Hello, and welcome to Preparing for the Laboratory Inspection. I'm your presenter, Bridget Smedrick. I'm the current director of CLIA Compliance for Doctors Management. I hold a Bachelor's of Science in Pre-Med Concentration in Biology and Chemistry from the University of Tennessee. I belong to the American Society of Clinical Pathology, and I'm a certified medical technologist since 2000. I have over two decades of laboratory experience from physician office laboratories to high complexity laboratories, and I'm a licensed laboratory supervisor. Doctors Management is a full-service medical practice management and consulting firm. Our goal is to simplify the business of medicine so that you can focus on caring for your patients and the future of your business. We advise both large and small medical practices and healthcare organizations on topics such as increasing practice profits, reducing compliance risk, improving patient satisfaction, and 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 are as follows. To understand the purpose of laboratory surveys. To learn what takes place during a survey. Help with organizing your data for a smooth survey. How to avoid common mistakes, and how to develop a plan of corrective action should that corrective action be necessary. Why laboratory surveys? They are required by CLIA 88 for both moderate and high complexity laboratories. Their purpose is to improve the quality of laboratory service in all settings. They are educational in nature, and statistics show that quality has improved with the start of laboratory surveys. Scheduling Surveys. Surveys are scheduled during your normal hours of operation. New labs are inspected three months after their opening. Recertification occurs between 6 and 12 months prior to your certificate expiration date. Laboratories may black out certain dates in advance. The date for your survey is provided to the lab up to two weeks in advance. Your laboratory may be allowed to reschedule one time. Some surveys may be unscheduled, meaning you will receive no notice. You will receive forms for completion prior to the survey. A CMS 116 or select COLA forms are often required. CLIA inspects 5% of all COLA laboratories either concurrently or after their survey as part of their quality assessment plan. Survey Notification. In most instances, you will be receiving advanced notification of your survey. This normally occurs within two weeks prior to your survey, however this time may be cut short depending on your state. You are usually notified by a fax or letter. COLA, however, is mostly paperless, so watch for a COLA alert and go to COLA Central for more details on your survey. Please note that your director or technical consultant do not have to be present for your survey. COLA usually asks for updated demographics about six months prior and again at the time of your survey on COLA Central. CLIA requires a new submission of a CMS 116 at the time of your survey. How the Survey Process Begins. You will be required to complete forms prior to your survey in order to verify or update your laboratory's latest information. These forms include the CLIA application, also known as your CMS 116 form, the Disclosure of Ownership and Controlling Interest form, CMS 1513, CMS 209, which is the Laboratory Personnel Report. You will also be required to provide the hours of operation and complete directions to your laboratory. COLA will send an alert on COLA Central to request any updates around six months prior to your survey. They will send any forms that they require you to complete prior to your survey and within this alert. Please complete and return all forms as requested to the state or back to COLA. Upon arrival, your surveyor will introduce themselves. They will present their credentials and ask to speak with someone in charge. This is not necessarily the director or your laboratory lead, so make sure that your front office staff is aware of your survey. How the Survey Will Proceed. Your surveyor will start with verifying the ownership, laboratory director, and other laboratory personnel, request test menu and volumes, take a tour of your laboratory, review personnel files for qualification purposes, review manuals, quality control records, quality assessment documentation, proficiency testing, record retention, and finally check requisitions, reports, and patient records. How the Survey Ends. Your surveyor will verbally summarize their findings. COLA provides a list of deficiencies by circling guideline numbers which correspond to the COLA criteria in the accreditation manual. They will provide advice for your improvement and invite your questions before leaving their initial evaluation report. You will receive a written report later with any deficiencies which were cited during the time of your survey. A response will be required to that report. CLIA calls this the Plan of Corrective Actions. COLA calls this the Plan of Required Improvements. Let's simplify your survey a bit. Your notification letter includes useful information and also may request information. Please read your notification letter carefully, follow the instructions, and answer if required. Respond to requests within the given time frame. Give directions to the office, your hours of operation, your test menu, the test volume, and the laboratory personnel list as requested by your surveyor. Now that you have been informed of your impending survey, get prepared and start as soon as possible. In your laboratory, check the fire