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Based on document review, interview and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.30 Utilization Review
CFR 482.42 Infection Control

A. Based on medical record review and staff interviews, it was determined that the facility failed to ensure that all patients are informed, involved in care planning and treatment, and able to request or refuse treatment.
Findings include:
1. Review of Medical Record #1, on 10/29/2013, in the presence of Staff #1 indicated the following:
a. Date of Surgery: 12/02/2009.
b. Operative Report: Brief History: "This is an (age of Patient #2) female, who underwent a right mastectomy and tissue expander placement in the right breast approximately 8 months ago. The patient underwent full expansion and was now ready to undergo phase II of her breast reconstruction... She did not want to be a very large size ... 'most likely she was aware' that she was going to get 500 to 700 mL implant on the right side due to the large width of her chest. A small implant would not look as aesthetically pleasing ... ."
2. There was no evidence of documentation in the medical record that Patient #1 was informed of the physician's plan to use a larger implant due to the large width of the patient's chest.
3. Staff #1, Staff #18, Staff #21 and Staff #26, confirmed the above findings.


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B. Based on medical record review, review of facility policy and procedure, and staff interview, it was determined that the facility failed to ensure the proper implementation of the informed consent policies and procedures for patient's undergoing Nuclear Medicine procedures.

Findings include:

Reference #1: Facility Administrative Policy & Procedure #: C-9, titled, "Consent, Informed" states, "Purpose: To establish mutual understanding between the patient and the physician or other licensed independent practitioner who provides care, treatment or services about the care, treatment, and services that the patient receives...To outline circumstances when a surrogate decision maker, rather than the patient, may give informed consent...Policy: This policy is intended to establish basic guidelines for physicians and hospital personnel to follow in obtaining valid consents as they pertain to the care of the patients. Consent forms and releases, when signed by patients or their Surrogate Decision Makers, serve as evidence that an informed consent has been obtained...1. Prior to any Procedure, the physician must obtain informed consent from the patient or Surrogate Decision Maker. For a consent to be valid, it must be the result of an informed decision making process. In addition, the physician must provide the patient or Surrogate Decision Maker necessary information to enable him/her to evaluate a proposed Procedure before agreeing to it. 2. The licensed physician, by virtue of education and training, has the knowledge to discuss and disclose the nature, risks, benefits and alternatives for Procedures requiring informed consent and answer any resulting questions before the licensed physician begins any such course of treatment. This knowledge is extended to nurse anesthetists for anesthesia administration, nurse midwives for obstetrical care and/or vaginal delivery and nurse practitioners with prescriptive authority for medications that require informed consent...II. Informed Consent: 6. It is the responsibility the physician providing the procedure to discuss the elements of informed consent with the patient and/or Surrogate Decision Maker. The informed consent process is documented on a consent form which musts be completed by the physician...7. It is preferred that the consent form be signed by the patient or the Surrogate Decision Maker at the time the procedure is explained by the physician...8. Staff shall serve as witness to the signature only and are not to discuss/explain the contents of the informed consent. All questions must be referred to the physician...III. Consent by a Minor or For a Minor: All patients under the age of 18 years shall have their consents signed by at least one (1) parent or patient's legal guardian..."

Reference #2: Facility Radiation Control Program Policy #29, titled "Pregnant or potentially pregnant patients" states, "Policy: All women of childbearing age (age 12-55) must be asked by the nuclear medicine technologist prior to their examination, as to the possibility of their being pregnant...Procedure: Women of childbearing age (age 12-55) must be asked the possibility of their being pregnant. If a patient suspects pregnancy the following procedure should be followed:...3. A release form must be signed by the patient (if the patient is conscious), prior to performing the procedure..."

1. On 10/30/13, at approximately 10:00 AM, the Nuclear Medicine Department was toured in the presence of Staff #19 , Staff #49, and Staff #50.

2. Staff #50 stated that Nuclear Medicine procedures do not require informed consent except in the case of minors and women who have confirmed or suspected pregnancies.

3. Staff #49 and Staff #50 stated that the nuclear medicine technologist explains the procedure and the risks and benefits to the patient and/or the Surrogate Decision Maker, then obtains the consent to administer radionuclides to a minor or pregnant patient.

4. Staff #49 and Staff #50 confirmed that the physician does not participate in the process of obtaining informed consent to administer radionuclides to minor or pregnant patients.

