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299 KINGS DAUGHTERS DRIVE

FRANKFORT, KY 40601

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on record review, staff interview, and facility policy and procedures, the facility failed to ensure informed consents for surgical and/or invasive diagnostic procedures were dated and timed by the patient prior to the procedure as required for seven (7) sampled patients. Patients #1, #3, #4, #27, #28,
#38, and #39.

The findings include:

Review of the facility policy for informed consent (RI.009) with a revision date of 01/2011 revealed all informed consent forms were to be completed and signed when the patient was to undergo any procedure performed by a Licensed Independent Practitioner. In addition, the policy required the patient to sign, date, and time the consent form after expressing understanding of the risks, benefits, and alternatives of the procedure.

1. Record review for Patient #1 revealed the patient underwent a left knee Arthroscopy Meniscectomy possible Chondroplasty on 03/29/11. The consent form for surgical or invasive diagnostic procedures was not dated or timed by the patient as required.

2. Record review for Patient #3 revealed the patient had a Endoscopic Sinus surgery , septoplasty, turbinate surgery, and resection of concha on 03/29/11. The consent form for surgical or invasive diagnostic procedures was not dated or timed by the patient as required.

3. Record review for Patient #4 revealed the patient had a left knee Arthroscopy Menisectomy with possible chondroplasty on 03/29/11. The consent form for surgical or invasive diagnostic procedures was not dated or timed by the patient as required.

4. Record review for Patient #27 revealed the patient had a Cystoscopy Fulguration bladder biopsy on 03/24/11. The consent form for surgical or invasive diagnostic procedures was not dated or timed by the patient as required.

5. Record review for Patient #28 revealed the patient had a Tympanoplasty, left ear procedure on 03/30/11. The consent form for surgical or invasive diagnostic procedures was not dated or timed by the patient as required.




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6. Record review for Patient #38 on 03/30/11 revealed an admission date of 03/28/11 with a diagnosis of Gastroesophageal Reflux and a proposed surgical procedure of a possible open laparoscopic exam. The surgical consent form did not reveal a date and time the patient had signed the consent. A witness had signed the surgical consent form on 03/15/11 at 11:30am and a registered nurse had signed the surgical consent form on 03/28/11 at 6:42am under the witness's name.

7. Record review for Patient #39 on 03/30/11 revealed an admission date of 03/29/11 with a diagnosis of a mass on the right kidney. The proposed surgical procedure for Patient #39 was a right renal exploration and a possible right nephrectomy (removal of the right kidney). The surgical consent form for this procedure was signed by Patient #39 but without a date and time of the patient's signature. The surgical consent form was signed by a witness on 03/17/11 at 2:00pm, signed again by a registered nurse on 03/28/11 at 1:00pm under the witness's signature and signed a third time by an untitled witness on 03/29/11 at 7:45am under the registered nurse's signature.




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Interview with the Quality Improvement Director on 03/31/11 at approximately 1:00pm revealed the Informed Consent forms were recently changed. The new Informed Consent form did not have a section to prompt staff to include a date and time as the previous forms had. She stated it was an oversight that will be corrected.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, staff interviews, and facility policy and procedures the facility failed to ensure their system for controlling infections were not implemented consistently. Observation of Operating Room #5 revealed the room had not been thoroughly cleaned between patients. A vacuum canister with body fluids identified by the facility as serosanguinous blood, was left from the previous procedure. Patient #31 was on the operating table being prepped for a left hip replacement procedure when the canister was observed. The facility failed to ensure a sterile field and surgical hand antisepsis was maintained during a surgical procedure for one patient.

In addition, multiple IV (Intravenous) tubing were not dated or timed upon use. A glucometer was not cleaned between patient use.

The findings include:

1. Review of the facility's policy for Operating Room cleaning (# Dec.542.042) with a revision date of 03/2011 revealed the scrub team or environmental service tech were to seal suction equipment/drainage system canisters & tubing and/or contained fluids and dispose in a designated Biohazard waste container after each case.

Observations on 03/30/11 at 9:45 am revealed Operating Room(OR) #5 was staffed and prepared for Patient #31's surgical procedure of a left hip replacement. Patient #31 was on the OR table. The vacuum suction canister (used to suction patient's blood during surgery) was available for use. The suction canister contained a serosanguinous substance identified by the OR manager as blood.

Interview on 03/30/11 at 9:49am with the Director of Surgical Services revealed the serosanguinous substance appeared to be blood from the previous patient. She ststed the suction canister should have been removed by the OR staff prior to the patient being brought into the OR.

