Regulatory Inspections: Are You Ready?

Part Three: The inspectors have left – now what?

In the previous 2 blog posts we discussed how to prepare for your inspection, and what to expect during the inspection itself. In the last of our 3 part series on regulatory inspection preparedness, today we’ll be covering what to do after the inspection ends.

Throughout the inspection itself, the inspectors should be communicating any issues or citations they uncover; ensure that your management staff is taking notes on any of these potential findings. Based on these notes, you should start working to address and correct any issues right away. Formal documentation regarding the nature of any official citations can take several weeks to receive back, depending upon the regulatory agency performing the inspection. Waiting for the formal report to begin making corrections will reduce the time you have to form a plan of correction, and can further impact patient care depending upon the citation received.

Have a Plan. Draft a spreadsheet to record: 1) each issue identified, 2) laboratory department(s) it was found in, 3) associated risk factor (patient care or safety issues = 1, regulatory requirements = 2, recommendations = 3), 4) staff member assigned to investigate and correct the issue, 5) due date for investigation response, and 6) status of the investigation (in progress, on hold, completed). Share this spreadsheet with your management team, and review at weekly/monthly staff meetings for updates on progress completion.

Risk 1 Issues. The safety of your patients and staff, along with ensuring accuracy in testing results is the number one priority of a laboratory. If the inspectors identified any weaknesses in these areas, they should be addressed first. This would include items such as staff not adhering to required safety precautions, not following manufacturer requirements for quality control testing or instrument maintenance/calibration, lack of follow-up for QC or proficiency testing failures, along with any other finding which questions the integrity and accuracy of the testing being performed.

Risk 2 Issues. Double check the regulatory standard to ensure you fully understand the requirements, and that you have appropriate evidence of compliance. As the testing activity menu and complexity of testing increases, the amount of documentation requirements can increase as well. Even with a paperless system, it is easy to overlook a signature of review or checkmark on a log. “If it’s not documented, it wasn’t done.” For simple administrative oversights, review your current processes to identify any gaps or areas that can be improved upon to ensure all documentation is properly filled out each month. If the inspectors noted a discrepancy between your current policy and how staff are actually performing a test, review the testing process to see where the true discrepancy is – is the policy outdated and needs to be revised, or do staff need to be retrained on the current policy with competency assessed for compliance?

Risk 3 Issues. Inspections are a great opportunity for further education for all those involved, both the inspector and staff being inspected as well. For some regulations, there is no one set way that must be followed in order to demonstrate compliance with a requirement. Hearing how someone else is meeting the requirements may spark an innovative idea from your own staff on how your current processes can be improved. Be open to hearing new ideas, and find ways to implement those which you feel would be successful at your institution.

Evaluate All Sections of the Lab. When investigating a finding in one laboratory department, ensure that any process improvements are shared across all areas of the lab. Just because microbiology didn’t get caught with expired reagents like hematology did this inspection, doesn’t mean that they aren’t at risk for future inspections.

Focus on the Positives. Congratulate and recognize your staff on their successes in the areas you performed exceptionally well in. It’s a joint effort to ensure the lab is inspection ready; be sure to pass along any compliments received throughout the inspection process to all levels of staffing. Focus on what you’re doing well and how you can continue to maintain those processes and implement them in additional areas.

A little bit of preparation ahead of time will make the inspection process smoother and less stressful for all involved. When viewed as a learning experience and opportunity for improvement rather than a visit from the “lab police”, laboratory inspections can be a useful tool to confirm the quality of your overall laboratory program.

 

Nevins-small

-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

Regulatory Inspections: Are You Ready?

Part Two: The inspectors are here!

In last month’s post we reviewed the importance of being prepared for your regulatory inspections, as well as some tips for how to accomplish this task. This month we’ll focus on the inspection process itself – areas the inspectors may focus on, and how your preparation work last month will make the process go smoothly.

Once your formal inspection is underway, don’t panic. Based on all of your preparation work in the months prior, you should be organized and ready to answer any question the inspectors may have regarding your current procedures and policies. The focus of each inspection will vary based on the regulatory agency it is being performed by, but the following areas have a high likelihood of being reviewed.

Utilize a Patient Tracer.  One of the easiest ways to evaluate your laboratory processes from pre-analytical, through analytical phase, and finally the post-analytical phase is to utilize a patient tracer. Inspectors may pick a specific date or date range, and ask to see all associated documents for a particular test.

Pre-Analytic. Gather a copy of the test requisition indicating the patient information, ordering physician, and specific tests requested. Ensure your phlebotomy team knows where your policies related to patient identification and specimen collection are located, and ensure they are following the requirements within these procedures. Inspectors may ask to observe the phlebotomy collection process, so prepare your staff ahead of time to reduce the potential for nervousness.

