2015 Urinalysis1 Event Notes Shipment Date: January 26-27, 2015

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1 Agriculture Drive Madison, WI (800) Urinalysis1 Shipment Date: January 26-27, 2015 Important Information: PT Central Updates: Enhancements will continue to be added throughout % of participants are reporting results online at PT-Central, thank you. General instructions are located online at Event Name now appears on your home page next to result entry. Single SAVE function with results editable until the due date. Data submission report now contains attestation signature. Result form and Report Delivery options: The settings for your facility are noted in the demographic information in the upper right corner of your PT Central home page. Results can be entered online or by fax. Online data entry is encouraged. If the data entry option is set to web, paper result forms will not be sent with your PT sample shipments. The Report Delivery option is set to attachment, notification, or Paper. Paper reports will only be mailed to facilities that are not set up to receive s. Please notify us at or use the Contact Us option on the website if you wish to change your data entry or report settings. Please review the reports carefully before filing this packet with the rest of your PT records. Documentation of all decisions and actions concerning incorrect responses should be maintained with your event reports to satisfy regulatory requirements. After trouble-shooting or corrective actions are completed and documented, all reports should be reviewed, signed/initialed by the appropriate personnel, and filed with your proficiency testing records to document your participation. Questions or comments Programs/Modules: UR (3260) and UH (3290) PM (3170) or SU (3320) Chelli Gosda Tracy Servey x x53 Next Event Ships: July 20-21, 2015 Overview: Report Notes Page 2 Scoring Notes Page 2 Urinalysis and Urine hcg Pages 2-3 Provider Performed Microscopy and Urine Sediment Pages 3-6 General Scoring Policies and Information Page 7 Urinalysis1 Page 1 of 7

2 Report Notes: Your Primary result set Evaluation Report now has a cumulative Performance Summary section showing your current and two previous performances. Event Statistics Reports are available at under the Reports menu. The additional result set reports were sent as a separate report from the Primary result set. Laboratories receiving additional result set reports, please be aware that the responses listed under the Acceptable Response column on the additional result set report may not include all of the Acceptable Responses that you see on the Primary result set report. If you want a comprehensive list of the acceptable responses for a given sample/analyte please refer to you Primary Evaluation Report. Scoring Notes: Our paper result forms are two sided. This is indicated by the following statement that is pre-printed on the forms: CAUTION! Additional Result Options May Appear on Reverse Side of this Form. If results are recorded on both sides of the forms, you must fax both sides. Labs that did not fax both sides of their forms were given a 0% no results received for the missing results. Laboratories enrolled to report additional result sets in our Quality Evaluation site had exception code 46 (Not reported) applied to those additional result sets that were left blank. If a laboratory wants to permanently drop an analyte from their test menu, the lab must use exception code 45 (Drop analyte from menu). If a laboratory applied code 16 (Procedure/source not performed in-house ) and the intent was to have the analyte permanently dropped from their test menu, it was not dropped unless a supportive comment was provided to drop the analyte. Laboratories entering results online are strongly encouraged to review their Data Submission reports for any missing or incorrect data. Confirming specific gravity results using a refractometer: Some laboratories as part of their testing protocol will confirm a low specific gravity result from their visual read or auto read dipstick by using a refractometer. Laboratories confirming specific gravity results by refractometer should compare their result(s) to the acceptable ranges below. Acceptable ranges for Refractometry All Methods: 2015 UR-1: UR-2: UR-3: Urinalysis and Urine hcg: Leukocyte esterase Roche Chemstrip-visual sample 2015 UR-2: Roche Chemstrip-visual users were scored by the All Methods score group for sample 2015 UR-2. Affected labs will notice AG-All Method Group for sample UR-2 instead of PG-Roche Diagnostics Chemstrips-visual. Urobilinogen Clinitek Atlas and Novus sample 2015 UR-2: The Clinitek Atlas and Novus were Not Scored for urobilinogen on the darkly colored sample 2015 UR-2 because the responses were running lower for these two analyzers in comparison to the Clinitek and All Methods groups. This happened in a previous event with a darkly colored urine on the Atlas. Because the Atlas and the Novus have the ability to correct for color this may account for their lower results in comparison to the other analyzers Urinalysis1 Page 2 of 7

