Tag Archives: Q&A

April 2024 Q. Ordering clinicians are requesting that our laboratory flag abnormally high absolute neutrophil counts (ANC) on peritoneal fluids. We cannot find sources for reference ranges, but there is literature that states that a polymorphonuclear cell count greater than 250/μL is a reliable discriminatory test for bacterial peritonitis. We would like to use this as our reference and flag results with an ANC greater than 250 cells/μL as abnormally high. Is this acceptable? Read answer. Q. How do you code fallopian tubes submitted for sterilization with a finding of a paratubal cyst? Read answer.

March 2024 Q. Is it a requirement that routine bacteriology cultures (for example, urine, sputum) be plated in a biological safety cabinet in your typical hospital biosafety level 2 laboratory? Is it safe to read these cultures on an open bench? Read answer. Q. What source should a laboratory use for reference intervals for analytes? Read answer.

Feburary 2024 Q. In a case of suspected drug-related death, how specific can an autopsy be in identifying the drug(s) that might have caused the person’s death and the amount of drugs present? For example, can a toxicology report say a person’s death was caused by a fake oxycodone pill containing fentanyl? Read answer. Q. A nephrology patient who has been treated with vitamin D₂ for several years contacted our laboratory to find out why their 25-hydroxyvitamin D level of 60 ng/mL is now considered elevated when before it was within the normal range. How can we explain this? Read answer.

January 2024 Q. Can a person who has a bachelor of science degree in health care administration sign off on competency assessments? Read answer. Q. Our laboratory uses a total protein assay from Beckman Coulter that has an analytical measurement range of 3–12 g/dL for serum determinations. The assay sensitivity states 1 g/dL of total protein. Can we loop sensitivity into our AMR and make our reporting range 1–12 g/dL? Will this make our assay a laboratory-developed test? Quite often our clinicians need assays reported to 1 g/dL, since they need to calculate the ratio of total protein serum to body fluid as per Light’s criteria. If we report to 1 g/dL, we have to loop sensitivity into our AMR. Read answer.

December 2023 Q. When using a sodium citrate blue-top tube due to platelet clumping, should the sample be kept warm, and does it have to be run within a certain time frame? Read answer. Q. Does the CAP require instrument-to-instrument comparability studies at least twice a year for waived point-of-care testing instruments, such as glucose meters, or nonwaived instruments, such as critical care analyzers? Are we required to perform a linearity study twice a year on all waived and nonwaived POC testing instruments? Read answer.

November 2023 Q. A molecular laboratory received an order from an oncologist for next-generation sequencing testing. The patient’s tissue sample was in the custody of a different laboratory, which has a policy requiring patient consent to release materials for reference lab testing. The oncologist planned to obtain consent from the patient during a scheduled appointment, but the patient’s condition unexpectedly worsened and the patient could no longer travel for the appointment. Neither the custodial laboratory nor the treating health system have mechanisms for electronic consent. As a result of the lack of options for obtaining consent remotely and the custodial laboratory’s stringent consent policy, potentially life-altering NGS testing was delayed for more than a month. Is this restrictive approach to releasing patient material for reference laboratory testing supported by CAP guidelines? Read answer. Q. Is it acceptable to perform weak D testing on a newborn who has an RhD-negative blood type and a positive direct antiglobulin test? We know a positive DAT might cause false-positive results on an Rh test, but can it cause false-negative results? Read answer.

October 2023 Q. What is the total allowable error for lupus anticoagulant testing? Read answer. Q. Our laboratory may relocate to a building five blocks from our current hospital. What kind of instrument validation or verification studies do we need to perform following a move? When should we update the address on our CLIA license and for CAP accreditation? Are we required to have a new CAP inspection before or after testing patient samples at the new location? Read answer.

September 2023 Q. Some recent clinical guidelines recommend lower therapeutic and toxic limits for digoxin than those provided in assay package inserts. What therapeutic ranges and toxic thresholds should laboratories use? Read answer. Q. One of our providers noticed that two laboratories—one in New York and one in Florida—reported very different thyroid-stimulating hormone values for a patient and called our laboratory to determine which was correct. How should we handle such situations? Read answer.

August 2023 Q. Is there a CAP guideline that recommends that patients stop taking drugs that may interfere with a blood or urine test before providing a specimen? Read answer. Q. Can laboratory managers and supervisors assess the competency of testing personnel if they do not perform the lab tests themselves? Read answer.

July 2023 Q. Should phosphate analysis be added to the comprehensive metabolic panel, especially given the test’s usefulness in distinguishing various bone disorders?Read answer. Q. Is it important to fast before a lipid panel? Read answer.

June 2023 Q. California Senate Bill 864 requires that fentanyl screening be included in every drug screen performed in a general acute-care hospital laboratory. The problem is there are no FDA-approved platforms for rapid screening of fentanyl. I found several for forensic use only. The only reagents I found are third-party products to run on open channels on large chemistry analyzers. This is a huge amount of work and expense for a small laboratory. Is sensitivity the stumbling block for rapid testing? How useful is a urine screen if an overdose is an immediate effect and it takes hours for fentanyl to show up in urine and then another hour to run it on a chemistry analyzer? Read answer. Q. How should a laboratory calculate analyzer throughput? Has a formula been published? Read answer.

May 2023 Q. How long do blood transfusions affect mean corpuscular volume values? A patient had a red blood cell count of 2.5 × 10⁶/μL, hemoglobin level of 7.3 g/dL, hematocrit of 22.7 percent, MCV of 90.8 fL, mean corpuscular hemoglobin of 29.2 pg/cell, and a mean corpuscular hemoglobin concentration of 32.2 g/dL. Thirteen days after transfusion, the patient’s values were an RBC of 3.61 × 10⁶/μL, Hgb 10.7 g/dL, Hct 34.6 percent, MCV 95.8 fL, MCH 29.6 pg/cell, and MCHC 30.9 g/dL, and the analyzer flagged the Hgb as abnormal because the MCHC was low. Read answer. Q. We perform a cell count and differential for bronchoalveolar lavages. I understand the importance of a differential cell count, but is a cell count clinically significant when the bronchoalveolar volume is not standardized? Read answer.

April 2023 Q. Which criteria should be used to interpret mixing studies, not only for lupus anticoagulants but also for other inhibitors? Read answer. Q. How does the CAP checklist requirement COM.30840 Pipette Carryover relate to blood bank automation? Are there CAP guidelines that address pipette carryover relative to such systems? Read answer. Q. Our laboratory is assessing criteria for determining quantity not sufficient for a microscopic urinalysis. We were using an automated instrument but have gone back to manual microscopy for reasons beyond our control. While most textbooks state that 10 to 15 mL is the desired amount of sample for testing, it appears that many laboratories require smaller amounts. Can you provide guidance? Read answer.