extinguishers and eyewash stations for compliance. Discard any unlabeled, outdated, and discontinued reagents, kits, and specimen containers, including those found in exam or treatment rooms as these areas are often forgotten. Remove all data more than two years old if it was reviewed during your previous survey. An exception to this would include any immunohematology and pathology data, all instrument installation documentation. You may store this information elsewhere if you choose or shred it. When it comes to preparing for your survey, advanced preparation is key. You can do things as follows. Write out your CLIA certificate. Obtain a copy of the CLIA certificate for each reference laboratory used, including any sister laboratories within your organization. Have a copy of the director's credentials available. Calculate your test volumes in advance using the Guidelines for Counting Tests for CLIA from CLIA's website or the COLA form on COLA's website. Find your report from the previous survey, which includes all of your corrective actions, if any, even if you've already submitted this report to COLA or CLIA. Now let's focus on organizing your data. Provide a clean area for your surveyor. Have documentation available, any forms that were sent previous to your survey, all personnel files, all manuals, including your procedure and QA manuals, user manuals for your instruments and package inserts, your reference lab catalog and safety manuals, installation records for any new systems since the last survey, calibration and calibration verification data, all maintenance logs, any quality control and quality control verification documentation, proficiency testing reports, quality assessment records, corrective action documentation, and sample requisition and patient reports. Organizing your data may seem like a daunting task. You can use binders and accordion folders or electronic storage. However, please recall that all electronic storage must be available for review from the surveyor upon request. Have all calibration documentation separated from daily QC so it is readily accessible. Keep calibration, calibration verification, quality control, and quality control verification data together for each individual analyzer. Also organize your data chronologically within each testing specialty. Put all proficiency testing data together. Please remember to include original instrument printouts and any corrective actions. And lastly, have a pen and pad ready so that you can take notes. Let's discuss an example of how to keep your data using a hematology analyzer. Obtain a binder or a file and label it hematology or CBCs. This data may be maintained electronically, but please remember that your electronic data must be able to be reviewed upon request. You should divide this data into sections. Examples include installation and service records, calibration or calibration verification. Keep your routine data listed together by month. Most recent at the front, all quality control printouts and IQAP reports should be included along with your daily printouts of startup, background, controls, and patients. Please remember anything your instrument prints must be maintained. Personnel files are required for everyone who works in your laboratory, from your director, your clinical consultant, technical consultant, to testing personnel. And please remember to include any mid-levels if they are performing provider-performed microscopy. Education is just one of the topics that should be covered in your personnel file. An education for your director may be an MD plus laboratory training and experience, a board-certified PhD, an MS or BS plus experience. The BS should include a total of four years, including two years supervising non-wave testing. Your clinical consultant should have a license to practice medicine, and your technical consultant should have a minimum of a BS in laboratory science plus two years experience in a non-wave specialty or subspecialty of service. Education records must also be maintained in your personnel files for your testing personnel. You must maintain the highest level of their education. This may be a high school diploma or GED, a college degree from an accredited school. If this person was educated outside the United States, you must maintain an equivalency report. You should maintain copies of any laboratory certificates, licenses, and registrations if required by your state, but please remember that these licenses, certificates, and registrations will not substitute for proof of formal education. In summary, your personnel files should include everything as follows. Education records, laboratory training, competency assessments performed as required by COLA or CLIA, continuing education for COLA laboratories, annual OSHA training for bloodborne pathogens, and a state license if required by your state. Some confidential information that may be maintained in your personnel file could include your employee's medical file as required by OSHA, their name and social security number, their hepatitis V vaccination documentation. This would be a signed declination form, shot records, or a copy of their current titer. You are also required to maintain all exposure records. Procedure manuals are heavily scrutinized during your survey. All manufacturer's instructions and user guides should be maintained. Laboratory operating procedures should be included. These procedures should have been reviewed and signed by the current director, and all changes and