TO: UCSF PHYSICIANS AND NURSES FROM: Steve Miller, M.D.
Director, UCSF Clinical Microbiology Laboratory
steve.miller@ucsfmedicalcenter.org

RE: UPDATE ON ANAEROBIC BLOOD CULTURE BOTTLE SHORTAGE

Materiel Services now has an adequate supply of anaerobic SN bottles (purple-top). The manufacturer has moved to an allocation process to supply customers based on usage. All units should be stocked with kits containing one aerobic FA bottle (green-top) and one anaerobic SN bottle (purple-top).

Please use both bottles in each set, filling each bottle with the recommended amount of blood, typically 5-10 mL for adult patients. If submitting peritoneal fluid in blood culture bottles, use both bottles in each set, filling each bottle with the recommended amount of fluid.

Units needing blood culture bottle kits should contact Materiel Services. If the inventory of blood culture bottles reaches a level that is below the medical center's needs, a product update will be issued to explain the steps that will be taken to alleviate the effects.

Please contact the Microbiology Laboratory at 353-1268 if you have any questions or concerns.

TO: UCSF PHYSICIANS AND NURSES FROM: Steve Miller, M.D.
Director, UCSF Clinical Microbiology Laboratory
steve.miller@ucsfmedicalcenter.org

RE: SHORTAGE OF ANAEROBIC BLOOD CULTURE BOTTLES

There is a critical shortage of anaerobic blood culture bottles due to production issues with the UCSF supplier. We do not know how long this shortage will last and are taking steps to alleviate the effects.

Materiel Services has consolidated existing blood culture bottles and is preparing kits for distribution. Some units will be stocked with kits containing two aerobic blood culture bottles rather than one aerobic and one anaerobic. In kits containing one aerobic and one anaerobic bottle, the anaerobic bottle may be either the anaerobic SN bottle (purple-top) or a substitute product, the anaerobic FN bottle (orangeÐtop).

Please continue to use both bottles in each set, filling each bottle with the recommended amount of blood, typically 5-10 mL for adult patients. If you're submitting peritoneal fluid in blood culture bottles, use both bottles in each set, filling each bottle with the recommended amount of fluid.

Units needing blood culture bottle kits should contact Materiel Services. We will triage bottles to provide anaerobic bottles to high-risk units when possible. Keep in mind that most organisms causing sepsis will grow in aerobic blood culture bottles and that culturing an adequate volume of blood is critical for blood culture yield. Please contact the Microbiology Laboratory at 353-1268 if you have any questions or concerns.

TO: INPATIENT NURSES FROM: Enrique Terrazas, M.D.
Chief, Laboratory Information Systems
enrique.terrazas@ucsf.edu

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

RE: POINT-OF-CARE SYSTEM DOWNTIME

The Point-of-Care information system, or RALS sever, will be down due to planned upgrades and maintenance on Wednesday, March 6 between 10 and 10:30 a.m. During the 15-to-30- minute server downtime, point-of-care instruments, such as glucose meters and iSTAT instruments, will not transmit results to APEX.

If you dock a point-of-care instrument and do not see the results in APEX, try re-docking at the end of the downtime window.

If you have any questions, please contact me at enrique.terrazas@ucsf.edu or 514-8931.

Please share this information with your colleagues. Thanks.

TO: UCSF INPATIENT NURSES

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


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

RE: POINT-OF-CARE SYSTEM DOWNTIME

The Point-of-Care information system (RALS sever) will be down for about 15 to 30 minutes for planned upgrades and maintenance on Saturday, Feb. 9. This downtime will occur sometime during the period of 11 p.m. to 3 a.m.

While the server is down, point-of-care instruments (glucose meters, iSTAT instruments) will not transmit results to APEX. If you dock a point-of-care instrument, and do not see the results appear in Apex, try re-docking at the end of the downtime window.

If you have any questions regarding the downtime, please send an email to enrique.terrazas@ucsf.edu.

TO: ALL UCSF PROVIDERS
FROM: Scott Kogan, M.D.
Head of Clinical Hematology Laboratory
scott.kogan@ucsf.edu

RE: VACUTAINER TUBE RECALL

Becton Dickinson and Co. recently recalled a lot of Vacutainer® 2.7ml Plus Citrate Blood Collection Tubes, which were in use at UCSF Medical Center from August to November this year. We have worked with Materiel Services to remove the affected lot — BD 363083, Lot 2180434.

The affected tubes may have falsely elevated the aPTT.

If you are aware of a patient you cared for in whom such a false elevation might have contributed to a clinically significant adverse event, please contact me at scott.kogan@ucsf.edu or the head of adult Non-malignant Clinical Hematology, Dr. Andrew Leavitt, at andrew.leavitt@ucsf.edu.

We believe all of the affected tubes have been removed from the medical center, but if you are aware of any remaining tubes, please return them to Materiel Services to the attention of Mike Reinert.

TO: ALL UCSF PROVIDERS FROM: Steve Miller, M.D.
Section Director, UCSF Microbiology Laboratory
steve.miller@ucsfmedctr.org

RE: CHANGE IN RESPIRATORY VIRAL TEST

On Monday, Dec. 3, UCSF Medical Center will discontinue the Respiratory Virus Antigen (DFA) test and replace it with the Rapid Influenza A/B/RSV PCR test.

Rapid Influenza A/B/RSV PCR (Flu/RSV PCR) is highly sensitive. Results are typically available in four to six hours, similar to the DFA test. It is intended for the diagnosis of symptomatic patients and ONLY runs on nasopharyngeal (NP) swab samples. Flu/RSV PCR detects all viral strains but does not provide subtype information. All currently circulating influenza strains are sensitive to oseltamivir (Tamiflu®).

For expanded respiratory viral testing, the Respiratory Viral Panel PCR (RVP) is available and includes influenza A and B, RSV A and B, adenovirus, parainfluenza types 1, 2 and 3, metapneumovirus and rhinovirus. It has a turnaround time of about three days and can be run on NP swab samples and other respiratory sample types (BAL, bronchial wash, ET aspirate, etc.). RVP testing is primarily indicated for patients in whom expanded respiratory viral testing would change clinical management (e.g., immunocompromised, transplant, ICU patients).

RVP and Flu/RSV PCR can be ordered simultaneously and performed from the same NP swab.

Key Changes

• DFA replaced with Flu/RSV PCR.
• Only NP swab samples used for Flu/RSV PCR.
• Other respiratory sample types and NP swab samples from immunocompromised or ICU patients can be tested with the expanded RVP.

