The Laboratorian - Volume 3, Issue 4

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The Laboratorian - Volume 3, Issue 4
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April 2012 - Volume 3, Issue 4

Article Index

- Opt-in Decision Form
- HL7 Communication
- Lab Tour
- Lean and CQI, part 2
- Lab Auditors
- iPassport

Editorial

As I watch my Kindergartener play t-ball and learn the role of a third baseman, I remember the saying “Everything I ever needed, I learned in Kindergarten.” He is learning an important life lesson: the value of teamwork. In the laboratory, we can see the successes achieved through teamwork. Each of us is a critical member of the laboratory team with a job that is incredibly important in achieving the Laboratory’s goal of safely providing accurate, reliable, and timely test results. 

A recent life-saving success story in the Newborn Screening Laboratory illustrates the value of teamwork.  For about a month before and after the Christmas holidays, staff rearrange their normal work schedules to expedite testing and reporting of newborn screening results. This takes tremendous efforts, personal sacrifice, and coordination between staff in check-in, data entry, testing areas, reporting, and clinical care coordination. At a time when people in many professions take time off, dedicated Laboratory staff are working harder and faster than usual.

A baby was born a few days before Christmas 2011. As required, the baby’s healthcare provider collected a blood sample when the baby was about a day old. Due to the holidays, mail was delayed, and the specimen didn’t arrive at the DSHS Laboratory until several days after Christmas. Because of holiday workflows and extraordinary teamwork, the specimen was tested and critically abnormal test results were reported within two days of arrival. The seemingly normal baby was sent to the hospital immediately for blood work and admitted to the pediatric intensive care unit, thus saving the baby’s life. Later diagnosed with congenital adrenal hyperplasia, the baby is alive today thanks to all of the members of the Newborn Screening team.

Regardless of where you work in the laboratory, you do not work in isolation. Your role is critical for the success of the DSHS Laboratory Team. As I explore my new position on this great team, I look forward to learning more about each of your areas and roles. 

by Susan Tanksley, PhD
Director, Laboratory Operations Unit

New “Opt-in” Decision Form an Important Step for Newborn Screening

 

This table contains the beginning of an article on the new NBS decision form (left column) and a photo (right column)

Since its modest beginning in 1963, the DSHS Newborn Screening (NBS) Program has expanded from testing for a single disorder to 28 disorders. Today, the DSHS Laboratory tests in excess of 700,000 specimens annually. Each baby born in Texas receives two “screens.” The first specimen, collected at 24 to 48 hours of age, allows detection and initiation of treatment at the earliest possible opportunity. However, some disorders may not be detected until the second screen, which is collected at one to two weeks of age. When specimens are collected for the two screens at the designated

Photo of a baby's foot in adult hands.

times, the screenings allow for early diagnosis and treatment to prevent serious complications, including early death.

Texas Health and Safety Code, Chapter 33, requires the Texas Department of State Health Services (DSHS) to test for certain heritable and congenital disorders in Texas newborns. Parents can only refuse newborn screening for their child if the screening conflicts with their religious tenets or practices (Texas Health and Safety Code Sec 33.012).

 

This table contains a photo (left column) and a portion of an article on the new NBS decision form (right column)
Punching NBS bloodspots

Newborn screening is done with dried blood spots collected on filter paper. Sufficient blood must be collected in order to screen, re-test, and perform second-tier testing when indicated. Typically, five blood spots are collected from the child’s heel for each of the two screens. Once newborn screening is completed, some residual blood spots may remain. These residual blood spots have many beneficial public health uses including

quality assurance and quality control (QA/QC) to ensure newborn screening tests are accurate, reliable and reproducible, and also for public health research into health problems like cancer, birth defects or other diseases.

In July 2002, DSHS began retaining residual blood spots for QA/QC testing and for potential use in approved public health-related research. Pursuant to a law passed in the 2009 legislative session, effective May 27, 2009, parents could direct DSHS to destroy their child’s residual specimens. Information about what uses were allowed by law was distributed to parents by their healthcare provider when the child was born. Soon after, as part of the settlement of a federal lawsuit, over 5 million residual samples were destroyed in February, 2010.

