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21298 OLEAN BLVD

PORT CHARLOTTE, FL 33952

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on observation, record review, interview and review of Diprivan (Propofol) protocols, the nursing staff failed to ensure they administered the medication according to hospital standards for use and titration for 1 (Patient #28) of 2 patients reviewed for the use of the medication.

The findings include:

1. Observation during the tour of the fourth floor ICU (Intensive Care Unit) on 7/30/12 at 9:45 a.m. revealed Patient #28 in bed and connected to a ventilator. The patient had bilateral wrist restraints, was receiving mechanical ventilation, and her eyes were closed.

Clinical record review, on 7/30/12, revealed Patient #28 was admitted to the hospital for shortness of breath and respiratory failure.

Review of the physician's orders for 7/27/12 revealed included printed orders for "Use of Diprivan (Propofol) for Mechanically Ventilated Patients."

1. Patient monitoring parameters on the printed form included:

a. Prior to initiation of Diprivan, record baseline data for HR (heart rate), heart rhythm, BP (blood pressure), respiratory rate, skin color, oxygen saturation, patient's mental status, level of consciousness.

b. Assess and document above parameters every 5 minutes for 30 minutes after initiation infusion, then every 15 minutes x 2, then every 30 minutes thereafter, if hemodynamically stable throughout infusion.

c. Assess and document above parameters every 5 minutes for 30 minutes with each increase in infusion rate.

3. Start Diprivan (Propofol 10 mg./ml) initially at 5 mcg/kg/minute for at least 5 minutes as an IV infusion... Increase by a rate of 5-10 mcg/kg/minute every 5-10 minutes until desired sedation level indicated below is achieved. The usual maintenance dose is 5-50mcg/kg/minute.

Record review, in the presence of the ICU Clinical Director (CD), revealed a baseline assessment of the patient, dated 7/27/12 at 0200, as well as a neurological evaluation at 0208.

Record review revealed the next nursing entry of the patient's condition was dated 7/27/12 at 0400, 2 hours later, and included, "...Diprivan up to 50 mcg...."

There was no assessment of the patient according to the Diprivan orders/protocol every 5 minutes for 30 minutes after initiation.

In an interview on 7/28/12 at 9:00 a.m., the CD confirmed he could not locate any assessments according to the written protocol for Diprivan in the clinical record. He stated nursing was doing the checks every 15 minutes; but, not in accordance with Diprivan implementation protocol.

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on record review and staff interview, the facility failed to ensure telephone orders were dated, timed and authenticated promptly by the ordering practitioner in accordance with hospital policy for 10 (Patients #25, #53, #1, #11, #12, #19, #59, #60, #61, #62) of 67 sampled patients.

The findings include:

The "Rules and Regulations of the Medical Staff" state, "208. All clinical entries in the patient's medical record shall be accurately dated, timed and signed. The use of rubber stamps will not be permitted.; 303. B. Verbal and/or telephone orders must be signed by the prescribing physician within forty-eight (48) hours. The following have been deemed high risk orders: TPN, Restraints, and DNR. These high risk orders must be authenticated by the responsible physician within twenty-four (24) hours."

The Hospital policy and procedure for "Verbal/Telephone/Read-back Orders" reads, "IV (Roman numeral 4). Verbal/telephone orders will be signed by the prescribing physician at the time of his/her next visit or any time during hospitalization, but not later than 48 hours after order written. The following orders have been deemed high risk for patients and must be authenticated by the responsible physician within 24 hours: A. DNR; B. Restraint orders; C. TPN."

1. Clinical record review on 7/31/12 for Patient #25 revealed numerous "sticky" arrows attached to the sides of the physician's telephone and verbal orders. The "flagged" arrows revealed unsigned physicians' orders for: Four (4) dated 7/22/12; (2) for 7/23/12; (3) for 7/26/12, and (2) for 7/27/12.