Respiratory viral testing algorithm

TO: ALL UCSF PROVIDERS

Please see the attached memo regarding duplicate bloodwork orders entered in APeX by different providers for the same patient . These duplicate orders are causing significant problems for the lab and for our patients. While APeX alerts you to existing test orders and asks if you would like to add yourself to the recipient list for the results, many providers are ignoring the message. As a result, the lab and phlebotomists are overwhelmed with duplicate orders that need to be reconciled, and our patients get excess testing or tests are missed. In order to mitigate the burden on our patients and the lab, the lab will now be combining duplicate laboratory orders from different providers. The attached documents details the effects of this change and provide tips on ordering. Important points: When orders are combined, all of the results for the draw are sent to all providers. Consequently, you may receive results for your patient in addition to those that you ordered. There is no way to avoid this happening. As always, you should exercise clinical judgment in deciding whether to act on a test result that you see but did not order. You are not required to act on the results that you did not order. Hopefully, this situation will not create significant extra work for you or your practice, but it is the only way to eliminate the excess testing burden on our patients and the chaos in the lab. If you do not specify an "expected" date for a study, the lab will assume that you want it done as soon as the patient presents to the lab. If you want a specific date, please specify the date in the order. Labs that are due <7d from the date that the patient presents to the lab and have "approx." checked in the order details will be drawn and combined with the other labs drawn at that time. In order to avoid unnecessary return visits to the lab, please always check "approx." if the specific day of the test is not critical. If you have any questions or concerns with this change, please contact Dr. Hamill (HamillT@labmed2.ucsf.edu) for further information.

Michael Blum
Josh Adler
Tim Hamill

Combining Orders Memo
Ordering Outpatient Labs
Ordering Outpatient Labs, Brief

TO: ALL UCSF PROVIDERS

FROM: Mima Geere, M.D., M.S.
Pathology Resident

T.R. Hamill, M.D.
Director, UCSF Clinical Laboratories

Betty Yalich, R.N.
Administrative Director, UCSF Clinical Laboratories

RE: DEVELOPING UTILIZATION GUIDELINES

To ensure appropriate utilization of resources, Laboratory Medicine is embarking on a program to work with clinical divisions to develop testing guidelines. We will collect data from APEX regarding test-ordering practices, particularly with regard to send-out tests, that we can use as a starting point in developing guidelines with selected services.

Once the mutually agreed guidelines are adopted, monitoring of test orders will allow us to provide feedback to departments regarding test utilization to assist in educating the clinical staff on the evidence-based testing.

If there are department-specific champions who might be interested in working with us on developing diagnostic guidelines for send-out testing, please contact us. We can work together to come up with mutually acceptable methods to decrease overall costs of send-out tests while still meeting your departments send-out testing needs.

If interested, please contact Dr. Mima Geere by email at mima.geere@ucsfmedctr.org.

Thank you for your help with this initiative.

TO: UCSF PHYSICIANS AND NURSES

FROM: Theodore Kurtz, M.D.
Director of Clinical Chemistry

Deborah French, Ph.D.
Asst. Director, Clinical Chemistry
Director of Mass Spectrometry

RE: ULTRASENSITIVE TESTOSTERONE TESTING

Effective May 1, the UCSF Clinical Laboratory at China Basin will perform ultrasensitive total testosterone testing in-house by an LC-MS/MS method instead of sending samples to Quest. Sample requirements for the new assay will be the same as the older Quest assay (e.g. 1 mL serum preferred, 0.5 mL minimum)

This change will have the following impact on test results:

Above 40 ng/dL, total testosterone levels will run about 20 percent higher in the new assay compared to the older Quest assay, owing to differences in assay calibration.

The assay reference ranges will be updated to reflect recent normal range studies in large numbers of pediatric and adult subjects performed with an LC-MS/MS testosterone assay that is closely calibrated to the new assay.

For the next three months, a comment will be attached to the results noting the date of the assay change. If you have questions, please contact Deborah French, director of Mass Spectrometry, Division of Clinical Chemistry at deborah.french@ucsf.edu.

TO: UCSF PHYSICIANS

FROM: Ashok Nambiar, M.D.
Director, UCSF Transfusion Service
Clinical Laboratories
ashok.nambiar@ucsfmedctr.org

RE: MASSIVE TRANSFUSION PROTOCOLS

The Blood Bank at the Parnassus hospital has implemented blood product order and issue protocols to support massively bleeding patients. Please review the attachment for key elements of the massive transfusion protocols (MTP) as well as updates to the process for emergency release of blood products. Please distribute this information to your staff.

MTP will be available shortly at Mount Zion. For now, massively bleeding patients will continue to be supported with existing protocols for the emergency release of specified blood products. Please order products as needed.

If you have any questions, please contact me by phone at 353-1311 or by email at ashok.nambiar@ucsfmedctr.org, or contact the UCSF Blood Bank at 353-1313.

TO: PHYSICIANS, NURSES, ADVANCED HEALTH PRACTITIONERS

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

RE SHORTAGE OF REAGENTS FOR SERUM KETONE ASSAY

Due to a manufacturer's shortage of serum ketone assay reagents, it is necessary to temporarily send test requests for serum ketones to an outside laboratory, which will cause substantial delays in turnaround time. This delay in serum ketone results will continue until the reagent shortage is resolved or a new assay is implemented.

The serum ketone results will be reported as beta-hydroxybutyrate, which typically accounts for about 75 percent of the ketone bodies in blood.

Please contact Dr. Ted Kurtz, chief of Clinical Chemistry, at kurtzt@labmed2.ucsf.edu or Joanne Wong, supervisor of the Chemistry Laboratory, at joanne.c.wong@ucsfmedctr.org, if you have any questions.

TO: UCSF PHYSICIANS

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

RE CHEMISTRY ANALYZER UPGRADE

On Thursday, Dec. 15, and Friday, Dec. 16, Clinical Laboratories will upgrade its chemistry analyzers. This will require that we shut down some of our automated processes and revert to manual sample processing on limited equipment. We will begin switching out analyzers at 10 a.m., Thursday so we can test and report inpatient morning draw samples before the analyzer downtime commences.

During these two days, we ask that you please limit the volume of test requests and refrain from calling the chemistry lab for results.

Results will be available electronically in UCare, STOR and Apex as soon as they are complete. Laboratory staff will make every effort to accommodate any testing required for patient care but our resources will be limited. Turnaround times for some tests may be longer than usual.

Laboratory staff will continue to phone all critical results.

If you have any questions, please contact Dr. Ted Kurtz, director of Clinical Chemistry at kurtzt@labmed2.ucsf.edu or Joanne Wong, supervisor in the Chemistry Service of Clinical Laboratories, at joanne.c.wong@ucsfmedctr.org.

TO: PHYSICIANS, NURSES, ALLIED HEALTH PROFESSIONALS

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

RE: CLARIFICATION NEW NCPL BLOOD GAS REQUISITIONS

Please note that the new blood gas requisition forms for the Neonatal Clinical Physiology Laboratory (NCPL) pertains only to the Parnassus hospital. The standard Clinical Laboratory STAT requisition is used at Mount Zion for ordering blood gas testing, and no modifications are required for that requisition.

