case study 2 1 quality assurance in a cow laboratory

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Quality Assurance in the Laboratory

Ms. Sterchi is a Histology Consultant in Indianapolis, IN.

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Diane Sterchi, Quality Assurance in the Laboratory, Critical Values , Volume 10, Issue 1, January 2017, Pages 10–12, https://doi.org/10.1093/crival/vaw051

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This month we are looking at quality assurance. Quality assurance rules every valuation in the laboratory. When laboratory professionals think of quality assurance, we often focus on the workings in the laboratory, but a deeper look tells us there is more than meets the eye. Broad definitions of quality assurance in the health field can be found in medical dictionaries, encyclopedias, and of course the famed (though sometimes not accurate) Wikipedia. An excerpt of an appropriate online definition is as follows: “Quality assurance in the healthcare field is a pledge to the public by those within the various health disciplines that they will work toward the goal of an optimal achievable degree of excellence in the services rendered to every patient. A quality assurance program takes into account the need to define that which is to be measured. Quality assurance implies a clear understanding of what is meant by ‘quality,’ and a valid and reliable method for evaluating the care that is provided.” 1

Quality assurance also involves developing programs that can measure outcomes and support good laboratory practices following recommendations from the Clinical Laboratory Improvement Amendments, International Standards Organization, and the US Food and Drug Administration, to name a few. Guidelines and regulations exist that support quality assurance, as do guidelines that evaluate ancillary services not controlled by laboratory professionals, such as the number of hands a specimen/sample may go through before it reaches the laboratory.

Organization and responsibility: code of ethics and organizational chart for laboratory personnel

Quality assurance objectives: precision, accuracy, completeness, development and implementation of procedures for laboratory analysis, chain of custody, and reporting sample collection procedures, including procurement, storage, and transportation of samples

Sample custody: tracking, identification, acceptance, preservation, and storage and disposal

Calibration procedures: traceability, reference standards, analytical support equipment, and instrument calibration

Standard operating procedures (SOPs)

Internal quality control checks

Performance and system audits

Corrective actions

Subcontracting and support services

Laboratory information management systems

Among the components for a good quality assurance plan, a few are worth emphasizing. For the first one, organization and responsibility, each laboratory employee should have a training binder available documenting that he or she has been trained to do the assigned job and been competency tested. Any SOP for a particular job must be signed by the employee who performs the procedure; the date read and SOP number should be included in his or her training binder. The training binder should also contain the employee's CV, job description, and documentation of any other training applicable to the job.

Be sure to nail down the quality assurance objectives, which can be difficult since no one wants to inadvertently omit an important process. Therefore, it is better to have a small group of people in the facility develop the list of objectives and then work from there. I learned this lesson when establishing documents for a start-up biotech company. Redundancy does not make it better.

A corrective action document is one of the most important that a laboratory needs. It must specify the steps personnel must take to remediate a problem, and thus can be the most difficult to develop, since not all problems are the same (for example, sometimes the corrective action is simply reanalyzing a sample). This document should be written under the advice of the facility's legal counsel, who can then seamlessly carry on after, if needed, since they know what was done at the start of the remediation.

To sum it up, we live quality assurance in and out of our jobs. We want to make sure that everything we do is the best for all and that we avoid mistakes. Unfortunately, we all make mistakes, so we must have a plan at work to ensure we act correctly in all cases for everyone (patients and laboratory professionals) and to make sure the facility delivers what it has promised. Quality assurance is a lifeline to the patient and caregiver, providing a sense of trust that the laboratory will deliver accurate results. We need to maintain that trust for the safety of our patients and the care they receive.

O'Tolle Marie , ed. Miller-Keane Encyclopedia & Dictionary of Medicine, Nursing, and Allied Health , 7e. Saunders; 2003 .

Basic Laboratory Inc., Quality Assurance Plan, Revision 15.0, January 2012 .

Author notes

• biotechnology
• calibration
• dictionaries, medical
• financial audit
• job description
• laboratory personnel
• management information systems
• quality control
• reference standards
• united states food and drug administration
• specimen collection
• transportation
• clinical laboratory improvement amendments
• international standards
• standard operating procedure

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Publication: Enhancing the Laboratory Quality Assurance using the MyKIMIA Proficiency Testing Provider (PTP) Food Scheme Data

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Everyday QA: A case study

Ever feel like theres not enough time to develop a good quality assurance (QA) program for your laboratory? Have inspectors ever cited your laboratory for lack of documentation of ongoing QA activities? Dont dismay

The secret to our successful QA program includes staff participation in data collection, review and report generation. In addition, the development of standardized computer templates for routine QA monitors has taken much of the effort out of the process by providing models for employees to follow. As a result, documenting quality assurance has become integrated into our everyday laboratory activities, rather than being viewed as an arduous task ever looming at the bottom of the lab managers to-do list.

