OPERATING PROCEDURE Florida State Hospital

OPERATING PROCEDURE Florida State Hospital NO. 152-5.10 Chattahoochee, Florida November 10, 2010

Nursing Services

BLOOD GLUCOSE METERS USER GUIDELINES

1. Purpose: To establish safe and accurate capillary blood glucose results that are used in clinical decision making for effective resident care.

2. Policy:

a. The designated Registered Nurse Consultant or designee shall inspect the records for each blood glucose meter periodically and unannounced to determine compliance. Copies of Attachment 1 Form 111 along with a Corrective Action Plan shall be sent to the Designated Registered Nurse Consultant or designee with the expected date of implementation.

b. Only licensed nurses who have current operator certification may perform blood glucose testing with meters. Annual recertification is required.

c. For purposes of discharge readiness, residents may be instructed and supervised by a licensed nurse in the use of the meter for testing his/her own blood glucose upon a physician/Advanced Registered Nurse Practitioner order for the resident to perform self- metering. The meter used by the resident must belong to the resident or be designated for resident use with documentation of same filed with the Designated Registered Nurse Consultant. Additionally the meter shall be stored in a safe place.

d. All blood glucose meters will be obtained from the Designated Registered Nurse Consultant initially and if replacements are needed.

3. Scope: This operating procedure applies to all nurses utilizing blood glucose meters located at Florida State Hospital.

4. Training Requirements: Nurses shall be trained on this operating procedure upon hire into the position during Discipline-Specific Training and by their supervisor each time the operating procedure is revised.

5. References:

a. Current Accu-Check Aviva Blood Glucose Meter User’s Manual, Roche Diagnostics, 9115 Hague Road Indianapolis, IN 46256

This operating procedure supersedes: Operating Procedure 152-5.10, dated October 6, 2010 Office of Primary Responsibility: Nursing Management Team Distribution: Florida State Hospital Computer Network Users Operating Procedure 152-5.10 November 10, 2010

b. Florida State Hospital Operating Procedure 015-02, Records Management, Clinical Nursing Skills Book by Smith, Duell, Martin, 2008

6. Procedure:

a. Calibration or coding of the blood glucose meter:

(1) General Information: Before using the meter for the first time and every time a new vial of test strips is opened, the meter shall be set to match the strips. The meter is automatically calibrated using the code key. A code key is found with each new vial of test strips.

(2) Make sure the meter is turned off when inserting the code key.

(3) The code key is properly inserted when it snaps in place.

(4) Turn meter on. A 3-digit code number appears. This number must match the code number on your vial of test strips. If it does not, repeat steps 1-4.

b. Quality Control Procedure:

(1) General Guidelines:

(a) The Unit Nurse Manager shall assure the Quality Control Sheets are kept with each meter for two (2) years, then discarded. (Florida State Hospital Operating Procedure 015-02, Records Management)

(b) Quality control testing shall be performed with a minimum of one high and one low quality control solutions.

(c) Quality control testing shall be performed daily prior to testing residents. It is the responsibility of the operator to assure that controls were run within limits during the last 24 hours prior to performing tests on residents.

(d) Additional quality control testing shall be performed as follows:

1. If the cap has been left off the vial of test strips.

2. When meter has not been in use for the month. Quality control checks on the last day of the month will provide evidence that the meter, battery, calibration and quality control solutions are working properly. These results shall be documented on the Quality Control Sheets.

3. When a new vial of test strips is opened.

4. Test results contradict clinical symptoms.

5. To rule out human error, recheck to see if you are testing correctly

6. If strips have been stored in extreme temperatures or humidity.

7. If the meter is dropped.

2 Operating Procedure 152-5.10 November 10, 2010

8. To check the meter and test strips.

(e) If both quality control test results fall within the acceptable control ranges, it is acceptable to proceed with resident testing.

(f) If quality control tests results fall outside of the acceptable control range, the User’s Manual is referenced if needed, and the problem is corrected with acceptable quality controls before proceeding with residents testing.

(g) Any quality control result that falls outside of the acceptable control range, along with any corrective action to restore that result to acceptable range, must be recorded on the Quality Control Sheet (Attachment 1) under Corrective/Action/Notes column.

(h) When attempts to correct an out-of-range result fail, call the Customer Service Center at Roche Diagnostic at 1-800-858-8072 for assistance. If you are still unable to restore the meter, return it to the unit nurse manager with a list of the actions recommended by the Customer Service Center.

(i) Internal proficiency testing to verify meter accuracy and operator competency shall be performed according to the standards set by Florida State Hospital’s Designated Registered Nurse Consultant.