New blood gas requisition forms for the Neonatal Clinical Physiology Laboratory (NCPL) were distributed at Parnassus today, Nov. 10. The new Form 740-008 includes a prompt for the date of the collected sample, which is a required element for all requisitions.

The old requisition form did not include a prompt to enter the date (only time) of the collected sample. Please discard all old requisitions upon receipt of the new ones. If using the old form, please include the date as well as the time the specimen was collected to ensure that the NCPL processes only those samples within the stability time period.

If you have questions regarding this change, please contact me at 514-8931.

TO: PHYSICIANS, NURSES, ALLIED HEALTH PROFESSIONALS

FROM: Enrique Terrazas, M.D.
Director, Neonatal Clinical Physiology Laboratory
Enrique.Terrazas@ucsf.edu

RE: NEW NCPL BLOOD GAS REQUISITIONS

New blood gas requisition forms for the Neonatal Clinical Physiology Laboratory (NCPL) will be distributed at Parnassus on Thursday, Nov. 10. The new Form 740-008 includes a prompt for the date of the collected sample, which is a required element for all requisitions.

Current requisition forms do not include a prompt to enter the date (only time) of the collected sample. Please discard all old requisitions upon receipt of the new ones. For the current forms, please include the date as well as the time the specimen was collected to ensure that the NCPL processes only those samples within the stability time period.

If you have questions regarding this change, please contact me at 514-8931.

TO: UCSF PHYSICIANS AND NURSES

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

RE: PERITONEAL FLUID CULTURES

Please review the updated guidelines below for submitting peritoneal fluid - such as abdominal fluid, ascitic fluid and dialysis fluid - for bacterial culture:

• First inoculate 10 ml into each of the aerobic and anaerobic blood culture bottles at the patients bedside for optimal growth and recovery of organisms. Divide the fluid equally among the bottles if < 20 ml is obtained.
• Additional fluid may be submitted in a sterile tube, which allows for gram stain to be performed and faster identification of bacteria present at high concentrations.

These guidelines differ from those previously recommended in 2009.

If you have any questions, contact me at steve.miller@ucsfmedctr.org or 353-9630.

TO: ALL UCSF PROVIDERS

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

RE: CLINICAL LABS COMPUTER DOWNTTIME

On Thursday, Sept. 15, the Clinical Laboratories computer will be down for about four hours during which there will be no electronic reporting of test results to Apex, UCare, Picis and STOR/CDS. This downtime will run from 8:30 p.m. to about 12:30 a.m. the next day.

As the lab is highly computer dependent, testing and reporting capabilities will be severely impacted and we will activate our computer crash procedures. During the downtime, the available test menu will be restricted to those assays 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. Product availability, however, will not appear in Apex, UCare, Picis and STOR/CDS. Samples collected for routine testing or send-out testing will be processed and held until after the downtime on Friday.

During the downtime, the lab cannot accept requests to add-on tests. Add-ons will be honored until 8 p.m. and will be accepted after the computer is fully operational.

Laboratory staff will report all Emergency Department, OR/PACU and Critical Care results by phone during the downtime.

We realize that this will pose a significant burden to all hospital staff. We appreciate your patience and assistance to limit, as much as possible, the volume of test requests and phone calls to the lab. The laboratory staff will make every effort to accommodate any testing required for patient care but our resources will be limited.

Please contact Clinical Labs at 353-1667 if you have any urgent patient care issues during the downtime.

TO: UCSF PHYSICIANS AND NURSES

FROM: Dr. Steve Miller
Director, Microbiology Section
UCSF Clinical Laboratory at China Basin
steve.miller@ucsfmedctr.org

RE: BLOOD CULTURE COLLECTION VOLUMES

Please be sure to draw the recommended quantity of blood when providing samples to Clinical Laboratories for blood culture. Larger volumes of blood increase the yield of true positive cultures.

After monitoring collected blood volumes, we found that a significant percentage of bottles contained less than the recommended volume. Lower volumes are sometimes being used to inoculate the aerobic FA (light green top) bottle as compared to the anaerobic SN (purple top) bottle. It is imperative that the aerobic FA are not underfilled because most bacteremic episodes are due to aerobic organisms.

For adult patients, perform venipuncture and collect 20 mL of blood (10 mL for each bottle). If less than 20 mL is obtained, divide volume in half for each culture bottle.

For pediatric patients, collect blood sample amount according to weight-based scale in blood culture collection instructions, and divide volume in half for each culture bottle. The anaerobic SN bottle may be omitted in neonates and other infants, if less than 2 mL is collected.

Please see the following instructions:

Peripheral Blood Culture Draw
http://labmed.ucsf.edu/labmanual/mftlng-mtzn/test/info/micro-peripheral_blood_culture_dttp.pdf

Central Line Blood Culture Draw
http://labmed.ucsf.edu/labmanual/mftlng-mtzn/test/info/micro-Line_blood_culture_dttp.pdf

If you have questions, contact me at steve.miller@ucsfmedctr.org.

TO: ALL UCSF PROVIDERS

FROM: Tim Hamill, M.D.
Director, Clinical Laboratories

Steve Polevoi, M.D.
Director, Emergency Department

RE: TROPONIN I TESTING IN EMERGENCY DEPARTMENT

Effective Monday, July 25, the UCSF Emergency Department will begin performing Troponin I as a point-of-care test, using the iStat handheld device. This will allow for more rapid identification of patients with AMI, admission and initiation of therapy.

Results of the iStat Troponin I test will be electronically interfaced and will be available in STOR, UCare and Apex.

Please note that the 99th percentile normal cut-off for the iStat Troponin I test is < 0.09 μg/L (mcg/L), which is slightly higher than the < 0.05 μg/L normal range for the central laboratory test.

Additionally, the IStat Troponin I test gives different absolute values compared to the Troponin I test performed in the central lab. The results of the iStat and central laboratory Troponin I assays should NOT be directly compared.

If additional Troponin I testing is desired after a patient is admitted, samples should be submitted to the central laboratory to establish a new baseline for trending.

If you have questions about the iStat Troponin I test, please contact Dr. Theodore Kurtz, director of Clinical Chemistry at 353-1979.

TO: PHYSICIANS, PHARMACISTS, NURSES, ALLIED HEALTH PROFESSIONALS

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

RE: NEW aPTT TESTING REAGENT AND FORMS

The aPTT (activated partial thromboplastin time) testing reagent used by Clinical Laboratories will change, effective Wednesday, July 20. This will result in a narrower aPTT target for therapeutic anticoagulation with heparin. The following forms have been modified to adjust for this change:

Order Form 105-0236 Children's Hospital Unfractionated Intravenous Heparin Therapy Order Form 734-033Z Intravenous Heparin Order Form 734-038 Cardiology Antithrombotic Therapy (adults)

New forms will be distributed to the inpatient units and Emergency Department on Monday, July 18, and can be used immediately. If patients on heparin drips on July 20 are not written for drip using the new forms dated June 2011, you will be contacted for new orders.

