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.

Improving Transparency in Healthcare

In December 2013, Forbes reported a new study that found that “organization transparency” (candid and open communication by management) plays crucial role in maintaining an engaged, motivated work force. The study results were based on analysis of over 40,000 survey responses. Three key findings were:

  1. The top factor when determining employee happiness is transparency of management,
  2. Managers did a solid job outlining employee roles and responsibilities, and
  3. Management did not do a good job outlining the organization’s vision, mission and values to their employees.

The survey respondents also said that they would work harder at work if they could “believe and trust” their management.

Failure to communicate can lead to disastrous consequences in an organization, including disengaged employees, non-congruence of employee interests, and organizational goals that could negatively affect the organization. Carlos Ghosn (CEO of Nissan and Renault) is known as a “Transcultural Leadership” and “Turnaround Specialist.” He has helped turn around three different companies from losses. Under Ghosn leadership, Nissan went from an annual loss of $5.5 billion at early fiscal 2000 to a stunning $2.7 billion profit at the end of the year 2000. Ghosn emphasized transparency across the organization and consensus among management in decision making. He based job promotions on talent and expertise instead of experience and age. He stated that “Once you set the direction for the company, you have to start heading that way. Success is 5 percent strategy and 95 percent execution … motivation of the employees was the greatest tool that led to the Nissan turnaround.”

On the other hand, John Chambers ( CEO of Cisco in Silicon Valley, CA) is known for his “Collaborative Leadership” that states: “There are three characteristics that make a good leader: first is producing results, second is building a quality team, and third is the ability to communicate direction.” Chambers helped grow the company from $70 million when he joined Cisco in January 1991 to $1.2 billion when he assumed the role of CEO to record revenues of $48.6 billion in FY13. Cisco has encouraged all employees to participate in the organization’s product development through blogs, YouTube, and videos that promote upward communication, feedback, and shared values as well as tying the executive bonuses to cross-functional team accomplishments.

Could the healthcare industry adopt the organizational successes in other industries? The New England Journal of Medicine published healthcare organization transparency successes by the adoption of disclosure, apology, and offer (DA&O) programs among healthcare organizations. In taking a principled approach to addressing medical errors, organizations instituting these programs commit to fully investigating adverse events and implementing interventions to prevent their recurrence. The organizations also openly admit their errors to patients (and make offers of compensation, when appropriate), letting the chips fall where they may when it comes to reputation and liability. Contrary to many predictions that DA&O programs could result in the proliferation of legal claims and costs, data from two pioneering programs have revealed improved liability outcomes, including a 60 percent decrease in legal and compensation costs in one program. University of Utah has started posting its Press Ganey patient satisfaction results online. Their physicians’ ratings have been boosted almost 10 times in less than a few years.

A clear and consistent sense of purpose when handling employee issues, such as removing or correcting employee behavior inconsistent to organization goal and objectives, would help shape a collaborative environment. Increasing transparency at the workplace could help healthcare organizations nurture a collaborative work environment, shared values and mutual engagement, which are all important key concepts in obtaining high commitment and motivation among all employees.

Kachalia, A. M.D., J.D (2013). Improving Patient Safety through Transparency, N Engl J Med 2013; 369:1677-1679, October 31.


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.

Improving Staff Morale in Healthcare Organizations

In 2009, Healthcare Finance News reported that twenty percent of more than 350 healthcare employers reported low morale among employees. Meanwhile, thirty-eight percent of healthcare workers cited lack of motivation and nearly twenty-five percent reported no loyalty to their employers! Nearly fifty percent of healthcare workers surveyed cite increased stress on the job, and fifty percent noted an increase in their workload in the last six months. Most would agree that these numbers will not go down in the next coming years but will go up.

Staff morale can make or break any organization. When employee morale is low, decreased productivity or little collaboration to support organization goals and objectives can result. Unfortunately, there is no magical formula in boosting employees’ morale. The challenge in improving employee morale is complex as it involves the organization’s culture and environment. Healthcare organizations should “prepare and support” their employees appropriately in this healthcare challenging time. As more new technology applications are introduced in healthcare , employees are faced with more complex accountability. It is crucial for healthcare organizations to reassess each employee’s “task alignment” whenever introducing new technology into the work environment.

