Point of Care Testing Program

UMG/UDL Point of Care Policy 4/3/2018

POINT OF CARE TESTING PROGRAM

Point of Care testing may seem, on its face, simple and 'fool proof', but in a study conducted by HCFA in Colorado and Ohio, quality problems were identified in more than 50% of Certificate of Waiver labs surveyed nationwide. It revealed "glaring quality control problems" and urged the FDA to provide more governmental oversight of these laboratories. The HCFA study noted problems in 50% of the laboratories surveyed and specifically cited the following performance problems:

o Obsolete instructions o Lack of instructions o Incorrect instructions o Failing to perform quality control as required by the manufacturer.

The University risks intervention by both federal and state authorities if clinical testing is performed in violation of CLIA and NJ State DOH requirements.

To assist clinical personnel within UMDNJ - Robert Wood Johnson Medical School who wish to perform clinical laboratory procedures on-site, the University Medical Group is in the process of adopting a POCT program designed:

 To provide quality care to our patients;  To meet the standards of quality review organizations;  To insure that UMG maintains required compliance with state and federal regulations regarding laboratory oversight;  To provide consistency of test offerings across the University Medical Group;  To achieve economies of scale in the acquisition of reagents and instrumentation within the group;  To provide additional revenue opportunities for UMG clinical departments;  To simplify billing procedures within UMG; and  To insure the highest quality of test performance to the patients of UMG

Under this proposal a standard package of Point of Care services will be provided at any UMG clinical facility, so long as the required training, proficiency testing, quality control procedures and validation procedures are performed. The Department of Pathology will oversee this program and provide Bioanalytical Laboratory Directorship (BLD) and all necessary state and federal licensing for these sites. The University Medical Group will allocate charges to departments based upon this methodology. Departments will, in turn be responsible for allocating this expense internally.

This program will:

 Establish a ‘point-of-care testing’ committee consisting laboratorians, physician users and nursing personnel to review point-of-care testing options. This committee will select the set of point-of-care tests UMG sites which will be supported by written procedures, a training program, a proficiency testing program, a quality control program and a competency assessment program  Provide each participating nursing unit with a package of standardized procedures which can be performed at any UMG facility so long as the requirements for training, competency assessment, quality control and periodic review are maintained within the facility  Standardize testing options for point-of-care tests and centralize inventory so that common reagents are used throughout the plan and lot to lot variability is minimized

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 Provide limited troubleshooting support to insure testing quality including a standardized procedure for reporting testing exceptions and problem resolution  Submit and maintain clinical laboratory licensure for any UMG site providing point of care testing  Provide for monitoring and initial review of testing records by UMG nurses  Provide for visits by the BLD or his designee to each clinical facility to review compliance efforts with state and federal regulations regarding clinical laboratories at least semi- annually and more frequently, if necessary.  Insure compliance with UMG billing requirements

Testing included in the UMG-wide Point-of-Care Testing Program:

 Glucose by monitoring device FDA cleared for home use – 82962 Urinalysis  Urinalysis by dipstick, non-automated – 81002 –  Urinalysis, microscopic ONLY – 81015  Urinalysis by dipstick, non-automated with microscopy – 81000  Pregnancy – Urine pregnancy test by visual color comparison methods – 81025  Guiac, stool – 82270 - Blood occult, by peroxidase activity, feces, 1-3 simultaneous determinations  Albumin, urine, microalbumin, semiquantitative – 82044-  Streptococcus, group A – 87430 -  H. Pylori – To Be Determined (TBD) by POC committee  Monospot – To Be Determined (TBD) by POC committee

Physician Performed Microscopy o KOH prep o Wet mount o Fern test

To perform tests on the above list, each UMG facility will need to be appropriately licensed by the State of New Jersey.

To participate in Point of Care Testing involves three steps: 1. Completion of a facility POCT survey. To ascertain all clinical laboratory testing being conducted on premises (UDL Central Administrative Offices (732) 235-8110). The Department of Pathology and Laboratory Medicine will then arrange for appropriate licensure of the facility.

2. Receipt of procedures and subsequent training. Upon completion of licensure, the Department will permit the site to provide any point-of-care procedure from the list of UMG supported procedures so long as the required training, proficiency testing, quality control procedures, record keeping and validation procedures are performed. The Department will a. Provide for POCT instruction manuals and provide forms to the unit b. Staff training will be provided periodically c. Competency assessment of staff will be determined by participation in d. on-going proficiency testing under an appropriate program, and/or additional assessment as deemed necessary by the Bioanalytical Laboratory Director e. Establish POCT approval for billing purposes with UMG operations

3. Adhere to UMG Point of Care Procedures. Continued participation in the UMG-wide Point of Care program requires that these procedures be performed in accordance with procedures described in our manual and including those related to quality control, recordkeeping, proficiency testing and competency assessment. Periodic inspections of all sites will occur and the results will determine continued participation in the program.

Obtaining necessary supplies. Supplies, including test and control reagents, may be requested by forwarding a POCT supply request to UDL Central Administrative Offices via fax (732) 235-8113 or by email ([email protected]). Charges for these supplies will be distributed to the Department/Division periodically. Supplies obtained by the Department on behalf of UMG will be validated prior to distribution. If supplies are obtained in any other way it is obligatory that they be validated by the site prior to use.

If a facility performs any other procedure aside from those listed above, complete clinical laboratory licensure under the University Diagnostic Laboratories auspices would be required. This can be arranged by contacting UDL central administrative offices (732) 235-8112.

The responsibility for successful participation in proficiency testing is ultimately the clinical sites’. The Department will provide assistance in troubleshooting of a limited nature. More extensive troubleshooting activities will be provided on an hourly basis to provide more complex troubleshooting of procedures on a unit specific basis.

University

Diagnostic

Laboratories

POCT Program PROCEDURE

Procedure: General Procedure Point of Care Testing Program

Prepared by Date Adopted Supersedes Procedure Evan Cadoff, M.D. 12/5/96 No Previous Procedure

Revision Date Revision Summary

Review Date Revision Date Signature 4/5/99

Distributed to Copies Distributed to Copies Point of Care Testing Areas 1

The clinical goals of the RWJ-UMG are to provide optimal laboratory services to inpatients, outpatients and reference clients, and to provide consultations directed to the medical staff. To provide such service, it is essential that the quality of results and their timeliness be assured. Proper use of Point of Care testing can reduce the volume of blood needed for lab testing. The following quality assurance/performance improvement guidelines for point of care testing are a necessary step for achieving these goals and for complying with the laboratory accrediting requirements of the Department of Health and Human Services, the New Jersey Department of Health, the Federal Drug Administration, and the College of American Pathologists.

POLICY:

Properly trained and certified physicians, nurses (RN or LPN) or qualified technical personnel may perform testing outside the laboratory, under the authority and licensure of the bioanalytical laboratory director. In order to assure the clinical reliability of the results obtained from such testing and to comply with federal and state regulations and the laboratory

4 of 3 UMG/UDL Point of Care Policy 4/3/2018 accreditation standards of the College of American Pathologists, the following guidelines must be followed. These guidelines will be used to establish specific procedures for each ancillary testing site. For each testing activity to be performed in an ancillary site, a procedure specific to the test and site will be developed from these guidelines. Failure to follow the procedures outlined will result in cessation of permission to perform ancillary testing. In order to consider setting up ancillary testing, one individual must be identified within the unit who will be responsible for seeing that these procedures are followed.

MAINTENANCE

Daily and other periodic maintenance procedures must be carried out by testing personnel. Any preventive maintenance service will be performed by the instrument service representative. Specific maintenance procedures will be outlined in the procedure manual for the test, and will be summarized for easy reference. Those performing the maintenance checks will document their activity.

QUALITY CONTROL

Following proper quality control procedures is essential. Lack of quality control can result in serious mis-interpretations of test results. All test procedures require that a fixed number of quality control (QC) samples be run at pre-determined intervals. QC samples are samples which contain a known concentration of the analyte being measured. If the result of the QC sample is not within its expected range, it is an indication that patient samples would give erroneous results. If QC results are out-of-range, patient samples may not be run. The ancillary testing site will be responsible for the purchase and storage of acceptable quality control material. Frequency: The frequency of such testing depends on the assay being performed. For instance, fingerstick blood glucose requires daily QC testing. Blood gas determinations require testing every 4 hours. Most other tests require QC checks every 8 hours. Number: For all tests, one QC sample within the reference (normal) range is required, and at least one abnormal sample. Thus a minimum of two, and usually a maximum of three samples must be run each time a QC check is done. Expected values: For each QC sample, the laboratory will establish the expected range. These ranges reflect the technical imprecision of the test and the biologic variation that is considered significant. The laboratory will also establish a flow sheet to aid in interpretation of the QC results, to determine whether patient results will be reliable. Laboratory supervisors will be available at all times to help with interpreting results of QC samples and advising whether patient testing may proceed. Record keeping: Results of all QC samples must be logged on record sheets that will be kept with each instrument and must indicate who performed the testing. These may be reviewed at any time by laboratory supervisors or representatives from regulatory agencies. They will be delivered to the lab monthly, and by law, must be kept for at least two years.

PATIENT TESTING

The test procedure manual will describe the steps necessary to perform the testing. It will also include information about proper specimen collection. Record keeping: Results of all patient tests must be permanently recorded. The result will be logged either in a logbook located with the instrument or in the patient file. The date and time the specimen was collected (and the date and time of analysis if there is a significant delay) must be recorded along with the identity of the person performing the test. These records must also be sent to the laboratory and retained for at least two years. Any printout provided by the instrument must also be retained in the lab’s permanent files.

OPERATOR PROFICIENCY

Each person running the test must be trained by an approved person, to be defined in the ancillary site’s procedure manual. Recertification: Recertification of individuals performing testing will be accomplished by documentation of having obtained proper results on daily quality control (QC) samples. Correct QC results must be performed in accordance with specific procedures, or certification will lapse.

PROFICIENCY TESTING

On a periodic basis (usually quarterly), unknown samples will be given to the ancillary testing site to be run. These samples are purchased from outside regulatory agencies to evaluate the accuracy of the results obtained by the laboratory. These “proficiency testing” samples must be run as patient samples are run, after proper maintenance and quality control procedures have been completed. The results will be reported back to the testing agency for their evaluation. Failure to perform adequately on proficiency testing challenges can result in loss of the laboratory’s license. Ongoing issues related to proficiency testing results will be cause to prohibit performance of point of care testing at a particular site.

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University

Diagnostic

Laboratories

Procedure: POINT OF CARE TESTING: UMG-UDL Quality Control Program

Prepared by Date Adopted Supersedes Procedure E. G. Martin, Ph.D. 1996 UDL-UMG Quality Control Program

Revision Date Revision Summary 4/28/99 Updated procedure to Word format. Remove references to outpatient services. 10/16/01 Update to Word XP format. Clarification of wording.

I. Purpose

The purpose of the quality control program is to monitor the quality of technical services provided by the Point of Care Testing staff and to ensure that problems related to these are identified and addressed.

The monitoring system is designed to be compatible with the standards of the College of American Pathologists and CLIA 88.

