Lab Updates
| 6/2008 |
To: UCSF Physicians and Nurses From: Timothy Hamill, MD Re: Assay changes for serum Vitamin B12, Ferritin, Cortisol, and RBC Folate Date: June 12, 2008 Effective June 17, 2008, the assays and reference ranges for serum vitamin B12, ferritin, cortisol, and RBC folate will be changed at Moffitt-Long and Mt Zion clinical laboratories. Details regarding the new assays and updated reference ranges can be found in the online Laboratory Manual beginning June 17, 2008 at the following website: http://labmed.ucsf.edu/labmanual/mftlng-mtzn/test/test-index.html For the next 6 months, a comment will be attached to the results noting the date when the assays were changed. For questions, please contact Dr. Ted Kurtz, Chief of Clinical Chemistry at KurtzT@ |
| 5/2008 |
To: UCSF Clinical Staff From: Timothy Hamill, MD Re: Changes in Hemoglobin A1c (HbA1c) assay Date: May 16, 2008 Effective May 21, 2008, the Moffitt-Long and Mt Zion clinical laboratories will make modifications to the HPLC assay for HbA1c that will influence results as described below. Impact of HbA1c assay modification The assay modification will cause HbA1c results to decrease on average by approximately 0.4 units. This change is occurring due to modifications in the assay procedure to bring values more closely in line with reference laboratory results of the National Glycohemoglobin Standardization Program. The normal range for the modified assay will be 4.3 % - 6.0%. Goals for HbA1c recommended by American Diabetes Association (ADA) When using this assay, the ADA recommended goal for A1c control for adult diabetic patients in general is <7% although use of an A1c goal as close to normal as possible without causing significant hypoglycemia may be appropriate for individual patients. In pregnant patients, the ADA recommends aiming within the normal range. The ADA recommended goals for other age groups are: < 7.5% for adolescents and young adults ages 13-19 ; < 8% for children ages 6 - 12; and between 7.5% - 8.5% for children ages 0 - 6. For the next 6 months, a comment will be attached to HbA1c results noting that the method was modified on May 21, 2008. For questions, please contact Dr. Ted Kurtz at Moffitt-Long Hospital (KurtzT@ |
| 5/2008 |
TO: UCSF PHYSICIANS FROM: UCSF Compliance Committee for Clinical Laboratories Re: OFFICE OF INSPECTOR GENERAL, COMPLIANCE PLAN As part of Clinical Laboratories' Compliance Plan for the federal Office of Inspector General (OIG), we are required to annually notify all physicians of the following policies, developed to reflect government guidance:
Clinical Laboratories consultation is available at 353-1667. Material contained in this yearly notification is current as of the date published and is subject to change without notice. The OIG believes that a physician who orders medically unnecessary tests and knowingly causes a false claim to be submitted may be subject to sanctions or remedies under criminal or administrative law. In addition, we are required by Audit Services to communicate to you the means by which you may report incidences of fraud, abuse, waste or misconduct. Reporting can be done through the UCSF Locally Designated Whistleblower Official, Abby Zubov, at 502-2810 or by calling the Universitywide Whistleblower Hotline at (800) 403-4744. If you have any questions regarding the content of this memo, please contact Betty Yalich, senior supervisor of Quality Assurance and Compliance, at (415) 353-9319 or betty.yalich@ |
| 5/2008 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. Re: CHANGE IN BLOOD CULTURE SKIN PREP MATERIALS The Iodine and Alcohol materials currently used for skin preparation for blood cultures at UCSF Medical Center will not be available for BLOOD CULTURE KITS due to a manufacturer back-order. The change outlined below is effective immediately until further notice. NOVAPLUS 70 percent isopropyl alcohol prep pads will be substituted for the Frepp pads previously used in the Blood Culture Kits. The iodine will be changed to Enturia PVP Iodine 10 percent U.S.P. in an internal ampule and applicator commonly called Sepp. Break the ampule and soak the applicator for use as described below. These supplies will be substituted in the Blood Culture Kits for the alcohol and iodine supplies and should be used according to the directions in the Instructions for Peripheral Blood Culture Draw found in the blood culture kits, items 1 and 2 below.
