HospitalInspections.org

Based on observation, staff interview, and review of facility documents, it was determined that the Governing Body failed to demonstrate that it is effective in carrying out the operation and management of the facility. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

482.13 Patient Rights

482.42 Infection Control

Based on document review and interviews, it was determined that the facility failed to ensure that the patient's right to receive care in a safe setting is promoted and protected.

Findings include:

1. The facility failed to ensure medication tampering and the possibility of transmission of bloodborne pathogens were reported to Patients Safety, Pharmacy & Therapeutic Committee, Infection Control Committee, Quality Committee or the Hospital Board at the time of the occurrence

2. The facility failed to inform the infection control preventionist a breach in safety medication practices at the time of the occurrence. (Refer to Tag 0144).

Based on review of 2 of 2 medical records and staff interview, it was determined that the facility failed to ensure that the patients are provided information regarding their rights about discontinuing patient care.

Findings include:

Reference: CMS regulation at 42 CFR 489.27(a) states that "each Medicare beneficiary who is an inpatient (or his/her representative) must be provided the standardized notice, "An Important Message from Medicare" (IM), within 2 days of admission ... The IM is to be signed and dated by the patient to acknowledge receipt ... Furthermore, 42 CFR 405.1205(c) requires that hospitals present a copy of the signed IM in advance of the patient's discharge, but not more than two calendar days before the patient's discharge."


1. On 3/24/16, the medical record of Patient #3 indicated that an admission IM was signed by the patient on 6/18/14. The patient was discharged on 7/1/14. There was no evidence that a signed copy of the Important Message Notice form was presented to the patient 2 days prior to the discharge.

2. On 3/24/16, the medical record of Patient #10 indicated that the patient was admitted on 2/10/16. The medical record lacked evidence of an admission IM form signed by the patient or his/her representative.

3. The above was confirmed by Staff #1.

Based on document review and interviews, it was determined that the facility failed to ensure that patient's receive care in a safe setting.

Findings include:

Reference: Facility policy, "Never Events and Patient Safety Reporting Requirements" state, '... Definitions: ... Sentinel Event--An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically ... The phrase, "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.
I. Procedure: A. The Risk Manager in conjunction with the Performance Improvement Department will be responsible for reporting and submitting the required reports ...

1. On 3/12/16 and 3/24/16, events related to an incident that involved a staff member tampering with medication vials that were dispensed to patients from July-September 2014 were discussed with Staff #1 and Staff #10. This tampering activity was confirmed via an outside lab on October 7, 2014.

2. Interviews with Staff #1 and Staff #10 revealed that this information was not reported to Patients Safety, Pharmacy &Therapeutic Committee Infection Control Committee, Quality Committee or the Hospital Board until February 2016.

3. Upon interview, Staff #5 confirmed that the Infection Control Preventionist was not made aware of this breach in safety medication practices until January 2016.

4. Staff #1 was unable to provide evidence that the appropriate reporting and process was implemented in accordance with the above Reference.

5. Staff #1 and Staff #10 confirmed that the possibility of transmission of bloodborne pathogens had not been addressed at the time of the occurrence.

Based on observation, staff interviews, review of facility policies and procedures, and review of other facility documentation, it was determined that the facility failed to ensure the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Findings include:

1. The facility failed to ensure that multi-dose vials accessed in an immediate patient care area were used for one patient and immediately discarded. (Refer to Tag 0749).

2. The facility failed to adhere to professionally acceptable standards for hand washing. (Refer to Tag 0749).

A. Based on observation and interview, it was determined that the facility failed to ensure that safe injection practices are implemented in accordance with CDC guidelines.

Findings include:

Reference: CDC guidelines for multidose vials website: http://www.cdc.gov/HAI/setting/outpatient/checklist/outpatient-care-checklist-observations.html>, titled "Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care" states, "Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g,. operating room, patient room/cubicle) (Note: If multi-dose vials enter the immediate patient treatment area they should be dedicated for single-patient use and discarded immediately after use.)"

1. During a tour of the OR suite, in the company of Staff #6, two anesthesia carts were opened. Each cart contained a sealed multidose vials of 10cc of Trandate.

a. Upon interview, Staff #17 stated that this multidose vial can be used for multipatient use in the OR.

b. Upon interview, Staff #18 stated that this multidose vial can be used in the OR for multipatient use, need be, and is then discarded at the end of the day.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 3/24/16, day of survey, upon receipt of an acceptable plan of correction.

2. The facility policy "Safe Injection Practices to Prevent Transmission of Infection to Patients" failed to address the above CDC requirement.

B. Based on document review, observation and staff interviews on 3/22/16 and 3/24/16, it was determined that the facility failed to provide a sanitary environment for prevention and control of infections and communicable diseases within the hospital. The infection control program has not implemented the nationally recognized infection control guidelines they have selected from the CDC (Centers for Disease Control and Prevention) and its policy.