In an interview during the record review, the Clinical Director stated the unit secretary tries to help the physicians know where signatures are needed by placing arrows on the unsigned orders; however, despite this attempt, they remained unsigned.

2. A review of the closed medical record for Patient #53 reveals the patient was admitted on 6/2/12 with acute appendicitis. The patient underwent laproscopic appendectomy. The patient developed post-operative complications which required hospitalization through 6/19/12. A review of the physician's orders reveals telephone orders (TOs) were not authenticated properly.

On 6/5/12, a phoned order, to "Insert PICC," from Dr. P., was never authenticated.
On 6/5/12, a phoned order, to ambulate the patient, from Dr. O.G., was never authenticated.
On 6/5/12, a phoned medication order from Dr. P. was signed, but not timed and dated.
On 6/7/12, a phoned medication order from Dr. K. was never authenticated.
On 6/7/12, a phoned order, to Increase IPAP, from Dr. K., was authenticated on 6/24/12.
On 6/10/12, Dr. G. phoned an order for Morphine; authenticated on 6/25/12.
On 6/11/12, Dr. K. phoned a diet order; authenticated on 6/24/12.
On 6/11/12, Dr. P. phoned a medication order; authenticated on 7/19/12.
On 6/12/12, Dr. P. phoned a medication order; authenticated on 7/19/12.
On 6/12/12, Dr G. phoned a medication order; authenticated on 6/25/12.
On 6/12/12, an x-ray order and STAT Lab order , phoned by Dr. P., were never authenticated.
On 6/14/12, Dr G. phoned a medication order; authenticated on 6/25/12.
On 6/14/12, a medication order, phoned by Dr G., was never authenticated.
On 6/16/12, Dr. B. phoned a TPN order; authenticated on 7/5/12.

In an interview on 8/2/12 at 10:00 a.m., the medical records manager stated when handwritten records are scanned into the hospital HIS (health information system), they are available immediately for the physician to review. The physician reviews were done more that 48 hours after telephone orders were given. The chief nursing officer stated the physicians are to sign all telephone orders indicating date and time. She stated the staff on the floor are to assist in getting the physicians to sign telephone orders.

3. On 7/30/12 and 7/31/12 during review of open and closed clinical records with the third floor nursing and medical records staff, the following information was found:
Sampled clinical records for Patients #1, #11, #12, #19, #59, #60, #61 and #62 contained telephone, verbal and written physician orders that were not dated, timed and signed by the ordering physicians.

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

18128


Based on observation, interview, and record review, the facility failed to document properly executed informed consent forms for 18 (Patients #1, #2, #3, #4, #9, #11, #17, #21,#23, #27, #43, #44, #46, #47, #60, #61, #62, and #63) of 67 patients sampled.

The findings include:

1. On 7/30/12, review of medical records revealed Patient #9 was admitted 7/23/12 with swelling of the left leg. Review of the patient's medical record revealed four (4) improperly executed consent documents.
- An "Informed Consent Moderate Sedation" form contained a patient signature, and a staff RN witness signature, but lacked the time and date of signatures, and a doctor's name.
- An "Informed Consent Moderate Sedation" form, signed by the physician on 7/26/12, contained the patient representative and staff witness signatures, without time or date of the signatures.
- A "Consent & Disclosure for Medical/Surgical Procedures" form for an internal jugular triple lumen catheter lacked notation for observation consent. This form had names on the signature line for the patient and patient representative with signatures and staff witness, dated 7/25/12. The physician signature was in place without time or date. The patient signature on this form did not match the patient signature on the other forms in the record. The patient representative signature did not match the signature of the patient's spouse found on other forms in the medical record.
- A "Consent & Disclosure for Medical/Surgical Procedures" form for an internal jugular triple lumen catheter lacked the layman's term of the procedure, the doctor's name, the notation for consent for blood administration, and the physician's signature. The patient and staff witness signatures were dated 7/30/12.

