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.