The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST MARY MEDICAL CENTER 18300 HIGHWAY 18 APPLE VALLEY, CA 92307 June 7, 2013
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on interview and record review, the hospital failed to ensure that:

1. The Medical Staff was accountable to the Governing Body (a group of people who formulate policy and direct an institution along with its management) for the quality of care provided to one surgical patient (Patient 21). (Refer A 347).

2. A comprehensive informed consent, which included the names of the proposed procedures, was completed per Medical Staff Bylaws and accepted standard of care, for one surgical patient (Patient 20). (Refer A 353).

3. All verbal orders were authenticated, dated, timed by the ordering practitioner within 48 hours per regulation and facility policy for 2 of 21 sampled patients (Patients 2 & 3) in a universe of 159. For Patients 2 and 3, several physician telephone orders were not authenticated, dated and timed by the ordering physician. This failure resulted in the potential for errors in transcription with the potential to affect patient safety. (Refer to A-0353)

The cumulative effect of these deficient practices meant that the hospital did not organize the medical staff to operate under the medical staff bylaws in order to provide quality patient medical care to a universe of 159 patients in the hospital.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based observation, interview and record review, the hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases as evidenced by:

1. Seven out of nine physicians (MD 4, MD 6, MD 9, MD 10, MD 11, MD 12, MD 13) did not have documented evidence of TB testing (Refer to A749).

2. Hospital provided disinfectants were not used according to the manufacturers' instructions (Refer to A749).

3. The Infection Control Nurse failed to ensure that the Certified Nursing Aide (CNA) students had competencies regarding the hospital's infection control and prevention practices (Refer to A749).

4. The Emergency Department (ED) patient care areas were not tracked to ensure that terminal cleans (patient care area thorough cleaning that is done after a patient has used the area and has been moved out of the ED) were conducted after they were used for one patient that required contact isolation precautions due clostridium difficile (C-Diff [colon bacterial infection]) (Refer to A749).

5. Personal Protective Equipment (PPE) was not worn appropriately by a registered nurse while she provided care and services for one patient that required contact isolation precautions due clostridium difficile (C-Diff [colon bacterial infection]) (refer to A749).

6. The hospital failed to ensure the maintenance of a sanitary hospital environment in the Operating Room (OR). This resulted in the possibility of incomplete antisepsis (the destruction of disease causing microorganism to prevent infection) of the OR floor and surfaces, increasing the risk of infection of patients cared for in this areas (Refer to A749).

7. The hospital failed to ensure that all staff adhered to isolation measures for 1 of 21 sampled patients (Patient 8) in a universe of 159. This failure had the potential to contribute to the spread of infection to other patients, personnel and visitors (Refer to A749).

The cumulative effects of these failures resulted in the hospital's inability to be in-compliance with the Infection Control Condition of Participation and increased the risk of infection and illness to a universe of 159 patients.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview and record review, the hospital failed to ensure that all staff and students adhered to the hospital's infection control and prevention practices as evidenced by the following:

1. That the TB infection prevention program included seven of nine staff physicians (MD 4, MD 6, MD 9, MD 10, MD 11, MD 12, MD 13). This practice increased the risk of TB infection for all staff and hospital patients.

2. One staff registered nurse and one certified nurses assistant student did not disinfectant reusable patient care equipment according to the disinfectants manufactures' instructions.

3. The Infection Control Nurse did not ensure that the certified nursing aide (CNA) students had competencies that reflected the hospital's infection control and prevention practices.

4. The Emergency Department (ED) patient care areas were not tracked to ensure that terminal cleans were conducted after they were used for Patient 6 that required contact isolation precautions due clostridium difficile (C-Diff [colon bacterial infection]).

5. Personal protective equipment (PPE) was not worn appropriately by one registered nurse while she provided care and services for Patient 6 that required contact isolation precautions due clostridium difficile (C-Diff [colon bacterial infection]).

6. The hospital failed to ensure the maintenance of a sanitary hospital environment in the Operating Room (OR). This resulted in the possibility of incomplete antisepsis (the destruction of disease causing microorganism to prevent infection) of the OR floor and surfaces, increasing the risk of infection of patients cared for in this areas.

7. The hospital failed to ensure that all staff adhered to isolation measures for 1 of 21 sampled patients (Patient 8) in a universe of 159. This failure had the potential to contribute to the spread of infection to other patients, personnel and visitors.

These failures had the potential to contribute to the transmission of potentially harmful microorganism to all patients, staff, students, and visitors that entered the hospital.

Findings:

1. Review of the hospital Tuberculosis Prevention and Exposure Control Plan, revised May 2013, indicated under "Purpose: The following is a written plan to identify individuals at risk for occupational exposure to Mycobacterium tuberculosis (TB), describes measures to minimize or eliminate risk of TB exposure, and provide guidelines for management of suspect and confirmed cases of Mycobacterium tuberculosis infection. Under "TB Screening Procedures: After baseline testing for infection with M. tuberculosis, HCW's (healthcare workers) should receive TB screening annually (i.e., symptom screen for all HCWs and testing for infection with M. tuberculosis for all HCWs with baseline negative test results)."

Review of nine physician credential files on June 7, 2013 at 9:15 AM with the Director of Medical Staff Services and the Credentials Coordinator indicated that seven out of nine physicians (MD 4, MD 6, MD 9, MD 10, MD 11, MD 12, MD 13) did not have documented evidence of TB testing. During a concurrent interview with the Director of Medical Staff Services and the Credentials Coordinator, both confirmed the lack of documented TB testing for seven out of nine physicians. The Director of Medical Staff Services stated that physicians who have recently joined the medical staff have been incorporated into the TB testing program and physicians who joined the medical staff many years ago, are not included in the TB testing program.





2. A. On June 3, 2013 at approximately 11:45 AM, a certified nurse assistant student (CNAS) was observed. The CNAS removed an oversized wheel chair (w/c) from a contact isolation room. He wiped off the w/c with one CaviWipes (a disinfectant wipe). The w/c remained wet for less than 60 seconds.

On June 3, 2013 at 11:50 AM, an interview was conducted with the CNAS. He confirmed that the w/c was removed from the contact isolation room. When asked what he used to disinfect the w/c after it was used for a patient with contact isolation precautions, the CNAS stated that he used the CaviWipes. When asked how long the w/c should have remained wet (contact time), he stated that the CaviWipes contact time was three (3) minutes. When asked how he determined that the patient care equipment remained wet for three minutes, he stated "I don't know." The CNAS confirmed that he used one CaviWipe when he wiped down the w/c and that the w/c did not remain wet for three minutes according the manufactures' instructions.

B. On June 4, 2013 at 11:20, RN 5 was observed. RN 5 removed the used a bedside glucometer (device used to obtain a patient's blood glucose level). She wiped off the device with one CaviWipe and returned the device to its docking station and walked away. The device dried within 60 seconds.

On June 4, 2013 at 11:22 AM, RN 5 was interviewed. When asked what the contact time was for the CaviWipes, RN 5 stated three (3) minutes. When asked how she ensured that the patient care equipment remained wet for three minutes, she stated that we were instructed to wipe off the reusable patient care equipment with the CaviWipes and let the device air dry. RN 5 stated that she did not confirm that the device remained wet for three minutes according to the manufacturers' instructions.

On June 4, 2013 at 3:00 PM, the Infection Control Nurse (ICN) was interviewed. When asked if she provided competencies for infection control and prevention to the CNA students prior to patient contact, the ICN stated that she was not directly involved in providing the students with the hospital's infection and prevention practices. She stated that it was the schools and preceptors responsibility to provide the students with infection prevention and control education.

3. On June 3, 2013 at approximately 11:45 AM, a certified nurse assistant student (CNAS) was observed. The CNAS removed an oversized wheel chair (w/c) from a contact isolation room. He wiped off the w/c with one CaviWipes (a disinfectant wipe). The w/c remained wet for less than 60 seconds.

On June 3, 2013 at 11:50 AM, an interview was conducted with the CNAS. He confirmed that the w/c was removed from the contact isolation room. When asked what he used to disinfect the w/c after it was used for a patient with contact isolation precautions, the CNAS stated that he used the CaviWipes. When asked how long the w/c should have remained wet (contact time), he stated that the CaviWipes contact time was three (3) minutes. When asked how he determined that the patient care equipment remained wet for three minutes, he stated "I don't know." The CNAS confirmed that he used one CaviWipe when he wiped down the w/c and that the w/c did not remain wet for three minutes according the manufactures' instructions.

On June 4, 2013 at 3:00 PM, the Infection Control Nurse (ICN) was interviewed. When asked if she provided competencies for infection control and prevention to the CNA students prior to patient contact, the ICN stated that she was not directly involved in providing the students with the hospital's infection and prevention practices. She stated that it was the schools and preceptors responsibility to provide the students with infection prevention and control education.

On June 5, 2013 at 11:10 AM, the CNA Student Clinical Instructor was interviewed. She stated the CNA students were provided with infection control orientation prior to entering the hospital. The Clinical Instructor stated that she provided the students with an in-service regarding the use of the CaviWipes to disinfect reusable patient care equipment after each use. She was unable to provide documented evidence to show that the CNA students received the in-service training.

On June 6, 2013 at 2:00 PM, during the Quality Assessment group interview, the ICN stated that the use of the CaviWipes, disinfectant, used to disinfect reusable patient care equipment were implemented in May 2013. She stated that she provided a CaviWipes in-service education to the hospital personnel and that the manufacturer also provided an in-service training during the month of May 2013.

On June 7, 2013, a review of the in-service training provided to the hospital personnel regarding the use of CaviWipes, dated May 29, 2013, was conducted. A review of the attendance sheet was conducted and did not show that RN 5 attended the in-service training.

On June 3, 2013, a review of the CaviWipes manufactures' instructions was conducted. It indicated that the required contact time was three (3) minutes to disinfect reusable patient care equipment.
On June 3, 2013, a review of the hospital's policy and procedure (P&P) titled, "Cleaning and Disinfection of Reusable Patient Care Equipment, dated September 2012, was conducted. The P&P included the following:

a. all patient care equipment is to be cleaned and disinfected using an EPA registered hospital approved disinfectant, disinfectant wipes or alcohol prep pads according to the manufacturers' instructions with the following procedure. Environmental Services (EVS), Central supply or other designated nursing personnel will clean and disinfect hospital equipment and place in a designated storage area as determined by each department.

b. Dedicated equipment will be used for patients in isolation precautions whenever possible. A bleach-based disinfectant must be used in isolation rooms when the patient has a suspect or confirmed C-Diff infection.

c. The user or the equipment has the ultimate responsibility of ensuring that only clean decontaminated equipment is used on the patient,

d. Patient care equipment, such as wheel chairs and glucometers, must be cleaned and disinfected between each patient use


4. On June 4, 2013, a review of Patient 6's ED record was conducted. The documentation noted that Patient 6 entered the ED at 1:35 AM. He was triaged at 1:44 AM. The patient had complaints of abdominal pain. The documentation noted that the patient had current C-Diff symptoms.

A review of the document, "Where has a Patient been," dated June 3, 2013, noted the following ED dispositions for Patient 6:

a. 1:35 AM - emergency room (ER)
b. 5:50 AM - ER Hold 16 (room 16)
c. 5:30 PM - Room 14- Telemetry Unit

On June 4, 2013 at 10:20 AM, an isolation cart was observed in the Emergency Department (ED) 1's hallway. The Emergency Department Manager (EDM) was asked why the isolation cart was in the ED hallway, she was not knowledgeable. When asked if the ED currently had a patient with contact isolation precautions, the EDM was not knowledgeable. When asked if the ED staff documented which rooms were previously used for patients that required contact isolation precautions, she stated, "no."

On June 4, 2013 at 10:25 AM, the ED Director (EDD) was interviewed. When asked if the ED currently had a patient with contact isolation precautions, the EDD Director stated, "no." When asked why there was an isolation cart in the ED hallway, she was not knowledgeable. The EDD stated that there was a patient in the ED yesterday (June 3, 2013) that was placed in contact isolation due to a C-Diff test result that was pending. When asked why the used contact isolation cart remained in the ED, she stated that it should have been removed. When asked which room the patient was in on June 3, 2013, she was not knowledgeable. When asked if the ED staff documented which rooms were previously used for patients that required contact isolation precautions, she stated, "no."

On June 4, 2013 at 10:35 AM, the EDM stated that the Environmental Services (EVS) staff would have informed the team leader after the terminal clean was completed. When asked to review documented evidence to show that the room was terminally cleaned, she was unable to provide documented evidence that showed that room 16 was terminally cleaned after it was used for a patient that required contact isolation due to C-Diff infection.

On June 4, 2013 at 10:45 AM, an interview was conducted with RN 6 (the team leader on June 3, 2013). RN 6 stated that Patient 6 was placed in room 16 with contact isolation precautions on June 3, 2013 due to C-Diff symptoms. She stated that he was subsequently admitted to the hospital on June 3, 2013. When asked if room 16 was terminally cleaned after the patient was transferred to the hospital, she stated "yes." When asked how she determined when a room was terminally cleaned, she stated, that the EVS staff person would inform her. When asked why the contact isolation cart remained in the ED's hallway one (1) day after the room was terminally cleaned, she stated that the EVS staff were supposed to remove the isolation cart after they terminally cleaned room 16. RN 6 also stated that their was no documented evidence that noted that room 16 was terminally cleaned.

On June 4, 2013 at 10:55 AM, EVS Staff 1 was interviewed. EVS Staff 1 stated that used isolation carts were removed by the Central Supply Department, not EVS staff. When asked if she terminally cleaned room 16 on June 3, 2013, she stated, "yes," but did not recall the time she conducted the terminal clean. When asked to review the documented evidence to show that the room was terminally cleaned, she stated that she did not document when ED terminal cleans were conducted.

On June 4, 2013 at 11:30 AM, the EDM was interviewed. When asked at what point in the ED visit was the patient transferred to room 16 with contact isolation precautions, she stated that the patient was triaged and remained in ED 2 on the "Swarm Side," until he was transferred into room 16. When asked if the patient care area in ED 2 was terminally cleaned after the patient was transferred to room 16, the EDM was not knowledgeable.

On June 4, 2013 at 12:50 PM, the Central Service (CS) Distribution Technician 1 and the Materials Manager were interviewed. The staff members stated that when a nursing unit required an isolation cart they would call the CS department. When asked how the CS department obtained used isolation carts, they stated the EVS staff was to call the department for removal. They also stated that the Central Service staff also made daily rounds to identify isolation carts that were no longer in use.

On June 6, 2013 at 11:30 AM, the Environmental Service Manager (EVSM) was interviewed. When asked how he ensured that terminal cleans were conducted in the ED, the EVSM stated that the EVS staff did not document when terminal cleans were conducted in the ED.

On June 4, 2013, a review of the hospital's policy and procedure (P&P) titled, "Terminal Isolation Cleaning, dated June 2012, was conducted. The P&P included the following:

a. In order to prevent the spread of infection, Environmental Services will apply appropriate disinfecting agent to all surfaces in isolation patient rooms in order to eliminate potentially harmful microorganisms.

b. It is policy to terminally clean isolation rooms at discharge/checkout time.


5. On June 4, 2013, a review of Patient 6's ED record was conducted. The documentation noted that Patient 6 entered the ED at 1:35 AM. He was triaged at 1:44 AM. The patient had complaints of abdominal pain. The documentation noted that the patient had current C-Diff symptoms.

On June 4, 2013 at 11:45 AM, RN 2 was observed in Patient 6's room. Patient 6 required contact isolation room due to C-Diff infection. RN 6 was wearing an isolation gown (PPE) that was untied and falling off her shoulders.

On June 4, 2013 at 11:55 AM, RN 2 was interviewed. She stated that the patient had a history of C-Diff. RN 2 stated that patients with a history of C-Diff were placed in contact isolation rooms until there were cleared. She confirmed that her gown was untied. RN 2 stated that the isolation gown should have been tied at the neck and waist to help prevent cross contamination of potentially infectious organisms.






