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Based on observation, interview, and record review, the hospital failed to provide an environment to avoid sources and transmission of infectious disease as evidenced by the hospital's failure to have effective systems in place to ensure:

1. Surgical instruments were sterilized in accordance with nationally accepted infection control standards when hinged instruments were not sterilized in the open position. (Refer to A749)

2. Expired supplies were removed from patient care areas when multiple expired supplies were found in the surgical area. (Refer to A749)

3. Policy and procedures were followed for isolation when one out of 18 sampled patients (2) was not placed in contact isolation after a positive MRSA (Methicillin-resistant Staphylococcus aureus-a bacterium responsible for several difficult-to-treat infections in humans) laboratory report. (Refer to A749)

4. The hospital failed to ensure housekeeping staff used a high level disinfectant in accordance with manufacturer's recommendations when housekeeping staff was observed not allowing a 10 minute wet dwell time after wiping down operating room equipment. (Refer to A749)

5. The hospital failed to ensure operating room doors were closed while setting up sterile instruments and supplies when during an observation, the operating room double doors were open during the removal of sterile instruments and gauze. (Refer to A749)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the statutorily-mandated Condition for Coverage for Infection Control Services.

Based on observation, interview, and record review, it was determined the hospital did not meet the Conditions of Participation (COP) for Surgical Services by failing to:

1. Ensure policy and procedures specified the sterilization of hinged surgical instruments must be in open position for surgical staff who were responsible for sterilization of instruments. (Refer to A951)

2. Ensure policy and procedures were in place for removing expired supplies from the surgical area. (Refer to A951)

3. Ensure policy and procedures were in place for the use of oxygen and cautery devices in the operating room. (Refer to A951)

4. Ensure policy and procedures were in place for the use of a disinfectant in the operating room. (Refer to A951)

5. Ensure policy and procedures were in place for closing the operating room doors to protect the internal environment. (Refer to A951)

6. The hospital failed to perform pre-procedure verification process on two sampled patients (4 and 8) resulting in a potential for procedure and/or surgery performed on the wrong body part. (Refer to A951)

The cumulative effect of these systemic practices resulted in the failure of the hospital to ensure the provision of quality surgical care in a safe environment.

Based on interviews and record reviews, the hospital failed to assure medical staff operated under current bylaws, rules and policies, when the proctoring of medical staff who were initially granted privileges, was not done as outlined in Rule 8 of the Medical Staff Rules.

Findings:

On 4/10/12 at 4:30 PM, Staff 1 was asked to describe the proctoring process. She said the new physician would be assigned a proctor in the same specialty. They had six months to finish the process, and then the reports were reviewed by the Chief, (it was not clarified whether this was Chief of Staff). He/she would decide whether to release or continue the monitoring. Then the process would go on to the Credentialing Committee, the Medical Executive Committee, then to the Board.

On 4/11/12 at 11 AM, proctoring reports were reviewed for five surgeons. The following data was obtained from these reports, (note: "Retrospective" reviews consisted of the proctor performing chart reviews of past surgery cases, which the person being monitored performed):

Dr. A:
Report 1: Retrospective. Patient admitted and discharged 11/08/11. Review 3/26/12. (4+ months later).
Report 2: Retrospective. Patient admitted and discharged 12/04/11. Review 3/26/12. (3+ months later).
Report 3: Retrospective. Patient admitted 1/6/12, discharged 1/8/12. Review 3/26/12. (2+ months later).

Dr. B:
Report 1: Unmarked type of monitor. Patient admitted 10/19/11. No discharge date. Review 10/19/11.
Report 2: Retrospective. No admission date and no discharge date. Review 10/19/11.
Report 3: Retrospective. No admission date and no discharge date. Review 3/16/12.

