Quality Corner. Laboratory Information System and Electronic Medical Records Backup and Computer Down By Rhonda Burgard, Client Services Supervisor

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1 Page 1 of 7 Volume 8 Issue North 9 th Street, Bismarck ND June 2012 Quality Corner Laboratory Information System and Electronic Medical Records Backup and Computer Down When quality control, maintenance, testing and/or patient records are maintained electronically, adequate back-ups should exist in the case of system failure. Electronic records should be retrievable for the entire length of the required record retention period. Electronic media such as magnetic tapes, optical discs or online computer storage are widely used for archiving documents. When planning record storage it is important to store all electronic records in a manner that protects them from damage and from accidental destruction or modification. It is recommended that archived records be stored in an off-site location to ensure that disasters will not affect both the original record and the backup. To be HIPPA compliant, the backup storage facility must be a secure location. Environmental conditions, temperature and humidity, should be maintained and monitored so that equipment and media are preserved for the required document storage life. Periodically, as a quality measure, a representative sample of archived records should be accessed and reviewed for completeness and accuracy. The organization should develop and maintain an alternate system of documentation in the event that computerized data is not available. Computer downtime protocols should include manual systems for test requisition, specimen labeling, reporting of test results, and documentation of quality control and maintenance. There should be a central location for storage of manual forms and labels for use in computer downtime. These forms should be reviewed periodically for discrepancies with electronic forms and records. Special attention should be made to changes in normal ranges or units of measure. Once the Laboratory Information System (LIS) or Electronic Medical Record (EMR) is restored, the recovery process should include a test of the system to ensure that newly entered data accurately and reliably reaches its final destination. The recovery process should also include entry of information manually recorded on backup forms into the LIS or EMR. Non-interfaced results, entered manually, should be checked by a second person to confirm accuracy of entry. Backup and recovery procedures should be tested periodically to ensure that staff maintain competency in the use of backup system forms and processes.

2 NPL Connect (HVR) Add On Orders Northern Plains Laboratory retains urine samples for 24 hours post testing, serum samples for 7 days post testing and EDTA samples for 2 days post testing. NPL Connect (HVR) users may add on additional testing to these specimens by completing the following steps: 1. Press F11 or click on Prev. Ord. button. This displays the Previous Orders window. This window contains the information on all previous transmitted orders made on the patient that was entered. Page 2 of 7 4. Enter the initials of the operator. The doctor fields and doctor code are required fields. 5. Enter the test code that corresponds to the test desired if known, or press F12 to search by test name. When the code is selected or entered, the test name, specimen code and specimen condition will be filled in automatically. (Specimen conditions: A=Ambient, R=Refrigerate or F= Frozen) When a Ref test code is used, the operator must type in the test name manually during the test request process. An additional information field may appear depending on the test ordered. Enter any additional information that may be needed on the comment line. 2. Use the arrow keys or double click with the mouse the desired order that the test should be added to. 3. After the request is chosen, the Add on Test Order Report window will appear. Fill in the appropriate information (blue areas) so that the add on order can be placed. The Control Number, Name Fields, Date, Time, DOB, Gender, Bill Route, Original Req # and Original Collection Date and Time will come across from the original test entered. 6. Press Add/Print which prints the Add on order and send the add-on information to Northern Plains Laboratory immediately. 7. The Cancel/Close button cancels the changes made to the order that hasn t been saved and will close the window. 8. The Next Order button saves the data and moves to the next order. 9. The Previous Order button saves data and moves to the previous order.

