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Tag No.: A0749
Based on observations, interviews, and document reviews, it was determined: (1) the facility staff failed to complete post-exposure actions for 1 of 3 reviewed employees with documentation of potential exposures to patients' blood and/or body fluids (Employee #26), (2) a facility staff member failed to appropriately clean equipment after caring for a patient on contact isolation precautions, (3) a facility staff member failed to ensure care was provided in a manner to minimize the risk of a potential spread of infectious organisms, (4) the facility staff failed to ensure that multi-dose, multi-patient medications were kept outside of direct patient care areas, (5) a facility staff member failed to disinfect the rubber septum prior to drawing up a patient's medication, (6) a facility staff member failed to perform hand hygiene, (7) a facility staff member failed to appropriately perform perineal care and indwelling urinary catheter care, and (8) a facility staff member failed to ensure that a mobile medication cart was not taken into the room of a patient on contact isolation precautions.
The findings include:
1. The facility staff failed to complete post-exposure actions when Employee #26 had a potential exposure to a patient's blood.
The facility's policy entitled, "Deemed Consent - Request for Testing" included the following information: "Any individual who is exposed to another individual's blood or body fluids, in a manner that might result in the transmission of Bloodborne [sic] disease, during the performance of health care, has the right to have the source individual tested for Bloodborne Pathogens (HIV, Hepatitis B and Hepatitis C) and to know the results."
Review of Employee #26's post-exposure documentation revealed laboratory blood tests for the employee but failed to reveal post-exposure laboratory blood tests for the patient whose blood to which Employee #26 was potentially exposed; based on the patient's medical record one or more laboratory test(s) would have been required at the employee's request. During a telephone interview with Employee #26 on 4/2/15 at 10:00AM, Employee #26 reported that he/she had witnessed the aforementioned patient having his/her blood drawn for post-exposure testing.
During the telephone interview with Employee #26 on 4/2/15 at 10:00AM, Employee #26 was asked if he/she had been informed about how to protect himself/herself and his/her family after the potential exposure. Employee #26 stated he/she had not been provided such information. Employee #26 stated the only paperwork he/she had been given was the paperwork from having his/her laboratory test completed.
Review of Employee #26's post-exposure documentation revealed a form entitled "EMPLOYEE CONSENT/INSTRUCTIONS FOR POST-EXPOSURE FOLLOW-UP AND TESTING"; this form had not been signed by Employee #26 and the original copy with two carbon copies remained with the post-exposure documentation. The following information was found in the aforementioned form:
- "You must remember that some recently HIV infected persons will test negative until the virus has had time to multiple to detectable levels. Until you are sure no infection has occurred you may also be at risk for transmitting such disease to others. To help protect yourself and others until final testing has been completed (at six months) you should be aware of the following: A. These diseases are blood borne and direct contact with your blood or blood containing body fluids needs to be avoided. *Sharing of personal care items is one way you can contact someone's blood or body fluids. This includes the sharing of needles and syringes for drug injection. *You should also avoid donating blood to blood banks or blood collection drives. B. These diseases are also sexually transmitted and you should use protection (condoms) during intercourse - every time. C. These diseases are also easily transmitted form a mother to a fetus and you should protect yourself from becoming pregnant."
- "Persons who become infected with a blood borne virus often experience an unexplained viral type illness shortly after becoming infection (such as flu like symptoms when it is not flu season). If you experience such symptoms, you should see your health care provider as soon as possible and be sure to inform him [sic] that you were recently exposed to someone else's body fluids."
During an interview with the facility's Infection Preventionist (IP) on 3/31/15 at 11:00AM, the IP reported the employee would need to request to have the patient's blood tested. Review of Employee #26's post-exposure documentation failed to include evidence of the completion of the formed entitled "DEEMED CONSENT & BLOODBORNE PATHOGEN TESTING NOTIFICATION STATEMENT"; and Employee #26's post-exposure documentation failed to reveal evidence of Employee #26 declining to have the patient's blood tested.
During an interview with the facility's IP on 4/7/15 at 1:40PM, the IP reported that Employee #26 had the post-exposure paperwork completed on 4/3/15.