II. Responsibilities

A. It is the responsibility of the Point of Care testing staff to successfully complete quality control on all testing performed.

B. A periodic evaluation to insure proper patient ID and preparation, specimen collection, specimen ID and specimen preservation and processing, along with accurate result reporting will be conducted by UDL central administration.

C. External Quality Control specimens will be analyzed by testing personnel on a rotating basis within a POCT site.

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D. External Quality Control specimens will be analyzed at a minimum of once per shift, with the first Quality Control analyzed before or simultaneously with the first patient sample being tested.

E. It is the responsibility of the Point of Care Testing site supervisor to review all quality control on a daily basis.

F. The POCT site supervisor will submit QC data to UDL central administration on a monthly basis for review and central maintenance records.

G. At his discretion, the UDL Medical Director may assign specific duties for the monitoring of performance and the correction of problems identified by the monitoring system to other individuals at the Point of Care Testing sites

III. Scope

The UDL provides technical support to the activities of UMG Point of Care Testing sites. The services provided may change from time to time to meet the needs of our faculty and patients.

IV. Elements of the Quality Control Program

Quality control is an ongoing process designed to insure that an analytic system is functioning correctly. The basic premise of most quality control systems is that known samples are tested simultaneously with patient unknowns and the results compared with expected results. Failure to obtain the expected values results in a series of actions designed to protect the patient and personnel from aberrant and incorrect data.

V. Principle

Most diagnostic manufacturers include internal control materials which are expected to be handled in the same manners that patient samples are handled and which are expected to return a known result during the performance of the analytical assay. Most manufacturers maintain a database which permits unexpected results to be reported and reviewed for errors in test performance versus possible reagent stability problems. In addition to these internal control materials, which are commonly referred to as ‘calibrators’, good laboratory practice usually involves the incorporation of external quality control materials which are either purchased or prepared to test the effectiveness of an assay.

Clinical testing methods and performance will be made available to any requesting individual. All physicians will be informed of significant changes in analytic methodology that will result in significant changes in the test results or their interpretation.

VI. Quality Control Failures

In the event of a quality control failure, the testing site must take a series of actions designed to:

A. Prevent the release of false data derived from the assay. B. Commence a series of steps designed to isolate the problem to either assay components, equipment malfunction of assay performance. C. Establish a means to follow-up and review the areas indicated by the QC failures. D. Document corrective action directly on a QC sheet.

VII. Recommended Range of Controls Used

The recommended range of controls is specified in the Quality Control section of each testing procedure.

VIII. Recommended Frequency of Quality Control Samples

A. Daily, as frequent as patient samples are analyzed covering the range of expected patient results; B. Each time an instrument has been serviced to verify proper operation; C. Each time testing personnel are suspicious of possible testing malfunction, e.g., unexpected patterns of patient results which raise the possibility of malfunction; D. Each time a new reagent lot number or new test kit lot number is introduced.

IX. Crossover Studies

A. Reagents and control materials are subject to manufacturing variances on a lot to lot basis. While some manufacturers perform internal lot comparisons, testing sites should verify the quality of a new lot of reagents and control materials before using them with patient samples.

B. Crossover studies will be performed on new lots of control materials by running the assay a sufficient number of times to permit determination of the mean of result and to allow comparison of the mean value to the manufacturer’s reported control assay value.

C. A new lot number of controls or in the case of diagnostic kits containing controls, the assay lot must be formally accepted or rejected by the Point of Care testing site supervisor and reviewed by the supervisor. Any corrective actions will be noted.

X. Acceptable Limits

Acceptable limits will be defined for each particular assay in the assay procedure protocol.

All QC data will be submitted to the UMG/UDL supervisor or his designee on a monthly basis to be reviewed and maintained.

XI. Corrective Actions

A. If a QC failure occurs:

1. Determine the cause of the failure.

2. One of the first steps in examining a QC failure is to suspect the quality of the reagents, controls, or the performance of the instrumentation. Consequently it is often useful to utilize a different lot of reagent and repeat the procedure.

3. In the face of a QC failure, do not release results without UDL- Supervisory approval. If the problem can be identified and solved internally, indicate the corrective action taken on the QC Log. For example, if you repeat the QC and it is now found to be within range, record the new result and indicate whether you repeated the same QC sample from the same lot of reagent or whether you employed a different QC sample or a different reagent lot.

4. If the problem cannot be readily identified:

a) Contact and document the contact with the technical support department of the control manufacturer and verify your specific performance. b) Request a service visit on the applicable instrument or send the instrument for service. 5. Document ALL QC actions DIRECTLY on the QC sheet to permit rapid review.

XII. QC Review

All QC results must be reviewed on a regular basis.

A. The Point of Care testing site supervisor will review and document QC on a daily basis. As necessary the site supervisor will institute corrective action for 'out of compliance' procedures. The site supervisor is responsible for submitting QC data to the UDL administrative offices (Medical Education Bldg. Rm. 212) for potential further review and central storage.

B. The site supervisor will also review and document QC on a monthly basis.

1. The purpose of this process is to:

a) Review ongoing technical problems and their resolution. b) Review problem cases c) Review QC failures

XIII. Action to Improve Services and to Resolve Problems

A. All problems identified by the monitoring system will be corrected, documented and brought forth at the Quality Assurance meetings quarterly.

University

Diagnostic

Laboratories

Procedure: POINT OF CARE TESTING: UMG-UDL Proficiency Testing Program

Prepared by Date Adopted Supersedes Procedure E. G. Martin, Ph.D. 1995 UDL-UMG Proficiency Testing Program

Revision Date Revision Summary 4/28/99 Updated procedure to Word format. Remove references to outpatient services. 10/16/01 Update to Word XP format

I. Purpose

The purpose of Proficiency Testing is to monitor the quality of technical services provided by nursing staff; medical assistants and any other individual trained and competent for Point of Care testing and to ensure that problems related to these are identified and addressed. The monitoring system is designed to be compatible with the standard of the College of American Pathologists and CLIA 88.

II. Responsibility

it is the responsibility of the UDL to oversee and evaluate the quality of technical offerings provided by UMG. It is the responsibility of the UDL to ensure laboratory compliance with existing federal and state regulations. Ultimately, the responsibility for Point of Care Testing falls upon the UDL license holder.

It is the responsibility of the Point of Care Testing staff to perform proficiency testing three to four times per year as they are received.

In order to participate in College of American Pathologists’ laboratory accreditation, Point of Care Testing sites are required to participate in all applicable proficiency testing programs which are offered by CAP. In addition, they are strongly encouraged to participate in other relevant proficiency programs and must participate in any state Department of Health mandated proficiency testing in support of their operations.

In order to provide central coordination of these activities and to alert the UDL of significant failures in proficiency performance, all proficiency testing is processed under the direction of the Administrative Director and the Bioanalytical Laboratory Director.

III. Procedure

Three to four times per year proficiency specimens will be received and performed on all relevant Point of Care Testing. Proficiency specimens will be received at the UDL administrative office and will be delivered to the individual testing sites. These specimens will be performed in the same manner and using the same testing methods as patient samples, by the same personnel who routinely test patient samples. Results will then be forwarded to UDL on appropriate result sheets including reagent and control lot numbers and expiration dates and indicating the testing individual. The UDL supervisor or designee will then review, initial and date all received data and submit the testing data for evaluation.

Proficiency testing will be rotated among Point of Care Testing staff to ensure that all personnel routinely performing patient testing will be evaluated.

IV. Scope

Federal regulations, state regulations and deeming authorities such as the College of American Pathologists mandate that all testing facilities must successfully participate in an approved proficiency program for all regulated testing being performed in each specialty.

V. Elements of the Proficiency Testing Program

Proficiency testing is an ongoing part of a process intended to ensure that the analytic system of the testing site is functioning correctly. The basic premise of proficiency testing is that known samples are testing simultaneous as patient unknowns and the results compared with results generated in many other institutions. Failure to obtain the expected values results in a series of corrective actions designed to protect the patient and the institution from the generation of aberrant and incorrect data.

VI. Analysis and Review of Proficiency Testing and Failures

All results from the interlaboratory comparison programs are maintained at the office of the UDL Administrative Director. The comparison program results will be reviewed, dated and signed by the Administrative Director and the Bioanalytical Laboratory Director for appropriate actions as necessary. Results will also be reviewed by the UMG Nursing Coordinator who will take necessary clinic action needed.

VII. Action to Improve Services and to Resolve Problems

Any significant failure of proficiency testing must be documented and corrective action implemented on the appropriate incident form which is to be submitted to the UDL Administrative Director and the Bioanalytical Laboratory Director.

University

Diagnostic

Laboratories

Procedure: POCT Result Reporting Procedure

Prepared by Date Adopted Supersedes Procedure Evan Cadoff, M.D. 1995 No Previous Procedure

Revision Date Revision Summary 4/28/99 Update to Word format. Remove references to Outpatient Svces.

Review Date Revision Date Signature

I. Purpose

The purpose of this procedure is to ensure the quality of technical services provided by the Point of Care Testing staff by establishing a standard for result reporting and reviewing.

II. Responsibility

It is the responsibility of the Point of Care testing staff to sign off on all testing performed. Verify and document any test findings which fall outside of the normal reference range. Report and document any critical values immediately to the physician.

It is the responsibility of the Point of Care testing site supervisor to review all testing results daily and document.

It is the responsibility of the physicians to review all testing results and document.

It is the responsibility of the UDL supervisor or designee to review quality control and

proficiency test results and patient logs.

III. Procedure

Reporting All patient testing will be documented on the Patient Log. All lot numbers and expiration dates will be documented. All controls will be indicated.

All testing personnel must sign off on the Patient Log for all testing performed.

Normal testing reference ranges may be found on the RWJ-UMG reference range sheet. Any results which are found to exceed the normal reference range must be verified and documented. Verification must be performed by repeating the test or by using an alternative method. Any results which fall outside the linear range must be reported as “Less Than” or “Greater Than” the linear limit.

Any unusual or unexpected test results must be followed up. Determine any technical or reagent problems and repeat the test in the laboratory.

Critical values may be found on the Patient Result Log and any exceeded by the testing personnel must be verified. The physician must be notified immediately and all actions documented. If the physician is unavailable, the on call physician may be called. Any problem encountered with this process must be documented.

All Patient Result Logs must be filed in the patient’s chart and a copy must be filed in a Point of Care Testing log book.

Review

All results must be reviewed and documented daily by the POCT Supervisor. If the supervisor is not available, the POCT Coordinator may review. If neither are available, the results may be reviewed and documented the next working day. This process will determine clerical errors, significant analytical errors, or any unusual or unexpected results.

IV. Scope

To ensure quality patient care through proper protocol in a consistent manner by all required personnel as mandated by the College of American Pathologists.

University

Diagnostic

Laboratories

Procedure: Guaiac Testing – Training and Competency Assessment.

Prepared by Date Adopted Supersedes Procedure # Evan Cadoff, M.D.

Distributed to Copies Distributed to Copies

Guaiac Testing – Training and Competency Assessment.