Task alignment is an approach to employee behavioral change that starts with the identification of key issues in the work units within the organization and asks employees to realign their roles, responsibilities and relationship to perform necessary tasks. Training encourages dialogue and feedback among employees. This feedback should focus on what needs to be improved from both the employee and the management perspectives.

According to Harvard Business Review (April 2014) in its article “Stop Trying to Control Employees or Make Them Happy,” the traditional management “hard” approach started in the 80s; however, this approach is not effective in the 21st century when dealing with digital communications and managing the “X” and “Y” generations. Management should try the “soft” approach by understanding and clarifying what employees do through dialogue and feedback loops; reassessing task alignment; increasing employee power; improving organization transparency; increasing employee reciprocity; and improving the working environment. That would in turn increase employee accountability. Give frontline employees more autonomy to do their job—for instance, by empowering them to make critical judgments and encouraging them to cooperate with each other. When there are dialogues and shared purposes among employees, challenging situations become less complex and employees can work collaborate together to create mutual engagement.

Scheduling regular “social events”, such as monthly /quarterly birthdays, ice-cream social or holiday potlucks can boost morale. Through social events, employees can strengthen their working relationship. Congruence between organizational values and individual values should be nurtured to create an organizational culture comprised of employees who have the desired traits in supporting the success of the organization. Increasing feelings of ownership among employees will boost employee morale and productivity.

Some healthcare organizations have focused on employee perks to increase morale and productivity. One company in Phoenix, Arizona built shower rooms to encourage its employees to bike to work and exercise; large healthcare organizations in California implement walking meetings across the organization and built walking tracks inside the building. Many managers find that walking meetings have strengthened relationships with their team members. However, not all meetings should have this type of structure. It is not the time for employee discipline or other formal business operations requiring lots of documents for the meeting.

At this time, Google, Inc. is probably at the top of all organizations to provide perks for its employees to boost their morale, productivity, loyalty and creativity; these include free meals, onsite day-care, fitness room, game room, free shuttle to and from work, etc. Not many organizations can compete with Google, Inc. for the employee perks and morale boosters; however, investing in flexible work schedules, organized work environment, day care program, comfortable break rooms, game room, family fun nights, discount programs, social clubs, and other amenities would be worthy investments for boosting employee morale.


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.

Root Cause Analysis

Root Cause Analysis (RCA) is a problem-solving tool that is most frequently used to determine the basic underlying factor(s) responsible for an event (ie, its root cause). This analysis is then used to determine the best method of preventing that event from occurring again.

A multitude of different RCA methods are available, but most of them have some basic principles in common. An RCA involves a systematic, data-driven, well-documented investigation into an event. It is a reactive method used to identify the steps in a system or process that are prone to failure, to determine the one or ones that failed and caused the event under investigation, and to determine how to prevent the failure from recurring. The RCA will also determine how many other factors were affected by the event under investigation.

The first step in an RCA is to clearly and factually describe the event or problem. Often the initial description of the problem will involve a timeline description of the proper process, the way the system SHOULD work, and then define the point or points at which the event under investigation differed from the proper course of events. Thus most RCA include a timeline, qualitative and quantitative data depicting the proper process and the failure steps, and thorough documentation of each step. Data is collected wherever necessary in order to be making decisions from data rather than from assumptions of how the system works. Once the root cause or causes of a problem have been clearly determined, an RCA again uses data to identify corrective actions to remedy anything that is wrong due to problem, as well as corrective actions to prevent the same problem from occurring in the future

Let’s pretend that patient test results were reported with the incorrect reference interval. In order to determine why this happened, we start by making a timeline depicting each step in the normal process. In our example, this means reviewing all the procedures in place for setting, maintaining, and changing reference intervals. Then, step by step, it can be determined where the process failed in this specific case, as well as other steps that might be prone to failure. Corrective actions to amend any incorrect patient results and notify caregivers would begin immediately, with thorough documentation. Once the root cause of the process failure is clearly identified and the step or steps that failed have been determined, additional corrective actions would be taken to remedy the necessary steps in the process so that this error cannot recur. Occasionally an RCA will lead to instituting an entirely new process in order to prevent problem recurrence. It’s important to note that everything associated with the RCA is fully documented.