Based on document review and staff interview, it was determined that the facility failed to ensure that all patient care data is incorporated into its QAPI program to monitor the effectiveness, safety, and quality of care provided by the nursing staff.

Findings include:

Reference: The facility's Prescriptive Nursing Plan for Patient Satisfaction states, "Guidelines for Patient Rounds [3rd bullet] Rounding will focus on the 4 P's: pain, positioning, personal hygiene and personal belongings close by. [5th bullet] Completed rounding logs will be collected on a daily basis. [6th bullet] All data will be reviewed and trended. Logs will be submitted to nurse managers daily and then to DONs and /or AVPs on a weekly basis."

1. On 10/29/13 at 2:00 PM, the Oncology Unit was toured in the presence of Staff #20 and Staff #33. At 3:00 PM, Room #246 had a patient in the room. On a clip-board hanging on the hallway handrail outside of Room #246, was an hourly rounding log for that patient.

2. The facility's Prescriptive Nursing Plan for Patient Satisfaction was reviewed on 10/30/13 and the aggregated and trended data was requested of facility staff for review.

3. On 10/31/13 the facility was unable to provide any trended data for the hourly rounding logs.

a. During an interview on 10/31/13 at 1:00 PM, Staff #23 confirmed that there is no trended data on the hourly rounding logs.

A. Based on medical record review and staff interviews, it was determined that the facility failed to have a written policy and procedure that guide nursing practices in the assessment and reassessment of the newborn circumcision site.

Findings include:

1. Review of Medical Record #19, #20, #21 and #22, in the presence of Staff #18, indicated the following:

a. Medical Record #19:

i. Progress Note: Circumcision; 10/26/13 at 9:30 AM.

ii. Newborn Flow Sheet: 10/26/13 at 9:30 AM; Circ. [circumcision] done...

iii. Newborn Flow Sheet: 10/26/13 at 1:09 PM; Circumcision-Healing.

iv. Newborn Flow Sheet: 10/26/13 at 2:38 PM; Discharged home...

v. The circumcision site was assessed 3 hours and 39 minutes after the procedure and reassessed 1 hour and 29 minutes later, then the patient was discharged home.

b. Medical Record #20:

i. Progress Note: Circumcision; 10/1/13 at 10:50 AM.

ii. Newborn Flow Sheet: 10/1/13 at 11:45 AM; Circumcision Condition - Red.

iii. Newborn Flow Sheet: 10/1/13 at 12:00 pm; Circumcision completed by (Physician's name) at 10:50 AM... Rechecked site at 11:45 AM... Ready for discharge.

iv. The circumcision site was assessed 55 minutes after the procedure and then reassessed 1 hour and 15 minutes later.

c. Medical Record #21:

i. Newborn Flow Sheet: 10/29/13 at 12:15 AM; Infant circumcised by (Physician's name)... Minimal bleeding noted...

ii. Newborn Flow Sheet: 10/29/13 at 1:30 PM; Circumcision Condition - Bleeding.

iii. Newborn Flow Sheet: 10/29/13 at 6:00 PM; Circumcision Condition - Healing.

iv. Newborn Flow Sheet: 10/29/13 at 6:45 PM; Circumcision Condition - Healing.

v. Newborn Flow Sheet: 10/29/13 at 7:50 PM; Circumcision Condition - Healing.

vi. Newborn Flow Sheet: 10/30/13 at 2:00 PM; Circumcision Condition - Healing.

vii. The circumcision site was assessed 1 hour and 15 minutes after the procedure. The site was then reassessed 5 hour and 30 minutes later, after bleeding was noted.

d. Medical Record #22:

i. Progress Note: Circumcision; 10/12/13 at 9:00 AM.

ii. Newborn Flow Sheet: 10/12/13 at 9:00 AM; Circumcision completed by (Physician's name)... Will continue to monitor...

iii. Newborn Flow Sheet: 10/12/13 at 10:00 AM; Circumcision Condition - Red; Swollen; Healing.

iv. Newborn Flow Sheet: 10/12/13 at 10:50 AM; Circ [circumcision] care done with mother... Circ [circumcision] red, no active bleeding noted, will continue to monitor.

v. Newborn Flow Sheet: 10/12/13 at 2:20 PM; Circumcision Condition - Red; Swollen; Healing.

vi. Newborn Flow Sheet: 10/12/13 at 9:18 PM; Circumcision Care - Cleanse with warm water; Petroleum Gauze.

vii. Newborn Flow Sheet: 10/13/13 at 2:00 AM; Circumcision Condition - Healing.

viii. Newborn Flow Sheet: 10/13/13 at 8:15 AM; Circumcision Care - Petroleum Gauze.

viiii. The circumcision site was assessed 1 hour after the procedure and reassessed 50 minutes later.

