general program guide table of contents - aab-pts

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GENERAL PROGRAM GUIDE TABLE OF CONTENTS General Instructions…………………………………………………………….............................................................................................2-5 Online Reporting Instructions……………………………………………………………..................................................................................6 Reporting Form Instructions...................................................................................................................................................7 Hematology………………............................................................................................................................................................8 Microbiology........................................................................................................................................................................8-9 Grading Procedures.........................................................................................................................................................10-11 Analyte Index...................................................................................................................................................................11-24 Proficiency Testing Corrective Action Form and Checklist…………………………………………………….............................................25 Investigation Checklist..........................................................................................................................................................26 Evaluating Proficiency Testing Results............................................................................................................................27-28 This new Program Guide format provides you with general program information and instructions. The specific program instructions are part of the reporting form attachments that come in every shipment. This allows us to keep the information current for each event. We maintain an online Program Guide that provides you with all the program specific instructions and information that includes photos of the samples shipped to help identify what you are receiving. You can access this Program Guide by going to our homepage www.aab-pts.org and clicking on the Program Guide link icon on the left side of the page.

http://www.aab-pts.org/

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GENERAL INSTRUCTIONS PRECAUTIONS All units of human blood or blood products used in preparing specimens, except those used in the Hepatitis and HIV Markers program, have tested negative for HBsAg, HCV antibody and HIV antibody at the donor level. When handling specimens from AAB-PTS, follow all precautions and recommendations from CDC and FDA, as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182). These recommendations and rules include but are not limited to the following:

1. The specimens should be handled only while wearing impermeable gloves. 2. Gloves should be replaced if torn or contaminated. 3. Specimens should be opened wearing a face shield or other appropriate eye, nose and mouth protection. 4. Do not pipet by mouth. 5. No eating, drinking or smoking is allowed in the laboratory. 6. Before leaving testing area, wash hands after removing gloves. 7. Specimens should be disposed of as biohazardous waste.

RECEIPT OF THE KIT • Samples are shipped via Federal Express. • E-mail notification of the FedEx tracking number is sent the day of each shipment to those participants that have

registered for email services. Call Customer Service to register. 800-234-5315. • Open immediately upon arrival. Check for damaged or missing specimens. • Call 800-234-5315 if replacements are required. Replacements will be sent only until the Monday following the

shipment date. Hours are Monday thru Friday 8 a.m. - 5 p.m. Central Time. • Most samples require refrigerated storage upon receipt and some frozen storage if not testing immediately.

Please open the kit and read storage instructions. Special instructions beyond refrigeration are found on the program reporting forms and in this Program Guide. Store samples as directed until they are analyzed.

• Participants are responsible for notifying AAB when the testing kit has not been received within 3 days of the shipment date.

• Alternate shipping dates cannot be provided. TESTING REGULATIONS The Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) requires PT specimens to be analyzed as if they were patient specimens. To be in compliance you must not delay testing PT specimens unless your patient testing is also being delayed. Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Failure to return PT results or have them postmarked by the cut-off date displayed in the 2018 schedule on page 4 is unsatisfactory performance and results in a score of 0 for the testing event. Per CMS requirement, under no circumstances should you ever send any proficiency testing sample to another laboratory for testing. This emphatically includes samples that you would normally send out for confirmation or follow up identification. This is to be followed REGARDLESS of your laboratory policy on such follow up testing. CMS will immediately revoke the license of any laboratory found to be referring proficiency testing samples, even if they are following their laboratory procedures for confirmation. Equally, CMS requires that you not perform testing on any sample that you suspect may be a proficiency testing sample received from another laboratory. You also must report laboratories you suspect of such activity. Severe penalties will apply to laboratories that perform proficiency testing for other laboratories or sites as well.

SPECIMEN HANDLING AND TESTING • Handle and test proficiency samples as you would patient samples unless otherwise instructed in the specific

program instructions in this Program Guide and reporting form instructions included in the event shipment. • Perform repeat or duplicate testing according to your laboratory’s protocol for repeat testing.

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GENERAL INSTRUCTIONS - continued REPORTING RESULTS

• See the sample reporting form on page 7 for more specific instructions on executing the forms. • To submit results via the internet, please see the instructions for online reporting on page 6 or go to the

website, www.aab-pts.org, for instructions. • The attestation statement on the Centers for Medicare and Medicaid Services (CMS) - scored analytes forms

must be signed for each analyte by the analyst performing the procedure. In addition to the analysts’ signatures, the director or the director’s designee must sign only once for each reporting form. The designee for moderate complexity testing is the technical consultant while the technical supervisor is the designee for high complexity testing. There is an attestation statement for non-CMS scored modules (1 & 2 vial programs). If your state or other regulating agency requires attestations for these programs, complete the general attestation form that is provided with your reporting form. CAP Participants, please note. The College of American Pathologists requires a signed attestation for all analytes.

• Retain the completed attestation statements for your records. Do not send the signed attestation statements with your mailed results. They are not required for grading and not kept on file.

• Retain photocopies of your results and submit the original printed forms in the envelope provided. For online results, be sure to click the SUBMIT button. Be sure to print the final results page which includes your confirmation number. No corrections can be made for any results without a confirmation number.

• Photocopies of the original forms must meet the requirements described page 7 for use in submitting mail results.

• Results must be postmarked by the cut-off date displayed in the 2019 schedule and in the General Instructions for each event.

• Late results will not be processed and will be scored as zero as per CMS. • AAB is not responsible for results lost or delayed in the mail. Please consider taking advantage of our online

reporting. If online reporting is not an option for you, consider the use of either an overnight service or a 2-day service that can provide confirmation of delivery.

CODING YOUR METHODS Each shipment includes Instruction sheets. Do not return the instruction sheets with your reports as they are for your use.

Method Data sheets are included with each shipment, which include your specific reported Method Codes from the last reporting event. Since this data will determine how your currently reported results will be evaluated, please verify the entries in this list. If an entry is correct, do not recode it. If entries are missing or incorrect, please amend this list by coding/recoding method data directly on your results form(s). One exception is the Method Codes for WHOLE BLOOD GLUCOSE. These must be entered each time.

When coding your methods, ensure that you use current method codes. Refer only to those codes listed in reporting form, the General Instructions pages or the Method Code Addendum for the current event. Only method codes (not method descriptions) can be used to code participants’ methods on the reporting forms.

If no acceptable method description can be found in the method list, leave the method code blank. Paperclip a package insert and/or method description to the report and we will code your method. If submitting results online, enter comment and fax insert and/or method description to 713-781-5008. Please write your AAB account number on the insert to allow us to match the new method with your results. If you do not report, or if you are late in reporting your results for an event, your method codes will be deleted from our database. You must recode all methods, reagents and instruments the following event or your results will be graded as “Method Code Not Reported”. Coding a method other than the one actually being used usually jeopardizes a participant’s grading, even when results are transformed to mimic those of the method coded. We strongly recommend that participants report their results without transforming them to look like results from a method other than the one actually being used. Reporting untransformed results is not in violation of CLIA ‘88. CLIA ‘88 mandates that sample processing (not result processing) conform to that routinely applied to patient specimens.

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SECONDARY METHODS / INSTRUMENTATION PT samples must be treated the same as patient testing. Testing proficiency samples by more than one test method or instrument during an event is not permitted by CMS, unless patients are also subjected to such testing.

CMS SCORING INSTRUCTIONS All scores for CLIA regulated analytes are automatically sent to CMS and State Agencies. Results are also sent to COLA and the CAP for participants that supply a COLA or LAP number. Scores will appear on the CMS cumulative score sheet only for those analytes that are regulated. The lists below indicate the priority assigned for reporting CLIA equivalent analyte groups to report to CMS. If you would prefer that different analyte from a group be preferentially sent to CMS, please let us know in writing as to your preference and we will be happy to accommodate your needs.