Why document? The benefit of having an effective QA program is that it can serve a multitude of purposes when used as the primary method of documentation of instrument and reagent problems, complaint investigations, personnel assessments and routine monitoring. It streamlines required documentation through the elimination of various problem logs by recording the information into one standard format. In regard to CLIA noncompliance, having no quality assurance program has consistently ranked in the top three of the most frequent survey deficiencies cited. 2  

As seen in Figure 1 , 26 percent of all labs inspected in the first survey were cited for no QA program. This percentage fell to 12 percent and 7 percent respectively, in the subsequent inspection cycles. In physicians office labs (POLs), no QA program was cited as a deficiency in 28 percent of these labs during the first inspection cycle. An identical decrease in POL QA-related deficiencies was also observed in the following inspection cycles. In light of this data, you can conclude that the majority of laboratories inspected now have a quality assurance program in place. It is, however, one thing to develop a comprehensive QA plan on paper and quite another to effectively monitor and evaluate the ongoing and overall quality of the total testing process. 3  

Table 1 3 outlines what components a comprehensive QA program must include. 

All significant lab-related occurrences are recorded as QA studies. ( Quality assurance – 493.1701 ). This approach incorporates into the laboratorys workflow review of the areas defined in the CLIA Standards listed under Subpart-P. This has been accomplished with minimal effort through the development of standardized templates, which are used by all laboratory personnel. 

Patient test management assessment (493.1703) is a routine activity in our laboratory. All laboratory results reported on a randomly selected workday are reviewed each month. In addition, all specimens submitted for reference testing are tracked on a monthly basis to assure laboratory reports are received in a timely manner. 

Another preanalytic monitor our lab regularly employs is assuring that specimens are processed and/or stored appropriately until testing. In one instance, an out-of-range incubator temperature was discovered. The incident was documented, including the corrective action taken (verifying proper operation and temperature of the incubator and clinic notification) and subsequent follow up (consisting of recollection dates for the microbiological cultures affected). 

One way that quality control (QC) assessments (493.1705) are conducted in our lab is by recording instrument or reagent problems via the QA template. It has been our experience that a quicker vendor response and a $1,300 reimbursement resulted by documenting a concise history of the various problems encountered with our chemistry analyzer. By including in our QA studies the detailed resolution to a particular instrument problem (i.e., a recurrent paper jam), this type of QA study dually serves as a record of the event and as a quick reference for laboratory personnel should problems of this nature recur.

Another example of a QC assessment documented by our lab involved a noted increase in faulty urine pregnancy test cassettes. As part of our investigation, the supplier was contacted regarding our observations. When questioned, the supplier stated that there was a change in the pipettes provided in the kit. To compensate for this problem, the manufacturers instructions had been amended to increase the amount of urine added to the test. However, our supplier could not give a sufficient answer as to why our laboratory was not alerted to this change. As corrective action, our facility began ordering pregnancy test packs directly from the manufacturer, which required a change in the contract agreement between the manufacturer and supplier. This assured us of prior notification by the manufacturer in the event of any future changes. Our follow up has verified that we have had no additional problems since making this change.

Proficiency testing (PT) assessments (493.1707) are documented for each PT event. Names of participating staff and the respective scores are recorded as part of the QA study. Any corrective action is also noted, along with appropriate follow up. In addition, an annual PT summary is generated, which evaluates the overall PT performance of the laboratory for the previous calendar year. 

Comparison of test results (493.1709) is conducted semiannually by comparing results from our four hemoglobin instruments, in relation to an established threshold. This type of comparison can be easily applied to multiple instrumentation or methodologies that a laboratory possesses, such as glucometers used for point-of-care (POC) testing.

Relationship of patient information to patient test results (493. 1711) is documented whenever a test result seems inconsistent with the patient information. Inconsistencies may be noted during a post-analytic review, such as in patient chart audits or when receiving conflicting results from an outside lab. Documentation of a reference lab computer glitch (our nursing staff questioned an inconsistent follow-up report on a patient) enabled our lab to track errors occurring at other facilities. A QA study was also implemented when a billing question arose due to two urine chemistry tests being performed at our health department several hours apart. The results were questioned since one ketone reading was 2+ and second reading was negative. This situation was resolved when brought to the attention of the clinician. The difference was due to her instructions to the patient to drink lots of water between the tests since the patient was dehydrated. 

