Part of the Healthcare Team

The laboratory is often considered a separate entity from the healthcare team. We are the “black box” that provides information and so some equate us with the healthcare IT department. Instead of being isolated with our instruments and microscopes while we crank out data like a big computer, we should be an integrated member of the team and involved in patient care. Imagine the benefits to the patient if a laboratory professional were included in patient rounds. Questions such as: “Can we test for that? Is that test performed on-site? What kind of sample do they need?” would have immediate answers. Laboratory professionals could also provide guidance in test selection and differential diagnoses.

Laboratory professionals and pathologists should work toward this level of involvement. And it doesn’t need to start by leaping into the middle of someone’s rounds. It can start as simply as expanding on an answered question. For example: the transplant team requests a STAT tacrolimus level, but tacrolimus is only performed once a day by tandem MS. Asking to speak with the transplant about tacrolimus testing can actually open many doors. Not only does everyone on the team now understand how tacrolimus testing works, the session also introduces the laboratory professional to a variety of healthcare providers. These providers now have a face to put with a name and a laboratory contact to call in the future when new questions arise. This initial contact could lead to cooperative efforts on other fronts. A rope bridge has been started, and it can become a freeway. All that’s required is to recognize opportunities, and get the laboratory professionals out of the lab and into the healthcare team.

This increase in visibility could feasibly become vital to the survival of the laboratory in the future. As healthcare dollars shrink, it’s incredibly important that the public and our healthcare colleagues understand just how much of their care is predicated by information the laboratory provides. It’s our job as laboratory professionals to help them understand. The doctors of pharmacology (PharmDs) led the way with this type of paradigm shift; now it’s time for laboratory professionals to follow suit. The laboratory can become one of the many faces of medicine rather than its most hidden profession.



-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

PGY-1: First Month

So, as another July 1st has come and passed, neophyte first years have begun their training in pathology residency training programs across the country. Many will begin with either a bootcamp-style orientation and/or an introduction to surgical pathology. Although I do have a PGY-1 friend who started with a CP rotation (and not an intro one at that).

I was fortunate to have a creative surgpath director who has an interest in different styles of medical education during my PGY-1. During the last two weeks of June, in addition to the general administrative orientation requirements, we had what we affectionately refer to as our “bootcamp.” First, we were taught proper blade/cutting technique with various food products (eg – potatoes, bratwurst) to get a feel for how to adjust our cutting technique for various specimen consistencies.

She was truly dedicated and personally went to a butcher in Chicago and picked up pig organ blocks three times for us during those two weeks. Then she and one of our two surgical fellows instructed us in the Rokitansky en bloc method of autopsy dissection after we had watched a narrated DVD that she had created from the previous year PGY-1 training sessions. We then would have to complete a fourth unsupervised pig block dissection and need to score at least a 75% in order to pass our autopsy competency exam. Those who did not pass, had to repeat the exam.

We also learned how to cut mock uteri and prostates since these are common specimens. She had molded and frozen ground turkey to simulate these organs and even added surprises like chick peas to represent leiomyomas. We practiced how to bivalve and cut the uteri for both endometrial and cervical cancers as well as how to gross prostates…although I did go through the whole year and never get one until I rotated in the fall of my second year at the VA where I got them almost daily.

Additionally, in order to learn how to cut frozen sections, we took ten sections from various organs from our pig blocks and embedded, cut, and stained frozen sections. This way we could understand how certain sections cut better than others (eg – fatty tissue is more difficult to cut), how to orient them, and how to cut them well without folding and unevenness. We were then graded on our sections for frozen section competency exam. For those who did not pass, they got some personal remediation at the cryostat with our assistant director of surgical pathology.

In the gross room, we had PAs who were good at teaching. We practiced dictating biopsies and placentas, grossing placentas, and grossing “smalls” like an appendix or gallbladder. Twice a week, we had multi-scope subspecialty sessions in dermpath, liver, renal, and neuropath since most of these types of specimens go to either our fellows or the subspecialty pathologists and our first years rarely saw them.

We initially started with a six-person, six-day schedule of frozens, grossing biopsies/smalls/bigs preview, grossing bigs, autopsy, peds path, and neuropath for 1.5 months. Our PAs usually gross our biopsies and benign smaller specimens. Then we were whittled down to a four-person, four-day schedule of frozens, preview, bigs, and autopsy with two of us taking “mandatory” vacations. The two residents that remained on SP after our five months of intro to SP were incorporate into our standard three-person, three-day schedule of frozen/grossing bigs, biopsy/smalls signout/bigs preview, and bigs signout.

