I'm your presenter, Bridget Smedrick. I currently serve as the Director of CLIA Compliance for Doctors Management. I have a Bachelor's of Science Pre-Med Concentration in Biology and Chemistry from the University of Tennessee. I'm a certified medical technologist since 2000 through the American Society of Clinical Pathology. I have over two decades of laboratory experience from physician office laboratories to high-complexity laboratories. And I currently hold a lab supervisor license. Doctors Management is a full-service medical practice management and consulting firm. We simplify the business of medicine so that you can focus on caring for your patients and the future of your business. We advise large and small medical practices and healthcare organizations on topics such as increasing practice profits, reducing compliance risk, improving patient satisfaction, reducing stress for physicians and staff. Our team consists of nationally recognized industry experts in compliance, coding, auditing, financial services, patient retention, human resources, and more. The learning objectives for this session will be as follows. Understand CLIA and COLA requirements for quality assessment. Know the necessary components of a quality assessment plan. Be able to implement a quality assessment plan for your laboratory. And have the tools to monitor quality for your laboratory system. Quality assessment is a process quality assessment. Quality assurance is defined by the College of American Pathologists as the systematic monitoring of quality control results and quality practice parameters to assure that all systems are functioning in a manner appropriate to excellence and healthcare delivery. COLA defines this as a program which helps standardize testing in the laboratory, identify sources of error in patient testing, and includes regular monitoring and evaluation of all aspects of the laboratory's activity from specimen collection to the delivery of the report to the physician. A QA program evaluates each process in the laboratory, quality control, proficiency testing, personnel training, test tracking, laboratory communication, and all error correction procedures. It provides laboratory staff with a roadmap to identify and investigate problems in these laboratory processes to develop appropriate corrective actions and to perform follow-up review to be sure problems are corrected. In the end, continuous improvement and error prevention is the goal. Quality systems. CLIA requires that every non-waved laboratory must establish written policies and procedures with a quality assessment component that ensures continuous quality improvement of performance and services through ongoing monitoring that identifies, evaluates, and resolves problems. COLA allows laboratories to incorporate quality assessment into daily testing protocols. The quality assessment process includes the following. Evaluate every step of the testing process. Ensure policies and procedures are effective. Learn if policies and procedures are being followed. Assess whether you are providing the right result on the right patient at the right time. Look for opportunities for improvement. Implement corrective actions. Document and repeat. COLA's quality assessment requirements are as follows. You must have a quality assessment plan. Your director must review and sign the plan initially and every year thereafter. You must include pre-analytic, analytic, and post-analytic phases of testing. You must periodically evaluate each component. We interpret for the physician office lab that periodically means annually. We also recommend that the physician office lab monitor one component each month. Quality assessment plan. CLIA and all accrediting agencies require every laboratory which is non-waved to develop a quality assessment plan. The director must review and sign this plan initially and annually thereafter. Your QA plan should state how you assess quality, and your laboratory should follow the established quality assessment plan. Components of a complete quality assessment plan are as follows. Confidentiality of patient information, specimen identification and integrity, complaints, personnel competency, proficiency testing, test request, specimen submission, handling, and referral. The confidentiality of patient information is the most important component of a quality assessment plan. The confidentiality of your patient's information is covered by HIPAA regulations as well. Independent laboratories, hospitals, and practices must have HIPAA compliance plans. Physician office laboratories need to be intentional to protect their patient's information within the laboratory, and these aspects are all covered by your practice's HIPAA plan. When considering patient confidentiality in your practice, you should ask yourself the following. Do you escort all non-staff individuals? Post patient schedules where unauthorized people can see them? Use a sign-in sheet that meets HIPAA guidelines? Ensure privacy during specimen collection? Do you use a fax cover sheet with a confidentiality statement? Do you verify fax numbers? Do you verify fax numbers? Or do you leave any protected health information where others can access it? If you are using paper charts in your practice, you should consider the following topics when it comes to confidentiality. Do you access only the information minimum necessary? Do you close your charts when they're not in use? Do you turn charts backwards or upside down? Do you leave protected health information where it is accessible to unauthorized individuals? And finally, do you store patient information in a secure