2. A facility staff member (Employee #18) failed to follow cleaning product instructions when cleaning equipment (used for multiple patients) after being using to care for a patient on contact isolation precautions.
On 4/6/15 at 10:15AM, Employee #18 was observed providing care for a patient on contact isolation precautions. After providing care for the patient, Employee #18 was observed by the surveyor (another facility employee (Employee #4) was present) to clean a pulse oximeter, a handheld patient ID scanning device, and a stethoscope. Employee #18 used a single cleaning wipe to clean all three devices. Employee #18 stored away the pulse oximeter prior to the surveyor seeing how long it remained wet from the cleaning wipe; the handheld patient scanning device and the stethoscope was observed to be dry in less than 30 seconds after being cleaned with the cleaning wipe. The cleaning wipe used by Employee #18 was labeled as: "PDI SANI-CLOTH PULSE GERMICIDAL DISPOSALBE CLOTH The 3-minute germicidal wipe / Bactericidal - Virucidal".
The following 'DIRECTIONS FOR USE' was found written on the PDI SANI-CLOTH PULSE GERMICIDAL DISPOSALBE CLOTH container: "It is a violation of Federal law to use this product in a manner inconsistent with its labeling ... Deodorizing and Disinfecting: To disinfect nonfood contact surfaces only: Use a wipe to remove heavy soil. Unfold a clean wipe and thoroughly wet surface. Treated surface must remain visibly wet for a full three (3) minutes. Use additional wipe(s) if needed to assure continuous three (3) minute wet contact time. Let air dry."
The following information was found in a facility policy entitled, "Cleaning Environment, Patient Equipment and Medical Devices": "All cleaning supplies will be used per the manufacturers label for contact time i.e. 3 min, 5 min, etc." [sic]
3. A facility staff member (Employee #19) failed to provide care to Patient #19 in a manner which would decrease the risk of potentially spreading infectious organisms.
On 4/6/15 at approximately 10:40AM, Employee #19 was observed to provide indwelling urinary catheter care to Patient #19. It was observed that Employee #19's facility ID and a small container of hand cleanser (both which were connected to Employee #19's upper body) was dangling over Patient #19; it was observed that both Employee #19's ID and the container of hand cleanser contacted Patient #19's skin (upper leg). After completing care, Employee #19 was observed to remove his/her gloves and touch the container of hand cleanser to perform hand hygiene after providing care.
Employee #4 (an employee in the Quality/Risk Department) was notified of the aforementioned observation on the morning of 4/6/15.
4. A. The facility staff failed to ensure that multi-dose, multi-patient medications were not stored in a direct patient care area.
On the morning of 4/1/15, an anesthesia medication cart was observed to remain in an operating room as the operating room was being cleaned between surgical patients/procedures. Two medication vials were observed to be open in the top drawer of the anesthesia medication cart (glycopyrroalte and neostigmine); both medications had a handwritten date on the label indicating when the opened medications would need to be discarded. Multiple syringes were observed in the second drawer; these syringes were labeled with the name and the amount of the medication but no patient name was on the syringes.
The facility's CNO (Chief Nursing Officer) was present during this observation; the CNO reported that multi-dose, multi-patient medications were used in the operating room if they were drawn-up behind the draped area where the anesthesiologist/anesthetists worked.
After the observation of the surgical procedure on the morning of 4/1/15, Employee #7 (a Certified Registered Nurse Anesthetist) was asked about the syringes that were in the second drawer of the anesthesia medication cart. Employee #7 reported the medications were drawn up for the first procedure of the day and had not been used during that procedure. The syringes were labeled to contain: succinylcholine, ephedrine, and neostigmine.
Review of a facility policy and procedure entitled, "Nursing Admixture Intravenous Medication Preparation" revealed the following information: "Do not keep multi-dose vials in the immediate patient treatment area and store in accordance with the manufacturer's recommendations..."
During an interview with the CNO on 4/2/15 at 3:55PM, the CNO reported that new medications were being ordered to address the use of multi-dose, multi-patient medications in the operating rooms.