3 Reducing Substance: Sample 2015 UR-3 was Non-Consensus for the 2 drop method. This was most likely due to the color similarity of Negative vs. Trace. The target response was negative. Three labs had incorrect reporting formats for reducing substance. These labs were Not Scored for this event. The affected labs should self-evaluate using the table below depending on their methodology. Below is a list of data distribution for the 5 drop and 2 drop methods. Reducing Substance Data Distribution *Denotes acceptable response 2015 Urinalysis1 5 Drop Method 2015 Urinalysis1 2 Drop Method UR 1 UR 2 UR 3 UR 1 UR 2 UR 3 Response # % Response # % Negative * Negative ¼% * Trace * ½% * ½% * * ¾% * % * * % * % * * % or more * % 5% or more Urine hcg sample 2015 UH-3 Non-consensus (module 3290, 3310): The only scorable peer group (n > 5) for sample 2015 UH-3 was the Quidel QuickVue+. All other peer groups did not reach consensus (>80%). The target for this sample was positive. Our vendor tested the sample on a Dimension RXL which gave a quantitative result of 55 miu/ml. Affected labs will see Not scored non-consensus listed on their evaluation report under the Comments column. The table below can be used to help with your self-evaluation of this sample. Raw peer group data for urine hcg sample 2015 UH 3 hcg kit 2015 UH 3 Results hcg kit 2015 UH 3 Results Alere hcg Pos n=1, Neg n=1 Quidel RapidVue hcg Pos n=1 Beckman Coulter ICON 20 Pos n=1 Quidel QuickVue One Step Pos n=7, Neg n=3 Cardinal Health SP brand hcg Pos n= 2, Neg n=2 Quidel Quick Vue One Step Combo Pos n=2, Neg n=3 Sure Vue Pos n=2 Quidel QuickVue+ Pos n=6, Neg n=1 Sure Vue hcg STAT Pos n=7, Neg n=2 No method on file Pos n=2 Meridian Bioscience ImmunoCard STAT hcg Pos n=1 Provider Performed Microscopy and Urine Sediment: 2015 SU-1/PM-1 Urine Sediment The arrowed structure is an example of a waxy cast. Waxy casts are easily identifiable because of their characteristic morphology listed below: Have a high refractive index. Are usually cylindrical and broad. Easily observed in the microscopic sediment under brightfield microscopy. Have lateral margin cracks or crevasses and blunt ends. May demonstrate wrinkling as seen in this image. Thick, somewhat smooth waxy surface of a neutral pale tan color. Waxy casts are an infrequent finding in the urinary sediment. They are always pathologic and are most often associated with chronic renal failure. The cast in this image can be distinguished from a hyaline cast because hyaline casts have a low refractive index which makes them difficult to see using ordinary brightfield microscopy. Also, hyaline casts have a more delicate, fibrillary matrix, whereas a waxy cast appears much more solid. Broad and granular casts were not accepted because the cast in this image exhibits most of the usual features of a waxy cast, and because of the clinical importance of recognizing waxy casts, this cast should be classified as accurately as possible. Both Waxy cast and Would refer-abnormal were accepted as appropriate responses Urinalysis1 Page 3 of 7