2. Review of facility policy for Sterile Field, Establishing & Maintaining (# DIC.542.084) with a revision date of 08/2008 revealed, "All individuals involved in surgical interventions have a responsibility to provide and maintain a safe environment. Adherence to aseptic practices aids in fulfilling this responsibility. Aseptic practices are implemented preoperatively, intraoperatively, and postoperatively to minimize wound contamination." 2. B. Sterile drapes should be handled as little as possible, rapid movement of draping materials creates air currents on which dust, lint, and other particles can migrate. 2. E. The surgical drape that establishes the sterile field should not be moved. Shifting or moving the sterile drape can compromise the sterility of the field. 6. E. revealed unscrubbed persons should face sterile fields on approach, should not walk between two sterile fields, and should be aware of the need for distance from the sterile field. Accidental contamination can be kept to a minimum by keeping sterile areas in view.

Review of the facility policy for Handwashing/Hand Antisepsis (#. IC.001) with a revision date of 12/2010 revealed staff were to decontaminate their hands before having direct contact with patients, prior to donning gloves, after contact with body fluids or excretions, mucous membranes, non-intact skin and wound dressings; after removing gloves; after contact with patient's intact skin; on leaving a patient care area or after handling soiled articles or equipment from a patient care area.

Observations on 03/30/11 at 9:50am revealed the Circulating Nurse was preparing OR #5 for a surgical procedure. The nurse bent down to the floor at the end of the OR table to move the compression stocking motor and adjust the electrical cord on the floor with her ungloved hands. Observation revealed she did not wash or disinfect her hands after handling the equipment on the floor. The nurse then opened a gown and handed it to the scrub tech for the physician without washing or disinfecting her hands. The Circulating Nurse was then observed to plug in a cord to the electrical outlet and then pulled the zipper on the back of the physician's gown down with her bare hands that had not been disinfected. The Circulating Nurse then assisted the surgeon by holding Patient #31's left foot with her ungloved hands that had not been washed or sanitized. The nurse then moved some equipment and unplugged the compression machine. She then used her fingertips to straighten out the sterile drape as it was placed over the patient. She had not washed or sanitized her ungloved hands. The Circulating Nurse turned the OR lights on and picked up the tubing from the floor to attach to the suction machine. At 10:03am the nurse documented on the computer then answered another staff member's cell phone at 10:05am. The nurse then walked passed the sterile instrument table and as she returned to the other side of the room, she swiped the skirt of the sterile drape. The Circulating Nurse then obtained and opened an orthopedic drive with ungloved hands (that had not been washed or sanitized) for the surgeon. The nurse placed plastic waste items and wrappers into the large black trash bag, tied up and removed the full trash bag, and replaced with a new bag. The Circulating Nurse did not wear gloves, wash or disinfect her hands with an alcohol based hand wash during the above observations. The nurse was observed to wash her hands at 10:15am.

Interview on 03/30/11 at 11:58am with the Circulating Nurse revealed staff were to wash their hands when coming in and out of a room, when you remove gloves, before and after touching patients, and when they were soiled. She stated she should have washed her hands and she should have used gloves. She stated the floor was not a sterile area and was considered "dirty". She stated she thought it was okay to hold the patient's foot with ungloved hands, but she should have washed her hands afterwards.

Interview on 03/30/11 at 4:20pm with the Director of Surgical Services revealed the Circulating Nurse should have washed her hands more frequently. She stated she did not see the nurse swipe the sterile drape and had no concerns with the technique displayed by the nurse during the surgical procedure.

3. Review of facility policy for Surgical Attire for operating room and obstetrics (OR & OB) # DPC.542.004 with a revision date of 08/2008, revealed all persons who enter the restricted areas of the surgical suite should wear surgical attire intended for use within the suite. The policy stated a clean uniform must be worn each day and changed when dirty or contaminated by blood or body fluids. All scrub team personnel must wear a sterile gown and the materials should minimize the passage of microorganisms and be resistant to the penetration of blood and other liquids.

Observation on 03/30/11 at 10:20am and 10:40am revealed the Anesthesiologist came into the room to check on the patient and was wearing a fleece jacket over his scrubs.

Interview on 03/30/11 at 11:45am with the Anesthesiologist revealed he kept his jacket in his locker and took it home to be washed about every two weeks. He stated he thought it was no different than staff wearing scrubs from home.


