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Lab Updates

10/2009

TO: UCSF PHYSICIANS AND NURSES

FROM: Enrique Terrazas, M.D.
Chief of Laboratory Information Systems
UCSF Clinical Laboratories
enrique.terrazas@ucsf.edu

RE: TIME CHANGE IMPACT ON LAB RESULTS

The Sunquest Lab Information System will be in a "read-only" state during the repeated hour beginning at 2 a.m. on Sunday, Nov. 1, when daylight saving time ends and clocks are set back an hour. No new lab results, including point-of-care glucose results, will be sent to downstream systems, such as UCare and Stor, during the repeated hour.

Please contact Clinical Labs at 353-1667 if you have any urgent patient care results during this time.

10/2009

To: UCSF Physicians, Nursing staff and Allied Health Providers

RE: New improved method for respiratory viral specimen collection

From: Steve Miller, MD, PhD
Director, UCSF Microbiology Laboratory

A new type of nasopharyngeal swab (Flocked swab) can be substituted for nasal wash when collecting samples for respiratory viral testing by Direct Fluorescent Antigen (DFA) and PCR methods. Nasal wash, nasal aspirate and BAL samples will still be accepted for viral testing.

Flocked swabs are preferable to nasopharyngeal washes for specimen collection due to:

  • Ease of collection
  • Superior recovery of virus

Order testing as: Flocked swab for Respiratory Virus DFA

Flocked swabs will be stocked on all units during the week of 10/12 10/16. They can be used as soon as they are available. Flocked swabs should NOT be used for collecting other types of samples for testing (throat swab, anterior nares swab, wound swab, etc.).

For respiratory virus testing sent to the UCSF Microbiology Lab:

  1. Use Flocked swab/Universal Transport Medium for collection.
  2. Insert swab into the nostril, gently rotating the swab inward until resistance is met at the level of the turbinates.
  3. Rotate the swab a few times against the nasopharyngeal wall (approximately 10 sec) and then withdraw swab.
  4. Insert swab into container with Universal Transport Medium. Break end of swab so top of vial can be screwed on securely.
  5. Appropriately label specimen and send to the laboratory with a completed Microbiology requisition.

Note: Use of a flocked swab for sample collection may be contraindicated after recent maxillofacial surgery.

More information and videos demonstrating proper collection technique are at: http://labmedx.ucsfmedicalcenter.org/videos/swab_technique.html

For additional information contact Dr. Steve Miller, UCSF Clinical Microbiology Laboratory at 353-9630 or by e-mail at: Steve.Miller@ucsfmedctr.org

09/2009

TO: UCSF PHYSICIANS AND NURSES

FROM: Clinical Laboratories
Hospital Epidemiology and Infection Control

RE: SPUTUM SAMPLES FOR TB TESTING

Effective Monday, Sept. 14, UCSF Medical Center is changing its requirements to rule out active pulmonary TB in adults. The new requirements are:

  • Three separate sputum samples
  • Obtained in 8-12 hour intervals
  • At least one specimen must be an early morning specimen

This change affects adult patients with suspected pulmonary tuberculosis and replaces the previous requirement for three morning sputum samples collected on consecutive days for acid-fast bacillus (AFB) smear testing to rule out pulmonary tuberculosis.

The new requirements will align UCSF practice with current national and state guidelines. Generally, this method will allow patients with negative sputum smear results to be released from airborne precautions in two days, after consultation with Infection Control.

Orders for the sputum samples should be written as

Sputum for AFB smear and culture Q8-12 hours x 3, including one early morning specimen. If induced use 10% saline.

Discontinuation of airborne/ AFB precautions still requires three negative AFB smear results, and consultation with Infection Control.

Sputum samples collected less than eight hours apart will be pooled and tested as a single specimen by the microbiology laboratory. There is no change in the lab requisition. Submit specimens for both AFB smear and culture as appropriate.

