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Based on facility policy, medical record review and interview, it was determined the facility failed to obtain informed consent for treatment for 3 of 27 (Patients #13, 14 and 27) sampled patients.

The findings included:

1. Review of the facility policy, "Admissions" documented: "PURPOSE: To clarify completion process for paperwork needed before inpatient admission. All admissions should include the following:
1. Conditions of Admissions/Consent to Treatment Form properly completed and signed.
2. Insurance form(s) signed and completed as needed.
3. Labels and armband.
4. Consent to Treat & Authorization to Release Information form properly completed.
5. A Good Faith Form is completed on those patient that are unable to sign for themselves without family present."

2. Medical record review for Patient #13 revealed the patient was admitted on 1/13/13 and the Conditions of Admission/Consent to Treatment form had "Good Faith" written in as the Patient/Patient's Authorized Signature. The patient had been discharged on 1/15/13 and there was no documentation that family/responsible party had signed for the patient to receive treatment at the facility.

3. Medical record review for Patient #14 with the Clinical Unit Manager on 1/16/13 at 1:45 PM revealed the consent to treat form was blank. The Clinical Unit Manager stated the patient was being discharged today and she could go get the form signed before the patient left.

During an interview in the conference room on 1/16/13 at 10:15 AM, the Chief Nursing Officer stated, "when patients come through the ER, if unable to sign consents because of medical condition, we do a GFF [Good Faith Form]. Admissions is suppose to follow up but based on their medical condition may not get consent for treatment signed by family"

4. Medical record review for Patient #27 with the Clinical Nurse Manager on 1/16/13 at 11:27 AM revealed no signed consent to treat form in the patient's medical record.
During an interview in the conference room on 1/16/13 at 11:27 AM, when asked about Patient #27's signed consent to treat form, the Clinical Nurse Manager stated, "...it's not here [medical record]...the nurses on the floor were responsible to call the responsible party to obtain consent to treat but failed to do so"

Based on record review and interview it was determined the Governing Body failed to ensure the hospital developed, implemented and maintained a hospital-wide data-driven quality assessment and performance improvement program that included all departments and services.


The findings included:

1. The Governing Body failed to ensure the Quality Assessment Performance Improvement (QAPI) program measured, analyzed and tracked quality indicators for Surgical Site Infections (SSI).
Refer to A 273

2. The Governing Body failed to provide oversight of the QAPI program related to SSI.
Refer to A 309

Based on record review and interview it was determined the facility failed to ensure the hospital wide performance improvement program included indicators to track, trend and analyze surgical site infections (SSI) in order to monitor the effectiveness and safety of the surgical services and quality of care.

The findings included:

1. Review of the hospital's "Performance Improvement Plan" revealed, "...The Performance Improvement Plan at [name of the hospital] is a planned, systematic, organization-wide effort to ensure that [name of hospital] designs processes well, and systematically monitors, analyzes, and improves its performance to improve patient outcomes and meet customer needs...The Performance Improvement Program at [name of hospital] encompasses all departments..."

2. Review of the Performance Improvement Council meeting minutes dated 4/3/12 revealed, "...Discussion: We will be participating with hospitals across the state to collectively work on several quality initiatives using teams of staff: SSI...Action: Team designated:..."

Review of the Performance Improvement Council meeting minutes dated 6/27/12 and 9/19/12 revealed no documentation of SSI's being discussed, data presented, analyzed or developed of action plans.

3. Review of the 2012 Infection Prevention Data revealed Surgical Site Infections were not investigated or reported by the Infection Control Program.

Review of the Laboratory and Infection Prevention Committee minutes dated 4/26/12 and 11/6/12 revealed no documentation Surgical Site Infections were discussed, no data collected, no review of the data, no evaluation or action plan related to Surgical Site Infections.

Review of the Surgery Department Minutes dated 2/9/12, 5/17/12, 8/16/12 and 11/29/12 revealed no documentation Surgical Site Infections were reported, investigated or reviewed.