(j) Glucose Control Solutions must be stored at room temperature. Do not refrigerate or freeze. Glucose Control Solutions are stable for three (3) months after opening or until the expiration date, whichever comes first. The date the vial is opened should be written on the vial label with initials of the nurse who opened the vial.

(k) Any outdated Glucose Control Solutions will be discarded.

(l) The test strip lot number and the acceptable glucose control ranges are found on the label of each vial of test strips. This information must be recorded on the Quality Control Sheet (Attachment 1).

(m) Test strips must be stored at room temperature. Do no refrigerate or freeze. Test strips are stable until the expiration date. Test strips must be stored in the same capped vial in which they were packaged, and the vial cap must be immediately replaced after removal of a test strip. Use the test strip within three (3) minutes after you remove it from the container. Do not apply blood or control solution to the test strip before you insert it into the meter.

(n) Do not use test strips other than test strips marked for use with the meter. Do not cut or alter strips in any other way.

(2) Quality Control Testing:

(a) The following equipment is needed for quality control testing.

1. Blood glucose meter

2. Test strips

3. Disposable latex or vinyl gloves

4. Level 1 and Level 2 Glucose Control Solution

(b) Put at test strip into the meter. The meter will turn on automatically.

(c) Make sure the code number on the display matches the code number on the test strip container. If you miss seeing the code number, take the test strip out and reinsert it into the meter.

(d) Select the control solution you want to test. You will enter the level later in the test.

(e) Place the meter on a flat surface.

(f) Remove the control bottle cap and wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip of the bottle. Touch the drop to the tip of the yellow end of the test strip. Do not put control solution on top of the test strip. When you see the hourglass symbol flash, you have enough control solution in the test strip. Wipe the tip of the bottle with a tissue, and then cap the bottle tightly.

(g) A result appears on the display, along with a control bottle symbol and a flashing “L.” Don’t remove the test strip yet. Press the right arrow button once to mark it as a Level 1. If you test the Level 2 control, press the right arrow button a second time. Press the set button to set the level in the meter.

(h) The range is printed on the test strip container label. The control result and “OK” alternate on the display if the result is in range. The control result and “Err” alternate on the display, if the result is out of range. If this occurs then repeat the test. If the result is still unacceptable, review the troubleshooting section in the user manual; if problems continue call the Customer Service Center at the number provided in the user manual and contact the Designated Registered Nurse Consultant-Quality Assessment and Planning.

(i) Repeat procedure to complete the test using the remaining Level control solution.

(j) Document the result on the Glucose Quality Control Sheet (Attachment1).

(3) Responsibility for Monitoring:

(a) The unit nurse manager or designee shall assure that all quality control procedures are followed and documented appropriately on the Quality Control Sheet.

(b) The unit nurse manager or designee shall photocopy the Quality Control Sheet monthly and forward to the Designated Registered Nurse Consultant or designee by the tenth of each month, recording the residential unit and the meter serial number on each copy for identification purposes.

(c) The Designated Registered Nurse Consultant /designee shall monitor all Quality Control Sheets for completion, as well as note any trends that may indicate potential problems. These trends include: gradual drifting of values, sudden shifts in glucose control values while using the same lot of strips, and operator performance.

(d) The Designated Registered Nurse Consultant/designee shall ensure that all units’ corrective actions are appropriate.

c. Testing with the Blood Glucose Meter:

(1) General Guidelines:

(a) Only a certified operator may perform a blood glucose test with the blood glucose meter. Immediately prior to testing the operator shall: explain the procedure to the resident, wash hands, don gloves, ensure the resident has washed hands, and will clean the finger area with soap and water or alcohol swab.

(b) Blood Glucose tests with the meter must be ordered by a physician unless the resident is experiencing symptoms of hypoglycemia or hyperglycemia, and quality care dictates a STAT test.

(c) Test strips must be stored at room temperature. Do not refrigerate or freeze. Test strips are stored in the same capped vial in which they were packaged and are stable until the expiration date on the vial. The vial cap should be immediately replaced after removal of the strip.

(d) Outdated test strips will be discarded.

(e) A physician shall be immediately notified when the blood glucose reading is less than 60 mg/dL or greater than 400 ml/dL. Appropriate treatment should be given followed by fingerstick blood glucose or blood glucose via lab.

(f) A physician’s order is needed for a stat blood glucose test. If ordered, a blood specimen shall be drawn in a red, green or gray top tube by a physician, nurse, or laboratory technician and sent to the lab for testing. During times that the lab is closed, the nurse shall notify the hospital operator who will notify the medical technologist of the testing need.