2. When asked about the post circumcision assessment and reassessment practice, Staff #64, Clinical Director of the Mother Baby Unit, stated "Nurses instruct the parents to call them when the baby needs a diaper change in order for them to do a post circumcision assessment."

3. Staff #65, a Mother/Baby nurse, stated "We would go back check the circumcision site within the hour. I chart the assessments in the nurses' notes but there is also a check off list we can use."

4. Staff #18 confirmed that there is inconsistency in the post circumcision assessment and reassessment times and that there is no policy and procedure for post circumcision assessment and reassessment.

B. Based on staff interviews and documentation review, it was determined that the facility failed to ensure that a policy and procedure is in place, addressing the monitoring of adverse drug reactions.

Findings include:

Reference #1: Hospira Medication Insert for Morphine Sulfate Injection states, "PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR."

1. When questioned by the surveyor regarding how the practice of monitoring patients who have had Duramoph (Morphine Sulfate Injection), the following statements were made:

a. Staff #66 stated, "We assess patients till the precautions are down, usually 12 hours."

b. Staff #67 stated, "We don't monitor respirations every hour, there's no set time to check respirations, we go in and peak at them (patients).

2. Staff #18 confirmed that there is no policy and procedure on the practice of monitoring patients who have had Duramoph (Morphine Sulfate Injection).

Based on observation, document review and staff interview, it was determined that the facility failed to supervise and evaluate the nursing care for each patient.

Findings include:

Reference: The facility's Prescriptive Nursing Plan for Patient Satisfaction states, "Guidelines for Patient Rounds [1st bullet] Rounding will occur on all patients every hour from 6a-10p ... [4th bullet] The RN caring for the patient will be responsible for assuring that the rounding has occurred as scheduled."

1. On 10/29/13 at 2:00 PM, the Oncology Unit was toured in the presence of Staff #20 and Staff #33. At 3:00 PM Room #246 was observed to have a patient within the room. On a clip-board hanging on the hallway hand rail outside Room #246, was an hourly rounding log for that patient. The last staff initialed time for an hourly round, was documented at 10:00 AM. There was no documented indication of a hourly round for the patient in Room #246 for a five hour period, from 10:00 AM-3:00 PM.

a. The primary nurse for the patient in Room #246 confirmed in interview on 10/29/13 at 3:10 PM, that the patient in Room #246 has been on the unit all day and was not off the unit for any procedures or testing.

Based on medical record review, staff interview and review of facility policies and procedures, it was determined that the facility failed to ensure that all medications administered by nursing personnel are administered in accordance with prescriber orders, medical staff policy, and all Federal and State laws and regulations.

Findings include:

Reference #1: The Nursing Practice Act for the State of New Jersey states, "The practice of nursing as a registered professional nurse (RN) is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as casefinding, health teaching, health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist."
Reference #2: Nursing / Pharmacy Policy and Procedure: "Medications, Administration and Documentation Of" states under Purpose, "To provide standards for administering medications safely, properly and in a timely manner."

1. Medical Record #1 on 10/29/2013, in the presence of Staff #18, indicated the following.
a. Surgical Post Operative Standing Orders dated 4/13/09 at 3:54 PM:
i. Morphine 2 mg IV every 4 hours PRN [2 milligrams every 4 hours if needed] for breakthrough pain.
b. Physicians Order dated 4/13/09 at 4:00 PM indicated:
i. Vicodin I tab PRN for pain 1-4.
ii. Vicodin II tabs PRN for pain 5-8.
c. The Medication Administration Record (MAR) indicated:
i. Morphine 2 mg was administered on 4/13/09 at 5:45 PM and 9:35 PM, and on 4/14/09 at 6:15 AM.
ii. There was no evidence in the MAR that Vicodin was administered.
c. The Pain Flow Sheet indicated the following:
i. Pain Scale of "4" on 4/13/13 at 5:45 PM.
ii. Pain Scale of "6" on 4/13/13 at 9:35 PM.
iii. Pain Scale of "7" on 4/14/13 at 6:15 AM.
2. Staff #18 confirmed that Vicodin was not administered according to the physician's written order and that Morphine was used as the primary pain medication, not just for breakthrough pain, as ordered.