If you have any questions, please contact the Microbiology Lab at 353-1268. |
| 4/2008 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. Re: NEW BLOOD PRODUCT LABELING International Society of Blood Transfusion (ISBT) 128 is an international standard for the labeling of blood components to achieve consistency in the information provided on component labels and the placement of such information. To implement ISBT 128, the blood banks at Parnassus and Mount Zion are upgrading their blood management software system. Beginning Monday, April 28, there will be significant changes to labels on blood components including:
Please see the attached image of the new product label. Products collected before April 28 will have labels in the old format. For more information and training materials for the proper identification of blood products and documentation of information from ISBT 128 labels, please contact your nurse manager or call the UCSF Blood Bank at 353-1313. |
| 4/2008 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. Re: ASSAY CHANGES FOR PROLACTIN, FSH, LI AND PROGESTERONE Effective Tuesday, April 15, Clinical Laboratories at Parnassus and Mount Zion will change the routine immunoassays used to measure prolactin, FSH (adult), LH (adult) and progesterone (adult). The ultrasensitive assays used to measure low level FSH, LH and progesterone concentrations (e.g., in children) will not be changed. These immunoassay changes are occurring due to installation of new instrumentation, which will have the following impact on test results:
The assay reference ranges will be updated when the new assays are started. For the next six months, a comment will be attached to the results, noting the date of the assay change. If you have any questions, please contact Dr. Ted Kurtz, chief of Clinical Chemistry, at KurtzT@ |
| 3/2008 |
TO: UCSF PHYSICIANS AND NURSES FROM: Lawrence Drew, M.D., Ph.D. Re: CLOSTRIDIUM DIFFICILE TESTING The UCSF Microbiology laboratory has implemented a two-step algorithm for Clostridium difficile testing that will allow us to provide results on C. difficile negative samples more rapidly. Initially, an antigen test that reliably detects the presence of C. difficile somatic antigen will be performed. Antigen-negative specimens will be issued a final report stating "NEGATIVE somatic antigen assay.(Interpretation:NEGATIVE TEST)". A cytotoxin assay will be performed on the somatic antigen positive specimens. Samples that are negative for toxin will receive a final report of "NEGATIVE toxin assay. Positive somatic antigen assay.(Interpretation: NEGATIVE TEST, not consistent with C. difficile induced disease.)". Samples that are positive for toxin will receive a final report of "POSITIVE toxin assay. POSITIVE somatic antigen assay.(Interpretation: POSITIVE TESTS consistent with C. difficile induced disease.)" Please contact the Microbiology Laboratory at 353-1268 if you have any questions. This two-step algorithm is diagrammed below:
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| 3/2008 |
TO: UCSF Clinical Staff FROM: Tim Hamill, M.D. Re: Increased sample volume for ionized calcium assay Effective March 10, 2008, the sample volume required for ionized calcium testing in venous blood will increase from approximately 100 microliters to 600 microliters. This will require that an additional full bullet tube sample be drawn on pediatric patients in whom other tests are being ordered in addition to ionized calcium. This change is occurring because the equipment manufacturer has stopped supporting the clinical assay instrument that uses the smaller sample volume. If there are any questions about this change please contact Dr. Ted Kurtz at 353-1979 or at kurtzt@ |
| 2/2008 |
TO: UCSF PHYSICIANS FROM: Tim Hamill, M.D. Re: HEPATITIS B DNA TESTING Effective immediately, UCSF Clinical Laboratories is no longer offering Hepatitis B Qualitative testing by polymerase chain reaction (PCR). The qualitative assay, performed by Quest, has a lower limit of sensitivity of 30 IU/mL. The current Hepatitis B DNA Quantitative assay by PCR, performed by Viracor, has a lower limit of sensitivity of 5 IU/mL. As the quantitative assay has better low end sensitivity, all requests for the qualitative assay will be converted to the quantitative test. If a clinical circumstance arises where a qualitative assay is desired over the quantitative test, the ordering practitioner should contact the clinical laboratory to discuss the situation and the need. Should you have questions regarding this change, please contact me at 353-1723 or hamilllt@ |
| 1/2008 |
