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.

 

Notification After the Fact

What does your lab do when you are notified about instrument/reagent problems after the fact? Let me give you two recent examples.

A vender sends a recall notice that goes back 6 months on one of their reagents. There has been a problem with a reagent for 6 months, but you are just now being notified. You look and determine that you have run 1000 tests on patients using that reagent during the problematic time period. What do you do?

Or another example, a reference laboratory changes their units of measure and you miss the notification. 23 patients had results come back from the reference lab and the values were entered into the computer with the incorrect units of measure and reference interval in place. The mistake is discovered on the 24th patient.

Laboratories work to have systems in place to prevent these scenarios. We try to carefully watch for changes from reference labs, and we hope that recall notices will not affect many patients. However, despite our best efforts, relatively large-scale lab errors like these happen. Laboratories need to have systems in place for dealing with these events. A few steps that are helpful when this happens include:

1) Determine whether the error is on-going
  a. Are immediate process changes necessary?
2) Fix the error so no new patients are affected
3) Determine the extent of the damage
  a. Often involves a Root Cause Analysis
  b. How many patients were affected
  c. How serious was the effect (changed treatment vs no effect at all)
  d. Do healthcare-providers need to be notified, and if so, who and how to notify
4) Notifications
  a. Healthcare-providers
  b. Hospital/laboratory Quality and/or Risk Departments
  c. Other clients
5) Documentation
6) Is there a way to turn this into an opportunity for improvement?

Occasionally an error can cause more headache than harm. For example, if you report a value of 35 mg/dL with a reference interval is 20 – 80 mg/dL, the result is normal. If the units of measure are supposed to be mg/L on both instead of mg/dL as reported, this is simply a clerical error because the result will still be normal if you change the units on measure on both the result and the reference interval. Unfortunately, it may still result in a corrected report on each patient, which depending on your system, may still flag your ordering physician. If you make this correction on a high volume test, a lot of irate physicians will be calling you regarding the number of corrected reports on their patients. Thus the error causes more headache than harm, but still requires that a procedure be in place to investigate and deal with it. All labs should have such a procedure.

 

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-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.

 

The Importance of Manual Urine Microscopy

Research presented today at the National Kidney Foundation spring clinical meeting indicates that manual microscopy surpasses automated analyzers when assessing kidney injury. The abstract is titled “Manual Microscopy: Not a Lost Art” and says, in part: “In this study, we examined if a significant difference exists between the reported ranges of granular and muddy brown casts using manual microscopy as compared to an automated urine analyzer in an acute kidney injury cohort.”

According to one of the abstract’s authors, Dr. Sharda, “What our research has been able to show so far is that the automated system under reported the value of granular casts in our patient cohort of acute kidney injury. The automated system still has utility as a screening test, but manual microscopy should be done in all cases of abnormal kidney function, as accurate quantification of casts could have some prognostic benefit to patients.”

The poster is available online. The authors are currently writing a paper on their research; their contact information is here.