Findings include:

Reference #1: CDC Guideline for Hand Hygiene in Health Care Settings 2002 page 32 states:
"Recommendations:
1. Indications for hand washing and hand antisepsis ...
(I) Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of patient
(J) Decontaminate hands after removing gloves.
...
2. Hand-hygiene technique...
(B) When washing hands with soap and water, wet hands first with water, apply an amount of product recommended by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds covering all surfaces of the hands and fingers.
... ."

Reference #2: Facility policy "Isolation and Standard Precautions, Hand Hygiene ..." states, "Standard Precautions 1. Hand Hygiene Indications for handwashing and hand antisepsis: ...
C. Decontaminate hands before having direct contact with patients.
G. Decontaminate or wash hands before inserting indwelling urinary catheters, or other invasive devices that do not require a surgical procedure.
H. Decontaminate or wash hands after contact with a patient's intact skin (e.g. when taking a pulse or blood pressure, and lifting a patient).
K. Decontaminate or wash hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient.
L. Decontaminate or wash hands after removing gloves.

Hand hygiene technique:
...
B. When washing with soap and water, ... rub hands together vigorously for a least 15 seconds, covering all surfaces of the hands and fingers ..."

Reference #3: Facility policy "Safe Injection Practices to Prevent Transmission of Infection to Patients" states, "Procedures: ... 4. Always use aseptic technique when preparing and administering injections starting with hand hygiene prior to accessing supplies, handling vials and intravenous solutions and preparing or administering medications."


1. On 3/24/16, at approximately 11:00 AM, in the Pre-operative area, Staff #14 was observed examining Patient #11. Staff #14 did not sanitize his/her hands after examining the patient.

2. During the procedure of Patient #11, Staff #14 was observed preparing medication for the spinal injection. Staff #14 did not sanitize his/her hands prior to placing on the sterile gloves and after removal of same.

3. On 3/24/16 at approximately 12:15 PM, during a glucose fingerstick observation, after the test, Staff #15 removed one of his/her gloves to write on the wall board, then removed the other glove and proceeded to go to the bathroom to wash his/her hand. Prior to going to the bathroom, he/she placed the glucose monitoring machine on the biohazard box on the wall. Staff #15 washed his/her hands briefly and then proceeded it to wipe the glucose monitoring machine with an approved sanitizing wipe.

a. Staff #15 failed to wash his/her hands for at least 15 seconds.

b. Staff #15 failed to place the glucose monitoring machine on the appropriate surface prior to washing his/her hands.

c. The above was confirmed by Staff 15.


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4. During a tour of the Intensive Care Unit, the following was observed:

a. Staff #12, Respiratory Therapist, was in contact with Patient #6, in Room #268, who was diagnosed with Methicillin-resistant Staphylococcus aureus (MRSA).

b. Staff #12 was observed washing his/her hands for seven (5) seconds.

2. Staff #12, was in contact with Patient #7 in Room #269.

a. Staff #12 was observed washing his/her hands for five (5) seconds.

3. Staff #2 and Staff #12 confirmed the above findings.

4. Upon interview, with Staff #13, a contracted environmental services personnel, stated he/she washes his/her hands for 10 seconds.

C. Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure the efficacy of the cleaning solution being used in patient rooms of patients with Clostridium difficile (C.diff).

Findings include:

Reference #1: Facility policy, Guidelines for the Environmental Prevention and Elimination of Clostridium difficile, states, "Prevent the spread of Clostridium difficile in the hospital... Procedure: ... 3. Perform Hand Hygiene... a. Because alcohol does not kill Clostridium difficile spores, soap and water will be used for hand hygiene. ...Environmental cleaning and disinfection: 1. A hypochlorite (chlorine bleach) will be used for cleaning and disinfect [sic] environmental surfaces... ."

1. During a tour of the Telemetry Unit on 3/22/16, Staff #13, a contracted Environmental Services Personnel, was observed cleaning patient Room #222.

a. A Contact Isolation sign was posted outside patient Room #222.

b. The patient in Room #222 (Patient #9), was identified as having Clostridium difficile.

c. Upon Interview, Staff #13 stated he/she was not using a bleach solution to clean Room #222.

2. This finding was confirmed by Staff #2.

3. Staff #8, from a contracted environmental services agency, stated that he/she was unable to provide any inservices regarding cleaning rooms of patients with Clostridium difficile.

A. Based on observation and interview, it was determined that the facility failed to ensure that safe injection practices are implemented in accordance with CDC guidelines.

Findings include:

Reference: CDC guidelines for multidose vials website: http://www.cdc.gov/HAI/setting/outpatient/checklist/outpatient-care-checklist-observations.html>, titled "Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care" states, "Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g,. operating room, patient room/cubicle) (Note: If multi-dose vials enter the immediate patient treatment area they should be dedicated for single-patient use and discarded immediately after use.)"

1. During a tour of the OR suite, in the company of Staff #6, two anesthesia carts were opened. Each cart contained a sealed multidose vials of 10cc of Trandate.

a. Upon interview, Staff #17 stated that this multidose vial can be used for multipatient use in the OR.

b. Upon interview, Staff #18 stated that this multidose vial can be used in the OR for multipatient use, need be, and is then discarded at the end of the day.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 3/24/16, day of survey, upon receipt of an acceptable plan of correction.