March 2023 Q. What is the best method to quantify ketones in serum? Can urine strips be used to detect ketones in serum? Read answer. Q. Is it acceptable to run hemolyzed specimens for coagulation testing? We have a Stago analyzer for coagulation testing and some of my co-workers run hemolyzed specimens on it. Read answer. Q. I am a medical laboratory scientist who would like to move into a laboratory information technology/information systems career to support the growing need of professionals in that aspect of health care. What education is advised and what licensing is required, and do you have any suggestions on how to make such a move? Read answer.

February 2023 Q. What is the most specific serologic test for diagnosing IgG4-related disease? Read answer. Q. Our new endocrine clinic is monitoring estradiol levels in transgender male patients (female to male) and asked if our standard estradiol immunoassay is appropriate to use in this setting. What do you recommend? Read answer.

January 2023 Q. I am updating our procedure for blood draw volume limits and using So You’re Going to Collect a Blood Specimen: An Introduction to Phlebotomy, 15th edition, by Frederick L. Kiechle, MD, PhD, as a guide. The chart in the manual lists volume limits for a single blood draw at 2 cc/kg. Other charts online list 2.5 cc/kg and a maximum milliliters per 30-day period that is twice the single blood draw (5 cc/kg). I am going to use 2 cc/kg and add a column for maximum milliliters in a 30-day period at 4 cc/kg. The phlebotomists are confused about whether a single blood draw means every day of the patient’s admission or if you would take the single blood draw and only allow the remainder of the 30-day limit. You could essentially draw the single blood draw volume limit on day one and the remainder on day two. Please clarify. Read answer. Q. An oncologist contacted the laboratory to ask if our standard estradiol immunoassay was appropriate to monitor her breast cancer patients who are on an aromatase inhibitor. What should I say? Read answer.

December 2022 Q. What is the appropriate way to measure or identify microcytosis or macrocytosis? Read answer. Q. A six-year-old female with B-cell acute lymphoblastic leukemia and Rh-negative blood is being treated with myeloablative chemotherapy to achieve durable remission or as a bridge to stem cell transplantation, during which supportive transfusions will include repeated platelet transfusions over many weeks. Clinicians are concerned that the patient could become alloimmunized to the D antigen, which, in turn, could affect her ability to eventually bear children. Apheresis platelets contain a small but finite amount of RBC contaminants, which are not usually quantitated. An optimal strategy to prevent anti-D alloimmunization is to use Rh-negative platelets, but they are often in short supply and cannot be ordered stat in a timely enough manner to ensure every platelet transfusion episode is Rh-negative. We considered using Rh immune globulin (RhIg). However, we recognize that commercial RhIg is designed to prevent D alloimmunization in the setting of obstetric fetal-maternal bleeding. Is there an optimal dose for RhIg or suggested timing of administration to prevent anti-D alloimmunization in this setting? Read answer.

November 2022 Q. Is secretory change in endometrial hyperplasia acceptable in the absence of progestin therapy? What is the appropriate way to address an endometrial biopsy with secretory glandular changes and an increase in the gland-to-stroma ratio? Read answer. Q. I want to inquire about verification of target mean/ranges for hematology analytes. We run a control material 20 times and calculate statistics such as mean, standard deviation, and coefficient of variation. We also calculate total analytical error based on a formula (TAE = bias + 2 SD) and compare the TAE with the allowable total error recommended by CLSI and other sources. For example, if TAE for platelets (based on reading control material 20 times) is less than 25 percent (a CLSI recommended value), we accept the target range; otherwise, we reject it. However, since low concentrations of analytes are prone to a higher degree of variation, the aforementioned target range verification process frequently fails. Is it necessary to accept or reject established target values based on total analytical error? Or is there an alternative way to do that? Read answer. Q. Should an accelerated APTT result be canceled for being clotted, even in the absence of a visible clot? Read answer.

October 2022 Q. How many blocks should a histotechnologist with multiple responsibilities cut per day in a semiautomated laboratory? Read answer. Q. Is it acceptable to release results from an analyzer with flags or alarms if a pathologist sends an email instructing to do so, even if the manufacturer’s instructions state that results with flags or alarms should be verified by another method before reporting? I am referring to hematology analyzer auto-differential results with asterisk flags. The emailed instructions from the pathologist are applied to all samples but are not incorporated into our standard operating procedure. We report auto-differential results that have asterisk flags and then perform a manual differential. The report, therefore, contains two differential results that, when compared, are almost always different clinically and statistically. Read answer. Q. How useful is an aPTT value if the value falls below the reference interval? Read answer.

September 2022 Q. The laboratory at which I work uses two proficiency testing programs—from the CAP and an alternate provider—for dermatologists who perform fungal smears. Our laboratory administers challenges for both programs every six months. The dermatologists have variably passed and failed challenges from both programs such that the record of satisfactory challenges alternates between the CAP and the alternate provider’s programs. Is our approach allowed? Do we need to stick with a single PT provider for one year before switching? Read answer. Q. Should flow cytometry be used to test a cerebrospinal fluid specimen with known or suspected Creutzfeldt-Jakob disease? Our hospital administration is pushing to run such samples. I think the testing should not be done because it would contaminate the instrument and potentially endanger the flow techs. Read answer.

August 2022 Q. Every month our anatomic pathology laboratory amends patient reports. Does the CAP have a benchmark for amended reports, such as how many are acceptable per month? Read answer. Q. What is the best practice for performing a urine specific gravity test? Which method is preferred—a refractometer or an automated dipstick? Should we correct for elevated glucose and protein or report high specific gravity? Should we correct for x-ray dyes or add a comment and list possible interfering substances? Read answer.

July 2022 Q. When a patient has a hematocrit level of ≥55 percent and a normal PT and APTT, do you still correct sodium citrate and ask for a redraw? Is it crucial to ask for a redraw when the emergency department orders a stat PT and APTT? Read answer. Q. Obtaining an accurate blood glucose level is hindered by continued glycolysis in the evacuated tube post collection, even if a gray top tube is used. This leads to falsely low blood glucose levels. What can laboratories do to limit ex vivo glycolysis? Read answer.

June 2022 Q. Can bronchoalveolar lavage specimens from multiple lobes be pooled for culture? Can multiple biopsies from the same joint be pooled for culture? Read answer. Q. We verify our reference intervals with each new reagent lot for coagulation tests (PT, APTT, fibrinogen, and TT). What difference in values between lots necessitates establishing a new reference interval? A CAP TODAY Q&A from January 2015 mentions limits within 1.5 seconds of each other between new and old reagent lots for human recombinant PT. What about limits for APTT and fibrinogen? Read answer.