Pediatric cases continue to be evaluated by gastric lavage AFB culture using three consecutive morning samples.

If you have questions, contact Dr. Steve Miller, director of the UCSF Microbiology Lab, at steve.miller@ucsfmedctr.org or the Department of Hospital Epidemiology and Infection Control at 353-4343.

Jensen PA et al. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR 2005:54.

Francis J. Curry National Tuberculosis Center, 2007: Tuberculosis Infection Control: A Practical Manual for Preventing TB. www.nationaltbcenter.ucsf.edu

09/2009

TO: UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, Clinical Laboratories
hamillt@labmed2.ucsf.edu

RE: LAB COMPUTER DOWNTIME SUNDAY, SEPT. 13

On Sunday Sept. 13, Clinical Laboratories will update its computer software, requiring that we shut down the lab computer for about eight hours -- from 11 a.m. to 8 p.m. The 11 a.m. shutdown will allow us time to test and report Sunday morning inpatient draw samples.

Because lab processes are highly computer-dependent, testing and reporting capabilities will be severely impacted. During the downtime, there will be no electronic reporting of test results to UCare, Picis or STOR/CDS. The available test menu will be restricted to those assays that are listed on the STAT requisition, microbiology testing and limited therapeutic drug monitoring.

Requests for additional tests to be performed during the downtime will require pathologist approval. The Blood Bank will be fully operational, but product availability will not appear in UCare, Picis or STOR/CDS.

Samples collected for routine testing or send-out testing will be processed and held until Monday.

During the downtime, the lab cannot accept requests to add-on tests. Add-ons will be honored until 10:30 a.m. and after the computer is operating.

Test results will be provided on paper reports delivered hourly to the wards. These reports should be placed in the patients chart. They may be discarded the following day after we have entered all test results into UCare, Picis or STOR/CDS. Lab staff will phone all Emergency Department, OR/PACU and critical results during the downtime.

Lab staff will make every effort to accommodate tests required for patient care but our resources will be limited. Please make an effort to limit the volume of test requests and phone calls to the lab, if possible, during this period. We realize that this will pose a significant burden to all hospital staff and we apologize for the inconvenience.

08/2009

TO: UCSF PHYSICIANS AND NURSES

FROM: Enrique Terrazas, M.D.
Medical Director, Neonatal Clinical Physiology Laboratory (NCPL)
enrique.terrazas@ucsf.edu

RE: NCPL DOWNTIME

The Neonatal Clinical Physiology Laboratory, also known as the 15th floor Blood Gas Lab, will complete a server maintenance project that will interrupt normal sample reporting to patient care areas on Saturday, Aug. 29 from 11 a.m. to about 5 p.m.

The electronic reporting of blood gas, electrolyte, co-oximetry and lactate results to UCare and Picis as well as normal hardcopy reports will be unavailable during this time. Other testing performed by the NCPL will not be affected by this maintenance.

Please inform your staff of this downtime schedule.

During the downtime, the lab will report results by phone or, by special arrangement on that day, by pneumatic tube "receipt-type" reports from the blood gas analyzers to the units.

We apologize for any inconvenience.

08/2009

TO: UCSF PHYSICIANS AND NURSES

FROM: Steve Miller, M.D., Ph.D.
Director, UCSF Microbiology Lab
steve.miller@ucsfmedctr.org

RE: BLOOD CULTURE COLLECTIONS

Effective Aug. 18, ChloraPrep Single Swabstick (2 percent chlorhexidine gluconate and 70 percent isopropyl alcohol) will replace tincture of iodine as the disinfectant in the peripheral blood culture collection kits. Because use of ChloraPrep is contraindicated for patients with sensitivity to chlorhexidine products, the collection instructions in the kits include the procedure to follow when use of ChloraPrep is contraindicated.

NO CONTRAINDICATION -- For patients with no contraindication for use of chlorhexidine products, cleanse the venipuncture site with ChloraPrep Single Swabstick using a back and forth motion for 30 seconds. Allow it to air dry.