Identifying and implementing solutions is probably the most important part of an RCA, yet it cannot occur effectively if the actual bottom-line cause of the problem has not been correctly identified in the first part of the process. If the root cause has not been correctly identified, the solutions become only a temporary patch on the problem, and the problem it will occur again. RCA generally involve time and work to do properly, and yet can be incredibly useful in preventing a recurrence. In a hospital or laboratory environment where potential patient harm can occur when a mistake it made, the RCA is often an important part of operating a healthcare system.



-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.

Improving Healthcare Delivery: Effective Performance Improvement

How do you conduct effective performance improvement for your clinical laboratory when facing the complex challenges under the Affordable Care Act (ACA) 2010 and regulatory compliances? Producing healthy revenues and manageable costs are crucial components and challenging objectives for any organizations. Healthcare organizations have performed strategic renewals and redesigned their business operations by enlisting performance improvement plans. However, after all that hard work, many organizations still end up with large deficits to their operational budgets and non-compliances on their accreditation agencies’ regulatory requirements that may require drastic measures to rectify (such as employee lay-off or early retirements). Some organizations, even after performance improvement programs or formal business reengineering, will end up closing their doors. According to Harvard Business Review, among Fortune 1000 companies, success rates of business reengineering is lower than 50 percent and can be as low as 20 percent! What can be learned from this? How do you get employees on-board to performance improvement plans toward improving healthcare delivery?

Management should not expect that employees share their desire for change when the organizations are not performing well. Nor should management create teams and expect those teams to produce changes without providing the context for that change. Effective performance improvement does not start with solutions that are prescriptive and instructional; however, it should start with shared diagnosis and mutual engagement involving all employees that result in shared values and collaboration. These in turn help build the organization’s culture toward long term success and not just temporary fixes. High levels of employee commitment result in higher productivity, creativity, and collaboration. This, in turn, creates successful performance improvement programs.

According to Bert Spector, scholar and author in organizational change management and Director for Emerging Executives for the Federal Bureau of Investigation, these five elements create high commitment among employees when implementing performance improvement:

  1. Clarity of the organization goals by employees at all levels,
  2. Teamwork
  3. Shared Information
  4. Organic Controls
  5. Individual development opportunities

Employee communications play a significant role in the success or failure of any major performance improvement or change program. Management needs to get feedback from their employees, and employees need to have a safe environment in which to give that feedback. A good understanding of theories for effective performance improvement (especially those that deal with employee motivation) is a crucial step in improving healthcare delivery.


Spector, B., (2013), Implementing Organizational Change: Theory into Practice, 3rd ed., Upper Saddle River, New Jersey: Pearson, pp. 51-98.

Barrett, D. J. (2002). Change communication: Using strategic employee communication to facilitate major change. Corporate Communications, 7(4), 219-231.


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.


Improving Patient Safety: Effective Communication for Performance Improvement

In 2014, the Joint Commission updated its National Patient Safety Goals (NPSGs) in order to address areas of concerns for patient safety to reduce harms to patients. These goals include standards for clinical alarms, transfusion errors related to patient misidentification, reducing likelihood of patient harm due to anticoagulation therapy, reducing the risk of healthcare-associated infections, implementing evidence-based practices to reduce healthcare associated infections due to multidrug resistant organisms, and prevention of central-line associated blood stream infections. A multidisciplinary team comprised of all clinical areas including nursing, laboratory, pharmacy, radiology, biomedical engineering, and environmental services are necessary to become compliant in all of the NPSGs.

How do you effectively communicate the NPSGs (or any other change initiative) to all personnel? Sometimes organizations will implement initiatives and performance improvement training with score cards, only to find that the initiatives did not produce the expected results. Prior to launching any new initiative for performance improvement toward NPSGs compliances, management needs to take the extra steps to communicate clearly to employees the background of the current situation within the organization, explain why there is a need for performance improvement, and emphasize what the stake are if the organization isn’t compliant.