4 A list of referee and participant responses appears in Table 1. Waxy cast Would Refer-Abnormal Table SU-1/PM-1 Distribution of Responses Waxy cast Hyaline cast Broad cast Granular cast Fiber Would Refer-Abnormal Other SU-2/PM-2 Urine Sediment The arrowed structure is an example of amorphous material. The term amorphous refers to formless and shapeless in the context of urine crystals. Two of the most common amorphous crystals found in urine are amorphous urates and amorphous phosphates. The two are microscopically indistinguishable and are differentiated based on the urine ph and their solubility characteristics. The table below illustrates the differences between amorphous phosphates and urates. Amorphous crystal Microscopic appearance Solubility characteristics Macroscopic appearance *Amorphous phospate Amorphous, granular, colorless Soluble in acid, insoluble at ~60 C Amorphous urate Amorphous, granular, colorless (can be yellow-brown) Soluble in alkali; soluble at ~60 C; converts to uric acid with concentrated HCL. *the amorphous material in this image is most likely amorphous phosphates because the ph is 8. White precipitate Orange-pink precipitate ( brick dust ) There were 18 labs that identified this amorphous material as artifact. To clarify, artifact refers to a number of contaminants that may be introduced when preparing urine sediment for examination. These would include muscle fibers and plant cells (secondary to fecal contamination), hair, air bubbles, oil droplets, scratches on glass slide, glass or plastic shards, synthetic fibers, starch, talc or pollen grains. This arrowed structure does not display any characteristics of these listed artifacts. Both Amorphous material and Would Refer-Abnormal were accepted as appropriate responses. A list of referee and participant responses appears in Table 2. Amorphous material Would refer - Abnormal 2015 Urinalysis1 Page 4 of 7

5 Table SU-2/PM-2 Distribution of Responses Amorphous material Artifact Would Refer-Abnormal <1 Bacteria <1 Ammonium biurate <1 Triple phosphate <1 Other PM-1 Wet Prep This vaginal wet preparation image is negative for the presence of clue cells, yeast, and Trichomonas. This image displays a cluster of overlapping squamous epithelial cells. Vaginal wet preparations are usually performed to assist with the diagnosis of vaginitis. This image lacks the presence of all three common causes of vaginitis (i.e., Trichomonas vaginalis, Gardnerella vaginalis [indicated by the presence of clue cells], and Candida albicans [yeast]). Yeast may be round or ovoid and are colorless cells that can closely represent red blood cells. Often, yeast present with characteristic elongate pseudohyphae with branching and terminal budding. Clue cells (indicator of Gardnerella vaginalis) are squamous epithelial cells covered with Gardnerella vaginalis coccobacilli. The bacterium covering the squamous epithelial cells gives the cytoplasm a refractile, stippled, or granular appearance with shaggy or bearded cell borders. To be reported as a clue cell, most (but not all) of the cell surface should be covered with bacteria and the bacteria should extend past the cytoplasmic margins. Squamous epithelial cells may have irregular keratohyaline granules in the cytoplasm that should not be mistaken for adherent bacteria. Trichomonas vaginalis is a flagellated protozoan that is usually pear shaped and about the same size as a large white blood cell or transitional epithelial cell. Three labs that faxed their results selected squamous epithelial cell from the urine sediment table of responses instead of the wet preparation table of responses listed on the supplemental instructions. Although squamous epithelial cells are present in this image, this was not accepted as an appropriate response for two reasons: Squamous epithelial cell is not a valid response under the wet preparation procedure. Typically, a vaginal wet preparation is used to determine the presence or absence of Trichomonas vaginalis, Gardnerella vaginalis (indicated by the presence of clue cells), and Candida albicans (yeast). It is not used to determine the presence or absence of squamous epithelial cells. Both No clue cells, yeast, or Trichomonas and No Trichomonas were accepted as appropriate responses. A list of referee and participant responses can be found in Table 3. No clue cells, yeast, or Trichomonas No Trichomonas 2015 Urinalysis1 Page 5 of 7