1. Credential attending physicians through the directions & quiz.

HEMOCCULT PRODUCT INSTRUCTIONS RWJ UMG Point of Care Testing

Intended Use

The Hemoccult test is a rapid, convenient, and qualitative method of detecting fecal occult blood, which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult test and other unmodified quaiac tests are not recommended for use with gastric specimens.

Reagents and Materials

 Do not use after expiration date which appears on each test component.

 Because this test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color blindness.

 Keep cover flap of slide (yellow and green striped card) sealed until ready to use. Protect slides from heat, light and volatile chemicals. Hemoccult slides present no hazard to the user.

 Hemoccult developer (bottle with yellow striped label with yellow bottle cap)should be protected from heat and the bottle kept tightly capped when not in use. It is flammable and subject to evaporation.

 Store product at controlled room temperature 15 to 30oC (59 to 86oF) in original packaging. Do not refrigerate or freeze. Protect from heat and light. Do not store with volatile chemicals (e.g., iodine, chlorine, bromine, or ammonia).

 Hemoccult slides and developer, stored as recommended, will remain stable until the expiration dates, which appear on each slide and developer bottle.

Specimen Testing

 The Hemoccult test requires only a small fecal specimen. The specimen is applied to the guaiac paper of the Hemoccult slide as a thin smear.

 If testing immediately, wait 3 to 5 minutes before developing.

 Open back of slide and apply two drops only of Hemoccult developer to guaiac paper directly over each smear.

 Read test results within 60 seconds. Any trace of blue on or at the edge of the smear is positive for occult blood.

 Apply one drop only of Hemoccult Developer between the positive and negative Performance Monitor areas.

 Read results within 10 seconds. If the slide and developer are functional, a blue color will appear in the positive Performance Monitor area and no blue will appear in the negative Performance Monitor area. Neither the intensity nor the shade of blue from the Positive Performance Monitor area should

be used as a reference for the appearance of positive test results. Any blue originating from the positive Performance Monitor area should be ignored when reading the sample test results.

 Always develop the test, read the results, interpret them, and decide whether the fecal specimen is positive or negative for occult blood before developing the Performance Monitor feature. Do not apply developer to the Performance Monitor area before interpreting the test results.

 Record patient results in the patient’s chart. By charting the result you are certifying that quality control was done and was correct.

 Occasionally, a light blue discoloration may be noticed on the guaiac test paper. This discoloration does not affect the accuracy or performance of the test when it is developed and interpreted according to the recommended procedure. When developer is added directly over the fecal smear on a discolored slide, the blue background color migrates outward. A blue ring forms at the edge of the wetted area, leaving the guaiac paper around the fecal smear off-white in color. Any blue on or at the edge of the smear is positive for occult blood. Proper storage or Hemoccult slides will help prevent blue discoloration.

 Addition of a drop of water (rehydration) to the guaiac slide prior to the addition of developer increases the sensitivity of the test, but also increases the number of false-positive test results.

 In general, patients should not ingest foods and vitamins, which can cause false-positive or false- negative test results, for at least 72 hours prior to and continuing through the test period. Aspirin and other non-steroidal anti-inflammatory drugs should be avoided for at least seven days prior to and continuing through the test period.

 Substances which can cause false-positive test results include red meat (beef, lamb) as well as processed meats and liver. In addition, some raw vegetables and fruits, which are high in peroxidase, such as horseradish, turnips, melons, and radishes, can cause false-positive when fecal specimens are tested immediately after collection. However, plant peroxidases are relatively unstable and when slides are developed several days after specimen preparation, even large quantities of raw fruits and vegetables have been observed to have no significant effect on test results.

 The application of antiseptic preparations containing iodine (Betadine-povidone/iodine mixture) to the anal area can cause false-positive results. Dietary iron supplements were reported in earlier literature to cause false positive guaiac test results. More recent literature has demonstrated that dietary iron supplements will not produce false positive test results with Hemoccult tests.

 Substances which can cause false-negative results include ascorbic acid (vitamin C) in excess of 250 mg/day, excessive amounts of vitamin C enriched foods (citrus fruits and juices), iron supplements which contain quantities of vitamin C in excess of 250 mg per day.

Hemoccult Credentialling

Name: Location:

Date: Division:

Department:

The Hemoccult test and other unmodified guaiac tests are not recommended T F

False positive test results can be obtained if the patient has ingested T F within 72 hours: aspirin, non-steroidal anti-inflammatory drugs; red meat;

False negative test results can be obtained if the patient has ingested T F within 72 hours: more than 250 mg/day of Vitamin C; excessive amounts of

Patient testing must be completed before developing the "Performance T F

Test results for patient areas must be read within 60 seconds of applying T F

After applying a thin smear of fecal material to the slide, you must wait T F

By recording the patient’s result, you are verifying that all procedures, T F including quality control, were correctly performed.

University

Diagnostic

Laboratories

Procedure: Rapid Strep Test –.

Date Adopted Supersedes Procedure # Prepared by E Lerner, MD 12/2/99 No Previous procedure

Revision Date Revision Summary 4/28/99 Updated procedure to Word format. Remove references to outpatient services. 10/16/01 Update to Word XP format. Clarification of wording.

Rapid Strep Testing using the Signify Strep A test by Abbott Diagnostics

I. Purpose

The purpose of this procedure is to enable medical staff to provide rapid diagnosis and treatment of group A streptococcal pharyngitis. It is essential that quality results are obtained. The following guidelines for the rapid antigen testing are a necessary step for achieving these goals and for complying with the laboratory accrediting requirements of the Department of Health and Human Services, the New Jersey Department of Health, the Federal Drug Administration, and the College of American Pathologists. ll. Policy

Properly trained and certified physicians, nurses (RN or LPN), Medical Assistant / Medical Technician or qualified technical personnel may perform the Signify group a rapid antigen testing outside the laboratory, under the authority and licensure of the bioanalytical laboratory director.

Ill. Principle

The Signify Strep A test uses color immunochromatographic technology with rabbit antibodies coated on the nitrocellulose membrane. In the test procedure, a throat swab is subjected to a chemical extraction of a carbohydrate antigen unique to Group A Streptococcus. The Lab Strip is then placed in the extraction mixture and the mixture migrates along the membrane. If Group A Strep is present in the sample, it will form a complex with the anti-Group A streptococcus antibody conjugated color particles The complex will then be bound by the anti-Group A Streptococcus capture antibody and a visible blue Test line will appear to indicate a positive result.

IV. Specimen Collection and Handling

1. Collect specimens with a sterile rayon or Dacron swab from the tonsil and /or back of the throat. Take care to avoid the teeth, gums, and tongue or cheek surfaces.

2. Process the swab as soon as possible after collecting the specimen.

3. The swabs and the test kit must be at room temperature before starting the test.

V. Internal Procedural Controls

Three levels of procedural controls exist with each test run. 1. The color of the liquid changes from pink to light yellow as you add Extraction Reagent 2 to Extraction Reagent 1. The color change means that you mixed the Extraction Reagents properly and that the reagents are functioning properly.

2. The red Control line means that the lab strip has absorbed the proper amount of sample and the Lab strip is working properly.

3. A clear background shows that there are no interfering substances in the specimen and the reagent strip is functioning properly,

Vi. Quality Control Testing

Each kit contains positive and negative control materials. These controls are used by the manufacturer to insure that the extraction reagents and the testing strips are functioning properly and to insure that the procedure is being performed correctly by testing personnel.

External controls are run every 25 tests (twice per kit), and/or when changing operators within the test kit.

Quality Control Test Procedure 1. Dispense three drops of reagent 1 and add three drops of reagent 2 into the test tube. 2. Vigorously mix the control contents. Add 1 free falling drop of control from the dropper bottle. 3. Place a clean swab into the tube. 4. Continue as you would for a patient sample, as instructed in the procedure section.

VII. Limitations . The Signify Strep A Test has been categorized as CLIA waived only for the application of qualitative detection of Group A Streptococcal antigen from throat swabs. In the State of New Jersey this waiver has no particular significance in an academic group practice setting. Page 21 of 54 UMG/UDL Point of Care Policy 4/3/2018 D:\Docs\2017-12-13\0f2cfcb7173c48db0fd7a8d7f242bc64.doc

Clinical laboratory testing under the College of American Pathologists requires periodic participation for each procedure offered under the license in some form of proficiency testing. Proficiency tests are performed by staff using materials supplied by the College as if the specimens were true patient specimens. The performance on these materials is statistically analyzed by the College and shared with participating laboratories in an effort to identify problems in the testing process.

The results obtained with this kit yield data that must be used only as an adjunct to other information available to the physician.

The Signify Strep A test should be used only with throat swabs or colonies taken directly from a plate. The quality of the test depends on the quality of the sample; proper throat swab specimens must be obtained.

This test does not differentiate between carriers and acute infections. Pharyngitis may be the result of infection with organisms other than streptococcus.

A negative result may be obtained if the specimen is inadequate or the antigen concentration is below the sensitivity of the test. A negative Signify Strep A test result should be followed up by a culture if clinically indicated.

Documentation:

1. All patient results are to be recorded on the Patient Result Form. Any abnormal results must be reviewed by the physician and documented.

2. All reference ranges are noted on the Patient Result Form.

3. Document any results given to the patient.

4. Document instructions provided regarding follow-up care.

5. Provide signature of person performing test, date of test, patient's full name, patient's social security number or medical record number, patient's results and performance of controls on the Patient Result Form.

X. Limitations

As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single result or method.

XI. References

XII. Author

Compiled by: Emanual Lerner, M.D.

All positive results should be confirmed and/or followed up by repeat testing at the laboratory.

University

Diagnostic

Laboratories POCT Program PROCEDURE

Procedure: Urinalysis Dipstick - Bayer MultisTix

Prepared by Date Adopted Supersedes Procedure # R. Hart, MLT (ASCP) 7/7/97

Revision Date Revision summary 6/8/99 Updated procedure to Word format. Remove references to outpatient services. Added lot to lot verification requirement

Revision Date Signature Review Date 6/8/99

# of # of Distributed to Copies Distributed to Copies UDL POCT sites 1

Urine Multistix: Tests for Glucose, Bilirubin, Ketones (acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrites and Leukocytes in Urine.

Purpose

The purpose of this procedure is to provide optimal Urinalysis Dipstick Point Of Care Testing services to Outpatients and to provide consultations directed to the medical staff. It is essential that the quality of results and timeliness of their availability are assured. The following guidelines for Urinalysis Dipsticks are a necessary step for achieving these goals and for complying with the laboratory accrediting requirements of the Department of Health and Human Services, the New Jersey Department of Health, the Federal Drug Administration, and the College of American Pathologists.

Policy

Properly trained and certified physicians, nurses (RN or LPN), Medical Assistant / Medical Technician or qualified technical personnel may perform Urinalysis Dipstick testing outside the laboratory, under the authority and licensure of the bioanalytical laboratory director.

Principle

The Diagnostic Strips for Urinalysis are firm plastic strips to which are affixed several separate reagent areas. These tests may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and urinary tract infection.