The transformation process in change management involves changing employees’ behavior to enhance personnel capabilities. According to Kurt Lewin’s model in the traditional change management, there are three phases of change: (1) unfreezing, (2) change, and (3) refreezing that specifically focuses on employees’ behavior or involvement. In general, employees would not necessarily change their behavior just because the organization performs poorly or there are new standards to follow. Employees will keep their attitudes or behaviors when they feel comfortable or safe with the current behavior and there’s no sense of urgency to change their behavior or the work environment allows them to choose not to change. Lewin’s model identifies that in the unfreezing phase there should be open communication and motivation to employees to understand the situation fully. Allowing employees to question the status quo or feel discomfort with the current practices creates “buy-in.” Employees feel invested in the process and that in turn facilitates employees’ participation in the next phase: “change,” when the new improvement strategy is adopted. The last phase, “refreeze,” is implementing and sustaining the change.

Employees’ attitudes are structured along three dimensions labeled as cognitive attitudes (beliefs), emotional attitudes (individual feelings), and intentional attitudes (evaluations based on past or intentional behavior). Communication to explain and motivate employees will help overcome uncertainties and enhance employees’ control and well-being, which in turn promotes empowerment. McEwan studied the indicators of personal empowerment include improved perceptions of self-worth, empathy and perceived ability to help others, the ability to analyze problems, a belief in one’s ability to exert control over life circumstances, and a sense of coherence about one’s place in the world. McEwan pointed out that within the empowerment framework change begins at an individual level; as an individual becomes more empowered, their increased personal capacity makes a positive impact on an organization or group, and ultimately, the wider community. In general, people are not resistant to change; however, they mostly object on being told to change. By investing the extra time and efforts on open communication to motivate employees and create buy-in, the organizational change initiatives will have a much higher probability of success and sustainability.



Lewin, K. (1947), “Frontiers in group dynamics”, Human Relations, 1(2), 143-53.

Pideret, S.K. (2000), “Rethinking resistance and recognizing ambivalence: a multidimensional view of attitudes toward an organizational change”, Academy of Management Review, 25(5), 783-94.

McEwan, Alexandra B,B.A. (Anthropology)(Hons), L.L.B.(H., Tsey, K.,PhD.(Social Sciences), McCalman, J., & Travers, Helen J,GradDip Primary Health Care. (2010). Empowerment and change management in aboriginal organizations: A case study. Australian Health Review, 34(3), 360-7.


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.

Improving Patient Safety: What is Your Laboratory’s Preanalytical Error Rate?

Errors can occur at any point in the preanalytical process: during patient preparation; the ordering process; sample collection; sample transportation, preparation, and storage. Some common errors include wrong test orders, missing specimens, improper mixing, and specimens contaminated with line fluid. Use of laboratory automation has reduced preanalytical errors within the laboratory, but what about those errors made outside of the laboratory’s four walls?

One way to decrease errors would be to implement computerized physician order entry. Due to the increased number and complexity of lab tests along with minimal training in medical schools, improper testing ordering is not uncommon. It would be wise for the core laboratory to provide adequate technical information on those commonly misunderstood tests by clinicians that could be accessed readily, such as an intranet website. Placing additional guards on high-priced molecular testing (such as requiring additional information at order entry) would be prudent. Making pathologists and laboratory professionals available to consult with clinicians about test ordering is also one way to reduce this sort of error.

As more facilities centralize their laboratory operations as a way to cut costs, preanalytical errors due to specimen transportation issues could be rise. Currently, there are no specific regulatory constraints on monitoring temperature and/ or humidity during sample transportation; however, studies show that depending upon the length of time and pressure and humidity involved, these external environment could influence the integrity, and therefore the result accuracy, of transported samples. Inaccurate test results could lead to delay in treatment or treatment errors that might harm patients, which also increase the organization’s liability and threaten the medical licensure and/ or the organization livelihood.