Bacterial Antigen Screen Hematology Parasitology Strep A Antigen Screen WBC Auto Differential Parasitology Chlamydia Antigen Screen Blood Cell Identification Cryptosporidium GC Antigen Antigen Screen Giardia Strep B Antigen Screen hCG / Pregnancy C. dificile A hCG/b-hCG (quantitative) pO2 / pCO2 / pH C. dificile B Serum pregnancy (qual. Basic Chem) Blood Gases Serum pregnancy (qualitative) i-STAT Chemistry Bilirubin, Total Urine pregnancy (qualitative) Basic Chemistry Syphilis Serology Bilirubin, Supplemental, 5-vial HIV FTA-ABS Anti-HIV-1 Confirmation MHA-TP/TP-PA Chloride/Potassium/Sodium Anti-HIV-1 Screen VDRL/USR Basic Chemistry Oral Fluid HIV Screen EIA Blood Gases Oral Fluid HIV Western Blot RPR, RST, Trust i-STAT Chemistry Microbiology Viral Antigen Screen Coagulation Bacteriology Influenza A Prothrombin Time Throat/Urine Influenza B Whole Blood Prothrombin Time Urine Respiratory Syncytial Virus (RSV Coaguchek XS Plus, Protime, Comp Throat Rota Virus GC Culture Glucose Gardnerella Serum Glucose Blood Gases i-STAT, Serum Whole Blood Glucose

Please follow all directions in filling out your reporting form completely. Once a report is graded, CMS does not allow for corrections due to participant’s clerical and/or omission errors.

If you are unable to participate for a proficiency testing event, you must notify us in writing in advance of the event close. A CLIA requirement for excused non-participation is that patient testing not be performed during the timeframe of the event. Therefore your statement of intent not to participate must include an attestation that patient testing is not being performed at the time of the event, the reason for not participating in a proficiency testing and event when or if patient testing is expected to resume. This excused non-participation can only be granted once within a reporting year. If the non-testing is permanent or has no anticipated resumption, then you will receive a code of “Dc” indicating to CMS or your CLIA deemed authority that you are no longer performing this test. You must indicate that you are discontinuing testing to receive a “Dc”.

If you anticipate resumption of testing by the next scheduled testing event, and if you meet the CLIA requirement of participation in the two prior events, you will receive a code of “Er” or exclusion requested. Please be aware, that a code of “Er” is subject to review by CMS or your CLIA deemed authority. We are required to abide by their decision and will remove the “Er” and convert your report to “NR” with a score of 0 if they feel your reason for non-participation is inadequate.

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CMS SCORING INSTRUCTIONS - continued CMS requires that laboratories failing to participate in testing events to be given unsatisfactory performance and results in a score of 0 for that testing event. CLIA Law states in PART 493--LABORATORY REQUIREMENTS, Subpart H- 493.823(b) the following: Sec. 493.823 Standard; Bacteriology (b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if--

1. Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results;

2. The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and

3. The laboratory participated in the previous two proficiency testing events. CORRECTIVE ACTION If the evaluation of your results indicates that corrective action is necessary, the Corrective Action Forms on the back section of this guide may be copied and completed for your internal records. Do not submit these forms to AAB as it is for your internal use only. Remember that ungraded samples require review. You must determine that you have met the CMS requirement to demonstrate the accuracy of your method. If your review indicates you may have an accuracy problem, you must complete a corrective action just as if you were flagged for a miss. ADDRESS CHANGES Address changes must be received in writing by either fax, email, or mail on institutional letterhead. Notice must be received 14 days prior to the next shipment date for the address to be updated. Participants will be responsible for shipping charges to resend a shipment due to a late address change. CANCELLATION POLICY A cancellation notice, on institutional letterhead, must be received by fax, email or mail 21 days prior to the shipping date in order to receive a credit or refund on a future shipment. Late enrollments received within the 21 days prior to the shipment waive the cancellation policy and no credit will be issued. The registration fee is nonrefundable.

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ONLINE REPORTING INSTRUCTIONS Go to www.aab-pts.org. Log on using your account number (do not type any leading zeros) and password. Your initial password is the last 5 digits of your account number; you can change this password after you log in. Please refer to the reporting forms you received with your specimens for result codes, method codes and special instructions. For questions pertaining to methods, testing procedures, or specimen problems call 800-234-5315 opt. 2 to contact technical support. You are required to sign and keep the Attestation Statement for your records (see reporting forms). Do not submit sign forms. For your convenience, we have included the Attestation Statement on your online reporting form(s). You can print and sign these forms for your records. If you have any questions pertaining to the submission of results via the internet, please call. The preferred method of reporting is via online submission, however if you prefer to mail your results, remember that the envelope must be postmarked by the cut-off date located on your reporting form. You will assume full responsibility for lost or delayed results that are sent by mail. Do not submit both mailed and online results.

IMPORTANT!

After logging in, please check the e-mail addresses we have on file by clicking “Update Account”.

1. Go to the Login page (http://www.aab-pts.org) a. Enter your AAB Account Number & Password and click “Submit”. Disregard leading zero. b. If this is your first time logging on you will can call Customer Service at 800-234-5315 for your initial

password or click “New Account?” in the Log on: box. Otherwise use your established password. 2. For qualitative results do not enter anything in the result fields other than the numeric codes listed on the

forms. Characters such as “+ -, pos neg, P or N” will not be recognized and results will not be processed. Note. When using the dropdowns, the fields will populate correctly.

3. Most method codes do not have to be entered if we have your codes on file from the previous reporting period. If you did not submit results for the previous shipment, then you will have to reenter your method codes. Your online report form will be prepopulated with the last code used. You can also see the “Method Data Sheet” for the current codes we have on file for your lab. This sheet is a historical representation of method and instrument codes reported and may include codes for analytes no longer reported by your lab.

4. Please enter the less than (<) and greater than (>) signs when appropriate in the online result field along with your lowest or highest reportable range.

5. Decimal points are designated for each analyte. The online reporting forms have fixed decimal place holders. For both online and paper reporting forms, be sure to enter proper decimal point designations. Boxes to the right of a decimal point should not be left blank.

6. After you complete each form, click the “Submit” button and print a copy for your records. The form you print should indicate a status of “Submitted” and include your confirmation number. Results are not accepted without a valid confirmation number. If you need to make changes to your form after clicking “Submit” simply click “Unlock This Form” and resubmit before the deadline. You must submit before adding any comments.

7. The on-line cut-off date and time is strictly enforced and once the deadline has passed you will no longer be able to enter results. Be certain to click submit and print a copy of your form.

We highly recommend you do not wait until the last day for on-line reporting to begin entering your results. Results reported on-line are downloaded at 10:00 pm Central time on the posted date, therefore, if you happen to still be logged on after the cut-off time, results will not be evaluated.

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MANUAL REPORTING INSTRUCTIONS

These forms are designed to be read by a scanner which translates hand print into characters a computer can use thus reducing human intervention. You can photo copy the blank form as a backup in case you need to correct an entry. The backup blank photocopy must show the complete barcodes at the top and bottom of each form. Please exercise care in filling out these forms. To ensure that your results are translated correctly please follow the rules listed below.

• Please adhere to the decimal points that appear on the form. Do not add decimal positions that do not appear on the form. This is also true if you report on-line using the web-based forms. The scanner will ignore any decimal points not already on the form. Example: If you enter a value such as “9.0” in a field that requires whole numbers, your result will be recorded as “90”. It is also very important to zero fill all positions to the right of the decimal points where applicable.

• Use a ball point pen with black or blue ink. • Place entries wholly within the result boxes. • Fill the bubbles completely. Do not mark with checkmark or X. • Do not write comments on the reporting form. These forms are scanned, and comments may not be detected.

Include a separate page with your account number and your comments. • Do not draw lines across the page. If you do not perform a procedure, simply leave it blank. • Do not use highlighters. Do not staple. Do not punch holes. • Photo copy the blank form as a backup in case you need to correct an entry. The backup blank photocopy

must show the complete barcodes at the top and bottom of each form. Complete barcodes will show both carats on either side. See below.

• Do not tape or stick anything to the form. • Do not include your machine print-outs unless you are communicating a problem running the tests. • Submit the completed original reporting form. Keep photocopies are for your records. Signed Attestations

Statements are for your records. Do not submit with your results. • When calling with questions regarding reporting, please have the AAB account number available so as to

expedite. Both carats ( ^ ) must appear at both ends of the barcodes at the top and bottom of the backup blank photocopies.

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HEMATOLOGY GENERAL HEMATOLOGY INSTRUCTIONS Mixing Instructions All specimens for all programs must reach room temperature (18- 25oC) before being re-suspended. To re-suspend contents, roll the vials between the palms of the hands for 20 seconds in upright, then inverted positions. Place the vials on a mechanical mixer or gently invert manually for five minutes per instructions. Please review specific program instructions to verify if a mechanical mixer is permitted for your samples.

General Precautions Automated Instrument Issues-Participants may experience “backlit” white counts or “R” codes; without any other indications of specimen degradation. Participants need not be reluctant to report these results.