Analytic. All records related to the testing of the sample will need to be produced. This includes the actual instrument print-out for the sample in question and/or worksheets used to document results, quality control records for the day of testing, instrument maintenance and calibration records, as well as the training and competency records for the technologist who performed the test that day. Training and competency assessment are two different tasks – ensure you have documentation to support both of these activities at the required intervals for the staff member in question. Depending upon the actual circumstances surrounding that particular sample, there may be additional documentation requested such as corrective action logs, critical call notification records, or confirmation testing records.

Post-Analytic. Inspectors will also need to review how your results are being documented and displayed on the patient charts. They will be focusing on accurate transcription of results including units of measure and reference ranges; the correct timing of sample collection, receipt in the lab, and result reporting times; in addition to all of the patient demographics properly being displayed. They may also ask to see a corrected report to see how clinicians are notified about any changes, so patient treatment can be adjusted accordingly in a timely manner.

Proficiency Testing (PT) Results. One of the common requirements of a laboratory accreditation program is the participation in a proficiency testing program for all regulated analytes. Since the intent of this program is to ensure accuracy in your patient testing results, inspectors will be focused on any unsuccessful PT surveys, and the root cause analysis you performed to investigate the occurrence. Was this an isolated and random error, or is there a systemic quality issue which caused the inaccurate result? Did you perform a look-back to confirm accuracy of patient results being reported between the time of PT analysis and when the laboratory was notified of the unsuccessful event? Were your preventive actions implemented and sustained, or are you still continuing to experience accuracy problems with your testing? Be sure to document all steps of your investigation, and have that documentation available to inspectors for review.

Quality Metrics. Laboratory directors have a responsibility to provide oversight of their laboratory’s quality program, and to ensure that medically reliable data is being generated. There are many ways to monitor the quality of your laboratory program, and you should be prepared to speak on your methods in use to the inspectors. Although labs are not expected to be perfect, there is a responsibility to monitor for issues and initiate appropriate corrective and preventive actions when they are identified. Ensure that your monthly performance improvement metrics are reviewed and signed by your laboratory director, and any metrics not meeting performance goals have documented corrective action initiatives. Metrics should be meaningful and demonstrate continuous monitoring and improvements within the laboratory.

Be Honest and Transparent. If an inspector asks for specific documentation which you do not have, be upfront and let them know. Trying to hide a problem or misdirect an inspector away from a problem area can result in even more citations as it creates an environment of mistrust. Inspections are an opportunity to identify and improve upon the weak points in your laboratory program, and the inspectors themselves can offer ideas and suggestions on better ways to meet certain requirements that you may be struggling with. Some regulations can be interpreted differently by different individuals – ensure that your staff can speak to your practices in use and explain to the inspectors how you are satisfying the requirements.

Coming up in part 3, we’ll discuss what to do next – how to address any issues identified during the inspection process, and how to keep the overall experience positive and beneficial to your staff.

 

Nevins-small

-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

Regulatory Inspections: Are You Ready?

Whether your laboratory is accredited by CAP, COLA, JCAHO, or simply adheres to local state and federal CLIA regulations, all laboratories are subject to regular inspections from their accrediting agencies. Normally the thought of an inspection places staff into panic or hiding mode (“Whew, glad I’ll be off that week!”), but if you prepare ahead of time, the inspection process can be an extremely valuable tool to access the overall quality of your laboratory program. Over the next 3 blog posts we’ll review tips on 1) how to prepare before your inspection, 2) what to expect during the inspection itself, and 3) how to address any deficiencies identified by the inspection team.

Part One: The Inspectors Are Coming!

Know the Regulations. As technology evolves and new laboratory methodology is introduced, the requirements for your respective regulatory agencies will be updated as well. Know what version of your checklists or standards you will be getting inspected on, and ensure all staff are familiar with any updates and changes. By engaging all staff in the inspection process from lab assistants up through management, everyone will be aware of what the requirements are and can actively participate to ensure the lab is meeting those requirements.

Focus on Previous Citations. Your inspectors will have access to your previous inspection results, and will be following up on any citations. Ensure that the corrective actions and preventive actions you said you were going to implement have actually gone into effect. For any procedural changes, have documentation (Read & Understand) ready to show that all staff were made aware of and have been trained on the changes. Make sure that those corrections have been sustained and are effective at addressing the noted citation. It’s great to add on new forms to document instrument maintenance – but not if your staff doesn’t have the time to complete them. Again, engage your staff to see what is working, and what needs to be reevaluated.