6. The OR was inspected on June 4, 2013 at approximately 11:20 AM. During the inspection of OR #3, 2 Environmental Services Staff (EVS) ( EVS 1 and EVS 2) were observed cleaning the floor with a wet mop, and a wet rag to wipe the bed and other surfaces.

It was observed that the OR bed surface contact time was 3 minutes. The actual contact time used by EVS 1 was 3 minutes.

During an immediate interview with EVS 1 and EVS 2, both stated that the contact time takes about 10 minutes. When told that the contact time for the OR bed took only 3 minutes on observation (wet solution took only 3 minutes for the OR bed to dry up) EVS 1 stated and confirmed she, "did not time the contact time."

The EVS Staff were using a disinfectant cleaner solution, 710 for surfaces and 243 for the floor. The product label states that the product must remain wet on the surface for a 10 minutes contact time to ensure proper antisepsis.

The cleaning solution dispenser was mounted on the wall. It dispensed a product called "710 Multi-Purpose Disinfectant Cleaner" and "243 Waxie- Green Neutral Cleanser." The Director of the Perioperative Services, who was present during the observation, and EVS 1 and EVS 2 all confirmed that this was the product used for cleaning the OR.

During an interview with the Environmental Manager (EVS Manager) on June 6, 2013 at 12:25 PM, EVS Manager confirmed and stated that the 710 solution was used for top surfaces in OR and regular rooms, and the 243 solution, a neutral cleaner was used for floors in OR and regular rooms. EVS Manager confirmed that the dwell time/contact time was 10 minutes for these solutions.

During a review of the hospital Policy and Procedure, titled Environmental Services Standard Work - Between Case Surgery Suite Cleaning, and OR Daily Terminal Cleaning of Rooms, stipulated that rooms identified as Tuberculosis or C-diff will be cleaned with Clorox Germicidal Solution. The 710 solution was used to clean ceilings/walls, fixtures, OR surgery table, cushions and bed boards, surgery lights and doors, glass and stainless steel, and floor. The document indicated, "Solution must remain on surface for 10 minutes to be effective." "Solution should stay on floor for 10 minutes."






7. On June 4, 2013, at 11:30 AM, an observation was made in front of a patient's room (Patient 8), of a hospital staff who was inside the patients room not wearing a gown or gloves. Patient 8's room had a sign which documented the following: "Stop Contact Precautions...Wear gloves when entering room or cubicle...wear gown when entering room or cubicle..." The Telemetry Manager was present and observed the staff. After speaking with the staff, the Telemetry Manager stated that the individual was a hospital Dietician and she should have worn proper PPE (Personal Protective Equipment) which included wearing gloves and a gown while in the room because the patient was on isolation.

A record review of Patient 8 and a concurrent interview were conducted with RN 9, on June 4, 2013, at 12:10 PM. RN 9 stated that Patient 8 was admitted on [DATE], for Chronic Obstructive Pulmonary Disease (COPD - a lung disease). According to RN 9, Patient 8 had a history of MRSA (Methicillin-resistant Staphylococcus aureus - bacteria that is extremely resistant to most antibiotics and is responsible for outbreaks of untreatable infections among patients in hospitals, World English Dictionary, 2013) and the patient was placed on isolation precautions. RN 9 also stated that everyone who enters a contact isolation room should wear gown and gloves.

A record review was conducted, on June 4, 2013, at 12:30 PM of the hospital policy titled, "Isolation Procedures, effective 12/2010." The purpose of the policy was, "To prevent and protect the spread of serious and epidemiologically important microorganisms and protect the patient, health care giver, and visitor from potential exposure to communicable or infectious diseases within the hospital. Isolation techniques have the purpose of preventing the spread f these diseases to other patients, personnel, and visitors. All personnel, physicians, nurses, technicians, students, and others are responsible for complying with isolation precautions...The quality of care for a patient requiring isolation will not be compromised Nursing care, the use of monitoring, and special equipment will be provided as indicated..." The policy also defined why wearing gloves and gowns were significant to preventing the spread of infection.

An interview was conducted on June 4, 2013, at 2:10 PM, with the Dietician 1who entered Patient 8's room without wearing a gown and gloves. She apologetically stated that she knew the facility policy and she should have worn a gown and gloves prior to entering the patient's room regardless if she would be touching the patient or not.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital failed to ensure that the Medical Staff was accountable to the Governing Body (a group of people who formulate policy and direct an institution along with its management) for the quality of care provided to one surgical patient (Patient 21) in a universe of 159 patient. This practice increased the risk of poor quality of care for all hospital patients.

Findings:

A review of the "Bylaws of the Medical Center, adopted April 2010" under Article 10.1, Quality of Professional Services, it indicated, "The Board of Trustees shall require..the conduct of specific review and evaluation activities to assess, preserve and improve the overall quality and efficiency of patient care in the ministry." Also under Article 10.2, Accountability to Board of Trustees "The Medical Staff shall conduct and be accountable to the Board for conducting activities that contribute to the preservation and improvement of the quality and efficiency of patient care provided in the Hospital."

During a record review conducted on June 4, 2013 revealed Patient 21 was admitted to the hospital on April 7, 2012 for severe sepsis (bacterial infection that spreads throughout the body via the blood vessels) secondary to urinary tract infection (an infection that affects part of the urinary tract), unstageable decubitus ulcers (ulcers relating to patients who have been lying down for a prolonged amount of time), and anemia (a low amount of oxygen carrying red blood cells). During this admission, the patient received debridement (cleaning of) of his right and left ischial (relating to the hip region) ulcers and his septic left hip. On April 19, 2012, Patient 21 had a flap surgery (a technique in plastic and reconstructive surgery where any type of tissue is lifted from a donor site and moved to a recipient site with an intact blood supply) to his left and right ischial wound performed by the plastic surgeon (Medical Doctor [MD]7) as planned. There was no documented follow-up Plan of Care for the left septic (infected) hip until Patient 21 presented back to the hospital on July 31, 2012 with "Left hip pain and swelling and shortness of breath."

During a review of the three Operative Reports dated April 15, 2012 it was revealed that Patient 21 underwent the following procedures:


a. A 14 x 7 cm (centimeter) right stage IV ischial wound debridement, consisting of debridement of granulation bed tissue debris, all the way down to ischial bone with circumferential contracture scar excision and right ischial pressure ulcer bursectomy with application of negative pressure therapy of wide ischial wound, stage IV ulcer. The plan was to "return back to OR (Operating Room) in the next near future for additional dressing change versus flap reconstruction." This procedure was performed by a Plastic Surgeon (MD 7).

b. Exploration (An active examination, usually involving endoscopy or a surgical procedure) of left ischial pressure ulcer, bursectomy (the surgical removal of a bursa; A bursa is a small sac filled with [DIAGNOSES REDACTED] fluid that cushions adjacent structures and reduces friction), and debridement of exudative material and curetting of exudative material over the ischial bone with vacuum-assisted closure placement. The plan was "for flap reconstruction on Friday." This procedure was performed by a Plastic Surgeon (MD 4).

c. Incision and excisional debridement of left septic hip, with capsulectomy (excision of a capsule [as of a joint, kidney, or lens]) and muscular release with vacuum assisted closure application. The report indicated that a vac sponge was placed all the way down to the true acetabulum (The cup-shaped cavity at the base of the hipbone into which the ball-shaped head of the femur fits) and up to the level of the abductor layer. The report also indicated another overlying sponge was placed on the abductor layer all the way to the skin. There was no documented evidence of follow-up care. This procedure was performed by an Orthopedic Surgeon (MD 1).


Further review of the operative report revealed no documented plan of care as to when the vacuum sponge had to be removed. There was no documented evidence that there was communication and coordination of care between the plastic surgeons and the orthopedic surgeon regarding the plan of care related to the removal of the vacuum sponge to the left septic hip.

During a review of the operative report dated April 19, 2012 dictated at 7:28 PM, it was revealed that Patient 21 underwent a surgical procedures that included, (performed by Plastic Surgeon [MD 7]):

a. 40 x 50 cm reverse right gluteal fasciocutaneous (tissue flaps that include skin, subcutaneous tissue and the underlying fascia) rotation of flap, and a 30 x 20 cm reverse right gluteal muscle flap.

b. 35 x 30 cm reverse left-sided gluteal fasciocutaneous rotational advancement flap for left ischial ulcer coverage, and 20 x 15 cm reverse gluteal muscle flap for coverage of left ischial stage IV ulcer.

There was no documented evidenced that the vacuum sponge placed on the left hip on April 15, 2012 by MD 1 was removed by MD 7 during the above procedures.

On July 31, 2012, Patient 21 presented to the hospital for left hip pain and swelling and shortness of breath. The Orthopedic Surgeon (MD 1) was consulted in case the patient needed any additional drainage of the left hip again.

During a review of the operative report dated August 1, 2012, it indicated that Patient 21 underwent a procedure that included: "Irrigation and debridement of his left hip wound down to bone...resection (surgical removal of part of a structure or organ) of necrotic (dead) tissue including bone, left hip...removal of foreign body, left hip", and "irrigation and debridement of left leg abscess (A swollen area within body tissue, containing an accumulation of pus)."

The Operative Report also stipulated that a CT (Computed Tomography - a modality to visualize the internal structure of the body) scan was performed that showed a large collection of fluid going from his left hip to above his knee joint. The report also indicated, "there appeared to be a foreign body adjacent to the opening I just made. As I opened up the IT (iliotibial) band (a band of fibers running along the side of the thigh), I noted that this appeared to be part of a retained VAC sponge." The foreign body was removed.

During an interview with the Director of Perioperative Services on June 4, 2013 at 10:35 AM, he stated, "The black VAC sponges were made to be placed superficially, as they encourage granulation."

During an interview with MD 1 on June 5, 2013 at approximately 4:26 PM regarding Patient 21, MD 1 confirmed and stated that he had placed one standard black sponge into and one on top of the surgical site, "in the form of a 'T'." MD 1 also stated that the surgical site was then covered and connected to a wound vacuum appliance (create suction to the surface of the wound for better healing.) MD 1 also stated that the sponges were not meant to be left in the body for a long time and that it was expected that the sponges were to be removed before the wound flap. MD 1 confirmed and stated that he did communicate to MD 4 and left a voicemail to MD 7 of what he had done during the April 15, 2012 procedure, however he did not document his conversation with MD 4 and MD 7.

During an interview with the hospital CMO (Chief Medical Officer) on June 6, 2013 at approximately 9:40 AM, the CMO stated, "I don't think there was a process in place. There was no formal to formal communication with the doctors."

During an interview with MD 4 on June 7, 2013 at 12:32 PM, MD 4 confirmed and stated that he had conversation with MD 1 to coordinate services but not discussion of care. MD 4 also stated that the black vacuum sponge was not intended for wound with significant distance and/or tunneling.

A review of the hospital in-service record conducted on November 20, 2012, included the "VAC Therapy Safety Information." The information included, "VAC foam dressings are not bioabsorbable (A bioprosthetic used for short-term fixation of an unstable bone, which is later eliminated from the body)." It continued, "Do not force foam dressings into any area of the blind/unexplored tunnels. Foam left in the wound for greater than the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse events."

During a review of the manufacturer's instructions, titled "VAC Therapy Safety Information" with copyright 2007 KCL Licensing, Inc it stipulated, "Do not place any foam dressing into blind/unexplored tunnels. The VAC White Foam Dressing may be more appropriate for use with explored tunnels. Do not force foam dressings into any area of the wound, as this may damage tissues, alter the delivery of negative pressure, or hinder exudate and foam removal."

The manufacturer's instruction also stipulated, "VAC Foam Dressings are not bioabsorbable. Foam left in the wound site for greater than the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse events."
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital failed to ensure that the medical staff adopted and enforced bylaws pertaining to the medical staff's responsibilities as evidenced by the following:

1. The staff not adhering to the accepted hospital rules and regulations pertaining to comprehensive informed consents for 1 of 21 sampled patients (Patient 20) and

2. The writing of diagnostic and therapeutic orders. This deficient practice increased the risk of harm to the universe of 159 patients by having the patients undergo treatments and procedures provided that may not be agreeable to the patients or as the attending clinician had intended. This deficient practice increased the risk of harm to the universe of 159 patients by having the patients undergo treatments and procedures provided that may not be agreeable to the patients or as the attending clinician had intended.

3. The hospital failed to ensure that all verbal orders were authenticated, dated, timed by the ordering practitioner within 48 hours per regulation and facility policy for 2 of 21 sampled patients (Patients 2 & 3) in a universe of 159. For Patients 2 and 3, several physician telephone orders were not authenticated, dated and timed by the ordering physician. This failure resulted in the potential for errors in transcription with the potential to affect patient safety.

Findings:

1.) A review on June 5, 2013 of the "Provider Certification of Informed Consent, dated 7/10/2012", for Patient 20, indicated under "For the following surgical, diagnostic or therapeutic procedure(s): Robotic partial left nephrectomy (partial removal of kidney using robotic assistant)." There was no other information written in this section. Also listed, "I, the undersigned physician, hereby certify that I have discussed the procedure described above with this patient...including...A description of attendant discomfort, complications, or risks to the patient that may occur. A description of particular discomfort, risks or complications, and their management and prevention."

During an interview on June 6, 2013 at 11:25 AM with Medical Doctor [MD] 2, the vice chair of Medical Staff, he was asked about the brief surgical consent documented in Patient 20's chart. He stated that in the catheterization (passage of a catheter into a body channel or cavity) lab department, all of the possible procedures (for example: the need to change from small holes in the abdomen to a larger vertical incision) must be put on the consent form. Also, he added that the form must be complete before the patient can be brought to the procedure table. When asked what he expected, he answered that he "expected a complete consent." He also acknowledged that the consent for Patient 20 was not complete.

During an interview on June 6, 2013 at 11:45 AM with MD 6, the physician who cared for the patient during his hospital stay, when he was asked about the brief consent form in Patient 20's chart, he agreed that the, "consent should be more complete..."

A review of the hospital policy entitled "Consents and Informed Consents, reviewed 7/2011" indicated, "Purpose: To ensure that the patient's fundamental rights of self-determination over his/her body or property are honored." Also," Informed consent is consent based on the disclosure of all material information that a reasonable person would want to have in order to make a decision about the treatment."

A review of the "Medical Staff General Rules & Regulations," undated, indicated , "4.1 Informed consent: It shall be the physician's responsibility to obtain an informed consent for any procedure or treatment from the patient or his/her legally constituted representative. Evidence of an informed consent shall be documented in the medical record by the physician prior to the commencement (beginning) of the procedure." It continued, "4.2 Consent: the consent form must state the name of the involved physician and/or operating surgeon and the name of the proposed procedures and/or nature of the treatment. It is to be understood that the informed consent is delivered only when the patient has been advised in lay terminology of the calculated risk, or complications, injury or even death, from known and unknown causes and no warranty or guarantee has been made as to the result or cure". The practitioner who is performing the procedure must document the consent discussion, listing the benefits, risks and alternatives."


2.) A record review of Patient 3 and a concurrent interview were conducted on June 5, 2013, at approximately 3:35 PM with the Telemetry Manager. The record review revealed that Patient 3 was admitted on [DATE], with the diagnoses which included perforated viscus (a rupture or hole of an internal organ located within the abdominal cavity).

A record review of Patient 3 and a concurrent interview were conducted on June 5, 2013, at approximately 3:35 PM with the Telemetry Manager. The record review revealed two physician orders dated June 2, 2013, and June 3, 2013, which had illegible physician signatures and the times of the orders were also illegible. After reviewing the orders with the Telemetry Manager, she stated that the orders should have included a date and time and that the physicians signatures were illegible.

A record review on June 4, 2013, at 4 PM, of the hospital policy titled, "Medication Administration Hospital-wide Plan," documented that following: "...All medication orders, must be dated, timed and signed by the ordering physician. Telephone and verbal orders must be completed with the date, time, name and strength of medication, route of administration, dosage and frequency of administrations, and signed by the prescriber or person eligible to accept verbal order within 48 hours..."