General Reporting Precautions Participants with 1-part differential instruments use only the first line designated “Lymphocytes” in the differential section of their forms. Participants with 2-part differential instruments must not use the second line designated “MD/MID/Mixed/Mono/Other” in the differential section of their forms; these participants must report one part on the “Lymphocytes” line and the remaining part on the “Granulocytes” line, regardless of more inclusive terms on their instruments (such as “MO+GR”). Some participants have instruments that report specific granulocyte results (eosinophils and basophils) in addition to the total granulocyte count. These participants should use a 5-part differential appropriate for their specific instrument. Diff B, C, E and G are 5-part differential programs. Diff A and D are 3-part differential programs MICROBIOLOGY

Determining Type (Extent) of Laboratory Service-All participants, regardless of the extent of their laboratory practice, evaluate the same specimens. In order to be graded appropriately, you must report the extent of laboratory practice (Extent 0, 1, 2, 3, 4 or 5) for each specimen according to the CLIA regulations below.

§ 493.911 Bacteriology. a) Types of services offered by laboratories. In bacteriology, for proficiency testing purposes, there are five

types of laboratories: 1) Those that interpret Gram stains or perform primary inoculation, or both; and refer cultures to another

laboratory appropriately certified for the subspecialty of bacteriology for identification; 2) Those that use direct antigen techniques to detect an organism and may also interpret Gram stains or

perform primary inoculation, or perform any combination of these; 3) Those that, in addition to interpreting Gram stains, performing primary inoculations, and using direct

antigen tests, also isolate and identify aerobic bacteria from throat, urine, cervical, or urethral discharge specimens to the genus level and may also perform antimicrobial susceptibility tests on selected isolated microorganisms;

4) Those that perform the services in paragraph (a)(3) of this section and also isolate and identify aerobic bacteria from any source to the species level and may also perform antimicrobial susceptibility tests; and

5) Those that perform the services in paragraph (a)(4) of this section and also isolate and identify anaerobic bacteria from any source.

Determine your extent as follows: Extent 0. Those that do not process or would refer this specimen source to another laboratory appropriately certified for the subspecialty of bacteriology for identification. Extent 1. Those that interpret Gram stains or perform primary inoculation, or both; and refer cultures to another laboratory appropriately certified for the subspecialty of bacteriology for identification. Extent 2. Those that use direct antigen techniques to detect an organism and may also interpret Gram stains or perform primary inoculation or perform any combination of these. Extent 3. Those that, in additions to interpreting Gram stains, performing primary inoculations, and using direct antigen tests, also isolate and identify aerobic bacteria from throat, urine, cervical, or urethral discharge specimens to the genus level and may also perform antimicrobial susceptibility tests on selected isolated microorganisms.

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MICROBIOLOGY – continued Extent 4. Those that perform the services of Extent 3 laboratory and also isolate and identify aerobic bacteria from any source to the species level and may also perform antimicrobial susceptibility tests. Extent 5. Those that perform the services of Extent 4 laboratory and also isolate and identify anaerobic bacteria from any source.

• Subject each specimen to your protocol for each source as described at each specimen number on your reporting form.

• Based on what you would report in the context of your specific laboratory practice, determine your extent for each specimen independently of each other, according to the definitions on the reporting form and clarified in the following table:

Results Reported Extent (Type) of Laboratory Service

0 1 2 3 4 5 Gram Stain must

not report may

report may

report may

report may

report may

report Antigen Screen must

not report may

report must

report may

report may

report may

report Antimicrobial Susceptibility Testing (ASTs)*

may report

may report

may report

may report

may report

may report

Identification to Genus Only

must not report

may report

may report

must report

must not report

must not report

Speciation of Aerobes

must not report

may report

may report

may report

must report

must report

Identification of Anaerobes

must not report

may report

may report

may report

may report

must report

*Reporting ASTs applies only to Specimen 1 and assumes the use of pure isolates. Participants performing ASTs without identifications, even presumptive ones, must use Extent 0 on Specimen 1 to avoid being given a score of zero for missing culture results.

We are required to categorize participants by extents and labs who fail to report their extent will be categorized as Extent 5. This must be reported with each event. For proficiency testing, you are required to report to the same extent as you would a patient. You may select a different Extent for each specimen. Your surveyor will evaluate your reports accordingly.

Coding for Presumptive Culture Identification-Participants reporting presumptive identifications by culture must not use result codes 750 to 911. If performing isolations only with selective media, these participants might need to report code 948 (No pathogen isolated), but should not report either code 949 (No aerobic growth) or 951 (No aerobic or anaerobic growth). CMS requires that we challenge many common pathogens found in a specific sample type. When reporting a negative result, select an answer which reflects the organisms you would normally detect (i.e. select code 927 if you only screen for Strep A and do not test for N. gonorrhoeae with throat cultures.)

Coding Extent 3, 4 and 5 Results-For Specimens 1, 2, 3 and 4, participants using Extent 3, 4 or 5 can report only the organism(s) which they consider to be the significant pathogen(s) that is/are clearly responsible for the illness described, excluding immunocompromised patients. Opportunistic pathogens occurring in immunocompromised patients, when included, will always appear in Specimen 5. All organisms, non-pathogens as well as pathogens, must be identified in Specimen 5. Code your answers using the Result Code list on the Microbiology Instructions. Antimicrobial susceptibility tests (ASTs) are to be performed on the most significant pathogen in Specimen 1 only, using the AST codes listed on the Microbiology Instructions. Caution: If you routinely report ASTs, but do not report ASTs for a particular specimen type or organism, you must report Result Code 100 or 196 as appropriate to your normal laboratory handling of such organism/specimens. Failure to do so will result in a Did Not Report being sent to CMS. Otherwise, leave method and result blank if you do not perform susceptibility testing in your lab. Due to CMS requirements, participants will be flagged for inappropriate selection of AST’s, as listed in the latest version of CLSI guidelines for Microbiology: M02-A12, M07-A10, and M100-S27.

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GRADING PROCEDURES INTRODUCTION Grading procedures must conform to the February 28, 1992 Final Rule which implements the CLIA ‘88. This rule retains two practices previously mandated regulations from CMS:

1. The principle of peer grading (participant consensus) determines target values (satisfactory performance), especially for quantitative results.

2. The principle of medical (fixed) performance standards primarily determines grading limits, but not to the total exclusion of the principle of methodological (statistical) performance standards.

CONSENSUS GRADING The grading of all results depends on the existence of a consensus of acceptable results. For most analytes or procedures, CMS defines consensus as acceptable performance among 80% or more of results from all participants or referees. Per CMS guidelines, if 80% consensus is achieved laboratories or referee laboratories, then the analyte must be graded. Exceptions to this rule exist for all CMS-scored procedures in Immunohematology, in which consensus is defined as agreement among 95% or more of results from all participants or referees.

SPECIAL GRADING FORMULAS IN MICROBIOLOGY When consensus grading is applied to microbiology modules in which more than one response may be reported for a given procedure in the same specimen, special formulas for generating percent scores for each specimen are mandated by the February 28 Rule of 1992. These formulas thus govern the grading of organism identifications and/ or antimicrobial susceptibilities in Bacteriology, GC Culture, Parasitology, Throat, Throat/Urine and Urine Culture programs.

For scoring organism identifications in a given specimen, the following ratio of responses is multiplied by 100: 1. The numerator is the sum of all gradable correct participant responses. Only one participant response per

organism is counted, and, in cases in which more than one response is given per organism, only the most definitive answer is used. For example, a species name takes precedence over a genus name which, in turn, takes precedence over an antigen screen result which, in turn, takes precedence over a gram stain result.

2. The denominator is the sum of all incorrect responses for the presence of organisms plus the total number of gradable correct responses for the specimen.

Since AAB determines which organism(s) to place in each specimen, AAB determines the total number of gradable correct responses for the presence of organisms.

For scoring antimicrobial susceptibilities in a given specimen, the following ratio of responses is multiplied by 100: 1. The numerator is the sum of all gradable correct responses. 2. The denominator is the sum of all responses.

Since each participant determines which antimicrobials to report on their patient specimens, each participant determines the total number of antimicrobial susceptibilities to report on PT specimens. The only reporting requirement is that the susceptibilities reported on a proficiency test specimen reflect the same list of drugs which would be tested by the laboratory on patient material in the same clinical context as that of the proficiency specimen.

