are the first tier, which include the CDC and military laboratories. The second tier consists of reference laboratories that are responsible for the investigation and/or the referral of specimens. These laboratories consist of over 100 state and local laboratories, including the Austin Laboratory. The third tier is made of sentinel laboratories. Sentinel laboratories are mostly hospital-based, clinical institutions and commercial diagnostic laboratories that play a key role in the early detection of biological agents.
When Renee first started at the Laboratory, she was asked to put on a “traveling road show” of workshops for the sentinel laboratories around Texas. The purpose of the “traveling road show” is to take the training to the sentinel labs so that they do not have to travel. In July of 2010, Renee traveled to Seattle to attend a training called “Train-the-Trainer for Sentinel Laboratory Wet Workshops,” hosted by the Association of Public Health Laboratories and the National Laboratory Training Network (NLTN). This training gave Renee the tools and the foundation necessary to start her Texas tour.
|She returned enthusiastic and ready to go. She recruited Ileana Valdez from the Biothreat team and, three short months later, they were ready for their first training session.
The wet workshop lasts one full day and consists of two parts. The morning session is a lecture that details the Laboratory Response Network and explains the five biothreat agents that will be observed later in the day. The agents covered are: B. anthracis, F. tularensis, Y. pestis, Brucella sp., and Burkholderia spp. The key characteristics and methods of detection are discussed in detail. The Select Agent Program and the importance of biosafety in the laboratory when handling these agents are also covered. After the morning of lecture, attendees break for lunch.
After lunch, the hands-on portion begins. Five stations are set up and the participants are able to observe various plates, slides, and related material. The plates have growth on various types of media and at different time points: 24 hours, 48 hours, and 72 hours. One set of plates consists of microorganisms that mimic the actual agent and its growth, but are not the actual agent. For example, an attenuated strain of B. anthracis is used which grows just as a virulent strain would. This allows the participants to see actual colony characteristics of the organisms being discussed. The other plates contain microorganisms that closely resemble the select agents and can be easily be misidentified. A common example would be Haemophilus influenzae, which is often mistaken for Francisella tularensis. They are grown at the same time points and on the same media as the biothreat organism in question. In addition to the plates, there are microscope stations with Gram stain slides for each of the organisms. These stations help familiarize the participants with each of the agents being observed while giving them a base knowledge of what to look for in the event a select agent is isolated in their laboratory.
In October 2010, Renee coordinated her first wet workshop with the LRN laboratory in Lubbock, Texas. Although most of the wet workshops throughout the state are within driving distance, Lubbock was not, making that workshop the most logistically challenging to prepare. She had to coordinate how to package and ship all of the training supplies.
Since her first training in Lubbock, Renee has traveled and provided training to laboratorians in Houston, Tyler, Corpus Christi, San Antonio, and Fort Worth. In June, she hosted a workshop in Austin at the DSHS laboratory. To date, over 100 sentinel laboratory staff across the state have received training.
The "traveling road show" wet workshops train participants how to safely rule out and refer specimens that may contain a select agent. If the sentinel labs are able to safely determine that a specimen is not a threat (using the protocols provided in the sentinel wet workshop training), they can continue testing in their laboratory. However, if they are unable to rule out that the organism is a select agent, they should refer it to the LRN reference laboratories. Besides obtaining critical knowledge in the rule-out and refer protocols, participants who attend these trainings are awarded five contact hours of continuing education through PACE.
by Vanessa Telles
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