May 2022 Q. Should peritoneal dialysis fluid collected directly from a patient be considered peritoneal fluid or peritoneal dialysate fluid? A clinician at my institution placed an order for peritoneal dialysate fluid because the fluid was to be collected from the patient, not from the bag. Read answer. Q. What types of materials (for example, QC materials, patient samples, or both) can be used to check new reagent lots on my chemistry analyzer? We have three chemistry analyzers of the same model. Do we need to perform reagent lot studies on all three? Read answer.

April 2022
Q. Is it necessary to perform a manual cell count for body fluids, including CSF, using a hemocytometer? Can clinical decisions be made based on low cell counts in body fluid reported by automated cell counters since these instruments have decreased precision and accuracy with low counts? Read answer. Q. Is there a time limit for a critical value—for example, when a specimen is drawn at 8 AM, the lab receives it at 5 PM (due to courier issues) and has a result at 10 PM, and the value falls in the critical range? Since it is now 14 hours after the draw, the lab value may no longer be actionable. No clinician would act on a critical value that is a week old, so at what point is the lab value no longer considered critical? Read answer. Q. Given that blood specimen collection tubes are in short supply, many laboratories may need to switch to an alternative collection tube manufacturer. What validation studies are necessary before an alternative collection tube can be implemented? Read answer.

March 2022 Q. Are Pancoast tumors a fast-growing, untreatable cancer? Read answer. Q. When performing reagent lot-to-lot correlation studies, some staff believe it is better to perform instrument calibration before a new reagent lot check while others believe calibration is not necessary. What is the appropriate practice? Read answer.

February 2022 Q. Are there established benchmarks for such transfusion services quality monitors as C:T ratio, blood product waste, and cancellation of suboptimal specimens? Read answer. Q. If we collect only enough blood to inoculate one blood culture bottle, should we inoculate the aerobic or anaerobic bottle? Read answer.

January 2022 Q. When reporting reference ranges for absolute differential counts, should the ranges be age specific or is a single reference range acceptable? Read answer. Q. Is it acceptable to use polystyrene tubes for aliquotting plasma for coagulation tests, such as platelet aggregation, and factor-related studies requiring serial dilutions of plasma? I recall seeing recommendations for using nonpolystyrene tubes for frozen plasma aliquots but did not see a reason for the recommendation. Read answer.

December 2021 Q. We use the CAP Competency Assessment Program to create quizzes to satisfy the problem-solving element of the CAP’s competency assessment requirements. Is there a requirement to create a new quiz each year or can the same quiz be given every year? Is it OK to use the same quiz for the initial competency and the annual competency? Read answer. Q. Are there red blood cell parameters, such as RBC count or mean corpuscular volume, that can affect a platelet estimate? When determining a platelet estimate, should we always look at the same area of the slide regardless of the patient’s RBC, hematocrit and hemoglobin levels, and indices results? Read answer.

November 2021 Q. I am a nurse in a cardiac cath lab that performs point-of-care testing, including for activated clotting time. At my hospital, the POC testing coordinator only allows other cath lab staff, usually nurses, to use POC testing equipment if they have a copy of their diploma. Can staff who have proof of licensure (such as from the American Registry of Radiologic Technologists) but do not have a copy of their diploma be authorized to use POC testing equipment? Read answer. Q. I recently joined a hospital laboratory that verifies reagents lot to lot with patient samples using a percentage difference of 10 for all parameters. The hospital lab where I previously worked used a CLIA allowable-error percentage. Is 10 percent allowable error acceptable for reagent lot-to-lot verification for all parameters? Read answer.

October 2021
Q. After naloxone is administered, are opiates still detectable in the body? If so, for how long and in what quantities? Read answer. Q. Why do proficiency testing specimen results for common immunoassay analytes sometimes vary greatly with different instrument manufacturers and their reagents? Does that mean the patient’s results for the same specimen could vary greatly based on the instrument used? If so, is this acceptable? Wouldn’t the variation in results confuse the clinician and patient? Read answer.

September 2021 Q. What is the ideal collection tube for measuring the level of ammonia in blood? Is a tube containing EDTA suitable?Read answer. Q. Is there a requirement to notify nursing personnel or doctors about each critical value obtained for a patient after the initial occurrence of the critical result?Read answer.

August 2021
Q. Is it necessary for a lab to report a corrected sodium level when the glucose level is really high? Studies show pseudohyponatremia can occur due to hyperglycemia. How common is this, and how do we decide which correction factor to use? Is it possible that this is easily overlooked by providers due to comorbidities in patients? Some references say there is a need to correct glucose for each 100 mg/dL increase above 400 mg/dL glucose. Read answer.
Q. Payers are limiting reimbursement for PCR respiratory panels to a small subset of tested pathogens and only with certain indications. Many panels available from manufacturers test for more pathogens than can be reimbursed. What is the best approach to deal with this issue? Should large respiratory panels no longer be offered? If a large panel is performed, should only a limited number of pathogen results be reported, even though the entire panel was performed? Should the entire panel be reported but only a limited number of pathogens billed for? Read answer.

July 2021
Q. Our lab does not have reference ranges established for body fluid manual differentials. Is it acceptable to use ranges from a reference material and include a disclaimer citing the source of the ranges? Read answer.
Q. In our lab, we perform semen analysis and make slides to send out for sperm morphology using Kruger’s strict criteria. We get quite a few results back as swollen sperm head for probable contamination. The reference lab insisted that liquefying agent was added, but when we reviewed the results, the sample was normal, so liquefying agent wasn’t used. What can cause a sperm head to swell, other than liquefying agent? Read answer.

June 2021
Q. If an exfoliative cytology specimen (for example, pleural fluid) is received fresh, how long can it stay refrigerated before it needs to be placed in formalin fixative for cell block preparation? That is, what is the recommended cold ischemic time? Read answer.
Q. Are two levels of a control required for a manual reticulocyte count? Read answer.
Q. What are the requirements for obtaining emergency use authorization versus 510(k) clearance? Read answer.
Q. Are the PCR assays for SARS-CoV-2 from most manufacturers quantitative? Read answer.
Q. Is there a best specimen type to use for SARS-CoV-2 molecular testing? Read answer.
Q. What is the primary test type used to detect SARS-CoV-2? Read answer.
Q. I know that a molecular test detects nucleic acid and an antigen test detects viral protein, but how do they compare for clinical use and which is better? Read answer.