Order sets for Lepirudin, Argatroban and Bivalirudin are not affected.

If you have questions regarding these changes, please contact pharmacist Anna Seto at 353-9868 or anna.seto@ucsfmedctr.org.

Dear Colleagues,

We are writing to clarify the requirements to document the need for clinical diagnostic studies at UCSF Medical Center.

To comply with the Centers for Medicare and Medicaid Services (CMS), all requests for laboratory studies require one of the following:

• A requisition personally signed by the attending physician.
• Documentation in the patient's medical record that states the studies requested and the medical indications or reasons for each study.

If the attending physician is not able to personally sign the requisition, the attending physician must indicate the studies ordered and provide a description of the medical necessity for each study as part of the documentation in the medical record.

If this information is documented by a resident physician, the attending physician must authenticate the indications in the medical record.

Additional information on signature requirements is available on the CMS website at https://www.cms.gov/transmittals/downloads/R94BP.pdf

If you have any questions about the requirements and how they should be documented, please contact Ellen Lingar in the Compliance Office at 514-2575 or via email at lingare@medsch.ucsf.edu.

Thank you!

Neal Cohen, MD, MPH, MS
Interim Vice Dean, Academic Affairs

Tim Hamill, MD
Director, UCSF Clinical Laboratories

Jim Herron
Interim Compliance Officer

TO: UCSF PHYSICIANS

FROM: UCSF Compliance Committee for Clinical Laboratories

RE: OFFICE OF INSPECTOR GENERAL, COMPLIANCE PLAN

As part of UCSF Compliance Committee forClinical 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-tzn/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 fromeachClinical Laboratory. Clinical Laboratories consultation isalsoavailableand 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 Whistleblower Coordinator at 502-2810 or by calling the Universitywide Whistleblower Hotline at (800) 403-4744.

If you have any questions regarding this memo, please contact Dr. Tim Hamill, chairman of the UCSF Compliance Committee for Clinical Laboratories, at (415) 353-1723.

Memo to UCSF Infectious Disease and Infection Control Providers:

RE: Changes in Interpretive Criteria for Enterobacteriaceae Susceptibility Testing

Beginning June 1, 2011 UCSF will apply Clinical and Laboratory Standards Institute (CLSI) lowered breakpoints for resistance testing on Enterobacteriaceae species with certain cephalosporins and carbapenems. This will allow for improved detection of isolates containing resistance genes that may test as susceptible using the old breakpoints.

* Not routinely reported at UCSF

Clinical testing for extended-spectrum beta lactamases (ESBL) and carbapenemase production (modified Hodge test) by these organisms will no longer be necessary. These tests will remain available for infection control purposes only.

Please contact the UCSF Microbiology Laboratory with any questions.

Steve Miller
Director, UCSF Clinical Microbiology Laboratory
Steve.Miller@ucsfmedctr.org

TO: All UCSF Clinical Staff
FROM: Tim Hamill, M.D., Medical Director, Clinical Laboratories
Theodore Kurtz, M.D., Director Clinical Chemistry
RE: Alert About Potential for Erroneous Electrolyte Results (Na+, K+, Cl-, Ca++)

The manufacturer of the instruments that are used to measure electrolytes in the Clinical Laboratories on Parnassus has requested that we distribute the attached letter (click here to view) describing reports they have received about erroneous results for sodium, potassium, chloride, and calcium in some patients.

Frequency of the problem

Over the past 16 months, the instrument manufacturer (Beckman Coulter) has received 80 reports of sporadic instances of erroneous electrolytes from a worldwide base of 1,598 instruments used to generate tens of millions of electrolyte tests each year. The frequency of erroneous results is unknown but appears to be extremely low compared to the total volume of electrolyte tests performed on these analyzers worldwide.

Status of electrolyte testing at UCSF

The Parnassus Clinical Laboratories has been using the Beckman analyzers for 10 years and has not experienced an unusual frequency of erroneous electrolyte results on these instruments. The Mt Zion Clinical Laboratories uses different instruments that were not included in this alert.

Recommendation for clinicians

Please be vigilant for potentially erroneous electrolyte results. As with any laboratory test, please ask the Clinical Laboratory to repeat any results that appear suspicious or incongruent with the clinical picture.

For further questions regarding this issue, please contact Dr. Ted Kurtz (KurtzT@Labmed2.ucsf.edu) in the Chemistry Laboratory. For questions about specific samples that you would like repeated, please call the laboratory at 353-1667 and ask to be transferred to the Chemistry Department.

TO: ALL UCSF PROVIDERS

FROM: Edward Thornborrow, M.D., Ph.D.
Director, UCSF Clinical Laboratories at Mount Zion
ed.thornborrow@ucsf.edu

RE: TROPONIN I TESTING AT MOUNT ZION

Effective May 18, Clinical Laboratories at Mount Zion will begin performing troponin I testing on-site. The test will be performed in the central laboratory on the Abbott iSTAT handheld device. Because of differences in methodologies, troponin results obtained from this test should NOT be compared to those obtained from the Parnassus central laboratory.

The test is performed on heparinized whole blood specimens (containers with light green or dark green tops). Because of sample stability limitations, the test must be performed within 30 minutes of sample collection. The test should be ordered STAT and samples delivered immediately to the Testing Section of the Clinical Laboratory on the second floor.

The normal range (99th percentile) for this test is <0.09 μg/L. The first positive troponin ( ≥0.09 μg/L) for a patient will be phoned to the clinical care team. Subsequent positive results for the same patient in the next 72 hours will not be phoned.

Given that heterophile antibodies or abnormal immunoglobulins may cause falsely increased or falsely decreased results and there are clinical conditions that can lead to an elevated troponin level without ischemic coronary artery disease, all values should be interpreted in the appropriate clinical context. Serial sampling is recommended to detect the temporal rise and fall of troponin levels characteristic of acute MI.

If you have any questions regarding the test, please contact the Mount Zion lab at 885-3615.

TO: UCSF PHYSICIANS

FROM: Suchitra Pandey, M.D.
Assistant Medical Director
UCSF Blood Bank

RE: EMERGENCY BLOOD RELEASE - CHECK SPECIMEN REQUIREMENTS

The UCSF Blood Bank is implementing changes, effective tomorrow, May 3, to procedures for Emergency Blood Release and Check Specimen. Please read the attachments for revisions in procedures and requirements.

If you have any questions, please call the blood bank at 353-1313 or contact me at suchitra.pandey@ucsfmedctr.org.