The reagent tests areas are ready to use upon removal from the bottle and the entire reagent strip is disposable. The strips are to be read visually. Accurate timing is essential to provide optimal results. The reagent strips must be kept in the bottle with the cap tightly closed to maintain reagent activity. To obtain optimal results, it is necessary to use FRESH, well-mixed, uncentrifuged urine.

This test is based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with a potassium iodide chromogen to oxidize the chromogen to colors ranging from green to brown.

Bilirubin - This test is based on the coupling of bilirubin with diazotized dichloraniline in a strongly acid medium. The color ranges through various shades of tan.

Ketone - This test is based on the development of colors ranging from buff-pink, for a negative reading, to purple when acetoacetic acid reacts with nitroprusside.

Specific Gravity - This test is based on the apparent pKa change of certain pretreated polyelectrolytes in relation to ionic concentration. In the presence of an indicator, colors range from deep blue-green in urine of low ionic concentration through green and yellow-green in urines of increasing ionic concentrations.

Blood - This test is based on the peroxidase-iike activity of hemoglobin, which catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3,3',5,5'-tetra methylbenzidine. The resulting color ranges from orange through green; very high levels of blood may cause the color development to continue to blue. pH - The test is based on the double indicator principle that gives a broad range of colors covering the entire urinary pH range. Colors range from orange through yellow and green to blue.

Protein - This test is based on the protein-error-of-indicators principle. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow for "Negative" through yellow-green and green to green-blue for "Positive" reactions.

Urobilinogen -This test is based on a modified Ehrlich reaction, in which p- diethylaminobenzaldehyde in conjunction with a color enhancer reacts with urobilinogen in a strongly acid medium to produce a pink-red color.

Nitrite -This test depends upon the conversion of nitrate (derived from the diet) to nitrite by the action of Gram negative bacteria in the urine. At the acid pH of the reagent area, nitrite in the urine reacts with p-arsanilic acid to form a diazonium compound in turn couples with 1,2,3,4- tetrahydrobenzo(h)quinolin-3-ol to produce a pink color.

Leukocytes - Granulocytic leukocytes contain esterases that catalyze the hydrolysis of the derivatized pyrrole amino acid ester to liberate 3-hydroxy-5-phenyl pyrrole. This pyrrole then reacts with a diazonium salt to produce a purple product.

Specimen Collection and Handling

Clearly label a clean collection container with the patient's name and date.

Collect 10 - 1 5 mL of urine in a clean container and test it as soon as possible.

Do not centrifuge. The use of urine preservatives is not recommended.

If testing cannot be done within an hour after voiding, refrigerate the specimen immediately and let it return to room temperature before testing.

Nitrite results are optimized by using a first morning specimen or one that has incubated in the bladder for four hours or more.

Prolonged exposure to room temperature may result in microbial proliferation with the resultant changes in pH. A shift to alkaline pH may cause false positive results with the protein test area. Urine containing glucose may decrease in pH as organisms metabolize the glucose. Bacterial growth from contaminating organisms may cause false positive blood reactions from the peroxidases produced. In random urine specimens from females.' a positive result for leukocytes may be due to a source external to the urinary tract.

Reagents, Controls, Equipment

1 . Clear Dry Urine Collection Container

2. LabelPen

3. Multistix 10 SG

4. Quantimetrix Level 1 and Level 2 Urinalysis Dipstick Controls

5. Timer or Watch with a Second Hand

6. Disposable medical gloves.

All reagents and controls must be labeled with: The Date Received, Date Opened, Expiration Date, and Contents.

Quality Control

For optimum performance, reagent strips must be confirmed and documented by testing known negative and positive controls once per shift, and when a new bottle of reagent strips is first opened. Monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. Quantimetrix Level 1 and Level 2 with defined results, provide a convenient basis for a quality control program.

1. On initial use remove the controls from the refrigerator and allow to come to room temperature (25 - 25 oC), about 15 to 30 minutes.

2. Remove cap and invert bottle. While holding dipstick, gently squeeze the sides of the dropper bottle, and touch the drop of fluid to the dipstick. Draw across the reagent pads, thoroughly saturating each pad. Do not aspirate excess control back into the bottle. Turn dipstick on its side and drain excess control onto absorbent material.

3. Read the urine dipsticks by comparing reagent blocks to the Color Chart on the label, in accordance to the Reagent Procedure.

4. Wipe off dropper tips and recap controls. The controls can be stored at room temperature when not in use. Record the room temperature expiration date in the space provided on the bottle label.

5. All control results must be documented on the control log.

6. If controls are successful, indicate on the Patient Result Log. If not, determine the cause and rectify. Document everything. Notify the UDL / UMG for technical assistance, if needed, at 235-8110.

7. All reagent lot #s must be documented on the reagent log.

Reagent and Control Storage and Stability

Reagents-

Store at room temperature between 15-30 oC (59 - 86F). Do not use product after expiration date. Do not store the bottle in direct sunlight.

The reagent test areas are ready to use upon removal from the bottle and the entire reagent strip is disposable. The reagent strips must be kept in the bottle with the cap tightly closed to maintain reagent activity.

All unused strips must remain in the original bottle. Do not remove desicant from bottle. Do not mix lot numbers. Do not touch areas of the reagent strips.

New lots of reagent will be compared against old lots by UMG/UDL supervisor personnel before new lots are placed into use.

Controls-

Store at 2-8 oC before initial use. Do not freeze. When stored at 2-8 oC, the controls are stable until the expiration date stated on the label.

After the initial use, the opened Control Bottles can be stored at room temperature. Do not store above 30 oC. (86 oF).

When stored at room temperature (20-25 oC) the controls are stable for one month. Room temperature expiration date can be noted on the control bottle label.

Discard the controls if turbid or any evidence of microbial contamination is present,

Procedure

1. Collect FRESH urine specimen in a clean, dry container. Label specimen with patient's name. Wear disposable medical gloves. Mix well immediately before testing.

2. Remove one strip from bottle and replace cap. Completely immerse reagent areas of the strip in FRESH urine and remove immediately to avoid dissolving out reagents.

3. While removing, run the edge of the strip against the rim of the urine container to remove excess urine. Hold the strip in a horizontal position to prevent possible mixing of chemicals from adjacent reagent area and / or contamination.

4. Visually compare reagent area to corresponding Color Chart on the bottle label at the time specified. HOLD STRIP CLOSE TO COLOR BLOCKS AND MATCH CAREFULLY. Avoid laying the strip directly on the Color Chart, as this will result in the urine soiling the chart.

Proper read time is critical for optimal results. Read the glucose and bilirubin test at 30 seconds after dipping. Read the ketone test at 40 seconds; the specific gravity test at 45 seconds; pH, protein, urobilinogen, blood and nitrite at 60 seconds; and leukocytes at 2 minutes.

Results and Interpretation

Results with the Diagnostics Reagent Strips are obtained in clinically meaningful units directly from the Color Chart comparison. All expected reference ranges are indicated on the Patient Result Form.

A routine urinalysis includes reporting of

1. Appearance: Clear, Hazy, Cloudy, Turbid 2. Color: Colorless, Straw, Yellow, Amber, Etc. 3. Specific Gravity: Note Result 4. Leukocyte Esterase: Negative, Trace, 1 +, 2 +, 3 + 5. Nitrite: Positive or Negative 6. pH: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 7. Protein: Negative, Trace, 1 +, 2 +, 3 +, 4 + 8. GIucose: Negative, Trace, 1 +, 2 +, 3 +, 4 + 9. Ketones: Negative, Trace, Small, Moderate, Large 10. Blood: Negative, Trace, 1 +, 2 +, 3 +, 4 + 11. Bilirubin: Negative, Small, Moderate or Large. 12. Urobilinogen: 0.2, 1.0, 2.0, 4.0, 8.0

All positive results should be confirmed and/or followed-up by repeat testing at the laboratory.

Documentation:

5. Provide signature of person performing test , date of test, patient's full name, patient's SS# or Medical Record #, patient's results and performance of controls on the Patient Result Form.

Limitations

References

Bayer Multistix Package Insert Revised 9/95

Bayer Corporation Diagnostics Division Elkhart, IN 46515 USA

Quantimetrix Dropper Plus Urine Dipstick Control Quantimetrix Corporation Package Insert 2005 Manhattan Beach Blvd, Cat # 1 440-04 Redondo Beach, CA 90278-1205

Author:

Compiled by: Renee Hart, UDL/UMG

All positive results should be confirmed and/or followed up by repeat testing at the laboratory.

UMG Required Documentation

5. Provide signature of person performing test , date of test, patient's full name, patient's SS# or Medical Record #, patient's results and performance of controls on the Patient Result Form.

Limitations

References

Bayer Multistix Package Insert Bayer CorporationDiagnostics Division Elkhart, IN 46515 USA

Quantimetrix Dropper Plus Urine Dipstick Control Quantimetrix Corporation 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278-1205

Package Insert Page 28 of 54 UMG/UDL Point of Care Policy 4/3/2018 D:\Docs\2017-12-13\0f2cfcb7173c48db0fd7a8d7f242bc64.doc

Cat # 1 440-04

Author

Compiled by: Renee Hart, UDL/UMG Outpatient Services.

University

Diagnostic

Procedure: Microscopic Examination of Urine

Prepared by Date Adopted Supersedes Procedure # Evan Cadoff, M.D. 7/7/97

Revision Date Revision summary 6/8/99 Updated procedure to Word format. Remove references to outpatient services. Added lot to lot verification requirement 10/10/01 Update formatting

# of # of Distributed to Copies Distributed to Copies UDL POCT sites 1

PRINCIPLE

Analysis of urine may be used for either one of two purposes. One is to determine the presence of body disturbances, such as endocrine or metabolic abnormality in which the kidneys function normally and excrete abnormal amounts of metabolic end products specific for a particular disorder. The second purpose is to detect intrinsic conditions that may affect the kidneys or urinary tract. Diseased kidneys cannot function normally in regulating the volume and composition of body fluids and maintain homeostasis. Therefore, substances normally retained by the kidneys or excreted in small amounts may appear in the urine in large quantities and substances normally excreted may be retained. Structural elements, such as red blood cells, cells from the urinary tract, leukocytes, bacteria, and casts from the impaired kidneys or lower urinary tract may appear in the urine.

SPECIMEN COLLECTION

The optimal container for collecting urine is the plastic screw top cup. For patients bringing specimens collected at home, small glass jars with screw caps (i.e. baby food jars), are acceptable but must be well cleansed and thoroughly dried before the specimen is collected. Other containers are not acceptable.

Specimens from infants and young children may be collected in a disposable collection apparatus consisting of a plastic bag with an adhesive backing around the opening to fasten it to the child allowing the specimen to be voided directly into the bag. After removal, the top of the bag is rolled down to close and then placed into a plastic screw top urine container to be transported to the laboratory.

The procedure most commonly used for obtaining urine for urinalysis along with bacteriologic examination and culture is the clean catch or midstream specimen. To avoid contamination of the voided specimen by organisms in areas adjacent to the urethral meatus, this area must be cleansed thoroughly before the patient voids. To avoid contamination of the specimen with organisms normally located in the distal urethra, the initial stream of voided urine which clears these organisms from the urethra is discarded and the subsequent midstream urine is collected. A description of the optimal technique for the clean catch urine collection can be found as an addendum to this procedure. Bladder catheterization and percutaneous suprapubic aspiration of the bladder may be used, but only in rare and unusual circumstances.

