Medical Staff Services

Updated: January 2013

It is expected that all Members of the Medical Staff will:

• Treat all colleagues, staff, patients, guests and family members with respect, dignity and courtesy.

• Treat each member of the hospital team in a professional manner; refrain from rude or abusive conduct toward other physicians, nurses, ancillary staff, support staff, or patients; refrain from threats or physical assaults.

• Refrain from making inappropriate comments to patients about other physicians, nurses, support staff or the patient’s treatment in the hospital.

• Maintain a work environment free of sexual harassment, which may include repeated unwelcome advances, requests for sexual favors or other verbal or physical conduct of a sexual nature which leads to negative employment consequences or creates and intimidating or hostile or offensive work environment.

• Engage in respectful debate during committee and department meetings; disruption based upon belligerent or disrespectful conduct will not be tolerated.

• Maintain the veracity and objectivity of records by documenting appropriately in the patient medical record or other official documents; refrain from documenting inappropriate comments.

• Maintain patient confidentiality at all times.

• Refrain from use of alcoholic beverages or illegal substances when caring for patients or on hospital premises.

• Demonstrate respect for the resources provided; refrain from willfully destroying, misusing or damaging hospital property or resources.

• Refrain from any other conduce that the Alfred I. duPont Hospital for Children, in its sole discretion, deems to be inappropriate.

Refer to Medical Staff Policy 57.68 Medical Staff Code of Conduct, for more information.

Unfortunately, impairment among physicians is a real problem. Impairment can be caused by drug use, alcohol use, physical and mental health illnesses, and the affects of advancing age.

If you suspect impairment or have any concerns regarding impairment in a colleague, you are obligated to immediately report your concern. Information will be treated confidentially to the extent allowed by law. All good faith reports of possible impairment can be made without fear of retaliation.

Medical Staff Policy 57.35 “Medical Staff Member Health Program: Medical Staff Members with Suspected or Known Impairment”, outlines the reporting processes.

Confidential Reporting System

The Medical Staff Member Referral Form (MSMRF) is located on the Medical Staff Services intranet page.

If you would prefer to speak with someone regarding this matter please contact the Hospital Medical Director: (302) 651-5829

Keep in Mind

• Social, family and emotional problems will often occur prior to signs of impairment in the clinical practice setting.
• Substance abuse issues frequently pre-date entry into the medical profession.
• No one sign signifies impairment. Collectively the signs may define a pattern or provide a warning that a potential problem exists.

Overt Clinical Signs of Impairment Due to Substance Abuse

• alcohol on breath
• unexplained weight change
• anxiety
• ataxic gait
• needle marks
• mood stability
• slurred speech
• disheveled appearance
• mood instability
• unexplained tremor
• deterioration of personal hygiene
• depressed mood

Behavioral Clues to Impairment

• heavy drinking, frequent drunkenness
• increase in accidents
• irritability/aggressiveness
• declining performance
• outbursts of anger/conflicts with colleagues
• driving under the influence (DUI's)
• frequent medical complaints without specific diagnosis (fatigue, insomnia, indigestion, depression)
• sexual promiscuity

Practice Warning Signs

• excessive absenteeism/lateness
• increased patient complaints
• sleeping/dozing on duty
  
• neglect of patients or duties
  
• inappropriate treatment
• hard to locate
• spends time behind locked doors
• does not respond to pages
• appointments/schedules disorganized
• unusual rounding times
• erratic job history
• incorrect charting/order writing
• decreased productivity

Professional Lapses

• writing prescriptions for narcotics, stimulants or sedatives for self or office staff
• requesting prescriptions for narcotics, stimulants or sedatives from colleagues
• diverting patient’s narcotics, stimulants or sedatives for self use

Report Your Concerns

• Hospital Medical Director: (302)-651-5829
• Confidential online report form (located on NemoursNet)

* Ross, Stephen, MD. Identifying an Impaired Physician. American Medical Association Journal of Ethics. December 2003. Vol. 5, Number 12.

The health care providers of Nemours/Alfred I. duPont Hospital for Children are committed to delivering the best level of pain control that can safely be provided for all children cared for at the Hospital. Pain is assessed on admission for all patients using age appropriate pain scales. All outpatients are screened regarding the presence of pain.

Pain Scales We Use

• Numeric Pain Scale (self report)

  Approximately 7 years or older, children with cognitive understanding of numbers rank and order. 0 = no pain and 10 = worst pain you can ever imagine. Child is asked to rate the amount of pain they are experiencing. Range is 0–10.