Dr. C:
Report 1: Retrospective proctoring. Patient admitted and discharged 12/21/10. Review dated 1/3/11.
Report 2: Retrospective proctoring. Patient admitted 9/15/10. No discharge date. Review 10/22/10.
Report 3: Retrospective proctoring. No admission date and no discharge date. Review dated 10/21/10.

Dr. D:
Report 1: A generalized summary from 5/2007 to 8/2007. No specific patients monitored included.
Report 2: Retrospective proctoring. No admission date and no discharge date. Review 8/26/03.
Report 3: Retrospective proctoring. No admission date and no discharge date. Review 8/26/03.
Report 4: Retrospective proctoring. No admission date and no discharge date. Review 8/26/03.

Dr. E:
Report 1: Proctored by observation. Patient admitted 4/4/12. No discharge date. Review dated 4/4/12.
Report 2: Proctored by observation. Patient admitted 4/4/12. No discharge date. Review dated 4/4/12.
Report 3: Proctored by observation. Patient admitted 4/4/12. Surgery cancelled due to heart issue.

On 4/11/12 at 1:15 PM, the proctoring reports were reviewed with Staff 1. When asked about the retrospective proctoring being done on invasive procedures, she concurred the proctoring should have been direct observation.

On 4/12/12 at 8:30 AM, an interview with Dr. F was conducted. When asked about the Medical Staff Rules regarding proctoring by direct observation of invasive procedures, he agreed. The copies of Proctoring Forms were reviewed, and many retrospective reviews were noted. He said they take into consideration the volume of previous surgeries the surgeons may have performed elsewhere, specifically at a local hospital. There was no mechanism in place for using the monitoring from another hospital.

Of the 16 reports reviewed, 11 were "retrospective" reviews, three were direct observations, and two were not clearly defined.

Review of the Medical Staff Rules, Rule 8.1.1, Proctoring, indicated that, "...all Medical Staff members initially granted Privileges shall be proctored."

Review of the Medical Staff Rules, Rule 8.3.2, indicated, "Invasive medical procedures will be proctored by observation..."

Review of the Medical Staff Rules, Rule 8.3.4, indicated, "Proctoring reports shall be completed fully and in a timely manner after the patient's discharge."

Review of the Medical Staff Rules, Rule 8.5, Proctoring Duration, indicated, "Each Practitioner granted Privileges must be proctored on at least 3 cases..."

Based on interview and record review, the hospital failed to ensure a registered nurse (RN) verified one of 18 sampled patients' (4) electrocardiography (ECG, heart rhythm waveform) strip mounted by a monitor technician (MT) 1 on the report sheet was accurate and reflective of Patient 4's condition. This failure resulted in an ECG recorded strip showing a flatline waveform (no electrical activity in the heart) in Patient 4's clinical record. No RN documentation was found to invalidate the flatline rhythm.

Findings:

The clinical record for Patient 4 was reviewed on 4/9/12. One of the ECG strips (five strips per sheet) dated 4/7/12, at 8:27 AM, indicated a flatline (meaning no heart beats). No documentation was found a registered nurse had assessed Patient 4's condition to correlate and/or to invalidate the flatline.

During a concurrent interview and record review with MT 1 on 4/9/12 , at 12:35 PM, she stated one of her responsibilities was to mount the recorded EKG strips to a sheet of paper for each patient who was on cardiac monitoring in the hospital. After mounting the EKG strips, she would perform required measurements and document on the paper. A RN on the unit who was taking care of the patient would interpret the rhythm and document accordingly. MT 1 reviewed Patient 4's EKG strip and stated after mounting the strip, she stated she did not perform required measurements and the unit RN who was taking care of the patient did not interpret the rhythm either. The RN did not verify the strip.

During an interview with the Director of Intensive Care Unit (ICU) on 4/10/12, at 9:35 AM, she stated the ECG patches were probably removed from Patient 4 during nursing care which resulted in the flatline of his cardiac rhythm. She stated she would address this issue with her staff. When asked if the monitor technicians were required to perform measurements of the cardiac rhythm, a necessary process for the ECG interpretation, she stated this was not a practice in their unit.