What is New? New regulatory requirements, new staffing, new instruments, new testing methodologies… These are all key areas that the inspectors will focus on. Have you kept current with your regulatory updates and implemented any necessary changes to address the new requirements? Do you have documented training and competency for each new staff member for each task they are performing? For new instruments, ensure they have been fully validated and correlated to similar instruments prior to being placed into use for patient testing. When adding on new tests, ensure you have a full validation summary with medical director approval and sign off, and that your testing activity menu has been updated as well.

Have a Plan. Depending upon the size and scope of your laboratory, there can be a lot to cover for your inspection preparations. If you wait until your inspection window opens to start getting ready, things will be overlooked or simple “quick fixes” will be implemented instead of finding a long term sustainable solution to any potential issues. Instead, schedule tasks throughout the year to continually review your quality assurance program. Ask management to review 3 – 5 SOPs each month for content (does SOP match the current manufacturer package insert, does SOP match current practice in use), rather than a mass annual sign off. Perform quarterly reviews of your maintenance documentation to ensure all logs have been filled out completely with corrective action documented when appropriate. Utilize calendar reminders to track proficiency testing sample results, and ensure proper follow-up for any non-satisfactory results.

Perform Meaningful Self-Audits. For most regulatory agencies, performing self-audits on your non-inspection years is a requirement. Make this task meaningful by using a fresh set of eyes to review your documents. Ask the hematology staff to inspect the chemistry department; chemistry to inspect urinalysis; urinalysis to inspect microbiology…. You don’t need to understand how to actually perform a specific weekly maintenance task on a particular instrument; you just need to ensure that all those weekly tasks have been documented every 7 days (or less). You don’t need to understand what reagent ‘XYZ’ is used for, you just need to ensure that the vial is properly labeled with an open and expiration date, and that it is not currently expired and still being used. Self-audits should not be punitive; they are meant to catch things that you may be taking for granted are compliant, when in fact they truly are not.

Stay tuned for part 2 coming out next month, where we’ll discuss the inspection process itself and what to expect from the inspection team.

 

Nevins-small

-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

CAP Inspections and the Resident

Hello, fellow blog readers! It’s about 4 weeks since we communicated last. Since my first half of the year was loaded with lighter CP rotations to allow me to complete interviews for two successive fellowships, this half of the year is surgpath heavy and so that’s why I took a short hiatus from posting.

Well, I have a 4 week reprieve before I have another surgpath rotation and I am on what we refer to as our “comprehensive CP” rotation. Basically, it’s a combination chemistry-microbiology rotation. Since both of those rotations don’t always have enough work to require a resident to remain at the hospital for the usual 8-5 schedule, we cover both rotations simultaneously. We also have 11 comp CP rotations throughout the 4 years at my new program which is quite a lot but after the initial 2 months of “wet lab” rotating through all the stations in the chemistry and microbiology labs, we have the flexibility to tailor our comp CP rotation. And so, right now, I write as I sit in a hotel in Baltimore about to meet for our third preparation meeting before my attending and I go inspect a new molecular genetic pathology laboratory for the College of American Pathologists tomorrow. Since this is this lab’s first inspection, unlike the usual CAP inspection, this one is announced – they know we are coming and can prepare for our visit. The two of us will complete the entire inspection; my program counts this as rotation duties even though I am off-campus.

This is the second CAP inspection that I’ve been asked to assist with since I transferred to my program as a PGY-3. I think it’s great that my program gives our residents this opportunity since as attendings (whether we are AP or CP), we will also have to either assist in or enforce adherence to CAP or other accreditation standards and supervise preparations for lab inspections every other year and self-inspections on the alternate off-years. At my program, residents assist in both the preparations for CAP and off-year inspections. I’ve said it before, but residency is the transition from passive learning to active learning where we should participate in the daily responsibilities that our attendings oversee and that we will have in the future.

So, this inspection will be much more work than when I inspected the chemistry and special chemistry sections with my last team. Since there are only two of us, we are responsible for splitting the duties for the lab director, general, common, and molecular pathology accreditation checklists. CAP suggests a “ROAD” approach: read (through their binders of policies, SOP’s, etc), observe (a sample from receipt in the lab and though processing and interpretation of results), ask (open ended questions), and discover.

Well, I guess it’s time for me to go inspect but before I leave, I’d like to encourage all trainees (residents and fellows) to apply to serve as a junior member on one of the CAP’s committees or councils. You need to be a junior member but membership is free as a resident. Each committee or council (that oversees multiple committees in a topic area) usually has one junior member on it, very rarely, two. I’m currently serving my second year as the junior member on the Council on Education and I can say it has been a very rewarding experience where I have met many role models who definitely take an interest in what I have to say about the trainee opinion and who also think of me when opportunities arise that they think might be good for me. You can access both the instructions to apply (which includes a list of the committees/councils with junior member positions opening up in 2016) and the junior member application here – you will need a letter of recommendation from your program director and email in your app before the deadline of March 31st. Good luck guys! If you have any questions, feel free to email me.