Most testing is done on a random specimen of urine, freshly voided by the patient, although a first morning specimen is preferable. The specimen is collected in a clean, dry container and should be examined within one hour as to avoid changes or deterioration in the urine. If the specimen is to be kept more than one hour before the analysis, it should be refrigerated at 2 - 8oC and returned to room temperature before analysis. All collection containers and testing vessels should be free of any disinfectants or detergents.

Specimens must be labeled with the patient’s name. The container should be labelled in advance, or the patient should be provided with a means of labelling the sample (ie, a pen or pencil available in the bathroom).

At least 10 ml. of urine is required for an optimal evaluation. If less than 5 ml is received, a microscopic evaluation should not be performed.

REAGENTS AND EQUIPMENT

Centrifuge Tubes Plain Glass Slides Cover Slips, 22x22 mm Timer Centrifuge

URINALYSIS PROCEDURE

Centrifuged urinary sediment is examined microscopically first under the 10X objective to tabulate casts and get an overview of the sediment. Then changed to the 40X objective to tabulate the cellular elements and to identify any crystals seen.

URINE MICROSCOPIC PROCEDURE

1. Ascertain that a microscopic examination is necessary based on your findings during the chemistry phase of the urinalysis.

2. Transfer 10 ml. of urine to a labeled conical urine centrifuge tube.

3. Centrifuge the tube for five minutes at 2400 RPM. A longer duration or faster speed will result in the cellular elements being damaged making identification difficult.

4. Decant the supernatant and resuspend the sediment by gently vortexing the tube with your finger.

5. Place a drop of the resuspended sediment on a clean slide, and coverslip with a 22x22 mm coverglass.

6. Observe and tabulate your findings of 10 fields each at 10X and 40X power.

REPORTING RESULTS:

Record your findings in the patients record. Record in the patient log the information required.

Since testing is physician performed, further reporting of results or documentation is not necessary.

LIMITATIONS

Despite care in specimen collection, various artifacts and contaminants may occasionally be found in a sample, such as talcum powder, starch particles, Vaseline, glass particles, clothing fibers, etc. Careful examination is required to correctly identify the artifact. If necessary, a repeat specimen may be required.

REFERENCES

Haber, Meryl H., M.D., Primer of Microscopic Urinalysis, Fountain Valley, Ca.: ICL Scientific; 1978

Ames Co., Div. Miles Laboratories, Inc., Modern Urinalysis, Chicago, III.: Stern's Printers; 1974

University

Diagnostic

Prepared by Date Adopted Supersedes Procedure # Eugene G. Martin, Ph.D. No Previous

Distributed to Copies Distributed to Copies

Procedure: Status hCG® Urine/Serum Combo

PRINCIPLE:

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the placental trophoblastic cells shortly after the fertilized ovum is implanted in the uterine wall.1-4 The primary function of hCG is to maintain the corpus luteum during early pregnancy. The appearance of hCG in both the urine and serum soon after conception and its rapid rise in concentration make it an excellent marker for confirmation of pregnancy. The hormone may become detectable in both urine and serum as early as 7 to 10 days after conception.1-4 The concentration of hCG continues to rise rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period and peaking in the 30,000–100,000 mIU range by 10 to 12 weeks into pregnancy. The hormone is comprised of two non-covalently bound, dissimilar subunits containing approximately 30% carbohydrate by weight.5 The alpha subunit is structurally similar to other human pituitary glycoprotein hormones, whereas the beta (ß) subunit confers unique biological and immunological specificity to themolecule.6,7

The Status hCG™ Serum/Urine—One Step Pregnancy Test is a rapid serum or urine test for confirming pregnancy. The test is a solid-phase, two-site immunometric assay in which a combination of monoclonal and polyclonal antibodies is used to selectively detect elevated levels of hCG in serum or urine with a high degree of sensitivity. In the test procedure, sample is added to the sample well with the aid of a transfer pipette and sample is allowed to soak in. If hCG is present in the specimen, it will react with the conjugate dye, which binds to the antibody on the membrane to generate a colored line. Presence of two colored lines, one in the test window and the other in the control window, indicates a positive result, while the absence of the line in the test window indicates a negative result.

SPECIMEN:

Urine Assay  Approximately 150 µL (0.15 mL) of serum or urine sample is required for each test.  For optimal early detection of pregnancy, a first morning urine specimen is preferred since it generally contains the highest concentration of hCG. However, randomly collected urine specimens may be used.  Collect the urine specimen in a clean glass or plastic cup without preservatives.  As in many test systems, urine containing excessive bacterial contamination should not be used since spurious results may occur with such specimens.

Serum Assay  Remove the serum from the clot as soon as possible to avoid hemolysis. When possible, clear, non-hemolyzed specimens should be used. Specimens containing particulate matter may give inconsistent test results. Such specimens should be clarified by centrifugation prior to assaying.  Bring specimens to room temperature (18–30°C) prior to testing. Frozen specimens must be completely thawed, thoroughly mixed, and brought to room temperature prior to testing by allowing the specimens to stand at room temperature for at least 30 minutes.

Specimen Storage:  If testing will not be performed immediately, the specimens should be refrigerated (2–8°C) for up to 24 hours.  For prolonged storage, specimens may be frozen and stored below -20°C for 15 days. Frozen specimens must be completely thawed, thoroughly mixed and brought to room temperature. Avoid repeated freezing and thawing.  If specimens are to be shipped, they should be packed in compliance with Federal regulations covering the transportation of etiologic agents. Add sodium azide to a concentration of 0.1% as a preservative and ship by the quickest means possible.

EQUIPMENT AND MATERIALS:

Materials:

Provided in the kit:

The Status hCG™ Serum/Urine—One Step Pregnancy Test kit contains enough reagents and materials to perform all the tests.

 Status device. Test device containing the polyclonal anti-hCG coated membrane and a pad with the mouse monoclonal IgG (anti-hCG)-dye conjugate in a protein matrix containing 0.1% sodium azide.  Transfer pipette (disposable plastic pipettes).  Instruction insert.

Storage Requirements: Status hCG™ Serum/Urine—One Step Pregnancy Test kit should be stored at 2– 30°C (36–86°F) in the sealed pouch. QUALITY CONTROL: User Quality Control  Control standards are not provided with this kit; however, it is recommended that controls be tested at regular intervals as good testing practice and whenever there is any doubt about the interpretation of the test result. It is recommended that a positive control which is near the sensitivity limit of the assay be used for assay control. For information on how to obtain controls, contact LifeSign for technical assistance. The positive control will produce a positive result and the negative control will yield a negative result (control line only). Before using a new lot, a quality control test using the positive and negative control should be conducted to confirm the expected Q.C. results and the validity of the assay. Upon confirmation of the expected results, the kit is ready for use with patient specimens.  The control line in the Control window can be considered an internal positive procedural control, i.e., a proper amount of sample is used; sample is added to the sample well, and not through the reading window; and the reagent system worked properly. A distinct pinkish-purple control line will always appear if the test has been performed correctly. If the control line does not appear, the test is invalid and a new test should be performed. If the problem persists, contact LifeSign for technical assistance.  A clear background in the Test Result Window (T) is considered an internal negative procedural control. If the test is performed correctly and the Status® hCG device is working properly, the background in the Test Result Window (T) should be clear, providing a distinct negative result.

PROCEDURE - STEPWISE: A. For Serum or Plasma: 1. For each test, open one Status hCG™ pouch, and label the Status device with the patient ID. 2. Holding the dropper in a vertical position, add 3 drops (150-200 µL) of sample into the sample well (S). 3. Read the result after 3 minutes, but within 10 minutes.

REPORTING RESULTS: Positive: Two pinkish-purple lines, one each in the test window (T) and in the control window (C).

Each of the following indicates a positive test result: a. Two strong pinkish-purple lines, one each in the test (T) and control (C) windows. b. One strong pinkish-purple line in the test window (T) and one light pinkish-purple line in the control window (C). c. One light pinkish-purple line in the test window (T) and one pinkish-purple colored line in the control window (C). Page 35 of 54 UMG/UDL Point of Care Policy 4/3/2018 D:\Docs\2017-12-13\0f2cfcb7173c48db0fd7a8d7f242bc64.doc

Negative: Only one pinkish-purple line, in the control window (C).

Notes on Results

Positive A specimen containing a detectable level of hCG will generate a pinkish-purple line in the test window (T) within 3 minutes. The time required to generate the line is dependent on the hCG concentration in the sample. Some positive results can be read in as early as one (1) minute. To be interpreted as positive, the pinkish-purple line in the test window should be clearly distinguishable from the background color of the membrane. In strong positive tests, the color intensity of the control line (C) may be much lighter than that of the test line (T).

Negative In the absence of hCG, or in the case that the hCG concentration is below the detection limit of the test, there will be no apparent line in the test window; rather, there may be a uniform background color over the membrane area. The control line in the control window should be clearly readable.

Inconclusive or Invalid Results If there is no distinct pinkish-purple line visible either in the test window or in the test control window, the test is inconclusive. If there is a suspected procedural error made by the user, the result should be considered inconclusive. It is recommended that in this case the test be repeated or a fresh specimen be obtained and tested 48 hours later. A control line should always appear; the absence of a pinkish-purple line in the control window means the test is invalid and should be repeated.

LIMITATIONS OF THE PROCEDURE:  In addition to pregnancy, elevated hCG levels have been reported in patients with both gestational and nongestational trophoblastic diseases.8,9,10 The hCG of trophoblastic neoplasms is similar to that found in pregnancy, so these conditions, including choriocarcinoma and hydatidiform mole, should be ruled out before pregnancy is diagnosed.  A very early pregnancy containing an extremely low concentration of hCG can give a negative result. In this case, another specimen should be obtained at least 48 hours later and tested.  The hCG level may remain detectable for several weeks after normal delivery, delivery by cesarean section, spontaneous abortion, or therapeutic abortion.11  The hCG level in the case of spontaneous abortion may be very low and eventually decrease. The test is highly sensitive, and specimens which test positive during the initial days after conception may later be negative due to natural termination of the pregnancy. Natural termination occurs in 22% of clinically unrecognized pregnancies and 31% of pregnancies overall.12 Subsequent testing of a new urine or serum sample after an additional 48 hours is recommended in order to confirm that the hCG level is rising as indicated in a normal pregnancy.  The concentration of hCG may be very low in the case of ectopic pregnancy.13 A suspected ectopic pregnancy may be further evaluated using a quantitative hCG assay.

 Very high levels of hCG may exist in certain pregnancies and pathological conditions (e.g., choriocarcinoma and hydatidiform mole). This may weaken the signal line.  As is true with any diagnostic procedure, the physician should evaluate data obtained by using this kit in light of other clinical information.  Samples which contain excessive bacterial contamination or have been subjected to repeated freezing and thawing should not be used because such specimens can give spurious results.  Urine samples with low specific gravity may not contain representative levels of hCG. If such a sample is negative or weakly positive, a first morning specimen should be obtained for retesting.