Practice Standards for Electrocardiographic Monitoring in Hospital Settings, American Heart Association Journals, Circulation, 2004 read in part, "...Documentation: When mounting rhythm strips in the medical record, the staff member doing so should place significant changes (eg, onset/offset of a tachycardia [fast heart rate]) in the center of the page, with adequate time preserved before and after the event to allow a clear understanding of the mechanism. Quality Improvement: Medical and nursing professionals in positions of unit and hospital leadership are responsible for the maintenance and improvement of quality in cardiac monitoring. Quality assurance is accomplished, in part, by establishing protocols that govern the roles and responsibilities of all levels of staff regarding cardiac monitoring, documentation of ECG changes, periodic documentation that alarms are set appropriately, and response to emergency and nonemergency cardiac events."

Based on interview and record review, the hospital failed to ensure the exact concentration of two sedatives, Fentanyl and Propofol (medications used to induce sedation and relaxation but could slow down breathing), were documented on one of 18 sampled patients' (4) Medication Administration Record (MAR). This failure had the potential to cause Patient 4 to overdose on the medications. Overdose of these two sedatives may slow down patients' breathing and possibly death.

Findings:

The MAR for Patient 4 was reviewed on 4/9/12. The following issues were identified:

1. On 4/1/12, the MAR indicated Fentanyl intravenous solution was documented as hung at 9:50 PM. The documentation did not contain the exact strength or concentration of the solution. In addition, the documentation on the MAR did not include the physician's prescribed dosage.

2. On both 4/2/12 and 4/3/12, on the MAR, it was documented to administer Fentanyl intravenous solution at 25-125 mcg/H (microgram per hour). No documentation was found on the exact strength or concentration of the solution. A second medication documented on the MAR read, "IV Propofol... titrate for sedation." New vials were hung at 11:15 PM and at 4:35 AM. No documentation of the exact strength or concentration was found.

3. On both 4/5/12 and 4/6/12, the MAR read, "Fentanyl... titrate to pain relief" and "Propofol...titrate to sedation." The orders did not include the exact strength or concentration.

During a concurrent interview and review of the MAR with the Director of ICU on 4/10/12, at 10 AM, she was unable to find documentation of the strength or concentration of these intravenous solutions. She stated dosage and concentration should be documented.

Based on interview and record review, the hospital failed to ensure consents for procedures and/or surgeries were properly executed on three of 18 sampled patients (4, 6, and 8) which had the potential to perform surgery on a wrong body part.

Findings:

1. Patient 4 had a physician's written order on 4/9/2012 read: "Consent pt (patient) for: right jugular (a large vein on right side of neck) permanent dialysis (people usually receive dialysis when they have damaged kidneys) cath (catheter) placement poss (possible) left. Removal [sic] right fem (femoral) cath (catheter)." However, there were two consents executed for this procedure. The first consent under the procedure read "PermCath (Permanent Catheter) Placement." The consent was signed by a person other than the patient without an indication of the signer's relationship to the patient. The consent did not specify where and what the catheter was for. A second consent read "RIGHT OR LEFT DYLASIS [sic] CATHITOR [sic]" "REMOVAL OF RIGHT GROIN CATHITOR [sic]." It was signed by Patient 4.

During an interview with the Director of Intensive Care Unit (Registered Nurse [RN] X), on 4/10/2012, at 10 AM, she stated Patient 4's consents were erroneous. No further explanation was provided.

2. Patient 6, a minor, underwent an abdominal surgery, had a consent signed by a person whose relationship to the patient was not identified on the consent form.

3. Patient 8 had a consent for surgery on one of his eyes. The signed consent did not indicate which eye the surgeon was to perform the surgery.