Chung

-Betty Chung, DO, MPH, MA is a third year resident physician at Rutgers – Robert Wood Johnson University Hospital in New Brunswick, NJ.

Bird Watching

Every inspection cycle we receive our checklists from the regulatory organizations and that is usually when the latent lawyer in me breaks out like the Hulk and I start interpreting the meaning of every word contained within the document. CAP has said on multiple occasions that some of the checklist items are open to interpretation and that there can be several ways to satisfy them. CLIA has their 6 elements of competency and when I first read them my eyes started to turn green and my clothes started to get a little snug. The element that I think is open to the most discussion is the first: “Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing.”  Some of my colleagues have interpreted this as once a year directly observing a technologist/technician perform each test and then signing them off. When I read this element I can’t help but think that once a year is not enough to verify that an employee is correctly performing each test. The question I always ask is how do we know that an employee does it correctly when we are watching but then does it a different way when we aren’t?

I am a very hands off leader. The reason I can do this is because when I train a new employee it is rigorous and I make sure that they can handle pretty much anything that comes their way. When I read that first CLIA element I feel as if they want us to babysit our employees. I understand the importance of direct observation but where is the line drawn that says so much observation is enough? If you ask me once a year is not enough; however, the more we observe the less time we have to do our countless other tasks as supervisors/managers.

When I thought about it, I came up with a couple methods or ways to “directly observe” my employees. The first obviously is to stand behind them and watch them perform a test. Then the question of how do we observe the off shifts without actually being there? We all have smart phones with cameras so could employees could set up their phones to record a procedure and then we could watch it back later. In blood bank I can have each employee save their gel cards so that I can read them at a later time and make sure the volumes in each well look ok. That would qualify as direct observation of their results and process since if the volumes are incorrect I would be able to tell. As supervisors we are also called to consult with other technologist/technicians frequently. Troubleshooting with your employees usually involves something test related and that to me would count as direct observation as well. Finally, we have students almost year round and our employees usually take on the role of teacher when they are in that spot for the day. When I observe them teaching the students how to perform tests this is a great way to confirm that the employee is competent.

My favorite way to observe is when my employees don’t know I’m watching. I have an office that is not directly in the blood bank so I have to wander in and out fairly often. Sometimes I will sit down or file papers all the while observing my employees and their technique and processes. There are many ways to “directly observe” and using all of them ensures that you are meeting the guidelines enforced by CMS. When inspection time comes you can show the signature that says you directly observed but also have a list of answers when they ask how you did it. When I need some practice I grab my binoculars and do a little bird watching.

 

Herasuta

Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.

Red Tape

I like debates so I’m going to start one and I hope people will comment below and get a dialogue going. How many pieces of paper do you have framed on your wall in the lab from regulatory bodies? If you are a reference lab that serves nationwide customers you may be putting up regulatory wallpaper! I have heard of more and more inspections in regards to laboratories.. My laboratory is inspected by CLIA, CAP, and AABB. With budgetary constraints the importance of the AABB certification has been discussed numerous times. I even feel myself that AABB is becoming more of a consulting company that publishes medically relevant treatment recommendations than an inspection body. I would like to see consolidation between CAP and AABB where the somewhat higher standards of AABB are adopted by CAP and laboratories would not have to pay separate fees for each.

Let’s take it a step further. If CLIA inspections are increasing are there rising tensions between them and CAP? What is making CLIA step up? Do they not trust the job that CAP is doing performing inspections of the laboratories? If CLIA inspections are becoming that difficult what do you as a manager/supervisor put your efforts toward to ensure you will be compliant no matter who inspects you? How does a laboratory go through 3 or more inspections a year and still stay on top of everything else? All these questions must be answered and quickly if you expect to have time to do what is required of you as a manager/supervisor. I don’t think too many laboratorians would care who inspects them, but I do think we would care about having one universal checklist that we can abide by and really dig in to what is important to keep the lab accurate and safe.

How are we expected to grow our business and serve our patients when we are constantly guessing on what checklist to abide by or who is coming to inspect us? We are consolidating in every other sector of healthcare to improve efficiency except in regulatory bodies. Is this just another consequence of big government or do we actually need them all? We should start the discussion and make our voices heard on what we feel we need from regulatory bodies to ensure we are doing our jobs as laboratorians. Are you as frustrated as I am? Or have I inadvertently started my career as a lobbyist for the laboratory field?  Comment below.

-Matthew Herasuta