• Wong Baker FACES Rating Scale (self report)

  Cognitive age 3 years and older or children who have difficulty with the numeric scale. A series of cartoon faces, face 0 = no pain to face 10 = hurts worst. Explain to the child that each face is for a person who feels happy because he has no pain (hurt) or sad because he has some or a lot of pain. Use descriptions under each face and ask the child to choose a face (not a number) that best describes their pain. Range is 0–10.

• FLACC Pain Scale (Behavioral)

  Children 2 months to 18 years of age who are non-verbal and/or cognitively impaired. Children who are unable to use a self-report scale. Pain intensity is identified by the provider based on patient behavior. Five variables are assessed and assigned a numeric score; scores are then added to obtain a total. Total score range is 0–10.

• CRIES Pain Scale (Behavioral/Physiological)

  Premature infants of 32 weeks gestation through infancy. Pain intensity is identified by the provider based on patient behavior and physiological signs. Five variables are assessed and assigned a score, then add scores to obtain a total. Total score range is 0–10.

Resources to Help You Manage Your Patient’s Pain

• Pain Management APN

  (302) 651-6434

• Pediatric Anesthesiologist

  (302) 651-6040

• Pharmacy

  (302) 651-5700

1. Testing Site

Refrigerator, testing area and POCT log sheet binder all located in the dirty utility room

2. Specimen Collection & Storage

1. A sterile container is preferred.
2. Clean container is acceptable for dipstick testing only (not acceptable for culture).
3. Acceptable specimen types: midstream and catheter
   • Cotton balls soaked in diaper are not acceptable.
   • Urine squeezed from diaper is not acceptable.
4. Label specimen with full patient name and medical record number or full name and date of birth, date, time and initials of collector.
5. Run within 30 minutes of collection.
6. If not run with in 30 minutes, refrigerate specimen up to 4 hours.

3. Reagents

Bottle

1. Locate lot number and expiration date.
2. Check for opening date, initials of person opening bottle and "QC'd" sticker.
3. Minimize the time the bottle is open.
4. Close lid tightly when not in use.
5. Make sure desiccant is present.

Dipsticks

1. Tests include: glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocyte esterase.

4. Quality Control

1. Daily check of testing site

1. Record temperature of refrigerator on log sheet
   • If temperature is out of range (<35°>46°F), record action taken (temperature adjusted, facilities contacted … ).
2. Check reagent bottle
   • Ensure proper storage at room temperature.
   • Check expiration date on bottle.
   • Check to see if QC has been performed on bottle.

2. Check of reagent performance

1. Storage: QC material is to be stored in the refrigerator.
2. Stability: QC material is good until expiration date on bottle.
3. Frequency: perform upon opening a new vial of dipsticks, if bottle is found open, if desiccant is missing or if results do not agree with the clinical picture.

3. Procedure

1. Check the lot number of the Dropper bottle and compare with the lot number on the “QC Log Sheet".
2. Record the results on the "QC Log Sheet".
3. Compare the results with the values printed on the top of each grid (Normal and Abnormal).
4. Values are specific to each different lot (box) of QC material.
5. If the results are not acceptable (not within the printed range):
   • Do not perform patient testing until QC problem has been resolved.
   • Repeat the QC testing using a new vial of dipsticks.
   • If not acceptable, repeat QC testing using a new bottle of QC material.
   • If still not acceptable, contact the Point of Care Coordinator (Adonica Wilson at 53-4324 or Carol Sise 53-5053).
   • Document the action taken on the QC log sheet.

5. Processing Specimens

1. Specimen should be at room temp (if the specimen has been refrigerated, allow specimen to sit at room temp for 5-10 minutes prior to testing)
2. Follow Standard Precautions
3. Gently swirl specimen to mix before testing
4. Open container
5. Shake dipstick from bottle (do not reach in the bottle to get a dipstick)
   • Observe strip for discoloration.
6. Tightly close container once strip is obtained
7. Immerse dipstick in specimen
   • Make sure all reagent pads (especially glucose) have been immersed in the specimen.
   • Do not "swirl" the dipstick in the specimen (will cause reagent colors to mix).
8. Immediately remove the dipstick from the specimen
   • Run the edge of the dipstick along the rim of the container to remove excess urine from the strip.
   • Do not run the reagent pads along the specimen container (will cause reagent colors to mix).
   • "Don't blot it; rim it."