The hospital's policy on "Physicians' Order Process for Same Day Surgery" effective 3/31/11 was reviewed on 4/9/12. Under "PROCEDURE 3a," it read, "The EXACT surgical procedure, that is to be performed, shall be written legibly on the Physicians Order Form. The surgical consent will be typed in the ...based on what is written on the order form."

Based on observation, interview, and record review, the hospital failed to develop effective systems for identifying, reporting, investigating, and controlling infectious diseases of patients and personnel in accordance with hospital policy and nationally recognized infection control guidelines as evidenced by:

1. The hospital did not sterilize hinged surgical instruments in the open positions and failed to have oversight by the Infection Control Nurse (ICN).

2. The hospital did not ensure expired supplies were removed from the surgical area.

3. The hospital failed to follow policy and procedures for isolation when one of 18 sampled patients (2) with MRSA (Methicillin-resistant Staphylococcus aureus-a bacterium responsible for several difficult-to-treat infections in humans) pneumonia was not placed in contact isolation.

4. The hospital failed to ensure housekeeping staff used a high level disinfectant in accordance with manufacturer's recommendations.

5. The hospital failed to ensure operating room doors were closed while setting up sterile instruments and supplies.

These failures had the potential to spread infection to the hospital's patient population, visitors, and staff resulting in adverse patient outcomes.

Findings:

1. During the initial tour of the perioperative area with the Operating Room Manager (ORM) on 4/9/12, at 1 PM, multiple pairs of hinged instruments (i.e. scissors and clamps) were in the closed position in sealed peel pouches (peel pouches are flexible packaging materials that combine a paper or synthetic barrier material and a transparent plastic film. They are used primarily when visibility of the instrument is critical for its effective use). Twenty peel pouches were inspected with the ORM. He confirmed the instruments viewed were in the closed position. He agreed all the hinged instruments in the perioperative area were probably in the closed position. He stated he was unaware the instruments should be in the open position during the sterilization process so all surfaces could be sterilized. The ORM stated the used surgical instruments were cleaned and then packaged for sterilization by the operating room technicians. After which, the surgical instruments were sent to the central processing area for sterilization before returning to the perioperative area.

During an interview with the ICN on 4/12/12, at 10:50 AM, he stated he had not checked the surgical instruments during his infection control rounds to verify the instruments were in the open position. He stated the hospital follows both the CDC (Center of Disease Control) and AORN (Association of PeriOperative Registered Nurses) guidelines for infection control.

The hospital's policy and procedure titled "High Level Disinfection, Sterilization, and Storage of Sterile Supplies" dated 2/23/12, read: "RN (registered nurse) Infection Preventionist: a. Reviews all infection prevention and control practices and processes in central processing. d. Makes periodic rounds and biannual high-risk area assessments to determine adherence to guidelines."

The 2012 Perioperative Standards and Recommended Practices published by the AORN were reviewed. Direction given read, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces...and instruments with hinges should be opened..."

2. During an inspection of the perioperative area with the ORM on 4/10/12 at 3:20 PM, the following items were found to have expired and were verified by the ORM:

Four Chlorapreps (a chemical used to clean the skin before an invasive procedure) with an expiration dated of 2/2011. Fifteen laboratory tubes with dates of 2/2012 (6), 1/2012 (6), and 12/2011 (3). A disposable anesthesia breathing circuit (the tubing used to connect the patient's airway to the breathing machine) with an expiration date of 10/2009. One Montgomery strap (a dressing used to hold together surgically separated skin) with an expiration date of 1/2003.

At this time, the ORM stated all expired items should be removed from patient care areas.

3. The clinical record for Patient 2 was reviewed on 4/912, at 3:25 PM. The physician progress record dated 4/8/12 at 10 AM, read, "RLL (right lower lobe) pneumonia-MRSA."

During an observation of the patient care area on 4/9/12, at 4:15 PM, a sign was posted on the door of Patient 2's room and read "droplet precautions-wear a mask (droplet precautions are designed to reduce the risk of transmission of infectious agents from a person while coughing, sneezing, or talking)."

