management/administration – Page 22

Product Recalls and Patient Safety

Manufacturers issue product recall notifications when their product doesn’t perform as it should. A few examples include control materials not performing as expected, instrument software malfunctions, or in-vitro diagnostic devices (IVDs) such as glucometers and hemoglobinometers failing to perform. There are different classification of product recalls according to the Food and Drug Administration (FDA).

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violate product will cause serious adverse health consequences or death.
Class II recall: a situation in which use of or exposure to a violate product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violate product is not likely to cause adverse health consequences.

In some cases, these situations also are considered recalls:

Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems would be a market withdrawal.
Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm.

These notifications require acknowledgement of receipt as well as an action plan to assess if the malfunctioning material or instrument affected patient care. Recalls need to be taken seriously due to the potential of patient harm resulting from inaccurate test results. It’s not uncommon for laboratories to receive non-compliance findings in this area, usually due to lack of documentation and proof of action to assure patient safety.

The Joint commission standard MSE.8.2 requires that an organization has a product/equipment recall system. Element of performance 11(EC.02.01.01) requires that hospitals have a way to respond to product recalls and notices. Accordingly, each laboratory needs to establish a product recall system that includes documentation of any actions taken in response to a Letter of Recall notice. This documentation should include distribution lists to departments in the hospital, acknowledgment of read/action from department (s), initial/ date, identification of the returned/ recalled products affected or confirmation that no products were affected per manufacturer’s instruction, and the patient safety assessment study conducted that’s reviewed and approved accordingly by the department manager and/or quality assessment manager. Management should insure that none of the recalled products were used to conduct patient tests. If the products were used and the resulting potential result inaccuracy might harm patients, communication to the providers and/ or patients, needs to be considered.

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.

Point of Care Testing Competency Assessment

Healthcare facilities can use point of care testing (POCT) devices to improve healthcare delivery. The majority of these POCT devices are waived tests, such as glucometers and hemoglobinmeters. In recent years, however, more facilities have moved toward moderate complexity testing such as troponin cardiac biomarker, blood gasses, prothrombin time, and bilirubin. Most POCT devices are operated by non-laboratory clinical personnel, such as nurses and respiratory therapists. Under CLIA regulations, these individuals are classified as testing personnel (an individual who perform laboratory testing and report test results for patient care) and must comply with competency assessment regulations.

CLIA does not have any requirement for assessing personnel competency on waived testing; however, CLIA requires that waived testing results are accurate to assist in making accurate patient diagnosis. This requires that personnel follow all manufacturer’s instructions, which generally includes personnel training, skill assessment for QC and patient testing, device maintenance and infection control procedures as the device is moved from patient to patient. When waived tests are included in the main laboratory’s CLIA license, most accrediting agencies (CAP, Joint Commission, COLA, HFAP, etc.) will also require fully established and documented personnel competency testing on all personnel who performed waived tests. It’s not uncommon for a healthcare facility to receive findings of non-compliances on POCT personnel competency assessment due to incomplete QC (both internal and external) skill assessments for each personnel. Some healthcare facilities erroneously have the laboratory POCT coordinator or supervisor perform the external QC on their POCT. All testing personnel must know how to perform all QC and their corrective action for out of control situations and documentation requirement pursuant to the organization policy.

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.

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.

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:

Direct observations of testing procedure, including specimen preparation, and handling/ pre-analytical as appropriate,
Monitor of recording and reporting of results,
Review of intermediate test results or worksheets, QC results, preventive maintenance and proficiency testing results,
Direct observation of actual preventive maintenance or function checks procedures,
Assessment of test performance on external proficiency testing samples, internal blind unknowns or previously analyzed samples,
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.

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.

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:

The top factor when determining employee happiness is transparency of management,
Managers did a solid job outlining employee roles and responsibilities, and
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.

Reference:
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.

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.

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.

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:

Clarity of the organization goals by employees at all levels,
Teamwork
Shared Information
Organic Controls
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.

References:

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.