Emergency Release of Blood

This refers to the rapid release of uncrossmatched, O-negative red cells to patients who need blood immediately, before compatibility testing can be completed. See attachment titled "Blood Bank Emergency Release" for a summary of changes to the Emergency Release Procedure and other important information on Emergency Release.

Check Specimen Requirements

The "check" specimen is an important safeguard against transfusion errors resulting from incorrectly labeled patient specimens. The ABO group and Rh type of the "check" specimen must agree with that of the initial specimen. A "check" specimen is a one-time requirement for ALL patients to confirm a patient's ABO/Rh type. See the attachment "Blood Bank Check Specimen" for a summary of changes to "check" specimen requirements and other important information.

In addition to the attachment, please refer to http://labmed.ucsf.edu/labmanual/mftlng-mtzn/test/info/4bb.html#SpecimensCrossmatchCheckSample.

May 2011 Emergency_Release

May 2011 Check Specimen

*Sent on behalf of Associate Vice Chancellor Elizabeth Boyd*

March 2, 2011

Dear Colleagues:

The Clinical Laboratory Improvements Act of 1988 (commonly known as CLIA) established standards to assure the accuracy, reliability, and timeliness of patient test results. These rules, along with their California counterpart, regulate the performance and reporting of clinical laboratory tests and generally require that lab tests be ordered by a physician and performed in a licensed lab.

The CLIA regulations may seem complex, but a few simple requirements are key to keep in mind:

1. Under CLIA, the testing of materials derived from the human body for the purpose of providing information that is used for the diagnosis, prevention, or treatment of any disease, or for the assessment of the health of any human being, must be performed by a CLIA-certified facility.

At UCSF, testing of human specimens where the results will be returned to a physician for use in the clinical setting (with a specific patient) must be handled through the Department of Laboratory Medicine, whose facilities are state licensed, certified under the federal Clinical Laboratory Improvement Amendments (CLIA) and accredited with distinction by the College of American Pathologists (CAP). Most research labs are not licensed as laboratory facilities nor are the faculty members who run those labs qualified by CLIA to serve as CLIA laboratory directors.

2. Research labs that test human specimens but do not report patient-specific results to be used by a physician in clinical care may be exempt from the CLIA regulations. However, if a research lab provides the results of any test it performs to anyone intending to use the results to provide care to a patient, the exemption no longer applies. Clinicians and other caregivers who provide test results from a non-CLIA-certified lab back to a patient would be in violation of the CLIA regulations and subject to civil and criminal sanctions.

3. CLIA regulations are independent of the billing status of a test procedure it is not the case that CLIA applies only when testing moves from research to clinical practice which is billed to a third party payer.

4. The fact that a clinical trial has IRB approval does not necessarily mean that the trial is exempt from CLIA and that the testing may be performed in a non-CLIA-certified lab.

Please Note: Violations of CLIA regulations may result in civil monetary sanctions up to $10,000 per day per violation, criminal sanctions (including imprisonment), and suspension of Medicare approval for billing.

If you have questions regarding the use of a research lab for a clinical trial or for patient care, please contact Dr. Tim Hamill (at HamillT@labmed2.ucsf.edu) for assistance.

Elizabeth A. Boyd, PhD Associate Vice Chancellor, Ethics and Compliance

**Please post or distribute hardcopies of this message with relevant individuals within your unit.**

TO: UCSF PHYSICIANS AND INTERNS

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

RE: REMINDER CUSTOMER SATISFACTION SURVEY

Please remember to complete the Clinical Laboratories' online Physician Customer Satisfaction Survey before the survey closes at midnight Monday, Jan. 24.

Your participation provides useful information to improve laboratory services. Please take a few minutes to respond to our 22-question survey, conducted every other year, at http://www.zoomerang.com/Survey/WEB22BMKWEHYCR/

Please note that the survey site will be down for maintenance on Thursday, Jan. 20 from 6 p.m. to midnight.

If you have any questions, please contact Betty Yalich, senior supervisor of Quality Assurance and Compliance, at 353-9319 or by email at betty.yalich@ucsfmedctr.org .

Thanks for your participation.

TO: UCSF PHYSICIANS AND INTERNS

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

RE CUSTOMER SATISFACTION SURVEY

Clinical Laboratories is conducting its online Customer Satisfaction Survey. Your participation provides useful information in our efforts to improve laboratory services. Please take a few minutes to respond to our 22-question survey, conducted every other year by clicking on the URL below:

http://www.zoomerang.com/Survey/WEB22BMKWEHYCR/

If you have any questions, please contact Betty Yalich, senior supervisor of Quality Assurance and Compliance, at 353-9319 or by email at betty.yalich@ucsfmedctr.org .

Thank you in advance for your response.

TO: ALL UCSF PROVIDERS

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

Neal Cohen, M.D.
Chair, Clinical Enterprise Compliance Committee
cohenn@medsch.ucsf.edu

RE: NEW SIGNATURE REQUIREMENT FOR OUTPATIENT LAB REQUISITIONS

In November, the Centers for Medicare and Medicaid Services (CMS) informed all clinical laboratories that effective Jan.1, 2011, paper outpatient laboratory requisitions must have the signature of the authorizing (attending) provider. This does not apply to lab test requests made by phone or transmitted electronically.

To comply with this requirement, UCSF lab requisitions have been updated to include a place for the authorizing provider (attending) signature at the bottom of the provider information box (see below):

The new requisitions will be available shortly from WorkFlowOne. When new forms are distributed, all outpatient clinical locations should replace the current forms with new versions.

Effective Jan. 1, when unsigned requisitions are received in the laboratory, lab staff will contact the attending physician and request that he or she verbally verify the test or tests requested and we will document this as a verbal confirmation.

Once we begin implementation of electronic ordering in the APEX electronic medical record, this requirement will largely disappear. If you have any questions, please contact Dr. Tim Hamill, medical director of Clinical Laboratories, at 353-1723 or by email at hamillt@labmed2.ucsf.edu.

TO: ALL UCSF PROVIDERS

FROM: Steve Miller, M.D., Ph.D.
Director, UCSF Clinical Microbiology Laboratory
Steve.Miller@ucsfmedicalcenter.org

RE: INFLUENZA A / H1N1 PCR (NEW TEST)

UCSF Clinical Laboratories will offer an in-house PCR test for influenza A, including 2009 H1N1, beginning on Monday, Dec. 20. This test is more sensitive for detection of influenza A infection than the current direct fluorescent antibody test (DFA). It does not detect influenza B.

• Order test by writing "Influenza A / H1N1 PCR" on the requisition.
• Appropriate patients for Influenza A / H1N1 PCR testing are those with respiratory symptoms and suspected influenza A, for whom antiviral therapy is being considered.
• Testing requires nasopharyngeal flocked swab in universal transport media (preferred), nasal wash or nasal aspirate. Lower respiratory tract specimens (e.g. bronchoscopy specimens) cannot be tested with this method.