On 7/30/12 at 10:30 a.m., Patient #9 was observed with a triple lumen catheter in her right neck. The dressing over the catheter was dated 7/27/12.

In an interview on 7/31/12 at 2:28 p.m., Patient #9's spouse verified his signature on "Informed Consent Moderate Sedation." He said did not see his signature on the "Consent & Disclosure for Medical/Surgical Procedures" for an internal jugular triple lumen catheter.

2. On 7/30/12, medical records review revealed Patient #23 was admitted 7/27/12 with acute hypoxemia/respiratory distress. Review of the patient's medical record revealed the "Conditions of Admission" form with a signature of patient/authorized representative dated 7/29/12. Under it, "If you are not the patient, please identify your relationship to the patient." There was no notation, suggesting the patient signed the consent. The form contained the signature of a staff witness. The form notes additional witness signature is "required for patients unable to sign..." This line is blank.

On 7/30/12 at 10:50 a.m., Patient #23 was observed in bed with a ventilation mask on with family at bedside. The patient appeared non-responsive.

In an interview on 7/31/12 at 10:42 a.m., the Director of Cardiac Services said the signature on the Conditions of Admission was not Patient #23's, rather it was the patient's sister. He admitted, "We should have circled that (pointing to the word sibling)."

3. Clinical record review on 8/1/12 revealed Patient #43 was admitted to the hospital for a cardiac catheterization. Review of the "Consent for Blood Plasma and/or Blood Derivatives Transfusion" form failed to include the name of the physician, or associate, who would inform the patient of blood transfusion therapy.

4. Clinical record review on 8/1/12 revealed Patient #44 was admitted to the hospital due to an abnormal stress test and was scheduled for a heart catheterization. Review of the "Consent & Disclosure for Medical/Surgical Procedures" form failed to reveal the date and time the physician explained the nature of the treatment to the patient.

5. Clinical record review on 8/1/12 revealed Patient #46 was admitted emergently to the hospital for a cardiac catheterization. While in the hospital, the record reflects the patient was scheduled for a thorancentesis and a gastrostomy tube placement.

Review of the "Consent & Disclosure for Medical/Surgical Procedures" form for the thorancentesis revealed a nurse witnessing the telephone consent of the patient's son for the procedure; however, the consent failed to include the name of the doctor performing the test, whether the patient consented to blood administration or whether students or other observers could be in the room during the procedure. The physician also failed to sign this consent form.

6. Clinical record review on 8/1/12 revealed Patient #47 was admitted to the hospital with increasing altered mental status.

Review of the "Consent & Disclosure for Medical/Surgical Procedures" form included the placement of a temporary pacer. The consent failed to reveal whether or not the patient consented to blood administration, or whether students or other observers, could be present during the procedure.

7. Clinical record review on 7/31/12 revealed Patient #27 was admitted to the hospital for right pupil dilatation. The record revealed the patient as alert and oriented and had not been deemed incapacitated to make her own health care decisions.

Review of the "Consent & Disclosure for Medical/Surgical Procedures" form lists the patient's son as Power of Attorney for 7/24/12, and revealed telephone consent for the procedure was provided by the patient's son. The consent failed to reveal authorization for blood administration or whether observers could be in the room during the procedure.

During an interview on 7/31/12 at 3:40 p.m., the clinical director stated nursing obtained consent from the patient's son because the patient had some confusion; however, could not define the severity of the confusion. The clinical director stated he called the patient's family, who brought in advanced directives.

Review of the patient's "Living Will" and "Designation of Healthcare Surrogate," dated 11/13/11, revealed her "Living Will" was to be honored - and and health care decisions made - by the patient's son only in the event Patient #27 was determined to be incapacitated by her attending/treating physician and another consulting physician.

The hospital failed to honor the patient's advanced directives by ensuring a properly executed consent was obtained.