PEER GROUPS FOR QUANTITATIVE RESULTS To provide optimal peer based grading, quantitative results are grouped by various means depending on the analyte. Primarily this is either by Method or by Instrument and Reagent. Various checks are run to insure that peer groups are statistically valid. If a group is deemed to not be statistically valid; most typically due to an insufficient number of members, a waterfall approach is taken to grading. This is to satisfy CMS requirements that once an analyte has achieved consensus of participant or referee results, every result which can be assigned to a statistically valid peer group must be evaluated. The waterfall process is analyte specific, but typically follows the path Reagent and Instrument -> Reagent -> Method Principle -> Total Population. Each default group is subject to similar validity checks before evaluation. Results are evaluated against the most granular default level which passes validity checks. Analyte composition or form may replace Method Principle for some analytes; e.g., intact vs N-terminal PTH. Other analytes where standardization is sufficient or even required are graded against Total Population only. Some analytes are evaluated against gold standard established reference values; e.g. eGFR certification for Creatinine.

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GRADING PROCEDURES - continued WOULD REFER “Would Refer” is a special response available for some interpretive programs such as Microbiology, Clinical Microscopy or Hematology with Manual Differential. It represents the situation where you would refer a non-routine result on to another entity such as a reference laboratory or pathologist for further interpretation or for a final result. You may only enter this response if this is your laboratory’s standard procedure for handling patient samples with similar results. You may not enter “Would Refer” for all 5 specimens in these programs. If you do report “Would Refer” for all 5 specimens, the grading record will be deleted from the current testing event only.

ANALYTE INDEX INTRODUCTION “Fixed” grading limits use either a constant concentration (type C limits) or a constant percentage of the target value (type P limits) to define a range of acceptable performance above and below the target value.

The target value for qualitative or semi-quantitative results is the most frequently reported (consensus) value(s) of all valid results.

The target value for quantitative results is the mean of all results after removal of outliers. In contrast to fixed limits, limits based on standard deviations (SDs) can lead to different grading ranges for the same analyte, even when different peer groups have the same means.

The limits required by CMS consist of all three types discussed above; fixed concentration (type C), fixed percentage (type P), and 3SD (type S):

• type C - plus/minus a fixed concentration from the mean; used in the absence of type P limits or when these limits exceed type P limits

• type P - the mean plus/minus a fixed percentage of the mean; used in the absence of type C limits or when these limits exceed type C limits

• type S - plus/minus three standard deviations (SDs) from the mean; mandated by CMS in the absence of type C and/or type P limits

All three types of CMS grading limits are used. Not all analytes listed have CMS limits.

Proficiency testing is not required by CMS or other agencies for analytes/procedures which have no CMS-mandated grading limits. Such analytes/procedures are identified in the Analytes Index as well as on the reporting forms.

Results for these CMS-unscored analytes are not included in computing participants’ overall CMS subspecialty scores. Therefore, these scores do not appear on CMS Cumulative Summary reports; they appear only on graded reports (which do not go to CMS).

In the interest of uniformity, the limits used for CMS-unscored analytes are derived from those used for CMS-scored analytes which are similar.

A listing of the limits used for all analytes/procedures, both CMS-scored (regulated analytes) and CMS-unscored, follows.

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CMS Regulated

CAP Accepted

Program Analyte SD

Grading Limits Concentration %

NR NR = CAP acceptance not required

Adulterated Urine NR Creatinine, Urine 3 mg/dL 15 NR Nitrite, Urine pos/neg, +/- 1 pad NR pH, Urine 0.5 (+/- 1pad) NR Specific Gravity, Urine 0.01

NR Interpretation correct/incorrect Alcohol CAP Acetone pos/neg, +/- 1 pad

CMS CAP Alcohol (Ethanol) 25 Beta Hydroxybutyrate (qualitative) 0.1 mmol/L 20

Ammonia NR Ammonia, Serum 10 umol/L 10

Bilirubin, Direct/Neonatal, 2 vial add-on CAP Bilirubin, Direct 0.4 mg/dL 20 CAP Bilirubin, Neonatal 0.4 mg/dL 20 Bilirubin, Total 0.4 mg/dL 20

Bilirubin, Direct/Neonatal, 5 vial CAP Bilirubin, Direct 0.4 mg/dL 20 CAP Bilirubin, Neonatal 0.4 mg/dL 20

CMS Bilirubin, Total 0.4 mg/dL 20

Blood Gases CAP Calcium, Ionized 0.25 mmol/L

CMS CAP Chloride 5 CMS CAP Glucose 6 mg/dL 10

Lactate (Lactic Acid), Whole Blood 2 mg/dL 25 CMS CAP pCO2 5.0 mm Hg 8 CMS CAP pH, Blood Gas 0.04 CMS CAP pO2 3SD CMS CAP Potassium 0.5 mmol/L CMS CAP Sodium 4 mmol/L

Cardiac Markers, 5-vial CAP BNP 3SD 20 pg/mL

CMS CAP CK-2/CKMB 3SD Myoglobin, Quantitative 15 ng/mL 30 CAP NT-proBNP 3SD 20 pg/mL CAP Troponin I 0.2 ng/mL 25 Troponin T 0.1 ng/mL 30

Cardiac Markers, 2-vial BNP 3SD 20 pg/mL Myoglobin, Quantitative 15 ng/mL 30 NT-proBNP 3SD 20 pg/mL Troponin I 0.2 ng/mL 25 Troponin T 0.1 ng/mL 30

Chemistry, Basic CMS CAP Albumin 10 CMS CAP Alkaline Phosphatase 30 CMS CAP ALT/SGPT 20 CMS CAP AST/SGOT 20

CAP Bicarbonate (CO2) 4 mEq/L 20

13 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


CMS CAP Bilirubin, Total 0.4 mg/dL 20 CMS CAP Calcium 1.0 mg/dL CMS CAP Chloride 5 CMS CAP Cholesterol, Total 10 CMS CAP Creatinine 0.3 mg/dL 15 CMS CAP Glucose 6 mg/dL 10

CAP Phosphorus 0.4 mg/dL 15 CMS CAP Potassium 0.5 mmol/L CMS CAP Pregnancy, Serum Qualitative pos/neg CMS CAP Protein, Total 10 CMS CAP Sodium 4 mmol/L CMS CAP Triglycerides 25 CMS CAP Urea Nitrogen, Blood 2 mg/dL 9 CMS CAP Uric Acid 17

Chemistry, Comprehensive CMS CAP Alpha-fetoprotein (AFP) 3SD CMS CAP Amylase, Serum/Plasma 30

CAP Bilirubin, Direct 0.4 mg/dL 20 CMS CAP Cortisol 25 CMS CAP Creatine Kinase, Total (CK or CPK) 30

NR Fructosamine, DMF 0.45 mmol/L 30 NR Fructosamine, Polylysine 45 mmol/L 30

CAP Gamma-Glutamyl Transferase (GGT) 10 IU/L 20 CMS CAP hCG Test, Serum Quantitative 3SD CMS CAP Iron 20 CMS CAP Lactate Dehydrogenase, Total (LD/LDH) 20

CAP Lactic Acid, Serum 0.3 mmol/L 25 CAP Lipase 30

CMS CAP Magnesium, mg/dL 25 CMS CAP Magnesium, mEq/L 25 CMS CAP T Uptake 3SD CMS CAP T3 (Triiodothyronine), Total 3SD CMS CAP T4 (Thyroxin), Free 3SD CMS CAP T4 (Thyroxin), Total 1.0 ugdL 20 CMS CAP Thyroid Stimulating Hormone (TSH) 3SD

Chemistry, i-STAT waived Bicarbonate (CO2) 4 mEq/L 20 Calcium, Ionized 0.25 mmol/L Chloride 5 Creatinine 0.3 mg/dL 15 Glucose 6 mg/dL 10 Hematocrit 6 Hemoglobin 7 Potassium 0.5 mEq/L Sodium 4 mEq/L Urea Nitrogen, Blood 2 mg/dL 9

Chemistry, i-STAT, non-waived Bicarbonate (CO2) 4 mEq/L 20 CAP Calcium, Ionized 0.25 mmol/L

CMS CAP Chloride 5 CMS CAP Creatinine 0.3 mg/dL 15 CMS CAP Glucose 6 mg/dL 10

14 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7

Lactate (Lactic Acid), Whole Blood 2 mg/dL 25 Magnesium, Ionized 25

CMS CAP pCO2 5.0 mm Hg 8 CMS CAP pH, Blood Gas 0.04 CMS CAP pO2 3SD CMS CAP Potassium 0.5 mmol/L CMS CAP Sodium 4 mmol/L CMS CAP Urea Nitrogen, Blood 2 mg/dL 9