NOTE: If skin is soiled, clean with 70 percent isopropyl alcohol before using ChloraPrep.

WITH CONTRAINDICATION -- For patients with a contraindication for use of chlorhexidine products, do not use ChloraPrep.

Follow this procedure: Clean skin of venipuncture site with 60-second friction scrub of 70 percent isopropyl alcohol to a 5 cm circular area. Apply 10 percent PVP iodine to venipuncture site skin in a circular motion to a 5 cm area starting in the center. Allow it to air dry.

Following the venipuncture, remove residual iodine from patients skin with 70 percent isopropyl alcohol. (Iodine is not included in the blood culture kits.)

07/2009

TO: UCSF PHYSICIANS, NURSES AND PHARMACISTS

FROM: Adrienne Green, M.D.
Associate Chief Medical Officer
adrienne.green@ucsfmedctr.org

Tim Hamill, M.D.
Medical Director, Clinical Laboratories
hamillt@labmed2.ucsf.edu

RE: CHANGES IN ANTICOAGULATION REAGENTS, ORDER FORMS

Clinical Laboratories has changed the reagents used to measure aPTT (activated partial thromboplastin time), causing a change in the therapeutic range and revisions to the following anticoagulation order sets for adults:

  • 105-0048 Lepirudin Order Form
  • 105-0049 Argatroban Order Form
  • 734-033Z Intravenous Heparin Order Form
  • Antithrombotic Therapy Order Form

New versions of these forms arrived at the Parnassus hospital today, July 30, and will arrive at Mount Zion tomorrow, July 31. After Saturday, Aug. 1, forms dated earlier than July 2009 will not be accepted for orders and must be rewritten.

Please note:

  • Changes involve the targeted therapeutic range and subsequent dosing algorithm.
  • There are no changes in initial dosing recommendations from previous forms. Loading doses and initial therapeutic dose recommendations are unchanged.
  • For unfractionated heparin, the therapeutic range for VTE and ACS is now 50 to 74.9 seconds thus changing the dosing algorithm.
  • The therapeutic range for lepirudin is now 45 to 65 seconds.
  • The therapeutic range for argatroban is now 50 to 69 seconds.

For UCSF Childrens Hospital, where there are no specific anticoagulation order sets, hematology should be contacted for all heparin drips, lepirudin or argatroban orders for the next two weeks. All adult order sets on pediatric units must be exchanged.

If you have questions or problems about these forms or the new dosing algorithms, please call:

  • Comprehensive Hemostasis and Antithrombotic Service at pager 443-4023
  • Adult Hematology Consult Service at 443-4276
  • Pediatric Hematology Consult Service at pager 443-6966, Monday to Friday 8 a.m. to 5 p.m. and after hours at 476-3831

07/2009

TO: ALL UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, Clinical Laboratories
hamillt@labmed2.ucsf.edu

RE: METHOTREXATE TESTING

At the request of the adult Hematology-Oncology service, we have shifted the testing schedule for Methotrexate to earlier in the day so that results are available for discharge planning.

Effective immediately, results for samples received in the lab by 9 a.m. will be available by 10:30 a.m.

07/2009

TO: ALL UCSF CLINICAL EMPLOYEES

FROM: Tim Hamill, M.D.
Medical Director, Clinical Laboratories
hamillt@labmed2.ucsf.edu

RE: CYCLOSPORINE AND SIROLIMUS ASSAY CHANGES

Effective July 16, Clinical Laboratories at Parnassus and Mount Zion will modify the cyclosporine and sirolimus assays, which will cause results to increase by about 20 to 30 percent. The assay changes are being made because of the need to install replacement instrumentation.

Cyclosporine Assay -- Cyclosporine results will increase on average by about 30 percent mainly due to calibration differences between the new immunoassay (Abbott Architect) and the current HPLC assay. On laboratory reports, the upper limit of the ordinarily recommended therapeutic trough range also will be extended from 400 to 500 micrograms/L.