REFERENCES: 1. Braunstein, G.D., Rasor, J., Adler, D., Danzer, H., and Wade, M.E. Serum Human Chorionic Gonadotropin Levels Throughout Normal Pregnancy. Am. J. Obstet. Gynecol.1976; 126:678. 2. Krieg, A.F. Pregnancy Tests and Evaluation of Placental Function in: Clinical Diagnosis and Management by Laboratory Methods, 16th ed., Henry, J.B. (ed.) W.B. Saunders Co., Philadelphia, pp. 680, 1979. 3. Brody, S. and Carlstrom, G. Immunoasay of Human Chorionic Gonadotropin in Normal and Pathologic Pregnancy. J. Clin. Endocrinol. Metab. 1962; 22:564. 4. Hussa, R.O. Human Chorionic Gonadotropin, A Clinical Marker: Review of its Biosynthesis. Ligand Review 1981; 3:6. 5. Swaminathan, N. and Bahl, O.P. Dissociation and Recombination of the Subunits of Human Chorionic Gonadotropin. Biochem. Biophys. Res. Commun. 1970; 40:422. 6. Ross, G.T. Clinical Relevance of Research on the Structure of Human Chorionic Gonadotropin. Am. J. Obstet. Gynecol. 1977; 129:795. 7. Reuter, A.M., Gaspard, U.J., Deville, J-L., Vrindts-Gevaert, Y. and Franchimont, P. Serum Concentrations of Human Chorionic Gonadotrophin and its Alpha and Beta Subunits. 1. During Normal Singleton and Twin Pregnancies. Clin. Endocrinol. 1980; 13:305. 8. Morrow, C.P., et al. Clinical and Laboratory Correlates of Molar Pregnancy and Trophoblastic Disease. Am. J. Obstet Gynecol. 1977; 50:424-430. 9. Dawood, M.Y., Saxena, B.B., and Landesman, R. Human Chorionic Gonadotropin and its Subunits in Hydatidiform Mole and Choriocarcinoma. Am. J. Obstet. Gynecol. 1977; 50:172–181. 10. Braunstein, G.D., Vaitukaitis, J.L., Carbone, P.P., and Ross, G. T. Ectopic Production of Human Chorionic Gonadotropin by Neoplasms. Ann. Inter. Med. 1973; 78:39-45. 11. Steier, J.A., Bergsjo, P., and Myking, O.L. Human Chorionic Gonadotropin in Maternal Plasma After Induced Abortion, Spontaneous Abortion, and Removed Ectopic Pregnancy. Am. J. Obstet. Gynecol. 1984; 64:391-394. 12. Wilcox, A.J., Weinberg, C.R., O’Connor , J.F., Baird, D.D., Schlatterer, J.P., Canfield, R.E., Armstrong, E.G., and Nisula, B.C. Incidence of early loss of pregnancy. N. Engl. J. Med. 1988; 319:189-194. 13. Thorneycroft, I.H. When You Suspect Ectopic Pregnancy. Diagnosis, January: 67-82, 1976.

University

Diagnostic

Prepared by Date Adopted Supersedes Procedure # Eugene G. Martin, Ph.D. 10/17/01

Distributed to Copies Distributed to Copies POCT manual/CAB nursing stations 1

Procedure: Precision PCx Point-of-Care System and POCT glucose measurement

OVERVIEW

UNDERSTANDING THE PRECISION PCX POINT-OF-CARE SYSTEM

The Precision PCx Point-of-Care System is a portable whole blood testing system which performs tests with quick and accurate results. This section is intended to provide an overview of the Precision PCx System's components and basic operations.

MEDISENSE PRECISION PCX POINT-OF-CARE SYSTEM COMPONENTS

The MediSense Precision PCx Point-of-Care System includes the following items:

1. The Precision PCx Monitor 2. Precision PCx Blood Glucose Test Strips

3. Accessory/Carry Case (optional) 4. Docking Station (optional)

The Precision PCx Monitor includes:

1. Test Strip Port 2. Large LCD Display 3. Barcode Scanner 4. Keypad 5. Data Port 6. Audible Indicator

PRECISION PCX BLOOD GLUCOSE TEST STRIPS

Each test strip is wrapped in a foil packet with a barcode label. This label holds the calibration information about the test strip, including the lot number, the expiration date and expected control solution ranges.

ACCESSORY/CARRY CASE

The case holds the Precision PCx Monitor and the following items:

1. Precision PCx Test Strips 2. Single-Use Lancing Devices 3. Alcohol Swabs 4. Gauze Pads 5. Precision Glucose Control Solution 6. Quick Reference Guide

TEST STRIP PORT

After the operator scans the barcode or manually enters information via the monitor keypad, the operator will insert a new test strip into the test strip port to perform a test.

DISPLAY

Here is where menu options, error codes, and test results are viewed. Press and hold "0" on the keypad to turn on or off the backlight for the monitor display.

KEYPAD

The keypad contains the following controls:

On/Off

Press this button to turn the monitor on or off. The monitor will automatically turn off after 4 minutes if the monitor is left on but has not been used.

Press the scan button to use the laser barcode scanner. The barcode scanner enables the operator to scan the information into the monitor instead of manually entering the data by using the keypad. The scanner can automatically enter the test strip information (calibration, control range, lot number and expiration date), as well as the operator ID, patient ID, and control lot number.

Numbers

The 10-digit keypad can be used to enter identification numbers or to select an option that appears in the display.

The operator can press clear to perform the following functions:

1. To back up one space while entering numbers on the keypad. 2. When clear is pressed two times, all entered numbers shown in the display will be cleared. 3. Clear a numerical code from the monitor after having pressed Enter. 4. Clear a barcode scanned by mistake. 5. Return to a previous screen.

When the Menu key is pressed the following functions can be performed:

1. Return to the top of the menu. 2. Switch between Test Mode and Menu Mode.

When the Enter key is pressed it will confirm the information that was manually entered.

BARCODE SCANNER

The Barcode Scanner is used to scan barcode information into the monitor. The operator will hold the barcode scanner 3-12 inches from the barcode to be scanned. When first using the barcode scanner, some precautions should be taken while mastering the device.

Place the object to be scanned on a flat surface, by itself. This will prevent other items from being accidentally scanned.

Press and hold down the scan button to start the barcode scanner. A visible red beam will be emitted from the monitor. Slowly move this beam over the barcode on the item to be scanned. When the monitor accepts the barcode, it will beep in acknowledgement. Without releasing the scan button, look down at the monitor. The operator can view the data that was scanned by the monitor. Release the scan button to stop the scan and continue with the next step.

CAUTION

Never look into the barcode scanner beam or point it toward anyone's eyes. The beam could cause permanent damage to the eye.

DATA PORT

The Data Port is located at the bottom of the monitor. This port enables the monitor to automatically transfer the data through a cable connector to a PC, laptop, Laboratory Information System (LIS), or Hospital Information System (HIS).

BATTERY COMPARTMENT

The monitor holds two AA alkaline batteries to power the monitor. A rechargeable battery

pack is also available from MediSense. To prolong the battery life of the monitor, the monitor should be turned off when not in use. If the monitor is left on and has not been used for 4 minutes, it will automatically shut itself off.

AUDIBLE INDICATOR

The monitor will beep to indicate one of the following:

1. A successful barcode entry. 2. Sample detection. 3. At three seconds before the result is to appear. 4. When an error occurs.

Specimen Collection and Handling

Universal Precautions apply.

COLLECTING BLOOD SAMPLES

How to Obtain a Capillary Blood Sample:

1. Collect the capillary blood using a lancing device and an appropriate technique. 2. Avoid squeezing the puncture sit excessively. 3. Apply the drop of blood directly to the target area of the test strip, covering the entire area. 4. If necessary, the blood can be collected in a heparin-coated capillary tube and then applied to the test strip.

How to Obtain a Venous Blood Sample:

1. Collect the venous blood sample in a collection tube containing sodium or lithium heparin, ensuring that the test tube is completely filled. 2. Do not use collection tubes that contain fluoride or oxalate. 3. If the blood is collected from an intravenous line, clear the line before drawing the sample into a syringe that contains sodium or lithium heparin. Allow the sample to reach room temperature before performing a test on the sample; use the sample within 30 minutes of collecting it. 4. Invert the tube with the sample several times immediately before taking a sample. 5. Use a disposable transfer pipette to obtain a sample from the center of the collection tube. 6. Apply a drop of blood directly to the target area on the test strip, covering the entire area.

How to Obtain an Arterial Blood Sample:

1. Clear the arterial line before drawing a blood sample into a syringe that contains sodium or lithium heparin. 2. Use the sample within 30 minutes of collection. 3. Mix the syringe several times immediately before applying the sample to the target area on the test strip. 4. Allow a drop of blood to form at the tip of the syringe. 5. Cover the entire target area on the test strip with the blood sample. The syringe can briefly touch the test strip without affecting the test result.

DISPOSING OF WASTE

Observe the following guidelines when disposing of biohazardous waste:

1. Dispose of used lancets in an approved sharps container. 2. Discard used capillary tubes, disposable transfer pipettes or tips and test strips in an approved biohazard container. 3. Follow UMDNJ - Robert Wood Johnson Medical School biohazard disposal policy.

Materials and Equipment Required

TEST INSTRUMENT: Manual

Supplier(s) for the above materials: Abbott Diagnostics Medisense Division

Representative(s): Tina O’Grady

Phone number of the supplier(s):#

Calibration Procedure

ELECTRONIC CALIBRATION

For Electronic Calibration, refer to pgs. 3-4 in the Operations Manual.

Quality Control

CONTROL TEST

This section describes the necessary steps to test the Precision Control Solutions in order to verify the performance of the Precision PCx Monitor and Precision PCx Test Strips.

The monitor has been set to require:

1. Tests of an External Control Solution, in addition to Low and High Control Solutions, daily or whenever patient specimens are being run. 2. Tests of Control Solutions at regular times or time intervals. 3. Qualitative Pass/Fail Set-Up Mode.

These quality control features are set through the Menu Mode menu (Change Setup/Test Setup Menu).

OPERATING GUIDELINES

To obtain optimal quality control results using the Precision PCx System:

1. Use only Precision, Precision-G or MediSense Control Solutions to verify the performance of the Precision PCx Test Strips and the Precision PCx Monitor. These solutions are present in the kit and can be obtained upon expiration, by contacting1 2. Store control solutions at temperatures between 39 degrees and 86 degrees F. (4 degrees and 30 degrees C.) with their bottle caps fully tightened. Do not freeze. 3. After opening, each bottle of control solution is stable for 90 days if tightly closed after each use. When you first open a new bottle, write the

1 UDL Central Administrative Office contact: 235-8110 Page 42 of 54 UMG/UDL Point of Care Policy 4/3/2018 D:\Docs\2017-12-13\0f2cfcb7173c48db0fd7a8d7f242bc64.doc

current date on the bottle label, your initials and the calculated expiration date. Discard all unused solutions 90 days after opening. 4. Invert the control solution bottle several times to ensure thorough mixing before use. 5. Invert and tap the capped control solution bottle to remove air bubbles from the nozzle of the bottle. 6. Do not scan one test strip packet's barcode and use a test strip from another packet, since incorrect assay results may be generated. 7. After each use, replace the correct cap on each bottle and immediately tighten the cap. 8. Do not use control solutions after the expiration date printed on the bottles and the box. The Precision PCx Monitor does not accept control solutions that have passed their expiration date.