8. During review of open and closed clinical records with the 3rd floor nursing staff and medical records staff on 7/30/12 through 7/31/12, the following information was found:
Sampled clinical records for Patients #1, #2, #3, #4, #11, #17, #21, #60, #61, #62, and #63 each lacked some of the required information on the facility's consent forms. Omissions included: layman's term of the procedure, authorization or refusal of blood administration, physician's signature, physician's name, name of family member signing for the patient, anesthesia service name, and consent or denial for observation of the procedure.


26933

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation and interview, the facility failed to ensure the facility's clean linen supply is stored in a safe and sanitary environment.

The findings include:

On 8/1/12 at 3:48 p.m. during an afternoon tour of the facility with the Environmental Services Director (EVSD), the clean linen storage room was inspected. In the clean linen room there was a red bicycle parked in front of a door with a sign marked "Do Not Block Door." One of the electrical outlet covers was broken, with a piece missing, leaving some of the electrical connections visible. Thirteen (13) holes in wallboard near floor were identified.

In an interview on 8/1/12 at 3:49 p.m., after viewing the broken electrical outlet and holes in the walls, the EVSD stated, "I'll get a work order."

For safety reasons, electrical connections should not be exposed. Holes in the walls could provide opportunity for insects and vermin to enter, which would contaminate the clean linen supply.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, interview, and policy and document review, the facility failed to ensure the development and effective implementation of an infection control program in regards to sterile central venous catheter care, handwashing, and equipment disinfection involving 7 (Patients #13, #26, #27, #64, #65, #66, #67) of 67 patients sampled.

The findings include:

1. Observation of the dialysis unit on 7/30/12 at 11:23 a.m. revealed Nurse "K" preparing to change the dressing to the right jugular Tesio catheter for Patient #26. A Tesio catheter is a central venous access device used for patients receiving hemodialysis.

Observation revealed Nurse "K" donned a protective gown and placed a face mask on the patient and herself. She donned a pair of gloves and opened the catheter package in such a way as to create a sterile field on top of the patient's chest. She tossed her gloves on top of the foot of the patient's bed and put on another pair of sterile gloves. After this, she removed the dressing from the right jugular area and tossed it onto the sterile field. With the same gloved hands, she cleaned the area site and reapplied a clean dressing to the right jugular access site.

Nurse "K" gathered the dirty supplies from the top of the patient, pulled her mask down under her chin and removed the patient's mask. Still wearing the same gloves, she laid the dirty supplies on top of the foot of the bed, removed wires from the patient's chest, removed a blood pressure cuff from the patient's arm, fastened the patient's gown and then gathered the dirty supplies and tossed them into the trash can.

Still using the same gloved hands, she gathered linen and papers off of the patient's bed, pressed control buttons at the foot of the patient's bed and laid the linen back on top of the bed. She then removed her gown, gloves and mask and tossed them into the biohazard container.

In an interview on 8/2/12 at 2:20 p.m., the Chief Nursing Officer (CNO) revealed the hospital follows the "on-line" Lippincott Nursing Policy and Procedures for Dressing Changes. She confirmed the nurse failed to use proper infection control techniques while conducting the dressing change.

The 2012 Lippincott Williams & Wilkins Nursing Policy and Procedures for "Central venous device dressing changes" includes the following guidelines,
-Preparation of Equipment: "...Open a waterproof trash bag, and place it near the patient's bed. Position the bag to avoid reaching across the sterile field when disposing of soiled articles...." The nurse failed to ensure she had a trash bag properly positioned in which to place the soiled dressing.
-Implementation: "...Remove the old dressing by lifting the edge of the dressing at the catheter hub and gently pulling the dressing perpendicular to the skin, toward the insertion site, to prevent catheter dislodgement. Discard it in the waterproof trash bag." The nurse tossed the dirty dressing on top of the patient's chest near the clean supply area. "...Remove and discard your gloves, perform hand hygiene, and put on sterile gloves." The nurse failed to remove the gloves she used to remove the soiled dressing. "...Clean the catheter insertion site...allow the site to dry...Dispose of all used supplies, remove and discard your gloves, and perform hand hygiene..." The nurse used the same gloved hands to change the soiled dressing, to reapply a sterile dressing and to handle patient supplies and equipment.