During an interview in the conference room on 1/16/13 at 11:00 AM, the Director of Performance Improvement/Infection Control was asked if Surgical Site Infections were identified, investigated and reported to the committee. The Director of Performance Improvement/Infection Control stated, "...No, they were pulled from a query, there were 5 and were not investigated...No, I did not document in the comment section of why it was a Surgical Site Infection...No, I don't know the organisms involved...No, I did not track or trend to see if there were any problems with practice..." The Director of Performance Improvement/Infection Control confirmed Surgical Site Infections were not reported or discussed in the Performance Improvement committee, Laboratory and Infection Prevention Committee, Surgical Services Committee, the Medical Executive Committee or the Board of Trustees.

Based on record review and interview it was determined the hospital's governing body failed to assume responsibility for the hospital wide performance improvement program to ensure the program addressed all areas of patient care and safety including that of surgical services to ensure surgical site infections (SSI) were tracked, trended and analyzed.

The findings included:

1. Review of the facility's "Performance Improvement Plan" revealed, "...Responsibility: The leaders of [named facility] are the Board of Directors, Administrators, Medical Staff, Departmental Managers and PI Council. They are responsible for: Overseeing the design of the Performance Improvement system; Fostering an organization-wide commitment to performance improvement; Establishing performance improvement responsibilities, Setting strategic priorities for performance measurement and improvement; Providing resources to implement and maintain performance improvement activities...Providing input to the Performance Improvement Council...Providing feedback on project approval and other Quality Team matters..."

2. Review of the 2012 Infection Prevention Data revealed Surgical Site Infections were not investigated or reported by the Infection Control Program.

Review of the Laboratory and Infection Prevention Committee minutes dated 4/26/12 and 11/6/12 revealed no documentation Surgical Site Infections were discussed, no data collected, no review of the data, no evaluation or action plan related to Surgical Site Infections.

Review of the Surgery Department Minutes dated 2/9/12, 5/17/12, 8/16/12 and 11/29/12 revealed no documentation of Surgical Site Infections were reported, investigated or reviewed.

3. Review of the Medical Executive Committee meeting minutes dated 5/17/12, 7/11/12, 9/12/12 and 11/13/12 revealed no documentation SSI or infection control issues were discussed.

Review of the Board of Trustees meeting minutes dated 3/14/12, 5/17/12, 7/11/12 and 9/12/12 revealed no documentation SSI or infection control issues were discussed.

Review of the Board of Directors meeting minutes dated 2/6/12, 6/5/12 and 9/10/12 revealed no documentation of the Performance Improvement Program or the Infection Control Program.

4. During an interview in the conference room on 1/16/13 at 11:00 AM, the Director of Performance Improvement/Infection Control confirmed Surgical Site Infections were not discussed in the Medical Executive or the Board of Trustee meetings.

Based on policy review, medical record review and interview, it was determined the facility failed to ensure a care plan was developed upon admission for 2 of 27 (Patients #7 and 16) sampled patients.

The findings included:

1. Review of the facility's "PLAN OF CARE" policy revealed, "...PURPOSE: To assure care is based on problems identified through assessment... A plan of care is established at the time of admission and a problem list developed..."

2. Medical record review for Patient #7 revealed an admission date of 1/2/13 with a diagnosis of Congestive Heart Failure. Review of the care plan documented Patient #7's care plan was initiated 1/4/13. The care plan was initiated two days after Patient #7 was admitted to the hospital.

3. Medical record review for Patient #16 revealed an admission date of 10/15/12 with a diagnosis of Severe Conjunctivitis with Vision Loss. Patient #16 was discharged 10/17/12. There was no documentation of a care plan for Patient #16.

4. During an interview in the Administrative conference room on 1/16/13 at 11:30 AM, the Director of Behavioral Health and Electronic Records (Director of BH/ER) verified Patient #7's care plan was not initiated until two days after admission. He verified there was no documentation of a care plan for Patient #16.