WHEN TO TEST CONTROL SOLUTIONS

1. Either once daily or prior to running a patient specimen 2. When you question blood glucose results. 3. When your test strips have been exposed to temperatures outside the storage conditions (39 degrees - 86 degrees F., 4 degrees - 30 degrees C.). 4. Prior to distributing a new lot of reagent strips to UMG sites, strips will be validated centrally.

CONTROL TEST PROCEDURE

Use the following procedure to perform control tests.

1. Press On/Off to turn on the monitor. The Abbott logo screen will appear for a few seconds followed by the product name, software version and then the Test Mode menu. 2. Press 2-Control Test. After control test is selected, the Operator ID screen will appear. 3. Press Scan to scan your Operator ID barcode which will be made available to you upon successful completion of your competency examination or re-examination. Alternately you may manually enter your Operator ID via the keypad, then press Enter. After the Operator ID is entered, the Low Level Solution Lot screen will appear. 4. Scan or manually enter the low control solution lot number via the keypad, then press Enter. The Strip Lot screen will appear next. If the Unexpected Level screen appears, the operator may choose to either: a. Enter 1 to test the correct level. b. Enter 2 to continue to test the unexpected level. 5. Scan or manually enter the test strip lot number via the keypad, then press Enter. After the test strip lot number is entered, the monitor will prompt for a test strip to be inserted into the test strip port. 6. Open the foil test strip packet at the notch and tear up or down to remove the test strip. 7. With the contact bars facing up, insert the test strip into the test strip port until it stops. The monitor will prompt the operator to apply the desired control solution to the test strip. 8. Gently invert the required control solution bottle 3-4 times then apply a drop to the target area on the test strip. The monitor will beep when the sample is accepted. The sample accepted screen will be displayed. Recap the control solution bottle tightly. The test starts automatically, as the sample is accepted. 9. Wait for the monitor to analyze the control solution and display the test results. The monitor counts down the seconds it takes to analyze the sample (20

seconds), then displays the test result. 10. Note the result and whether it falls within the expected range. Control test results will appear as a PASS/FAIL. The display will show the control range, date and time. An "X" will appear in front of a test result that is out of range. 11. Scan or manually enter the comment code via the keypad, then press Enter. The monitor may be set to enter a 1- to 2-digit comment code.

If a prompt is not displayed to enter a comment code, skip down to step 12. 12. Remove the test strip. 13. The operator may select one of the following:

Press 1-Next Level. Operator will skip back to step 4. Press 2-Repeat Test. Operator will skip back to step 5. Press Menu to return to the Menu Mode menu. Press On/Off to turn off the monitor.

If the control test result is within range, the operator can continue to the next level test. The operator has the option to perform the next level control test (1-Next Level) or can repeat the same level control (2-Repeat Test) by returning to step 5.

NAME{} protocol for reporting control results:#

NAME{} protocol for frequency of testing controls:#

NAME{} protocol for out of control results:#

Procedure (Step-by-Step Instructions)

PATIENT TEST

This section describes the steps to be taken to test patient blood samples using the Precision PCx Monitor.

OPERATOR GUIDELINES

Please follow the recommended guidelines so the most accurate results will be obtained. 1. Use only Precision-G, MediSense or Precision Control Solutions to verify the performance of the Precision PCx Test Strips and the Precision PCx Monitor. 2. Use the test strips before their expiration date. 3. Do not use test strips that are wet, bent, scratched or damaged. Use the test strip immediately after opening its foil packet. 4. Do not scan a packet's barcode and use a test strip from another packet. This may cause incorrect assay results to be generated. 5. Cover the entire target area of the test strip with the blood sample. The test results will not be affected if the target area has been briefly touched with the patient's finger, a capillary tube or pipette. 6. If the test fails to start, apply a second drop of blood to the target area within 30 seconds. If the test fails to start after the second drop is applied, or if more than 30 seconds have passed, discard the used test strip and repeat the test. 7. After the blood is applied to the test strip and the test starts, do not touch the test strip. 8. Use each test strip only once. 9. Refer to the package insert in the test strip box for specific directions on storage and use of the test strips.

PATIENT TEST PROCEDURE

Use the following procedure to perform patient tests.

1. Press On/Off to turn on monitor. The Abbott logo screen will appear for a few seconds followed by the product name, software version screen and then the Test Mode menu. 2. Press 1 to select Patient Test. After the operator selects the type of test, the display may next prompt for an Operator ID to be entered. 3. Press Scan to scan the Operator ID barcode, or manually enter the Operator ID via the keypad, then press Enter. The display will next prompt for a Patient ID to be entered, if this setting has not been disabled. 4. Manually enter the Patient ID via the keypad, then press Enter. After entering the Patient ID, the test strip lot screen appears next. 5. Press Scan to scan the test strip barcode, or manually enter the test strip lot number via the keypad, then press Enter. After the test strip lot number has been entered, the Sample Type screen will appear. 6. The operator can select one of the following: Press 1-Capillary or Arterial Press 2-Venous. 7. Open the foil test strip packet at the notch and tear up or down to remove the test strip. 8. With the contact bars facing up, insert the test strip into the test strip port until it stops. The Apply Sample screen will appear next. 9. Apply a drop of blood to the target area on the test strip. Apply the blood directly from the patient's finger, or a syringe to the test strip. The test starts automatically, as soon as the sample is accepted. 10. Wait for the monitor to analyze the sample and display the result. The monitor counts down the 20 seconds it takes to analyze the sample, then displays the test result. 11. Note the result and whether it falls outside the action range. If the result is above or below the action range, an up or down triangle appears in front of the test result.

The Outside Action Range screen will appear if the Patient Test Out of Range Comment Code is set to optional or required, and the following two conditions are met:

A. The action range is set up. B. The result is out of the action range.

The In-Range Action Range screen will appear if the Patient Test In-Range Comment Code is set to optional or required and either of the following conditions are met:

A. The action range is defined and the result is within this action range. B. No action is set up.

The monitor may be enabled to scan or enter a 1- to 2-digit comment code. If there is no prompt to enter a comment code, skip down to step 12.

12. Remove the test strip from the monitor.

Remember to remove the test strip from the monitor when finished with testing. 13. The operator can select one of the following options:

Press 1-Next Patient. Press 2-Repeat Test. Press 3-Patient History.

If 1 is selected, the scan Patient ID screen will appear. Return to step 4 to continue with testing on the next patient. If 2 is selected, the scan or enter the test strip lot screen will appear. Return to step 5 to repeat the test. If 3 is selected, the monitor will display the last test result for this patient as well as allow the operator to view previous results.

Refer to the section entitled Data Review for Patient History for further information.

PROFICIENCY TEST

The Proficiency Test menu enables the operator to perform unknown sample test challenges.

Use the following procedures to perform a proficiency test.

If the monitor displays a message not indicated in these procedures, please refer to section 10, Troubleshooting, in your operation manual.

1. Press the On/Off button to turn on the monitor. The Abbott logo screen appears for a few seconds, followed by the product name, the software version screen, then the Test Mode menu. 2. Press Menu. The Menu Mode screen now appears. 3. Press 2 - Proficiency Test. The monitor will now prompt for the Operator ID to be scanned or entered. 4. Scan or manually enter the Operator ID via the keypad, then press Enter. The monitor will now prompt for the Sample ID to be scanned or entered. 5. Manually enter the Sample ID via the keypad, then press Enter. The monitor will now prompt for the Strip Lot number to be scanned or entered. 6. Scan or manually enter the test strip lot number via the keypad, then press Enter. The monitor will prompt the operator to insert the test strip. 7. Open the foil test strip packet at the notch and tear up or down to remove the test strip. 8. With the contact bars facing up, insert the test strip into the test strip port until it stops. The monitor will prompt the operator to apply sample to the test strip. 9. Gently invert the sample bottle 3-4 times then apply a drop of the sample to the target area on the test strip. The monitor will beep when the sample is accepted and the test starts. "Sample Accepted" is displayed on the screen. 10. Recap the sample bottle tightly. 11. Wait for the monitor to analyze the sample and display the test results. The display counts down the seconds it takes to analyze the proficiency test sample (20 seconds), then displays the result. 12. If the operator is prompted to enter a comment code, continue to step 13; otherwise skip forward to step 14. 13. Scan or manually enter the comment code via the keypad, then press Enter. The monitor returns to the Results menu. The comment code number that was entered will appear in a box to the left of the test result. 14. The operator will select one of the following options:

Press 1 - Next Test. Press Menu to return to the Menu Mode. Press On/Off to turn off the monitor. The operator can refer back to step 5 for the steps to perform any additional proficiency testing at this time.

LINEARITY TEST

The Linearity Test menu enables the operator to verify method linearity using a linearity Assessment Kit. The following procedures are used to perform a Linearity Test. Please note the linearity testing is performed by UDL Central Administration where necessary. If the monitor displays a message not indicated in these procedures, please refer to section 10, Troubleshooting, in your operation manual. 1. Press On/Off to turn on monitor. The Abbott logo screen will appear for a few seconds, followed by the product name, the software version, then the Test Mode menu. 2. Press Menu. The Menu Mode menu now appears. 3. Press 3- Linearity Test. The monitor will prompt for the Operator ID to be scanned or entered. 4. Press Scan to or manually enter the Operator ID via the keypad, then press Enter. The monitor will next prompt for the linearity kit lot number to be scanned or entered. 5. Scan or manually enter the linearity kit lot number via the keypad, then press Enter. If the monitor prompts for a level to be entered, skip to step 7. If the linearity kit lot number that was entered is different from the previous one, the monitor will prompt the operator to do one of two actions: either re-enter the existing linearity kit lot number or replace the existing linearity kit lot number with the new linearity kit lot number. 6. The operator can perform one of the following actions: Press 1 - ReEnter Kit Lot. Press 2 - Replace Panel. If 1 is pressed, the monitor will return to the previous screen so the operator can scan or manually enter the linearity kit lot number. The monitor will prompt the operator to select a level. 7. Enter the number of the level of the next test to run. There can be up to 4 replicates per level. The number in the parenthesis indicates the number of replicates already run for that level. When a level is full, the menu item (1 - Level 1) will no longer appear. If the operator presses 6 for a new panel, the monitor will again prompt the operator to select a level. The monitor will prompt the operator to scan or manually enter the test strip lot number. 8. Scan or manually enter the test strip lot number via the keypad, then press Enter. The monitor will prompt for a new test strip to be inserted into the test strip port. 9. Open the foil test strip packet at the notch and tear up or down to open the packet, then remove the test strip. 10. With the contact bars facing up, insert the test strip into the test strip port until it stops. The monitor will prompt the operator to apply the sample to the test strip. 11. Gently invert the sample 3-4 times then apply a drop of the sample to the target area on the test strip. When the sample is accepted, the monitor beeps and Sample Accepted is then displayed on the monitor. 12. Recap the sample bottle tightly. The display counts down the seconds it takes to analyze the test sample (20 seconds), then displays the result. 13. Note the result. If the operator is prompted to enter a comment code, continue to step 14, otherwise skip to step 15.