3 ARUP Hepatitis C Virus Antibody (RIBA), Supplemental ( ) and Associated Tests Due to a nationwide reagent backorder from a single source vendor, the Hepatitis C Virus Antibody (RIBA), Supplemental and associated tests are unavailable as of 3/21/2012. The vendor has provided no plan for resolution of the backorder in the near future. The following tests will be unavailable as of March 21, 2012 due to the reagent backorder: Hepatitis C Virus Antibody (RIBA), Supplemental (ARUP test code ) Hepatitis C Virus Antibody with Reflex to Supplemental RIBA (ARUP test code ) Hepatitis C Virus RNA Quantitative bdna with Reflex to Hepatitis C Virus Antibody (RIBA), Supplemental (ARUP test code ) Hepatitis C Virus Antibody RNA Qualitative PCR with Reflex to Hepatitis C Virus Antibody (RIBA), Supplemental (ARUP test code ) Hepatitis C Virus Antibody RNA Quantitative by Real-Time PCR with Reflex to Hepatitis C Virus Antibody (RIBA), Supplemental (ARUP test code ) Recommendations for follow-up testing: The HCV RIBA reagent back order presents an educational opportunity to adopt efficient HCV testing algorithms. For more information regarding diagnosis and laboratory testing refer to the Diagnosis tab of the entry in ARUP Consult for Hepatitis C Virus - HCV at For follow up to a low positive Hepatitis C Virus Antibody by CIA (Chemiluminescent Page 3 of 7 Immunoassay) result, and in lieu of the unavailable HCV RIBA, ARUP offers the two options below. Please note that due to stringent specimen integrity requirements for testing by PCR, specimens may not be eligible for PCR testing subsequent to antibody testing. If you have any questions or concerns please contact Rhonda Burgard, Client Services Supervisor at Hepatitis C Virus RNA Quantitative, Real-Time PCR Specimen Required: Collect: Lavender (EDTA), pink (K2EDTA), or serum separator tube. Specimen Preparation: Separate serum or plasma from cells within 6 hours. Transfer 3.5 ml serum or plasma to an ARUP Standard Transport Tube. (Min: 1.8 ml) Storage/Transport Temperature: Frozen. Unacceptable Conditions: Heparinized specimens. Stability (collection to initiation of testing): On Cells: Ambient: 6 hours; After separation from cells: Refrigerated: 72 hours; Frozen: 6 weeks This assay has a lower limit of detection of 18 IU/mL, and a lower limit of quantitation of 43 IU/mL Hepatitis C Virus RNA Qualitative PCR Specimen Required: Collect: Lavender (EDTA), pink (K2EDTA), or serum separator tube. Specimen Preparation: Separate serum or plasma from cells within 6 hours. Transfer 2 ml serum or plasma to an ARUP Standard Transport Tube. (Min: 0.25 ml) Storage/Transport Temperature: Frozen. Unacceptable Conditions: Heparinized specimens. Stability (collection to initiation of testing): On cells: Ambient: 6 hours. After separation from cells: Refrigerated: 72 hours; Frozen: 4 months This assay has a lower limit of detection of 100 IU/mL. NPL Fall Seminar The NPL Fall Seminar will be held Wednesday, September 12 th at the Ramkota Hotel in Bismarck, ND. Registration forms and a brief description of the presentations are included in this newsletter mailing. HEPCQNT HEP C PCR

4 Beta-Hydroxybutyrate Replaces Serum Ketone Test By Todd Pace, Core Lab Supervisor Northern Plains Laboratory (NPL) is pleased to announce the addition of the beta-hydroxybutyrate assay to our in house test menu. Measuring blood levels of betahydroxybutyrate can determine the presence and degree of ketosis. Ketosis is a common feature in acutely ill patients. In subjects suffering from starvation, acute alcohol abuse, or diabetes mellitus, ketosis can result in severe life threatening metabolic acidosis. Normally, beta-hydroxybutyrate is the ketoacid present in the greatest amount in serum. It accounts for approximately 75% of the ketone bodies, which also contain acetoacetate and acetone. During periods of ketosis, beta-hydroxybutyrate increases even more than the other two ketoacids, acetoacetate and acetone, and has been shown to be a better index of ketoacidosis including the detection of subclinical ketosis. In diabetics, the measurement of betahydroxybutyrate as well as the blood glucose is needed for the assessment of the severity of diabetic coma and is essential for the exclusion of hyperosmolar non-ketotic diabetic coma. Moreover, the insulin requirements are often based on the extent of the existing hyperketonemia shown by the blood levels of betahydroxybutyrate is therefore extremely important in the assessment of ketosis. The American Diabetes Association recommends measuring BHB over acetoacetate for diagnosing and monitoring of patients with diabetic ketoacidosis. Test CPT Code Code Test Name BHB B- hydroxybuty rate serum Specimen Serum or Heparinized plasma Page 4 of 7 Reference Range <0.3 mmol/l If you have any concerns or questions regarding this information, please contact Todd Pace, Core Lab Supervisor at or Dr. Laurie Linz at Updated Insurance Information By: Patti Schmidt, CPC, Billing Supervisor When ordering laboratory, cytology and pathology tests that are to be billed by our office, please verify that the patient s insurance information is updated and correct in the HVR Connect. This will eliminate frequent calls to your facility s billing office to obtain the correct information. Thanks for your help! Go Green! Cardboard Recycling By Wanda Giedd, Purchasing Coordinator Each week Northern Plains Laboratory mails out large cardboard boxes with supplies or shipping containers. For clients that are interested in recycling these boxes, we can generate a shipping label for bundles of ten boxes for return to NPL to be re-used. Please contact Wanda Giedd at if you are interested.

