Second Case of MERS-CoV in the United States

A second case of MERS-CoV has been confirmed in the United States. The patient lives and works as a healthcare provider in Saudi Arabia. The patient arrived in the US from Saudi Arabia on May 1st and presented to an Orlando, Florida emergency room with a fever and respiratory symptoms on May 8th. The patient experienced symptoms during his flights from Saudi Arabia to London, England; London to Boston, Massachusetts; Boston to Atlanta, Georgia; and finally, from Atlanta to Orlando, Florida. The CDC and local health officials are contacting travelers who may have come into contact with the infected patient. As with the case in Indiana, the patient’s family is voluntarily quarantining themselves at home. The patient is still hospitalized and in good condition.

MERS does not pose a risk to the general public. Evidence suggests that close contact with infected individuals—such as care givers—is needed for transmission. Because antiviral therapy or vaccines aren’t currently available, infection control procedures and rapid detection are our only weapons against MERS.

For more information about this virus, its appearance in the US, and specimen requirements from suspected cases, visit Lab Medicine’s MERS information page.

Edited to add: two healthcare workers who came in contact with the Florida patient have flu-like symptoms.

 

The End of the Rotation

Since my program is on a monthly rotation schedule, last Thursday was the last day of my 2-month surgpath rotation at our busiest site, which is private practice at a community hospital that serves a more middle class and affluent patient population than our main academic hospital. So, it seems appropriate to finish my “Adventures in Grossing, Part I” post from 2 weeks ago now. As I think I mentioned in that previous post, my first day at this site (right after I just had gotten back from almost 10 hours of traveling due to layovers coming back from USCAP and getting a migraine during my flight to boot), was a disaster to say the very least.

I had made the mistake of jokingly saying to my rotation director that I was the most CP oriented of those in my year (I’m the last 2nd year to rotate at this site this year)…and he had mistakenly heard my statement as “I dislike surgpath and because of that probably wouldn’t work hard at this rotation.” We were reminiscing about it today as we had our face-to-face end of the rotation evaluation about how much has changed since that first day.

Communication is very important and sometimes that also entails knowing what not to say in a situation, especially if it can be misinterpreted. Luckily for me, after I had another talk with my rotation director, he was willing to ‘start fresh’ and see whether his initial impression of me held true. We did not work together again until the end of the month as I was assigned to other attendings during the interim. But by the time, we were assigned together again, he was “happy” with what he had heard about me from the other attendings.

As a first year, I had heard rumors about how hard this site and some of the attendings were…the stuff of legend so to speak. First years do not rotate at this site as we need to build up our grossing and time management skills to be able to adequately manage the higher volume of grossing at this site. We have a three-day schedule that includes two days allotted to finish grossing and a third intra-operative consultation day which includes frozen sections, sentinel node touch preps, and intra-op gross examination of specimens.

I still need to work on my grossing speed and time management skills but after two months of instruction and experience at this site, I do recognize that I have improved. It’s almost the end of my second year and I generally do fine with diagnoses at sign-out because they are either things I’ve seen before or things that I have some time to read about prior to sign-out. But when it comes to unknown conferences or my RISE surgical pathology scores for the past two years, I know that I am horribly deficient and need some work.

In two months, I will be transferring to a much smaller program in my home state for personal family reasons. My medical school friend will be one of the chiefs next year and one of their incoming first years is also from my medical school. Plus, they rotate mainly at one site and do 1-2 rotations/year at another site that is near where my parents live and where I went to medical school. So it will be different than my current program which has 27 residents that rotate at four sites. The culture also seems very different and I worry that I may be behind the curve in terms of my surgical pathology (SP) knowledge. I’m not worried about CP as my strengths and background are in CP.

So, I’ve been wondering…what are some good resources to learn SP and some good approaches to learn while busy on rotations? I still haven’t found a good solution to these questions yet.

 

Chung

Betty Chung, DO, MPH, MA is a second year resident physician at the University of Illinois Hospital and Health Sciences System in Chicago, IL.

Simplify Equipment Validation with a Validation Master Plan

How compliant are you with all your clinical equipment validation (including the point of care equipment)? The equipment validation process is a crucial component in any clinical laboratory practice; any serious deficiency in equipment validation could threaten the business continuance of the institution. Clinical Laboratory Improvement Amendments (CLIA) regulations set standards on test systems, equipment, instruments, reagents, materials, and supplies for clinical laboratories. Laboratories must properly qualify, monitor, and verify or establish performance specifications for any test systems used for patient testing. The federal regulations and explanation for Verification of Performance Specification and Calibration and Calibration Verifications (as well as other CLIA regulations) can be found on the CMS website.

New equipment comes to the laboratory with settings already in place by the manufacturer. For example, urine drug screen analytes may be preset at certain cutoff levels. It is the laboratory’s responsibility to recheck all new equipment validation on all the so called “manufacturer settings.” A detailed guidance document on equipment validation was published by the Clinical and Laboratory Standards Institute (CLSI) in August 2011. QMS13A (formerly GP37A Equipment Validation) outlines the equipment validation process into several crucial validation components: Selection Qualification (SQ), Installation Qualification (IQ), Operational Qualification, and Performance Qualification (PQ).

Laboratories should start a strategic and simple approach to equipment validation with a validation master plan (VMP). This plan provides a structured approach to equipment validation that will allow many problems to be addressed before they become crises. It also assures equipment needs (functional, business and technical) are met. A VMP should:

  • Be approved by the laboratory’s medical director.
  • Appropriately assess and mitigate any potential hazards.
  • Establish policies and procedures.
  • Assign equipment data reviews.
  • Include personnel training for all shifts.
  • Comply with all patient safety requirements.
  • Outline the timeframe from equipment acquisition to “go live” date.
  • Include accuracy and precision studies.
  • Specify the reportable range and normal values for all analytes.

