Examples: collecting the right sample on the right patient; labeling the sample accurately;

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1 Quality Assessment: Basics & EMR is called by several names: and are just two of them. Quality Assessment (QA) is an on-going program designed to monitor and evaluate the quality or accuracy of all laboratory processes-from patient preparation to results in the patient chart or Electronic Medical Record (EMR). QA is the big picture of your labs processes. Some people confuse Quality Assessment with Quality Control. You can look at QA as a wheel. There are spokes attached to the rim. The spokes are the different pre-analytical, analytical and post analytical components of QA. All the spokes are held in place by the rim-qa monitoring. QC is just one aspect of QA. QA is divided into three areas: PRE-analytic has to do with things that happen BEFORE you actually perform the test. Examples: collecting the right sample on the right patient; labeling the sample accurately; storing or processing the sample correctly, etc. ANALYTIC has to do with the testing process itself. Examples: Performing quality control and ensuring it is acceptable prior to testing patients; testing patients and reviewing results for critical, abnormal, or unusual results; retesting patient samples when necessary to verify the accuracy of results, etc. POST-analytic has to do with things that happen after the test is complete and you have an answer. Examples: result in the correct patient record; transmitting the result promptly and accurately to a provider if it is a critical result, etc. There will be errors in your laboratories. If you have no errors documented and when asked, you say it is because there have not been any errors, we worry! That means there have been errors, but you have not found the errors. Errors must be investigated to see what caused them and how you can prevent them from recurring and then followed up to see if your solution was effective. Follow up is very important with QA documentation! This can help pinpoint bigger problems (like insufficient training or communication) that may not be obvious at first. We have developed QA Plans and tools to help you monitor QA in your labs. The plans are specific to your lab s complexity level, while some elements are common to all labs. The requirements for the three complexity levels are summarized as follows:

2 Waived labs complete a quarterly Electronic Medical Record (EMR) QA monitor. Serious Incidents There is a difference between routine problems, such as a lab report does not come back on a patient s result, and serious incidents, such as a patient fainting during a blood draw, falling from the chair, and striking his or her head on the corner of the tabletop on the way down. For serious incidents involving actual or potential harm to one or more patients and/or staff, notify your office manager, who will contact Risk Management. On your PAL, the only documentation you need is a brief statement indicating the general (no details!) nature of the problem (ex. patient incident during blood draw ). Include a note that the problem was referred to the practice manager and a Care event was completed. Care Events For incidents that could or did result in harm to a patient or staff member, complete a Care Event and document Care Event completed on the Pal along with the issue number. PPMP labs complete assigned QA monitors quarterly along with an Electronic Medical Record (EMR) QA monitor. Moderate labs complete an assigned monthly QA monitor and an Electronic Medical Record (EMR) QA monitor. All labs use the Problem Action Log to document problems as they occur. Problem Action Log The Problem Action Log (PAL) is a tool that should be used continuously to record problems, corrective action and follow up. The PAL is used to document all problems (except for equipment issues with the AcT Diff or another analyzer) that occur in the lab. Examples are: patient complaints, incorrect specimens collected, unlabeled specimens, delay in reference lab reports, expired tubes, etc. Keep completed PAL log sheets under a tab in the very back of the QA Manual (not in the accordion file!) For all corrective action taken as a result of a QA monitor or a problem logged in the PAL, be sure to FOLLOW UP and make sure the corrective action fixed the problem! (Hint if the problem repeats itself, your corrective action didn t work and you must activate Plan B.)

3 Chart Reviews All Labs with Canopy as their Electronic Medical Record should do a Chart Review and Order/Results Validation Review each quarter, to ensure that the lab tests that are ordered are performed and results are transmitted correctly into the electronic medical record. There is a separate Problem Action Log to record problems related to EMR and a Cerner /Canopy policy manual. To save time, you can use the charts you pull quarterly to help complete the paper chart review.

4 Do Keep your package inserts current. Remove and store package inserts for two years. Keep your procedures current; remove procedures for tests no longer tested or that have been revised and keep for 2 years. Ensure that your manuals are signed and dated by the lab director prior to beginning a new test When we send you a new or revised procedure, have the lab director read and sign it. The lab staff needs to review the policy prior to adding it to the Procedure Manual. Do Not: Tamper with the manuals they are in a specific order. Keep duplicate procedures in the Procedure Manual Re-arrange, rewrite, or remove CHS Medical Group policies and procedures. Communication CLIA requires that all QA activities be shared with all testing personnel. CHS Medical Group requires that all testing personnel read and initial the monthly (for moderately complex labs) and quarterly for PPMP & Waived (EMR monitors) QA monitors. Record Retention Retain all records at least 2 years. This includes: Orders for lab tests Retired/ discontinued procedures (2 years from date retired) QC records (including instrument printouts or summaries printed from instruments) Patient test records (including instrument printouts AND transcribed results) Proficiency test records QA documentation Test reports (these are usually on the charts) Analyzer records (installation, verification, service, and calibration) must be kept for the life of the instrument PLUS two years.

5 Procedure Manuals kept up to date Your procedure manuals are the source you go to for directions to perform all lab testing. Testing personnel should be able to perform any lab test your lab does by reading the Procedure Manual. They must be kept in good repair. Forms: We create QC logs and Reports based on CLIA requirements Use the forms we provide you so you will be in compliance with CLIA if you have a better idea for a form share it with us- we ll give you credit for it. Do not create your own log and start using it without our permission. This may result in a CLIA citation. Critical Value Log Critical ( panic ) values are those that must be verified & reported to the provider immediately because failure to follow up could have adverse effects on the patient. Examples of critical value results are WBC, Hgb, Plts, Glucose, Protime, Sodium, Potassium Each lab must have and follow an in house Critical Value Policy Carolinas Laboratory Network Critical Values are used for consistency Critical values must be documented on the Critical Value log Documentation must include the name of the test, the results and the repeated value, who was notified, the date and time and who notified Failure to notify a provider could result in serious harm or even the death of a patient Personnel Requirements CLIA requirements for laboratory personnel differ by complexity for Waived, PPMP and Moderate laboratory personnel. Documentation for Moderate Testing Personnel must include: 1. Proof of education (High School diploma or equivalent is the minimum) 2. Documented Training (for each moderate complexity test) 3. Semi-annual and annual performance evaluations (competency) the first year and annual evaluations thereafter. Performance evaluations must be done for providers performing Provider Performed Microscopy Procedures (PPMP) and for the laboratory Technical Consultants. Technical Consultants must complete the performance evaluations for the lab testing personnel and the PPMP evaluations. Lab oratory directors must sign the evaluations for the Technical Consultants.