A record review on June 4, 2013, at 4:40 PM, of the "Medical Staff General Rules & Regulations," revealed the following, "...DIAGNOSTIC AND THERAPEUTIC ORDERS: All diagnostic and therapeutic orders shall be written by a medical staff member or allied health professional within their scope of duties. Orders shall be dated and authenticated as necessary...3.2 TIME/DATE: All hospital orders shall be timed as well as dated...3.3 ORDER WRITING: All physician's orders shall be written clearly, legibly and completely..."

3a.) A record review of Patient 2 and a concurrent interview were conducted on June 4, 2013, at approximately 2:15 PM with the Intensive Care Unit (ICU) Supervisor. The record review indicated that Patient 2 was admitted on [DATE], with diagnosis which included chest pain, myocardial ischemia (a painful heart condition caused by lack of blood flow to the heart) and diabetes type 2 (also known as adult onset diabetes which is a disorder resulting from the body ' s inability to properly use or make enough insulin, {a hormone that helps regulate sugar and starches required for energy}).

A record review of Patient 2 and a concurrent interview was conducted on June 4, 2013, at approximately 2:15 PM with the ICU Supervisor. The record review revealed that several physician telephone orders, which included medication orders, two dated May 22, 2013, and four dated May 23, 2013, were not authenticated, dated and timed by the ordering physicians. The ICU Supervisor stated that the orders should have been authenticated within 48 hours of the Registered Nurses obtaining the telephone orders.

3b.) A record review of Patient 3 and a concurrent interview were conducted on June 5, 2013, at approximately 3:35 PM with the Telemetry Manager. The record review revealed that Patient 3 was admitted on [DATE], with the diagnoses which included perforated viscus (a rupture or hole of an internal organ located within the abdominal cavity).

A record review of Patient 3 and a concurrent interview were conducted on June 5, 2013, at approximately 3:35 PM with the Telemetry Manager. The record review revealed that three physician telephone orders, which included medication orders, two dated June 1, 2013, and one dated June 2, 2013, were not authenticated, dated and timed by the ordering physicians. The Telemetry Manager stated that the orders should have been authenticated within 48 hours of obtaining the orders.

A record review on June 4, 2013, at 4 PM, of the hospital policy titled, "Physician Orders (Written, Verbal and Telephone Orders) Improving Communication," indicated the following, "AUTHENTICATION OF VERBAL OR TELEPHONE ORDERS...(B). The ordering physician authenticates verbal/telephone orders within 48 hours of order..."

A record review on June 4, 2013, at 4:40 PM, of the "Medical Staff General Rules & Regulations," revealed the following, "...3.1 VERBAL/TELEPHONE ORDERS: Verbal/telephone orders for medications shall be signed, dated and timed within 48 hours by the ordering physician..."
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview and document review, the Governing Body (a group of people who formulate policy and direct an institution along with its management) failed to fulfill its responsibilities in oversight and conduct of the hospital as an institution. The hospital failed to ensure that:

1. The Governing Body failed to hold the medical staff responsible for maintaining the quality provided to the patients when the medical staff did not act on the findings of the hospital's ongoing program for quality improvement and patient safety when a Wound Vacuum Sponge (a sponge that can attach to an appliance that provides suction to the surgical wound for better healing) was left in the surgical patient (Refer to A049).

2. The Governing Body organized an effective Quality Assurance Program which improved patient safety by reducing the number of medical errors (Refer to A309).

3. The Quality Assurance Program focused on prevention of medical errors (Refer to A263).

4. The Infection Control Program was effective in reducing the risk of infection for the staff and patients (Refer to A747).

5. Surgical care and services achieved the highest standards of medical practice and patient care (Refer to A940).

6. Laboratory examinations/tests were performed accurately for 1 of 21 sampled patients (Patient 15) in a universe of 159, which resulted in an inaccurate Human Immunodeficiency Virus laboratory test result for Patient 15 (Refer to A266).

7. All Intensive Care Unit (ICU) Registered Nurses (RNs) and Emergency Department RNs administered all intravenous (IV) titratable drips and IV vasopressor medications (medications to increase blood pressure) to patients (Patient 1 & 2) in a safe manner and with proper physician guidance and complete orders (Refer to A405).

8. Radiological Services were provided according to the needs of 1 of 21 sampled patients (Patient 16) in a universe of 159, when they failed to report a positive right leg deep vein thrombosis (DVT - a blood clot) test result to the clinical or medical staff. This failure contributed to the death of Patient 16 and had the potential to affect the quality of care and services provided to other patients who may require Radiological Services (Refer to A529).

The cumulative effect of these systemic problems resulted in the possibility of patient harm in a universe of 159 patients.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on interview and record review, the hospital's Governing Body (a group of people who formulate policy and direct an institution along with its management) failed to ensure that the medical staff was responsible for maintaining its accountability for the quality provided to the patients as evidenced by the medical staff not acting on the findings of the hospital's ongoing program for quality improvement and patient safety when, for Patient 21, the hospital failed to ensure that a thorough investigation was conducted to identify causal factors after a Wound Vacuum Sponge (a sponge that can attach to an appliance that provides suction to the surgical wound for better healing) was left in the surgical patient. This increased the risk of harm to the patient and to other patients who may need surgery in the hospital in the future for a universe of 159 patients.

Findings:

A review of the "Bylaws of the Medical Center, adopted April 2010" (Bylaws for the Governing Body) under Article 10.1, Quality of Professional Services indicated, "The Board of Trustees shall require..the conduct of specific review and evaluation activities to assess, preserve and improve the overall quality and efficiency of patient care in the ministry." Also under Article 10.2, Accountability to Board of Trustees "The Medical Staff shall conduct and be accountable to the Board for conducting activities that contribute to the preservation and improvement of the quality and efficiency of patient care provided in the Hospital."

A review of the hospital "Sentinel/Significant Events Policy and Procedure, dated 12/18/2012" indicated, "The purpose of this policy/procedure is to focus attention on serious unexpected events that have taken place in the course of delivery of services to patients and their families that may affect the patient, personnel, physician or visitors: and enhance understanding of the causes that underlie the event and implement appropriate changes in systems and processes that will reduce the probability of such an event in the future." It continued, "Root Cause Analysis (RCA) is a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. An RCA focuses primarily on systems and processes, not individual performance...identifies potential improvements in processes or systems that would tend to decrease the likelihood of such events in the future, or determines, after analysis that no such improvement opportunities exist."

A review of the hospital "Performance Improvement Plan 2012" indicated under the plan's purpose, "The goal of this plan is to provide the Board of Trustees, Medical Staff, Administration, and hospital staff the framework for ensuring patients receive safe, quality care. (Name of hospital) is committed to measuring, assessing, and improving processes to enhance the quality of services to patients, community, physicians, employees, volunteers and payers." Also, under Goals/Objectives "Integrate (bring together) Patient Safety and Risk Management (reduce/eliminate patient risk) activities into performance improvement processes (improvement projects)." The plan continued, "Activities encompassed by the Performance Improvement Plan include: Operative and Other Procedure Review."

During a review of the large black foam packet label provided to the survey team by the Director of Perioperative Services (services related to surgery) on June 5, 2013 it was noted that the manufacturer's instructions were written on the label cover of the packet that indicated, "Always count and record number of foam pieces used in wound."

During a review of the manufacturer's instructions, titled "VAC Therapy Safety Information" with copyright 2007 KCL Licensing, Inc stipulated, "Do not place any foam dressing into blind/unexplored tunnels. The VAC White Foam Dressing may be more appropriate for use with explored tunnels. Do not force foam dressings into any area of the wound, as this may damage tissues, alter the delivery of negative pressure (suction to improve wound healing), or hinder exudate (excess wound fluid) and foam (sponge) removal. Always count the total number of pieces of foam (sponge) used in the wound and document that number on the drape (sterile surgical covering) and in the patient's chart. Also document the dressing change date on the drape."

The manufacturer's instruction also stipulated, "VAC Foam Dressings (sponges) are not bioabsorbable (it will not absorb into the patient's body naturally). Always count the total number of pieces of foam (sponges) removed from the wound and ensure the same number of foam pieces (sponges) was removed as placed. Foam (sponges) left in the wound site for greater than the recommended time period may foster ingrowth of tissue into the foam (sponges), create difficulty in removing foam (sponges) from the wound, or lead to infection or other adverse events."

A review of the medical record for Patient 21 on June 5, 2013, revealed that the patient was admitted to the hospital on April 7, 2012 for severe sepsis (life threatening infection) secondary (due to) to urinary tract infection, un-stageable decubitus ulcers (large wounds from prolonged sitting or laying in one place), and anemia (low number of oxygen carrying red blood cells) with subsequent re-admission to the hospital on July 31, 2012 for left hip pain and swelling, as well as shortness of breath.

During a review of the three Operative Reports dated April 15, 2012 revealed the following:
The operative report dated April 15, 2012, dictated at 3:42 PM, indicated that Patient 21 underwent the following procedures:

1. A 14 x 7 cm (centimeter) right, stage IV (a wound reaching the level of the bone) ischial (bones of the hip) wound debridement (surgical cleaning), consisting of debridement of granulation (new tissue formation) bed tissue debris, all the way down to ischial bone with circumferential (all the way around) contracture scar excision (removal of scar tissue), thus wound depth preparation.
2. Right ischial pressure ulcer bursectomy (removal of tissue around pressure ulcer).
3. Three liter copious antibiotic pulse lavage (cleaning with lots of water under pressure) of wound/washout.
4. Application of negative pressure therapy of wide ischial wound, stage IV ulcer (use of a sponge attached to an appliance that applies suction to the wound for better healing).

These procedures were performed by a plastic surgeon (Medical Doctor [MD] 7). The plan was to "return back to the OR (Operating Room) in the near future for additional dressing change versus flap reconstruction (Flap-movement of a piece of muscle over the wound to strengthen the area)."

The operative report dated April 15, 2012 dictated at 3:43 PM, indicated that Patient 21 underwent the following procedures:

1. Exploration of left ischial pressure ulcer.
2. Bursectomy measuring 8 cm x 8 cm.
3. Preparation of wound bed, left ischial pressure ulcer.
4. Debridement of exudative material (surgical cleaning) and curetting (cleaning with sharp instrument) of exudative material over the ischial bone.
5. Washout with pulse lavage and vacuum-assisted closure placement.

These procedures were performed by a plastic surgeon (MD 4). The plan was "for flap reconstruction on Friday."

The operative report dated April 15, 2012 dictated at 5:19 PM, indicated that Patient 21 underwent the following procedures:

1. Incision and excisional debridement (surgical cleaning of wound) of left septic (infected) hip, with capsulectomy (opening and removal of surrounding tissue) and muscular release (40% more difficult than usual due to altered anatomy).
2. Vacuum assisted closure application, left hip.

The report indicated that a vac sponge (sponge that is attached to a suction device to improve wound healing) was placed all the way down to the true acetabulum (part of the hip joint) and up to the level of the abductor layer (muscle layer that helps move the hip away from the midline). The report also indicated another overlying sponge was placed on the abductor layer all the way to the skin. These procedure was performed by an orthopedic surgeon (MD 1).

Further review of the Operative Report revealed that there was no documented plan of care as to when the vacuum sponge had to be removed. There was no documented evidence that there was communication nor coordination of care between the plastic surgeon and the orthopedic surgeon regarding the plan of care related to the removal of the vacuum sponge to the left septic hip of the patient.

During a review of the operative report dated April 19, 2012 dictated at 7:28 PM, revealed that Patient 21 underwent the following procedures:

1. Right-sided ischial wound bed preparation with circumferential scar excision 12 x 8 cm.
2. Right ischial wound bursectomy 12 x 8 cm.
3. Copious 3 L (liter) irrigation with antibiotic solution, pulse lavage on right-sided ischial wound.
4. Right-sided ischial bone biopsy.
5. 40 x 50 cm reverse right gluteal fasciocutaneous rotation of flap (Flap).
6. 30 x 20 cm reverse right gluteal muscle flap (Flap).
7. 40 cm multilayer complex repair with retention sutures of the right ischial wound.
8. 10 x 6 cm left-sided wound bed preparation of ischial wound with circumferential scar excision of ischial wound.
9. 10 x 6 cm left ischial bursectomy.
10. Copious 3 L antibiotic pulse lavage irrigation of left ischial wound.
11. Left ischial bone biopsy.
12. 35 x 30 cm reverse left-sided gluteal fasciocutaneous rotational advancement flap (Flap) for left ischial ulcer coverage.
13. 20 x 15 cm reverse gluteal muscle flap (Flap) for coverage of left ischial stage IV ulcer.
14. 35 cm multilayer complex repair of left ischial wound with retention suture of left ischial wound.

These procedures were performed by MD 7. There was no documented evidenced that the vacuum sponge placed on the left hip on April 15, 2012 by MD 1 was removed by MD 7 during the above mentioned procedures.

During a review of the clinical record dated July 31, 2012 dictated at 9:04 AM, it indicated that Patient 21 presented to the hospital for left hip pain and swelling and shortness of breath. The orthopedic surgeon (MD 1), who treated the patient in April, was consulted in case the
patient needed a repeat surgical drainage of the left hip.

A review of the operative report dated August 1, 2012, revealed that Patient 21 underwent the following procedures that included:

1. Irrigation and debridement of left hip wound down to bone.
2. Resection of necrotic tissue (surgical removal of dead tissue) including bone, left hip.
3. Removal of foreign body, left hip.

The report indicated that a CT (Computed Tomography) scan was performed that showed a large collection of fluid from his left hip and extending all the way down to an area above his knee joint.

The report also indicated that "there appeared to be a foreign body adjacent to the opening I just made. As I opened up the IT (iliotibial) band (a group of fibers running along the side of the thigh), I noted that this appeared to be part of a retained VAC sponge."

A review of the Unusual Occurrence file regarding the Wound Vacuum Sponge, undated, indicated that the event was referred to Peer Review (a committee of hospital staff that looks at and comments on physician care decisions) and then to the Department Chair and the Significant Event Review Committee (SERC - a committee that reviews unexpected events). The SERC would then decide if a Root Cause Analysis (RCA - a specific type of formal, thorough investigation into the cause of the unusual event) is needed for the specific event. The SERC decided that this event did not meet the criteria to perform an RCA. The event was discussed with other committees and sent back to the Peer Review Committee.

During an interview with MD 1 on June 5, 2013 at 4:30 PM, he was questioned about the details of the surgery for Patient 21, performed on April 15, 2012 for a septic (infected) hip. He stated that he placed two black sponges, one into and one on top of the surgical site," in the form of a 'T'." The surgical site was then covered and connected to a wound vacuum appliance (applies suction to the surface of the wound for better healing). MD 1 stated that after surgery, he called at least one of the two other surgeons (MD 4 & MD 7) to inform them that he placed the sponge in the wound and that it needed to be taken out during the next surgery. MD 7 returned to the Operating Room (OR) with Patient 21 on April 1, 2012. Despite the communication between the physicians, at least one sponge was discovered on August 1, 2012 when Patient 21 was taken to the operating room with a hip and leg abscess (infection). Patient 21 underwent another operative procedure to remove the sponge and clean out the abscess (infection) to allow the wound to heal.

During an interview with the Director of Perioperative services (Operating Room related services) on June 5, 2013 at 5:00 PM, when asked "Does the Operating Room (OR) staff keep a count of vacuum sponges put into the patient?" He answered, "not until this case."

During a telephone interview with MD 3, a member of The Board of Trustees, on June 6, 2013 at 11:00 AM, two past unexpected events were briefly discussed (Patient 20 & Patient 21). When MD 3 was asked if he expected an RCA to be performed by the appropriate staff for both unexpected events, he replied "yes", he expected an RCA to be performed for both. MD 3 was informed that an RCA was performed for only one of the two unexpected events (Patient 20).