Because the law allows parents to direct destruction of their child’s residual specimens, Texas is what is called an “opt-out” state. However, this will soon change as a result of House Bill 411 (Texas 82nd Legislative Session). While some of the bill’s amendments to Texas law went into effect September 1, 2011, provisions of the bill which change Texas to an “opt-in” state go into effect on June 1, 2012.

“Opt-out” Versus “Opt-in”:  Switch from the Destruction Request Form to the Decision Form.

Through May 31, 2012, Texas remains an “opt-out” state, with parents having the ability to “opt-out” of storage/use of residual specimens by filling out the Destruction Request Form. Upon receipt of the form, DSHS destroys the requested specimens within sixty days. Starting on June 1, 2012, Texas becomes an “opt-in” state, via the phase-in provisions of House Bill 411. Beginning on that date, DSHS can only use residual specimens for limited purposes (e.g. QA/QC necessary to keep the Texas NBS Program generating accurate test results, and in the process maintain federal laboratory certification) for a two-year period. After that time, the residual specimens must be destroyed unless parental consent is obtained for further storage/use as provided by law. Such consent would be needed before the specimens could be released to public health researchers seeking the blood spots from DSHS.

The new “Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards” form allows parents to decide what they would like DSHS to do with their baby’s residual specimens after testing is completed. If the parent selects “OK” and signs the form, all of the baby’s blood spot cards will be securely stored for up to 25 years, and may be used for public health related research which may take place outside of DSHS. If a parent selects “NO” or does not sign, fill out, or return the form, then the baby’s blood spot cards will be destroyed within two years of receipt of the specimen at DSHS, and the baby’s blood spot cards will not be used for public health research outside of DSHS. Regardless of what the parent does or does not do with this consent form, the newborn screening sample will still be collected and tested in accordance with Texas law.

If a parent grants consent for storage/use under Texas law, that parent can later revoke consent for storage and use at any time. The child can also revoke consent on his/her own behalf once they reach age of majority.

Regardless of a parent’s decision regarding consent, any information that can link a specific child to a specific specimen cannot be released outside of DSHS without specific written consent from the parents, except in a few specific circumstances provided by law (e.g. to doctors for the care of the child, or to a medical examiner investigating the child’s death). Blood spots are stored securely. Within DSHS they can be used for QA/QC to ensure newborn screening tests, equipment and supplies are working correctly, to implement additional newborn screening tests for the Texas NBS Program and/or for DSHS studies of diseases that affect public health. For external public health research, the DSHS Commissioner or designee and the DSHS Institutional Review Board (IRB) must approve the request to release residual blood spots for the proposed study. The IRB is a specially constituted review body established by an entity to protect the rights and welfare of human subjects in research. All approved uses will be posted on the DSHS Laboratory website Bloodspots Use page.

To implement this change to Texas law, the DSHS Laboratory will hire additional staff to develop and provide notification and education about HB 411 to healthcare providers and parents, communicate and train personnel statewide about distributing the new parental information and decision form, and monitor and process the resulting forms that will be received by DSHS.

The new parental decision form, along with the “Texas Newborn Screening Parent Information” form, must be distributed to parents when each newborn screening specimen is collected, by the hospital, birthing facility, healthcare practitioner, midwife, clinic or laboratory. DSHS recommends that providers advise parents to read the parent information sheet and take it to their pediatrician when the child is 7 to 14 days old and to read the decision form and select an option. If the parent wishes to complete the Decision form at that time, the provider must return the form to DSHS. The parents can also mail the decision form to the DSHS Laboratory themselves. Providers are not required to ensure that parents complete and sign the form, but they must verify that they distributed the information and decision forms to the parent.