During an observation of the patient care area with Registered Nurse (RN) 1 on 4/10/12, at 9:40 AM, Certified Nursing Assistant (CNA) B was observed entering Patient 1's room with a mask on her face and gloves on both hands. RN 1 verified the only sign on the door was for droplet precautions and she verified CNA B entered Patient 1's room without wearing a protective gown.

During an interview with the Nurse Manager on 4/10/12, at 2 PM, she verified Patient 1 had been placed in droplet isolation and should have also been in contact isolation (used to reduce the risk of transmission of a microorganism by direct or indirect contact by wearing protective equipment such as gowns, gloves, and masks).

During an interview with the ICN on 4/12/12, at 10:50 AM, he stated he was unaware Patient 1 was not in contact isolation as well as droplet isolation. He verified Patient 1 should have been placed in both isolations.

The hospital policy and procedure titled "Isolation Precautions for Infection Control" dated 1/26/12, read "MRSA: If an active infection is present, contact precautions are instituted. Droplet precautions (in addition to Contact Precautions) should also be in effect in the event a patient is coughing, sneezing and/or has MRSA pneumonia."

4. During an observation of the perioperative area on 4/12/12, at 11:50 AM, the Housekeeper was cleaning Operating Room 1. She was observed cleaning a table, two electrical cords, and a wall with the same cloth. None of the items remained wet after she had wiped them. She stated the cloths were wet with a disinfectant cleaner. When she was asked about how long the above items should remain wet after they were cleaned, she stated the items were left for air dry and would usually dry within 10 minutes.

The label for the disinfectant cleaner was reviewed on 4/12/12, at 12 PM. The label read, "To disinfect hard, non-porous surfaces, treated surfaces must remain wet for 10 minutes."

During an interview with the Company Representative on 4/12/12, at 1:30 PM, he stated the hard surfaces in the operating room must remain wet with the disinfectant cleaner for 10 minutes to properly disinfect the hard surfaces.

5. During an observation of perioperative area on 4/12/12, at 12:15 PM, the double doors to Operating Room 2 were open. Inside, the staff was preparing for the next operation by opening sterile packages onto the operating room table. At this time, the ORM stated the doors should be kept closed while the staff was preparing the the next operation.

The 2012 Perioperative Standards and Recommended Practices published by the AORN were reviewed. The "Recommended Practices for Traffic Patterns in the Perioperative Practice Setting" under Recommendation III (2) read "Doors to the operating or procedure rooms should be closed except during movement of patients, personnel, supplies, and equipment. The air pressure within each operating or procedure room should be greater than in the semi-restricted area. The air in the OR (operation room) should be maintained under positive pressure with a minimum of 15 total room air exchanges per hour. When the doors are left open, the heating, ventilation, and air conditioning system is unable to maintain these critical environmental parameters. Leaving the door open can disrupt pressurization and cause turbulent airflow that could increase airborne contamination. Traffic in and out of the OR should be minimized by preplanning so that turbulence from this activity is minimized during the procedure or when sterile supplies are opened."

Based on observation, interview, and record review, the hospital failed to ensure policy and procedures on surgical services were developed and implemented as evidenced by:

1. The hospital did not sterilize hinged surgical instruments in an open position as per the recommendation of the Association of PeriOperative Registered Nurses (AORN) which had the potential to spread infection to surgical patients.

2. The hospital did not ensure expired supplies were removed from the surgical area which had the potential for the spread of infection.

3. The hospital failed to discontinue the use of oxygen during the operation of a battery operated cautery device (a medical device that cuts and seals, or cauterizes, tissues and blood vessels by way of a direct electrical current) which resulted in injury to one of 18 sampled patients (1).

4. The hospital failed to ensure housekeeping staff used a high level disinfectant in accordance with manufacturer's recommendations which had the potential for the spread of infection.