Based on facility policy, medical record review and interview, it was determined the facility failed to follow physician orders for medication changes for 1 of 27 (Patient #14) sampled patients reviewed.

The findings included:

1. Review of the facility policy for Medication Administration documented, "... Hours that medications and treatment are administered (unless otherwise indicated):...Twice a day (b.i.d.) 09 [9:00 AM] & 17 [5:00 PM]...Newly ordered medications should be administered at the next scheduled time (unless otherwise specified) and then according to routine administration times....PROCEDURE... Checking the eMAR [electronic mediation administration record]...the night nurse will verify the accuracy of the medication profile by comparing the profile to the last 24 hours of MD's orders. The nurse will then select the icon that indicates the MAR as been reviewed"

2. Medical record review for Patient #14 documented an admission to the facility on 1/7/13. Review of the physician order dated 1/13/13 at 4:10 PM revealed, "Change Risperdal to 1 mg [milligram] PO [by mouth] BID [twice a day]" The order was signed off by the RN at 6:55 PM. The physician progress note dated 1/13/13 at 4:10 PM documented, "reportedly pt [patient] was "acting out" earlier today...required PRN [as needed] Geodon"

There was no documentation in the medical record the physician's order to increase the Risperdal to 1 mg had been changed.

During an interview on the nursing unit on 1/14/13 at 2:55 PM Nurse #1 stated, "It looks like it hasn't been changed [the Risperdal order]...I will call pharmacy..."

Based on policy review, observation and interview, it was determined the facility failed to keep all drugs and biologicals in a secured area.

The findings included:

1. Review of the facility's "EXPIRATION OF OPEN VIALS AND MULTI-DOSE INJECTIONS" policy revealed, "...It shall be the responsibility of the nurse or pharmacist first opening a multi-dose vial to take the following steps...1. An open date will be applied to the side of the bottle. Multi-dose vials are good for 30 days from open date...All insulin vials must be dated on the bottle. These vials will be expired 28 days from the day of initial use or expires according to the manufacturer, whichever date is shorter."

Review of the facility's "CONTROLLED SUBSTANCES: DISPENSING, STORAGE, AND INVENTORY PROCEDURES," policy revealed, "...All controlled substances released from the pharmacy will be controlled and properly stored under lock at all times...Due to the fact that controlled substances are to be placed in individual patients' drawers, the medicine cart has to be locked at all times except when the medicine nurse is preparing medications..."

2. Observations in the 2 South Medication Room on 1/14/13 at 2:00 PM, revealed the door to the medication room was unlocked. The following medications were stored in the unsecured medication room: Clindamycin intravenous piggy-back (IVPB), Zosyn IVPB, Dextrose 5% Normal Saline 9% with 20 milliequivalents Potassium intravenous fluid and a pharmacy medication bin for discontinued medications on top of the medication dispenser which contained various medications.

During an interview on the 2 South Hallway on 1/14/13 at 2:35 PM, Nurse #6 confirmed the medication cart was unlocked and unattended and stated, "...nurses are to lock the med cart..."

3. Observations on the 2 South Hallway on 1/14/13 at 2:30 PM, revealed the medication cart was unlocked and unattended. An opened vial of insulin labeled, "...Do not use after 1/6/13..." was stored inside the medication cart.

During an interview on the 2 South Hallway on 1/14/13 at 2:30 PM, Nurse #8 confirmed the vial of insulin was stored in the medication cart past the expiration date.

4. Observations in the Preoperative Area of Surgery on 1/14/13 at 11:00 AM, revealed the following medications in the anesthesia block cart opened and not dated:
1 vial of .5% Bupivacaine 50 ml (milliliters)
1 vial of .25% Bupivacaine 50 ml
1 vial of 1% Lidocaine 10 mg (milligrams)/ml
1 vial of Sensorcaine and Epinephrine 30 ml.

During an interview in the Preoperative Area of Surgery on 1/14/13 at 11:00 AM, Certified Registered Nurse Anesthetist #1 confirmed the medications in the anesthesia block cart were opened and not dated.