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On 03/31/15 at approximately 11:40 am the surveyor observed Employee #32 take their mobile medication cart into a patient room. He/she obtained a multi-dose insulin vial from the medication cart. The surveyor asked if the medication was kept in the medication cart and given to multiple patients. He/she stated the medication was kept on the cart and was given to multiple patients.
On 03/31/15 at approximately 2:25 pm the surveyor conducted an interview with the Chief Nursing Officer. He/she stated that the medication was kept in the medication cart and was given to multiple patients.
On 04/08/15 at 10:02 am the surveyor was given a policy, Nursing Admixture Intravenous Medication Preparation. Procedure: 2. "Safe Injection practices"
G. "Do not keep multi-dose vials in the immediate patient treatment area and store in accordance with the manufacturer' s recommendations; discard is sterility is compromised or questionable".
5. On 03/31/15 at approximately 2:00 pm the surveyor observed Employee # 31 open a medication vial and withdraw the medication without disinfecting the rubber septum prior to piercing the rubber septum.
On 04/01/15 at 3:30 pm the surveyor conducted an interview with the Chief Nursing Officer (CNO). He/she stated the expectation would be to disinfect the vials with alcohol prior to piercing the rubber septum.
On 03/31/15 at 1:30 pm the Infection Preventionist Director gave the surveyor, Intravenous Medication Preparation beyond Pharmacy Hours; Training for Nursing Staff. "When Entering A Vial": "Wipe the stopper with an alcohol swab".
The CNO stated these were the standards used by the facility, adding that each year nurses attended a skills day and demonstrated how to properly draw up medications.
6. On 03/31/15 at approximately 10:22 am the surveyor observed a facility staff member fail to perform hand hygiene. The surveyor observed an Anesthesiologist perform an Epidural (a very thin flexible tube, hollow tube, that's inserted in the epidural space just outside the membrane that surrounds your spinal cord and spinal fluid) in the Obstetrics Department. He/she did not perform hand hygiene prior to or after the procedure.
On 04/07/15 at 2:25 pm the Director of Medical Staff Credentialing was interviewed. He/she stated all medical staff were educated on hand hygiene during their orientation. He/she stated the Anesthesiologist was given an orientation manual at the time of hire.
On 04/07/15 at approximately 2:38 pm the Director of Medical Staff Credentialing provided the surveyor with a copy of the Orientation Manual for New Medical Staff Members. On page 25 of the manual under Services provided: "Physicians are expected to comply with CVMC Policies and Procedures for Infection Control, which include but are not limited to: "Routine Hand washing".
On 03/31/15 at 1:30 the CNO provided the survey team with a hand hygiene procedure that is followed by the facility. Lippincott Procedures, Hand Hygiene;
"Using an alcohol-based hand rub is appropriate for decontaminating the hands before direct patient contact; before putting on gloves; before inserting an invasive device; after contact with a patient; when mucous membranes, non-intact skin, or wound dressings (if hands aren't visibly soiled); after removing gloves; and after contact with inanimate objects in the patient's environment".
7. On 03/31/15 at approximately 2:40 p.m. the surveyor observed a Licensed Practical Nurse (LPN) perform perineal care and Foley catheter (a Foley catheter is a thin, sterile tube inserted into the bladder to drain urine) care. He/she did not perform hand hygiene or change gloves when going from a dirty procedure to a clean procedure. The LPN assisted the patient with perineal care after the patient had a bowel movement. After assisting the patient back to bed the nurse went into the bathroom and wet a towel. The nurse then proceeded to wipe the Foley catheter tube with the wet towel and took another towel and dried the area.
On 04/02/15 at approximately 9:45 am the surveyor interviewed the CNO. He/she stated he had witnessed the LPN giving Foley catheter care and had already reeducated the nurse in the proper technique of Foley catheter care. He/she stated they did not witness the LPN go from a dirty procedure to a clean procedure without performing hand hygiene or not changing gloves.