Q. I am part of a two-pathologist practice in a rural community hospital of 110 beds. We have been asked more frequently lately to evaluate liver and kidney biopsies for organ transplantation. We are hesitant to evaluate these biopsies for transplantation purposes due to frozen section artifacts and because we send all of our kidney biopsies performed by local nephrologists to a reference laboratory and do not evaluate kidney biopsies. It seems that regardless of what we say about the biopsies, the surgeons transplant the organs. We believe it is out of our scope of practice to evaluate liver and kidney biopsies for organ transplantation. What do you think? Read answer. Q. What is the minimum and maximum formalin fixation time for cytology specimens for optimal immunohistochemical and nucleic-acid–based molecular testing? Read answer.

Q. What is the recommended procedure for analyzing cerebrospinal fluid from patients suspected of having Creutzfeldt-Jakob disease? In addition to sending the specimen to the National Prion Disease Pathology Surveillance Center for 14-3-3 testing, should the laboratory perform a cell count and/or meningitis panel? Read answer. Q. Is light protection needed for folate samples? Most major reference laboratories do not require folate samples to be protected from light, and I could not find any studies on the topic. Read answer. Q. Many times a platelet count on an automated hematology system indicates some degree of thrombocytopenia or the analyzer reports a high mean platelet volume or platelet large cell ratio, while a blood smear shows large platelets and/or giant platelets. Is it OK to include a comment in the report that the platelets are adequate or that the count could be due to large platelets, especially with values that indicate marked thrombocytopenia? Read answer.

Q. In our hospital, respiratory therapy runs most of the blood gas tests on instruments in centralized locations. Staff are able to enter into the blood gas instrument, which is connected to the LIS, to whom they gave critical results. However, staff do not have a way to document that a result was read back. The majority of these critical results happen in the neonatal intensive care and intensive care units, where respiratory therapy is a part of the care team, so results are given in person. Is documenting a read-back necessary when critical results are communicated verbally? How does the CAP checklist COM.30100 relate to point-of-care testing? Read answer.

Q. Can toxicology testing be performed on a person who has been deceased for two years? Read answer. Q. Is there a standardized procedure for performing platelet estimates that incorporates the dilution effect for low hemoglobin in anemic patients? The formula I found for platelet estimation works well with low hemoglobin levels but not with levels greater than 13 g/dL. Read answer.

Q. If an instrument is moved a short distance, is it necessary to conduct revalidation? Read answer. Q. At what level or time is aPTT considered incorrect? Is an aPTT of less than 22.0 seconds an acceptable result? Read answer.

Q. Can a heel stick for a basic metabolic panel with magnesium and phosphorus be performed on a two-month-old baby? Read answer. Q. Due to nationwide supply shortages affecting COVID-19 and other testing in the laboratory, we are concerned about using up critical supplies when assessing competency. Do you have suggestions or strategies we can use? Read answer. Q. When a patient is admitted to our hospital, we collect MRSA nares PCR, MRSA axilla by culture, MRSA groin by culture, and vancomycin-resistant Enterococcus by PCR for infection control purposes. Many surrounding facilities have told us they have removed the axilla and groin cultures, but no references were cited to support removing these procedures. Our facility would like to follow the practices of other hospitals, but our providers would like a reference to cite. Are there best practices or benchmarks from an infection control and microbiology point of view that would allow us to remove the axilla and groin MRSA screen cultures? Read answer.

Q. What can laboratories expect to see after a medication such as Narcan is given for an opioid overdose? Read answer. Q. There are conflicting views among my colleagues regarding the meaning of initial competency assessment. Some think that using a training checklist for new staff counts as the initial competency assessment because we are signing off that staff are competent to perform patient testing and report results. Others believe an initial competency assessment is done shortly after training is completed, followed by the mid-cycle/six-month competency assessment and annual competency assessment. Please clarify. Read answer. Q. How do you calculate RDW-SD and RDW-CV values in dimorphic anemia cases on the Sysmex XN-3000? Most of the dimorphic anemia cases report a masked parameter. Read answer.

Q. What is the minimum cutoff value for total nucleated cells and red blood cells in body fluids after which we need to perform cytospin? Read answer. Q. We treat all elevated troponins as critical values that necessitate a phone call to the ordering physician and documentation on the patient’s chart. Is this necessary? How does it affect patient treatment? Read answer.

Q. Is it acceptable for a clinical laboratory to calculate ionized (free) calcium if calcium ion-selective electrode is not available? Are results of calculated ionized (free) calcium of acceptable accuracy in clinical practice? And what is the recommended formula for performing this calculation? Read answer. Q. Under checklist requirement COM.04250 “Comparability of Instruments and Methods —Nonwaived Testing,” what is the minimum number of samples that should be analyzed and which acceptance criteria should be used for the comparison? In addition, what parameters in the complete blood count do not apply for comparison purposes? Read answer. Q. I read an article about phlebotomy that stated for proper patient care, the recommended maximum number of blood draw attempts is four. The hospital at which I work recently implemented a procedure in which the nurses perform blood draws, instead of laboratory personnel. The procedure requires a nurse to attempt a blood draw twice and, if not successful, ask another nurse, and then ask the nursing supervisor before finally calling the laboratory. This policy has been difficult for hospital staff, and I feel terrible for patients who get stuck numerous times. Can you provide feedback that I can use to express my concerns to hospital administration? Read answer.

Q. Are there high-specificity IHC stains for diagnosing mesothelioma that differ from those recommended in the “Guidelines for pathologic diagnosis of malignant mesothelioma: 2012 update of the consensus statement from the International Mesothelioma Interest Group”? Read answer. Q. For our hospital tissue and blood committee, we would like to expand the tissue component to look at more preoperative versus postoperative diagnoses (acute appendicitis, for example) and anything else that should be evaluated, such as adequacy of tissue and blood samples. Is there a resource that provides a list of tissue-related quality metrics that we can evaluate? Read answer.

Q. Can you provide a current reference for the various modifications of transfused red blood cells — for example, irradiation and white cell depletion — and their indications? Read answer. Q. In the context of allowable error relative to the immature platelet fraction test, is the analytical measurement range applicable to the IPF? Read answer. Q. What is the normal random plasma glucose value? Read answer.

Q. For the population with diabetes, what can the clinical laboratory do to promote evidence-based testing and monitoring for chronic kidney disease? Read answer. Q. What are the proficiency testing enrollment requirements if an analyte is tested in multiple locations within the laboratory? Read answer. Q. With regard to specimens from oncology patients exhibiting hyperleukocytosis, the Beckman Coulter DxH 800 analyzer used by our laboratory autocorrects the RBCs, but the lab is still seeing errors on the indices (hemoglobin, MCV). What is the best way to correct for potential WBC interference on the RBC indices? Read answer.