area? Confidentiality and electronic records can sometimes be risky. Ask yourself the following to minimize that risk. Do you check for privacy and security of your practice management software, EMR, LIS, and their interfaces? Do you use password protection to access the minimum amount of information necessary? Do you share passwords? Do you change your password at least every six months? Do you position terminals where unauthorized individuals cannot see your patient data? Do you minimize or go to a screensaver before leaving your terminal? Do you have firewalls in place? CLIA often overlaps with other regulatory agencies. For example, CLIA and OSHA. CLIA regulations require that the laboratory director provide a safe working environment. That safe environment is achieved through OSHA regulations surrounding hepatitis B vaccination, safer needles, biomedical waste, fire extinguisher monitoring, eyewash station monitoring. OSHA required testing must be performed by a CLIA certified laboratory. The next example is CLIA and HIPAA. HIPAA regulations defer to CLIA, which defer to state regulations for the release of laboratory results. OSHA and HIPAA often overlap in the following ways. OSHA requires confidentiality for information concerning vaccinations and exposure follow-up. HIPAA does not cover employment related health information or workers' compensation information. In order to ensure specimen identification and integrity for your samples, you should ask yourself the following when reviewing your policies and procedures. Do these policies and procedures ensure identification and integrity of each specimen from collection through final testing and result reporting? You should verify that you are collecting the proper specimen for the test ordered. You should enforce a specimen labeling policy. You should follow your written policies. Your practice should use two unique identifiers, one being numerical. And your practice should follow the manufacturer's or reference laboratory's processing and storage requirements. Further investigation into your policies and procedures should lead you to the specimen labeling procedure. Ask yourself the following, does your procedure require that the patient's name plus numeric identifier are used on each specimen? Do you require that the date and time of the specimen being collected is written down on each sample? Also, does this procedure require the identity of the collector? Then go one step further and actually look at specimens to see if they contain this information. You can review a sample of specimens, document this using at least 20 specimens, and that would be a great quality assessment activity for specimen identification and integrity. CLIA requires that all non-wave laboratories have a procedure to document and investigate complaints. Does your practice have a procedure to document and investigate complaints? Are your employees aware of this procedure? Does management encourage employees to report laboratory problems? If so, do you document each reported complaint about the laboratory service from testing personnel, providers, or patients? In order to complete a proper complaint investigation, you should do the following, investigate each complaint, evaluate those complaints, evaluate those complaints, and implement corrective actions. Monitor those corrective actions for their effectiveness, and post a notice about how individuals can report problems to an alternate source and remain anonymous. Personnel competencies are a vital part of quality assessment when it comes to your laboratory. Do you verify that your laboratory personnel meet certain qualification standards in education, training, and continuing education? Does your director or technical consultant perform these competency assessments initially, meaning prior to testing patient specimens, at six months for all new operators, and annually thereafter? Do your assessments meet competency requirements? And do you evaluate competency of your technical consultant? Proficiency testing is required by CLIA for all non-waived regulated analytes. You should verify that you're enrolled in an approved proficiency testing program for all regulated analytes. Review proficiency testing reports in a timely manner, grade any challenges that are not graded or scored, investigate and implement corrective actions if appropriate for every missed challenge, even one analyte. You should also remember to stop testing for any analytes whose score is less than 80% on two out of three challenges. For any failed analytes, you're required to order two remedial challenges past these challenges prior to resuming patient testing. In order to evaluate the reliability of your non-regulated analytes, you can enroll in proficiency testing, perform split specimen testing at least twice each year, and please remember to include provider-performed microscopies. When it comes to proficiency testing, you should document everything and keep all documents for at least two years. Another important aspect of quality assessment for your laboratory pertains to the test request itself. You should ask yourself the following, are tests ordered only by an authorized individual? An authorized individual is defined by state laws. Is there a written or electronic request for every laboratory test run? This may be in the form of a requisition or encounter form, progress notes or dictation in charts, protocols or standing orders in writing. If the chart is used as a requisition, is it available to the laboratory during the entire process and also to your surveyors? A closer investigation upon your test request should reveal the following. Does