During an interview with MD 4 on June 7, 2013 at 12:30 PM, when asked if the black wound vacuum sponges were counted by the OR staff, he replied "no, there was no counting of these type of sponges."

During an interview with MD 5, a member of the SERC, on June 7, 2013 at 1:25 PM, he was asked why there was no RCA for the retained sponge case (a sponge that was left in the surgical site after the surgery was completed). MD 5 replied, "the committee thought that it was caused by a lack of communication between the physicians, and so it was sent to the Peer Review Committee."
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, the hospital did not ensure that there was an effective Quality Assurance Program which focused on the prevention of medical errors by failing to ensure that:

1. A thorough investigation to identify causal factors was performed after a Wound Vacuum Sponge (a sponge that can attach to an appliance that provides suction to the wound for better healing) was left in one surgical patient (Patient 21) (Refer to A286).

2. Laboratory examinations/tests were performed accurately for 1 of 21 sampled patients (Patient 15). This failure resulted in an inaccurate human immunodeficiency virus (HIV: Human immunodeficiency virus, a retrovirus that causes AIDS) laboratory test result and had the potential to contribute to a delay in the diagnosis and treatment of the patient affecting the quality of care and well-being of Patient 15 (Refer to A266).

3. Operating Room Electrosurgical Equipment (equipment that provided electricity to surgical tools used to make incisions or stop bleeding) and Wound Vacuum Sponges (sponges used with equipment that provided suction to the wound for better healing) were used according as appropriate (Refer to A286).

4. Its Governing Body (a group of people who formulate policy and direct an institution along with its management) was responsible for maintaining an ongoing program for quality improvement and patient safety as it related to the reduction of medical errors. (Refer to A309)

5. The Infection Control Nurse confirmed that the Certified Nursing Aide (CNA) students had competencies that reflected the hospital's infection control and prevention practices (Refer to A266).

The cumulative effect of these practices resulted in the increased risk that similar medical errors may occur in the future for a universe of 159 patients. The deficient practices could contribute in the increased risk of harm to the patients due to the delay in potentially necessitated treatment and the spread of infection among the patient population.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and record review, the hospital failed to identify and reduce medical errors for 1 of 21 sampled patients (Patients 15) in a universe of 159.

1. For Patient 15, the hospital failed to ensure that laboratory examinations/tests were performed accurately for 1 of 21 sampled patients (Patient 15) in a universe of 159. This failure resulted in an inaccurate Human Immuno-deficiency Virus (HIV: Human immunodeficiency virus, a retrovirus that causes AIDS) laboratory test result and had the potential to contribute to a delay in the diagnosis and treatment for the patient and affect the quality of care and well-being of Patient 15.

2. The Infection Control Nurse did not ensure that the Certified Nursing Aide (CNA) students had competencies that reflected the hospital's infection control and prevention practices.

The deficient practices had the potential to contribute in the increased risk of harm to the patients due to the delay in potentially necessitated treatment and the spread of infection among the patient population.

Findings

1. Record review of an entity reported incident from the hospital indicated the following: "A false negative HIV test was reported for a known positive HIV patient. Patient was re-tested next day and results were reported to the physician."

An interview was conducted on June 3, 2013 at 3:30 PM, with the Manager of Accreditation, the Laboratory Director, the Laboratory Supervisor and the Vice President of Operations. They stated that a Clinical Lab Scientist (CLS 1) read a false negative HIV test which was conducted on a known positive HIV patient (Patient 1 who had a history of more than 20 years of HIV). According to the above individuals, the false negative test was conducted on November 28, 2012. The hospital's Infection Control Officer, who reviewed all HIV tests, identified the error and informed the Laboratory's Management team. Patient 1's specimen was re-tested by a different CLS, on November 29, 2012 and revealed that Patient 1 was HIV positive. CLS 1 was then asked to test 5 additional HIV specimens. Two of the 5 specimens were known positive, however CLS 1 reported all 5 specimens as negative. Immediate action was taken, a 90 Day Action Plan was developed for CLS 1 and she was also placed on administrative leave however CLS 1 decided to resign. According to the Laboratory Supervisor, the hospital's investigation revealed that CLS 1 had not been wearing her eye glasses at the time of the HIV specimen readings because they were uncomfortable. The Laboratory Supervisor stated that they reviewed all past HIV tests that CLS 1 had conducted and found that CLS 1 had tested 108 HIV specimens, all which were read as negative. The Laboratory Supervisor stated that they attempted to contact all 108 patients to make arrangements to retest them. According to the Laboratory Supervisor and the Laboratory Director, they have left this case open in an effort to continue to contact the patients who had not been available to get re-tested .

A record review of CLS 1's "90 Day Action Plan" was reviewed on June 3, 2013 at approximately 3:30 PM. The document outlined CLS 1's "Observed Behavior Below Standards," which included "...accurate test results and documentation, report accurate HIV results, wear appropriate prescription lenses and use appropriate equipment for visual aid..." The 90 Day Action Plan also described the Laboratory Supervisor and Director's "Expectations" of CLS 1. The expectations included, "...Accurately result all patient tests...All HIV results must be confirmed by a second CLS after you have tested the sample. Observation that you are using your prescription eyeglasses when reading and that you use the proper lighting and other visual aid equipment as appropriate..."

A record review of Patient 15 was conducted on June 7, 2013, at 9:15 AM. A physician ' s history and physical (H&P), dated November 29, 2012, indicated that Patient 15 had a long history of HIV and was being followed by a physician for many years. The physician ' s H&P also documented, "Interestingly, the patient had a rapid HIV test done by the emergency room staff, which came back negative."





2. On June 3, 2013 at approximately 11:45 AM, a certified nurse assistant student (CNAS) was observed. The CNAS removed an oversized wheel chair (w/c) from a contact isolation (preventive actions to prevent the spread of illness that is usually transmitted to another susceptible individual via direct contact/touch) room. He wiped off the w/c with one CaviWipes (a disinfectant wipe). The w/c remained wet for less than 60 seconds.

On June 3, 2013 at 11:50 AM, an interview was conducted with the CNAS. He confirmed that the w/c was removed from the contact isolation room. When asked what he used to disinfect the w/c after it was used for a patient with contact isolation precautions, the CNAS stated that he used the CaviWipes. When asked how long the w/c should have remained wet (contact time) with the disinfectant, he stated that the CaviWipes contact time was three (3) minutes. When asked how he determined that the patient care equipment remained wet for three minutes, he stated, "I don't know." The CNAS confirmed that he used one CaviWipe when he wiped down the w/c and that the w/c did not remain wet for the three minutes according the manufacturers' instructions.

On June 4, 2013 at 3:00 PM, the Infection Control Nurse (ICN) was interviewed. When asked if she provided competencies for infection control and prevention to the CNA students prior to patient contact, the ICN stated that she was not directly involved in providing the students with the hospital's infection and prevention practices. She stated that it was the schools and preceptors responsibility to provide the students with infection prevention and control education.

On June 5, 2013 at 11:10 AM, the CNA Student Clinical Instructor was interviewed. She stated that the CNA students were provided with infection control orientation prior to entering the hospital. The Clinical Instructor stated that she provided the students with an in-service regarding the use of the CaviWipes to disinfect reusable patient care equipment after each use. She was unable to provide documented evidence to show that the CNA students received the in-service training.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and record review, the hospital failed to ensure that Operating Room Electrosurgical Equipment (equipment that provided electricity to surgical tools used to make incisions or stop bleeding) and Wound Vacuum Sponges (sponges used with equipment that provided suction to the wound for better healing) were used according to the Manufacturer's Instructions. This practice resulted in a retained wound vacuum sponge inside 2 of 21 sampled patients (Patient 20 and 21).

Findings:

1. A review of the hospital "Performance Improvement Plan 2012", under Goals/Objectives it indicated, "(Name of Hospital)'s objective is to measure and assess processes and outcomes, and identify opportunities for improvement of patient care services, systems and/or individual performance. These objectives are achieved through the following strategies and tactics: Provide the Board of Trustees, Medical Staff, Administration and the hospital staff with the structure for ensuring that patient safety and quality patient care is provided and continuously improved."

A review of the Operator's Manual for the "System 5000 Electrosurgical Unit (ESU), dated 2010" indicated, "Electrosurgery (surgery using tools that require electricity to make incisions or stop bleeding) can be dangerous to patients, staff and other equipment if misused. Please understand and follow the warnings and cautions that are included in this manual." Also, under "Cautions For Equipment Preparation" the manual indicated, "Confirm all accessories (surgical tools that require electricity, example bipolar) are properly connected to the appropriate receptacles (electrical outlet area) before powering (turning on) the ESU." Also, "Confirm bipolar (tool that uses two poles of electricity) leads are connected only to the bipolar receptacles. Connecting bipolar accessories to monopolar (one pole) outputs may result in patient injury." Also, under "Cautions for Use: Temporarily unused active electrodes (plugged in and electrically active surgical tools) should be stored in an electrically insulated (stored in a manner that prevents the passage of heat or electricity) holster. The unused active electrode should never be placed on the patient. This is especially important for laparoscopic procedures (surgery performed through small holes in the abdomen, with guidance provided by using video) ."

During review of the medical record for Patient 20 on June 5, 2013 it was noted that Patient 20 was admitted to the hospital on July 10, 2012 for robotic assisted laparoscopic surgical removal of a kidney mass.

According to the dictated operative report dated July 10, 2012:

Preoperative Diagnoses: Left renal (kidney) mass.
Postoperative Diagnoses: Left renal mass descending colonic thermal injury.
Procedure Performed:

1. Attempted robotic assisted partial nephrectomy (removal of part of kidney).
2. Exploratory laparotomy (larger incision in abdomen to perform surgery).
3. Descending colonic Wedge resection (removal of the damaged portion of the colon in a wedge shape).
4. Fulton partial nephrectomy (removal of part of kidney).

According to the Operative Findings:

"Upon attachment of left arm and the instrument being in close proximity of the colon, for some unexplained reason, the cautery unit began to fire (let out heat created by electricity), even though there was no active activation on the partner physician or staff (without staff pushing the foot pedal). Within 3-4 seconds this problem was recognized because of audible noise from the cautery unit, but by then the heat injury has already occurred. Because the robotic instruments had been rested close to the proximity of the colon. The patient electric shock that was delivered began to score (burn) the serosa (outer covering of the intestine)."

According to the Discharge Summary dictated on July 22, 2012 after the thermal injury to the patient's colon, "Initially, the patient was opened (a larger incision was made and surgery was performed under direct visualization instead of laparoscopically) and the situation was contained by performing a wedge resection and not have gross contamination (spillage of stool out of colon into sterile abdominal cavity). Because patient did not have a bowel prep (medicine to clean out of the colon before surgery) and regular colon segmental resection, would have required colostomy (surgical diversion of part of bowel out through the skin to allow lower colonic operative site to remain clean during healing) for safety features. The decision was made to perform a wedge resection, contained this situation to make sure there is no extravasation (spillage of stool out of colon into abdominal cavity) and bring her back (to the OR) to undergo segment of colon resection (removal of a complete section of bowel) after a bowel prep."

Because of the colon injury, the patient had a second surgery to thoroughly remove the damaged portion of the colon. According to the dictated operative report dated July 17, 2012:

Preoperative Diagnosis: Left colonic injury
Postoperative Diagnosis: Left colonic injury
Procedure performed: Left colon resection (removal), segmental.

According to the Discharge Summary for Patient 20, dictated July 22, 2012 "She underwent the procedure (left colon resection, segmental) uneventfully through the same incision." Patient 20 was discharged home on July 21, 2012 in good condition.

During an interview with the Director of Perioperative Services on June 5, 2013 at 2:00 PM, he remembered being called into the Operating Room (OR) after the Electrosurgical Unit fired unexpectedly. Because the bipolar was close to the patient's bowel, it caused a burn on the patient's bowel. The Biomedical team (electrical equipment experts) tested the equipment and found it to be in good working order. When asked what caused the unexpected event, the Director of Perioperative Services explained that during the set up of a robotic surgery, one end of the bipolar tool is put through the trocar (tool that creates a small opening into the patient's abdomen) while the other end is being hooked up to the robot arm. Once this is done, the surgeon can walk over to the console and take control of the bipolar tool via the robotic arm. Also, he added that because the ESU must be covered for sterility during robotic surgery, this may have contributed to decreased visualization by staff of the proper plug in area for the bipolar on the ESU. He stated that the hospital concluded that the cause of the unexpected event was that the bipolar was plugged into the monopolar plug in area by mistake, which caused the bipolar tool to fire unexpectedly. When asked about the sequence of events, it was confirmed that the ESU was turned "on" before the bipolar accessory was plugged into the ESU.

During an interview with MD 6 , the assistant surgeon for Patient 20's surgery, on June 6, 2013 at 11:45 PM he stated that he was not in the OR when the bipolar (two poles) accessory fired unexpectedly, however, he arrived in the OR soon after the event. He stated that a repeat of the same unexpected firing of the bipolar tool occurred again in the very next robotic surgery case. In that case however, the bipolar tool was not in the trocar (tool that creates a small opening into the patient's abdomen) and therefore the patient did not become injured. Because of this second occurrence, the Biomedical team (electrical equipment experts) was asked to test the electrical equipment including the ESU and the bipolar accessory. The equipment was tested and was found to be in good working order. When Medical Doctor (MD) 6 was asked if the bipolar tool should have been plugged into the ESU and tested before the surgeon connected the bipolar to the robotic arm, he answered "yes, they should have set up the equipment first." When asked if he agreed that the bipolar accessory should not have been placed through the trocar and into the patient during the set up, he said "yes, and we can change that." He added that, "there were no laparoscopy policies and procedures."

2. During a review of the large black foam packet label provided to the survey team by the Director of Perioperative Services (services related to surgery) on June 5, 2013 it was noted that manufacturer's instructions were written on the label cover of the packet that indicated, "Always count and record number of foam pieces used in wound."

During a review of the manufacturer's instructions, titled "VAC Therapy Safety Information" with copyright 2007 KCL Licensing, Inc it stipulated, "Do not place any foam dressing into blind/unexplored tunnels. The VAC White Foam Dressing may be more appropriate for use with explored tunnels. Do not force foam dressings into any area of the wound, as this may damage tissues, alter the delivery of negative pressure (suction to improve wound healing), or hinder exudate (excess wound fluid) and foam (sponge) removal. Always count the total number of pieces of foam (sponge) used in the wound and document that number on the drape (sterile surgical covering) and in the patient's chart. Also document the dressing change date on the drape."

The manufacturer's instruction also stipulated, "VAC Foam Dressings (sponges) are not bioabsorbable (will not absorb into the patient's body naturally). Always count the total number of pieces of foam (sponges) removed from the wound and ensure the same number of foam pieces was removed as placed. Foam left in the wound site for greater than the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse events."

A review of the medical record for Patient 21 on June 5, 2013, revealed that he admitted to the hospital on April 7, 2012 for severe sepsis (life threatening infection) secondary (due to) to urinary tract infection, un-stageable decubitus ulcers (large wounds from prolonged sitting or laying in one place), and anemia (a low amount of oxygen carrying red blood cells) with subsequent re-admission to the hospital on July 31, 2012 for left hip pain and swelling, and shortness of breath.

During a review of the three Operative Reports dated April 15, 2012 revealed the following:
The operative report dated April 15, 2012, dictated at 3:42 PM, indicated that Patient 21 underwent the following procedures:

1. A 14 x 7 cm (centimeter) right stage IV ischial wound debridement, consisting of debridement (surgical cleaning) of granulation bed tissue debris, all the way down to ischial bone (one of the three sections of the hip bone) with circumferential (all the way around) contracture scar excision (removal of scar tissue), thus wound depth preparation.
2. Right ischial pressure ulcer bursectomy (removal of tissue around pressure ulcer).
3. Three liter copious antibiotic pulse lavage (cleaning with lots of water under pressure) of wound/washout.
4. Application of negative pressure therapy of wide ischial wound, stage IV ulcer (use of a sponge attached to an appliance that applies pressure to the wound for better healing).