TO: UCSF PHYSICIANS FROM: Tim Hamill, M.D. Re: CREATININE ASSAY CHANGES Effective Monday, Feb. 4, Clinical Laboratories at Parnassus and Mount Zion will change the creatinine assay, causing serum creatinine results to decrease on average by approximately 0.09 mg/dL. This change is being made because the manufacturer of the assay has modified the calibration to be traceable to the isotope dilution mass spectrometry (IDMS) reference method. Creatinine reference ranges also will be modified. Glomerular Filtration Rate (GFR) The laboratory will begin reporting an estimated GFR result whenever a serum creatinine is ordered in an adult patient. The estimated GFR will be calculated using the Modification of Diet in Renal Disease (MDRD) formula for IDMS traceable creatinine methods. The MDRD formula is not suitable for estimating GFR in children. A calculator for estimating GFR in children can be found at http://www.nkdep.nih.gov/professionals/gfr_calculators/gfr_children.htm. NOTE -- For each creatinine result in an adult, two values for estimated GFR will be reported, with one of the values calculated using the formula applicable to Caucasian patients and the other value calculated using the formula applicable to African American patients. Because the formula is not considered sufficiently accurate for estimating GFR in patients with normal or mildly reduced renal function, results greater than 60 mL/min/1.73 meters squared body surface area will be displayed as > 60 mL/min and will not be reported as an exact number. WARNING -- The estimated GFR result is not reliable in certain groups, including severely ill patients. The MDRD equation used to estimate GFR has been validated only in Caucasian and African Americans 18 - 70 years of age. The equation has not been validated in other population groups, pregnant women, transplant recipients, medically unstable patients including those with acute renal failure or in persons with extremes of body size, muscle mass or nutritional status. Application of the MDRD calculation in these cases may lead to errors in GFR estimation. For the next six months, a comment will be attached to all creatinine results noting that the methods were changed on Feb. 4. If you have questions, please contact Dr. Ted Kurtz at Parnassus at kurtzt@labmed2.ucsf.edu or Dr. Steve Miller at Mount Zion at steve.miller@ucsfmedctr.org. |
| 1/2008 |
TO: All Inpatient Nurse Managers FROM: Tim Hamill, M.D. RE: Reminder about ice and the Pneumatic tube system Please remind all staff that samples on ice should NOT be sent through the pneumatic tube. The biohazard bags are not designed to contain liquids and the melting ice often leaks into the pneumatic tube system. This results in potential contamination of the tube as well as excess wear and tear on the components. We eliminated the recommendation for sending blood gas samples on ice quite some time ago. Icing blood gas samples is unnecessary as they are relatively stable at ambient temperature for up to 30 min. after collection. The lab will reject samples drawn that are greater than 30 min. old regardless of whether they are received on ice or not. For samples (see attached list) that must be sent on ice, they should be hand carried to the laboratory. DO NOT use the pneumatic tube to transport these samples. Thank you for your cooperation in this regard. If there are questions please feel free to contact me at x3-1723 or Dr. Terrazas at x3-1375. SAMPLES THAT MUST BE HAND CARRIED TO LABORATORY ON WET ICE
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| 12/2007 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. RE: NEW LABORATORY REQUISITIONS UCSF Clinical Laboratories has developed two new test requisitions to accommodate an increased number of infectious disease serologic and molecular tests as well as the rapid expansion of molecular genetic tests. The new forms will be available, effective Jan. 7. Attached are PDFs of the new forms as well as instructions for ordering them. These new requisitions will be stocked in the warehouse and can be obtained by submitting the attached WorkflowOne requisition form. The new forms are related to the following tests: Infectious Disease Serologic and Molecular Testing (400-0005) This requisition lists the most commonly ordered infectious disease serologic and molecular tests and should be the primary requisition used to order these tests. The listings for several infectious disease serologies (CMV Ab, HIV Ab, Hepatitis serologies, etc.) will remain on the routine requisition form as a convenience since they historically have been ordered on the routine requisition. For diagnostic HIV testing, the new form contains an attestation area to be signed by the ordering provider to document that consent was obtained. This will eliminate the need for the cumbersome "HIV Consent" form and will help streamline the