your requisition include the name and address and other identification of the individual who ordered the test? Does it list who is authorized to receive the results and who is to be contacted with alert values? Does your requisition contain the patient's name and unique identifier, sex, age, and date of birth? Does this requisition include the tests that are ordered and the source of the specimen? Does your requisition include a date and time of collection along with the individual who collected the specimen? And finally, are your requisitions missing any information? You should be aware that if your test requests are transcribed or entered into an LIS, you are required to verify the accuracy of that information. You can perform a chart review to determine the following. If your test requisition system meets the guidelines, if you are following your policies and procedures, if your requisitions are completed properly, and if there are any problems that need to be addressed. Your policies and procedures for specimen submission, handling, and referral should be evaluated for the following, patient preparation. For example, should the patient be fasting when they do their test? Are they on any medications? The specimen type, the appropriate specimen containers, specimen labeling, meaning you should have at least two unique identifiers, one of which should be numerical. The appropriate storage conditions for the specimen. And finally, specimen processing. In order to ensure the quality of your specimens, you should ask yourself the following when reviewing your policies and procedures. Have you established criteria for specimen acceptance and specimen rejection? Have you developed policies and procedures for submitting specimens to another laboratory for testing? Do you submit referred tests only to a CLIA certified laboratory? And do you process each specimen in a timely manner? When it comes to your procedure manual, you should ask yourself the following. Do you have written policies and procedures for every test that you perform? Are your manuals available to laboratory personnel and surveyors? Have your manuals been approved, signed, and dated by the current laboratory director, both initially and annually thereafter? Do you document the dates of initial use and discontinuance of tests? Do you keep discontinued procedures two years after they are discontinued? A complete procedure manual should include the following. Patient preparation guidelines, specimen collection, labeling, storage, processing, transport, and referral guidelines, criteria for specimen acceptance or rejection, criteria for how to evaluate adequate slides for microscopic studies, how to properly prepare reagents, controls, and stains, calibration and calibration verification procedures. Your procedure manual should also include how to determine a reportable range, corrective actions for unacceptable calibration or quality control, limitations including interfering substances, literature references, a system for reporting results, including panic values, and a downtime procedure for when a test system is inoperable. Manufacturer's instructions may be used, but the laboratory must address site-specific information. For example, who is authorized to order tests? How are these tests ordered? What actions are you to take if quality control is not acceptable or if the test system is inoperable? And also, how are results reported? If you have ever experienced communication difficulties or breakdowns within your laboratory, you understand that communication is a two-way process. You may evaluate your communication system for the following problems, illegible or lost orders, lost phone messages, failure to collect or run a test, the wrong test, wrong patient, wrong instructions, failure to report results to the appropriate person within the appropriate time, and insufficient information to correctly interpret the results. If problems are experienced, do you document these problems, evaluate the cause, and implement your corrective actions? When it comes to evaluating your test systems, you should ask yourself the following, have you established and verified test performance specifications for any new tests or new problems? Do you have any new tests or new test systems? Any modified procedures, replacement analyzers or loaners? Do you periodically verify general laboratory conditions such as sufficient space and ventilation, water quality, electricity reliability, and proper waste removal? As part of quality assessment for the test systems included in your laboratory, do you periodically verify the following and implement any corrective actions? Water quality should meet the standards of your manufacturer. Temperatures and humidity should be monitored and acceptable. Are your instruments protected from electrical fluctuations and interruptions? Reagents should be in date and not contaminated or deteriorated. Culture media plates have not expired or become contaminated and damaged. Reagents solutions are labeled with identity, strength, titer, concentration, storage requirements, preparation and expiration dates. Test systems in your laboratory should be evaluated using maintenance and function checks according to the manufacturer's guidelines. Do you check your centrifuge timer and speed? Is your annual microscope maintenance performed by a professional? Do you clean the microscope regularly? Do you keep documentation of all of this? How about your calibration and calibration verification? Is it performed at least every six months? Quality control performance is a direct reflection of the quality of your laboratory. When