Chemistry, Special CAP Ferritin 4.5 ng/mL 30 CAP Folate 0.9 ng/mL 30 CAP Homocysteine 2.5 umol/L 20 CAP Pre-albumin 25 CAP Prolactin 3.6 ng/mL 30 CAP Prostate-specific Antigen (PSA), Total 0.9 ng/mL 30 CAP T3 (Triiodothyronine), Free 0.3 ng/mL 30 CAP Testosterone,Total 0.3 ng/mL 30 CAP Vitamin B12 60 pg/mL 30

Chemistry, Urine/Fluids Albumin, Fluids 10 CAP Amylase, Urine/Fluids 30 CAP Calcium, Urine 1.0 mg/dL CAP Chloride, Urine/Fluids 5 Cholesterol, Fluids 10 CAP Creatinine, Fluids 3 mg/dL 15 CAP Glucose, Urine/Fluids 6 mg/dL 10 Lactic Acid, Fluids 0.3 mmol/L 25 Lactate Dehydrogenase (LD or LDH), Fluids 20 CAP Magnesium, Urine 25 Osmolality, Urine 9 mOsm/kg 10 pH, Fluids 0.5 CAP Phosphorus, Urine 3mg/dL 15 CAP Potassium, Urine 3mmol/L 15 CAP Protein, Total, Urine/Fluids 1 mg/L 25 CAP Sodium, Urine/Fluids 4 mmol/L 4 Triglycerides, Fluids 25 CAP Urea Nitrogen, Urine 9 CAP Uric Acid, Urine/Fluids 0.3 mg/dL 17

Chemistry, waived Albumin 10 Alkaline Phosphatase 30 ALT/SGPT 20 AST/SGOT 20 Bicarbonate (CO2) 4 mEq/L 20 Bilirubin, Total 0.4 mg/dL 20 Calcium 1.0 mg/dL Chloride 5 Cholesterol, HDL 30 Cholesterol, Total 10 Creatine Kinase, Total (CK or CPK) 30

15 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


Creatinine 0.3 mg/dL 15 Gamma-Glutamyl Transferase (GGT) 10 IU/L 20 CAP Glucose 6 mg/dL 10

Phosphorus 0.4 mg/dL 15 Potassium 0.5 mmol/L Protein, Total 10 Sodium 4 mmol/L Triglycerides 25 Urea Nitrogen, Blood 2 mg/dL 9 Uric Acid 17

C-Reactive Protein, high sensitivity (hs-CRP) CAP C-Reactive Protein, high sensitivity (hsCRP) 3SD

D-dimer NR D-Dimer, Qual pos/neg CAP D-Dimer, Quant, ng/mL 3SD 30 ng/mL CAP D-Dimer, Quant, ugFEU/mL 3SD 0.3 ugFEU/mL

Drug Monitoring, Therapeutic CAP Acetaminophen 2.5 mg/mL 25

CMS CAP Carbamazepine 25 CMS CAP Digoxin 0.2 ng/mL 20 CMS CAP Gentamicin 25 CMS CAP Lithium 0.3 mmol/L 20 CMS CAP Phenobarbital 20 CMS CAP Phenytoin 25

CAP Salicylates-mg/dL 0.2 mg/dL 25 CMS CAP Theophylline 25 CMS CAP Tobramycin 25 CMS CAP Valproic Acid 25

CAP Vancomycin 1.5 ug/mL 25

Drug Screen, Urine Acetaminophen pos/neg Alcohol (Ethanol) pos/neg

CAP Amphetamines pos/neg CAP Amphetamines pos/neg CAP Barbiturates pos/neg CAP Benzodiazepines pos/neg NR Buprenorphine pos/neg CAP Cannabinoids / Marijuana pos/neg CAP Cocaine Metabolites pos/neg NR Cotinine pos/neg NR Ecstasy (MDMA) pos/neg Fentanyl pos/neg NR LSD (Lysergic Acid Diethylamide) pos/neg

NR K2 Metabolite (UR-144) (JWH-073) pos/neg NR MDMA (Ecstasy) pos/neg CAP Methadone pos/neg NR Methadone Metabolite pos/neg CAP Methamphetamine pos/neg CAP Methaqualone pos/neg CAP Opiates pos/neg NR Oxycodone pos/neg

16 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


CAP Phencyclidine (PCP) pos/neg CAP Propoxyphene pos/neg Tramadol pos/neg CAP Tricyclic Antidepressants (TCA) pos/neg Zolpidem pos/neg

Fertility Endocrinology CAP DHEA-S 6.0 ug/dL 15 CAP Estradiol 3 pg/mL 30 Estriol (unconjugated) 3.0 ng/mL 25 CAP Follicle Stimulating Hormone (FSH) 2 mIU/mL 25 CAP Luteinizing Hormone (LH) 2 mIU/mL 25 CAP Progesterone 0.3 ng/mL 30

Fructosamine NR Fructosamine, DMF 0.45 mmol/L 30 NR Fructosamine, Polylysine 45 mmol/L 30

Glucose & Hemoglobin, Hemocue, waived Glucose 6 mg/dL 10 Hemoglobin 7

Glycohemoglobin Glycohemoglobin, 2 vial 1 percentage unit 15 CAP Glycohemoglobin, 5 vial 1 percentage unit 15

Hemoglobin A1C, Afinion Hemoglobin A1c, Afinion (HbA1c) 1 percentage unit 15

Immunochemistry C-Peptide 1.0 ng/mL 30 CAP Insulin 1.5 uIU/mL 30 CAP PTH (Parathyroid Hormone) 0.9 ng/mL 25 CAP Vitamin D 3SD 2 ng/mL

Iron Binding CAP Iron, Binding Capacity, Total (TIBC) 25 CAP Iron, Binding Capacity, Unsaturated (UIBC) 25 CAP Transferrin 10 mg/dL 7

Lactoferrin, Fecal Fecal Lactoferrin pos/neg Lead, Blood, waived CAP Lead, Blood 4ug/dL 10

Lipids CAP Apolipoproteins, A1 25 mg/dL 30 CAP Apolipoproteins, B 20 mg/dL 25

CMS CAP Cholesterol, HDL 30 CAP Cholesterol, LDL (Direct) 15 mg/dL 20 CAP Lipoprotein (a) 10 mg/dL 30

Microalbumin/Creatinine, Urine CAP Creatinine, Urine 3 mg/dL 15 CAP Creatinine, Urine, Semiquantitative pos/neg CAP Microalbumin, Quantitative 10 mg/L 25 CAP Microalbumin, Semiquantitative & qualitative pos/neg Occult Blood, Fecal NR Occult Blood, Fecal (FOB) pos/neg Occult Blood, Gastric NR Occult Blood, Gastric pos/neg NR Occult Blood,pH pos/neg

17 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


Oximetry, Blood Carboxyhemoglobin 3 percentage units 25 CAP Hemoglobin 7 Methemoglobin 2 percentage units 10 Oxyhemoglobin 3 percentage units 7 p2PSA p2PSA 0.9 ng/mL 30

Pregnancy, Serum/Urine CMS CAP Pregnancy, Serum pos/neg CMS CAP Pregnancy, Urine pos/neg

Pregnancy, Waived Pregnancy, Urine pos/neg

SHBG & Testosterone Sex Hormone Binding Globulin (SHBG) 3SD 10 nmol/L Testosterone, Bioavailable 0.3 ng/mL 30 Testosterone, Free 0.3 ng/mL 30

Testosterone, Total 0.3 ng/mL 30

Tumor Markers Beta-2-microglobulin 0.06 mg/L 30 CAP CA 125 9 U/mL 30 CAP CA 15-3 3SD 2 IU/mL CAP CA 19-9 3SD 1.5 IU/mL CAP CA 27.29 3SD 3 IU/mL CAP Carcinoembryonic Antigen (CEA) 1.2 ng/mL 30 Prostate-specific Antigen (PSA), Free 0.9 ng/mL 30 Prostatic Acid Phosphatase (PAP) 1.2 ng/mL 30 Thyroglobulin 3SD 1 ng/mL Thyroglobulin Antibody 3SD 2 IU/mL

Urinalysis CAP Bilirubin, Urine pos/neg, +/- 1 pad CAP Creatinine, Urine pos/neg, +/- 1 pad CAP Glucose, Urine pos/neg, +/- 1 pad CAP Hemoglobin/Blood, Urine pos/neg, +/- 1 pad CAP Ketones pos/neg, +/- 1 pad

CAP Leukocyte Esterase pos/neg, +/- 1 pad CAP Nitrite pos/neg, +/- 1 pad CAP pH, Urine pos/neg, +/- 1 pad CAP Protein, Total, Urine pos/neg, +/- 1 pad