These procedures were performed by a plastic surgeon (Medical Doctor [MD] 7). The plan was to "return back to the OR (Operating Room) in the near future for additional dressing change versus flap reconstruction (Flap-movement of a piece of muscle over the wound to strengthen the area)."

The operative report dated April 15, 2012 dictated at 3:43 PM, indicated that Patient 21 underwent the following procedures:

1. Exploration of left ischial pressure ulcer.
2. Bursectomy measuring 8 cm x 8 cm.
3. Preparation of wound bed, left ischial pressure ulcer.
4. Debridement of exudative material (surgical cleaning) and curetting (cleaning with sharp instrument) of exudative material over the ischial bone.
5. Washout with pulse lavage and vacuum-assisted closure placement.

These procedures were performed by a plastic surgeon (MD 4). The plan was "for flap reconstruction on Friday."

The operative report dated April 15, 2012 dictated at 5:19 PM, indicated that Patient 21 underwent the following procedures:

1. Incision and excisional debridement (surgical cleaning of wound) of left septic (infected) hip, with capsulectomy (opening and removal of surrounding tissue) and muscular release (40% more difficult than usual due to altered anatomy).
2. Vacuum assisted closure application, left hip.

The report indicated that a vac sponge (sponge that is attached to a suction device to improve wound healing) was placed all the way down to the true acetabulum (part of the hip joint) and up to the level of the abductor layer (muscle layer that helps move the hip away from the midline). The report also indicated another overlying sponge was placed on the abductor layer all the way to the skin. These procedure was performed by an orthopedic surgeon (MD 1).

Further review of the Operative Report revealed no documented plan of care as to when the vacuum sponge had to be removed. There was no documented evidence that there was a communication and coordination of care between the plastic surgeon and the orthopedic surgeon regarding the plan of care related to the removal of the vacuum sponge to the left septic (infected) hip.

During a review of the operative report dated April 19, 2012 dictated at 7:28 PM, revealed that Patient 21 underwent the following procedures:

1. Right-sided ischial wound bed preparation with circumferential scar excision 12 x 8 cm.
2. Right ischial wound bursectomy 12 x 8 cm.
3. Copious 3 L (liter) irrigation with antibiotic solution, pulse lavage on right-sided ischial wound.
4. Right-sided ischial bone biopsy.
5. 40 x 50 cm reverse right gluteal fasciocutaneous rotation of flap (Flap).
6. 30 x 20 cm reverse right gluteal muscle flap (Flap).
7. 40 cm multilayer complex repair with retention sutures of the right ischial wound.
8. 10 x 6 cm left-sided wound bed preparation of ischial wound with circumferential scar excision of ischial wound.
9. 10 x 6 cm left ischial bursectomy.
10. Copious 3 L antibiotic pulse lavage irrigation of left ischial wound.
11. Left ischial bone biopsy.
12. 35 x 30 cm reverse left-sided gluteal fasciocutaneous rotational advancement flap (Flap) for left ischial ulcer coverage.
13. 20 x 15 cm reverse gluteal muscle flap (Flap) for coverage of left ischial stage IV ulcer.
14. 35 cm multilayer complex repair of left ischial wound with retention suture of left ischial wound.

These procedures were performed by MD 7. There was no documented evidenced that the vacuum sponge placed on the left hip on April 15, 2012 by MD 1 was removed by MD 7 during the above procedures.

During a review of the clinical record dated July 31, 2012 dictated at 9:04 AM indicated that Patient 21 presented to the hospital for left hip pain and swelling and shortness of breath. The orthopedic surgeon (MD 1), who treated the patient in April, was consulted in case the
patient needed a repeat surgical drainage of the left hip.

A review of the operative report dated August 1, 2012, revealed that Patient 21 underwent the following procedures that included:

1. Irrigation and debridement of left hip wound down to bone.
2. Resection of necrotic tissue (surgical removal of dead tissue) including bone, left hip.
3. Removal of foreign body, left hip.

The report indicated that a CT (Computed Tomography - a modality to visualize the internal structures of the body) scan was performed that showed a large collection of fluid going from his left hip to above his knee joint.

The report also indicated, "there appeared to be a foreign body adjacent to the opening I just made. As I opened up the IT band, I noted that this appeared to be part of a retained VAC sponge."

During an interview with MD 1 on June 5, 2013 at 4:30 PM, he was questioned about the details of the surgery for Patient 21, performed on April 15, 2012 for a septic (infected) hip. He stated that he placed two black sponges, one into and one on top of the surgical site," in the form of a 'T'." The surgical site was then covered and connected to a wound vacuum appliance (applies suction to the surface of the wound for better healing). MD 1 stated that after the surgery, he called at least one of the two other surgeons (MD 4 & MD 7) to inform them that he had placed the sponge in the wound and that it needed to be taken out during the next surgery. MD 7 returned to the Operating Room (OR) with Patient 21 on April 19, 2012. Despite the communication between the physicians, at least one sponge was discovered on August 1, 2012 when Patient 21 was taken to the operating room with a hip and leg abscess (infection). Patient 21 underwent another operative procedure to remove the sponge and clean out the abscess (infection) to allow the wound to heal.

During an interview with the Director of Perioperative services (Operating Room related) on June 5, 2013 at 5:00 PM, when asked "Does the Operating (OR) Room staff keep a count of vacuum sponges put into the patient?" He answered, "not until this case."

During an interview with MD 4 on June 7, 2013 at 12:30 PM when asked if the black wound vacuum sponges were counted by the OR staff, he answered "no, there was no counting of these type sponges."

A review of the Unusual Occurrence file regarding the Wound Vacuum Sponge, undated, indicated that the event was referred to Peer Review (a committee of hospital staff that looks at physician care decisions) and then to the Department Chair and the Significant Event Review Committee (SERC - a committee that reviews unexpected events) and that the SERC would decide if a Root Cause Analysis (RCA - a specific type of formal, thorough investigation into the cause of the unusual event) was required. The SERC decided that the event did not meet the criteria to perform an RCA. The event was discussed with other committees and sent back to the Peer Review Committee.

During a telephone interview with MD 3, a member of The Board of Trustees, on June 6, 2013 at 11:00 AM, two past unexpected events were briefly discussed (Patient 20 & Patient 21). When MD 3 was asked if he expected an RCA to be performed by the appropriate staff for both unexpected events, he replied "yes," he expected an RCA to be performed for both. He was informed that an RCA was only performed on one of the two unexpected events (Patient 20).

During an interview with MD 5, a member of the SERC, on June 7, 2013 at 1:25 PM he was asked why there was no RCA for the retained (left in) sponge case. MD 5 replied, "the committee thought that it was caused by a lack of communication between the physicians, and so it was sent to the Peer Review Committee."
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interview and record review, the hospital failed to ensure that its governing body was responsible for maintaining an ongoing program for quality improvement and patient safety as it related to the reduction of medical errors as evidenced by for 1 of 21 sampled patients (Patient 15) in a universe of 159, the hospital failed to ensure that laboratory examinations/tests were performed accurately. This failure resulted in an inaccurate Human Immuno-deficiency Virus (HIV) laboratory test result and had the potential to contribute to a delay in diagnosis and treatment and affect the quality of care and well-being of the patient.

Finding:

An entity reported incident reported by the hospital indicated the following: "A false negative HIV test was reported for a known positive HIV patient. Patient was re-tested next day and results were reported to the physician."

An interview was conducted on June 3, 2013 at 3:30 PM, with the Manager of Accreditation, the Laboratory Director, the Laboratory Supervisor and the Vice President of Operations. They stated that a Clinical Lab Scientist (CLS 1) read a false negative HIV test that was conducted on a known positive HIV patient (Patient 1, who had a history of HIV for greater than twenty [20] years). According to the individuals present during this interview, the false negative test was conducted on November 28, 2012. The hospital's Infection Control Officer, who reviewed all HIV tests, identified the error and informed the Laboratory's Management team. Patient 1's specimen was re-tested by a different CLS, on November 29, 2012 and revealed that Patient 1 was HIV positive. CLS 1 was then asked to test five (5) additional HIV specimens. 2 of the 5 specimens that were to be tested , were known HIV positive individuals. Once the tests were accomplished, CLS 1 reported that all five (5) specimens as negative test results. Immediate action was taken, a 90 Day Action Plan was developed for CLS 1 and she was placed on administrative leave. CLS 1 decided to resign. According to the Laboratory Supervisor, the hospital's investigation revealed that CLS 1 had not been wearing her eye glasses at the time of the HIV specimen readings because she stated that they were uncomfortable. The Laboratory Supervisor stated that the staff reviewed all past HIV tests that CLS 1 had conducted. CLS 1 had tested 108 HIV specimens, all which were read as negative test results. The Laboratory Supervisor stated that they attempted to contact all 108 patients to make arrangements to re-test them. According to the Laboratory Supervisor and the Laboratory Director, they left this case open in an effort to continue to contact the patients who had not been available to get re-tested .

A record review of CLS 1's "90 Day Action Plan" was reviewed on June 3, 2013 at approximately 3:30 PM. The document outlined CLS 1's "Observed Behavior Below Standards," which included, "...accurate test results and documentation, report accurate HIV results, wear appropriate prescription lenses and use appropriate equipment for visual aid..." The 90 Day Action Plan also described the Laboratory Supervisor and Director's "Expectations" of CLS 1. The expectations included, "...Accurately result all patient tests...All HIV results must be confirmed by a second CLS after you have tested the sample. Observation that you are using your prescription eyeglasses when reading and that you use the proper lighting and other visual aid equipment as appropriate..."

A record review of Patient 15 was conducted on June 7, 2013, at 9:15 AM. The patient's history and physical (H&P), conducted by a physician, dated November 29, 2012, indicated that Patient 15 had a long history of HIV and was being followed by a physician for many years. The physician's H&P also documented, "Interestingly, the patient had a rapid HIV test done by the emergency room staff, which came back negative."
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, interview and record review, the hospital failed to ensure that the Nursing Services provided were organized and that the delivery of nursing care was supervised as evidenced by the following:

1. The hospital failed to ensure that the registered nurses supervised and evaluated the care for 1 of 21 sampled patients (Patient 5) in a universe of 159 patients, that required 1:1 observation due to disorientation manifested by potentially harmful behaviors. This failure had the potential to result in serious injuries for Patient 5 (Refer to A395).

2. The hospital failed to ensure that the nursing staff developed and kept current a nursing care plan for 2 (Patients 2 and 5) of 21 sampled patients, in a universe of 159, based upon nursing care needs, ongoing nursing assessments, and responses to interventions. These failures had the potential to affect the health outcomes and quality of care for Patients 2 and 5 (Refer to A396).

3. The hospital failed to ensure that all Intensive Care Unit (ICU) Registered Nurses (RNs) and Emergency Department RNs administered all intravenous (IV - given through the blood vessels) titratable (adjustable) drips and IV vasopressor medications (medications to increase blood pressure) to the patients (Patient 1 & 2) in a safe manner and with proper physician guidance and complete orders (Refer to A405).

The cumulative effect of these systemic problems resulted in the Nursing Department's inability to ensure the provision of quality health care in a safe environment for a universe of 159 patients.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on interview and record and document review, the hospital failed to ensure that the registered nurses supervised and evaluated the care for 1 of 21 sampled patients (Patient 5) in a universe of 159 patients, that required 1:1 observation due to disorientation manifested by potentially harmful behaviors. This failure had the potential to result in serious injuries for Patient 5.

Findings:

On June 7, 2013, a review of the hospital's policy and procedure titled, "One to One (1:1) Observation (Sitter)," dated December 2012, was conducted and included the following:
a. 1:1 observation is appropriate for those patients that require constant observation for safety.
b. A physicians order is to be obtained to place a patient on 1:1 observation status
c. Patients may be placed on 1:1 observation status with the following criteria: #4 Patients disoriented and requiring constant monitoring to prevent harm to self.

On June 7, 2013, Patient 5's medical record was reviewed with Registered Nurse (RN) 3.

A review of the face sheet noted that Patient 5 was admitted to the hospital on June 5, 2013 for an abdominal aortic aneurysm repair.

A review of the physician admission orders, dated June 5, 2013 noted that the patient underwent an abdominal aortic aneurysm repair on June 5, 2013. The physician orders (PO) included orders for intravenous fluids (fluid administration through the vein), indwelling catheter (tube inserted in the bladder to drain urine) and a sitter (1:1 direct observation).

A review of the nursing shift assessments documentation noted the patient had both long and short term memory deficits. Patient 6 was disoriented to place, situation/event and time as follows:
a. June 5, 2013 at 7:17 PM
b. June 5, 2013 at 10 PM
c. June 6, 2013 at 10 AM
d. June 6, 2013 at 10 PM

A review of the nursing documentation, dated June 6, 2013 at 6:35 AM, noted that the patient had periods of on and off confusion.

A review of the nursing documentation, dated June 7, 2013 at 3:41 AM, noted that the patient was previously agitated, restless, felt urgency to get up and void after constant reminders that he had a tube in his bladder. The sitter had a difficult time keeping the patient in bed. The patient was more cooperative after being reminded of recent surgery, but at one point pulled back left fist defensively.

On June 7, 2013 at 10:30 AM, RN 3 was interviewed. RN 3 stated that Patient 5 had a history of dementia (cognitive impairment). RN 3 stated that the patient required a sitter because Patient 5 was confused and attempted to pull out the intravenous line (IVL) and the indwelling catheter (IC). RN 3 also stated that the patient would try to get out of bed unassisted to go to the restroom because he needed to be reminded that he had an indwelling catheter. RN 3 stated that there was a sitter (certified nursing assistant [CNA] 1) in the room providing care for Patient 5 and his roommate. When asked if Patient 5 could potentially harm himself if he pulled out his IVL, IC or got up out of bed unassisted, she stated, "yes."

On June 7, 2013 at 11:15 AM, the Telemetry Unit Director (TUD) was interviewed. The TUD stated that the physicians order for a "sitter," was not considered 1:1 observation, because the patient did not exhibit behaviors, such as suicidal ideations. She confirmed that the sitter assigned to Patient 5 had also provided care and services for his roommate (1:2). She confirmed that Patient 5 was confused and attempted to pull out his IVL, indwelling catheter and attempted to get out of bed unassisted. The TUD reviewed the hospital's policy regarding the use of a sitter (1:1 observation) and confirmed that the behaviors that Patient 5 exhibited could potentially be harmful to the patient.

On June 7, 2013 at 12:30 PM, CNA 1 was interviewed. When asked what behaviors Patient 5 exhibited, she stated that the patient would try to get out of bed unassisted, pull out his IVL and indwelling catheter. CNA 1 stated that she needed to constantly remind Patient 5 that he had an indwelling catheter so that he would not try to get up to go the restroom unassisted. CNA 1 confirmed that she did not provide 1:1 care for Patient 6, because she also cared for his roommate (1:2). She confirmed that if she was caring for Patient 6's roommate when Patient 6 pulled out his IVL, indwelling catheter or got up out of bed unassisted there was a potential for harm for Patient 6.

On June 7, 2013 at 12:30 PM, the CNO was interviewed. When asked if a patient that exhibited behaviors that could potentially bring harm to the patient required a sitter, she stated, "yes." She confirmed that if the sitter was caring for Patient 6's roommate when Patient 6 pulled out his IVL, IC or got up out of bed unassisted there was a potential for harm for Patient 6. The CNO reviewed the hospital's policy and procedure titled, "One to One (1:1) Observation (Sitter)," dated December 2012. She confirmed that according to the policy Patient 6 met the criteria for a 1:1 sitter, not 1: 2.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital failed to ensure that the nursing staff
developed and kept current a nursing care plan for 2 of 21 sampled patients (Patients 2 and 5), based upon nursing care needs, ongoing nursing assessments and responses to provided interventions. These failures had the potential to affect the health outcomes and quality of care provided per the patients' wishes for a universe of 159 patients.