(2) Testing Procedure:

(a) The following equipment is needed for testing:

1. Meter

2. Test strips

3. Lancets

4. Soap and water cleaning material or Alcohol swabs

5. Cotton balls

6. Disposable latex or vinyl gloves

(b) Wash your hands with soap and water and dry thoroughly. Apply gloves. 5 Operating Procedure 152-5.10 November 10, 2010

(c) Remove a test strip from the vial; immediately replace the cap on the vial, insert test strip into the meter. The meter will turn on automatically.

(d) Check the code number on the display to be sure it matches the code on the test strip vial label. If you miss seeing the code number, remove the test strip and reinsert it into the meter.

(e) When the blood drop flashes, obtain a drop of blood by puncturing the side of the resident’s fingertip with the lancet. Gently squeeze the finger to assist the flow of blood. Do not “milk” the finger. Only fingertip testing is allowed. Touch the drop to the tip of the yellow window of the test strip. Do not put blood on top of the test strip.

(f) When you see the hourglass symbol flash, you have enough blood in the test strip. If you applied blood but do not see the flashing hourglass symbol you may reapply more blood within 5 seconds.

(g) Your result appears on the display. If “Hi” is displayed, the blood glucose result may be above the reading range of the meter. If “Lo” is displayed, the blood glucose result may be lower than reading range of the meter. If either reading does not appear accurate (not consistent with resident symptoms) perform a quality control test. If the control result is within acceptable range, review the proper testing procedure and repeat the blood glucose test with a new test strip. If the result is still not acceptable, you may contact the Designated Registered Nurse Consultant-Quality Assessment and Planning.

(h) Remove the test strip and throw it away. Turn the meter off by pressing the ON/OFF/SET button. Discard the used test strip and cotton ball in a medical waste container.

(i) Discard the used lancet in a medical waste sharps container per policy.

(j) Remove gloves and wash hands thoroughly with soap and water

(k) Document the blood glucose in the residents chart and on Form 553, Glucose Monitoring Form (attachment 2). Record the date, time and initials of the tester, resident name, meter number and glucose value on the Quality Control Sheet.

(l) If the meter displays anything other than numerical blood glucose, refer to the Screen Messages and Troubleshooting Section of the User Manual.

1. Physician notification and treatment for hyperglycemia shall be initiated if the blood glucose value is greater than 400 mg/dL, unless otherwise ordered by the physician. Likewise, notification and treatment for hypoglycemia shall be initiated if the blood glucose value is lower than 60 mg/dL.

2. Display messages--Refer to User’s Manual for explanations.

d. Preventive Maintenance of the Meter and Replacement of Batteries

(1) Latex or vinyl gloves are worn when performing preventive maintenance and cleaning.

(2) Cleaning Outside of Meter: Clean the outside of the meter with a germicidal disinfectant wipe: (1) before beginning, (2) between each resident’s use, (3) and after

6 Operating Procedure 152-5.10 November 10, 2010 completion of glucose monitoring. Do not get moisture into the Advantage Code Key slot and the test strip guide.

(3) Handle the meter with care. Sudden shocks caused by dropping or rough treatment may affect performance. If the meter is dropped, the meter performance must be verified by quality control testing.

(4) Protect the meter from extreme temperatures and humidity.

(5) A list of all meters, serial numbers, assigned inventory numbers, and locations is maintained by the Designated Registered Nurse Consultant-Quality Assessment and Planning.

(6) The batteries are to be changed if a symbol of a battery appears on the display. If the battery is low or dead, change batteries.

(7) The meter requires one 3-volt Lithium battery.

(8) Replacing the Battery:

(a) check that the meter is turned off;

(b) open the battery door on the back of the meter by pushing the tab in the direction of the arrow.

(c) remove old battery;

(d) insert the new battery. Make sure the plus (+) sign on the Lithium battery face up. Put the battery door back in place and snap it closed. After you change the battery, your meter prompts you to confirm the meters time and date setting. All test results are saved in memory.

e. Limitations of the Method:

(1) Extremes in hematocrit can affect the glucose if the glucose value is above 200 mg/dL. Hematocrits greater than 55% can lower the glucose as much as 15%. Hematocrits below 35% can increase the glucose by as much as 10%.

(2) The use of dopamine or methyldopa at blood concentrations of 10 mg/dL will inhibit the reaction of the test strips. However, the therapeutic blood concentration of dopamine is 0.01 mg/dL. The therapeutic blood concentration of methyldopa is 0.01-0.35 mg/dL. At therapeutic levels, no interference was found.

f. Infection Control Guidelines:

(1) Because of the hazardous nature of handling blood products, it is mandatory that disposable latex or vinyl gloves be used when collecting specimens, performing test procedures, and cleaning blood glucose monitoring equipment.