Failure to change gloves after removing a contaminated dressing, and handling patient equipment and supplies increases the risk of cross contamination of potentially harmful micro-organisms.

2. Observation on the dialysis unit, on 7/30/12 at 11:45 a.m., revealed Nurse "N" preparing to check the blood glucose level on a patient receiving dialysis. After obtaining blood from the tubing, the nurse inserted the test strip inside the glucometer. After results were obtained, Nurse "N" removed disinfecting wipes from a PDI Super Sani-Cloth container, wiped the outside of the glucometer and immediately placed the glucometer into the holding device.

Review of the manufacturer's specifications for using the disinfecting wipes revealed: "To Disinfect and Deodorize...Unfold a clean wipe and thoroughly wet surface. Treated surface must remain visibly wet for a full two (2) minutes. Use additional wipe(s) if needed to assure continuous two (2) minute wet contact time. Let air dry..."

The nurse failed to assure there was a 2-minute wet contact time of the disinfectant on the glucometer before placing it back into the holding device.

An interview was conducted with the Infection Control Nurse (ICN) in the presence of the CNO, on 7/31/12 at 1:23 p.m. The ICN stated, "You can't possibly expect them to keep rubbing the glucometer for 2 minutes to make sure it's wet..." The ICN was informed of the manufacturer's specifications for properly disinfecting the glucometer. The CNO indicated she would look into the matter.

3. On 7/30/12 at 9:45 a.m., observation during the tour of the ICU (Intensive Care Unit), fourth floor, revealed signage posted in front of Room #459 which stated the patient was on "contact precautions." The nurse accompanying the tour indicated the patient was on contact precautions for respiratory MRSA (Methicillin Resistant Staph Aureus), and the use of gown and gloves was indicated while in the patient's room.

During this observation, a physician removed his gown and gloves, discarded them into a trash receptacle inside the patient's room, and exited the room without washing his hands. The nurse accompanying this tour walked up this physician and encouraged him to wash his hands. The physician walked back into the patient's room, turned on the spigot, washed his hands, less than 10 seconds, turned the spigot off with his wet hands, dried his hands with a paper towel and exited the patient's room.

Observation during the tour of the ICU on the third floor, on 7/30/12 at 10:32 a.m., revealed signage posted in front of Room #354 indicating the patient was on "contact precautions." A respiratory therapist was observed removing gown and gloves and placing them in a trash receptacle inside the patient's room. The therapist walked out of the patient's room, pulled back the sliding glass door and then sanitized her hands.

Observation during the tour of the ICU on the third floor, on 7/30/12 at 10:35 a.m., revealed a CNA (Certified Nursing Assistant) wearing gloves. She walked out of Room #353 and tossed dirty linens into the linen container and, while wearing the same gloves, walked across the hall and over to the supply area. Still wearing the same gloves, she transported oxygen back into the patient's room.

Observation during the tour of the ICU on the 3rd floor, on 7/30/12 at 10:40 a.m., revealed a nurse exit Room #359. A sign revealing the patient was on "contact precautions" was posted on the outside of the room. The nurse exited the room and then quickly used hand sanitizer. After this, he walked across the corridor and over to a sink. After washing his hands, less than 10 seconds, the nurse turned off the spigot with his wet hands and then dried his hands with a paper towel.

Review of the hospital policy and procedures for hand hygiene includes the following statement, "Hand washing is the single most important method to reduce the spread of infectious agents from one person to another. It is the accepted concept, as noted by the American Hospital Association, that 'decontamination of the hands is absolutely essential for prevention and control of health care associated infections, there is no substitute for it.'"