Sirolimus Assay -- Sirolimus results will increase on average by about 20 percent mainly due to better recovery of sirolimus from blood samples with the new immunoassay (Abbott Architect) versus the current immunoassay (Abbott IMx). Although sirolimus levels will increase due to the assay changes, the upper therapeutic range will be lowered slightly from 17 to 15 micrograms/L to bring it closer to agreement with generally recommended guidelines.

For the next six months, reminder comments will be attached to all cyclosporine and sirolimus results, noting the impact of these method changes and the date when the assays changed. If you have questions, please contact Dr. Ted Kurtz at Parnassus at kurtzt@labmed2.ucsf.edu.

06/2009

To: All UCSF Physicians

From: T.R. Hamill, M.D.
Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

Re: Ordering Chemistry Panels

Please DO NOT write orders for chemistry panels. The only exception is the electrolyte panel for sodium, potassium chloride and carbon dioxide (Na, K, Cl, CO2). UCSF Clinical Laboratories does not perform any other chemistry panels such as Chem 7, Chem 10, Chem 20 and the comprehensive metabolic panel.

Although panel tests may be offered at other institutions, it is well documented that they lead to test over-utilization and often result in "chasing" a test abnormality that is clinically inconsequential. Panels are not listed on our laboratory requisitions and do not exist in our test database. Writing orders for them creates problems for unit staff and lab employees who must determine what tests should be ordered, and can result in inappropriate tests performed and appropriate tests not performed.

Select only the tests required and order those individually. It doesn't take longer to do this and will result in better patient care.

Please share this with the residents and fellows in your departments.

Thank you.

06/2009

TO: UCSF PHYSICIANS AND NURSES

FROM: Joseph Musallam, C.L.S.
Hospital Phlebotomy Supervisor
Clinical Laboratories
joseph.musallam@clinlab.ucsfmedctr.org

RE: FILLING COAGULATION TUBES (LIGHT BLUE TOP)

This is a reminder that citrate coagulation tubes (with light blue tops) must be filled between the minimum and maximum fill lines to ensure accurate laboratory results. If a specimen is received with a level below the minimum line, it may be rejected by Clinical Laboratories. Tubes should not be filled past the maximum fill line, as illustrated in the picture below.

Hematology recently found over 20 tubes with blood quantities not sufficient (QNS) to conduct the tests. Some of these tubes were drawn by inpatient phlebotomists.

If you use a butterfly needle, draw about 1 cc to remove air from tubing, discard the first tube and then draw a second tube. Wait until the tube stops filling before removing it from the needle.

Check the blood level before you affix the patients label, according to protocol.

Fill indicator image

05/2009

TO: UCSF PHYSICIANS

FROM: Tim Hamill, M.D.
Medical Director, Clinical Laboratories
hamillt@labmed2.ucsf.edu

RE: LETTERS REGARDING PARATHYROID HORMONE ASSAY

A problem with the Julian date interpretation between computers resulted in incorrect test dates in letters you may receive regarding a PTH assay problem we encountered earlier this year for some patients. The date of the PTH test listed for these patients is incorrect in both the information to ordering physicians and the attached letters for patients.

Please disregard these letters, revised letters will be distributed shortly.

I apologize for this problem.

05/2009

TO: UCSF PHYSICIANS

FROM: UCSF Compliance Committee for Clinical Laboratories

RE: OFFICE OF INSPECTOR GENERAL, COMPLIANCE PLAN

As part of UCSF Compliance Committee for Clinical Laboratories' oversight 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:

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 at http://labmed.ucsf.edu/labmanual/mftlng-mtzn/account/reqs/mednecessity.html. The ordering physician is required to provide ICD-9 diagnosis codes that support the medical necessity of all tests ordered.

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 the lab manual at http://labmed.ucsf.edu/labmanual/mftlng-mtzn/test/info/2text2.html. For those tests for which non-mandatory reflex tests exist, reflex testing may be declined on the laboratory requisition.