CAP Specific Gravity, Urine 0.01 CAP Urine Sediment (Microscopic ID) correct/incorrect CAP Urobilinogen pos/neg, +/- 1 pad WB Glucose, Basic NR Glucose, Whole Blood 6 mg/dL 20 WB Glucose, Comprehensive NR Glucose, Whole Blood 6 mg/dL 10

18 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


Clinical Microscopy CAP Fern(ing) Test present/absent CAP KOH Skin Preparation pos/neg CAP Nasal Eosinophils pos/neg CAP Pinworm Preparation pos/neg CAP Sperm, Qualitative (Digital Image) pos/neg CAP Vaginal Wet Mount correct/incorrect

Provider Performed Microscopy CAP Fern(ing) Test present/absent CAP KOH Skin Preparation pos/neg CAP Nasal Eosinophils pos/neg CAP Pinworm Preparation pos/neg CAP Sperm, Qualitative (Digital Image) pos/neg CAP Urine Sediment correct/incorrect CAP Vaginal Wet Mount correct/incorrect

Coagulation

Activated Clotting Time (ACT), 2 vial CAP Activated Clotting Time 20 Activated Clotting Time (ACT), 5 vial CAP Activated Clotting Time 20

CoaguChek XS/XS Plus, Basic INR 20 NR Prothrombin Time 15

CoaguChek XS/XS Plus, Comprehensive INR 20

CMS NR Prothrombin Time 15

Coagulation, Plasma CMS CAP Activated Partial Thrombin Time (APTT) 15 CMS CAP Fibrinogen 20

CAP INR 20 CAP INR Calculation 0.2 percentage units

CMS CAP Prothrombin Time 15

Prothrombin Time, WB CAP INR 20 CAP INR Calculation 0.2 percentage units

CMS CAP Prothrombin Time 15 Hematology

Blood Cell Identification CMS CAP Blood Cell Identification correct/incorrect

Erythrocyte Sedimentation Rate (ESR) NR Erythrocyte Sedimentation Rate (ESR) 3SD

Erythrocyte Sedimentation Rate (ESR), Rapid NR Erythrocyte Sedimentation Rate (ESR), Rapid 3SD

Hematology w/Diff A CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

19 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


Hematology w/Diff B CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff C CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff Centrifugal (QBC) CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff D CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff E CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hematology w/Diff G CMS CAP Erythrocyte (RBC) Count 6 CMS CAP Hematocrit 6 CMS CAP Hemoglobin 7 CMS CAP Leukocyte (WBC) Count 15 CMS CAP Leukocyte (WBC) Differential, Auto 3SD CMS CAP Platelet Count 25

Hemoglobin & Hematocrit CMS Hematocrit 6 CMS Hemoglobin 7

Hemoglobin & Hematocrit, waived CAP Hematocrit 6 CAP Hemoglobin 7

Reticulocytes CAP Reticulocytes, Automated 0.5 30 CAP Reticulocytes, Manual 2.5 30

20 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


Sickle Cell Screen CAP Sickle Cell Screen pos/neg

Urinary Eosinophils (DigitalScope) NR Eosinophils, Urine present/absent

Immunohematology

D (Rh) Typing Only CMS CAP D (Rh) Typing pos/neg

Direct Antiglobulin Test (DAT) CAP Direct Antiglobulin pos/neg

Fetal RBC Fetal Screen pos/neg Fetal RBC’s %, 3SD +/- 0.3 percentage units

Immunohematology, Basic CMS CAP ABO Typing correct/incorrect grouping CMS CAP D (Rh) Typing pos/neg

Immunohematology, Comprehensive CMS CAP ABO Typing correct/incorrect grouping CMS CAP Compatibility Testing (Crossmatch) compatible/incompatible CMS CAP D (Rh) Typing pos/neg CMS CAP Unexpected Antibody Detection detected/ undetected CMS CAP Unexpected Antibody Identification correct/incorrect

Immunohematology, Comprehensive, Plus CMS CAP ABO Typing correct/incorrect grouping CMS CAP Compatibility Testing (Crossmatch) compatible/incompatible CMS CAP D (Rh) Typing pos/neg CMS NR RBC Antigen Typing correct/incorrect CMS CAP Unexpected Antibody Detection detected/ undetected CMS CAP Unexpected Antibody Identification correct/incorrect

Immunology/Serology

Antinuclear Antibody (ANA) CMS CAP Antinuclear Antibody (ANA) Screen pos/neg

Anti-dsDNA pos/neg Anti-ssDNA pos/neg Anti-RNP pos/neg Anti-Sm pos/neg Anti-RNP/Sm pos/neg Anti-SSA pos/neg Anti-SSB pos/neg Anti-SSA/SSB pos/neg Florescence Pattern correct/incorrect

Anti-Streptolysin O (ASO) CMS CAP Antistreptolysin O (ASO) pos/neg

C-Reactive Protein (CRP) CAP C-Reactive Protein (CRP), Qualitative pos/neg

CAP C-Reactive Protein (CRP), Quantitative 3SD 0.4 mg/dL Diagnostic Immunology

CMS CAP Antistreptolysin O (ASO) pos/neg CAP C-Reactive Protein (CRP), Qualitative pos/neg CAP C-Reactive Protein (CRP), Quantitative 3SD 0.4 mg/dL

CMS CAP Infectious Mononucleosis pos/neg CMS CAP Rheumatoid Factor (RF), Qualitative pos/neg CMS Rheumatoid Factor (RF), Quantitative, titer +/- 2 dilution

Rheumatoid Factor (RF), Quantitative, u/mL 2 U/L 30

21 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


H. Pylori Antibody CAP Helicobacter Pylori Antibody pos/neg

Hepatitis Markers CAP Hepatitis, Anti-HAV, IgM pos/neg CAP Hepatitis, Anti-HAV, Total pos/neg

CMS CAP Hepatitis, Anti-HBc, IgM pos/neg CMS CAP Hepatitis, Anti-HBc, Total pos/neg

CAP Hepatitis, Anti-HBs pos/neg CAP Hepatitis, Anti-HCV pos/neg

CMS CAP Hepatitis, HBeAg pos/neg CMS CAP Hepatitis, HBsAg pos/neg

HIV Antibodies, Oral Fluid CMS HIV, Oral Fluids (confirmation) pos/neg CMS CAP HIV, Oral Fluids (screening) pos/neg

HIV Markers, Rapid/Waived CAP HIV, Waived pos/neg HIV, p24 Antigen pos/neg

HIV Markers CMS CAP HIV, Anti-HIV 1 (confirmation) pos/neg CMS CAP HIV, Anti-HIV 1 or 1/2 (screening) pos/neg

HIV, p24 Antigen pos/neg

Immunoproteins CMS CAP Complement C3 3SD CMS CAP Complement C4 3SD CMS CAP IgA 3SD CMS CAP IgE 3SD CMS CAP IgG 25 CMS CAP IgM 3SD

Lyme Disease NR Lyme Disease pos/neg

Mononucleosis, Infectious CMS CAP Infectious Mononucleosis pos/neg

Mononucleosis, Infectious, Waived CAP Infectious Mononucleosis pos/neg Mycoplasma Antibody Mycoplasma Antibody pos/neg

Rheumatoid Factor CMS CAP Rheumatoid Factor (RF), Qualitative pos/neg CMS Rheumatoid Factor (RF), Quantitative, titer +/- 2 dilution

Rheumatoid Factor (RF), Quantitative, u/mL 2 U/L 30

Rubella CMS CAP Rubella, IgG pos/neg

Syphilis Serology CMS CAP Syphilis, Qualitative pos/neg CMS CAP Syphilis, Quantitative +/- 1 dil

ToRCH Cytomegalovirus, IgG pos/neg Cytomegalovirus, IgM pos/neg Herpes Simplex Virus, Type I, IgG pos/neg Herpes Simplex Virus, Type I, IgM pos/neg Herpes Simplex Virus, Type I/II, IgG pos/neg Herpes Simplex Virus, Type I/II, IgM pos/neg

22 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


Rubella, IgM pos/neg Toxoplasma, IgG pos/neg Toxoplasmosis, IgM pos/neg

Microbiology

Acid Fast Smears CMS CAP Acid-Fast Bacteria/Smears pos/neg

Bacteriology CMS CAP Antimicrobial Susceptibility correct/incorrect CMS CAP Organism Identification, Stool Culture correct/incorrect CMS CAP Organism Identification, Blood Culture correct/incorrect CMS CAP Organism Identification, CSF Culture correct/incorrect CMS CAP Organism Identification, Genital Culture correct/incorrect CMS CAP Organism Identification, Throat Culture correct/incorrect CMS CAP Organism Identification, Urine Culture correct/incorrect CMS CAP Organism Identification, Wound Culture correct/incorrect