1. For Patient 2, the hospital failed to ensure that nursing staff developed a plan of care for the patient who was identified as having an infection of the nares (nostrils).

2. For Patient 5, the hospital failed to develop a patient care plan based on the patient's Advanced Directives (AD) to address the patient's potentially harmful behaviors to himself .

Findings:

1.) An observation of Patient 2, a record review and a concurrent interview was conducted on June 4, 2013 at approximately 2:15 PM with the with Registered Nurse (RN) 7. The record review indicated that Patient 2 was admitted on [DATE] with diagnoses which included chest pain, myocardial ischemia (a painful heart condition caused by lack of blood flow to the heart) and diabetes type 2 (Also known as adult onset diabetes which is a disorder resulting from the body's inability to properly use or make enough insulin [a hormone that helps regulate sugar and starches required for energy]). Patient 2 was lying in bed and was on contact isolation (isolation techniques used to prevent the spread of infection and diseases to other patients and individuals). When RN 7 was asked why Patient 2 was on contact isolation, she stated that she was not certain if the patient was positive or if the patient had a history of MRSA (Methicillin-Resistant Staphylococcus aureus - a bacteria that is extremely resistant to most antibiotics and is responsible for outbreaks of untreatable infections among patients in hospitals, World English Dictionary, 2013).

During an interview with the ICU Supervisor and a concurrent record review, on June 4, 2013, at approximately 2:15 PM, indicated that Patient 2 was positive for MRSA. The ICU Supervisor stated that the MRSA was in the nares. Further review of the medical record revealed that there was no care plan (care plans outline the nursing care to be provided to a patient. It is a set of actions nurses implement to resolve or support patient problems, serves as a guide in the ongoing provision of nursing care and assists in the evaluation of patient care). The ICU Supervisor stated that the hospital did not contain "actual infection" care plans only risk of infection and it was something that they would be addressing because if a patient had an actual infection then it should be identified in a care plan. In this case, the ICU Supervisor stated, Patient 2 did have an actual infection. Additionally, Patient 2's care plan did not address the isolation precautions for the patient.

During a record review, on June 4 at approximately 2:30 PM, of the hospital policy titled, "Standards of Care," indicated that the purpose of the policy was to "Describe a competent level of nursing care, using the nursing process, involving assessment, diagnosis, outcome identification, planning, implementation and evaluation. The nursing process includes all significant actions taken by nurses in providing care to all patients, and forms the foundation of clinical decision making ...STANDARD IV: A plan of nursing care will be developed for each patient based on prescribed nursing actions to achieve the goals. The plan for nursing care will describe a systematic method to attain the goals. 1. The plan will include priority setting for appropriate nursing actions. a) The plan will contain all current problems ...






2a. On June 7, 2013, Patient 5's medical record was reviewed with RN 3. A review of the face sheet noted that Patient 5 was admitted to the hospital on June 5, 2013 for an abdominal aortic aneurysm (ballooning of the abdominal aorta [a major blood vessel]) repair.

A review of the Advance Directive Acknowledgement, dated June 5, 2013 was conducted and noted that the patient had an Advance Directive for Health Care. The name of the patient representative was listed on the document.

A review of the blank form, "Advance Directives Alert, Attention Primary Nurses," was conducted with RN 3. The form noted that, "this patient has an AD and we need a copy for the chart. Please follow the steps below:

a. Inform patient that we need a copy of their AD
b. Document your efforts to obtain AD from patient or family member in the nurses note
c. Obtain a copy and place under AD tab in patient's chart
d. Contact admitting ... after you obtain a copy ..."

A review of the medical record failed to show documented evidence that the primary nurses informed the patient or a patient representative that a copy of the patient's AD was required for the chart. RN 3 confirmed the finding.

On June 7, 2013 at 11:15 AM, the Telemetry (monitoring of the heart's function) Unit Director (TUD) was interviewed. She reviewed the patient's medical record and was unable to locate the patient's Advance Directive for Health Care. She confirmed the finding and stated that if the nurses spoke with the patient representative regarding bringing in a copy of the AD it should have been documented in the nurses' notes.

b. On June 7, 2013, Patient 5's medical record was reviewed with RN 3. The review of the face sheet noted that Patient 5 was admitted to the hospital on June 5, 2013 for an abdominal aortic aneurysm (ballooning of a large blood vessel) repair.

A review of the physician admission orders, dated June 5, 2013 noted that the patient's physician orders (PO) included orders for intravenous fluids (catheter inserted into the vein for fluid administration), indwelling catheter (tube inserted in the bladder to drain urine) and a sitter (1:1 direct observation).

On June 7, 2013 at 10:30 AM, RN 3 was interviewed. RN 3 stated that Patient 5 had a history of dementia (cognitive impairment). RN 3 stated that the patient required a sitter because he was confused and attempted to pull out the intravenous line (IVL) and the indwelling catheter (IC). RN 3 also stated that the patient would try to get out of bed unassisted to go to the restroom because he needed to be reminded that he had an indwelling catheter.

On June 7, 2013 at 11 AM, RN 3 confirmed that the medical record did not contain a plan of care that reflected the patient's disorientation that was manifested by his attempts to pull out the intravenous line (IVL), the indwelling catheter (IC) and get out of bed unassisted.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the facility failed to ensure that all Intensive Care Unit (ICU) Registered Nurses (RNs) administered titratable (incremental increases to a medication until an optimal therapeutic level is obtained) intravenous (IV) medications and IV vasopressor medications (potent medications used to help increase blood pressure if given incorrectly, can cause too much increase in blood pressure or, if not given in a sufficient amount, can prevent a therapeutic blood pressure) to patients' in a safe manner and with proper guidance. As a result, 2 RNs (RN 7 & 8) administered IV titratable medications and a vasopressor to 2 of 21 sampled patients, (Patients 1 & 2), in a universe of 159 and titrated the medication without proper guidance and complete physician orders. This failure had the potential to adversely affect Patients 1 & 2's health and contributed to the unsafe administration of potent (powerful) medications and unsafe facility practice of IV administration of vasopressors.

Findings:

1.) A record review of Patient 1 was conducted on June 4, 2013, at 3:15 PM and revealed that the patient was admitted on [DATE], with the diagnoses which included Coronary Artery Disease (a narrowing or blockage of the arteries and vessels that provide oxygen and nutrients to the heart).

A record review of Patient 1's physician orders, dated June 4, 2013 at 1:35 PM included the following medication order: Nitroglycerin (a potent medication used to open the arteries and helps relieve chest pain) IV to maintain a MAP (mean arterial pressure - an average blood pressure) between 65 and 75. The order was incomplete and did not include an initial dose, a max or stop dose for the medication. Additionally, there were no specific orders written to guide the RNs on how much to titrate the Nitroglycerin or how often to titrate it.

A record review of Patient 1's physician orders, dated June 4, 2013 at 2 PM included the following medication order: Dopamine (a medication that increases heart rate and strengthens the heart's contraction) - 5 micrograms to keep cardiac index (a measurement of an individual's blood flow and relates it to how their heart is performing) greater than 2.2. The order was incomplete and did not include an initial dose, a max or stop dose for the medication. Additionally, there were no specific orders written to guide the RNs on how much to titrate the Dopamine or how often to titrate it.

An interview was conducted with RN 8, on June 4, 2013, at 3:30 PM. When she was asked about the referenced medication orders, she stated, "There are no specific titrating orders, we (referring to the ICU RNs) titrate according to who the RN is and primarily the patient's needs." RN 8 also stated, "I worked at...(provided another hospitals name), I know where you're going with this. I knew the time was coming. The doctors will have to get used to it. They don't like such specific orders. It's going to take some educating."

An interview was conducted with an ICU Charge Nurse on June 4, 2013, at 3:30 PM to discuss the Dopamine and Nitroglycerin orders. The ICU Charge Nurse stated that the physicians' do not write titratable orders and realized that the orders were incomplete orders but that was how it was done at this hospital.


2.) A record review of Patient 2 and a concurrent interview were conducted on June 4, 2013 at approximately 2:15 PM with the Intensive Care Unit (ICU) Supervisor. The record review indicated that Patient 2 was admitted on [DATE] with diagnoses which included chest pain, myocardial ischemia (a painful heart condition caused by lack of blood flow to the heart) and diabetes type 2 (also known as adult onset diabetes which is a disorder resulting from the body's inability to properly use or make enough insulin [a hormone that helps regulate sugar and starches required for body energy]).

A record review of Patient 2's physician order dated June 3, 2013, at 10:55 AM indicated the following: "Levophed (a potent IV medication used to treat life-threatening low blood pressure and administered in an ICU setting where the patient can be closely monitored) gtt (drip), keep SBP (systolic blood pressure - Refers to the pressure on the arteries as the heart contracts) greater than 90 mmHg (millimeters per mercury)." The order was incomplete and did not include an initial dose, a max or stop dose for the medication and did not include the concentration of the medication. Additionally, there were no specific orders written to guide the RNs on how much to titrate the Levophed or how often to titrate it.

An interview was conducted with RN 7 on June 4, 2013, at 2:25 PM to discuss the Levophed physician order. RN 7 stated that she realized that the order was incomplete but that was how they (referring to the physicians) do it at the facility. She also stated that the physicians did not write titration orders and that each RN titrated the dose differently, depending on their experience and the patient's blood pressure response to the medications and the patient needs.

A record review on June 4, 2013, at 4 PM, of the hospital policy titled, "Medication Administration Hospital-wide Plan," documented that following: "...All medication orders, must be dated, timed and signed by the ordering physician. Telephone and verbal orders must be completed with the date, time, name and strength of medication, route of administration, dosage and frequency of administrations, and signed by the prescriber or person eligible to accept verbal order within 48 hours..."

A record review on June 4, 2013, at 4:40 PM, of the "Medical Staff General Rules & Regulations," revealed the following, "...DIAGNOSTIC AND THERAPEUTIC ORDERS: "...3.3 ORDER WRITING: All physician's orders shall be written clearly, legibly and completely....Orders which are illegible or improperly written will not be carried out until rewritten or understood by the nurse..."

A Quality Assurance Performance Improvement (QAPI) interview, was conducted on June 5, 2013, at 2 PM. Two hospital staff that attended the interview included the Chief Nurse Officer (CNO) and the Chief Medical Officer (CMO). One of the topics discussed included the administration of IV titratable and vasopressor medications which were incompletely written and did not contain proper guidance for the ICU RNs who administered the medications. The CNO stated that they were aware that the orders were not complete but that it was the hospital's standard of practice and the way that the physicians wrote those types or orders (referring to the titratable medications). The CNO and the CMO stated that they could understand how without proper titration orders, it could be unsafe for RNs who did not have the experience administering those medications.

A Governing Body interview was conducted on June 6, 2013 at 10:50 AM. Two hospital staff that attended the interview included the Vice Chair of Medical Staff and a Quality Manager. When asked why the hospital did not identify that ICU RNs were titrating IV medications without complete orders or proper titration guidance. They stated that they were aware that the nurses were titrating the medications but that it had been a standard of practice and that the practice was now going to be changed.
VIOLATION: RADIOLOGIC SERVICES Tag No: A0528
Based on interview and record review, the hospital failed to ensure that Radiological Services were provided according to the needs of all patients.

Radiological Services failed to ensure:

That a positive right leg deep vein thrombosis (DVT - a blood clot) ultrasound (a modality to visualize internal structures of the body) result, for Patient 16, was reported to a clinical or medical staff member. This failure contributed to the death of Patient 16 and had the potential to affect the quality of care and services provided to other patients who required Radiological Services (Refer to A-0529).

The cumulative effect of this deficient practice contributed to the death of a patient and had the potential to affect the health of any patient requiring radiologic diagnostic modalities for a universe of 159 patients.
VIOLATION: SCOPE OF RADIOLOGIC SERVICES Tag No: A0529
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital failed to ensure that Radiological Services were provided according to the needs of 1 of 21 sampled patients (Patient 16) in a universe of 159, when it failed to report a positive right leg deep vein thrombosis (DVT - blood clot) result to the hospital's clinical or medical staff. This failure contributed to the death of Patient 16 and had the potential to affect the quality of care and services provided to other patients who required Radiological Services.

Findings:

An interview was conducted on June 3, 2013, at approximately 3:30 PM, with the Director of Imaging Services, Vice President of Operations, Accreditation Risk Manager and Risk Coordinator 1. They stated that on November 21, 2012, Patient 16 was ambulating prior to being discharged home, with a Physical Therapist. Patient 16 took a few steps, collapsed and required cardiopulmonary resuscitation (CPR). After the two CPR attempts, Patient 16 expired. They also stated that the day before Patient 16 was going to be discharged , on November 20, 2012, the physician (Medical Doctor [MD] 13) ordered an Ultrasound (US) Venous Doppler (a test which uses high frequency sound waves [ultrasound] that evaluates the flow of blood through the veins within the arms or legs), due to pain and swelling of the patient's legs. According to Risk Coordinator 1, the test result was positive for a right leg DVT, however, the positive findings were not reported to MD 13 or to the nurse. Risk Coordinator 1 stated that a Clinical Laboratory Specialist (CLS) documented that he informed the primary Register Nurse (RN) but got busy and never reported the findings to anyone. Risk Coordinator 1 stated that MD 13 did not become aware of the findings until November 21, 2013, the day the patient collapsed and required CPR. Risk Coordinator 1 stated that MD 13 would have known of this signinficant condition, Patient 16's discharge and course of treatment would have been different. According to Risk Coordinator 1, Patient 16 discharge would have been postponed and the patient would have been on bed rest. Risk Coordinator 1 stated that Patient 16's death was reported to the Coroner's Office.

A record review was conducted on June 3, 2013 at approximately 3:30 PM, of the hospital Root Cause Analysis (RCA - an investigation that identifies a class of problem solving methods aimed at identifying the root cause of a problem or incident). The investigation documented the following: "...Radiologist nor Technician communicated the findings. Positive finds of US not noted in synapse/PACS (the hospital's Picture Archive Computer System) or called to RN or MD. Technician became busy after downloading other images for MD to read and didn't notify RN or MD as documented on US worksheet. Nursing staff inconsistent in reviewing pending orders to see if they are completed or any note in PACS/Synapse. Lengthy turnaround time 72 hours for tests to be dictated ..."

During an interview, on June 3, 2013, at approximately 3:30 PM, with the Director of Imaging Services, he stated that in November 2012, when Patient 16 expired, DVT results were not considered a critical value and therefore were not immediately reported to the clinicians. The Director also stated that since that incident, they have modified their policy to include DVT results as critical values and have made changes to ensure that the physicians are immediately informed of the findings.

A record review was conducted on June 3, 2013, at approximately 3:30 PM, and indicated that the patient was admitted on [DATE] with diagnosis which included, Peritonitis secondary to ruptured diverticulitis colon (an infection caused from a ruptured intestine), sepsis (a bacterial infection in the bloodstream or body tissues) and possible abscess (A swollen area within body tissue, containing an accumulation of pus). Patient 16 also had a history of open heart surgery, high blood pressure, obesity and coronary artery disease (fatty deposits inside the arterial walls which cause narrowing of the arteries).

A record review was conducted on June 3, 2013, at approximately 3:30 PM, of Patient 16's "Bilateral Lower Extremity Venous Duplex" results, dated November 20, 2012. The study's findings were as follows: "In the right leg, there is extensive but non-occlusive deep venous thrombosis in the right common femoral vein ..."