Quality Improvement or Performance Improvement program addressing these pre-analytical errors combined with appropriate training and tools to mitigate the errors by tracking the time points related to the sample transportation would improve patient care quality and safety. As part of a good quality management system, laboratories should track the preanalytical errors made each month and categorize them to make designing improvement efforts easier.

Suggested reading:

Felder, R. A. (2011). Preanalytical errors introduced by sample-transportation systems: A means to assess them. Clinical Chemistry, 57(10):1349-1350.

Plebani, M., & Piva, E. (2010). Medical errors: Pre-analytical issue in patient safety. Journal of Medical Biochemistry, 29(4):310.

Carraro, P., Zago, T., & Plebani, M. (2012). Exploring the initial steps of the testing process: Frequency and nature of pre-preanalytic errors. Clinical Chemistry, 58(3):638-42.

Plebani, M. (2012). Pre-analytical errors and patient safety. Journal of Medical Biochemistry, 31(4):265.

Tiwari AK, Pandey P, Dixit S, Raina V (2011). Speed of sample transportation by a pneumatic tube system can influence the degree of hemolysis. Clin Chem Lab Med. Nov 10;50(3):471-4.

Zaninotto, M (2012) Effect of Sample Transportation on Commonly Requested Laboratory Tests. Clinical Chemistry and Laboratory Medicine, 50(10):1755-1760


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.

Does Your Laboratory Personnel Meet the CLIA Regulation and Accreditation Requirements?

On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency. It cites the six minimal regulatory requirements for assessment of competency for testing personnel:

  1. Direct Observation of testing procedure
  2. Monitoring the recording and reporting of test results
  3. Review of test results
  4. Performance of instrument Preventive Maintenance
  5. Test performances, i.e. blind unknowns, etc.
  6. Assessment of problem solving skills.

Since early 2013, some CMS surveyors have joined accrediting agencies such as The Joint Commission (TJC) and College of American Pathologists (CAP) in their bi-annual lab accrediting surveys to check testing personnel’s qualification. This qualification includes proof of a minimum education requirement (usually a college diploma). Healthcare organizations need to assure the qualifications for testing personnel are fully met pursuant to the federal, state, and accrediting agency requirements. This includes personnel that perform point-of-care testing (POCT). Because this testing might be performed by non-laboratory staff, these personnel might not have the required education requirements for moderate complexity testing pursuant to the CLIA requirements.

In such cases where the testing personnel licensure is required (for example, by the state) copies of staff diplomas would not be necessary. Licensure is different than certification, which is sponsored by a private sector, nongovernmental institution, such as American Society of Clinical Pathology (ASCP). By requiring personnel licensure, the state government has taken additional measures to protect harm to the public in the state. Currently, there are 12 states with laboratory personnel licensure requirements (California, Florida, New York, North Dakota, Rhodes Island, Tennessee, Louisiana, Nevada, West Virginia, Montana and Georgia). The components of the laws for personnel licensure vary from one state to another; it usually involves a fee, a continuing education provision, and a minimum education requirement, and a professional competency requirement.

Due to the economic situation in the United States and the laboratory workforce shortage, some state government agencies have not actively enforced all compliance aspects among healthcare organizations. For example, some laboratories allow medical lab technicians (MLTs) to perform high-complexity testing due to the medical lab technologists’ (MTs) shortages across the country. However, according to CLIA regulations, MLTs should only work in moderate complexity testing areas that require limited independent judgments. The high complexity testing environments that include blood banking, microbiology identification procedures, microscopy, etc. require a high level of independent judgment and should only be performed by MTs.

Technical supervisory positions in the clinical laboratory require a minimum of five years technical experience. It would not be in compliance with the regulations when the clinical laboratory general supervisors are chosen from MLTs or related field, such as cytology or histology or radiology. Healthcare organizations need to assess their lab personnel qualification and competency to assure that they are meeting the standard requirements pursuant to CLIA regulations, state regulations, and accreditation requirements.

If you’d like more information about these regulations, please read the Code of Federal Regulations part 493.


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.