5. Observations on the 2 South Hallway on 1/15/13 at 8:40 AM, revealed the medication cart was unlocked and unattended. An ampule of Hydromorphone 1mg/ml was stored inside the medication cart.

During an interview on the 2 South Hallway on 1/15/13 at 8:40 AM, Nurse #7 confirmed the medication cart was unlocked, unattended and stored an ampule of Hydromorphone. Nurse #7 stated, "...I should have locked the med cart when I left it..."
During an interview on the 2 South Hallway on 1/15/13 at 9:20 AM, when asked about storing medications in a secured area, Nurse #4 stated, "...expect med carts to be locked when unattended..." Nurse #4 confirmed the medication room should be locked and stated, "...we need a keypad on the door..."

Based on observation and interview, it was determined the facility failed to maintain equipment that was not out of date to ensure an acceptable level of safety and quality for the Wound Care Clinic and the pediatric Broselow Cart.

The findings included:

1. During the initial tour of the Emergency Department with the nurse manager on 1/14/13 at 10:10 AM, the following supplies were observed to have expired on the Broselow Cart [Pediatric Emergency Resuscitation Cart]:
Pink/Red Intubation Module expired 06/2012
Yellow Nasogastric tube expired 11/2012
Yellow Intubation Module expired 04/2012
Blue Intubation Module expired 04/2012
Orange Intubation Module expired 04/2012
Green Intubation Module expired 04/2012.

2. Observations in the supply room of the Wound Care Clinic on 1/15/13 at 9:30 AM, revealed the following supplies were expired:
1 Gauze Dressing Kit with Port expired 02/2012
1 Gauze Dressing Kit with Port expired 07/2012
1 Gauze Dressing Kit with Port expired 10/2012
3 Gauze Dressing Kits with Port expired 11/2012
1 Gauze Dressing Kit with Port expired 12/2012

During an interview in the Wound Care Clinic hallway on 1/15/13 at 9:30 AM, Nurse #5 confirmed the Gauze Dressing Kits with Port were stored in the supply room past their expiration date. When asked how often the staff are to check the supply room for out-of-date supplies, Nurse #5 stated, "...about once a month..."

Based on policy review, record review, observations and interview, it was determined the facility failed to provide a sanitary environment to avoid sources and transmission of infections, failed to integrate the infection control program into it's hospital wide Performance Improvement Program, and failed to have an infection control program that developed a system for identifying, reporting, investigating and controlling infections of patients and personnel.

The findings included:

1. The facility failed to develop a system for identifying, reporting, investigating and controlling infections of patients and personnel.
Refer to A 749

2. The facility failed to maintain a log of incidents related to infections and communicable diseases for patients and staff.
Refer to A 750

Based on policy review, record review and interview, it was determined the Infection Control Officer (ICO) failed to develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

The findings included:

1. Review of the facility's "Infection Control: Contact Isolation" policy revealed, "...C difficile [Clostridium Difficile] - The patient's room is disinfected daily and at discharge by housekeeping staff with a bleach solution..."

2. During an interview in the hallway outside Pre-Operative Holding on 1/14/13 at 12:00 PM, the Operating Room (OR) Attendant was asked if cleaning equipment is different when a patient has Clostridium Difficile (C-Diff). The OR Attendant stated, "...Yes, I wear a mask..." When asked if used a different cleaning/disinfecting agent for C-Diff the OR Attendant stated, "...No, I use Virex 256..." The ICO confirmed Virex 256 was not an approved disinfectant for C-Diff.

During an interview in the 2 South Medical Surgical Floor on 1/14/13 at 2:20 PM, the Housekeeper was asked if cleaning a patient room is different when a patient has C-Diff. The Housekeeper stated, "...I use Chlorox wipes on the high touch area but Virex 256 on the floor..." The ICO confirmed C-Diff can be on the floor and Virex 256 was not an approved disinfectant.