Bacteriology, Complete CMS CAP Antimicrobial Susceptibility correct/incorrect

CAP Colony Count, Urine growth/ no growth CMS CAP Gram Stain Identification pos/neg

CAP Gram Stain Organism Morphology correct/incorrect CMS CAP Organism Identification, Stool Culture correct/incorrect CMS CAP Organism Identification, Blood Culture correct/incorrect CMS CAP Organism Identification, CSF Culture correct/incorrect CMS CAP Organism Identification, Genital Culture correct/incorrect CMS CAP Organism Identification, Throat Culture correct/incorrect CMS CAP Organism Identification, Urine Culture correct/incorrect CMS CAP Organism Identification, Wound Culture correct/incorrect

Strep Group A, Ag Screen, Supplemental pos/neg

Blood Culture, Supplement, Bact. Complete Organism Identification, Blood Culture correct/incorrect

C. Difficile Toxin/Antigen, 5 vial CMS CAP C Difficile Toxin A Antigen Detection pos/neg CMS CAP C Difficile Toxin B Antigen Detection pos/neg

Campylobacter Detection, supplemental Campylobacter correct/incorrect Chlamydia/CG/Strep Group B Antigen Screen

CMS CAP Chlamydia Antigen Screen pos/neg CMS CAP GC, Antigen Screen pos/neg CMS CAP Strep Group B, Antigen Screen pos/neg

Colony Count, Urine CAP Colony Count, Urine correct/incorrect Genital Culture

CMS CAP Organism Identification, Genital Culture correct/incorrect

Gram Stain CMS CAP Gram Stain Identification pos/neg

CAP Gram Stain Organism Morphology correct/incorrect

MRSA MRSA pos/neg

Rotavirus, 2 vial add-on Rotavirus Antigen Screen pos/neg

Rotavirus, 5 vial CMS CAP Rotavirus Antigen Screen pos/neg

23 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


Shiga Toxin Shiga Toxin pos/neg

Step Group A, Antigen Screen CMS CAP Strep Group A, Antigen Screen pos/neg

Strep Group A Antigen Screen, Molecular CMS Strep Group A Antigen Screen pos/neg

Step Group A, Antigen Screen, waived CAP Strep Group A, Antigen Screen pos/neg

Throat Culture CMS CAP Organism Identification, Throat Culture correct/incorrect

Throat/Urine Culture CMS CAP Antimicrobial Susceptibility correct/incorrect

CAP Colony Count, Urine correct/incorrect

CMS CAP Organism Identification, Throat Culture correct/incorrect CMS CAP Organism Identification, Urine Culture correct/incorrect

Urine Culture CMS CAP Antimicrobial Susceptibility correct/incorrect

CAP Colony Count, Urine correct/incorrect CMS CAP Organism Identification, Urine Culture correct/incorrect

Urease, Rapid (CLO Test) Urease pos/neg

Vaginosis Screen CAP Candida pos/neg

CMS CAP Gardnerella pos/neg CAP Trichomonas pos/neg Viral Antigen Screen

CMS CAP Adenovirus Antigen Screen pos/neg CMS CAP Influenza, Type A. Antigen Screen pos/neg CMS CAP Influenza, Type B, Antigen Screen pos/neg CMS CAP Respiratory Syncytial Virus (RSV) Antigen pos/neg

Viral Antigen Screen, Waived Adenovirus Antigen Screen, Waived pos/neg CAP Influenza, Type A, Antigen Screen, Waived pos/neg CAP Influenza, Type B, Antigen Screen, Waived pos/neg Respiratory Syncytial Virus (RSV) Antigen, Wv pos/neg

Mycology KOH Preparation KOH Preparation correct/incorrect

Parasitology Cryptosporidium/Giardia Immunoassay

CMS CAP Cryptosporidium Immunoassay pos/neg CMS CAP Giardia Immunoassay pos/neg

Parasitology CMS CAP Parasitology correct/incorrect

24 PROG 019.103

CMS Regulated

CAP Accepted

Program Analyte SD


Embryology/Andrology Antisperm Antibody CAP Antisperm Antibody pos/neg Embryo Grading NR Embryo Grading correct/incorrect Fetal Fibronectin (fFN) CAP Fetal Fibronectin (fFN) pos/neg Fetal Membrane Rupture Test NR Fetal Membrane Rupture (PAMG-1) pos/neg IVF Embryo Culture Media

NR IVF, Human Sperm Cell Survivial, Media Acceptability acceptable (yes/no)

NR IVF, Mouse Embryo, Media Acceptability acceptable (yes/no) Preimplantation Genetic Screening Sex Status correct/incorrect Euploid or Anuploid Status correct/incorrect Chromosome addition or deletion correct/incorrect Sperm Count NR Sperm Count, Qualitative (Post Vasectomy) pos/neg CAP Sperm Count, Quantitative 7 million/mL 30 Sperm Morphology NR Sperm Morphology, % 3SD 5 percentage units NR Sperm Morphology, Cell ID correct/incorrect Sperm Motility NR Sperm Motility 12 percentage units 25 NR Sperm Motility, Forward Progression % 12 percentage units 25 NR Sperm Motility, Frwrd Progression, semi-qnt. correct/incorrect Sperm Viability CAP Sperm Viability 10 percentage units 20

Specialty

WB Glucose, Basic-EQAS (Multi-site) CAP Glucose, Whole Blood 6 mg/dL 20

Proficiency Testing Action Form LABORATORY NAME: ____________________________________________________________________________ Section: __________________________________________________________________________________ Completed by: ___________________________________________________________________________________ Core lab Manager / Department Supervisor: ____________________________________________________________ Problem: _______________________________________________________________________________________ Attach documents as needed Corrective Action/Preventive Action: _______________________________________________________________ Attach documents as needed Reviewed by: Laboratory Manager ____________________________________________________________ Date: ______________ Medical Director _______________________________________________________________ Date: ______________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------

PROFICIENCY TEST CORRECTIVE ACTION CHECKLIST FORM

Laboratory Name: ___________________________________________________________ CLlA #: __________________ Testing Event: ______________________________________________________________ Year: ____________________ Proficiency Testing Module: ___________________________________________________ Analyte: __________________ Date PT Sample Rcvd __/__/___ Test Date: __/__/___ Report Date: __/__/___ Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) Sample #:___________________ Reported Results: ___________________ Expected Range: ___________ Expected Results: ____________ Repeat Analysis Result _______________ (Original or new specimen) I. Does this failure represent unsatisfactory performance for this analyte, specialty, or subspecialty? Y / N 2. Does this failure represent unsuccessful performance for this analyte, specialty, or subspecialty? Y / N (Unsatisfactory performance for two events in a row or two out of three consecutive testing events: ------------------------------------------------------------------------------------------------------------------------------------------------------------------ PT Failure Classification: Submitted Late Lack of Consensus Failure to Submit

Clerical Error Equipment Error Educational Challenge Trend / Bias Other

FINDINGS:_____________________________________________________________________________________________________________________________________________________________________________________________________________ CORRECTIVE ACTION: _______________________________________________________________________________________ ___________________________________________________________________________________________________________ COULD THIS ERROR AFFECT PATIENT RESULTS? Y / N If yes, state course of action: ___________________________________________________________________________________ [Review process to be modified by each lab to what is appropriate for that lab] Investigated by: ______________________________________________________________________ Date: ___/___/____ Technical Consultant/Supervisor: ________________________________________________________ Date: ___/___/____ Laboratory Director: ___________________________________________________________________ Date: ___/___/____

INVESTIGATION CHECKLIST This form is to be used as a guide to assist in investigating, documenting, and correcting proficiency test failure or unacceptable results. Identify the reasons for failure or unacceptable results in proficiency testing and take appropriate corrective measure. Complete Proficiency Testing Corrective Action Form and attach copies of all records reviewed to this form. 1) SPECIMEN HANDLING

a) Were proficiency test specimens checked for acceptability when received? (Review notes made at the time proficiency test was received). Y / N / NA

b) Were the specimens handled properly? (Review instruction for specimen preparation). Y / N / NA 2) CLERICAL ERRORS

a) Verify correct value was transcribed from instrument printout to report form, or that the correct response was entered from the list of results. Y / N / NA

b) Verify that decimal point and units of measure were honored on the report form. Y / N / NA c) Verify that the correct code from the instrument or reagent list was entered on the report form. Y / N / NA d) Verify that the correct testing method information was provided. Y / N / NA e) Verify that any calculations were performed correctly. (even if automated calculation) Y / N / NA f) Check summary report to verify value on report form was honored by the PT service. Y / N / NA