A current Medicare lab fee schedule with CPT (current protocol terminology) codes is available upon request from each Clinical Laboratory. Clinical Laboratories consultation is also available and accessed by calling the main line for each Lab.

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 Tim Hamill, M.D., chair of the UCSF Compliance Committee for Clinical Laboratories, at (415) 353-1723.

04/2009

TO: UCSF PHYSICIANS

FROM: Tim Hamill, M.D.
Medical Director, Clinical Laboratories
hamillt@labmed2.ucsf.edu

Geo. F. Brooks, M.D.
Director, UCSF Microbiology Laboratory
geo.f.brooks@ucsf.edu

RE: SUBMITTING BODY FLUID SAMPLES FOR CULTURE

It has come to our attention that members of the house staff and others at the Parnassus and Mount Zion hospitals are submitting body fluid cultures in blood culture bottles ONLY. This is an inappropriate practice.

Body fluids (joint, abdominal, CAPD, pleural, pericardial, etc.) should be submitted as 10 ml in a sterile black-screw-top tube. If you want to inoculate blood culture bottles at the bedside, this should be done after adequately filling the black-top tube. The blood culture bottles can be submitted with the black-top tube, but the blood culture bottles are of secondary importance.

Submitting body fluid cultures in blood culture bottles only is inadequate because:

We cannot do a gram stain if the entire specimen is in the blood culture bottle, which greatly dilutes the specimen. This can result in a one-day, or longer, delay in obtaining important data.

We are unable to directly plant the original specimen on solid aerobic and anaerobic media, which can result in a delay in obtaining bacterial growth for evaluation. There are delays even when we subculture the blood culture bottles on arrival in the laboratory.

In a mixed infection, when the specimen is inoculated into a blood culture bottle, the more hardy organisms might out grow the others obscuring the truly important bacteria.

When fluids are collected in a sterile tube, we routinely inoculate about 10 ml of the specimen into a 100 ml bottle containing a highly enriched broth made especially for UCSF, which probably works better than blood culture bottles.

Laboratories at other institutions should have some of the original specimens for reasons stated above. We know of no other institution that uses large volume bottles of enriched medium to culture body fluids. At other institutions, use of blood culture bottles for body fluid cultures might help increase the culture yield, but probably not at Parnassus or Mount Zion.

If you have any questions, please contact Dr. Geo. Brooks, director of the UCSF Microbiology Laboratory, at geo.f.brooks@ucsf.edu.

04/2009

TO: UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, Clinical Laboratories
hamillt@labmed2.ucsf.edu

RE: FALSELY ELEVATED PTH RESULTS

Due to a defective lot of reagents supplied by the manufacturer of the PTH assay used at the Parnassus and Mt Zion campuses, routine PTH results in the range of 0 200 ng/L reported between Nov. 19 and March 31 were falsely elevated by about 25 percent.

Because the reagent problem affected PTH values encompassing the normal reference range of 12 65 ng/L, it could have led to an incorrect diagnosis in some patients. The reagent problem did not affect the intraoperative PTH assays and did not appear to impact PTH results above 200 ng/L.

The reagent problem has been fixed by the assay manufacturer (Siemens Immulite 2000) and Clinical Laboratories began using the new reagents as of April 1.

We will send alert notices to all physicians who ordered PTH tests between Nov. 16 and March 31 with results in question and a comment will be appended to the affected results in the electronic medical record. Physicians who ordered PTH tests that were affected during the time in question will be notified on how to order repeat PTH testing at no charge to the patient.

If you have any questions, please contact Dr. Ted Kurtz, chief of Clinical Chemistry. at kurtzt@labmed2.ucsf.edu.