2. The facility policy "Safe Injection Practices to Prevent Transmission of Infection to Patients" failed to address the above CDC requirement.

B. Based on document review, observation and staff interviews on 3/22/16 and 3/24/16, it was determined that the facility failed to provide a sanitary environment for prevention and control of infections and communicable diseases within the hospital. The infection control program has not implemented the nationally recognized infection control guidelines they have selected from the CDC (Centers for Disease Control and Prevention) and its policy.

Findings include:

Reference #1: CDC Guideline for Hand Hygiene in Health Care Settings 2002 page 32 states:
"Recommendations:
1. Indications for hand washing and hand antisepsis ...
(I) Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of patient
(J) Decontaminate hands after removing gloves.
...
2. Hand-hygiene technique...
(B) When washing hands with soap and water, wet hands first with water, apply an amount of product recommended by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds covering all surfaces of the hands and fingers.
... ."

Reference #2: Facility policy "Isolation and Standard Precautions, Hand Hygiene ..." states, "Standard Precautions 1. Hand Hygiene Indications for handwashing and hand antisepsis: ...
C. Decontaminate hands before having direct contact with patients.
G. Decontaminate or wash hands before inserting indwelling urinary catheters, or other invasive devices that do not require a surgical procedure.
H. Decontaminate or wash hands after contact with a patient's intact skin (e.g. when taking a pulse or blood pressure, and lifting a patient).
K. Decontaminate or wash hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient.
L. Decontaminate or wash hands after removing gloves.

Hand hygiene technique:
...
B. When washing with soap and water, ... rub hands together vigorously for a least 15 seconds, covering all surfaces of the hands and fingers ..."

Reference #3: Facility policy "Safe Injection Practices to Prevent Transmission of Infection to Patients" states, "Procedures: ... 4. Always use aseptic technique when preparing and administering injections starting with hand hygiene prior to accessing supplies, handling vials and intravenous solutions and preparing or administering medications."


1. On 3/24/16, at approximately 11:00 AM, in the Pre-operative area, Staff #14 was observed examining Patient #11. Staff #14 did not sanitize his/her hands after examining the patient.

2. During the procedure of Patient #11, Staff #14 was observed preparing medication for the spinal injection. Staff #14 did not sanitize his/her hands prior to placing on the sterile gloves and after removal of same.

3. On 3/24/16 at approximately 12:15 PM, during a glucose fingerstick observation, after the test, Staff #15 removed one of his/her gloves to write on the wall board, then removed the other glove and proceeded to go to the bathroom to wash his/her hand. Prior to going to the bathroom, he/she placed the glucose monitoring machine on the biohazard box on the wall. Staff #15 washed his/her hands briefly and then proceeded it to wipe the glucose monitoring machine with an approved sanitizing wipe.

a. Staff #15 failed to wash his/her hands for at least 15 seconds.

b. Staff #15 failed to place the glucose monitoring machine on the appropriate surface prior to washing his/her hands.

c. The above was confirmed by Staff 15.


26599


4. During a tour of the Intensive Care Unit, the following was observed:

a. Staff #12, Respiratory Therapist, was in contact with Patient #6, in Room #268, who was diagnosed with Methicillin-resistant Staphylococcus aureus (MRSA).

b. Staff #12 was observed washing his/her hands for seven (5) seconds.

2. Staff #12, was in contact with Patient #7 in Room #269.

a. Staff #12 was observed washing his/her hands for five (5) seconds.

3. Staff #2 and Staff #12 confirmed the above findings.

4. Upon interview, with Staff #13, a contracted environmental services personnel, stated he/she washes his/her hands for 10 seconds.

C. Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure the efficacy of the cleaning solution being used in patient rooms of patients with Clostridium difficile (C.diff).

Findings include:

Reference #1: Facility policy, Guidelines for the Environmental Prevention and Elimination of Clostridium difficile, states, "Prevent the spread of Clostridium difficile in the hospital... Procedure: ... 3. Perform Hand Hygiene... a. Because alcohol does not kill Clostridium difficile spores, soap and water will be used for hand hygiene. ...Environmental cleaning and disinfection: 1. A hypochlorite (chlorine bleach) will be used for cleaning and disinfect [sic] environmental surfaces... ."

1. During a tour of the Telemetry Unit on 3/22/16, Staff #13, a contracted Environmental Services Personnel, was observed cleaning patient Room #222.

a. A Contact Isolation sign was posted outside patient Room #222.

b. The patient in Room #222 (Patient #9), was identified as having Clostridium difficile.

c. Upon Interview, Staff #13 stated he/she was not using a bleach solution to clean Room #222.

2. This finding was confirmed by Staff #2.

3. Staff #8, from a contracted environmental services agency, stated that he/she was unable to provide any inservices regarding cleaning rooms of patients with Clostridium difficile.