The display includes the level and test numbers, date and time. Level indicates level 1-5 test indicates replicates 1-4 for that level. 14. Press Scan or manually enter the comment code via the keypad then press Enter. The monitor will return to the results screen. The comment code number that was entered will appear in a box, to the left of where the result is displayed. 15. The operator can do one of the following options: Press 1 - Next Level. Press 2 - Same Level. Press the Menu button to return to the Menu Mode. Press On/Off to turn off monitor. The operator can press 2 to perform more tests for the same level (return to step 8) or press 1 to perform tests for another level (return to step 7).

REVIEW/CHANGE SETUP

The Precision PCx Monitor provides setup options to customize the testing procedures and requirements. These standards promote good laboratory practices for operators.

Since the steps to review or change setup options are similar, the two sub-menus are combined in one section. Any operator can review the setup information; only an administrator (manager) with the password can change the setup information. Please contact UDL central administration at 235-8110 if you wish to discuss a change in the current operating configuration.

The Review Setup feature enables an operator to review only the settings for Test Setup, System Setup, System Status and Date and Time.

The Test Setup menu includes: All Tests, Patient Test, Control Test, Security and Test Type.

The System Setup menu defines the look or appearance of the data as it is displayed on the monitor, such as language and formats. The menu includes: language, beeper on/off, data format, time format, set password and restore defaults.

The System Status menu allows a review of the current status of the monitor's operating system: battery power, temperature, memory gauge and software version.

The Date and Time menu displays the current date and time.

The Edit Lists changes the approved Operator ID or Test Strip Lot lists.

MOVING AROUND THE REVIEW/CHANGE SETUP MENU

The Review/Change Setup menu offers additional sub-menus (as shown in the Precision PCx Menu Tree in your operation manual). The operator may have to select additional options to access the desired change or review option.

To access these sub-menus or options in the Review menu, the message 1-Next appears at the bottom of the display. The operator presses 1 to move to the next option. The monitor also allows the operator to go back to the previous option by pressing Clear. The current status or selection for the option appears in bold type on the display.

To change an option, the administrator must access the Change Setup menu (this is password protected). In addition to the 1-Next message that appears at the bottom of the option screen, there is the 2-Change message. The administrator presses 2 to change the option. The active selection for the option now appears in bold type.

When finished reviewing or changing the options, the operator or administrator can press

Menu once to return to the beginning of Menu Mode or press Menu twice to go to Test Mode.

REVIEW SETUP

If the monitor displays a message not indicated in these procedures, please refer to section 10, Troubleshooting, in your operation manual.

Use the following steps to access the Review Setup menu:

1. Press On/Off to turn on the monitor. The Abbott logo screen will appear for a few seconds followed by the product name, the software version screen and then the Test Mode menu. 2. Press Menu. The Menu Mode screen will now be displayed. 3. Press 4 for Review Setup. The Review Setup menu appears. The operator can review Test Setup, System Setup, System Status and Date and Time by following the appropriate steps for these procedures.

REVIEW SETUP FOR TEST SETUP

The Review Setup menus enable the operator to review the settings for tests.

Under the Test Setup Menu, the following options can be viewed: 1. All Tests 2. Patient Test 3. Control Test 4. Security 5. Test Type In the All Tests menu, the following options can be viewed: 1. Upload Intervals for sending stored data to other systems. 2. Establish Operator ID requirements and barcode format. In the Patient Test menu, the following options can be viewed: 1. Establish Patient ID requirements and barcode format. 2. Set the requirement for out-of-range and/or in-range comment codes. 3. Management of memory full overwrite. In the Control Test menu, the following options can be viewed: 1. Enable/disable normal control testing. 2. Control test results presented as numbers or Pass/Fail. 3. Set the requirement for in-range and/or out-of-range comment codes. 4. Management of memory full overwrite. In the Security menu, the following options can be viewed: 1. Set QC interval requirements. 2. Set requirements to prevent testing by non-certified operators. 3. Set requirements to prevent testing using test strip lots that have not been qualified for use. In the Test Type menu, the following options can be viewed: 1. Set units of measurement. 2. Set sample type prompts. 3. Set action ranges.

REVIEW/CHANGE TEST SETUP FOR ALL TESTS

The options that are associated with the Review/Change Test Setup for All Tests apply to all test types.

Use this menu to review or change these options for all tests:

UPLOAD INTERVAL The monitor can be set up to warn or lockout a task if the monitor has not been uploaded at a regularly scheduled interval. The upload interval options are: 1. Allow Test - allow the testing to continue and no message will appear on the monitor. 2. Warn - allows the testing to continue but the operator will receive a message that the upload interval (as specified below) has expired. 3. Lockout - does not allow any testing until the data has been uploaded. This option is set to designate a required maximum number of hours or days (from 1 to 99) between data uploads. When a task is selected and the upload interval is due, the operator will view a message saying that the Upload Interval is due. If Upload Interval is overdue, the monitor will prevent an operator from doing other tasks until the stored data is uploaded. OPERATOR ID The Operator ID menu has the following options which can be viewed or changed: 1. Disabled, Optional or Required entry of an Operator ID for all testing. 2. Require a minimum and/or a maximum number of digits for the length of an Operator ID number. 3. Allow any combinations of five common barcode formats used in the facility: I2 of 5 (with or without check digit) Code 39 (with or without check digit, alphanumeric or ASCII format) Code 128 Codabar Code 93 4. Truncate (ignore) leading and/or trailing barcode digits. NOTE The display shows selected options in bold type.

Procedure (Step-by-Step Instructions)

DATA UPLOAD

Once the test results have been collected during a prescribed period of time, they will then be uploaded into the MediSense QC Manager Data Management System. The QC Manager Data Management System provides a simple and automated way to collect, report and transfer data to a personal computer (PC).

Data upload is initiated by the computer and requires no special steps by the operator, as long as the monitor is connected properly and the QC Manager Program is running. For the data upload to begin, either the monitor must be in the optional docking station or the communications cable must be plugged into the data port on the monitor. Once the connection is established, communication between the monitor and the PC will begin, automatically.

The monitor can send and receive data. During data upload, the monitor cannot be used for testing. When this occurs, the monitor will display the following message, "please wait for Data Upload". Testing is preempted while the monitor is sending or receiving data.

The technical details of the data upload are described in the QC Manager manual. Data is transferred in ASTM E-1381 format.

If the monitor is removed before data transmission is complete, no data will have been uploaded. The data will be uploaded as part of the next data transmission.

If a problem occurs with the data upload, an error message will appear on the monitor. Error messages are shown in the Troubleshooting section of your manual. Further

troubleshooting information for any data upload question is provided in the QC Manager manual.

Interpretation: Reporting Results

DATA REVIEW

PATIENT HISTORY

The Precision PCx Monitor stores up to 4,000 patient tests that can be retrieved by the following categories: All Tests: This option displays all patient test results, starting with the most recent test results (reverse chronological order). Patient ID: This will display the test results for a particular patient, starting with the most recent test. Operator ID: This will show test results performed by a particular operator, starting with the most recent test. Action Range: This will display the test results that fall outside of the action range. Comment Code: This shows the test results for all tests tagged with a specific comment code. Date: This will display all the test results for a specific date, starting with the most recent test done on that date. DATA REVIEW

Follow these steps to access the Data Review menu: If the monitor displays a message not indicated in these procedures, please refer to section 10, Troubleshooting, in your operation manual. 1. Press the On/Off button to turn the monitor on. The Abbott logo screen will appear for a few seconds, followed by the product name, software version and then the Test Mode menu. 2. Press the Menu button. The Menu Mode screen will appear next. 3. Press 1-Data Review. The Data Review menu appears. At this point, Patient History, Control History, Proficiency Data as well as Linearity Data can be viewed.

DATA REVIEW FOR PATIENT HISTORY BY PATIENT ID

1. Press 1 - Patient History. The Patient History menu now appears. 2. Press 2 - Patient ID. The monitor will prompt for the Patient ID to be scanned or entered. 3. Scan or manually enter the Patient ID via the keypad, then press Enter. 4. The operator can select one of the following options: Press 1 - Previous, view the previous test result. Press 2 - Next, view the next test result. The monitor shows the result of the patient's most recent test result. If there are other test results to view, the bottom line of the monitor shows the following menu options: 1-Previous and 2-Next. The numbers that appear to the right of Previous and Next indicate the number of tests available for review. The display also shows: P: Patient ID

O: Operator ID 12: Comment Code ven: Venous Sample 5. When finished reviewing the data, the operator can: Press Clear to return to the Patient ID screen. Press Menu to return to the Menu Mode menu. Press On/Off to turn off the monitor.

CONTROL HISTORY

The Precision PCx monitor can store up to 1,000 control tests that can be retrieved by the following categories: All Tests: This shows all control test results in memory starting with the most recent test result in memory (reverse chronological order). Operator ID: This shows the control test results that were performed by a particular operator, starting with the most recent test. Outside Range: This shows all the control test results that fell outside of the acceptable ranges. Comment Code: This shows all the control test results by comment code. Date: This shows the control test results performed on a specific date, starting with the most recent test of the day.

DATA REVIEW FOR CONTROL HISTORY FOR ALL TESTS

If the monitor displays a message not indicated in these procedures, please refer to section 10, Troubleshooting, in your operation manual. 1. Press 2 - Control History. The Control History menu now appears. 2. Press 1 - All Tests. The monitor shows the result of the most recent control test. 3. The operator can select one of the following options: Press 1 - Previous, view the previous test result. Press 2 - Next, view the next test result. If there are other test results to view, the bottom line of the monitor shows the following menu options: 1-Previous 2-Next. The numbers that appear to the right of Previous and Next indicate the number of tests available for review. The display also shows the acceptable range for this test and: O: Operator ID 0: Comment Code 5. When finished reviewing the data, the operator can: Press Clear to return to the Control History menu. Press Menu to return to the Menu Mode menu. Press On/Off to turn off the monitor.

Procedure Notes

TROUBLESHOOTING

For Troubleshooting, refer to your operation manual.

MAINTENANCE

For Maintenance, refer to your operation manual.

SPECIFICATIONS

For Specifications, refer to your operation manual.

TECHNICAL SUPPORT

Number to call for technical support:#

SERVICE

Institution responsible for service: Abbott Diagnostics

Number to call for service:#

References

1. ABBOTT Precision PCx Point-of-Care System Operation Manual Abbott Laboratories PN 125-085 Revision 0 10/98

Effective Date

Effective date for this procedure:#

Author

Compiled by Hematronix, Inc. D.A.H.

Revised by: Eugene G. Martin, Ph.D.