02/2009

To: UCSF Physicians

From: Timothy Hamill, MD
Medical Director, Clinical Laboratories
hamillt@labmed2.ucsf.edu

TEST AND PROCEDURAL CHANGES

New CMV DNA Test

Clinical Laboratories will begin performing a quantitative viral load test for cytomegalovirus (CMV) DNA using an in-house PCR method for blood samples, effective Monday, March 9. Currently, samples are sent to an outside lab. The new test will be performed on EDTA plasma on Mondays, Wednesdays and Fridays and is capable of accurate quantitation between 1000 and 5 x 10e6 copies/ml.

The assay can reliably detect CMV DNA to a limit of about 100 copies/ml. Samples with DNA detected below 1,000 copies/ml will be reported as "Detected, < 1,000 copies/ml." There is no exact number indicative of disease but consecutive tests trending upwards and high values are suggestive.

Prior results from outside labs may differ somewhat from UCSF results due to differences in test methods. CMV PCR on non-blood samples will continue to be sent to outside labs.

6/2008

To: UCSF Physicians and Nurses

From: Timothy Hamill, MD
Director of Clinical Laboratories

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@Labmed2.ucsf.edu

5/2008

To: UCSF Clinical Staff

From: Timothy Hamill, MD
Director of Clinical Laboratories

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@Labmed2.ucsf.edu).

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:

  • 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 at http://labmed.ucsf.edu/labmanual/mftlng-mtzn/account/reqs/mednecessity.html.
  • 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 the lab manual at http://labmed.ucsf.edu/labmanual/mftlng-mtzn/test/info/2text2.html. For those tests for which non-mandatory reflex tests exist, reflex testing may be declined on the laboratory requisition.
  • 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 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@clinlab.ucsfmedctr.org.

5/2008

TO: UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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.

  1. After finding a suitable venipuncture site, release tourniquet and use pad with 70 percent alcohol, rubbing vigorously for 60 seconds to cleanse a 5 cm circular area.
  2. Apply 10 percent iodine in a circular motion, beginning at the center of the selected site. Air dry.

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.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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:

  • A 13-character donor identification instead of a seven-character ID.
  • Changes to placement of product description, e.g. "irradiated" or "negative for antibodies to CMV."

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.

New Product Label

4/2008

TO: UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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:

  • Prolactin levels will run about 20 percent to 25 percent lower.
  • Progesterone levels below 35 micrograms/L will run about 20 percent higher.  Progesterone levels above 35 micrograms/L will run about 10 percent lower.
  • FSH and LH levels will not be significantly affected.

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@Labmed2.ucsf.edu.

3/2008

TO: UCSF PHYSICIANS AND NURSES

FROM: Lawrence Drew, M.D., Ph.D.
Director, UCSF Virology Laboratory
lawrence.drew@clinlab.ucsfmedctr.org

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:

3/2008

TO: UCSF Clinical Staff

FROM: Tim Hamill, M.D.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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@labmed2.ucsf.edu.

2/2008

TO: UCSF PHYSICIANS

FROM: Tim Hamill, M.D.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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@labmed2.ucsf.edu or contact Dr. William Karlon, director of the lab's Immunology section, at 353-4721 or william.karlon@ucsf.edu.

1/2008

TO: UCSF PHYSICIANS

FROM: Tim Hamill, M.D.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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

  • Adrenocorticotropic hormone
  • Antidiuretic Hormone
  • Ammonia
  • Antimicrobicidal Activity (versus the patient's own organism)
  • C1 Esterase Inhibitor Deficiency Panel
  • Free Catecholamines, Fractionated, plasma
  • Fatty Acids, Nonesterified
  • Gastrin
  • Glucagon
  • Homocysteine, Total
  • Lactate, CSF
  • Red Cell Osmotic Fragility
  • Parathormone Related Protein
  • Porphyrins, Fractionated, RBC
  • Pyruvate
  • Uroporphyrinogen I Synthase, RBC
  • Vasoactive Intestinal Peptides
  • Metanephrines, plasma
  • Proinsulin
  • Oxalic acid, plasma
  • Busulfan
12/2007

TO: UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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@labmed2.ucsf.edu. Thank you.