consent process, in response to the Centers for Disease Control and Prevention (CDC) recommendation for universal testing. The new requisition will serve as documentation of consent, which is held for three years. There is no requirement to document patient consent for tests used in monitoring HIV positive patients. If a patient presents with a request for HIV testing that is not signed, we will perform the requested test but will indicate with the result that the attestation was not signed and remind the physician to document consent in the patient record. Molecular Genetic Tests (400-0006) This form contains the available in-house molecular genetic tests. The laboratory will continue to accept written requests for these tests on the routine requisition but the new form will help ensure the correct test is ordered. For ALL non-neoplastic test requests, the patient should be offered genetic counseling prior to testing. The form provides an area to document this information. For pre-symptomatic BRCA 1/ BRCA2 and Huntington's disease tests, the patient must receive genetic counseling prior to testing. The name of the genetic counselor who provided counseling is required on the form before samples are collected from the patient. For more information, please contact me at hamillt@ |
| 10/2007 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. TRIGLYCERIDE ASSAY CHANGE Effective Nov. 1, UCSF Clinical Laboratories will change the triglyceride assay, which will influence lipid panel results for patients at the Parnassus and Mount Zion campuses. This change is occurring because the manufacturer of the assay has modified the procedure so results more closely match those of the Centers for Disease Control and Prevention (CDC) reference method. The impact of triglyceride assay change on lipid panel results are:
During the next six months, a comment will be attached to all triglyceride and lipid panel results, noting the effect of this assay change on test values. For more information, please contact Dr. Ted Kurtz, chief of Clinical
Chemistry at kurtzt@ |
| 10/2007 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. Geo. F. Brooks, M.D. VIROLOGY TESTING ON WEEKDAYS The Clinical Virology Laboratory will close at 3 p.m. on weekdays, rather than midnight, effective today, Oct. 10 to Oct. 24, due to staffing. Test requests submitted after 3 p.m. will be processed the following day. This temporary change in hours of operation may impact the turnaround time for Clostridium difficile toxin assay, Respiratory virus DFA, Herpes simplex virus DFA and Varicella-zoster virus DFA, when these specimens are received after 3 p.m. Regular hours on Monday to Friday -- 7:30 a.m. to midnight -- will resume on Oct. 24. Weekend hours -- 8 a.m. to 4:30 p.m. -- are not changing. |
| 8/2007 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. RE: EPSTEIN-BARR VIRUS TESTING UCSF Clinical Laboratories will perform quantitative viral load testing for Epstein-Barr Virus (EBV) DNA using an in-house real-time PCR method starting Thursday, Aug. 30. This test will be performed on EDTA plasma and has a linear range of 1,000 copies/ml to 1x10e6 copies/ml. Samples with DNA detected below the linear range will be reported as "Detected, <1000 copies/ml." Prior results from outside laboratories may differ somewhat from UCSF results due to variations in test methods. We recommend monitoring for change in viral load over time as a more accurate indicator of disease progression, or control, than the absolute copy number. For more information, see the UCSF Clinical Laboratories manual online at http://labmed.ucsf.edu/labman/, or contact the Microbiology Laboratory at 353-1268. |
| 7/2007 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. RE: CHANGE IN FREE T4 ASSAY The new free T4 assay implemented on June 13 has yielded results that are biased about 5 units higher than the previous free T4 assay method used at UCSF Medical Center, most notably in patients on levothyroxine therapy as well as some patients with free T4 levels above the normal reference range. This bias was confirmed by an independent third party assay. Therefore, starting Wed., Aug. 1, Clinical Laboratories will revert to its previous free T4 method to provide test values more consistent with those generated in the past and with those generated by other free T4 assays. Special thanks to Dr. Ken Woeber and Dr. Frank Greenspan for their help in identifying and addressing this problem. For the next three months beginning Aug.1, a comment will be attached to all FT4 results noting the date of the assay change. If you have any questions, please contact Dr. Ted Kurtz, chief of Clinical Chemistry, at KurtzT@ |
| 6/2007 |