3. Review of the 2012 Infection Prevention Data revealed Surgical Site Infections were not investigated or reported by the Infection Control Program.

Review of the Laboratory and Infection Prevention Committee minutes dated 4/26/12 and 11/6/12 revealed no documentation Surgical Site Infections were discussed, no data collected, no review of the data, no evaluation or action plan related to Surgical Site Infections.

Review of the Surgery Department Minutes dated 2/9/12, 5/17/12, 8/16/12 and 11/29/12 revealed no documentation of Surgical Site Infections were reported, investigated or reviewed.

During an interview in the conference room on 1/16/13 at 11:00 AM, ICO was asked if Surgical Site Infections were identified, investigated and reported to committee. The ICO stated, "...No, they were pulled from a query there were 5 and were not investigated...No, I did not document in the comment section of why it was a Surgical Site Infection...No,I don't know the organisms involved...No, I did not track or trend to see if there were any problems with practice..." The ICO confirmed Surgical Site Infections were not reported or discussed in the Laboratory committee meetings, Infection Prevention Committee meetings, Surgical Services Committee meetings, the Medical Executive committee meetings or the Board of Trustee meetings.

4. When requested by the surveyor, there was no documentation presented to verify the ICO had developed and implemented a system for identifying, reporting, investigating and controlling infections of personnel.

During an interview in the conference room on 1/16/13 at 1:40 PM, the ICO was asked if personnel infections or illnesses were identified, reported, investigated, tracked and trended. The ICO stated, "...No, we don't review employee illness...No, we don't keep up with it..." The Employee Health Nurse and Human Resource Director confirmed the facility does not keep up with employee illness or infections.

5. Review of the 2012 Infection Prevention Data revealed no documentation of an evaluation of the 2011 Flu Vaccination Program and no action plan to increase compliance of immunization.

During an interview in the conference room on 1/16/13 at 11:15 AM, the ICO was asked if the 2011 Flu Vaccination Program data was analyzed and an action plan developed based on the analysis and reported to Performance Improvement Committee. The Director stated, "...No don't evaluate the Flu program except to say percentage...No did not evaluate and look to see what to do to increase compliance to make it better...No did not take the Flu Program to PI [performance improvement]...No we have no plan in place to improve immunization rates..."

6. Observation during tour on 1/14/13 at 10:05 AM on the 4th floor ambulatory surgery floor revealed the following:
a. In the clean linen room: an open soft drink can on the linen shelf, 10 linen bags on the floor, 3 bags of mop heads on the floor, a mop bucket with mop heads in the corner of the room.
b. Vesphene gallon jug with solution stored under the sink in the Biohazard bathroom.

During an interview in the nurses' station on the ambulatory surgery floor on 1/14/13 at 10:30 AM, the ICO and the ambulatory surgery floor Charge Nurse confirmed the findings. The Charge Nurse stated, "...This should not be in here..."

7. Review of the facility's "Standard Precautions" policy revealed, "...HAND HYGIENE...Handwashing...How - Thorough and vigorously wash hands with soap under a stream of water for 15 seconds. An antimicrobial soap will be used by clinical employees...PERSONAL PROTECTIVE EQUIPMENT (PPE)...Gloves...Change gloves between tasks and procedures on the same patient after contact with material that may be infectious. Remove gloves promptly after use, before touching noncontaminated items and environmental surfaces..."

Medical record review for Patient #4 revealed an admission date of 1/13/13 with an open right plantar foot wound.

Observations in Patient #4's room on 1/15/13 at 11:30 AM, revealed Patient #4 had an open wound approximately half-dollar in size to the lateral, plantar area of the right foot. Nurse #2 removed the old dressing, irrigated the wound with 10 milliliters (ml) of normal saline, packed the wound with a small strip of silvasorb and applied a new dressing. Nurse #2 did not change gloves after irrigating the wound and touched the clean supplies with contaminated gloves. Nurse #2 washed hands after preparing the supplies and after completing the dressing change but did not use soap while washing hands.