By law, healthcare providers (or any other person attending a birth) cannot start distributing the new parental decision form to parents until June 1, 2012. Before May 31, 2012, healthcare providers must continue to provide the directive to destroy to each parent during specimen collection. Beginning on—but not before—June 1, 2012, healthcare providers must distribute the new parental decision form to parents when collecting the specimen. The new form will also be available on the DSHS NBS website in English, Spanish and Vietnamese in May 2012. DSHS recommends all 2010 and 2011 kits be used until they expire prior to using 2012 kits. This includes using the 2010 and 2011 kits after June 1, 2012 with the old “Directive to Destroy” form removed and the new parental decision form added. Updated 2012 Newborn Screening collection kits will be available to order in May 2012. More information and regular updates will be distributed through mail-outs, the Texas NBS Listserv, and the DSHS Laboratory website. Electronic examples of the new forms, for information purposes, will be available in May on the NBS website.

HB 411 does not include provisions requiring healthcare providers to educate prospective parents about newborn screening. However, DSHS strongly encourages providers to undertake such education because it is necessary to ensure that parents understand that the new parental consent form pertains to the storage and use of residual blood spots and not to whether the newborn screening itself will be performed. This will require providers to have a strong grasp of how the system works, and DSHS is committed to helping educate healthcare providers on an on-going basis.

According to a study by Jeffery R. Botkin, “Public Attitudes Regarding the Use of Residual Newborn Screening Specimens for Research”(1), many parents are poorly informed because information is not readily available to them about the newborn screening program in general or about the retention and use of residual bloodspots. In addition, a 2010 briefing paper by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children recommends well-defined strategies and policies, including promotion of education for parents and healthcare providers. Public concern has shown a need for additional parental education and provision of informed choice for the use and storage of blood spots. DSHS is responding by providing greater transparency and educational information. Information about the retention and use of residual blood spots in Texas can be found in the Newborn Screening: Disclosure Webinar for Providers. The new DSHS “opt-in” decision form promises to be an important step in attaining a greater level of support, public trust, and acceptance of newborn screening and public health research.

(1) Jeffrey R. Botkin, “Public Attitudes Regarding the Use of Residual Newborn Screening Specimens for Research,” Pediatrics (January 16, 2012)

by NBS Program Staff

 

 

Communicating Newborn Screening Data Efficiently

 

This table contains a photo (left column) and a portion of an article on the communicating via HL7 (right column)
HL7 Logo

In today’s society, lightning fast communication is the norm, as evidenced by the proliferation of smart phones and books on speediness and efficiency. High expectations for technological advancements and the often-overheard cry of “why is this taking so long?” dictate a need for faster communication. In the healthcare community, Health Level Seven (HL7) provides rapid and effective communication between healthcare organizations.

Health Level Seven (HL7) International is a nonprofit organization founded in 1987 to provide a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information between healthcare organizations (http://www.hl7.org/). “Level Seven” refers to the seventh level of the International Organization for Standardization (ISO) seven-layer communications model for Open Systems Interconnection (OSI), the application level. HL7's messaging format is the most widely used by healthcare facilities to exchange key sets of data with each other using a common message structure. As it pertains to the DSHS Newborn Screening (NBS) Laboratory, HL7 provides faster and more accurate demographic data entry and faster return of test results to submitting health facilities. Results are available as soon as 1 to 3 days after the corresponding specimen is received, tested, and accessioned into the DSHS computer system.

Historically, the NBS Laboratory has used its own local text and codes for reporting results. Result reports are generally sent by mail to the submitting health facility, as indicated on the demographic form received with the specimen. The Clinical Care Coordination team then follows up with healthcare providers and/or parents on all out-of-range test results to ensure that the baby receives any necessary follow-up, confirmatory testing, and/or treatment. The NBS Laboratory also provides 24/7 access to result reports via a secure web-based application and an automated voice response system for approved healthcare providers. More recently, the NBS program has established HL7 messaging partnerships with several major Texas hospital systems.

The DSHS NBS program implementation of HL7 began in October 2007 and went live in April 2009, receiving demographic information and reporting results via HL7. Currently, the NBS Laboratory HL7 is fully functional with three large hospital systems that include 38 large submitting facilities. Approximately 75,000 specimens a year (10 percent of all specimens) are processed via HL7.