Based on observation and staff interview, it was determined that the facility failed to ensure that outdated and mislabeled medications were not available for patient use.

Findings include:

Reference: United States Pharmacopoeia Chapter 797 (USP-797) states, "Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs [compounded sterile products] shall be used within 1 hour if opened in worse than ISO [International Organization for Standardization] Class 5 air quality and any remaining contents must be discarded."

1. On 10/29/13 at 11:50 AM in the presence of Staff #27, one pre-drawn 5ml (milliliter) syringe containing clear liquid labeled "Lidocaine" and one pre-drawn 5ml syringe containing clear liquid labeled "Ephedrine" were found in the Remote Anesthesia Traveling Box.

a. The labels on both syringes did not indicate the date and time of when the medications were prepared, drug strength, and the initials of the person who prepared the medications.

b. Upon interview, Staff #27 could not determine when the syringes containing the medication were prepared. A beyond-use time of 1 hour from the time of preparation could not be determined. (Reference)

2. On 10/29/13 at 12:00 PM, in the presence of Staff #13, one pre-drawn 3ml syringe containing clear liquid was found in the Anesthesia Adult Bag with no label.

a. The contents of the syringe, the date and time of when the medication was prepared, and the initials of the person who prepared the medication could not be determined.

b. A beyond-use time of 1 hour from the time of preparation could not be determined. (Reference)

3. The manufacturer's recommendation for the medication Succinylcholine is to discard after 14 days once taken out of the refrigerator and stored at room temperature.

a. On 10/29/13 at 11:00 AM, two unopened vials of Anectine (Succinylcholine) 200mg (milligram)/10ml were found in the Endoscopy Room #3 Pyxis (automated dispensing machine) without any indication of when the vials were taken out of the refrigerator nor a beyond-use date. Thus, a beyond-use date of 14 days could not be determined.

b. On 10/29/13 at 12:00 PM, two unopened vials of Anectine (Succinylcholine) 200mg/10ml were found in the Anesthesia Pediatric Bag and Anesthesia Adult Bag without any indication of when the vials were taken out of the refrigerator nor a beyond-use date. Thus, a beyond-use date of 14 days could not be determined.

c. Upon interview, Staff #13 stated that the practice of the facility was to discard and replace unused Succinylcholine vials every Wednesday by pharmacy staff.

4. These findings were confirmed with Staff #13, Staff #14 and Staff #27.

Based on document review and staff interview, it was determined that the facility failed to ensure that the hospital has in effect, a utilization review (UR) plan that provides for review of services furnished by the institution and by members of the medical staff to patients entitled to benefits under the Medicare and Medicaid programs.

Findings include:

The Utilization Review (UR) Committee failed to meet and carry out the UR function. Refer to Tag A-0654.

Based on document review and staff interview, it was determined that the facility failed to ensure that the Utilization Review (UR) Committee carried out UR functions as indicated in the Utilization Review Plan.

Findings include:

Reference: The "2013 Utilization Review Plan" states under Frequency of Meetings, "The Utilization Review Committee shall meet at least 10 times per year with Ad Hoc meeting called as needed."

1. On 10/29/13, Staff #1 was asked to provide for review, the 2013 Utilization Review Plan and the UR Committee meeting from January 2013 to present, October 2013.

2. Staff #1 provided the "2013 Utilization Review Plan" and "Utilization Review Meeting Minutes" dated March 1, 2013.

3. On 10/30/13 at 9:45 AM, Staff #1 stated that March 1, 2013 was the only time that the UR Committee met in 2013. He/she stated that there was a change in leadership and the physician Chairman of the committee left in March. The next UR Committee meeting is scheduled for November 2013.

a. Staff #1 confirmed on 10/30/13 at 9:45 AM that the UR Committee did not meet in accordance with the 2013 Utilization Review Plan referenced above.

Based on observation, staff interview, and review of documentation on September 30, 2013, October 29 and 30, 2013, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program has not adequately implemented the Association for the Advancement of Medical Instrumentation (AAMI) standards and the CDC Guideline for Prevention of Surgical Site Infection, 1999, that was selected by the hospital.