additions or revisions should also be signed and maintained. All current non-wave procedures and provider-performed microscopy procedures should be included with the date they were implemented. Procedure manuals must also include site-specific information. For example, who orders your tests and how do they order those? What do you do if controls are not acceptable? What actions are taken if the system is inoperable? Specify that no one will alter your reference laboratory test results. You should also state how and to whom results are reported. Include date procedure was implemented, and you may also include package inserts and other user manuals. Other manuals reviewed during your survey will include a quality assurance plan and how you monitor that plan. This may be incorporated into your procedure manual. Your plan must be reviewed and signed annually by the director. You should include all monitoring documentation, and this documentation should also be signed by your director. Safety and equipment manuals will also be reviewed. Your OSHA policy and procedure manual, your SDS binder, eyewash station and fire extinguisher maintenance logs, your reference laboratory manual will also be reviewed. For current manuals may be online. You can also have a written copy. Have employees read and sign an acknowledgment of all of these manuals. Package inserts should be maintained for each piece of equipment that you use. For example, your microscope, thermometers, centrifuges. They should also be maintained for every kit and test that you use, including all reagents, diluents, calibrators, and controls. Proper documentation of quality control includes the following, a package insert of your controls, quality control verification records, data summary and graphs, IQAP reports, corrective actions for all unacceptable controls, evidence of director involvement, and COLA requires documentation of weekly review for your Levy-Jennings graphs. When it comes to calibration, it is important to remember to keep everything. This includes the package insert for calibrators, your instrument printouts, including pre and post cal factors, precision studies, carryover if required, and controls that you run after your calibration. Please remember that calibration verification is required every six months if fewer than three levels of calibrators are used. During your survey, your instrument documentation and facility documentation will be reviewed. Instrument maintenance, including the instrument startups, background counts, system checks, preventative maintenance and cleaning, professional maintenance, repairs, and part replacements will all be reviewed. Please remember this will include your centrifuges and microscopes. Your facility documentation will also be reviewed, including your temperature and humidity logs, all water quality data, electricity records, space requirements, and any corrective actions for unacceptable conditions. Proficiency testing records will also be reviewed during your survey. Facility documentation, including invoice for enrollment, package inserts and online printouts with date of receipt, handwritten logs and instrument printouts, and the date of testing and testing personnel identification will all be reviewed. In addition, the original or copy of your form submitted for grading will also be reviewed. The attestation statement is required to be signed by the director and all testing personnel. Your surveyor will also review your graded report from your proficiency testing provider. Documentation is required of the review by way of signature from your director or technical consultant and all testing personnel. An investigation for unacceptable results will also be reviewed. Any results less than 100% should be investigated. All corrective actions, if necessary, including repeat testing if possible, and then indicate if patients may have been affected and what was done for these patients. During your survey, patient records will be reviewed. These records may be in paper charts or electronic health records. They will review in-house testing and referred tests. Your surveyor may ask you to pull patient results or may choose patient names from laboratory logs or use dates for you to choose the patients to be reviewed. You must keep all instrument printouts, if generated, but they do not have to be in physical charts. You can shred these documents if they are scanned into the electronic health record. Please remember that you should not use tape on thermal printouts as your information will disappear over time. Because of our current pandemic, all COVID-19 testing results are required to be reported to your local health department. Your surveyor will look for proof of this reporting at your survey. Please note, it is not a HIPAA violation for your surveyor to review patient charts. Your surveyor will be reviewing electronic data. They will verify that all information is available. For example, are your results there? Did the reference laboratory report get pulled into the electronic health records? Do you have the correct name and address of your laboratory listed on your results? They will also verify that information is accurate. Did the report get onto the right chart? Did the right result cross over into the correct slot if you have an LIS system? Do the results in your electronic health record match the results on your printout? Do they remain the same over time? Are the units of measure available? Are calculations correct? And finally, they will be