HL7 messaging requires submitting facilities to have IT systems in place to support HL7 interfaces. If a facility wishes to establish an HL7 file transfer interface for NBS results, the DSHS NBS program will provide the site with system specifications, readiness surveys, and additional information to ensure that they are prepared to develop and implement the project. Facilities determined to be properly prepared will be contacted by the DSHS NBS program to initiate necessary contracts and agreements. DSHS will then assist as necessary to ensure submitting facility systems are properly configured to transfer test orders to DSHS and to receive the NBS results. DSHS will provide HL7 implementation assistance and ongoing messaging services at no cost to the health care facility.

How It Works

The submitting facility enters a specimen’s demographic information into their Hospital Information System and/or Laboratory Information System which configures the necessary information to be transferred to the DSHS HL7 engine. The encoded message can then be sent to the DSHS HL7 software where the information is extracted and placed in a holding table. When the specimen’s demographic form is scanned by the DSHS demographic entry group, the information is imported into the Demographic Entry module of the DSHS Laboratory Information Management System (LIMS). Demographic Entry operators verify the electronic data versus the data on the physical form and save the data into the LIMS. After the specimen is tested, results are transferred from the DSHS LIMS into the HL7 Messaging Software. A result message is created and sent to the facility’s HL7 software which then transfers the results into the hospital’s information system where they can be quickly accessed by healthcare providers.

Challenges

Although the use of HL7 provides faster exchange of information, the implementation process is very complicated. It is a long journey with potential roadblocks and delays due to various factors.

One challenge is the need to coordinate many groups, including DSHS IT and program staff, DSHS vendors, facility vendors, facility IT staff and end user testing staff to complete implementation. With so many groups and interacting systems involved, multiple points for possible error are also introduced, thus requiring changes by both DSHS and the healthcare facility to be very deliberate, calculated, and organized. Possible limitations to setting up HL7 messaging include the strength of the facility’s data interface, IT system requirements, facility’s funding availability to cover potential system changes, and availability of committed facility and DSHS IT project managers to facilitate and coordinate implementing, testing, and validating of the data interface and information exchange. In addition, there is a risk for problems encountered due to limited DSHS management control of submitter front-end validations of demographic information (about five percent of data is historically miss-entered or not transferable). The varying quality of facility end-user training and communication can also lead to decreased data accuracy.

DSHS and facility IT staff also have to conquer the moving target caused by the current expansion of testing for additional NBS disorders concurrent with implementation of a major HL7 system. Whenever the DSHS NBS result report changes, due to addition of tests or other reasons, the HL7 messaging requires a re-evaluation, updating, and re-validation for accuracy. Major delays can occur due to slow approval processes within facility vendors, facility vendor contracts, and lack of committed project managers to facilitate, coordinate, document, and assist with implementation roadblocks.

Although the ultimate goal for HL7 data exchange is 100 percent of specimens from all the many hospital systems, clinics, doctor’s offices, and other collection sites, this is a very long and complicated road. However, NBS program staff look forward to improving the efficient communication of Newborn Screening test results to as many providers as possible.

by NBS Program Staff

 

 

This table contains the beginning of an article about touring the Laboratory (left column) and a photo (right column)

Walking around a public health laboratory is seriously cool.

Giant humming machines, rows of test tubes and small, round dishes containing specimens with hard-to-pronounce names, biohazard warnings and emergency shower stations, an egg incubator and liquid nitrogen generator, people in protective gear with bulky white hoods and face shields. Oh, and boxes with severed animal heads inside.

"Everything is just so unusual and every day is different," Dr. Grace Kubin told me as she took me on a tour of the Texas state public health lab in Austin last week.

After years of writing about public health, I finally got the chance to look behind the proverbial curtain, if only for a couple hours.

Rows of tubes for testing

Like the state it serves, the Texas public health lab is huge. It houses nearly 400 staff and processes 6,500 samples and specimens every day. That's 1.5 million every year and means the lab handles the largest volume of testing of any public health lab in the country.