Personnel assessment (493.1713) is documented for all competency assessments conducted, including any corrective action taken or comments made on the assessments. At the end of the year, a QA study is completed listing all testing personnel, including nursing staff who perform testing, the number of laboratory continuing education units (CEUs) required by our facility, along with the actual number of laboratory CEUs earned. This QA study is shared by request with the administration to fulfill the nursing CEU requirements. 

Communications (493.1715) may be the focus of a QA study when there is a need to share new information with our clinicians or when a breakdown in communications has occurred. In one instance, an unusual test request by a new clinician was missed because it was not part of a standing order. The medical consultant and requesting clinician were contacted, and the issue was resolved. The lab supervisor initiated corrective action by re-emphasizing the necessity to examine all laboratory requests carefully.

Complaint investigations (493.1717) are documented whenever a laboratory procedure or test result is questioned and the complaint is deemed valid by the laboratory supervisor. Examples of frivolous complaints may include those lodged by an overly anxious patient during phlebotomy, or a physician who demands an unreasonable turnaround time. On the other hand, no complaint should be dismissed without ample consideration of the circumstances. For example, a discrepant hemoglobin result was noted and reported by a clinician to the laboratory. Upon investigation, it was determined that this discrepancy was caused by reagent deterioration, due to improper storage of reagent microcuvettes. Corrective action included the replacement of the microcuvettes in use, verification of proper QC performance of the new microcuvettes, and review with all testing personnel the manufacturers instructions regarding proper handling, storage and use of the microcuvettes.

Quality assurance review with staff (493.1719) is documented in the laboratory monthly staff meeting minutes. Each month, we review the patient test management QA studies for the in-house tests, as well as the referred specimens. Review of the semiannual QA team meetings between the laboratory supervisor, medical consultant, health director and director of nursing are also reviewed and documented in the staff meeting minutes. 

Our quality assurance records (493.1721) are located in the single-lab QA manual and are accessible to all lab personnel. The QA policy, all QA studies conducted within the last two years, and QA team meeting minutes are compiled in the QA manual for easy reference. 

Staff involvement in quality assurance reduces documentation errors

Because our laboratory uses a team approach to quality assurance, QA documentation has become an efficient aspect of the daily workflow, rather than a separate, time-consuming task. Templates have been developed for routine monitoring, making completion of these studies a standardized yet simple task. Rotation of the laboratory staff for routine QA studies provides everyone a chance to be involved in the QA process. With a standard, computer template format, completion of the QA study is straightforward. It has been our observation that the monthly rotation of staff for completion of assigned QA studies has significantly reduced documentation errors in our laboratory. There has been a threefold decrease in documentation errors since staff involvement was implemented four years ago. Our in-house test documentation error rate has dropped from 4.6 percent to 1.0 percent, and the referred test documentation error rate has dropped from 1.5 percent to 0.3 percent. Credit on annual performance appraisals is given to lab personnel for their participation.

Example of QA study template

One of the patient test management assessments surveys all patient requisitions, including specimen-collection information and results reported on a single day. The time and date the specimen is received and tested, initials of laboratory technician performing the test and the implementation of standing orders and panic values are monitored. The required patient information, which is entered by registration, is also monitored. In addition, the date, time of collection and clinician ID are evaluated for completeness if the specimen is collected outside the laboratory. Our report format 4 contains three sections under Survey Findings: lab error, registration error and clinic error (See Table 2 ). These reports are used agency-wide to improve documentation in the preanalytic, analytic and post-analytic testing process.

Other routine QA studies, such as comparison of test results, provide first-hand knowledge to the staff on how to verify the accuracy of the instruments they use. Routine assessment of proficiency and competency testing allows the staff to become familiar with the entire process of personnel assessment; not just the testing, but also the corrective action and follow-up. QA assessments of reagent or instrument problems, complaint investigations or communications are assigned to the laboratory staff member most directly involved. Completion of the QA study gives the employee a chance to recognize a laboratory problem and follow it through to its resolution. Extensive knowledge of QA gained in our laboratory has provided better job opportunities for our staff members. This was demonstrated when one of our former lab technicians was hired by a pharmaceutical company into an advanced position as QA technician, instead of an entry-level QA trainee. 

The QA studies conducted fall into one of three categories: complaints, observed problems or routine monitoring. There are many benefits of using QA studies as a tool for documentation.

Elimination of various problem logs and assurance of CLIA compliance for ongoing QA activities are just a few. Financial rewards for your laboratory are possible by detailed documentation of instrument and reagent problems. Saving time is another valuable benefit that can be realized by documenting the resolution of mechanical problems and thus avoiding further calls to the manufacturer.