At my new program, it is different because we don’t have surgpath fellows. Since we are a small program, each senior resident serves as a co-chief and one of their responsibilities is the training of the PGY-1 residents in surgpath during an initial one-month intro to SP rotation. Other senior residents on the surgpath rotation also help out with the teaching. They also give AM lectures on grossing topics in Lester’s Manual of Surgical Pathology and the specific nuances of the grossing preferences of our attendings.

As for me, I start off with a comprehensive CP rotation that combines working in both the chemistry and microbiology sections. As a PGY-1 here, they have 2 months of ‘Wet Lab’ or an intro to CP rotation. But since I am a PGY-3 transfer, I am a cross between a PGY-1 in terms of knowing how things are exactly done here and a senior resident. So this month for me combines intro to SP, Wet Lab, and the subsequent comp CP rotation that would come after Wet Lab. So, I get to gross a little (since things may be done differently here), learn about where and how things are done in the labs, and study more specialized CP topics. Since I came from a program where we rotate at four different hospitals for surgpath and can be self-directed in terms of CP, this works fine for me but still can be initially daunting in terms of trying to fit in do things the way they would like them done here.

So what do you think are the best ways to train PGY-1 residents most effectively? Should they start off with an intro to SP rotation and how should that be structured in terms of time, topic areas, and teaching of those topic areas? Or does it matter if they don’t do an intro to SP rotation and go straight into a CP rotation? And who should teach them how to gross? Let us know how things are done at your institution.



-Betty Chung, DO, MPH, MA is a third year resident physician at Rutgers – Robert Wood Johnson University Hospital in New Brunswick, NJ.

Personnel Competency Assessment

On December 21, 2012, the Center for Clinical Standard and Quality/Survey & Certification group (part of the United States Centers for Medicare and Medicaid Services) published S&C-13-07-CLIA. This letter outlines competency assessment requirements for compliance with federal regulation 42 CFR, Part 493, Subpart M. The Clinical Laboratory Improvement Amendments (CLIA) law for personnel competency applies to testing personnel, clinical and technical consultants, and technical and general supervisors. Competency assessments can only be performed by personnel qualified as technical consultants, technical supervisors, or general supervisors. The competency assessment must cover a minimum of six required procedures in addition to their federally regulated responsibility:

  1. Direct observations of testing procedure, including specimen preparation, and handling/ pre-analytical as appropriate,
  2. Monitor of recording and reporting of results,
  3. Review of intermediate test results or worksheets, QC results, preventive maintenance and proficiency testing results,
  4. Direct observation of actual preventive maintenance or function checks procedures,
  5. Assessment of test performance on external proficiency testing samples, internal blind unknowns or previously analyzed samples,
  6. Assessment of problem solving skills (42 CFR 493.1413 (b)(8) and 493.1451(b)(8)).

It’s important to note that peer reviews among testing personnel are NOT acceptable for regulatory personnel competency assessment.

An update to this policy involves the laboratory director’s competency assessment requirement. When the director is the only individual testing and reporting test results (such as a pathologist in a small hospital), the organization must establish and document a minimum level of competency via external proficiency testing or peer reviews for the tests reported on patients. This competency must be performed a minimum of three events throughout the year.

The competency assessment procedure is further differentiated by the regulations for moderate and high complexity testing. For moderate complexity testing, the technical consultant can perform the competency assessment, whereas in high complexity this can be performed by the technical supervisor, which can be further delegated to a general supervisor as long as the general supervisor is qualified for high complexity testing. All delegations must be delineated appropriately by the laboratory director as a written policy. Testing personnel requirements might additionally vary from state to state because some states (CA, FL, HI, LA, MT, NV, ND, RI, TN, WV, and Puerto Rico [PR]) require licensures for their laboratory practitioners.

For new employees, competency assessments must be performed six months and one year after employment; this assessment happens annually thereafter. Whenever testing errors serious adverse events occur, management should conduct personnel retraining and requalification to establish personnel competency. Also, establish limits on how many times such events can occur before prompting a transfer for other work duties or termination.

How can you measure the effectiveness of your organization’s personnel competency assessment? Since personnel competency encompasses multi factors, developing a balance score card (BSC) for each department or specialty can be useful. Percentages can be assigned for external testing (such as CAP proficiency tests), attending internal education sessions, number of serious adverse events or errors, and accrediting agency findings on on-site personnel technical competency during licensing surveys. This BSC can aid management in producing score of effectiveness on each individual and department.