The people's laboratory

After slapping a visitor's badge to my jacket, we start the tour. We're barely a few steps down the first hall when Kubin, who directs the Texas Department of State Health Services' Laboratory Services Section, points to a stack of boxes the lab recently received. Inside are dead animals waiting to be tested for rabies—"but just the heads," Kubin says. Last year, the lab received about 8,000 specimens for rabies testing, mostly skunks and bats. The lab's diagnostic work helps public health workers in the field decide where to drop millions of rabies vaccine bait packets so they'll have the biggest impact on preventing the spread of wild rabies strains, Kubin explains. Texas health officials recently announced that public health efforts had effectively eliminated canine and fox strains of rabies in the state.

From rabies to babies, I follow Kubin to what she says everyone calls the "punching room." And you can hear why before you get to the door. It sounds like the constant punching of holes being made in paper and that's exactly what it is. The room is filled with staff punching three-millimeter holes in specially made testing paper that has a blood sample from a newborn's heel on it. And considering more than 1,000 babies are born in Texas every day and their blood samples have to be processed as quickly as possible to catch disorders that must be diagnosed and treated quickly to prevent serious problems that's a whole lot of hole punching. In fact, Texas public health laboratorians screen 400,000 newborns for 28 disorders every year. And they do it twice. That's 800,000 specimens a year, making the Texas public health lab the largest newborn screening lab in the world, Kubin says. (Public health newborn screening programs test for conditions such as phenylketonuria, congenital hypothyroidism and galactosemia—disorders that if not detected early in a newborn's life and promptly treated can lead to severe health complications, developmental disorders and even death.)

After the tiny paper blood samples are sorted and prepared, the testing begins. Twenty of the 28 disorders are tested for using tandem mass spectrometry machines—what Kubin calls the "work horses" of the newborn screening lab. The noisy machines are constantly churning out data, helping public health workers pinpoint disorders as quickly as possible so they can notify an infant's doctor. The lab's capacity and skill for effective newborn screening are literally saving lives, Kubin says proudly.

I was getting hungry just as we got to the part of the lab that protects our food. As we walked past workstations, Kubin told me about a listeria outbreak that happened about a year ago and resulted in five deaths. After epidemiologists tracked the outbreak back to chicken salad, the lab began testing its ingredients. The culprit was the celery, Kubin says, which was traced back to a San Antonio produce company with the help of DNA testing done at the public health lab. (To read more on the role of public health labs in safeguarding our food supply, click here and here.)

After food came water—bottles and bottles and bottles of drinking water waiting to be tested for harmful contaminants. Kubin notes that the public health lab is the only facility in Texas that conducts radiochemical testing for contaminants like uranium.

Complex and invisible work

Near the end of our tour, Kubin invites me inside the State Medical Operations Center, a command center where public health workers prepare for and confront emergencies. The room is framed in large televisions and long tables are set up with different signs, such as "Logistics" and "Dispatchers." Kubin notes the center was activated during the 2009 H1N1 flu outbreak, when the lab received about 8,000 flu-related specimens in a week and a half. The 2009 outbreak was an "all hands on deck" moment, she adds.

Public health labs are critical pieces of the nation's emergency preparedness and response system and after years of investment, training and capacity building, Texas is now home to 10 Laboratory Response Network (LRN) labs capable of responding to a range of emergencies, including chemical and biological terrorism, Kubin says. Such preparedness work means that despite Texas' geographical proportions, "there's a (LRN) lab within three hours of every community in the state," she tells me.

In my short time at the Texas public health lab, I only got a tiny glimpse of the breadth of its work. You'd literally have to spend months exploring a lab this size—and probably go back to school—to really appreciate the complexity and just sheer volume of the work it does to stay one step ahead of preventable death, disease and disability as well as respond to emerging threats and disasters.

It's often said that the work of public health is invisible—in other words, most people don't know what public health does or how it relates to their daily lives. If that's true then the work of public health labs is...well, even more invisible. And that's a problem for a field struggling with unpredictable funding streams—as Kubin said: "Sustainability is a big issue."

"We're laboratorians," Kubin said. "We quietly do our work, we don't advertise. But at the end of the day, we really can say that we've saved lives."

To learn more about the work of public health labs and what we'll lose if they're not adequately supported, visit the Association of Public Health Laboratories.