TO: UCSF PHYSICIANS AND NURSES FROM: Richard A. Jacobs, M.D., Ph.D. Peggy S. Weintrub, M.D. Geo. F. Brooks, M.D. RE: CATHETER TIP CULTURES Effective Monday June 25, catheter tips will not be accepted for culture at UCSF Medical Center. It has been determined that catheter tip cultures are not useful to identify catheter-related bloodstream infection. If a catheter-related bloodstream infection is suspected, clinicians are strongly urged to request Differential Time to Positivity (DTTP) of a peripheral vein blood culture and an intravenous line blood culture drawn simultaneously. If the line culture turns positive > 2 hours faster than the peripheral vein culture, it strongly suggests colonization of the line as a source of catheter-related bloodstream infection. Instructions for requesting and performing DTTP blood cultures are in the collection kits for peripheral draw and line draw blood culture. Instructions also are in the nursing blood culture procedure. NURSE MANAGERS: Please distribute this message to your staff. |
| 6/2007 |
TO: UCSF PHYSICIANS AND NURSES FROM: Tim Hamill, M.D. RE: SERUM TSH AND FREE T4 REFERENCE RANGES Effective Wednesday, June 13, Clinical Laboratories at Parnassus and Mount Zion will begin using new assays for serum TSH and free T4 (FT4) testing. This will result in some changes to the assay reference ranges. The new TSH assay reference range will be 0.4 - 4.0 mIU/L, compared to current reference range of 0.5 - 4.7. The new FT4 reference range will be 12 - 24 pmol/L, compared to current reference range of 9 - 24 pmol/L. For the next three months, a comment will be attached to all TSH and FT4
results noting that the methods were changed on June 13. If you have
any questions, please contact Dr. Ted Kurtz, chief of Clinical
Chemistry, at kurtzt@ NURSE MANAGERS: Please distribute this message to your staff. |
| 5/2007 | TO: UCSF PHYSICIANS
FROM: Tim Hamill, M.D. RE: CHANGES IN SERUM HCG ASSAYS Effective May 7, Clinical Laboratories at Parnassus and Mount Zion will use new assays for serum hCG testing. This change is occurring because the manufacturer of our current assays has stopped selling hCG test reagents due to problems with its assay diluent. Tumor Monitoring -- The new hCG assay for tumor monitoring (DPC Immulite 2000 two-site immunoassay) reads approximately 20 percent higher than the previous assay. The new assay detects all forms of hCG and is calibrated to the World Health Organization (WHO) 3rd International Standard 75/537. To enable re-base lining of hCG levels with the new assay, the laboratory will run both the new and old assays on each sample and report out both results at no additional charge until May 31, when the old hCG assay reagents are expected to run out. Pregnancy Testing -- The new serum hCG assay for pregnancy testing (Beckman Access two-site immunoassay) generates results similar to the old assay in the cutoff range for pregnancy. Healthy, non-pregnant individuals less than 40 years of age have hCG levels less than or equal to 5 IU/L. This assay detects most forms of hCG and is calibrated to the WHO 3rd International Standard 75/537. NOTE: All increased hCG results will be flagged with a reminder that increased hCG levels can occur in pregnant patients and those with certain tumors including trophoblastic malignancies. Increased hCG levels also can occur in some normal, non-pregnant peri- or post- menopausal women with increased pituitary hCG levels and in some patients with heterophile antibodies or other serum proteins that can cause false positive elevations in hCG immunoassays. For the next six months, a comment will be attached to all hCG results noting that the methods were changed on May 7. If you have any questions, please contact Dr. Ted Kurtz, chief of Clinical Chemistry, at KurtzT@Labmed2.ucsf.edu. |
3/2007 | TO: UCSF PHYSICIANS
FROM: Tim Hamill, M.D. RE: VIROLOGY TESTING ON WEEKENDS Effective Saturday, April 7, all requests for tests performed by the Clinical Virology Laboratory received after 3 p.m. on Saturday and Sunday will be processed the following day. This includes tests for respiratory virus direct fluorescent antibody (DFA). A review of services indicated that there are very few requests for tests by the virology section on weekend evenings. This is especially true for respiratory virus testing outside the influenza season since there are no therapies for the other respiratory viruses. Even if a DFA is negative, isolation should be ordered and continued for all suspected respiratory viral infections. |
| 2/2007 | TO: UCSF PHYSICIANS