A record review was conducted on June 3, 2013 at approximately 3:30 PM, of Patient 16's Death Summary and course of hospitalization which was dictated by MD 13, on November 21, 2012. The report indicated that the patient was admitted with abdominal pain and was found to have a perforated viscus (a perforation within the abdominal cavity). Patient 16 had an emergency surgery and was transferred to the Intensive Care Unit (ICU). According to the summary, the patient eventually was transferred out of ICU and was progressing "okay." Patient 16 was provided physical therapy, was placed on Lovenox (a blood thinner) but had problems with ambulation. The Physical Therapy staff had been ambulating Patient 16 every day and the surgeon cleared the patient for discharge. On the day prior to the patient's death, November 20, 2012, MD 13 noticed the patient had swelling and edema of the bilateral lower extremities and scrotal swelling and decided to obtain a Doppler Ultrasound. MD 13 also documented the following, "...We did not get the result until the patient has been coded. On the morning of death, the patient was doing well. Awake, alert, oriented X4 (the patient knew his name, the time, the place and what was occurring around him) and I told him that I need to wait for the result of the Ultrasound before I discharged him. All of a sudden, I got paged that the patient, while he was walking with the therapist, he felt dizzy and then crashed on the floor and became unresponsive, and Code Blue started...During the code also, I asked the radiologist to read the ultrasound for me, and they detected only the right lower extremity DVT, so we are assuming that the patient had a massive PE (Pulmonary Embolism - a blockage of an artery in the lungs which could be caused by a blood clot in a vein, especially a vein in the leg or in the pelvis (hip area) and that is why he had a code and all of a sudden, crashed and passed away, in spite of being on prophylactic Lovenox ..."

A record review was conducted on June 3, 2013, at approximately 3:30 PM, of an emergency room Physician's report. The physician responded to Patient's 16 Code Blue (A medical emergency in which a team of medical personnel work to revive an individual in cardiac arrest) on November 21, 2012. The report indicated the following: "I responded to a CODE BLUE situation on this patient where apparently he became hypotensive and lost his pulse. When I arrived, there was Dr ....(a physician's name provided), who was conducting the code, and who was subsequently replaced by Dr ...(a cardiologist) who is very aware of this patient and he told me that this patient was positive for DVT of the right leg and also the echo (a heart test) of the heart showed that there was a right ventricular dilatation (an enlargement of the heart chamber that pumps blood away from the heart) and the patient most likely had a pulmonary embolism ..."

The Coroner's Autopsy Report was reviewed and documented the "Cause of Death: (A) Pulmonary Embolus Due to (B) Right Leg Deep Venous Thrombosis and (C) Perforated Viscus."
VIOLATION: SURGICAL SERVICES Tag No: A0940
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observations, interviews and record review, the hospital's Surgical Services failed to ensure that provided care and services achieved the highest standards of medical practice and patient care by failing to ensure the following:

1. The hospital failed to coordinate services and delegate responsibility between the plastic surgeon and orthopedic surgeon, as evidenced by the untimely removal of the black vacuum sponge from Patient 21's left hip, which resulted in Patient 21 developing a wound infection and a subsequent hospitalization for treatment and a repeat I&D (incision and drainage.) (Refer to A941).

2. That for one surgical patient (Patient 20), who had surgery at the hospital, the Electro-Surgical Unit (ESU) was checked to verify electrical activity before its use. This failure caused an electrical burn injury to the patient which resulted in the patient undergoing an additional surgical procedure (Refer to A951).
3. The immediate availability of emergency medications that may be needed to treat [DIAGNOSES REDACTED] (MH) according to accepted standards of medical practice and patient care. This failure had the potential for the hospital to be unprepared during life threatening emergency related to a surgical procedure (Refer to A951).

4. That the hospital's sterile processing procedures/practices were consistent with the facility's policy and procedure and the manufacturer's recommended instructions. The hospital failed to routinely clean the interior sterilization chambers. This failure had the potential for the sterilization equipment to malfunction (Refer to A951).

5. That for one surgical patient (Patient 21), who had surgery at the hospital, the Wound Vac Sponge was removed from the surgical site before the patient was discharged home. This failure caused a wound infection and resulted in the patient undergoing an additional surgical procedure. (Refer to A951).

6. That a comprehensive informed consent, which included the names of the proposed procedures, was completed per Medical Staff Bylaws and accepted standards of care, for one surgical patient (Patient 21). This practice increased the risk that a patient may not receive enough information, before having a surgical procedure, to make an informed decision (Refer to A955).

The cumulative effect of these deficient practices had the potential to affect the health and safety for a universe of 159 patients that may require surgical interventions in the hospital.
VIOLATION: ORGANIZATION OF SURGICAL SERVICES Tag No: A0941
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital failed to coordinate services and delegate responsibility between the plastic surgeon and orthopedic surgeon, as evidenced by the untimely removal of the black vacuum sponge (a sealed wound dressing to promote healing) from Patient 21's left hip (1 of 21 sampled patients), which resulted in Patient 21 developing a wound infection and a subsequent hospitalization for treatment and a repeat I&D (incision and drainage (a surgical procedure).)

Findings:

A record review conducted on June 4, 2013 revealed Patient 21 was a [AGE] year old male, admitted to the hospital on April 7, 2012 for severe sepsis (a potentially life-threatening complication of an infection) secondary to urinary tract infection, unstageable decubitus ulcers (full thickness tissue loss in which actual depth of the ulcer the cannot be determined), and anemia with subsequent re-admission to the hospital on July 31, 2012 for left hip pain and swelling, and shortness of breath.

During a review of the three Operative Reports dated April 15, 2012 revealed the following:
The operative report dated April 15, 2012, dictated at 3:42 PM, indicated that Patient 21 underwent the following procedures:
1. A 14 x 7 cm (centimeter) right stage IV (a full-thickness skin loss with extensive destruction; damage in muscle, bone, or supporting structures) ischial (hip joint) wound debridement (removal of dead, damaged, or infected tissue to improve healing), consisting of debridement of granulation bed tissue debris, all the way down to ischial bone (hip joint) with circumferential (surrounding) contracture (skin pulls together) scar excision (removal by cutting), thus wound depth preparation (removing barriers to healing).
2. Right ischial pressure ulcer bursectomy (surgical removal of an inflamed bursa (fluid-filled sac).).
3. Three liter copious (large quantity) antibiotic pulse lavage (mechanical hydrotherapy (use of water) that uses a pressurized, pulsed antibiotic solution to irrigate and debride wounds) of wound/washout.
4. Application of negative pressure therapy of wide ischial wound, stage 1V ulcer.

These procedures were performed by a plastic surgeon (MD 7). The plan was to "return back to the OR (Operating Room) in the near future for additional dressing change versus flap reconstruction (procedure uses tissue from other parts of the patient's body)."

The operative report dated April 15, 2012 dictated at 3:43 PM, indicated that Patient 21 underwent the following procedures:
1. Exploration of left ischial (hip joint) pressure ulcer (skin lesion).
2. Bursectomy measuring 8 cm x 8 cm.
3. Preparation of wound bed, left ischial pressure ulcer.
4. Debridement of exudative (oozing fluid) material and curetting (surgical instrument shaped like a scoop used to remove tissue from a body cavity) of exudative material over the ischial bone.
5. Washout with pulse lavage and vacuum-assisted closure (negative pressure (suction) device) placement.

These procedures were performed by a plastic surgeon (MD 4). The plan was "for flap reconstruction on Friday."

The operative report dated April 15, 2012 dictated at 5:19 PM, indicated that Patient 21 underwent the following procedures:
1. Incision and excisional (removal by cutting) debridement of left septic hip, with capsulectomy (cutting of a sac that surrounds hip joint) and muscular release (muscle cutting) (40% more difficult than usual due to altered anatomy).
2. Vacuum assisted closure application, left hip.

The report indicated that a vac sponge was placed all the way down to the true acetabulum (cup-shaped part of the hipbone into which the ball-shaped head of the femur (thigh bone) fits) and up to the level of the abductor layer (layer of muscle). The report also indicated another overlying sponge was placed on the abductor layer all the way to the skin.

These procedure was performed by an orthopedic surgeon (MD 1).

Further review of the Operative Report revealed no documented plan of care as to when the vacuum sponge had to be removed. There was no documented evidence that there was a communication and coordination of care between the plastic surgeons and the orthopedic surgeon regarding the plan of care related to the removal of the vacuum sponge to the left septic hip.

During a review of the operative report dated April 19, 2012 dictated at 7:28 PM, revealed that Patient 21 underwent the following procedures:
1. Right-sided ischial wound bed preparation with circumferential scar excision 12 x 8 cm.
2. Right ischial wound bursectomy 12 x 8 cm.
3. Copious 3 L (liter) irrigation with antibiotic solution, pulse lavage on right-sided ischial wound.
4. Right-sided ischial bone biopsy.
5. 40 x 50 cm reverse right gluteal fasciocutaneous rotation of flap (tissue flap that includes skin, subcutaneous tissue (the deepest layer of human skin) and the underlying fascia (tissue that surrounds muscles).).
6. 30 x 20 cm reverse right gluteal muscle flap (portion of muscle transferred with its blood supply to another part of the body).
7. 40 cm multilayer complex repair with retention sutures (used to take pressure off of a patient's other sutures so that a wound does not pull open as it is healing) of the right ischial wound.
8. 10 x 6 cm left-sided wound bed preparation of ischial wound with circumferential scar excision of ischial wound.
9. 10 x 6 cm left ischial bursectomy.
10. Copious 3 L antibiotic pulse lavage irrigation of left ischial wound.
11. Left ischial bone biopsy.
12. 35 x 30 cm reverse left-sided gluteal fasciocutaneous rotational advancement flap for left ischial ulcer coverage.
13. 20 x 15 cm reverse gluteal muscle flap for coverage of left ischial stage 1V ulcer.
14. 35 cm multilayer complex repair of left ischial wound with retention suture of left ischial wound.

These procedures were performed by MD 7. There was no documented evidenced that the vacuum sponge placed on the left hip on April 15, 2012 by MD 1 was removed by MD 7 during the above procedures.

During a review of the clinical record dated July 31, 2012 dictated at 9:04 AM indicated that Patient 21 presented to the hospital for left hip pain and swelling and shortness of breath. The orthopedic surgeon (MD 1) who had seen the patient before was consulted in case the patient needs any drainage of the left hip again.

Review of the operative report dated August 1, 2012, revealed that Patient 21 underwent the following procedures that included:
1. Irrigation and debridement of left hip wound down to bone.
2. Resection of necrotic (death of cells) tissue including bone, left hip.
3. Removal of foreign body (object originating outside the body), left hip.

The report indicated that a CT (Computed Tomography) scan was performed that showed a large collection of fluid going from his left hip all the way above his knee joint. The report also indicated, "there appeared to be a foreign body adjacent to the opening I just made. As I opened up the IT band, I noted that this appeared to be part of a retained VAC sponge."

During an interview with the Director of perioperative Services on June 4, 2013 at 10:35 AM, he stated, "The black VAC sponges were made to be placed superficially, as they encourage granulation."

During an interview with MD 1 on June 5, 2013 at approximately 4:26 PM, MD 1 confirmed and stated that he placed black vacuum sponge on the left hip, vertically to the joint. MD 1 also stated that the sponge are not meant to be left long time and was expected to be removed before the wound flap. MD 1 confirmed and stated that he did communicate to MD 4 and left a voicemail to MD 7 what he did during the April 15, 2012 procedure, however he did not document his conversation with MD 4 and MD 7.

During an interview with the hospital CMO (Chief Medical Officer) on June 6, 2013 at approximately 9:40 AM, CMO stated, "I don't think there was a process in place. There was no formal to formal communication with the doctors."

During an interview with MD 4 on June 7, 2013 at 12:32 PM, MD 4 confirmed and stated that he had conversation with MD 1 to coordinate services but not discussion of care. MD 4 also stated that the black vacuum sponge was not intended for wound with significant distance and/or tunneling (wound has channels extending from the central injury into the surrounding tissue, such as muscle and skin).

A review of the hospital in-service record conducted on November 20, 2012, included the "VAC Therapy Safety Information." The information included, "VAC foam dressings are not bioabsorbable." "Do not force foam dressings into any area of the blind/unexplored tunnels." "Foam left in the wound for greater than the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse events."
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital did not maintain high standards of surgical patient care by failing to ensure the following:

1) That wound vacuum sponges were used according to Manufacturer's instructions for 1 of 21 sampled patients (Patient 21) and that wound vacuum sponges (sealed wound dressings to promote healing) were incorporated into the hospital's sponge & instrument count Policy and Procedures.

2) That the electrosurgical unit (cuts tissue and/or stops the bleeding by coagulating (change a fluid to a solid or semisolid state) the blood) was used according to Manufacturer's instructions for 1 of 21 sampled patients.

3) The immediate availability of emergency medications to treat [DIAGNOSES REDACTED] (a life threatening medical emergency) for 2 of 2 emergency carts.

4) That the sterile processing (a service within the hospital in which medical/surgical supplies and equipment, both sterile and nonsterile, are cleaned, prepared, processed, stored, and issued for patient care) procedures/practices were consistent with the hospital's policy and procedure as well as the Manufacturer's instructions for 6 out of 6 autoclaves (devices that use steam to sterilize equipment used during surgery) .

These failures created an increased risk of a poor surgical outcome for the patient.

Findings:

1. During a review of the hospital Policy and Procedure, titled "Count: Sponge, Sharp, Instrument" revised March 2013 stipulated its purpose: "Sponge, sharp and instrument counts are performed to account for all items and lessen the potential for injury to the patient as a result of a retained foreign body ..." The policy stipulated, "There will be a count performed for all sponges, needles and blade on all surgical procedures ..."

A review of the label for the large black foam packet provided by the Director of Perioperative Services on June 5, 2013 at 8:55 AM revealed an instruction encrypted on the label cover of the packet that indicated "Always count and record number of foam pieces used in wound."

During a review of the manufacturer's instructions, titled "VAC Therapy Safety Information" with copyright 2007 KCL Licensing, Inc stipulated, "Do not place any foam dressing into blind/unexplored tunnels. The VAC White Foam Dressing may be more appropriate for use with explored tunnels. Do not force foam dressings into any area of the wound, as this may damage tissues, alter the delivery of negative pressure, or hinder exudate and foam removal. Always count the total number of pieces of foam used in the wound and document that number on the drape and in the patient's chart. Also document the dressing change date on the drape."

The manufacturer's instruction also stipulated, "VAC Foam Dressings are not bioabsorbable. Always count the total number of pieces of foam removed from the wound and ensure the same number of foam pieces was removed as placed. Foam left in the wound site for greater than the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse events."
During a record review conducted on June 4, 2013 revealed Patient 21 was admitted to the hospital on April 7, 2012 for severe sepsis (a potentially life-threatening complication of an infection) secondary to urinary tract infection, unstageable decubitus ulcers (full thickness tissue loss in which actual depth of the ulcer the cannot be determined), and anemia. During this admission Patient 21 recieved debridement (removal of dead, damaged, or infected tissue to improve healing) of his right and left ischial (hip joint) ulcers and his septic left hip.

Review of the operative report dated April 15, 2012 dictated at 3:43 PM indicated, Patient 21 underwent incision, bursectomy (surgical removal of an inflamed bursa (fluid-filled sac), washout, and vac placement to his right and left ischial ulcer.

Review of the operative report dated April 15, 2012 dictated at 5:19 PM, indicated that Patient 21 underwent incision and excisional debridement of his left septic hip, with capsulectomy (cutting of a sac that surrounds hip joint) and muscular release (muscle cutting). The report indicated that a vac sponge was placed all the way down to the true acetabulum (cup-shaped part of the hipbone into which the ball-shaped head of the femur (thigh bone) fits) and up to the level of the abductor layer (layer of muscle). The report also indicated another overlying sponge was placed on the abductor layer all the way to the skin.

During a review of the hospital Anesthesia Record dated April 15, 2012, revealed no documented evidence of the number of pieces of black VAC foam sponges used during the surgical procedure: ischial and left hip debridement, were counted and accounted for.

During an interview with MD 1 on June 5, 2013 at apprpoximately 4:26 PM regarding the details of the surgery he performed on April 15, 2012 for Patient 21's septic (infected) hip, MD 1 confirmed and stated that he placed one standard black sponge into and one on top of the surgical site, "in the form of a T." MD 1 also stated that the surgical site was then covered and connected to a wound vacuum appliance (create suction to the surface of the wound for better healing.)