Findings include:

1. The facility failed to ensure implementation of its hand hygiene policy. Refer to Tag A-0748.

2. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. Refer to Tag A-0749.

A. Based on observation, staff interview, and review of documentation on September 30, 2013, October 29 and 30, 2013, it was determined that the facility failed to ensure that an ongoing program designed to prevent, control, and investigate infections and communicable diseases, was maintained. The infection control and prevention program has not adequately implemented the CDC Guideline for Prevention of Surgical Site Infection, 1999, that was selected by the facility.

Findings include:

On October 29, 2013, Staff #30 was observed transporting soiled surgical instruments from the Operating Room (OR) into the soiled OR workroom. He/she put the soiled instruments into the soiled cart, logged in a pathology specimen, filled the specimen container with formalin and placed the specimen in the refrigerator. He/she then changed his/her gloves and went back to the OR to assist in the next patient procedure. Staff #30 did not wash his/her hands after various glove changes and prior to going back to the OR, therefore providing a potential for cross contamination.


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B. Based on observation and review of facility policy and procedure, it was determined that the facility failed to provide a clock with a second hand, near the scrub sink, in the Neonatal Intensive Care Unit (NICU), to ensure implementation of the hand hygiene procedure for the initial hand washing of staff and visitors prior to entering the NICU.

Findings include:

Reference: Facility Policy #: 618-006-000, titled, "Hand Hygiene in the Regional Newborn Center (RNC)" states, "PURPOSE: To reduce the transmission of nosocomial infection in the RNC. ... QUALIFICATIONS: All patient care providers, visitors and hospital employees that enter the RNC. ... PROCEDURE: 1. Remove all jewelry from their hands and wrists. ... 4. Begin the appropriate hand washing technique: a. Initial hand hygiene: [1st bullet] Wash with the soft side of the scrub brush up to the elbows for 2 minutes. First wet hands up to the elbows with water, scrub for 2 minutes with the soft side of the brush, rinse with water then dry with a towel."

1. On 9/30/13 at 11:00 AM, the NICU was toured in the presence of Staff #1, Staff #3, and Staff #4. The surveyors were asked to remove all jewelry and scrub in prior to entry to the NICU. There was not a clock with a second hand within the area to time the two minute scrub, as per the above referenced policy.

A. Based on observation and staff interview on October 29 and 30, 2013, it was determined that the facility failed to ensure a clean, safe and sanitary environment for patient care services in surgical suites, sterile processing and storage rooms.

Findings include:

1. One gray table in the Sterile Processing Department (SPD) contained corners that were in poor repair, making effective cleaning difficult.

2. The area around and behind the cart washing equipment in the SPD was soiled.

3. The wooden cabinet storing Bronchoscopes in the Respiratory Therapy department is constructed with porous wood, making effective cleaning difficult.

4. The plastic cover on the cart in Endoscopy Room #2 was in poor repair with torn and taped surfaces, making effective cleaning difficult.

5. The floor area adjacent to the Washer Disinfector #1 in the SPD was soiled.

a. The wall adjacent to the Washer Disinfector #1 in the SPD contained water damage.

Reference: ST79, Section 3.3.6.1 Floors and walls states, " Walls should be constructed of materials capable of withstanding frequent cleaning."

6. On October 29, 2013, the wall in the Operating Room Decontamination Room, behind the Dornoch suction equipment, had exposed non-sealed sheet rock.

B. Based on observation and staff interview on October 29 and 30, 2013, it was determined that the facility failed to ensure that an ongoing program designed to prevent, control, and investigate infections and communicable diseases, was maintained.

Findings include:

Reference #1: The Association for the Advancement of Medical Instrumentation (AAMI) ST 79: 2005. ST 79 replaces and super cedes ST 46 by consolidating with 4 other AAMI standards [ST 33, ST 37, ST 42, and ST 35] approved 7/10/09.
The AAMI document titled, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" ST 79, section 3.2.4, Traffic Control states, "Traffic in all areas in which decontamination, preparation and packaging, sterilization processing, sterile storage, and distribution are carried out should be restricted to authorized personnel. This will reduce the potential for cross contamination."

1. The designated authorized personnel for the soiled Operating Room (OR) workroom is Staff #17 and one Sterile Processing Technician. Non-authorized OR staff were observed entering the Decontamination Room and performing various soiled and clean functions thus creating a potential for cross contamination to personnel, patients and equipment.