FROM: Tim Hamill, M.D. RE: REFERENCE RANGE FOR PROLACTIN, VITAMIN B12 Effective March 1, 2007 reagent changes have been made to bring our prolactincassay more closely in line with the 3rd International Reference Preparation. This will reduce patient values by about 20 percent. The reference range for prolactin will change to: Effective March 15, 2007vreagent changes have been made to vitamin B12 that reduce patient values by about 15 percent. The reference range for vitamin B12 will change to > 210 ng/L |
| 1/2007 | TO: UCSF PHYSICIANS AND NURSES
FROM: Geo. F. Brooks, M.D. W. Lawrence Drew, M.D., Ph.D. RE: REPORTING POSITIVE MICROBIOLOGY RESULTS For decades, many positive results for diagnostic microbiology tests have been reported to clinicians by phone. Major upgrades in the computer system for reporting results have obviated the need for many of Effective Feb.1, the Microbiology and Virology Laboratories will call to report initial results only for life-threatening infections and those that are a public health concern. All results are promptly entered into The following results will be reported by phone:
Please let us know if you have any questions or concerns about this change. |
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12/2006 |
CUSTOMER SURVEY REMINDER This is a reminder to please complete the customer satisfaction survey The deadline for survey submissions is Friday, Dec. 8. Please let us know what you think. Your feedback is very helpful in our efforts to improve our service. If you have any questions, please contact Betty Yalich, senior supervisor for Quality Assurance and Point of Care Testing, at 353-9319 or by email at betty.yalich@clinlab.ucsfmedctr.org Thank you in advance for your response. |
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11/2006 |
CHANGES IN ASSAYS TO CA 15-3, CA 19-9 Effective Nov. 1, the Clinical Laboratory Chemistry section began in-house testing for CA 15-3 and CA 19-9. Due to the variability of results when using different methods, tests for patients with prior positive values will be sent to the outside lab that performed the previous tests at no additional charge -- in addition to the in-house test -- so a new baseline value can be established. If you have any questions, please contact the Laboratory Medicine resident by paging 443-3654. |
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11/2006 |
NEW ROUTINE LAB REQUISITION I have received several inquiries regarding the new routine laboratory test requisition, form 701-020, particularly regarding the shaded areas of the form that are for internal lab use only. I would like to explain some of these changes. The pink shading indicates tests that require some special or expedited processing once they reach the laboratory. The grey shading simply highlights groups of commonly ordered serum/plasma chemistry tests that previously were scattered throughout the requisition. This will make it easier for those using the form to order these tests and make it easier for lab staff to transcribe the orders into the laboratory computer system. Other changes are related to test names and the list of specific tests displayed on the form. One change of note is that the type of primary sample tube for common chemistry tests is now the light green top "Plasma Separator Tube." This heparinized tubes allows us to handle samples faster than the serum tubes that must fully clot before they can be processed. Although serum is an acceptable sample for these tests, the laboratory prefers the light green top vacutainers. Tim Hamill |
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4/2006 |
WARNING - SPURIOUS BLOOD GLUCOSE VALUES The U.S. Food and Drug Administration has issued a warning regarding the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose, The Roche Accucheck Point-of-Care glucometers, employed at UCSF for bedside and clinic testing, use the implicated enzymatic method to determine whole blood glucose levels. Glucose should NOT be measured A preliminary listing of U.S. products that may cause glucose test interference can be found on the web at NOTE -- The glucose tests performed in the Clinical Laboratories are not subject to this interference and therefore samples for glucose levels for at-risk patients should be sent to the laboratory for analysis. Please review this information with all faculty, residents, fellows and students. |
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4/2006 |