Originally published in the public health blog The Pump Handle.

by Kim Krisberg

 

 


Improving Laboratory Efficiency: Lean in the DSHS Laboratory

The CQI team, from left to right. Front Row: Monty Gomez, Nora Berrios, Hongan Ngo, Renee Beckham, Shontel Willie (leaning on table), Linda Cao, Donna Williams, Tiffunee Odoms, Jan Adversario, Patricia Hunt, Megan Snyder - Back Row: Vanessa Telles, Jill Wallace, Kathleen Street, Sherry Clay, Priscilla Trevino, Sandra Navarro, Cathy Snider (No pictured: Christina Chavez and Joe Aguilera)

In the January edition of The Laboratorian, the history and concepts important in Lean Six Sigma were outlined. Now it is time to apply these tools and concepts in the DSHS laboratory.

The last Legislative session mandated that the laboratory must achieve a $7.9 million reduction by August 2013. In an effort to realize that goal, one component of the overall project focuses on looking at laboratory efficiencies.

To evaluate efficiencies and processes, the Laboratory is using Lean Six Sigma. In review, Lean Six Sigma is a combination of two concepts working together. Lean looks at eliminating waste in workflows to improve production, capacity, and efficiency and Six Sigma uses metrics and performance tools to focus on customer acceptance.

As this project unfolds, there have been several exciting milestones, including the formation of the Laboratory's first Continuous Quality Improvement (CQI) Team in over 15 years. Twenty individuals from different operational areas within the laboratory were selected by their supervisors to participate on the team and attended a three day Lean Six Sigma Yellow Belt training course. The participants will now serve as resources and trainers to other staff members as various quality projects unfold.

The first project of the CQI Team is called a 5S project. The 5S’s come from Japanese and are translated in English to mean: Sort, Set in Order (or Straighten), Shine, Standardize, and Sustain. The goal is to optimize performance, comfort, safety and cleanliness. The benefits provided are reduced cycle times, improved team work, improved safety, improved morale, and improved working conditions, just to name a few.

Sort is the first “S” in the process and it involves eliminating nonessential items from the workplace. This step helps to achieve an uncluttered workplace. Every nook, cranny, drawer, cabinet, desk, or closet is investigated and items are sorted based on frequency of use. A good practice is to take pictures to document before and after the sorting phase. The second “S” stands for set-in-order (or straighten). This entails arranging items in the work area according to use. Many times in the laboratory, a new piece of equipment arrives and is placed where there is available space. Set-in-order involves organizing equipment and materials in the order with which work flows to maximize efficiency. Then we shine. This “S” literally refers to cleaning your work area to make it shine by removing dirt and debris and eliminating any potential for contamination. When the workplace is organized and clean, staff review and document the activities accomplished in the first three S’s and standardize and develop procedures to maintain this work environment. Standardization is an important step in being able to maintain the 5S improvements made. Finally, we sustain the process as we monitor, expand, and refine the results. This becomes part of the daily work flow and allows for continuous improvements.

The best feature of a 5S project is that it is something everyone can do and training is certainly not a requirement. Everyone in the lab can be involved and participate to make the workplace a more organized, efficient, and clean place to be.

by Vanessa Telles

 

 


Laboratory Analytical Testing Auditors: Understanding Who, Why, and How

From February 5 through April 11, many at the Austin Laboratory held their breath, waiting for College of American Pathologists (CAP) auditors to arrive. The suspense ended with their appearance at 8am on April 12. The Women’s Health Laboratory in San Antonio received their CAP Audit on February 27 and the South Texas Laboratory's next CAP inspection is due between May 29, 2013 and August 29, 2013. So who is CAP and why do they audit our Laboratories? Here’s the scoop on the Laboratory’s analytical auditors.

CLIA and CAP

Before we can understand CAP, we need to take a look at CLIA (Clinical Laboratory Improvement Amendments). Established by the US Congress in 1988, the Amendments are quality standards by which all human testing laboratories must abide. The standards were created to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the tests were performed. CLIA is managed by the Centers for Medicare and Medicaid Services.