Typically, 20 samples for each level of normal and abnormal results should be tested for accuracy and precision studies. Clinical equipment should never be used for patient testing until all validation processes reviewed, assessed and approved by the appropriate medical lab director. When determining the reportable range, calibrators and samples should reflect the full range. For example, if the manufacturer suggests a reportable range for glucose of 10 mg/dl to 600 mg/dl, having the lowest sample test at 50 mg/dl would be unacceptable.

In summary, creating and designing a good VMP can save all the agonies and time spent in later future in equipment validation in any clinical laboratory or point of care department. Once one successful VMP have been accomplished and produced, future equipment validation would become much easier and manageable. The overall process would ultimately assure accuracy and reliability of the equipment system in the institution, thereby improving patient safety.

 

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.

 satyadi

-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.

 

 

Updated Information about Indiana MERS-CoV Patient

The Community Hospital in Munster, Indiana held a press conference today (5/5/2014) regarding the MERS patient. This hospital is in northwest Indiana near Chicago, Illinois. Speakers included Mike Pence, Governor of the State of Indiana; William VanNess II, MD, Indiana State Health Commissioner; Daniel Feikin, MD, Medical Epidemiologist with Centers for Disease Control and Prevention; Don Fesko, CEO of Community Hospital; and Alan Kumar, Chief Medical Information Officer at Community Hospital. During the discussion, several facts about the case emerged:

  • The patient lives and works in Saudia Arabia and is in the United States for a planned family visit.
  • Patient doesn’t remember working directly with a MERS patient but does work at a facility that houses MERS patients.
  • The patient presented to Community Hospital on the evening of 4/28 with flu-like symptoms. He has been in private triage, examination, and patient rooms for the duration of his visit.
  • Infectious Disease doctors consulted on the case; quickly suspected MERS based on travel history and notified the CDC.
  • Healthcare workers that came in contact with the patient are currently on home isolation. They will most likely be kept on isolation for 14 days, which is currently the longest known incubation period for the MERS virus.
  • Currently, all evidence about MERS-CoV suggests that direct, sustained contact and exposure to droplets (from a cough or sneeze, for example) is necessary for transmission. NO evidence currently suggests that MERS can be transmitted through casual community contact.
  • The current mortality rate for MERS is 30%; most patients who succumb to the virus are elderly, have concomitant health conditions, or both.
  • The virus could mutate, and if it does there is a possibility that it could become more transmissible. However, there is NO EVIDENCE that has occurred.
  • The CDC is working to identify people who traveled on the same plane and bus as the patient. So far, three-quarters of travelers have been contacted and identified.
  • The patient is in good condition and is expected to go home soon.
  • Discharge instructions, including how long the patient will be in isolation, are still being determined.

If a suspected case comes to your facility and your laboratory needs to handle specimens, contact your local health department for instructions. Also, bookmark Lab Medicine’s resource page for up-to-date information.

Confirmed Case of MERS-CoV in the United States

Today, the CDC and the Indiana State Department of Health announced the first confirmed case of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in the United States at a community hospital in Munster, Indiana. The patient is currently in good condition.

If you’d like more information about MERS-CoV and how laboratory professionals should treat specimens from suspected cases, see Lab Medicine’s MERS information page.

 

Antiobiotic Resistance Worldwide

The World Health Organization assessed worldwide antibacterial resistance and recently published their findings. The report notes that a post-antibiotic era isn’t a dystopian fantasy but, in fact, a real possibility in the 21st century. Dire? Yes, but if you’ve been following the news, unsurprising.

The press release is here.

You can download or order the report here.

You can read a summary of the report here.

 

 

Should Laboratory Personnel’s Total Work Hours be Regulated?

In the past decade, a higher number of medical laboratory personnel work more than one job due to the medical lab personnel shortage situation nationwide and the depressed global economy overall. With more of the baby boomers retiring now, the threat of increasing lab personnel shortages is imminent. Healthcare organizations face challenges in recruiting lab personnel, especially in the highly specialty areas such as microbiology and blood banking. Alarmingly (but perhaps not surprisingly) in metropolitan areas a significant number of clinical personnel work two full-time jobs – that means these employees are working for a minimum of 16 hours per day! If travel time is considered, these employees could have less than 5.5 hours sleep per day. How many people can function long term with such limited sleep? While federal laws do govern how many slide reviews a cytotechnologist can perform per day, there are none that govern the number of hours per day laboratory professionals can work.   Should such laws exist?

In December 2011, the Joint Commission (JC) published a very important Sentinel Event Alert (SEA) Issue on “Healthcare worker fatigue and patient safety.” The publication addressed the effects and risks of an extended workday and cumulative days of extended work hours beyond 12.5 hours. The SEA cited the 2004 study that when nurses worked more than 12.5 hours, they were three (3) times more than likely these personnel created errors in patient care. This alert raised awareness that fatigue could jeopardize patient safety. Transcription errors or reading a patient ID number incorrectly can occur when personnel are fatigue or sleep deprived.

Are efforts to reduce or prevent the errors jeopardized by allowing laboratory professionals to work long hours? Should clinical personnel’s total hours be regulated for patient safety protection? Regardless of the answers to the above questions, healthcare leaders should start planning on how to perform root cause analysis on the medical errors pursuant to the best practices guideline. It is crucial to identify whether or not sleep deprivation and fatigue are a contributing factor and then implement strategies to mitigate the risks on patient safety.

 

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.

satyadi

-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.