On 03/31/15 at approximately 1:30 pm the CNO provided the survey team with a hand hygiene procedure and an indwelling urinary catheter care and management that is followed by the facility. Lippincott Procedures, Hand Hygiene; "Using an alcohol-based hand rub is appropriate for decontaminating the hands before direct patient contact; before putting on gloves; before inserting an invasive device; after contact with a patient; when mucous membranes, non-intact skin, or wound dressings (if hands aren't visibly soiled); after removing gloves; and after contact with inanimate objects in the patient's environment". Lippincott Procedures, Indwelling urinary catheter care and management; Equipment: Gloves, Implementation; "Provide routine hygiene for meatal care; note that cleaning the meatal area with antiseptic solution isn't necessary. To avoid contaminating the urinary tract, always clean by wiping away from never toward the urinary meatus. Use soap and water or a perineal cleaner to clean the periurethral area after each bowel movement".
8. On 04/01/15 at approximately 1:15 pm the survey observed Employee #33 take a mobile medication cart in a patient room that was on contact isolation precautions. During the observation the Infection Preventionist Director (IP) was with the surveyor and he/she was asked if this was a standard practice. The IP stated the mobile medication cart should not be taken into room when a patient was on contact isolation precautions.
On 04/01/15 at approximately 1:30 pm an interview was conducted with the Respiratory Department Leader. He/she stated that if a patient was on contact isolation precautions the mobile medication cart should be left in the hallway or in the ante room (room prior to going into the direct patient room).
On 03/31/15 at approximately 3:00 pm the CNO gave the survey team a copy of the isolation procedures policy. Isolation Procedures; Policy; 5. "General information: Items which cannot be disinfected, autoclaved, or are not disposable should remain outside the room whenever possible. Disposable items are to be used whenever available".
Tag No.: A0749
Based on observations, interviews, and document reviews, it was determined: (1) the facility staff failed to complete post-exposure actions for 1 of 3 reviewed employees with documentation of potential exposures to patients' blood and/or body fluids (Employee #26), (2) a facility staff member failed to appropriately clean equipment after caring for a patient on contact isolation precautions, (3) a facility staff member failed to ensure care was provided in a manner to minimize the risk of a potential spread of infectious organisms, (4) the facility staff failed to ensure that multi-dose, multi-patient medications were kept outside of direct patient care areas, (5) a facility staff member failed to disinfect the rubber septum prior to drawing up a patient's medication, (6) a facility staff member failed to perform hand hygiene, (7) a facility staff member failed to appropriately perform perineal care and indwelling urinary catheter care, and (8) a facility staff member failed to ensure that a mobile medication cart was not taken into the room of a patient on contact isolation precautions.
The findings include:
1. The facility staff failed to complete post-exposure actions when Employee #26 had a potential exposure to a patient's blood.
The facility's policy entitled, "Deemed Consent - Request for Testing" included the following information: "Any individual who is exposed to another individual's blood or body fluids, in a manner that might result in the transmission of Bloodborne [sic] disease, during the performance of health care, has the right to have the source individual tested for Bloodborne Pathogens (HIV, Hepatitis B and Hepatitis C) and to know the results."
Review of Employee #26's post-exposure documentation revealed laboratory blood tests for the employee but failed to reveal post-exposure laboratory blood tests for the patient whose blood to which Employee #26 was potentially exposed; based on the patient's medical record one or more laboratory test(s) would have been required at the employee's request. During a telephone interview with Employee #26 on 4/2/15 at 10:00AM, Employee #26 reported that he/she had witnessed the aforementioned patient having his/her blood drawn for post-exposure testing.
During the telephone interview with Employee #26 on 4/2/15 at 10:00AM, Employee #26 was asked if he/she had been informed about how to protect himself/herself and his/her family after the potential exposure. Employee #26 stated he/she had not been provided such information. Employee #26 stated the only paperwork he/she had been given was the paperwork from having his/her laboratory test completed.
Review of Employee #26's post-exposure documentation revealed a form entitled "EMPLOYEE CONSENT/INSTRUCTIONS FOR POST-EXPOSURE FOLLOW-UP AND TESTING"; this form had not been signed by Employee #26 and the original copy with two carbon copies remained with the post-exposure documentation. The following information was found in the aforementioned form:
- "You must remember that some recently HIV infected persons will test negative until the virus has had time to multiple to detectable levels. Until you are sure no infection has occurred you may also be at risk for transmitting such disease to others. To help protect yourself and others until final testing has been completed (at six months) you should be aware of the following: A. These diseases are blood borne and direct contact with your blood or blood containing body fluids needs to be avoided. *Sharing of personal care items is one way you can contact someone's blood or body fluids. This includes the sharing of needles and syringes for drug injection. *You should also avoid donating blood to blood banks or blood collection drives. B. These diseases are also sexually transmitted and you should use protection (condoms) during intercourse - every time. C. These diseases are also easily transmitted form a mother to a fetus and you should protect yourself from becoming pregnant."