6 Table PM-1 Distribution of Responses No clue cells, yeast, or Trichomonas Clue cell present No Trichomonas Clue cells and Trichomonas present <1 Yeast <1 Other < PM-2 Wet Prep The arrowed structure in this image is Trichomonas ( trich ). Trichomonas vaginalis is a protozoan flagellate. Its habitat is the vagina and prostate, where it feeds on epithelial cells, leukocytes, and bacteria. The most helpful clue to identification of Trichomonas is the characteristic jerky and gently rotating movement in a wet mount. Although this important characteristic feature cannot be assessed in a photograph, you can still identify this arrowed structure as Trichomonas based on its size, posterior flagellum and pyriform or pear shape. There were 18 labs that reported Clue cells and Trichomonas present. There are squamous epithelial cells in this image, but they are not Clue cells. Clue cell was not accepted as an appropriate response for two reasons: Participants were supposed to identify the arrowed structure and the arrow is pointing to Trichomonas. As stated above, to be reported as a clue cell, most (but not all) of the cell surface should be covered with bacteria and the bacteria should extend past the cytoplasmic margins. Squamous epithelial cells may have irregular keratohyaline granules in the cytoplasm that should not be mistaken for adherent bacteria. Both Trichomonas and Would Refer-Abnormal were accepted as appropriate responses. A list of referee and participant responses can be found in Table 4. Trichomonas Would Refer-Abnormal Table PM-2 Distribution of Responses Trichomonas Clue cells and Trichomonas present Would Refer-Abnormal <1 References: Nancy A. Brunzel. Fundamentals of Urine and Body Fluid Analysis. W.B. Saunders Company, Karen Ringsrud and Jean Linné. Urinalysis and Body Fluids: A ColorText and Atlas. Mosby, Susan King Stasinger. Urinalysis and Body Fluids. F.A. Davis Company, Haber, Blomberg, Galagan, Glassy, Ward. Color Atlas of the Urinary Sediment. An illustrated Field Guide Based on Proficiency Testing. College of American Pathologists, Urinalysis1 Page 6 of 7

7 General Scoring Policies and Information: Non-consensus: If less than 80% of the results fall within the range for the peer group, the report will list not scored - non-consensus." Federal regulations require an automatic score of 100% when non-consensus occurs. Customers are required to self-evaluate and document acceptable performance for any non-consensus scores. Not scored: WSLH PT may choose to utilize this option in the following cases: If there are not enough participants using a specific instrument and/or method to create a statistically significant peer scoring group and results from that instrument/method could not be combined with other related instruments/methods to constitute a valid peer scoring group. If sample matrix or instrument/method incompatibility issues exist and results could not be scored by the All Methods scoring group. In both cases, results are given an automatic 100% but the score may not be indicative of instrument/method performance. This action requires the participant to perform a written self-evaluation of the affected analytes/samples as per CLIA regulations. Qualitative/Semi-quantitative scoring policies: Qualitative responses (positive/negative) are scored based on 80% or greater consensus for each method or peer group. Semi-quantitative responses are scored based on the mode (most frequent response) for each method or peer group. The mode and, usually, one response above and one response below the mode are considered acceptable. Additional responses (no more than four) may be selected until 80% or greater consensus is reached. If the mode reaches a consensus of 90% or greater, additional responses may not be accepted. Negative responses will not be added to positive responses to achieve 80% consensus. Methods that do not achieve 80% or greater consensus will not be scored and will automatically be given a 100% score for the challenge. Referee Scoring (urine sediment & wet prep): Scoring for urine sediment and wet prep is based upon consensus among referee laboratories. If the referee laboratories reach 80% or greater consensus on a sample, WSLH PT is required to score that sample according to the results obtained by the referee laboratories. Referee laboratories are selected from currently enrolled participants who achieved successful performance for the past three events and represent a mixture of both moderately complex and highly complex classifications. Disagreement with referee accepted responses can be documented on the participant s review of proficiency testing results, but scores CANNOT be changed by the proficiency provider. Use of Would Refer Abnormal result code 3996: if reporting Would Refer-Abnormal as your response, you must have proper internal documentation in place outlining your referral criteria for this type of cell/feature Urinalysis1 Page 7 of 7