The PCR method detects the matrix gene that is conserved among all influenza A strains, and has a specific probe for the 2009 H1N1 hemagglutinin (H1) gene. Test sensitivity is very high, ranging between 95 and 100 percent in various studies.

Droplet Precautions should be used for in- and out-patients with respiratory viral symptoms regardless of test result.

The test will be available during influenza season Monday to Friday. Most samples will be resulted the weekday afternoon following receipt in the laboratory.

Additional Respiratory Virus Testing (ordered separately)

• Viral DFA - Detects 7 viruses: Influenza A, Influenza B, RSV, Parainfluenza 1-3 and Adenovirus.
• Viral Panel PCR - Send-out test for immunocompromised and critically ill patients. Detects 12 viruses, including influenza A, with improved sensitivity over DFA. Requires negative respiratory viral DFA and influenza A PCR (during flu season) results prior to sending. Turnaround time is 3 to 5 days.

Both tests can be performed on upper and lower respiratory samples. Requests for respiratory viral DFA and Respiratory Viral Panel PCR testing require a separate nasopharyngeal swab sent to the lab.

Recommended Respiratory Viral Testing Algorithm

Influenza A Antiviral Therapy

• Currently there are rare reports of influenza A in Northern California.
• Predominant strains nationwide are 2009 H1N1 and H3N2
• Both of these strains are generally sensitive to Oseltamivir (Tamiflu)
• There will be periodic updates on influenza and recommended treatment algorithms through the respiratory season.

Repeat Testing of Influenza A Positive Patients (testing for cure)

• Repeat testing is generally not indicated for immunocompetent patients.
• Discontinuation of respiratory precautions is symptom-based for most patients.
• Immunocompromised patients for whom symptoms are not a reliable means for determining continued infection can be tested at most weekly by Influenza A / H1N1 PCR.

Contact Infection Control at 353-4343 if you have questions regarding droplet precautions.

TO: UCSF PROVIDERS

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

RE: LAB COMPUTER DOWNTIME

On Sunday, Nov. 7, Clinical Laboratories is updating its computer software. This will require that we shut down the lab computer for about three hours. During this time, there will be no electronic reporting of test results to UCare, Picis or STOR/CDS.

The downtime is scheduled from 11 a.m. to about 2 p.m. This will allow us to test and report inpatient morning draw samples before the downtime commences.

As laboratory processes are highly computer dependent, lab testing and reporting capabilities will be severely impacted and we will activate our computer crash procedures.

During the downtime, the available test menu will be restricted to assays 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 resume after the computer is fully operational.

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

We realize the downtime will pose a significant burden to all hospital staff and appreciate your patience. Please limit test requests and phone calls to the lab during this time, if possible. Lab staff will make every effort to accommodate testing required for patient care but our resources will be limited.

Please contact Clinical Labs at 353-1667 if you have any urgent patient care issues during the downtime.

TO: ALL UCSF PROVIDERS

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

RE: ELECTROLYTE ORDERS

There appears to be some confusion when ordering individual electrolyte tests now that the electrolyte panel has been eliminated. We are receiving requisitions that are incorrectly requesting "Anion gap" and "HCO3." Here's some additional information to clarify electrolyte orders.

Common Serum Electrolytes
These are:

• Sodium (NA)
• Potassium (K)
• Chloride (CL) and
• Total CO2 (CO2)

Bicarbonate (HCO3)
This is a component of Blood Gas analysis and is not offered as a serum electrolyte. For serum samples, order "Total CO2," which can be selected from the list on the Routine Adult, Routine Pediatric and "stat" lab requisitions. Written requests for "HCO3" on non-blood gas samples will automatically convert to "Total CO2."

Anion Gap
This is calculated from the results of serum Sodium (NA), Chloride (CL) and Total CO2 (CO2) determinations. When these three items are ordered together, an Anion Gap is calculated. "Required for Anion Gap" will be added to the entries for each of these tests on the next version of requisitions.

If you have any questions, please contact me at hamillt@labmed2.ucsf.edu.

TO: ALL UCSF PROVIDERS

FROM: Steve Miller
Director, UCSF Clinical Microbiology Laboratory
steve.miller@ucsfmedctr.org

RE: TEST CHANGE FOR CLOSTRIDIUM DIFFICILE

Effective Monday, Oct. 11, UCSF Clinical Laboratories is replacing the current cell culture neutralization assay with PCR as a confirmatory test for C. difficile toxin B gene. This change will improve our ability to detect disease and enable more rapid results.

There will be no change to the microbiology requisition. Continue to submit diarrheal stool specimens and check the box labeled "Clostridium difficile."

Toxin production from C. difficile is the cause of C. difficile infection (CDI). Only symptomatic patients should be tested as asymptomatic carriage is common.

Submit stools from patients with diarrhea ONLY
• 3 unformed stools in 24 hours.
• Stool must conform to shape of container.
• If CDI is clinically suspected in a patient with ileus, a rectal swab may be submitted. Please note this on requisition.

Please remember: "If it ain't loose, the test is of no use"

Stool samples will continue to be screened with a sensitive test for bacterial glutamate dehydrogenase (GDH) somatic antigen and an immunoassay for toxin. Stools positive for either GDH antigen or toxin (but not both) will be tested by PCR. PCR for C. difficile toxin B gene is a very sensitive and specific method for detection of CDI. PCR will be performed and reported the same or next day that the sample is received in the lab.

Repeat testing is of limited value unless there is a change in clinical status or a significant time period has passed (one week). Repeat tests within 72 hours are not allowed without approval by the microbiology laboratory.

Institute contact precautions when ordering the test and contact Infection Control as appropriate. For more infection, see http://infectioncontrol.ucsfmedicalcenter.org/assets/Diarrhea_Decision_Treev_Final.pdf

TO: ALL UCSF PROVIDERS

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

RE: LAB REQUISITIONS -- ELIMINATION OF ELECTROLYTE PANEL

In a review of test data from last year, there were about 163,000 electrolyte panels ordered for inpatients. In a similar review of orders for individual electrolytes, there were extremely few individual requests for Chloride (245) or Total, CO2 (198). This suggests that the vast bulk of Chloride and Total CO2 tests are performed merely because they are part of the electrolyte panel and the volume of these two tests could be dramatically reduced by eliminating electrolyte panel orders.

Based on this information, UCSF Clinical Laboratories is eliminating the electrolyte panel from our test menu. It will no longer appear on laboratory requisitions. In the future, electrolytes will be ordered as separate tests. If Na, Cl and CO2 are ordered together, a calculated anion gapwill alsobe reported.