10/2007

TO: UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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:

  • The assay change will cause triglyceride results to increase about 20 percent (median 21 percent, with 25th to 75th percentile range of 18 percent to 24 percent).
  • The triglyceride increase will cause calculated LDL cholesterol results to decrease about 5 percent (median 5 percent, with 25th to 75th percentile range of -4 percent to -8 percent).

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@labmed2.ucsf.edu.

10/2007

TO: UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

Geo. F. Brooks, M.D.
Chief, Microbiology Section
Clinical Laboratories
Geo.F.Brooks@ucsf.edu

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.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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@Labmed2.ucsf.edu.

6/2007

TO: UCSF PHYSICIANS AND NURSES

FROM: Richard A. Jacobs, M.D., Ph.D.
Chief, Clinical Infectious Diseases
jacobsd@medicine.ucsf.edu

Peggy S. Weintrub, M.D.
Chief, Pediatric Infectious Diseases
pweintru@peds.ucsf.edu

Geo. F. Brooks, M.D.
Chief, Microbiology Section, Clinical Laboratories
geo.f.brooks@ucsf.edu

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.
Medical Director, UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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@labmed2.ucsf.edu

NURSE MANAGERS: Please distribute this message to your staff.

5/2007 TO: UCSF PHYSICIANS

FROM: Tim Hamill, M.D.
Medical Director
UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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.
Medical Director
UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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.
Medical Director
UCSF Clinical Laboratories
hamillt@labmed2.ucsf.edu

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:
* Males 3.3-19.7 micrograms/L
* Females 3.2-29.1 micrograms/L

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.
Chief, Microbiology Section, Clinical Laboratories
Geo.F.Brooks@ucsf.edu

W. Lawrence Drew, M.D., Ph.D.
Director, Clinical Virology Laboratory
lawrence.drew@clinlab.ucsfmedctr.org

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
those time-consuming calls.

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 lab computer system and are available in STOR and UCare. These changes were discussed with and approved by the Infectious Disease Management Program.

The following results will be reported by phone:

  • Stat smears
  • Blood cultures - Only gram stain results from the first positive blood culture
    for each patient
  • Positive CSF cultures
  • Sterile site gram stains - Only positive CSF and pericardial fluid stains
  • Gonococcus from all sources
  • Group A streptococci - Only from sterile sites
  • Group B streptococci - From patients in Labor and Delivery and the Nursery
  • Stool cultures positive with E coli O157:H7, Vibrio cholerae or Salmonellae that cause enteric fevers (e.g., S. Typhi)
  • Potential bioterrorism agents
  • First B. cepacia isolate on a CF patient
  • Positive PCR for B. pertussis, HSV, VZV or parvovirus B19
  • Mycobacteriology - First positive AFB smear; first positive AFB culture if smear negative or no smear; first isolate of M. tuberculosis; positive M. tuberculosis sputum PCR (SFDPH)
  • Mycology - Biphasic fungi (e.g., Coccidioides immitis) and Zygomycetes (e.g., mucormycosis); positive CSF cryptococcal antigen
  • Parasites - Any blood parasite (e.g., malaria) and parasites from CSF
  • Virology - Influenza A and B on weekends and positive C. difficile toxin
    assays

Please let us know if you have any questions or concerns about this change.

12/2006

CUSTOMER SURVEY REMINDER

This is a reminder to please complete the customer satisfaction survey
available at http://www.zoomerang.com/survey.zgi?p=WEB225TJHHX298

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.

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.

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
Medical Director
UCSF Clinical Laboratories

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,
galactose or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. There have been reports of the inappropriate administration of
insulin and consequent life-threatening or fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can
go untreated if the hypoglycemic state is masked by false elevation of glucose readings.