5 Urine Protein/Creatinine Ratio By Todd Pace, Core Lab Supervisor A new test code is now available for providers that wish to have a Urine Protein/Creatinine ratio reported. This new group test can be ordered using the test code UPCRR. This test can be ordered on 24 hour urine collections or random urine collections. Test Code Individual components Units Reference Range UPCRR Total Volume ml/24 hr None Urine mg/dl None Creatinine Urine Creatinine/24 mg/ mg/24 hr hr hr Urine Protein mg/dl 1-14 mg/dl Urine Protein/24 hr mg/ mg/24 hr hr Urn Prot/Creat Ratio mg/g <150 mg/g Questions or comments should be directed to Todd Pace at NPL ( ) or to Laurie Linz, MD ( ). Supply Order The orderable unit of measure for biohazard specimen transport bags (item # ) has changed from 50 bags/package to 100 bags/package. Please order accordingly. CAP Top Ten Deficiencies The top ten deficiencies cited during College of American Pathologists (CAP) inspections are: 1. Gen The competency of each person to perform his/her assigned duties is assessed. CAP requires that all 6 elements, including direct observation, must be used for evaluation of each test method. New employees must have their competency Page 5 of 7 assessed twice during the first year of employment Gen and GEN The laboratory must have a document control system. This document control system must include all forms and records as well as policies and procedures. 4. Gen Fire drills must be conducted annually and must include participation by all staff. 5. Gen The laboratory must have adequate eyewash in areas where there are hazardous chemicals. Eyewashes must be within 100 ft of hazardous materials and must be checked weekly. 6. Gen Personal files are maintained on all current technical personnel and must indicate if personnel require supervision and/or review of work prior to releasing results. 7. CHM There is documentation of policy and procedure review every two years. 8. CHM There is ongoing evaluation of PT and alternative assessment results. Corrective action must be complete within 30 days for any proficiency failure. 9. COM The laboratory must have a written policy for proficiency testing that includes handling, analysis, review, investigation of unacceptable results or results showing bias or trends suggesting problems. 10. Gen Refrigerator/freezer temperatures are checked and recorded daily. This includes weekends and holidays for laboratories staffed M-F. Min/Max thermometers can be used to document temperatures on closed days. Other areas frequently cited include instrument validation, instrument maintenance, instrument calibration, quality control, reagent labeling and expiration, safety and quality management. Reference: Jean Hood, Amerinet Presentation Not Your Average Top Ten List: CAP s most Frequently Cited Top Ten Phase II Deficiencies

6 Page 6 of 7 Test Changes The following test changes have gone into effect. Interfaced clients will need to add or remove these test numbers in your LIS or EMR. Individual Test Modify: ADAFL Modify ARUP # from to Modify Name from Adenosine Deaminase, Fluid to Adenosine Deaminase, Pleural Fluid Modify Name from CFTR 5T to CFTR 5T Mutation ICABG Modify Name from Islet Cell Ab IgG to Islet Cell Cytoplasmic Ab, IGG Add: Alpha-PGH not orderable part of group test ASPGH A7114 Source not orderable part of group test BORDP Source not orderable part of group tests - CNGAM, CNLTA, NGA Interpretation not orderable part of group test CORTU Viral Load not orderable part of test HCVGN this test will be reflexed on to all HCVGN orders BHB B-Hydroxybutyrate new test UCRPR Urn Prot/Creat ratio not orderable-part of group test UPCRR, specimen type is 24 hr urine PTHIO PTH, Intraoperative orderable, specimen type is plasma Inactivate: Alpha Subunit part of group test - ASPGH Source part of group tests BORDP,CNGAM,CNLTA,NGA KETO Ketones, Serum no longer orderable Group Test Modify: ASPGH BORDP CNGAM CHLTA NGA CORTU OLIG PB Add individual test (Alpha-PGH) Modify ARUP # from to Add individual test A7114 (Source) Add individual test (Source) Add individual tests (APTIMA-Media Type) & (Source) Add individual tests (APTIMA-Media Type) & (Source) Add individual test (Interpretation) Modify name from Oligoclonal Bands to Oligoclonal Bands Profile Modify name from Porphobil, Urine to Porphobilinogen (PBG), Urine Add: UPCRR Urine Protein/Creat Ratio Orderable, includes-tv24, UPR, UCRER, UP24, CRE24, UCRPR

7 Page 7 of 7 Packaging specimens Please remember with summer weather to package specimens to avoid excessive heat. Place specimens in the center of the shipping container surrounded by refrigerator or freezer packs as indicated. Add additional ice pack to maintain temperature in warmer weather. Fill empty spaces in the shipping container with paper towels, bubble wrap or other packing material. To preserve specimen integrity, do not pack specimens preserved in formalin in the same container as slides for hematology. Fibrinogen Reference Range Change By Todd Pace, Core Lab Supervisor Northern Plains Laboratory has implemented a new Fibrinogen assay reagent. Based on reference range studies conducted in house, the reference range for Fibrinogen with this new reagent has been changed to mg/dl. (Previous reference range mg/dl) If you have any concerns or questions regarding this information, please contact Todd Pace, Core Lab Supervisor at or Dr. John Hipp at Test Code FIB Test Name Fibrino gen Specimen Requireme nts Sodium Citrate Plasma New Reference Range mg/dl