As a reminder, UCSF Clinical Laboratories has not and does not offer other chemistry panels as orderable tests: e.g. Chem 7, Chem 10, Chem 20, Comprehensive Metabolic Panel, etc. Although these may be offered at other institutions and laboratories, it has been well documented that the use of test panels leads to over-utilization of tests.

Please DO NOT write orders for electrolyte or chemistry panels. Beginning Oct. 1, if nursing staff receive electrolyte panelor chemistry panelorders, nurses will ask the provider to select the specific test or tests needed for patients.

TO: ALL UCSF PROVIDERS

FROM: Neal Cohen, M.D.
Chair, Clinical Enterprise Compliance Committee

Tim Hamill, M.D.
Director, UCSF Clinical Laboratories

RE: MEDICAL NECESSITY DOCUMENTION FOR DIAGNOSTIC STUDIES

All diagnostic studies (laboratory, pathology, radiology, etc.) require a physician order with appropriate documentation of the medical necessity for the study. The description of the medical necessity is required to comply with Medicare and other regulations. We cannot submit claims for payment for these services unless there is sufficient documentation in the medical record supporting the medical basis for the test. Without appropriate documentation, Medicare and other payers will not pay for studies that are not medically necessary and, if we are audited for compliance with these requirements and were paid, they will request refund of the payments. Additionally, payers could impose penalties for "fraudulent billing" for diagnostic services, if the documentation of medical necessity is not provided.

To comply with the requirement to document medical necessity, every request for a laboratory, radiology or other diagnostic study must include documentation of the order as well as clinical information in the progress notes supporting the medical necessity for the study. Most importantly, the paper requisition form DOES NOT constitute an order and, because it is not retained as a permanent part of the medical record, cannot serve as documentation to support medical necessity.

With the implementation of the Epic EMR, the method for documenting the order and medical necessity will improve. Until the EMR implementation is completed, we must rely on the written physician order and documentation in the progress notes to demonstrate medical necessity for ordered diagnostic studies. Please ensure that you include the required documentation whenever a diagnostic study is required.

For your reference, a summary of the Medicare (CMS) requirements is as follows:

There must be an attending/treating physicians order for each test documented in the patients medical/clinical record. Medical records must clearly document the reason for the test, results, frequency, and an appropriate history and physical examination.

The ordering physician is required to retain in the patients medical record, history and physical, examination notes documenting evaluation and management of one of the Medicare covered conditions/diagnoses, with relevant clinical signs/symptoms or abnormal laboratory test results, appropriate to one of the covered indications.

TO: UCSF PHYSICIANS

FROM: UCSF Compliance Committee for Clinical Laboratories

RE: OFFICE OF INSPECTOR GENERAL, COMPLIANCE PLAN

As part ofUCSF Compliance Committee forClinical Laboratories'oversight planfor 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 fromeachClinical Laboratory. Clinical Laboratories consultation isalsoavailableand 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 Whistleblower Coordinator at 502-2810 or by calling the Universitywide Whistleblower Hotline at (800) 403-4744.

If you have any questions regarding this memo, please contact Dr. Tim Hamill, chairman of the UCSF Compliance Committee for Clinical Laboratories,at (415) 353-1723.

TO: ALL PATIENT CARE PROVIDERS

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

Josh Adler, M.D.
Chief Medical Officer
josh.adler@ucsfmedctr.org

RE: LAB, RADIOLOGY & PATHOLOGY REQUISITIONS

Order forms for laboratory, radiology and pathology have been revised and will be available in all units and clinics on Monday, June 14. This change is part of a comprehensive, multidisciplinary effort to optimize the safe, effective and timely communication of test results.

The new forms will have a common format at the top of the page (see the attached sample of a laboratory request form) where the ordering provider, attending provider (as applicable) and "copy to" provider information should be entered (see attached example of how to fill out the header portion).

The form must include the name and five-digit UCSF number of the person ordering the test or examination. This information must be entered in the "ordering provider section" and must be legible. Additionally, one of the three check-boxes in that section should be selected indicating the status of the ordering provider, such as attending, housestaff, fellow or allied health practitioner.

When the ordering provider is NOT an attending, the name of the supervising attending must be legibly entered in the attending provider section along with his or her five-digit UCSF number. This is a "safety net" to ensure all patient results are routed to the responsible attending. In cases where the ordering provider is an allied health provider, and the ordered services or tests are within his or her allowed scope of services, the entry of the attending provider is not required unless requested by the attending.

UCSF provider numbers are available in STOR and on the UCSF Intranet at http://ucare.ucsfmedicalcenter.org/privileges/ .

The laboratory, radiology and pathology staffs have been instructed to rely solely on the information written on the requisition for reporting purposes. They no longer will use information from IDX labels, which often don't reflect the individuals who should receive the reports.

If you have any questions or concerns, please contact Dr. Tim Hamill at 353-1723 or at hamillt@lanbmed2.ucsf.edu .

TO: UCSF PHYSICIANS AND NURSES

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

RE: LABORATORY COMPUTER DOWNTIME

On Sunday, May 16, Clinical Laboratories will update its computer software, which will require that the system is shutdown for about three hours from about 11 a.m. to 2 p.m. We will test and report inpatient morning draw samples before the downtime commences. During the shutdown, there will be no electronic reporting of test results to UCare, Picis or STOR/CDS.

Because the lab is highly computer-dependent, testing and reporting capabilities will be severely impacted. The test menu will be restricted to assays listed on the STAT requisition, microbiology testing and limited therapeutic drug monitoring. Requests for additional tests 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 after the software update is completed.

While the system is shutdown, the lab will not accept requests to add-on tests. Add-ons will be honored until 10:30 a.m. We will resume accepting add-on requests after the system is back online.

Laboratory staff will phone or fax STAT results during this period. All critical results will be phoned to the number listed on the requisition.

Please limit the volume of test requests and phone calls to the lab as much as possible. Lab employees will make every effort to accommodate any testing required for patient care but our resources will be limited.

We realize this will pose a significant burden to all hospital staff and we appreciate your cooperation. If you have any questions regarding the May 16 shutdown, please contact Dr. Enrique Terrazas, chief of Laboratory Information Systems, at enrique.terrazas@ucsf.edu or 514-8931.

TO: UCSF PHYSICIANS AND NURSES

FROM: Tim Hamill, M.D.
Medical Director, Clinical Laboratories

William Karlon, M.D., Ph.D.
Medical Director, Immunology Section
william.karlon@ucsf.edu

RE: NEW FECAL TEST FOR COLORECTAL CANCER

UCSF Clinical Laboratories has replaced the "take-home" 3-card Coloscreen kits with an antibody-based test called Fecal Immunologic Testing (FIT), which has greater sensitivity. A single stool sample replaces the guaiac 3-card test, making it more convenient for patients. Additionally, this new method generally does not show interferences from dietary sources, so there's no need to avoid red meat or vegetables containing peroxidases. Lastly, upper GI sources of bleeding, such as ulcers or esophagitis, do not result in positive tests unless bleeding is severe.