Staff involvement in QA has produced a threefold decrease in documentation errors in our laboratory, as well as many other benefits. By sharing the QA activities, no staff member is overburdened with the task. All members of our laboratory team have an increased awareness and knowledge of QA through their participation. The staff receives positive reinforcement in performance evaluations and improved job opportunities. The time it takes to initiate this type of active participation in a QA program is well rewarded.

Ann McKenzie is laboratory program manager at the Wayne County Health Department in Goldsboro, NC. Lisa Ballance, BMST(ASCP), is a laboratory improvement consultant at the NC State Laboratory of Public Health.

Authors acknowledgements: Special thanks to Pat Thigpen, MT(AMT), Lisa Tyndall, BS, Karen Creech, PBT(ASCP), Michael Elzas, MT(ASCP), Evelyn Coley, RN, BSN, MSA, Mark Swedenburg, MD, MPH. 

• Stevens, Carole, CLIA Inspection of Wayne County Health Department, June 2001 
• Yost, Judy, CMS CLIA Data Base; April 2002
• Division of Laboratory Services (DLS): Subpart P-Quality Assurance for Moderate Complexity (including the Subcategory) of High Complexity Testing, or Any Combination of The Tests. Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). Available at: www.phppo.cdc.gov/clia/regs/subpart_p.asp . Accessed June 11,2002
• North Carolina State Laboratory of Public Health (NCSLPH), Health Department Laboratory Management Skills, Part 4: Quality Assurance workshop, November 1994.

March 2003: Vol. 35, No. 3

© 2003 Nelson Publishing, Inc. All rights reserved.

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Directions: Read through the case study/scenario. Answer the assigned questions

Directions:Read through the case study/scenario .Answer the assigned questions in a paper format. (Don’t just answer the question, you will need an introduction, body and conclusion). It needs to be 1-2 pages in length.Submit case study/scenario to the appropriate assignment drop box.The due date for this assignment is posted on the course calendar. I will not accept late submissions . NO EXCEPTIONS!Case Study 2-1 Quality Assurance in a COW laboratory.The COW lab in a large internal medicine group practice performed over 50 waived tests a day. The medical assistants and the phlebotomists who performed the waived testing were all trained OJTs. It was obvious from the inconsistent results recorded on the cumulative report that everyone’s technique differed somewhat. When notification came from CLIA that they would be visiting the site within the next month, the lead physician decided that a QA process had to be put into place. He directed the lab staff to the CLIA Website for instructions on waived testing standardization in the form of GLPs issued by CLIAC.QuestionsWhat are CLIA and CLIAC?Why is CLIA visiting their site?What are the GLPs and what makes them valuable in standardizing the waived testing process?What are other examples of QA Components that could be put in place in this lab setting?Case Study 2-2 Blood Draw Fails Delta CheckIt was a very busy day in the hospital laboratory since two phlebotomists were out for medical reasons. An order came from the fourth floor for a timed draw. Joe, a phlebotomist from a temporary agency, was still there, even though he was supposed to have gotten off 2 hours earlier. No one was there to collect the specimen except Joe. Knowing how important it was, he decided to go ahead and collect it. When he arrived in the room, the patient was seated in a chair between the beds. Joe asked the patient his name and in which be he belonged. When the seated patient answered with the right last name and pointed to the correct bed, Joe proceeded to collect the specimen from him while he sat in the chair. Joe labeled the specimen tubes at the nursing station while noting the draw on the desk clipboard. When a second specimen was drawn from the patient later that morning, it failed the delta check. The second specimen was recollected and the results showed the specimen that Joe had drawn to be in error.Questions:What is a delta check?What do you see that could have caused this discrepancy?What should Joe have done differently?What were Joe’s obligations to the laboratory after his regular shift?Will need to be in MLA formatEvaluation of case study response will be based on the following criteria:CriteriaRating ScaleScoreCase study response includes an explanation of why the decision was selected221814129630Case study response is well organized43210Case study response evidences are in complete sentences with correct grammar, punctuation and spelling.43210

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Homework answers.

1. CLIA is clinical laboratory improvement amendments and CLIAC is the advisory committee of CLIA that monitors the quality assurance .

2. CLIA is visiting this site because of the inconsistent results .

3. GLP's is good laboratory practices and it assures the quality of the test which makes them valuable in standardizing the waived testing process .

4. The examples of components of quality control are :-

Human resources

Relevant ethical requirements, acceptance and continuance of clients relationships

Engagement performance

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