If a laboratory is going to conduct testing on human patients and report these tests, they must be CLIA accredited. CLIA also provides interpretive guidelines and inspects laboratories yearly to ensure they are in compliance. To assist in this work, CLIA has approved other accreditation organizations that must meet or exceed CLIA standards; one of these is College of American Pathologists (CAP). CLIA will waive their inspections and accept CAP’s procedures and documentation of compliance of regulations. CAP inspectors only come every two years, with the Laboratory itself conducting an interim inspection. CAP provides a checklist of questions for members to complete prior to the inspection. The inspectors themselves are laboratorians and are peers of those in the laboratory they inspect. For example, a Parasitologist would not inspect a DNA laboratory or vice versa.

The inspectors look for documentation that answers the checklist questions. A target date range for their arrival is given. The inspectors call one hour before arrival and complete their inspection in one day. At the end of the day, an exit meeting is conducted where CAP presents their findings to Laboratory Management. Management then has 30 days to dispute or resolve the findings.

TNI, EPA, and TCEQ

The Laboratory’s Environmental analysis groups have a different oversight organization. They are audited by The NELAC Institute (TNI) and Environmental Protection Agency (EPA). TNI has gone through a few name changes since its origination in 1995, but whether called NELAC, NELAP, or TNI, the purpose of the organization is to ensure environmental laboratory competency and data integrity. The basis for TNI is the ISO 17025:2005 quality system approach. TNI focuses primarily on standards, but they do review methods.

The Laboratory’s TNI accreditation and auditing is performed by the Texas Commission for Environmental Quality (TCEQ). TCEQ can send out one of its own auditors or a third party agent. The Austin Laboratory recently received an Audit by a third party agent in January 2012. The South Texas Laboratory is due sometime in March 2013. The audit lasts for three days and is performed every two years. TCEQ gives an expected arrival date, but they only give a preliminary report at their exit conference. The formal report is received 30 days after the audit. Laboratory Management then has 30 days to respond to the findings.

The EPA was formed in December of 1970 as a result of rising concerns over environmental protection and conservation. When EPA inspectors appear at the Austin Laboratory, they are inspecting the Environmental Science Branch and Consumer Microbiology. South Texas Laboratory does environmental testing, but they only do drinking water analyses, not chemical analysis. The EPA’s primary focus is on methods, but they have a certification manual as well. The certification manual serves as a general checklist. The inspections are performed every three years and last three to five days. The times and dates are pre-arranged, and they bring a team of five inspectors. Our last inspection, which ended in November 2011, was an exceptional inspection which was an off-site inspection. The inspection involved sending requested documentation to the EPA. This passing of information back and forth took 10 months. Once the Laboratory received the findings, they had 30 days to respond. Recently, there has been an agreement between EPA and TNI that they can perform co-inspections. The Laboratory is expecting that this will happen in the next EPA/TNI audit.

FDA

There is a final auditing group that comes to inspect the Consumer Microbiology Group at the Austin Laboratory. It is the Food and Drug Administration (FDA). The FDA is the oldest consumer protection agency in the US. It was established in 1848 under the Department of Agriculture. Its purpose is to provide chemical analyses of agricultural products. However, when the FDA comes to perform an audit, they are interested in looking at the Laboratory’s milk and shellfish programs. The FDA Milk Program comes every three years. It has been many years since they have audited the shellfish program. The FDA shellfish Program has limited inspectors and depends on the State’s Laboratory Evaluation Officer (LEO) to assist with the Laboratory’s compliance. The FDA’s concern is how the laboratory performs the methods and whether there is consistency among all the analysts. They also review the Quality Control and Quality Assurance records. Prior to their inspection, they provide a very detailed, step by step checklist. Only one auditor comes, on a pre-arranged date, and it takes up to two-and-a-half days to perform the inspection. When the auditor leaves, he or she gives a preliminary report of deviations with an official report following 30 days later. The Laboratory has 30 days to contest or resolve the findings.