5. The hospital failed to ensure operating room doors were closed while setting up sterile instruments and supplies which had the potential for instruments and supplies to lose sterility and cause infection.

6. The hospital staff failed to implement its policy and procedures in "Pre-procedure verification process" on two of 18 sampled patients (4 and 8) which had the potential for surgical procedures performed on wrong-site of body.

These failures had resulted in an injury to a patient and had the potential to cause unexpected adverse surgical outcomes to its patients.

Findings:

1. During the initial tour of the perioperative area with the Operating Room Manager (ORM) on 4/9/12, at 1 PM, multiple pairs of hinged instruments (i.e. scissors and clamps) were in the closed position in sealed peel pouches (peel pouches are flexible packaging materials that combine a paper or synthetic barrier material and a transparent plastic film. They are used primarily when visibility of the instrument is critical for its effective use). Twenty peel pouches were inspected with the ORM. He confirmed the instruments viewed were in the closed position. He agreed all the hinged instruments in the perioperative area were probably in the closed position. He stated he was unaware the instruments should be in the open position during the sterilization process so all surfaces could be sterilized. He stated the hospital's policy and procedures did not include sterilizing instruments in the open position. He confirmed the hospital follows the recommendations of the AORN and the CDC (Center of Disease Control) for the Operating Room (OR) and infection control.

The hospital policy and procedure titled "High Level Disinfection, Sterilization, and Storage of Sterile Supplies," effective 2/23/12, did not specify sterilizing instruments in an open position.

The 2012 Perioperative Standards and Recommended Practices published by the AORN were reviewed. Direction given read, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces...and instruments with hinges should be opened..."

2. During an inspection of the perioperative area with the ORM on 4/10/12, at 3:20 PM, the following items were found to have expired and were verified by the ORM:

Four Chlorapreps (a chemical used to clean the skin before an invasive procedure) with an expiration date of 2/2011. Fifteen laboratory tubes with expiration dates of 2/2012 (6 tubes), 1/2012 (6 tubes), and 12/2011 (3 tubes). A disposable anesthesia breathing circuit (the tubing used to connect the patient's airway to the breathing machine) with an expiration date of 10/2009. One Montgomery strap (a dressing used to hold together surgically separated skin) with an expiration date of 1/2003. At this time, the ORM stated all expired items should be removed from patient care areas.

On 4/12/12, at 2:15 PM, during an interview, the Quality Manager (QM) stated the hospital did not have a policy and procedure for the removal of expired supplies.

3. The operative report for Patient 1 was reviewed on 4/11/12, at 8:15 AM. The report, dated 2/17/12, read: "...due to the nasal cannula of oxygen, the gauze ignited and flamed and extended to the patient's mustache, and nasal cannula." The history and physical dated 2/17/12, read: "...during the procedure, the patient got burnt from the cauterization. Impression: Second-degree burn on the upper lip and nostrils." The discharge summary, dated 2/18/12, read: "During resection, fire occurred from the application of nasal oxygen and the use of cautery. The external nares, upper lid, lip, and mustache were cinched."

During an interview with the ORM on 4/9/12, at 1 PM, he stated the cause of the fire was due to the lack of the OR staff to ensure the oxygen was turned off before the surgeon started using the cautery device. He stated the anesthesiologist should have turned off the oxygen source before the cautery device was activated. He stated the hospital did not have a policy and procedure for the proper use of the cautery device.

On 4/11/12, at 10:15 AM and 4/12/12, at 10:40 AM, the anesthesiologist was contacted by phone for an interview but he refused stating he was too busy.

The package containing the cautery device was reviewed on 4/12/12, at 8:40 PM. The following was printed on the back of the package "WARNING: Do not us in the presence of flammable gases/materials or oxygen rich environments. Fire could result."