Q. Is there a place for procalcitonin testing alongside PCR testing on the BioFire system? Read answer.
Q. We are looking into validation methods for lower breakpoints for carbapenems. The CDC has banks of organisms available to run on our Vitek 2 (BioMerieux). Are there guidelines on which organisms to include and how many times to test? Read answer.

Q. Does the CAP have recommendations regarding diagnostic criteria for evaluating HER2 in colorectal carcinoma? Read answer.

Q. How do you report the presence of immature granulocytes in a 100-cell differential? Read answer. Q. Should a patient with a hematocrit greater than 55 percent be redrawn for correction always or only when prothrombin time and partial prothrombin time are elevated? Read answer.

Q. Does a histotechnologist need a bachelor’s degree to run in situ hybridization? Read answer. Q. Does using an alcohol swab affect the results of an ethanol blood test? Read answer. Q. Is there a recommended procedure for or reference article about checking APTT reagent sensitivities (for the identification of factors VIII and IX) when changing lot numbers and reference range? Read answer.

Q. What are your recommendations for using viscoelastic assays to perform platelet mapping studies? What is the clinical value of obtaining these test results? Read answer. Q. Would the results of tests for routine and special coagulation studies be affected if I thawed frozen plasma samples using a dry heating block? Are we allowed to use dry heating blocks? Read answer.

Q. What is the current standard practice for collection tube order for CSF testing? Read answer. Q. What is the significance of the absence of coagulation of seminal fluid in a patient who previously experienced normal seminal fluid coagulation, followed by normal liquefaction, and had fathered children? Are there medications that can prevent seminal fluid coagulation? Read answer.

Q. Is there a specific CAP recommendation regarding which anticoagulants are acceptable for synovial fluid crystal analysis? If not, what does the CAP recommend? Read answer. Q. What is the next step in resolving platelet clumping when it also occurs in a citrate tube? Read answer.

Q. Are there any FDA-approved laboratory-developed assays or point-of-care assays for detecting oxycodone or fentanyl in urine or blood? Read answer. Q. What was the cause of a sudden shift in values in the triglyceride assay at one clinical laboratory? Read answer.

Q. Can you describe the contemporary significance and use of osmolality testing in the clinical laboratory? Read answer. Q. Is it necessary to include a comment on the patient report indicating that a test result was obtained after dilution? Read answer.

Q. I just read the 2018 HER2 guideline update. Can you provide an example of how a previously equivocal case is resolved under the new guideline? Read answer.

Q. When performing a manual differential that contains immature cells, such as metamyelocytes and myelocytes, do you report an absolute count on all of the individual cells in the myelocytic line, or do you group them together and calculate one ANC? What about lymphocytes and reactive lymphocytes? Read answer. Q. Why and in what employment screening settings is the two-step skin test for Mycobacterium tuberculosis recommended? Read answer.

Q. Which gynecological slides can cytotechnologists report? Read answer. Q. Is it recommended that a hospital streamline its reference ranges for point-of-care and main laboratory tests? Read answer.

Q. Can you explain further the revised CAP checklist requirement COM.40850 “LDT and Class I ASR Reporting,” which says to describe the method and performance characteristics in test reports unless the information is available to the clinician in an equivalent format? Read answer. Q. Can we see reactive lymphocytes in the pediatric population (under age two), and can we report them? Read answer.

Q. Is anticoagulant adjustment in citrate tubes necessary when a patient’s hematocrit is less than 20 percent? Read answer. Q. What is the substitute test for HbA1c for a patient with homozygous variant hemoglobin? Is a fructosamine and/or glycated albumin test appropriate? Read answer.

Q. How can one wisely apply GATA3 immunohistochemistry as a useful tumor marker in diagnostic surgical pathology? Read answer.

Q. Is there expert advice or standard practice for releasing preliminary critical values for patients to the LIS pending subsequent technologist or technician verification and documentation? Read answer. Q. We hope to validate a procedure for the fixation, decalcification, and staining of bone marrow specimens but we will not be able to access fresh marrow specimens for our decalcification validation. Can you recommend an alternative tissue to validate the preservation of tissue morphology and antigenicity after decalcification? Read answer.

Q. What is the best way to report fecal fat testing? Read answer. Q. Who developed the formula for the corrected white blood cell count for nucleated red blood cells, and how was the formula established? Read answer.

July 2018—Is CD30 currently being used as a predictive marker for therapy? Due to laboratory construction, our molecular instruments were relocated within the lab. Is full test validation required in this case? Or is running at least 20 known samples enough to verify the instrument/assay performance specifications?

June 2018—What is the role of total testosterone and free testosterone in gauging the effectiveness of androgen deprivation therapy?

We are planning to validate the mismatch repair panel in our immunohistochemistry laboratory. Do we use the CAP guidelines for antibody validation for a nonpredictive marker or a predictive marker?

May 2018—Our immunohistochemistry laboratory is moving to a new building across the street. We are not getting new equipment, just moving the machines to the new building. Do we need to perform a full revalidation of all our antibodies?

April 2018—A semen analysis for viability was collected at 9:30 AM and not received in the laboratory until 1:40 PM. Our standard operating procedure says this test must be analyzed one hour after collection, with no disclaimers stated for late receivables. Therefore, it is my understanding that a specimen received five hours after collection would be considered unacceptable because the viability of the semen is compromised and the collection delivery does not follow our SOP.

March 2018—Our pathology group has an unusual case of residual squamous cell carcinoma of the lung in a lobectomy specimen after chemotherapy. The lung shows a hilar scar (1.7 cm) involving the lung parenchyma and the peribronchial adipose tissue. In the scar there is residual carcinoma (0.4 cm) that focally is involving the peribronchiolar adipose tissue around the lobar bronchus. The focus is located at 0.3 cm of the final surgical resection margin of the bronchus. Because the tumor involves peribronchiolar adipose tissue, is it considered outside the lung (extension outside the lung)? Since the tumor is in the mediastinal fat around the bronchi and had to invade the viscera pleura to invade the peribronchial adipose tissue, would the tumor stage be ypT2a? Or T3 since it is invading part of the mediastinal fat? Or should it be pT1?

February 2018—I come from a core (hematology/chemistry) background, and I would like practical, how-to guidance in developing an effective QC strategy for HIV viral load testing. What performance characteristics do you verify? How many and what type of samples do you use? What are the chosen acceptable thresholds? Do you use L-J charts? If so, what do you plot, what control rules do you select, and how do you select them?

January 2018—We are in the process of validating the Stago STA Compact Max and Stago STA R Max with cap piercing. The company is stating that the open and closed modes follow the same testing pathway and therefore validation between modes is not necessary. Is this correct? Is PHI (phosphohexose isomerase), also known as GPI (glucose phosphate isomerase), mainly responsible for metastasis and circulating tumor cells?