- "Persons who become infected with a blood borne virus often experience an unexplained viral type illness shortly after becoming infection (such as flu like symptoms when it is not flu season). If you experience such symptoms, you should see your health care provider as soon as possible and be sure to inform him [sic] that you were recently exposed to someone else's body fluids."
During an interview with the facility's Infection Preventionist (IP) on 3/31/15 at 11:00AM, the IP reported the employee would need to request to have the patient's blood tested. Review of Employee #26's post-exposure documentation failed to include evidence of the completion of the formed entitled "DEEMED CONSENT & BLOODBORNE PATHOGEN TESTING NOTIFICATION STATEMENT"; and Employee #26's post-exposure documentation failed to reveal evidence of Employee #26 declining to have the patient's blood tested.
During an interview with the facility's IP on 4/7/15 at 1:40PM, the IP reported that Employee #26 had the post-exposure paperwork completed on 4/3/15.
2. A facility staff member (Employee #18) failed to follow cleaning product instructions when cleaning equipment (used for multiple patients) after being using to care for a patient on contact isolation precautions.
On 4/6/15 at 10:15AM, Employee #18 was observed providing care for a patient on contact isolation precautions. After providing care for the patient, Employee #18 was observed by the surveyor (another facility employee (Employee #4) was present) to clean a pulse oximeter, a handheld patient ID scanning device, and a stethoscope. Employee #18 used a single cleaning wipe to clean all three devices. Employee #18 stored away the pulse oximeter prior to the surveyor seeing how long it remained wet from the cleaning wipe; the handheld patient scanning device and the stethoscope was observed to be dry in less than 30 seconds after being cleaned with the cleaning wipe. The cleaning wipe used by Employee #18 was labeled as: "PDI SANI-CLOTH PULSE GERMICIDAL DISPOSALBE CLOTH The 3-minute germicidal wipe / Bactericidal - Virucidal".
The following 'DIRECTIONS FOR USE' was found written on the PDI SANI-CLOTH PULSE GERMICIDAL DISPOSALBE CLOTH container: "It is a violation of Federal law to use this product in a manner inconsistent with its labeling ... Deodorizing and Disinfecting: To disinfect nonfood contact surfaces only: Use a wipe to remove heavy soil. Unfold a clean wipe and thoroughly wet surface. Treated surface must remain visibly wet for a full three (3) minutes. Use additional wipe(s) if needed to assure continuous three (3) minute wet contact time. Let air dry."
The following information was found in a facility policy entitled, "Cleaning Environment, Patient Equipment and Medical Devices": "All cleaning supplies will be used per the manufacturers label for contact time i.e. 3 min, 5 min, etc." [sic]
3. A facility staff member (Employee #19) failed to provide care to Patient #19 in a manner which would decrease the risk of potentially spreading infectious organisms.
On 4/6/15 at approximately 10:40AM, Employee #19 was observed to provide indwelling urinary catheter care to Patient #19. It was observed that Employee #19's facility ID and a small container of hand cleanser (both which were connected to Employee #19's upper body) was dangling over Patient #19; it was observed that both Employee #19's ID and the container of hand cleanser contacted Patient #19's skin (upper leg). After completing care, Employee #19 was observed to remove his/her gloves and touch the container of hand cleanser to perform hand hygiene after providing care.
Employee #4 (an employee in the Quality/Risk Department) was notified of the aforementioned observation on the morning of 4/6/15.
4. A. The facility staff failed to ensure that multi-dose, multi-patient medications were not stored in a direct patient care area.
On the morning of 4/1/15, an anesthesia medication cart was observed to remain in an operating room as the operating room was being cleaned between surgical patients/procedures. Two medication vials were observed to be open in the top drawer of the