Now you can make sense of the accrediting organizations and their acronyms, reasons, and processes for analytical audits. Hopefully this will make your next audit experience a worthwhile exercise.

by Cindy Crouch

 

 

Introducing iPassport for Document Control

 

This table contains the beginning of an article on iPassport (left column) and a photo (right column)

Document control is no small feat. This statement cannot be any truer than at the DSHS Laboratory. In a production environment where hundreds of tests are performed daily, recording volumes of data and storing them on paper can quickly lead to disorder without the proper mechanisms in place. Beyond sheer chaos in the workplace, the lack of document control in a laboratory poses serious consequences. Imagine laboratory personnel unknowingly using an outdated standard operating procedure (SOP) because that version has neither been destroyed nor marked outdated.

What is document control? “Document control refers to a group of information management practices related to documents. Document control practices generally include provisions to ensure that documents are available to staff who need them, are current, have been properly authorized

A stack of documents.

by the laboratory director or by someone the director appoints, and are properly archived when taken out of service” (Valenstein, et. al, 2009). Document control issues present a matter of concern for laboratories. In fact, a document control system is a requirement of the College of American Pathologists (CAP) and The NELAC Institute (TNI), both of which are accrediting bodies for the DSHS Laboratory.

At the DSHS Laboratory, document control is needed primarily for SOPs and laboratory policies and procedures. The Laboratory has approximately 700 authorized SOPs. Paper copies of these SOPs are stored in the Quality Assurance Unit office and designated testing areas. In the quest to fortify the Laboratory’s document control system, the Quality Assurance Unit acquired a quality management system in 2011 that enables the laboratory to systematize controlled documents. Genial Genetics’s iPassport™ system, is a web-based Quality Management Software with numerous features valuable to the Laboratory.

There are many benefits of using the iPassport™ system. One advantage is reducing paper waste and redundancy. For example, it allows the process of updating and reviewing SOPs to be completed online. Users may add, access, review, update, and authorize their document. Also, the use of this system eliminates the risk of uncontrolled documents lurking in the laboratory by identifying whether a document is a draft, superseded, uncontrolled, or controlled. Further, through this system one can track a user’s activity—whether a document was either viewed or printed—by having a traceable audit trail using electronic signatures.

Jonathan Douglas, an iPassport™ representative, claims that iPassport's comprehensive document control module is what most attracts users. According to Douglas, “This is understandable when you consider that the most common CAP citations now include incomplete documents, important information missing from a procedure, multiple versions of the same document in the laboratory simultaneously, failure to review procedures annually, failure to make complete procedure manuals available at the workbench, failure to archive previous versions, failure to demonstrate staff procedure and policy review, and failure to demonstrate management procedure and policy review”

Because iPassport™ is a web-based system, one of the main concerns of the Laboratory is security and access restriction. Douglas said that the iPassport system is 100 percent secure. “The system uses a high specification encryption method that is identical to that of internet banking and secure payment methods provided on the internet. This specific type of security works by encrypting the data at the client side (web browser) using an authenticated security certificate and decrypting the data on the web/application server (iPassport™). Therefore, no plain text information is sent between the two points,” Douglas said.

In mid-January 2012, iPassport™ was introduced to the Laboratory, marking the official kick-off for its implementation. Shortly after that, the iPassport™ project implementation team began providing training for the end-users, including branch managers, group managers, and team leaders. In this phase of the project, the team is specifically familiarizing users on how to use iPassport™ in the revised SOP review process. In the near future, other modules of iPassport™, such as Incident Reports, Trainings, Audit, and other functions, will be explored to provide better optimization of the system in the Laboratory.

In a time and an industry where rapid changes occur often, one might question the adaptability of iPassport™ to technology and quality requirement upgrades. Douglas said that iPassport™ has a “fantastic development team, who keep the system up-to-date with the latest document control and quality management requirements. A combination of ease-of-use and advanced functionality is key to the success of the system.”

by Jan Adversario

 

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THE LABORATORIAN
April 2012, Volume Three, Issue Four                          (Publication #E14-13156)
Published by DSHS Laboratory Services Section
PO Box 149347, MC 1947
Austin, TX 78714

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LABORATORY DIRECTOR
Grace Kubin, PhD
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NEWSLETTER EDITOR
Jimi Ripley-Black
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Last updated November 03, 2014