OFFICE OF INSPECTOR GENERAL -- COMPLIANCE PLAN As part of the Clinical Laboratories' Compliance Plan for the federal Office of Inspector General (OIG), we are required to annually notify all physicians of the following policies, which have been developed to reflect government guidance: * Medicare national and local medical review policies exist for certain lab tests. Specific test information is in Medicare Bulletins distributed by the local carrier, United Government Services or online at http://pangloss.ucsfmedicalcenter.org/LabMan/LMRPweb/ * Medicare and some other payers will not pay for screening tests if the patient displays no symptoms or evidence of disease and may not pay for tests that are not FDA approved or are experimental. * Medi-Cal fees are equal to or lower than Medicare lab fees. * All panels -- organ and disease or custom -- will be billed and paid only when all components are medically necessary. * Reflex tests and reflex test criteria are listed in theLaboratory Manual online at * A current Medicare lab fee schedule with CPT (current protocol terminology) codes is available upon request from Clinical Laboratories. Clinical Laboratories consultation is available at (415) 353-1667. Material contained in this yearly notification is current as of the date published and is subject to change without notice. The OIG believes that a physician who orders medically unnecessary tests and knowingly causes a false claim to be submitted may be subject to sanctions or remedies available under criminal or administrative law. If you have any questions regarding the content of this memo, please contact Betty Yalich, senior supervisor of Quality Assurance and Compliance, at (415) 353-9319 or betty.yalich@clinlab.ucsfmedctr.org . |
| 1/2006 | ANTI-CARDIOLIPIN ANTIBODY TESTING
Effective Wednesday, Jan. 18, testing for anti-cardiolipin antibodies will change to specific assays to detect IgG and IgM anti-cardiolipin antibodies individually rather than the current assay that detects total antibody. The new assays performed on serum and samples should be drawn in either a gold top (SST) or red-top vacutainer rather than the citrate or blue-top container as specified on the requisition. Requests for cardiolipin antibodies (CLIP) on the routine requisition will be changed automatically to order both the IgG and IgM anti-cardiolipin tests. If you wish to order only one of these tests, enter ACLG for the IgG anti-cardiolipin antibody test or ACLM for the IgM anti-cardiolipin antibody test in the lower right area of the form for "Other Tests." Please review the interpretation of these results below and in the lab manual under the specific test names. Please contact the laboratory at 353-1712, Immunology Lab Medicine resident at 353-1438 or one of us if you have questions regarding these test changes. RESULTS INTERPRETATION ACLG (IgG anti-cardiolipin) is reported in GPL units.
ACLM (IgM anti-cardiolipin) is reported in MPL units.
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1/2006 |
CHANGE IN ASSAYS -- GROWTH HORMONE, IGF-1, THYROGLOBULIN, THYROGLOBULIN ANTIBODY Substantial changes in the reference ranges and results for growth hormone, IGF-1, thyroglobulin and thyroglobulin antibody measurements will be occurring later this month and next month at the Parnassus and Mount Zion hospitals due to upcoming changes in assay methods. These changes are occurring because the manufacturer of the current assays, Nichols Diagnostics, announced that it will no longer sell the test reagents. There will not be any changes in sample requirements or turnaround times. Dates and details of the changes and the impact on assay results are outlined below. Growth Hormone
IGF-1
Thyroglobulin
Thyroglobulin Antibody
For the next six months, a comment will be attached to the results for each assay noting that the methods and reference ranges were changed on a specific date. For questions, please contact the Laboratory Medicine resident by paging 719-3654 or send an email to me at KurtzT@Labmed2.ucsf.edu. |
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1/2006 |
SIROLIMUS TESTING CHANGE Effective Jan. 18, the whole blood assay for sirolimus, also known by brand name Rapamune, will be performed by Clinical Laboratories at UCSF Medical Center rather than a commercial laboratory. This will allow for faster results and a slight modification of the target therapeutic ranges related to the change in assay methodology. Current Testing Method through Jan. 17
New Testing Method effective Jan. 18
NOTE -- The new EIA method yields results about 15 percent higher than the current LC-MS assay. The correlation coefficient of the two assays is r = 0.94 or greater (1, 2). For questions, please contact the Laboratory Medicine resident by paging 719-3654 or send an email to KurtzT@Labmed2.ucsf.edu. References: 1. Johnson RN, et al. 2005. An evaluation of the Abbott IMx sirolimus assay in relation to a high-performance liquid chromatography-ultraviolet method. Ann. Clin. Biochem. 42:394-7. 2. Fillee C, et al. 2005. Evaluation of a new immunoassay to measure sirolimus blood concentrations compared to a tandem mass-spectrometric chromatographic analysis. Transpl. Proceed. 37:2890-1. |