December 2017—Is a tumor embolus in the capsule of the lymph nodes considered metastasis? Does the lung, like the lymph nodes of the breast, have the concept of isolated tumor cells? As the staging rule is “when in doubt, understage,” would the case therefore be pT2, N0?

November 2017—A laboratory owns chemistry analyzers from company X. Company X recommends that its customers use company X’s calibration material to perform their linearity studies, starting with the highest concentration and using the chemistry analyzer’s autodilution feature to provide a total of four measurable concentrations and a final zero point. Does this protocol fulfill CAP checklist requirements?

October 2017—Our doctors request strep group A culture on throat specimens that are negative for rapid strep group A. On culture workup, if we have beta-hemolytic strep, we perform latex grouping only for group A strep; we report negative for GAS if latex is negative and positive if latex is positive. I think we should confirm all GAS with pyrrolidonyl arylamidase (PYR), and group and report other non-GAS. What do you think?

September 2017— I received a sample with very high hemoglobin grossly. When I ran the sample on the Cell-Dyn Ruby, it was unable to calculate the parameters related to Hgb. I diluted the EDTA blood and ran the test again. In this scenario, should I multiply all the indices and Hgb-related parameters with the dilution factor? Which parameters should I multiply with the dilution factor?

August 2017—Due to an ever-changing workforce, many new and inexperienced technologists are working in the microbiology lab and appear to be having difficulty interpreting cultures and troubleshooting when an organism in question may not be significant. As an example, a scant growth of Micrococcus was isolated and reported from a cerebrospinal fluid culture; it was not seen in the Gram stain and was negative for leukocytes. Contaminants had been noted on some of the media plates at this time as well, but many of these inexperienced technologists do not have the confidence to ignore obvious contaminants or suggest the possibility of contamination. Is there some guidance or troubleshooting tools for these situations?

July 2017—A laboratory is considering the implementation of a laboratory test for the diagnosis of Zika virus infection. This test is currently labeled as a test under the issuance of an Emergency Use Authorization. What specific regulations regarding the use of this test, quality control, and proficiency testing apply when performing this test on patient specimens?

June 2017—Our analyzer reported nucleated red blood cells of six, with no cellular interference flag. The technologist missed that the automated NRBC was six. When he performed the manual differential, he noted more than five NRBCs and performed a corrected count and certified it. Is it acceptable to report out the automated white blood cell value as well as the corrected WBC?

May 2017—Is there any medical reason why a physician would ask the lab to run a complete blood count on cord blood? Does CAP checklist requirement HEM.23050 treat automated and manual differentials equally? That is, does the recommendation to report absolute counts apply also to manual differentials or only to automated differentials? What is the next step in resolving platelet clumping when it occurs in a citrate tube also?

April 2017—Our laboratory receives requests for breast predictive marker testing (estrogen receptor, progesterone receptor, HER2, Ki-67) on biopsies of bone metastases. Is it appropriate to perform this testing on decalcified tissue? Is there a regulatory speed limit—whether a per day or a per hour “at the microscope” workload limit—on surgical pathology slide interpretations, similar to workload limits for cytology screening?

March 2017—Our hospital system is implementing Sysmex instruments with a focus on the accuracy of the absolute white blood cell values—use of the absolute neutrophil count and immature granulocytes with the WBC as markers for septicemia. I then became aware that the hospital purchased the St. John Sepsis v14 protocol, which lists 10 percent bands as one of the markers for septicemia. The Rumke for 10 percent is 4–16. Using bands is not consistent with reducing manual differentials and is not an accurate parameter to use. Are there other protocols using WBC/ANC?

February 2017—I have an oncology patient with a diagnosis of immune thrombocytopenia. The patient’s sample has been drawn in sodium citrate, EDTA K2, sodium heparin, and warm saline replacements, and a true platelet count cannot be obtained. Platelets clump in all tubes, and multiple platelet clumps are observed under the microscope. The patient doesn’t have thrombocytopenia. What else can I do?

January 2017—I have a technologist who is a recent graduate from a medical technology school. She has her BA but the school she attended did not offer an internship program. We are offering her one year of on-the-job training so she will be able to sit for her ASCP certification exam after completing the one year of training.

Q. Are there guidelines on microsatellite instability analysis by immunohistochemistry on colorectal adenocarcinomas? Specifically, should immunohistochemical stains for the mismatch repair enzymes be performed on all colorectal adenocarcinomas regardless of the clinical or pathological findings? A medical group recently requested these studies on all colorectal adenocarcinomas.

November 2016—As originally described, there are technically five Gleason patterns: 1, 2, 3, 4, 5. However, since patterns 1 and 2 are never used, there are no Gleason scores 1 + 1 = 2, 1 + 2 = 3, 2 + 1 = 3, 2 + 2 = 4, 2 + 3 = 5, and 3 + 2 = 5. Why is this? Isn’t this an alteration of Gleason’s original classification concept? Furthermore, there are cases in which a biopsy may contain a few glands that are diagnostic of carcinoma but insufficient to assign an accurate Gleason score. Would it simply be best to make a descriptive comment to that effect?

October 2016—What are the guidelines for proper handling and processing of blood specimens collected in serum separator tubes? Are there regulations guiding the practice of taking additional blood samples from a patient even though there are no orders for the blood samples? These “just in case” specimens are sent to our laboratory by the emergency department when a port or catheter is placed in the patient. The ED’s reasoning is that it prevents a patient from being stuck twice if there is an order for blood tests later. Our lab has to either store the samples or process them (centrifuge or separate RBCs from serum) so they are ready in case an order is entered later. Should this practice be banned? Should we refuse to accept these samples?

September 2016—We know we can count fewer than 100 cells for a manual differential if there is a very low white cell count. But if the white cell count is very high, should we count more than 100 cells? Some references state that >30,000 WBC/µL require a 200 cell differential, others >50,000 WBC/µL, and many do not mention at all the need to increase above 100 cells counted.

August 2016—If you obtain a platelet count from a blood sample collected in a sodium citrate tube, the result is multiplied by 1.1 to correct for the volumetric difference in anticoagulant compared with EDTA. When you result the platelet count from the sodium citrate tube, is it a CAP requirement to attach a comment such as: “_#__ Results reported from blue top tube. The reference range and other method performance specifications have not been established or approved by FDA. Use results with caution.”

July 2016—What are the steps to validating maximum dilution for certain analytes when the stated manufacturer dilution is not enough? What is considered best practice for verifying platelet-poor plasma for coagulation? Is it necessary to measure platelet counts from 2.7 mL and 1.8 mL tubes? Is annual verification consistent with best practice?