Reference #2: ST 79, section 3.2.3, Functional workflow patterns states, "Workflow patterns should be designed to ensure that contaminants are contained and employee exposure to blood borne and other disease producing organisms is minimized."

1. The fiber optic bronchoscopes are manually disinfected in containers on the counter adjacent to the hand wash sink in the clean OR Anesthesia workroom. This area also functions as a sterile storage area and general work/office area for OR personnel. The area is inadequate in design and space for the designated function, and may provide a potential for cross contamination.

2. The hand wash sink in the Anesthesia workroom is also used to discard OPA disinfectant and rinse fiber optic bronchoscopes, providing a potential for cross contamination to personnel and equipment.

Reference #3: ST 79, section 7.2.1 Policies and procedures states, "Policies and procedures should be followed for all methods of decontamination of reusable items."

1. Staff #16 indicated that bronchoscopes used for patient procedures in the Respiratory Department are wiped and flushed with saline solution immediately after the patient procedure.

a. Facility policy titled, "Processing of Flexible Fiber Optic GI and Bronchoscopes, states under Initial Cleaning and transport of used Scopes,
"Immediately after removing the endoscope from the patient, wipe the insertion tube with a sponge soaked in freshly prepared enzymatic solution. Place the distal end of the endoscope into the enzymatic detergent solution. Suction the solution through the biopsy/suction channel until the solution is visibly clean."

i. The facility policy and procedure for the care of bronchoscopes immediately following a procedure is not followed.

Reference #4: ST 79, section 7.2.2, Manufacturer's instructions states, "The written instructions of the device manufacturer should always be followed."

1. The LF Type V Visera Bronchoscope and BF 160 Bronchoscope are not leak tested according to the written instructions of the Olympus manufacturer.
Manufacturer instructions indicate that the MB-155 wet leak testing equipment is to be used. Staff #17 indicated that the bronchoscopes are dry leak tested and then wet leak tested using a syringe filled with water.

a. The manufacturer instructions for leak testing is not followed.

2. One peel pouch containing a single use disposable electrosurgical snare was observed resealed and stapled at the bottom of the pouch in Endoscopy Procedure Room #2.

a. Staff #31 indicated that the single use disposable snare was opened by the physician but not used. One of the Endoscopy staff members had resealed the pouch with the snare and stapled the bottom closed. The manufacturer's instructions for single use/disposable-only items was not followed.

Reference #5: ST 79, section 8.9.2, Storage facilities states, "Sterile items should be stored in a manner that reduces the potential for contamination ... Items should be positioned so that packaging is not crushed, bent, compressed or punctured and so that the sterility is not otherwise compromised."

1. Several sterile peel pouches of Gynecological instruments were observed cramped and crowded into bins in the OR supply storeroom, which may compromise the sterility of the instruments.

2. Sterile peel pouches of dilation balloons and biliary stents were cramped and crowded in the ERCP Procedure room upper cabinets, which may compromise the sterility of the items.

3. Sterile peel pouches of forceps and snares used in Bronchoscopy procedures are stored uncovered on a portable cart in the procedure room, creating a potential for cross contamination.

4. Approximately 4 sterile GYN instrument trays were stored on their vertical sides, which may compromise the sterility of the equipment.

5. Clean Bronchoscopes used in the Respiratory Department were stored coiled in the cabinet which does not allow for drainage of residual fluids and may allow growth of bacteria.


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C. Based on observation, document review and staff interview, it was determined that the facility failed to ensure that safe air handling systems in areas of special ventilation are maintained.

Findings include

Reference #1: ST 79, section 3.3.6.4 Ventilation states, "The soiled and decontamination area should be designed so that air flows into the area negative pressure, with a minimum of 10 air exchanges per hour."

1. On September 30, 2013 and October 29, 2013, the air flow in the Operating Room Decontamination Room did not have a negative or positive pressure. No air flow was observed within this room. During interview, Staff # 45 stated that air flow in this room is not currently being monitored.

Reference #2: ST79, Section 3.3.6.6 Relative humidity states, "Relative humidity should be controlled between 30% and 60% in all work area except the sterile storage area, where the relative humidity should not exceed 70%. An independent humidity monitor should be located in each area that requires controlled relative e humidity. Relative humidity should be recorded daily. Processing personnel in each work area are responsible for monitoring and recording the relative humidity to ensure that the correct relative humidity is being achieved."