During an interview with the Director of Perioperative Services on June 6, 2013 at approximately 10:00 AM, when asked if the OR (Operating Room) staff keep a count of wound vacuum sponges put into the patient's wound, he stated, "We obviously did not do the counting of the sponge, not until this case."

During an interview with MD 4 on June 7, 2013 at approximately 12:32 PM, when asked if the black wound vacuum sponges were counted by the OR staff, MD 4 stated, "No, there was no counting of these type of sponges."

2. Review of the Operator's Manual for the "System 5000 Electrosurgical Unit (ESU)," dated 2010 indicated, "Electrosurgery (surgery using tools that require electricity to make incisions or stop bleeding) can be dangerous to patients, staff and other equipment if misused. Please understand and follow the warnings and cautions that are included in this manual." Also, under "Cautions For Equipment Preparation" the manual indicated, "Confirm all accessories (surgical tools that require electricity, example bipolar) are properly connected to the appropraite receptacles (plug in area) before powering (turning on) the ESU." Also, "Confirm bipolar (tool that uses two poles of electricity) leads are connected only to the bipolar receptacles (plug in area). Connecting bipolar (two poles) accessories to monopolar (one pole) outputs (plug in area) may result in patient injury." Also, under "Cautions for Use: Temporarily unused active electrodes (plugged in and electrically active surgical tools) should be stored in an electrically insulated (prevents the passage of heat or electricity) holster. The unused active electrode (plugged in and electrically active surgical tools) should never be placed on the patient. This is especially important for laparoscopic procedures (surgery performed through small holes in the abdomen, using video) ."

During review of the medical record for Patient 20 on June 5, 2013 it was noted that Patient 20 was admitted to the hospital on July 10, 2012 for robotic assisted laparoscopic (surgery through small holes in the abdomen, using video) surgical removal of a kidney mass.

According to the dictated operative report dated July 10, 2012:

Preoperative Diagnoses: Left renal (kidney) mass.
Postoperative Diagnoses: Left renal mass descending colonic (the last part of the digestive system) thermal injury (damage to tissue from a heat source).
Procedure Performed:

1. Attempted robotic assisted partial nephrectomy (removal of part of kidney).
2. Exploratory laparotomy (larger incision in abdomen to perform surgery).
3. Descending colonic Wedge resection (removal of the damaged portion of the colon in a wedge shape).
4. Fulton partial nephrectomy (removal of part of kidney).

According to the Operative Findings:

"Upon attachment of left arm and the instrument being in close proximity of the colon, for some unexplained reason, the cautery unit began to fire (let out heat created by electricity), even though there was no active activation on the partner physician or staff (without staff pushing the foot pedal). Within 3-4 seconds this problem was recognized because of audible noise from the cautery unit, but by then the heat injury has already occurred. Because the robotic instruments had been rested close to the proximity of the colon. The patient electric shock that was delivered began to score (burn) the serosa (outer covering of the intestine)."

According to the Discharge Summary dictated on July 22, 2012 after the thermal injury to the colon, "Initially, the patient was opened (a larger incision was made and surgery was performed under direct visualization instead of laparoscopically) and the situation was contained by performing a wedge resection (removal of the damaged portion of the colon in a wedge shape) and not have gross contamination (spillage of stool out of colon into sterile abdominal cavity). Because patient did not have a bowel prep (medicine to clean out of the colon before surgery) and regular colon segmental resection, would have required colostomy (surgical diversion of part of bowel out through the skin to allow lower colonic operative site to remain clean during healing) for safety features. The decision was made to perform a wedge resection, contained this situation to make sure there is no extravasation (spillage of stool out of colon into abdominal cavity) and bring her back (to the OR) to undergo segment of colon resection (removal of a complete section of bowel) after a bowel prep."

Because of the colon injury, the patient had a second surgery to thoroughly remove the damaged portion of the colon. According to the dictated operative report dated July 17, 2012:
Preoperative Diagnosis: Left colonic injury
Postoperative Diagnosis: Left colonic injury
Procedure performed: Left colon resection (removal), segmental.

According to the Discharge Summary for Patient 20, dictated July 22, 2012 "She underwent the procedure (left colon resection, segmental) uneventully through the same incision." Patient 20 was discharged home on July 21, 2012 in good condition.

During an interview with the Director of Perioperative Services on June 5, 2013 at 2:00 PM he remembered being called into the Operating Room (OR) after the Electrosurgical Unit fired (let out heat created by electricity) unexpectedly (without staff pushing the foot pedal). Because the bipolar (tool using two poles) was close to the patient's bowel, it caused a burn on the patient's bowel. The Biomedical team (electrical equipment experts) tested the equipment and found it to be in good working order. When asked what caused the unexpected event, the Director of Perioperative Services explained that during the set up of a robotic surgery, one end of the bipolar tool (two poles) is put through the trocar (tool that creates a small opening into the patient's abdomen) while the other end is being hooked up to the robot arm. Once this is done, the surgeon can walk over to the console and take control of the bipolar tool via the robotic arm. Also, he added that because the ESU must be covered for sterility during robotic surgery, this may have contributed to decreased visualization by staff of the proper plug in area for the bipolar (two poles) on the ESU. He stated that the hospital concluded that the cause of the unexpected event was that the bipolar (two poles) was plugged into the monopolar (one pole) plug in area by mistake, which caused the bipolar (two poles) tool to fire unexpectedly. When asked about the sequence of events, it was confirmed that the ESU was turned "on" before the bipolar (two poles) accessory was plugged into the ESU.

During an interview with MD 6 , the assistant surgeon for Patient 20's surgery, on June 6, 2013 at 11:45 PM he stated that he was not in the OR when the bipolar (two poles) accessory fired unexpectedly, however, he arrived in the OR soon after the event. He stated that a repeat of the same unexpected firing of the bipolar tool occurred again in the very next robotic surgery case. In that case however, the bipolar tool was not in the trocar (tool that creates a small opening into the patient's abdomen) and therefore the patient did not become injured. Because of this second occurrence, the Biomedical team (electrical equipment experts) was asked to test the electrical equipment including the ESU and the bipolar accessory. The equipment was tested and was found to be in good working order. When MD 6 was asked if the bipolar tool should have been plugged into the ESU and tested before the surgeon connected the bipolar to the robotic arm, he answered "yes, they should have set up the equipment first." When asked if he agreed that the bipolar accessory should not have been placed through the trocar and into the patient during set up, he said "yes, and we can change that." He added that there are no laparoscopy (surgery through small holes in the abdomen, using video) policies and procedures. He stated that he will make sure it gets done (policies and procedures)."





3. [DIAGNOSES REDACTED] (MH) is a life threatening emergency associated with the use of succinylcholine (a medication used to relax muscles during surgery) and anesthetic gases used during surgery. MH is characterized by a rapid rise in body temperature that can be life threatening, and can result in an irregular rhythm (heart beat). The [DIAGNOSES REDACTED] Association of the United States (MHAUS), a nationally recognized organization has published (MHAUS 2013) recommended medications to be contained in an MH emergency kit for the treatment of MH.

During an observation of the MH emergency cart #1, on June 4, 2013 at 3:50 PM, located in the main hospital ' s surgical department, with the Director of Perioperative Services present, the following MHAUS recommended medications were not available on the cart:
5 vials of Sodium bicarbonate (8.4%) 50 ml/vial (an electrolyte (minerals in blood) replenisher and systemic alkalizer (agent that counteracts or neutralizes acidity),

2 vials of Dextrose (50%) 50 ml/vial (a fluid and nutrient replenisher),

1 vial of Regular Insulin (a hormone) 100 units/ml (refrigerated medication),
3 preloaded syringes of Lidocaine (2%) 100 mg/5 ml or 100 mg/10 ml
3,000 ml of refrigerated cold saline solution
During a concurrent interview and record review with the Director of Perioperative Services, he verified that MH medication contents report noted that the drug box was last filled by the hospital ' s pharmacy department on March 26, 2013.

An observation was done of the MH emergency cart #2, on June 4, 2013 at 4:45 PM, located in the hospital ' s out-patient surgery department pavilion, with the Nurse Manager present. The following MHAUS recommended medications were not available on the cart:
5 vials of Sodium bicarbonate (8.4%) 50 ml/vial
2 vials of Dextrose (50%) 50 ml/vial
1 vial of Regular Insulin 100 units/ml (refrigerated medication)
3 preloaded syringes of Lidocaine (2%) 100 mg/5 ml or 100 mg/10 ml (a local anesthetic to induce the absence of sensation in part of the body)

3,000 ml of refrigerated cold saline solution (an electrolyte replenisher)

During a concurrent interview and record review with the Nurse Manager of the out-patient surgery department pavilion, she verified that MH medication contents report noted that the drug box was last filled by the hospital ' s pharmacy department on March 26, 2013.

During an interview, on June 6, 2013 at 1:45 PM, with the hospital ' s Acting Director of Pharmacy regarding the medications stocked in the MH emergency cart #1 and cart #2, she stated that the hospital had used an outdated published MHAUS recommended medication list. The further stated that the hospital does not and the pharmacy department does not have policies and procedures regarding the medications to be stocked in the MH emergency carts.

4. During a tour of the sterile processing department, on June 4, 2013 at 11:55 AM, with the Manager of the sterile processing department present, two large capacity autoclave machines (devices that use steam to sterilize equipment used during surgery) were observed. One of the machines, autoclave #8, was observed to have a sticker which noted " machine to be cleaned every 6 months - last cleaned 11/13/11 " .

During an interview with the instrument technician (IT 1), on June 4, 2013 at 12:00 PM, she stated that the department does not keep a tracking record of when the autoclave machines are cleaned. IT 1 stated that the autoclave machines are cleaned " during down times " . IT 1 stated that when the machines are cleaned, the outside of the machine is wiped down and debris (tags that have fallen off the surgical instrument packages) would be removed from the inside of the machine.

During a concurrent interview with the Manager of the sterile processing department, he verified that the department does not keep a tracking record of when the autoclave machines undergo a wipe-down cleaning. The Manager stated that he had contacted the hospital ' s equipment maintenance provider, via e-mail about two weeks prior and is awaiting a response regarding a cleaning date of the autoclave machines. The Manager stated that the two large capacity autoclave machines have not been deep cleaned for over one year.

Record review, on June 4, 2013 at 12:15 PM, of the e-mail sent by the Manager of the sterile processing department to the hospital ' s equipment maintenance provider noted " ...the autoclaves have not been cleaned in over a year. The flashers (two small capacity autoclave machines, autoclave #9 and autoclave #10, that are used for Flash sterilization; processing unwrapped surgical instruments with a 3 minutes exposure at 132-135 degrees Celsius [270 - 275 degrees Fahrenheit] for nonporous items, 10 minutes exposure for porous items) have not been cleaned since 2008 .... "

During a telephone interview, on June 5, 2012 at 10:05 AM, with the Clinical Education Specialist employed with the hospital ' s autoclave machine manufacture; Steris Corporation, she stated that routine cleaning, weekly or bi-weekly, is determined at the facility ' s discretion but cleaning should not go beyond a monthly basis. If routine cleaning is not preformed than professional cleaning on an annual basis is recommended.

During a tour of the sterile processing department of the out-patient surgery department pavilion, on June 5, 2013 at 11:05 AM, with the Nurse Manager of the out-patient surgery department pavilion present, one large capacity autoclave machine, autoclave #1, and one small capacity autoclave machine, autoclave #2, were observed.

During an interview with the instrument technician (IT 2), on June 5, 2013 at 12:00 PM, she stated that the department does not keep a tracking record of when the autoclave machines are cleaned. IT 2 stated that she cleans the autoclave machines every Monday morning by wiping down the outside of the machine and using a cleaning solution on inside chamber and removes debris from the inside of the machine. During a concurrent interview with the Nurse Manager of the out-patient surgery department pavilion, she verified that the department does not document when routine cleaning of the two autoclaves is performed.

Record review on June 6, 2013, of the hospital ' s policy and procedure titled " Autoclave Steam Sterilizer, Cleaning of " , dated 3/2013, noted " Policy, an autoclave/sterilizer is an apparatus for sterilizing objects by steam under pressure two hundred seventy degrees Fahrenheit (132 degrees Celsius) and fifteen (15) pounds of pressure for four (4) minutes. Weekly cleaning of the autoclave/sterilizer is necessary to keep the apparatus clean and away from scale and rust. "

During an interview, on June 7, 2013 at 2:50 PM with the Director of Perioperative Services, he verified no documentation of routine cleaning exists for a total of six (6) autoclaves used to sterilize the surgical equipment used in the main hospital and in the out-patient surgery department pavilion. The Director of Perioperative Services provided the dates when each of the six autoclaves were cleaned:

For the out-patient surgery department pavilion:
Autoclaves # 1 and # 2 last cleaned November 30, 2011.

For the main hospital surgical department:
Autoclave # 8 last cleaned November 30, 2011.
Autoclaves # 9 and # 10 last cleaned October 28, 2008
Autoclave # 2, there was no recorded date of the last cleaning.
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on interview and record review, the hospital failed to ensure that a comprehensive informed consent, which included the names of the proposed procedures, was completed per Medical Staff Bylaws and accepted standard of care, for one surgical patient (Patient 21). This practice increased the risk that a patient may not receive enough information, before having a surgical procedure, to make an informed decision.

Findings:

Review of the hospital policy entitled "Consents and Informed Consents," reviewed 7/2011" indicated, "Purpose: To ensure that the patient's fundamental rights of self-determination over his/her body or property are honored." Also, Informed consent is consent based on the disclosure of all material information that a reasonable person would want to have in order to make a decision about the treatment."

Review of the "Medical Staff General Rules & Regulations," undated, indicated , "4.1 Informed consent: It shall be the physician's responsibility to obtain an informed consent for any procedure or treatment from the patient or his/her legally constituted representative. Evidence of an informed consent shall be documented in the medical record by the physician prior to the commencement (beginning) of the procedure." "4.2 Consent: the consent form must state the name of the involved physician and/or operating surgeon and the name of the proposed procedures and/or nature of the treatment. It is to be understood that the informed consent is delivered only when the patient has been advised in lay terminology of the calculated risk, or complications, injury or even death, from known and unknown causes and no warranty or guarantee has been made as to the result or cure". "The practitioner who is performing the procedure must document the consent discussion, listing the benefits, risks and alternatives."

According to the Society of Laparoendoscopic Surgeons, Prevention & Management of Laparoendoscopic Surgical Complications, 3rd Edition, August 10, 2012, Chapter 66, "Complications of Laparoscopic and Robotic Nephron Sparing Surgery" (surgery through small holes in the patient's abdomen, using video and use of a robotic assistant) indicated, "Preoperatively, patients should be consented for the possibility of radical nephrectomy (removal of kidney) or open surgery (surgery performed through a large vertical incision)."

Review on June 5, 2013 of the "Provider Certification of Informed Consent, dated 7/10/2012", for Patient 20, indicated under "For the following surgical, diagnostic or therapeutic procedure(s): Robotic partial left nephrectomy (partial removal of kidney using robotic assistant)." There was no other information written in this section. Also, "I, the undersigned physician, hereby certify that I have discussed the procedure described above with this patient...including...A description of attendant discomfort, complications, or risks to the patient that may occur. A description of particular discomfort, risks or complications, and their management and prevention.."

During an interview on June 6, 2013 at 11:25 AM with MD 2, he was asked about the brief surgical consent documented in Patient 20's chart. He stated that in the catheterization lab department, all of the possible procedures (example: the need to change from small holes in the abdomen to a larger vertical incision) must be put on the consent form. Also, he added that the form must be complete before the patient can be brought to the procedure table. When asked what he expected, he answered that he "expected a complete consent." He also acknowledged that the consent for Patient 20 was not complete.

During an interview on June 6, 2013 at 11:45 AM with MD 6, when he was asked about the brief consent form in Patient 20's chart, he agreed that the "consent should be more complete, and I will make sure that consents are more complete in the future."