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4. Review of facility policy on general intravascular therapy with a revision date 08/10 revealed IV tubing should be labeled with the date, time, and expiration date. Primary and secondary tubing should be changed every ninety-six (96) hours.

Observation of the facility's fourth (4th) floor medical-surgical patient rooms #407, 418, 419, 424, and 425 on 03/30/11 at 2:30pm revealed patient IV (intravenous) lines which were not dated and timed upon use. In addition, the IV tubing had no date/time the IV line would need to be changed, for infection control purposes.

Observation of the third floor on 03/29/11 at 11:00am revealed several IV tubing that were not dated upon use. Patient #5 's Normal Saline and Arythromycin IV tubing was not dated. Patient #9's Normal Saline and Arythromycin IV tubing was not dated. Patient #11's Levaquin IV tubing was not dated. Patient #38's Normal Saline and Arythromycin IV tubing was not dated.

Interview with the Nursing Manager of the third floor on 03/30/11 at 3:20pm revealed the IV tubing should be dated upon use. She indicated Spot checks were conducted to ensure compliance and quality assurance does a quarterly assessment.

Interview with RN #8 on 03/30/11 at 2:40pm revealed all patient IV lines should have a date and time when they were hung by the nursing staff. Interview with RN #7 on 03/30/11 at 2:45pm revealed she confirmed that all patient IV lines should be dated with a time when the IV was hung by the nursing staff.



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5. Review of facility policy for equipment cleaning (patient care) dated 12/10 revealed each department shall be responsible for cleaning equipment after use in any patient care area and as needed. The procedure states the equipment needed: a) hospital approved germicidal disinfectant cleaner or pre-moistened wipes, b) cleaning cloths, c) gloves. Guidelines: a) remove obvious soiling, b) saturate a cloth with cleaning solution or spray the surface with the germicidal spray, c) wipe down equipment completely with saturated cloth, d) do not rinse, allow to air dry at least five minutes.

Observation on 03/29/11 at 11:55am revealed Registered Nurse (RN) #5 performed a fingerstick for a blood sugar reading for Patient #6 who was admitted on 03/19/11 with a diagnoses of Pneumonia and history of Diabetes. RN #5 removed the glucometer from the carrying case. The RN placed a strip in the glucometer, scanned the patient's identification band, cleansed the finger with alcohol and performed the fingerstick. A drop of blood was placed on the glucometer strip. After obtaining the reading, the strip was discarded and the glucometer was returned to the carrying case. RN #5 walked into the hallway and cleaned the glucometer with an alcohol wipe and returned the glucometer to the carrying case.

Observation on 03/29/11 at 11:20am revealed RN #6 performed a fingerstick on Patient #38, admitted with a history of Diabetes. The RN washed her hands and put on gloves. The glucometer was removed from the carrying case and a strip was inserted. The patient identification band was scanned and the RN proceeded to wipe the the patient's finger with alcohol. A fingerstick was performed and a blood sugar was obtained. The RN discarded the strip after obtaining the reading. The glucometer was placed into the carrying case. RN #6 gave insulin as ordered. The glucometer was returned to the area by the nurses station.

Interview with the Infection Control Nurse on 03/30/11 at 3:00pm revealed the expectation of staff is to clean the glucometer before it is returned to the carrying case. The nurse explained there is no specific policy for cleaning the glucometer but it is expected the staff would follow the equipment cleaning policy. The Infection Control Nurse states alcohol wipes can be used to clean the glucometer but sani wipes are preferred.

Interview with the RN #6 on 03/30/11 at 3:10pm revealed she/he was aware the glucometer should be cleaned before it is returned to the carrying case. The RN stated the carrying case is contaminated if the glucometer had not been sanitized. RN #6 stated alcohol wipes are readily available and sani wipes are in the hallway.






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Review of the Quality Assurance minutes for January and February 2011 revealed infection control goals for 2011 were: improved hand hygiene, environment cleaning (including equipment), and improved surgical site infections.

Interview with the Infection Control Director on 03/31/11 at 1:30pm revealed staff receive training on infection control procedures during orientation, annually, with quarterly updates. Infection control policies and procedures are reviewed annually and as needed. The facility track and trend infections including IV lines (peripheral and central), MRSA rates per unit, C-diff, and others. The facility reports to NHSN (national health surveillance network), CMS (center for medicare and medicaid), and go by CDC (Center for Disease Control) guidelines.