8. Medical record review for Patient #27 revealed an admission date of 1/11/13 with a Stage IV sacral ulcer.

Observations in Patient #27's room on 1/16/13 at 10:35 AM, revealed Patient #27 had a Stage IV sacral ulcer. Nurse #3 removed the old dressing, irrigated the wound with 10 ml of normal saline, wiped the wound with 4 X 4's and applied maxorb gauze and a new dressing. Nurse #3 did not change gloves after irrigating the wound and touched the clean supplies with contaminated gloves.

9. During an interview in the Intensive Care Unit on 1/16/13 at 11:15 AM, when asked when staff should change their gloves and wash their hands during a dressing change, Nurse #4 stated, "...in between, from dirty to clean..." When asked if staff should change gloves and wash hands between irrigating a wound and applying a new dressing, Nurse #4 stated, "Yes"

Based on record review and interview, it was determined the ICO failed to maintain a log of incidents related to infections and communicable diseases for patients and staff/personnel.

The findings included:

1. When requested by the surveyor, there was no documentation of a log of incidents related to infections of staff/personnel presented for the surveyor review.

During an interview in the conference room on 1/16/13 at 1:40 PM, the ICO was asked if personnel infections or illnesses were identified, reported, investigated, tracked and trended. The Director of Performance Improvement/Infection Control stated, "...No, we don't review employee illness...No, we don't keep up with it..." The Employee Health Nurse and Human Resource Director confirmed the facility does not keep up with employee illness or infections and there was no log.

2. There was no documentation of a log of patients who met the Center for Disease Control (CDC) criteria for requiring isolation precautions during their hospitalization.

During an interview in the conference room on 1/16/13 at 11:15 AM, the ICO was asked if data was collected or monitoring performed of the patients who required isolation. The ICO stated, "...No, we are not collecting data or monitoring isolation..." The ICO confirmed the facility does not keep a log of patients who require isolation precautions during their hospitalization.

Based on policy review, medical record review and interview, it was determined the facility failed to ensure a medical history and physical examination was completed and documented no more than 30 days before or 24 hours after admission for 1 of 5 (Patient #15) sampled surgical patients.

The findings included:

1. Review of the facility's "General Rules and Regulations" policy revealed, "...History and Physical Timeframes/Updates...If a History and Physical Examination has been performed and documented within (30) thirty days of the patient's admission...or admission for a scheduled operative or invasive procedure, a copy of that history and physical examination may be used in the patient's medical record...If a patient is admitted to the hospital, this update must occur at the time of or within (24) twenty-four hours of the inpatient admission and be on the chart prior to any surgical procedure..."

2. Medical record review for Patient #15 documented an admission date of 1/14/13 with an incarcerated hernia. Review of the "Ambulatory Surgery History and Physical" for Patient #15 revealed an incomplete history and physical not dated.

During an interview at the 2 South Nurses' Station on 1/15/13 at 9:15 AM, the Nurse Educator confirmed Patient #15 had an incomplete history and physical not dated in the medical record.

Based on policy review, medical record review and interview, it was determined the physician failed to document a Medical Screening Exam (MSE) for 16 days for 1 of 19 (Patient #8) sample Emergency Department (ED) records reviewed.

The findings included:

Review of the facility policy, "The Medical Record" documented, "VII. TIMELINESS OF ENTRIES A. Entries to the patient record will be made as soon as possible after an event or observation is made. Each entry will include the date (including month, day and year) and time the entry was made."

ED medical record review for Patient #8 documented the patient presented to the ED on 12/22/12 at 7:45 PM with a lacerated eyebrow. The physical exam was documented by the physician at 5:49 AM on 1/7/13, 16 days after presentation to the ED. The physician documented a laceration repair to the face. The patient was discharged from the ED on 12/22/12 at 9:36 PM with instructions.

On 1/15/13 at 10:00 AM the ED nurse manager verified the physician documented the MSE 16 days after the patient was seen in the ED.