The new test kits contain a collection device, patient instructions and a mailing envelope and are available through Material Services using the same order number as the old packets (PMM# 44780). The kits also are available at the outpatient phlebotomy stations (ACC, 2330 Post St., Cancer Center). Patient instructions are available in Spanish, Vietnamese, Chinese, Hindi and Russian, and can be downloaded from the lab manual Web site at http://labmed.ucsf.edu/labmanual/db/dataall/tests/1288.html.

The collection devices are small and our current labels do not fit well on the tubes. Please do not place standard patient labels on the collection device. Please instruct patients to fill out the information directly on the collection device itself before sending the sample back to the laboratory (name, collection date, etc.).

NOTE: This test replaces only the 3-card colorectal cancer screening kits and does not replace point-of-care testing for stool occult blood after rectal or pelvic examinations. For these purposes, Coloscreen cards will continue to be available in the ED, clinics and on the wards.

The clinical lab will continue to accept the 3-card Coloscreen sets that already have been provided to patients, but sites should convert to the new test as soon as possible. The laboratory will no longer accept the single Coloscreen card test from inpatient units. These should be performed as point-of-care tests.

Please review this information with all faculty, residents, fellows and students. If you have any questions, please contact Dr. William Karlon in the Immunology Lab at 353-4721 or by email at william.karlon@ucsf.edu.

TO: UCSF PHYSICIANS AND NURSES

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

RE: NEW TROPONIN ASSAY POSTPONED

The launch date of the new troponin assay, plannedforWednesday, Feb. 17, has been temporarily postponed due to a vendor-related technical issue. The current troponin assay will continue to be available until a launch date for the new assay is determined.

An email notice will be sent once a new launch date is established. If you have any questions, please contact Dr. Ted Kurtz, chief of Clinical Chemistry, at kurtzt@labmed2.ucsf.edu.

TO: UCSF PHYSICIANS AND NURSES

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

RE: FALSELY ELEVATED GLUCOSE READINGS

The FDA has issued a warning regarding the potential for falsely elevated glucose readings in patients who have received parenteral products containing or metabolized to MALTOSE, GALACTOSE OR XYLOSE, when these patients are tested with glucose monitoring systems that are glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) based.

These falsely elevated glucose results have led to incidents of inappropriate administration of insulin and consequent life-threatening or fatal hypoglycemia in patients receiving these medications. Additionally, cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.

The Roche Accucheck Point-of-Care glucometers uses the GDH-PQQ enzymatic method to determine whole blood glucose levels. Therefore, glucose should NOT be measured with this device in patients who are receiving medications containing or metabolized to maltose, galactose or xylose. All glucose measurements in such patients must be performed by the Clinical Laboratory during administration of these products and for a minimum of 24 hours after they are discontinued.

Here is a list of the medications currently available at UCSF that contain these sugars or are metabolized to them:

Extraneal Gamimune N 5% Octogam D-xylose WinrhoD SDF Liquid Hepatgam Adept adhesion reduction solution Orencia

Please review this information with all faculty, residents, fellows and students. If you have any questions, contact me at 353-1723 or by email at hamillt@labmed2.ucsf.edu.

TO: UCSF PHYSICIANS AND NURSES

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

RE: NEW SERUM TROPONIN ASSAY

Effective Wednesday, Feb. 17, the Parnassus and Mount Zion clinical laboratories will change the troponin assay, after installing new equipment. The impact will include:

Earlier detection of troponin elevations -- The new assay has better functional sensitivity than the current assay and like other sensitive troponin assays, is capable of detecting low level troponin elevations earlier (1-3). With the new, more sensitive assay, blood sampling at 3-hour intervals (e.g., sampling on admission and 3 hours later) may be as useful as blood sampling at 6- to 8-hour intervals when used to rule out the possibility of acute myocardial infarction (1-3).

REMINDER -- Increased troponin levels can occur with many types of cardiac injury, not just acute myocardial infarction. Normal troponin results obtained over suitable time intervals can be used to rule out acute myocardial infarction. However, abnormal troponin results in the absence of appropriate clinical evidence are not sufficient to make the diagnosis of acute myocardial infarction.

Same "normal" cutoff value and sample requirements -- 99 percent of "normal" blood donors have troponin values in the range of 0 - 0.04 micrograms/L in the new assay with the vast majority being between 0 - 0.02. This 99th percentile upper "normal" limit of 0.04 for the new assay is the same as the existing assay. All troponin results of 0.05 or greater will continue to be flagged as abnormal and the lab will call the ordering location with the first abnormal troponin result on a patient. The recommended heparin sample tube (light green top) remains the same.

Absolute troponin values similar to current -- Absolute troponin values with the new assay are generally similar to those with the current assay and the two assays are highly correlated.

Better analytic sensitivity, precision and linearity -- The new assay has a coefficient of variation of less than 10 percent around the 99th percentile cutoff for "normal" of 0.04 micrograms/L. The lower limit of detection for the new assay is 0.01 micrograms/L. Results lower than 0.01 will be reported as < 0.01. The new assay is linear up to 100 micrograms/L.

REMINDER 99 percent of "normal" subjects will have troponin values in the range of 0.0 - 0.04 micrograms/L by the new assay.

False positive results -- False positive results due to technical artifacts or interfering substances may occasionally occur with any troponin assay, including the new assay. Absence of the expected rise or fall in troponin levels over time suggests the possibility of false positive results (e.g., chronically elevated troponin levels that show little or no change over time). If false positive results are suspected and further investigation is required, please contact Dr. Ted Kurtz for assistance at kurtzt@labmed2.ucsf.edu.

For the next three months, a comment will be attached to all troponin results, noting the date of the method change.

For more information, please contact Dr. Ted Kurtz at kurtzt@labmed2.ucsf.edu or check the lab manual at http://labmed.ucsf.edu/labmanual/mftlng-mtzn/test/test-index.html, which will provide method details after the change occurs.

References

1. Keller T, et al. Sensitive Troponin I Assay in Early Diagnosis of Acute Myocardial Infarction. NEJM 361:868-77, 2009.

2. Reichlin T, et al. Early Diagnosis of Myocardial Infarction with Sensitive Cardiac Troponin Assays. NEJM 361:858-67, 2009.

3. MacRae A, et al. Assessing the Requirement for the 6-Hour Interval between Specimens in the American Heart Association Classification of Myocardial Infarction. Clinical Chemistry 52:812818 (2006)

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.

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

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.

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.

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.

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.)

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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).

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.

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.

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

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.

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:

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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 .

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.