6. Reading Results

1. Hold the dipstick horizontally by the color chart on the bottle
   • Do not touch the dipstick to the bottle (contamination).
2. Compare the reagent pads to the color chart at the specified times:
   • 30 seconds: Glucose, Bilirubin
   • 40 seconds: Ketone
   • 45 seconds: Specific Gravity
   • 60 seconds: Blood, ph* Protein*, Urobilinogen, Nitrate
   • 2 minutes: Leukocyte Esterase

   * pH and Protein can be read at any time from 60 seconds to 2 minutes

3. Dispose of all testing materials (gloves, specimen and dipstick) in the biohazard trash

7. Documentation & Result Reporting

1. Record the results on the appropriate form (POCT Daily Log or Urine Dipstick Result Sheet if applicable) and on the patient flow sheet/EMR.
2. Record FULL patient name (full first and last or last name and medical record number).
3. Do not use "–" for negative, write "neg".
4. Check for critical values (large glucose or ketones on patients less than 4 months old)
   • Record the name of the physician, date and time notified on the log sheet.

1. Check expiration date on occult slide

2. Specimen processing

1. Use a thin smear from 2 different areas of the stool specimen or 2 drops of gastric fluid, apply to each window – leave an outer periphery.
2. Close the card & turn over
3. Grip where indicated. Lift up silver tab so the white developer pad is visible.
4. Pull silver table slowly all the way to the right and completely remove. Developer pad will “flip over as tab is pulled.
5. Wait 60 seconds before interpreting results.

3. Reading Results

1. Any blue color in the window after 60 seconds is considered a positive.
2. Any other color is a negative result.

4. Internal Controls

1. Positive Control: Appearance of a Blue checkmark (√)
2. Negative Control: White background behind blue checkmark
   Note: Controls must appear for valid results.

5. Recording Results

1. Record the results on the appropriate form (POCT Daily Log If applicable) and on the patient flow sheet/EMR.
2. Complete patient information and result on front of card (patient ID, date and sample source).
3. Complete Hemaprompt QC on the front of the card.
4. Remove label and place on POCT logsheet along with patients second identifier, operator initials and time of test.

6. Interfering substances

1. Fecal Specimens
   • Red and rare meats, horseradish, raw fruits and vegetables such as broccoli, cauliflower, red radish, cantaloupe, parsnips and turnips or other high peroxidase containing vegetables, which can cause false positive results.
   • Certain medications such as aspirin, indomethacin, phenylbutazone, reserpine, corticosteroids and nonsteroidal anti-inflammatory drugs can cause gastrointestinal bleeding and therefore give positive results. Iron containing compounds may cause false positive results.
   • Vitamin C in dosages greater than 250 mg per day has been shown to cause false negative results.
2. Gastric Specimens
   • All foods and medications listed above may cause false positive (or negative) results in gastric specimens.
   • Cimetidine (Tagamet) may cause false positive results.

1. Understand Quality Control procedure

• Performing all three levels of buffers upon opening a new vial of test strips.
• Recording the results on the appropriate log sheet.

2. Understand Testing procedure

• Allowing ample time for the specimen to react.
• Reading the result by comparing to color chart.
• Interpreting the results.

3. Understand documentation

• Recording the results on the appropriate form (POCT Daily Log If applicable) and on the patient flowsheet/EMR.

1. Specimen Collection

Collect a specimen with a sterile swab from the tonsils and/or the back of the throat. Take care to avoid teeth, gums, tongue or cheek surfaces.

Use a sterile rayon or Dacron swab to collect specimens. Swabs with transport tubes containing liquid media can also be used. Modified Stuart’s Transport Media is an acceptable liquid media.

Do not use swabs that have cotton tips or wooden shafts. Do not use calcium alginate swabs. Do not use a collection system that contains charcoal or semisolid transport media.

Testing should ideally be performed immediately after the specimens have been collected. Swab specimens may be stored at room temperature for up to four hours prior to testing. The swabs and the test kit must be at room temperature before performing the test.

2. Quality Control

Internal Procedural Controls

The Strep A test provides three levels of procedural controls with each test run. For internal quality control, document these controls were OK with each patient test resulted in the EMR.