June 2016—Can you offer feedback on the growing trend of using type A fresh frozen plasma in emergencies instead of type AB? Is this being used mainly in trauma hospitals and military sites or is the trend becoming more popular in smaller hospitals too?

May 2016—What laboratory test should be used to monitor the effect of the heart failure medication Entresto (sacubitril/valsartan)? After getting a consultation report, I usually issue an addendum without changing my own diagnosis. Some of my colleagues use an amended report with their own diagnosis changed. They say this will help clinicians with patient management. I do not feel confident about many of these difficult cases, so I do not want to change my diagnosis. We would like to establish a department policy to address this. Can you provide guidance?

April 2016—We review peripheral blood smears and sometimes provide recommendations. For microcytic anemia with high red blood cell count, iron study and hemoglobin electrophoresis are suggested to rule out hemoglobinopathy. But for cases of microcytosis with high RBC count but without anemia, should we give the same recommendation as for an anemic patient?

March 2016—I have a question regarding auto-verification delta checks, not for a single patient but between all patients tested during a given period. Are there labs that use postanalytic comparisons of clinical lab results during the testing interval between quality assurance checks to ascertain if the autoverified results being released are reasonable?

February 2016— I am a practicing board-certified pathologist and I have one cytotechnologist to screen Pap tests. She is moving to another city, and I must decide whether to send all Paps to a reference laboratory or to another lab just for screening and then returned to me for sign-out of normal and abnormal Paps.

January 2016—The current recommendation of the Centers for Disease Control and Prevention to screen baby boomers for hepatitis C virus may cause stress on laboratory resources. Is this the most prudent way to capture those individuals who will progress to liver cancer? Current data/literature suggest that 80 percent of those who may screen positive will not progress to cancer but will eliminate the virus on their own.

December 2015—How is haloperidol usually administered in a hospital? If blood is drawn within one to two hours after a dose, should the drug’s concentration be in the therapeutic range?

November 2015—Is there a recommended procedure for or reference article about checking APTT reagent sensitivities (for the identification of factors VIII and IX) when changing lot numbers and reference range? The activated partial thromboplastin time (APTT) clot-based assay is a global test used to detect factor deficiencies in patients with a bleeding diathesis or as a preoperative screen to ensure normal coagulation laboratory parameters before an invasive procedure.

October 2015—We have always considered the absolute neutrophil count to include segmented neutrophils and bands only. Should other immature cells such as myelocytes, promyelocytes, and metamyelocytes be included in this calculation?

September 2015—In the article on novel oral anticoagulants in the May 2015 issue of Archives of Pathology & Laboratory Medicine (139:687–692), a few blood products that are mentioned are not described. What is the composition of 3-factor PCC, 4-factor PCC, and FEIBA, and how are they prepared commercially?

August 2015—Our laboratory is adding urine total protein to its Siemens Dimension EXL test menu. The test is being performed now at our reference lab on the Siemens Advia 1800. Our Dimension EXL method validation studies have revealed an average 40 percent positive bias over the Advia method. This bias is also evident in peer group evaluations for the quality control product we are using.

July 2015—Q. We recently reorganized the workflow in our blood bank in hopes of improving process control and reducing distractions. In doing so, we increased the potential for workplace injuries. The ergonomic issues are a major concern for a lot of workers. Employees on all three shifts are developing back and knee issues. We are an 800-plus-bed hospital lab with more than 30 people working in our department. The following issues have arisen:

June 2015—Can IgA-deficient patients who require transfusion receive blood only from donors who are also IgA deficient? Patients who are IgA deficient and do not have a history of a prior anaphylactic transfusion reaction ...

May 2015—Q. I am a pathologist practicing in a small community hospital. I was involved with a patient who was declared brain-dead and subsequently designated a donor of multiple organs. The organ procurement agency ordered additional testing during the two days before the organ harvest, including a CT scan of the chest. The latter revealed a solitary pulmonary nodule.

April 2015—Why is the number 12 for lymph node retrieval in colon cancer protocol reporting not specific to the kind of resected specimens and whether a total colectomy was performed? We are establishing a list of maximum allowable dilutions for our clinical chemistry analytes. Are you aware of any reference that would list absurd or invalid values for such analytes, i.e. the endpoint that would determine the most dilutions we would have to do for the highest possible value for that analyte?

Are red blood cell parameters (Hb, MCV, MCH, MCHC, and RDW), especially a normal MCV, a reliable screening tool for ruling out beta thalassemia trait? Is the sickle solubility test reliable in ruling out sickle cell disorder? The absence of coagulation of seminal fluid has been attributed to bilateral congenital absence of the vas deferens and seminal vesicles due to the absence of the coagulation substrate (fibrinogen-like precursor).

February 2015—Can our laboratory use ALK immunohistochemistry in lung adenocarcinoma to select patients for targeted therapy? ALK gene rearrangements (the most common of which results in expression of the EML4-ALK fusion protein) are found in approximately five percent of lung adenocarcinomas, and these ALK-rearranged tumors show marked clinical response to the tyrosine kinase inhibitor crizotinib.

January 2015— How can we establish or verify our PT and APTT reference intervals? Is it necessary to verify the reference interval with each new reagent lot? Does the CAP recommend mentioning “mean normal PT” with patients’ results?

December 2014—What are the legal ramifications for medical technologists or medical laboratory technicians if they release results on suboptimal specimens on the insistence of physicians? What are the consensus recommendations for the diagnosis of eosinophilic esophagitis, eosinophilic gastroenteritis, and eosinophilic colitis? What is the clinical significance of increased lymphocytes in esophageal biopsy? Has there been a significant increase in diagnosed eosinophilic disorders over the past 10 or so years?

November 2014—When performing a platelet count from a blood sample collected in a sodium citrate tube, the result is multiplied by 1.1 to correct for the volumetric difference in anticoagulant compared to EDTA. Which other CBC parameters, if any, should be similarly corrected?

October 2014—My laboratory reports the color of a body fluid after it’s spun down. So bloody fluid may be reported as “color: yellow, appearance = bloody.” Is this common practice? We have had phone calls from a neurologist who questioned the color and pointed out that it doesn’t make sense, except for spinal fluid when it’s important to record xanthochromia versus a bad tap.

September 2014—Occasionally on certain patients, when we draw for a CBC in the early morning, we get a low Hgb of 6 or 7 g/dL. We draw the same patient for a CBC in the afternoon and we get a higher Hgb by at least 1–1.5 g/dL. Can you explain the reason for this difference? We would like to standardize reference ranges throughout our system of regional facilities, using our main laboratory to establish the ranges. How does the CAP view using the transference process as described in CLSI document C28-A3C, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline? Is this an approved method for establishing reference ranges? Is it an acceptable process once the laboratory director approves it?