3) QUALITY CONTROL

a) Were quality control materials within the acceptable range on the date of PT testing? (Verify the quality control acceptable range in use.) Y / N / NA

b) Any evidence of trends or shifts in the periods just before and just after PT was tested? Y / N / NA

4) CALIBRATION a) What was the date of the last calibration? ___/___/____ b) How often is calibration to be performed? ___/___/____ c) When was last calibration verification performed? ___/___/____ d) Were any calibration problems noted? Y / N / NA

5) INSTRUMENT

a) Were instrument parameters entered correctly? Y / N / NA b) Was daily maintenance performed on the date of PT testing? Y / N / NA c) Was special maintenance performed just prior to PT? Y / N / NA d) Were instrument problems noted when PT was performed? Y / N / NA

6) REAGENTS

a) Check reagent / instrument log for notation of recent problems. Y / N / NA b) Check reconstitution instructions in package insert versus procedure -any changes? Y / N / NA c) Verify that open stability of reagent was not exceeded by reviewing procedure with testing personnel.

Y / N / NA 7) TESTING PERSONNEL

a) Date of last competency assessment for testing personnel. ___/___/____ b) Review assay procedure and proficiency test sample preparation instructions with testing personnel to ensure that instructions

were followed. Y / N / NA c) Review with testing personnel how samples were loaded to rule out misidentification or transposition of samples.

Y / N / NA d) Was retraining of testing personnel required and if so is this completed? Y / N / NA

8) PROCEDURE

a) Review procedure versus manufacturer’s most current recommendation for any changes. Y / N / NA b) If retained frozen or refrigerated specimens were retested, were the results the same as those reported?

Y / N / NA c) Call instrument or reagent manufacturer for input if cause is not readily identified. Y / N / NA

9) INTERPRETATION ERRORS

a) Was PT challenge beyond the scope and extent of the testing routinely performed in your lab? Y / N / NA b) Has summary report been reviewed for an explanation of key features of the element presented in the photomicrographs

and/or pictures? Y / N / NA c) Have textbook references been consulted for additional information? Y / N / NA d) (Microbiology) Compare the test characteristics found in your laboratory with the characteristics of the

correct identification. Review your results and procedure for the key to distinguish the correct identification from the incorrect identification. Y / N / NA

Evaluating Proficiency Testing Results Suggested Process The role of proficiency testing (PT) has traditionally been one of an external quality assurance check. However, since successful PT performance has become an assessment tool for determining regulatory compliance, effectively evaluating your PT results is imperative. This sheet suggests a process to follow when evaluating your PT results. Feel free to incorporate this outline into your policy/procedure manual and use it to evaluate previous PT reports or when you get your next set of PT results. If you aren't already preserving your PT specimens, then consider retaining them for use in this evaluation process. A Beneficial Process for Evaluating Your PT Results Once you receive your PT results, review the CMS summary page to determine if all regulated analytes were scored for CLIA (regulatory) purposes. If you performed PT on a regulated analyte and this analyte does not appear on the summary page contact AAB-PTS. Check to be sure the CLIA number for the lab is included and/or correct on the report, along with the name and identifier of any other regulatory or accrediting body (I.e., CMS/State/COLA) that should receive copies of your PT report. If the CLIA number and/or regulatory information are lacking or incorrect your regulatory or accrediting agency will have problems receiving and monitoring your PT enrollment and scores. Notify AAB-PTS of any corrections to this information. Review your scores for the individual analytes and review the overall specialty scores. The criterion for satisfactory performance is a minimum score of 80% for all analytes (except a minimum score of 100% for ABO/Rh and compatibility testing). For analytes in the same specialty, the scores are averaged to obtain the overall specialty score. "Unsatisfactory" PT performance occurs when there is a failure in one event. PT performance is "unsuccessful” if there are two consecutive PT event failures or two out of three PT event failures. If repeated analyte / specialty scores indicate unsuccessful PT performance, then the lab is at risk of losing its ability to continue to test the analyte and/or specialty. After completing this initial review, continue with the more extensive review that follows: I. All results were passing; you should:

A. Review the report. 1. Are three of five results for an analyte outside +/-1.5 Standard Deviations, if this information is provided? 2. Are three results for an analyte outside +/-50% of mean? 3. Do the five results for the analyte range from -50 to +50% of mean? 4. Did any analytes receive an automatic 100% because they could not be graded?

B. If conditions 1, 2, or 3 exist, then take corrective action since it identifies gradual long term trends and indicates test instability.

C. If condition 4 exists, perform a self evaluation, since the score does not reflect actual laboratory performance. D. If none of these conditions exist, document this review.

[Stop review here.] II. If PT results for any analytes are unsatisfactory:

A. Check your original documentation for discrepancies. Look for: 1. Clerical errors (transcription, transposition, method coding). 2. PT program errors.

B. Check testing records for technical processing errors. Look for: 1. Misidentification of specimen. 2. Misinterpretation of results. 3. Results mistakenly reported outside the reportable range or when QC was out of range.

C. If any of the above appear to be the reason for the PT problems: 1. Document the causes and the corrective action taken to prevent them from happening in the future.

[Stop review here.] III. If the reason for the problems is still not apparent, then evaluate the test systems affected.

A. Expand the scope of the inquiry by asking: 1. Is the problem affecting more than one test on an instrument?

a. If yes, expect an instrument-related problem. 2. Is the problem affecting only tests results in a certain range, e.g., only specimens with high values are

affected?

a. If yes, this could be due to a linearity/calibration problem. 3. Are several tests affected from the same PT specimen?

a. If yes, it could be a problem of PT specimen integrity or reconstitution. B. Evaluate status of the affected tests at the time of initial testing and determine:

1. Has maintenance been performed appropriately? 2. Are controls in range, or starting to trend or shift? 3. When was the last calibration? 4. Is temperature a factor? 5. Are all reagents or controls in date?

C. Retest PT specimens retained specifically for this purpose. Serum specimens may be frozen; however, check to determine the time period your PT program's hematology specimens will be stable when refrigerated (they cannot be frozen). If the results in question are now in range and: 1. One test or specimen was affected, it is termed "random analytical error" that may have been due to:

a. Aliquot evaporation. b. Pipetting error/dilution error c. Instrument instability/power surge.

2. Two or more poor results for the same test were biased in the same direction, it is referred to as short-term systematic analytical error" that may have been due to: a. Improper instrument maintenance. b. Reagent deterioration. c. Improper calibration.

3. If all of the PT problems were explained by the above, then check for possible effects on patient results since the PT specimens were done. If the effect could have been clinically significant, then document appropriate corrective action. Take steps to prevent the problems from recurring.

[Stop review here.] IV. If the results of the retest are NOT in range, obtain a new sample of the PT material in question from your PT program

and test it Availability of these specimens varies greatly. If they aren't available, then consider performing split specimen testing on several patient specimens instead. A If the new specimens are in range, then the problem could have been due to:

1. Problems with the PT material specimen itself, such as: a. Bacterial/fungal contamination. b. Delay or temperature damage in shipment. c. Hemolysis of specimen. d. Evaporation of the specimen. e. Reconstitution error or delay in testing.

B. Document the cause of the errors and the corrective action taken to prevent future problems. [Stop review here.] V. If the results of these newly obtained specimens are out of range as well, then it's most likely due to a Iong-term

systematic error." A. Examples of some of these problems and their solutions are:

1. Miscalibration -recalibrate the instrument. 2. Repetitive procedural error -reread procedure / retrain staff. 3. Infrequent performance of the test-retrain staff or consider discontinuing the test. 4. Major instrument maintenance problem··call for service. 5. Matrix effect /incompatibility with your method -call AAB-PTS.

B. If the problems are corrected by any of the above reasons, then check the effect of the problem on patient results since the PT was originally performed. If the effect was clinically significant, then take appropriate corrective action. Document the corrective action taken to prevent them from happening again.

VI. Perform a scheduled QA follow-up review of the effectiveness of all corrective actions taken to prevent future PT

problems. Document this review. [Stop review here.] Proficiency Testing is a well-justified laboratory expense. Taking the time to evaluate the results according to the above outline will aid in your efforts to attain successful proficiency testing results, as well as produce quality laboratory test results.

general program guide table of contents - aab-pts

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