The policy continued:
II. Indications for hand washing: "...before and after delivering direct patient contact...after contact with any blood, body fluids, secretions, excretions, mucous membranes, or non-intact skin to include wounds...BEFORE AND AFTER THE REMOVAL OF GLOVES...before and after patient contact."
VI. Hand washing Procedure: "...apply selected hand washing agent and distribute thoroughly over hands...vigorously rub hands together for 10-15 seconds creating friction on all surfaces of the hands and fingers. Paying particular attention to the thumb, backs of fingers, backs of the hands, and under fingernails...dry hands with paper towels, turning faucets without food pedals or with the paper towel to prevent recontamination of the hands..."

Facility staff failed repeatedly to wash their hands using proper hand hygiene techniques. The failure of the nursing staff to use proper hand washing techniques increases the risk of cross contamination of potentially harmful microorganisms to patients and/or visitors.

4. On 7/30/12, review medical records revealed Patient #9 was admitted 7/23/12 with swelling of the left leg.

On 7/30/12 at 10:30 a.m., Patient #9 was observed with a triple lumen catheter in her right neck. The dressing over the catheter was dated 7/27/12.

On 7/31/12 at 3:57 p.m., the surveyor observed Nurse "A" perform a sterile dressing change on the catheter in the right side of the patient's neck. The nurse sanitized her hands and donned clean gloves. She took off her left glove and untangled oxygen line, then reapplied the glove. She donned mask. The patient was not masked. The nurse set up sterile supplies on the bed beside the patient. The nurse then removed old dressing with some difficulty, as there was additional tape over the old dressing. She disposed of the old dressing. She sanitized her hands and donned sterile gloves. She then removed stat-lock (a clip holding the catheter in place). Without sanitizing her hands, the nurse re-gloved with new sterile gloves. She draped the patient with a sterile drape. She cleaned the site with chlorhexidine swabs and swabbed with skin prep while holding the catheter "pig tails" with her left hand. Using both hands, the nurse applied a new stat-lock and antimicrobial patch over the site. She applied an occlusive dressing, changed the caps on the "pig tails," sanitized and flushed the lines.

In interview on 7/31/12 at 4:26 p.m., Nurse "A" was unaware she had held the non-sterile lines then handled the sterile stat-lock and patch. She admitted she failed to sanitize her hands between the sterile glove changes. The surveyor explained that glove changes cannot substitute for hand sanitation.

5. On 7/31/12 at 4:27 p.m., the surveyor observed CNA "S" perform accucheck (a test for blood sugar level) on Patient #9. After the test, she gave glucometer to CNA "C," who passed it to CNA "M". CNA "M" placed glucometer into the charger in the clean utility room. The glucometer was not sanitized after use on Patient #9.

In an interview on 7/31/12 at about 4:30 p.m., CNA "M" said they clean the glucometer after every patient. They "wipe it with the purple-top (Super Sani-Cloth). It dries in a few seconds." CNA "M" was not aware of the 2-minute wet contact time requirement to disinfect the equipment.

6. At various times on 8/1/12, CNA "J" was observed performing accuchecks revealing:
Patient #67 - 10:56 a.m. Wiped glucometer for about 1 minute with Super Sani-Cloth and returned it to the carrying case.
Patient #66 - 11:00 a.m. Wiped glucometer with Super Sani-Cloth for 45 seconds and returned it to carrying case.
Patient #64 -11:02 a.m. Wiped glucometer with Super Sani-Cloth for 25 seconds and returned to carrying case.
Patient #13 - 11:07 a.m. Wiped glucometer with Super Sani-Cloth for 35 seconds.
Patient #65 - 11:01 a.m. Wiped the glucometer with Super Sani-Cloth for 25 seconds.
Patient #27 - 11:19 a.m. Wiped the glucometer with Super Sani-Cloth for 30 seconds.

In an interview on 8/1/12 at 11:29 a.m., CNA "J" stated was not aware of the 2-minute wet contact time requirement to disinfect the equipment.


26933