(2) Gloves are to be removed and hands washed thoroughly with soap and water after completing the test procedure and prior to handling equipment not related to the procedure.

(3) Standard precautions shall be observed for all blood specimens. They shall be handled at Biosafety Level 2 as recommended for any potentially infectious material in the Centers for Disease Control/National Institutes of Health Manual, “Biosafety in Microbiological and Biomedical Laboratories,” 1988.

(4) A new disposable lancet is used for each resident. Under no circumstances is a previously used lancet employed.

(5) The meter shall be disinfected after it is contaminated with blood.

(6) The used lancet shall be placed in the sharps container.

g. Operator Certification/Recertification:

(1) A certified blood glucose meter instructor shall be a nurse in the Staff Development Department. A designated Unit Nurse may provide annual recertification upon completion of the Train the Trainer for Blood Glucose Recertification each year.

(2) Each Operator must initially successfully complete a Knowledge Test and Skills Checklist to be certified to perform blood glucose testing with the meter. This shall be administered by a nurse in the Staff Development Department during Discipline Specific Training for Nurses.

(3) An initial certification training roster will be maintained in Staff Development.

(4) Operators will be evaluated for competency and recertified annually by completing a Knowledge Test and Skills Checklist. This shall be completed by a trained designated nurse in the unit as specified above.

(5) Staff Development will forward a copy of the certified operator training roster with monthly updates by the tenth of each month to the Registered Nurse Consultant in Quality Assessment and Planning.

(6) Nurse managers will forward a copy for the annual recertified training roster to Staff Development and Registered Nurse Consultant or designee in Quality Assessment and Planning upon completion. The original with the Knowledge Test and Skills Checklist will be kept on file by the Nurse Manager.

(Signed original on file in Central Health Information Services)

DIANE R. JAMES 2 Attachments Hospital Administrator 1 Glucose Quality Control Sheet (Form 111) 2. Glucose Monitoring Form (Form 553)

SUMMARY OF REVISED, ADDED, OR DELETED MATERIAL

This revision includes the designated Registered Nurse Consultant in Quality Assessment and Planning monitors the use of Blood Glucose Meters. 8 Operating Procedure 152-5.10 November 10, 2010

9 GLUCOSE QUALITY CONTROL SHEET FLORIDA STATE HOSPITAL

INSTRUCTIONS: To be completed by the nurse when performing levels and quality controls. Before testing residents, BOTH CONTROLS MUST BE RUN with acceptable results within the previous 24 hours. By the 10th of each month, a copy of the prior month’s log will be forward to the Registered Nurse Consultant in Quality Assessment and Planning by the Unit Nurse Manager.

UNIT/WARD: ______METER SERIAL #: ______

OPENED: EXPIRATION DATE: CURRENT CONTROL SOLUTION LOT #:

NEW CONTROL SOLUTION LOT #:

CURRENT TEST STRIP LOT #:

CURRENT STRIP LOW LEVEL CONTROL RANGE: ______TO ______

CURRENT TEST STRIP HIGH LEVEL CONTROL RANGE: ______TO ______

NEW TEST STRIP LOT #:

NEW TEST STRIP LOW LEVEL CONTROL RANGE: ______TO ______

NEW TEST STRIP HIGH LEVEL CONTROL RANGE: ______TO ______

CONTROL NURSE LOW HIGH # DATE TIME INITIALS LEVEL LEVEL RESIDENT’S FULL NAME HOSPITAL # RESULT CORRECTIVE ACTION / NOTES 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Form 111, (Revised) September 10 Attachment 1 Office of Primary Responsibility: HNMT Operating Procedure 152-5.10

Date/Time Meds FSBG Initials Date/Time Meds FSBC Initials

Printed Name/Signature and Title Initials Printed Name/Signature and Title Initials

INSTRUCTIONS: 1. Record test results indicating date ADDRESSOGRAPH: and time. 2. Record medication and dosage related to diabetic state. 3. Complete in black ink and initial all entries. To be filed in flow sheet section of ward chart and master record. Key: *FSBG-Finger stick Blood Glucose ** CONFIDENTIAL & PRIVILEGED INFORMATION ** FOR PROFESSIONAL USE ONLY ** FLORIDA STATE HOSPITAL, CHATTAHOOCHEE, FL 32324 Form 553 (Updated), September 10 FLORIDA STATE HOSPITAL GLUCOSE MONITORING FORM Office of Primary Responsibility: HNMT Attachment 2 Operating Procedure 152-5.10