it comes to quality control, you should do the following. Always follow manufacturer instructions. If analytes are non-waved, you're required to run at least two levels of controls every day of patient testing. You should maintain documentation of control values and evaluate those control results. You should implement corrective actions when controls are not acceptable. Review statistics and Levy-Jennings graphs and have your director or technical consultant review an initial quality control results. Comparison of test results. Do you use more than one method or more than one instrument for the same analyte? Or do you run tests at different sites? If so, is the secondary system also enrolled in proficiency testing? If not, do you compare the results of the secondary system with the results from the primary system at least twice yearly? If you are using internal comparisons, have you established an acceptable comparison range such as plus or minus 10% or plus or minus three micrograms per deciliter? In order to properly compare test results, you should have a mechanism for comparing patient results to other patient information. For example, using lab test results, their age, gender, diagnosis, or treatment plan. Can you recognize discrepancies and access them? Do you document any discrepancies that you find? Documenting corrective actions is a vital part of the quality assessment plan in your laboratory. You should document any corrective actions for calibration errors, QC problems, communication breakdowns, systems failures, complaints, specimen problems, incomplete requisitions, and missing reports. CLIA requires the proper retention of test records. You should verify that your test records include the identity of the specimen, the date and time received in the laboratory, a record of the condition for any specimens which do not meet your criteria, the results and date of testing, and testing personnel identification. You should keep these records for at least two years and maintain all instrument printouts. Test reports should be evaluated to make sure they include the following, a positive way to identify your patient, meaning their name, date of birth, medical record number, the name and address of the laboratory, the test performed, the test result, the specimen source, the date of testing, any calculated data, reference intervals, normal ranges or expected results, the units of measure, the identity of testing personnel, and any information about unacceptable specimens. If you are using a fax or an LIS to transmit results, do you have security measures in place? Are your records available to surveyors upon request? Do you release results only to authorized individuals? Do you immediately notify the appropriate person concerning panic values? Do you document all actions? Do you notify the appropriate personnel of testing delays? For referred testing, you should ask yourself and examine your policies and procedures for the following. Do you have a policy which prohibits the changing of reference laboratory reports? Do you track reference laboratory reports? Do you maintain the original or an exact duplicate of reference test reports? Or can you access it electronically? Do you keep partial or preliminary reports? For reports with errors, you should immediately notify the person authorized to receive the report, make appropriate corrections, and then maintain the original and corrected reports. Your laboratory may use electronic methods in order to maintain patient records, such as an LIS or an EMR. You must verify that the patient data is correct, verify laboratory results are correct, meaning the correct results are with the correct patient and have the correct calculations, and also verify laboratory data is accessible. Is it available? Not altered. Quality assessment monitoring. You should use your quality assessment plan to develop monitoring procedures, evaluate compliance with each probe annually, document your findings, perform corrective actions if needed, document corrective actions, and repeat quality assessment again in a few months to evaluate the effectiveness of your corrective actions. CLIA requires that you develop and implement an incident management plan. Do you have an incident management plan for your laboratory? Have laboratory employees been informed about this plan and how to use it? Have all incidents been documented and investigative? And lastly, have effective corrective actions been implemented? Your quality assessment plan should include a process for device-related adverse event reporting. Do you have a procedure for reporting device-related adverse events to the appropriate agency, meaning the manufacturer and the FDA? Have employees been trained on your procedure for reporting adverse events? And is this training documented? In summary, you should develop your quality assessment plan to cover all required elements discussed during this session. You should have your director sign the quality assessment plan initially and each year thereafter. You should draft a procedure for executing each facet of your plan, design forms for monitoring each component of your laboratory, monitor at least one facet per month, document and implement a quality assessment plan, document and assess your findings, implement and document all corrective actions as needed, repeat the monitor at a later date to evaluate the effectiveness of your corrective actions, and most importantly, keep all documentation for at least two years.

Bridget Smedrick

CLIA Compliance

Quality Assessment

Medical Practice Management

Healthcare Organizations

Continuous Quality Improvement