1. The color of the liquid changes from pink to light yellow as Reagent 2 is added to Reagent 1. This is an internal extraction reagent control. The color change means that you mixed the extraction reagents properly. The color change also indicates the reagents are functioning properly.
2. The pink Control Line is an internal control. The dipstick must absorb the proper amount of sample and the dipstick must be working properly for the pink Control Line to appear. For the dipstick to be working properly, the capillary flow must occur.
3. A clear background is an internal background negative control. If no interfering substances are in the specimen and the dipstick is working properly, the background in the Control Line area will remain clear. A discernible result will be seen.

If the pink Control Line does not appear, the test may be invalid. If the background does not clear and interferes with the test result, the test may be invalid. Call the Customer Support Line if either of these occur.

External Quality Control Testing

Each kit contains positive and negative control material. The controls are for external quality control testing. Use the controls to test that the extraction and the dipsticks are working. Also use the controls to test that you are able to correctly perform the procedure.

A positive and a negative control must be tested once with each 25 tests.

QC testing procedure

1. Dispense 4 drops of Reagent 1 and 4 drops of Reagent 2 into a test tube.
2. Vigorously mix the control contents. Add 1 free falling drop of control from the Positive control dropper vial into the test tube. Repeat with the Negative control into a different test tube.
3. Place a clean swab into the test tube.
4. Continue as you would for a patient sample (listed under patient test procedure).

3. Patient Test Procedure

1. Collect the patient sample as described above.
2. Just before testing, add 4 drops of Reagent 1 (pink) and 4 drops of Reagent 2. The solution should change to light yellow.
3. Immediately put the swab into the test tube.
4. Vigorously mix the solution by rotating the swab forcefully against the side of the tube at least ten (10) times. Best results are obtained when the specimen is vigorously extracted in the solution.
5. Let stand for 1 minute.
6. Express as much liquid as possible by squeezing the sides of the tube as the swab is removed.
7. Discard the swab.
8. Place the absorbent end of the dipstick into the sample (arrows pointing down).
9. Read results at 5 minutes. Positive results may be read as soon as the pink control line appears.

4. Reporting & Interpreting Results

• A pink test line and a pink control line are a positive result for the detection of Group A Streptococcus antigen. Note that the pink line may be any shade of color.
• A pink control line and no pink test line is a presumptive negative result.

Notes

• A pink line that appears uneven in color density is considered a valid result. In cases of moderate or high positive results, some red color behind the test line may be seen. As long as the test line and the control line are visible, the results are valid.
• If after 10 minutes, no pink control line appears or background color makes reading the red line impossible, the test is invalid. Repeat the testing on a new dipstick or contact the Customer Support Line.
• All results and internal QC results are to be recorded on the QC Log sheet and on the Patient Chart/EMR.

1. Storage & Stability

Store as packaged in the sealed pouch at 2°–30°C. The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

2. Quality Control

Internal Procedural Controls

Internal procedural controls are included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result.

External Quality Control Testing

Two levels of Quantimetrix Controls should be performed when opening a new box of uHCGs. The Level 1 control is to be used as the negative control and Level 2 is to be used for the positive control. The controls should be tested the same as patient samples (see “Procedure”). These results are to be recorded on the uHCG patient log sheet as QC.

Notes:

• Controls should be allowed to come to room temperature (20–25° C), at least 15 minutes, before using for testing.
• Use the positive and negative controls as if they were patient specimens. Use Standard Precautions.
• Immediately recap the controls and return them to the refrigerator when not in use.

Remedial Actions

When correct control results are not obtained, do not report patient results. Contact Technical Services at (800) 637-3717 or Point of Care Coordinator at (302) 651-4324.

3. Test Procedure

Specimen Collection and Handling

• A urine specimen must be collected in a clean and dry container.
• A first morning urine specimen is preferred since it generally contains the highest concentration of hCG; however, urine specimens collected at any time of the day may be used.
• Urine specimens exhibiting visible precipitates should be centrifuged, filtered or allowed to settle to obtain a clear specimen for testing.
• Urine specimens may be stored at 2–8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.

Test Procedure

Allow the test device, urine, and/or controls to equilibrate to room temperature (15–30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100µl) to the specimen well of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well.
3. Wait for the red line(s) to appear. The result should be read at 3 minutes. It is important that the background is clear before the result is read.

Interpretation of Test Results

POSITIVE*: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the test region (T).

NOTE*: The intensity of the red color in the test line region (T) will vary depending on the concentration of hCG present in the specimen. However, neither the quantitative value nor the rate of increase in hCG can be determined by this qualitative test.

NEGATIVE: One red line appears in the control region (C). No apparent red or pink line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact Technical Support at (800) 637-3717.