Reference: CLIA brochure #10.


Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.


-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

Laboratory Professional’s Role in Electronic Health Records

Electronic Health Records (EHRs) will play a large role in the future healthcare landscape; it’s imperative these systems display laboratory data accurately and efficiently. The Center for Surveillance, Epidemiology, and Laboratory Services at the Centers for Disease Control recently published a paper about the role Laboratory Professionals can play in the development of electronic health records.

The paper concludes, in part, that “Laboratory professionals and organizations can support the future vision and help improve the overall quality of healthcare for individual patients and the national population.”

If you’d like to read the announcement and the paper in full, it’s here.

Quest to Sustainability: Is Your Healthcare Institution “Going Green?”

“Going green” means an organization focuses on practices that limit waste harmful to the environment, increases benefits to the environment and society, and encouraging sustainable practices. If an organization wishes to “go green,” leaders need to clearly present the vision to staff at all levels. The values and behavior of the organization leaders help shape the organization culture that in turn helps shape employee behaviors. Evidence suggests “going green” can save money or generate revenue for a company. In April 2014, Tim Cook (CEO of Apple) narrated a video on renewable energy to boost Apple’s environmental efforts; this in turn has boosted Apple’s stock value. A healthcare system in the Pacific Northwest with over 25 hospitals and 200 clinics adopted the Energy Star program in 2003 and saved ~$700,000; by 2005, the savings were ~$2.3 million.

These days, organizations are “going green” to create and gain a competitive advantage in business while boosting the organization’s image in the society. Healthcare organizations need carefully implement the principles of “recycle, reduce and reuse when direct patient care is involved. In the United States, all properties of medical devices, instrumentation and clinical materials are designed by medical manufacturers and approved by FDA for their intended. It’s important to remember that costs saving initiatives are ill-served when they’re executed at the risk of harms on patients. Any intervention in patient care needs to be “patient safety tested” and the results evaluations documented and approved accordingly by the appropriate medical authorizing body. All clinical procedures, includes any interventions, should be reviewed and approved and performed pursuant to the approved policy to avoid harm to patients.

On June 18, 2014, the Joint Commission published its sentinel alert “Preventing Infection from the Misuse of Vials.” This alert advised healthcare providers to avoid using single-dose vials multiple times, reenter multiple-dose vials using the same syringe, or saving these vials for use on another patient. These dangerous practices were driven by the desire to save materials and reduce waste, but these policies were implemented without consideration for the impact on patient care. It’s reported that the practices have resulted in spreading the hepatitis B or C virus, meningitis, and other types of infections.

There are ample opportunities for healthcare organizations to join the “quest for sustainability” by reducing wastes, cost savings, and enhancing the organization’s image in the community. Hospitals could serve environmentally friendly food or support a sustainable food system for patients, by partnering with the local farmers or their own organic vegetable garden. Other practices, such as going paperless, using energy-efficient light switches, choosing renewable energy sources, using the same vendor for the same materials, implementing a recycling program, and the careful disposal of chemicals, stains, and other infectious agents are all possible areas for improvement. In addition, encouraging activities and “greener” lifestyle choices by employees, i.e. taking public transportation or bicycling to work, picking up phone or walking up to ask a colleague directly rather than email or using department memos, and walking meetings. A safe work environment with healthy employees is a solid investment toward sustainability in any organization.


Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.


-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

Never a Dull Moment

Every now and then it’s good to be reminded that laboratories are all very dynamic and play an active role in the delivery of healthcare worldwide. We are often so focused on our day-to-day operations, the tests we’re performing, the myriad of measures we use to assure safety and quality that we tend to fit rather nicely inside the “black box” just by doing what we do every day. So once in a while it’s good to have interesting conversations and experiences that remind us that labs add value in so many areas.

Just this past month I have had the privilege to be part of multiple unique conversations that involved laboratory services and career paths. These included: sitting in on a panel discussion around the Medical Laboratory Technician (MLT) training programs; exchanging thoughts and challenges faced by couriers who serve very remote Native American communities in our country; shared and compared notes on world primary care clinics and the need for laboratory services in both western Africa and eastern China; brain-storming ideas and initial plans for merging several lab operations into an efficient and effective new model; and of course, the next exciting adventure for me with ASCP Global Outreach coming up later this summer in Central Asia! These conversations with various experts and leaders in our field covered staffing, recruiting and training, operations, remote challenges, international services, and the vision for the future of laboratory medicine nationally and globally—just about everything from the ground up and every facet from the top down in laboratory medicine was in there somewhere!