reviewing to check physician portals. This is often a pitfall for surveys because your report from the hospital may not have the hospital name and address, which is a CLIA requirement. If your laboratory is accredited by COLA, here are some specifics to keep in mind. First, your COLA notice should be posted in your laboratory. You're required to have an incident management plan to document any qualifying incidents. You're required to have an FDA reporting plan and proof of training for your staff. CLIA may ask for the FDA reporting plan as well. You're required to maintain all LIS policies and procedures. And your director is required to sign and review of your manuals every two years. In preparation for drafting your response, which would be a plan of corrective action for CLIA and a plan of required improvement for COLA, remember the following. Don't panic. Read and date the report as soon as it's received and take note of the due date. Make a working copy and file the original report. When drafting your response, remember to respond to every deficiency and only respond when you're satisfied with your work. As you begin to draft your response, you should remember to document the following. What do you plan to do about the deficiency? Who will be responsible for making sure the deficiency is corrected? When your corrective actions will be completed? How you plan to prevent a future recurrence of this deficiency? The director must sign the Form 2567, which is your response. You should make a copy and file your response away, ready to be reviewed during your next survey. CLIA requires that you submit your response within 10 days of receipt. You only should send documentation if it is requested by the surveyor. When drafting your response, it is important for all CLIA labs to remember the following. You must document on the form provided. Add any additional pages as attachments. Indicate on the attachments the laboratory's CLIA ID number and the DTAG being addressed. Your director must sign and you should submit by the deadline given. CLIA allows 10 days for your response. CLIA laboratories drafting a response should remember the following. You may upload your corrective actions to CLIA Central or fax your response directly to CLIA. You should indicate on every sheet the laboratory's CLIA ID number and the criteria being addressed. Your director must sign and review and you must submit by the deadline provided by your surveyor. Now let's discuss some frequent deficiencies and their appropriate corrective actions. Number one, you're missing high school diplomas or college degrees. The corrective action for this deficiency would be that the laboratory supervisor is responsible for obtaining high school diplomas for all testing personnel within 10 days. Potential employees must present documentation prior to hire. Number two, lack of director involvement. Corrective action for this deficiency could be the laboratory supervisor will immediately begin taking all quality control and proficiency testing data to the director for review monthly. Number three, no employee competency assessments. The director is responsible for technical evaluations. She will perform them within the next three weeks and again next year. Number four, lack of hepatitis B vaccination documentation. The corrective action could be the safety coordinator is responsible for obtaining hepatitis B vaccination documentation or offering the vaccine. She will have all forms completed by March 29, 2022. New hires must bring documentation or be offered the vaccine on the first day of work. Number five, no proficiency testing for provider performed microscopies. The laboratory supervisor has been assigned the responsibility for ensuring that split specimen testing is done for provider performed microscopy. She will develop a procedure and implement it within the next six months. Number six, your procedure manual lacks a slide preparation and evaluation procedure. The lab supervisor will write a procedure for preparation of slides and evaluation of adequate slides by March 29, 2022. Number seven, no documentation of panic values or rejected specimens. The corrective action for this deficiency could be the supervisor will develop and implement a policy for documenting actions for panic values and for documenting all rejected specimens. This will be completed by March 15, 2022. Deficiency number eight, missing package inserts for controls and calibrators. The corrective action could be the director will ensure that the lab maintains all package inserts. Number nine, a failure to maintain all documentation for two years. The correct response could be the lab supervisor is responsible for ensuring that all documentation is maintained for at least two years. Number 10, no corrective actions for previous inspection deficiencies. The corrective action for this deficiency could be the technical consultant is responsible for responding to CLIA surveys. She will immediately prepare the response for this inspection and return it within 10 days. She will also prepare the response for all previous surveys within two weeks. All responses will be kept on file. For further information on any of the topics we discussed during this session, you may receive information at the following websites www.cola.org, www.cms.hhs.gov, forward slash CLIA forward slash or at www.drsmgmt.com. Thank you.

laboratory inspection

CLIA 88

survey scheduling

certification process

laboratory personnel verification

common deficiencies