Limitations

1. Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
2. False negative results may occur when the levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
3. Very low levels of hCG (less than 50 mIU/mL) are present in urine specimen shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons,⁵ a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.
4. A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer and lung cancer, cause elevated levels of hCG.^6,7 Therefore, the presence of hCG in urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.
5. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

Expected Values

Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant women have hCG present in their urine and serum specimens. The amount of hCG will vary greatly with gestational age and between individuals.

The Sure-Vue Urine hCG has a sensitivity of 25 mIU/mL, and is capable of detecting pregnancy as early as 1 day after the first missed menses

Principle

Microscopic urine examination serves as an adjunct to medical history taking and physical examination in an outpatient setting. Physicians performing these tests should keep in mind their technical limitations as well as the attending practitioner's complete responsibility for microscopic examinations performed by residents or other staff. Physician performed microscopy, like all laboratory procedures, is subject to the rules of good laboratory practice. Among these rules of good practice is confirmation of significant diagnoses by multiple test methods, when such are available and clinically appropriate.

The providers performing the test must have had specific training in this mode of testing from their professional training. They will also be oriented to the specific procedures in place at the hospital. The competency assessment is monitored by the credentialing committee.

These tests must be performed by a physician on the physician's own patients and must be carried out in compliance with good laboratory practices regarding:

1. proper specimen collection, especially patient identification
2. maintenance of the testing site
3. proper record keeping, especially result recording

Specimen Collection

The urine should be collected in a labeled clean, plastic container with adequate (e.g. 50 mL) capacity and a screw tip lid. During and after examination, excess specimen should be disposed of. The urine specimen should be tested within 30 minutes of collection. Urine should not be tested if left at room temperature for more than two hours. Artifacts introduced by longer delay include:

• dissolution of casts
• variation in presence of appearance of some crystals
• lysis of cells (both human and bacterial)
• miscellaneous changes, such as bacterial overgrowth

The usual acceptable volume for routine examination is at least 12 mL of urine. Distribution or presence/absence of casts, crystals, cells (human or bacterial) or other miscellaneous elements is likely to be unrepresentative in smaller samples, especially among children out of the newborn period. Such small specimens should be examined directly without centrifugation ("unspun urine").

Testing Site

The urine microscopic examination should be performed on a designated area of the counter top. This area should be wiped down with a paper towel before and after each use. On the counter top should be a centrifuge with centrifuge tubes, disposable pipettes, microscopic slides, coverslips, the examining microscopes and a notebook with the log sheets where the results are recorded. The equipment should be kept clean by wiping down after each day of use.

Procedure

1. Gross examination of the urine specimen for color, clarity, odor, amount and color of foam and the chemical examination (urine dipstick for pH, specific gravity, protein, hemoglobin, nitrite, leukocyte esterase, glucose, ketone and bilirubin) should be performed by a certified operator and the results recorded according to the Urine Dipstick Procedure.
2. The 12 mL of urine aliquot of well-mixed urine is centrifuged at 400g for 5 minutes.
   • Note: aliquots of urine less than 12 mL should be examined without centrifugation.
   • Note: aliquots less than 3 mL will yield highly misleading results.
3. 11 mL of supernatant are pipetted off and discarded in the sink.
4. The remaining 1 mL of urine should be mixed well, ensuring the button on the bottom of the centrifuge tube is re-suspended in the urine.
5. A drop of the urine left in the centrifuge tube is dropped onto a microscope slide and covered with a coverslip.
6. The urine under the coverslip is scanned with the 10X objective (across "low power fields") and the identity of constituents is confirmed using the 40X objective (in "high power fields"). The slide should be viewed with the light sufficiently reduced by closing the condenser aperture diaphragm to increase contrast. Increased contrast makes casts and cells easier to visualize.
7. Results are recorded on the log sheet provided by the Clinical Laboratory. Refer to the section "Result Reporting" for proper documentation procedures.

Result Reporting

The following categories of findings deserve classification, semi quantification and reporting.

The results are to be recorded on the log sheet provided by the Clinical Laboratory, as well as in the patient chart.

The patient's name, medical record number or date of birth, date of examination, the results of the microscopic examination and the name of the examining physician are to be recorded on the log sheet provided by the Clinical Laboratory.

Questions regarding this procedure are to be referred to the POCT Coordinator at (302) 651-4324 or the Microbiology Department at (302) 651-5658 or (302) 651-5659.