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
with this device in patients who are receiving oral xylose, galactose, maltose or pharmaceuticals that may contain these substances. The latter appear to be primarily immune globulin preparations and dialysis solutions.

A preliminary listing of U.S. products that may cause glucose test interference can be found on the web at
http://www.fda.gov/cber/safety/maltose110405.htm.

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.

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
http://pangloss.ucsfmedicalcenter.org/LabMan/LMRPweb/mednecessity.html.
For those tests for which non-mandatory reflex tests exist, reflex testing may be declined on the laboratory requisition.

* 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.

  • <15 GPL units is negative
  • 15 - 20 GPL units is indeterminate
  • 20 - 80 GPL units is a moderate positive
  • >80 GPL units is a high positive

ACLM (IgM anti-cardiolipin) is reported in MPL units.

  • <12.5 MPL units is negative
  • 12.5 - 20 MPL units is indeterminate
  • 20 - 80 MPL units is a moderate positive
  • >80 MPL units is a high positive

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

  • When -- Jan. 24

  • New Assay -- DPC Immulite 2000 chemiluminescent assay

  • Impact -- Growth hormone results will read about 40 percent to 50 percent higher with the new assay and reference ranges will increase accordingly due to use of different antibody reagents and calibrator materials. The new assay is standardized relative to the World Health Organization (WHO) 1st IS 80/505 reference preparation. Well defined, normative values for stimulation tests are not available for either the previous assay or the new assay. However, cutoffs that might used to interpret the results of stimulation tests should be greater than with the previous Nichols assay and should more closely approximate cutoffs that have been traditionally used in stimulation testing.

IGF-1

  • When -- Jan. 24

  • New Assay -- Immulite 2000 chemiluminescent assay

  • Impact -- On average, IGF-1 results will read approximately 10 percent lower with the new assay. Results will be reported with new reference ranges based on studies from the manufacturer in approximately 800 healthy children and 700 healthy adults.

Thyroglobulin

  • When -- Feb. 1

  • New Assay -- Immulite 2000 chemiluminescent assay

  • Impact -- On average, thyroglobulin results will read about 35 percent to 40 percent lower with the new assay although some samples may show greater or lesser variation between assays. Therefore, differences in thyroglobulin levels between earlier measurements with the previous assay and later measurements with the new assay should be interpreted with caution and new thyroglobulin baselines may need to be established with the new assay. The functional sensitivity of the assay defined as the lowest value that can be measured in thyroglobulin-negative antibody serum with a 20 percent coefficient of variation has been estimated to be 0.9 microgram/L. Results below this level will be reported as less than 0.9 microgram/L. Note that thyroglobulin antibodies can interfere in an unpredictable fashion with thyroglobulin assays and test results must be interpreted with extreme caution in their presence.

Thyroglobulin Antibody

  • When -- Feb. 1

  • New Assay -- Immulite 2000 chemiluminescent assay

  • Impact -- The cutoff for presence of thyroglobulin antibodies in the new assay is greater than for the old assay and is set at 20 IU/mL. Results greater than or equal to 20 IU/ml will be flagged as positive.

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.

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

  • Lab -- Quest Diagnostics

  • Method -- LC-MS

  • Target Range -- Trough levels per Clinical Pharmacy = 5-15 ng/mL (mg/L) depending on time from transplant and other immunosuppressant therapy

  • Sample -- 3 mL EDTA whole blood (1 mL min.)

  • Result Availability -- 3 to 7 days

New Testing Method effective Jan. 18

  • Lab -- UCSF Clinical Laboratories, Chemistry

  • Method -- EIA following an extraction

  • Target Range -- Trough levels = 6 - 17 mg/L (adjusted slightly upwards to account for change in assay method)

  • Sample -- 3 mL EDTA whole blood (0.5 mL min.)

  • Result Availability -- 1 to 2 days depending on receipt of sample. Samples received in the lab by noon Monday to Friday and by 10 a.m. on weekends and holidays will be reported by 4 p.m. that day.

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.

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