August 2014—Is there a trough and crest occurrence with blood testosterone levels, or is it like thyroid testing, where one’s result is the total of the previous several days? What is the relationship between the presence of moderate to many spherocytes and the MCHC parameter? We always thought cases that show spherocytes on the blood smear are usually associated with high MCHC. We had a case of autoimmune hemolytic anemia with moderate spherocytes, but the MCHC was normal.

July 2014—Our laboratory is thinking of validating additional immunostains to aid in identifying metastatic melanoma. What are the best markers to identify metastatic melanoma?

June 2014—Treatment with rasburicase seems to affect the uric acid analysis. Drawing the specimen in a pre-chilled lithium heparin tube appears to eliminate the falsely low uric acid results we see. Are there current studies regarding uric acid test analysis on patients receiving rasburicase?

May 2014—Checklist requirement HEM.23050 regarding reference intervals includes a note that if absolute cell counts are reported with their reference ranges, then percent cell count reference ranges should not be reported because they can lead to misinterpretation of CBC data. I understand that many laboratories, like ours, have been reporting reference ranges for both absolute and percent cell counts, and I would like to clarify whether this is permissible.

April 2014—I have a question about the meaning of the word “guideline” versus “procedure.” Checklist requirement ANP. 11670 Specimen—Gross Examination says the following: “Documented instructions or guidelines are readily available in the laboratory for the proper dissection, description, and histologic sampling of various specimen types (e.g. mastectomy, colectomy, hysterectomy, renal biopsy, etc.).” This leads me to question whether the word guideline means the same as procedure. Procedures need to be signed bi­ennially. Does the same apply to guidelines? The formatting is different for procedures. Could guidelines also mean references?

March 2014—Q. What are the actionable mutations in melanoma that warrant routine molecular testing? Who should be tested, and what specimen should be tested? Is there a role for stat BRAF testing and for next-generation sequencing?

February 2014—We are thinking about using a reference laboratory for HER2 FISH testing of breast carcinomas with an arrangement in which that lab performs the technical component and we perform the interpretation. A “frequently asked question” from 2011 on the CAP Web site seems to say that we must perform bright-field ISH proficiency testing to be in compliance, since we are not performing the hybridization and cannot refer PT to another laboratory. Can you clarify the PT requirement, if any, for this situation? The vendor we are dealing with has offered to establish its own FISH PT program.

January 2014—I read a question and answer in the April 2001 CAP TODAY about platelet clumping on EDTA and whether vortexing is an acceptable procedure. A common solution suggested was to redraw the specimen into sodium citrate or acid citrate dextrose (ACD). How do you calculate the correction factor for blood drawn in an ACD tube? Our lab has an old procedure for ACD correction, and it is to divide the RBC of the EDTA tube by the RBC count of the ACD tube. I don’t have any reference for this and would appreciate information.

December 2013—Our hematology standardization committee has asked us for input on performing cell counts on tubes No. 1 and No. 4 for cerebrospinal fluid. Each site in our system has a different protocol set up with its emergency department with regard to when a count is performed on tube No. 1 after counting tube No. 4. Some sites use RBC greater than five to automatically count tube No. 1 with or without an order to not delay patient care, whereas other sites use greater than 50 or greater than 200. Is there an established guideline recommendation for the number of RBCs seen on CSF tube No. 4 before doing an additional count on tube No. 1?

November 2013—Can you explain the logic behind doing a full workup for identification and sensitivity on multiple positive blood culture bottles on the same patient, drawn on the same day?

October 2013—We are standardizing procedures across our system. In thrombocytopenic patients with low platelet counts, some sites perform manual platelet counts using the Unopette system; others perform slide estimates to confirm an automated count. The need for improved turnaround times and greater accuracy and precision is clear. Are there studies that have evaluated the true accuracy of a low platelet count via a manual dilution technique versus the many automated techniques, and is there a true value in performing the time-consuming manual platelet count?

September 2013—Our clinicians are asking about testing for IgG4-related disease. What role does IgG4 immunohistochemical staining play? IgG4-related disease is a recently recognized fibroinflammatory condition that may affect a wide variety of organ systems, producing mass lesions and generally responding to immunosuppressive therapy. The pancreas, salivary/lacrimal glands, and kidney are frequently affected, but almost any tissue may be involved, including aorta, pleura, retroperitoneum, and lymph nodes.

August 2013—What are considered best practices for tracking re-sult trending in the lab? We use hemoglobin running mean in our hematology department because it is built into the analyzer software. The chemistry department will have a difficult time applying moving averages without purchasing middleware.

July 2013—Can you clarify the difference between the terms “optimization,” “validation,” and “verification” as used in immunohistochemistry? These three terms relate to the processes that the laboratory must undertake before new diagnostic, prognostic, or predictive immunohistochemistry markers are used for clinical and/or pathologic decisionmaking.

June 2013—Say an individual is stuck with an HIV-contaminated needle or occult infected with HIV by bodily fluid transmission and is started on preventive antiretroviral treatment to prevent permanent infection. (Treatment protocol is one-month intensive treatment.) Is there any known laboratory procedure by which a specimen could be isolated to determine by culture if the patient was indeed infected (assuming the patient is seronegative six months plus after treatment was initiated)?

May 2013—We are relocating to a new laboratory on a different floor in our hospital. There is little guidance from regulatory agencies on revalidating analyzers after the move. Decisions are left to the discretion of our pathologist. What kind of precision/accuracy/ normal range/patient sample/control testing do you recommend?

April 2013—In the point-of-care test for the determination of prothrombin time and International Normalized Ratio by fingerstick in a physician’s office, are controls (normal and elevated) available for adequate QC determination? Are physician office labs not governed by the same basic principles governing formal clinical laboratories? Are they permitted to run tests without running QC? Are there potential legal ramifications for having obtained an incorrect result for a POC test performed in a physician’s office without the proper use of QC, leading to a catastrophic patient result?

March 2013—Submit your pathology-related question for reply by appropriate medical consultants. CAP TODAY will make every effort to answer all relevant questions. However, those questions that are not of general interest may not receive a reply. For your question to be considered, you must include your name and address; this information will be omitted if your question is published in CAP TODAY.

February 2013—What are the limitations of using myoepithelial markers in diagnostic breast pathology? Immunohistochemical studies using antibodies to highlight myoepithelial cells (MEC) can be useful adjuncts to traditional morphologic diagnosis in the practice of breast pathology. Antibodies commonly used to detect MEC include smooth muscle actin, calponin, smooth muscle myosin heavy chain, p63, CD10, cytokeratin 5/6, and p75, and each shows varying sensitivity and specificity.