1. On September 30, 2013 and October 29, 2013, during a tour of the Operating Room Decontamination and Storage Rooms and the Ambulatory Surgery Center's Storage Rooms, the humidity levels were below the minimum requirement. The humidity levels were as follows:

a. Operating Room Sterile Storage Room: 20%

b. Ambulatory Surgery Center Substerile Rooms: 17% and 18%

i. The third Storage Room in the Ambulatory Surgery Center lacked any independent humidity monitor.

2. No records were available for review to show how staff are monitoring and recording the humidity in the required rooms.

D. Based on observation, it was determined that the facility failed to ensure that aseptic technique practices, including sterilization of instruments, was addressed.

Finding include:

Reference: ST79 Section 8.4.3, Inspection states, "Instruments should be carefully inspected for cleanliness and flaws or damage."

1. On September 30, 2013, approximately 20% of sterilized instruments contained in peel packs in the Ambulatory Surgery Center's Sterile Storage Room, contained tape on the instrument handles, which were peeling and no longer firmly affixed to the instrument.

Based on medical record review, staff interview and review of the facility Bylaws, Rules and Regulations, it was determined that the facility failed to ensure that the operative report was dictated or written immediately following surgery.
Findings include:
Reference #1: "Medical/Dental Staff of Monmouth Medical Center Bylaws Rules and Regulations" state, "Surgery: 1. Operative report are dictated or written... in the medical record and signed immediately after surgery... 3. If there is a delay in dictation due to unusual circumstances, the dictation must be completed by the end of that calendar day. 4. Automatic suspension from the medical staff will be invoked if a surgical procedure is not dictated within 48 hours following surgery."
1. Review of the Operative Report for Medical Record #1 indicated the following:
a. Admission date and date of Surgery: 12/02/2009
b. Preoperative Diagnosis: Breast cancer of the right breast and left macromastia and acquired absence of the right breast.
c. Postoperative Diagnosis: Breast cancer of the right breast and left macromastia and acquired absence of the right breast.
d. The Operative note was dictated 12/16/2009, this was 14 days after the surgery/procedure.
e. The Operative note was transcribed 12/17/2009, this was 15 days after the surgery/procedure.
f. The Operative note was E-Signed (electronically signed) on 2/22/2009, this was 82 days after the surgery/procedure.
2. This was confirmed by Staff #18, Staff #21 and Staff #26.

Based on medical record review, staff interview and review of policies and procedures on 10/29/13, it was determined that the facility failed to ensure that respiratory therapists provided patients with education regarding respiratory care treatment.

Findings include:

Reference: Facility policy # 601-335-000, titled "Education, Patient and Family" states, "Purpose: To ensure that patients and families have been given sufficient information to make decisions and to take responsibility for self management activities related to their healthcare needs...Policy:...2. All members of the health care team have the responsibility to provide patient and/or family education directed at improving the outcomes of care by promoting healthy behavior and involving patients in their care, treatment, and service decisions...Procedure:...II. Provision of Education: 1. Education is provided in a multi-disciplinary, collaborative manner and based upon the individualized needs of the patient. The educator may be the nurse, physical therapist, radiology technician, physician, pharmacist, dietitian, respiratory therapist or other professional health care provider..."

1. Greenwall 5, a patient care unit was toured on 10/29/13, in the presence of Staff #2, Staff #16, Staff #37, and Staff #39.

2. On 10/29/13, Staff #39 stated, "The person who starts therapy with the patient, documents the patient education."

3. On 10/29/13, Staff #16 stated, "If the therapist notices education has not been initiated, then that respiratory therapist should initiate the documentation."

4. Four Electronic Medical Records (EMR) were reviewed in the presence of the above staff members. Two of the four EMRs (Medical Records #13 and #15) did not indicate any evidence that respiratory care education was provided.

a. Patient #13 was admitted to the facility on 10/23/13. On 10/29/13, at approximately 11:30 AM, there was no evidence in the EMR that respiratory care education was provided to Patient #13, who was receiving nebulizer treatments as ordered by the physician.

b. Patient #15 was admitted to the facility on 10/25/13. On 10/29/13, at approximately 11:45 AM, there was no evidence in the EMR that respiratory care education was provided to Patient #15, who was receiving nebulizer treatments as ordered by the physician.

5. The above findings were confirmed by Staff #16, Staff #37, and Staff #39.