As I reflect on the past month or two, I’m reminded that there has never been a dull moment in my laboratory career. In retrospect, what an excellent choice I made all those years ago. Encountering a B positive bleeder in surgery while on the night shift or working solo on Christmas Day with only Shigella group D cultures to keep me company were a few of those times I wasn’t so sure I had made a good decision. Now, looking back, experiences like that have gifted me with knowledge and the experience to share in dialogue with colleagues and perhaps inspire new students in our field both at home and internationally. And lo and behold, even after all these years, there’s still never a dull moment.




Beverly Sumwalt, MA, DLM, CLS, MT(ASCP) is an ASCP Global Outreach Volunteer Consultant.

Autoantibodies in Diabetes Testing

In order to diagnose diabetes, technologists measure glucose or hemoglobin A1C concentrations or perform an oral glucose tolerance test. That being the case, what are autoantibody tests ordered on patients with diabetes or pre-diabetes, or those suspected of having diabetes?

Diabetes is classified as type 1, type 2, gestational and “other specific types”, with about 40 different types of diabetes known. Type 1 and type 2 account for the majority of the diabetes cases, with type 1 accounting for roughly 10% of all diabetes and type 2 accounting for roughly 90%. Type 1 diabetes (sometimes referred to as autoimmune diabetes) is caused by the autoimmune destruction of the pancreatic beta cells. This results in an absolute insulin deficiency and requires insulin to treat. Type 2 diabetes is associated with obesity and insulin resistance and is usually treated initially with diet, exercise and weight loss. Several drugs are currently available to treat hyperglycemia in type 2 diabetes if behavioral modifications do not succeed in lowering glucose levels.

The diagnosis of diabetes is made based on the glucose level and/or hgbA1c concentration, however, not all cases are clear-cut or follow the classic presentations or indications to allow classification as type 1 or 2. Yet determining whether diabetes is type 1 or 2 is important since the treatments are different. Also, persons with type 1 diabetes are prone to other autoimmune disorders, such as autoimmune thyroid disease. In cases that are less than clear-cut, measuring autoantibodies can provide useful information. The main autoantibodies, along with their utilities include:

ICA – Islet cell cytoplasmic autoantibodies are rare in the general population but are present in 70-80% of new-onset type 1 diabetics. They are also present before the onset of type 1 diabetes, so the presence of ICA in a non-diabetic is indicative of a markedly increased risk of type 1 diabetes. If ICA are detected in a type 2 diabetic, it suggests the slowly progressive autoimmune destruction of the beta cells, and that the person actually has a form of diabetes known as latent autoimmune diabetes of adulthood (LADA). Although present in 70-80% of newly diagnosed type 1 diabetics, ICA decline to a frequency of about 5 – 10 % by 10 years post diagnosis.

GAD65/GAD67/GADA – these are the 65 KD and 67KD forms of glutamic acid decarboxylase autoantibodies. GADA like ICA are present in roughly 70-80% of new-diagnosis type 1 diabetes. They also are indicative of progression to type 1 diabetes if found in non-diabetics or type 2 diabetics. However GADA are also found in up to 3% of the general population, so ICA are more specific for type 1 diabetes.

IA2 or IAA – insulin autoantibodies are the least common type of autoantibody present at onset of type 1 diabetes, only occurring in 50-60% of children, and occurring uncommonly in adults with new onset type 1 diabetes. They are also the least disease-specific of the autoantibodies. In addition assays to measure IA2 do not distinguish between antibodies to insulin that may be produced against insulin being administered, versus insulin autoantibodies.

IA-2A – insulinoma-associated-2 autoantibodes are present in roughly 60% of new-onset type 1 diabetes and generally more prevalent then IAA.

ZnT8A – This is the newest autoantibody discovered and it is raised against the transporter that moves zinc from the cytoplasm to the insulin-containing secretory granules in the beta cells. ZnT8A are present in 60-70 % of new onset type 1 under the age of 20, and about 40% after 20 years old. They are also present in 14% of cases which are negative for GADA, IAA and IA-2A. They are also common in LADA patients so can be useful in that diagnosis.

The autoantibodies are especially useful when the diagnosis of the type of diabetes is unclear, and when there is some suspicion that a person with type 2 diabetes may in fact have autoimmune diabetes. Because none of these autoantibodies are present in greater than 80% of type 1 diabetics, measuring several of them is sometimes necessary in order to sort out the diagnosis.



-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.