4. During an observation of the perioperative area on 4/12/12, at 11:50 AM, the Housekeeper was cleaning Operating Room 1. She was observed cleaning a table, two electrical cords, and the wall with the same cloth. None of the items remained wet after she had wiped them. She stated the cloths were wet with the disinfectant cleaner. When she was asked about how long the above items should remain wet after they were cleaned, she stated it would usually take less than 10 minutes.

The label for the disinfectant cleaner was reviewed on 4/12/12, at 12 PM. The label read "To disinfect hard, non-porous surfaces, treated surfaces must remain wet for 10 minutes."

During an interview with the Company Representative on 4/12/12, at 1:30 PM, he stated the hard surfaces in the operating room must remain wet with the disinfectant cleaner for at least 10 minutes to properly disinfect the hard surfaces.

On 4/12/12, at 2:15 PM, the QM stated she could not locate a hospital policy and procedure requiring 10 minutes contact time for the disinfectant cleaner.

5. During an observation of perioperative area on 4/12/12, at 12:15 PM, the double doors to Operating Room 2 were open. Inside, the staff was preparing for the next operation by opening sterile packages onto the operating room table. At this time, the ORM stated the doors should be kept closed while the staff was preparing the the next operation. The SM stated the hospital did not have a policy and procedure addressing when the doors of the operating room should be closed.

The 2012 Perioperative Standards and Recommended Practices published by the AORN were reviewed. The "Recommended Practices for Traffic Patterns in the Perioperative Practice Setting" under Recommendation III (2) read "Doors to the operating or procedure rooms should be closed except during movement of patients, personnel, supplies, and equipment. The air pressure within each operating or procedure room should be greater than in the semi-restricted area. The air in the OR should be maintained under positive pressure with a minimum of 15 total room air exchanges per hour. When the doors are left open, the heating, ventilation, and air conditioning system is unable to maintain these critical environmental parameters. Leaving the door open can disrupt pressurization and cause turbulent airflow that could increase airborne contamination. Traffic in and out of the OR should be minimized by preplanning so that turbulence from this activity is minimized during the procedure or when sterile supplies are opened."



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6. The clinical record for Patient 4 was reviewed on 4/9/12. Patient 4 had a procedure called "Right Thoracentesis (a procedure to remove excess fluid from the lung) with Possible Right Chest Catheter to Gravity Drainage" on 4/8/12 to treat his congested lungs. The hospital's "UNIVERSAL PROTOCOL - PROCEDURAL VERIFICATION" form included a "Procedure Side/Site Marked and Verified" to be checked as a "Yes" or "N/A (not applicable)." "N/A" was checked.

During an interview with the Director of Intensive Care Unit (ICU) on 4/10/12, at 9:35 AM, she stated the registered nurse (RN) 2 who was at the procedure room informed her Patient 4's procedure was performed under ultrasound and did not require the site/side to be marked. RN 2 was not available for comment.

The clinical record for Patient 8 was reviewed on 4/11/12. Patient 8 had a surgical procedure "Eye Mini Express Shunt Placement" on 1/18/12. No documentation on the "AUTHORIZATION FOR AND CONSENT TO SURGERY OR SPECIAL DIAGNOSTIC OR THERAPEUTIC PROCEDURES" form of which eye the surgical procedure was to be performed. On the "UNIVERSAL PROCEDURE - PROCEDURAL VERIFICATION" form, "N/A" was checked on the "Procedure Side/Site Marked and Verified."

The hospital policy and procedure titled "Universal Protocol for Surgical and Non-Surgical Invasive Procedures," effective 4/23/09, read in part "...2. Mark the procedure site: A. Marking the procedure site allows staff to identify without ambiguity the intended site for the procedure. For all procedures involving incision or percutaneous (via needle puncture of the skin) puncture or insertion, the intended procedure site is marked." "H...b. Confirmation that the correct side and site are marked. c. Accurate procedure consent form signed." The hospital staff did not implement the policy and procedure as written.