HospitalInspections.org

Based on interview and record review the facility failed to ensure when telemedicine services were furnished through an agreement the agreement was written for one of two telemedicine services provided. This deficient practice placed all facility patients receiving Endocrinology services through Telemedicine at risk. The facility census was eight.
Findings included:
1. During an interview on 11/13/13 at 10:45 AM, Staff P, RN, Director of Operating Room (OR) and Telemedicine Services stated that:
- The facility utilized Telemedicine to provide Endocrinology (practice of medicine dealing with the endocrine system, its diseases, and its specific secretions called hormones such as Diabetes and Thyroid disease) clinics and Diabetes Education for the facility patients one time per month by the same Endocrinology Group.
- The Endocrinology clinics were provided by two physicians who rotated. She stated that Diabetes Education was provided by a nurse at the distant site and the facility staff monitored the classes and assisted the patients with testing.
- She had not seen a written agreement for the services.

2. During an interview on 11/14/13 at 8:45 AM, Staff E, Chief Operating Officer (COO) stated that the facility did not have a written Telemedicine agreement for Endocrinology. Staff E stated that all she had on file for Endocrinology Services was some email correspondence.
3. During an interview on 11/14/13 at 3:00 PM, Staff B, Chief Executive Officer (CEO) stated that the facility credentialed the physicians and he was not aware a written agreement was necessary.

Based on observation, interview and policy review, the facility failed to monitor and remove outdated emergency supplies from patient care areas in the Emergency Department (ED). The facility census was eight.

Findings included:

1. Record review of the facility's policy titled, "Checking for Out-dated Supplies" revised 09/07/01, directed the C/S (Central Service) Tech (technician) to survey patient use items that are stored in the ED on a quarterly basis, and remove any items which are currently out-dated.

2. During an interview on 11/12/13 at 1:50 PM, Staff G, Registered Nurse (RN), ED Manager, stated that:
- The night shift was responsible for keeping inventory and re-stocking the ED.
- The night shift write on a C/S purchase order what the department needed and C/S brought the supplies to the department.
- Supplies in the ED were checked weekly.
- It was her responsibility to monitor the supplies and equipment for the department.

3. During an interview on 11/13/13 at 10:50 AM, Staff G stated that the facility did not provide obstetric (OB) services but the ED did have a room that could be set-up with needed equipment to deliver a baby in an emergency. Staff G stated that the room set up for deliveries had an emergency OB kit and other equipment readily available in case an OB patient came into the facility and delivered in an emergency situation.

4. Observation on 11/13/13 at 10:50 AM, of the ED room set-up to deliver OB patients showed two emergency disposable OB kits with an out-date of 08/12.

Based on observation and interview, the facility failed to ensure fresh water supply resources serving three of five janitor sinks remained free of potential cross-contamination from human waste or infectious waste. This failure could affect staff, visitors and patients. The facility census was eight.

Findings included:

1. Observation on 11/12/13 at 2:10 PM through 11/14/13 at 11:30 AM showed the following:
- A length of hose attached directly to a faucet in the laundry room with the opposite end of the hose lying in the sink basin, and no siphon break, or air gap attached to the plumbing.
- A length of hose attached directly to a faucet in a janitor's closet on the patient wing and no siphon break attached to the plumbing;
- A length of hose attached directly to the faucet of a deep basin sink in the men's toilet located in the basement, with no siphon break attached to the plumbing.
Without an air gap to prevent it, a hose immersed in water or plugged sink could siphon wastewater back through freshwater plumbing and spread contamination to other areas of the building.

2. During an interview on 11/14/13 at 9:00 AM, Staff Z stated that he did not know about all three of the devices. He stated that he did not have a policy that addressed use of hoses on janitor and mop sinks.

Based on policy review and interview, the Chief Executive Officer (CEO) failed to effectively manage the facility's Disaster Plan, list selected key staff and assign responsibilities to Command Staff for training all staff in planning/preparation, rehearsal, live drill and post-drill reviews. This deficient practice affects staff, visitors, and patients. The facility census was eight.

Findings included:

1. Record review of the Disaster Plan, signed by the CEO on 05/06/11 and last approved by the Medical Staff on 05/19/11 showed no job duties and no developed Job Action Sheets (a detailed list of duties and responsibilities for each title) assigned for Incident Commander, Safety Officer, Finance Officer, Logistics Section Chief, Operations Chief

2. During an interview on 11/14/13 at 10:30 AM, Staff EE, Environmental Services Manager, stated that no staff were named to fill key positions in the Command Staff. She stated that the disaster drills the hospital conducted during the past year have only been accomplished with several staff doubling up on assigned positions, "acting" the part of the Incident Commander, Safety Officer, Finance Officer, Logistics Section Chief, Operations Chief and other key leadership staff who would be responsible for assigning duties to support staff and volunteers. She stated that the Disaster Plan was last review by the Medical Staff in 2011 and has not been presented to the board since.

Based on interview and policy review the facility failed to follow established policies related to reporting adverse drug reactions (ADR) that occur in the facility to the Food and Drug Administration (FDA)/Med-Watch Program (the FDA's reporting system for an adverse or sentential event-an unexpected or unanticipated outcome, death or serious physical or psychological injury, or the risk thereof). This had the potential to affect all patients that received medication therapy throughout the facility. The facility census was eight.

Findings included:

1. Record review of the facility's policy titled, "Adverse Drug Reactions" dated 02/12/07, showed direction for staff to monitor and report new and/or serious ADR's to the FDA as an important part of their post marketing drug surveillance program. All personnel who dispense, prescribe or administer medications will be responsible for reporting ADR's. Observing patient populations that are prone to ADR's and monitoring medications that frequently result in ADR's increase detection and reporting when pharmacists take an active role. Pharmacists will look for suspicious orders and then follow up on these orders to determine if an ADR has occurred. ADR's will be reported on the hospital Adverse Drug Reaction Report form and a FDA ADR Report form.

2. During an interview on 11/13/13 at 3:30 PM, Staff U, Director of Pharmacy, stated that he calls the manufacture to report when an ADR is suspected and not the FDA/Med Watch Program.

Based on observation, interview and policy review, the facility failed to ensure:
- Staff followed the facility's hand hygiene policy and personal protective equipment (PPE) policy during a dressing change for one (#8) current patient out of one observed.
- The Infection Control Preventionalist (ICP) performed facility-wide surveillance to monitor for infection control issues throughout the facility.
- That the employee health nurse maintained an infection control log of employees, volunteers and contracted staff.
This had the potential to affect all departments and patient care areas throughout the facility. The facility census was eight.

Findings included:

1. Record review of the facility's policy titled, "Handwashing" dated 02/24/11, showed the following direction:
- Most routine, brief patient-care activities involving direct and indirect patient contact for example, taking a blood pressure, handing a patient medications, food or other objects require handwashing.
- When to use soap:
- Before coming on duty;
- Before and after direct or indirect patient contact;
- Before preparing or serving food and medications.
- If hands are not visibly soiled, an employee may use an alcohol-based hand agent for routine decontamination during clinical situations. When hands are visibly dirty or contaminated with proteinaceous (pertaining to or the nature of protein) material or are visibly soiled with blood or other body fluids, employees should apply handwashing techniques with soap and water.

Record review of the facility's policy titled, "Personal Protective Equipment" dated 02/11/11 showed direction for staff to wash hands after removing gloves.

2. Observation on 11/13/13 at 11:00 AM, showed Staff N, Licensed Practical Nurse (LPN), entered Patient #8's room to perform a dressing change to the patient's right knee. Staff N put on non-sterile gloves and cleansed the right knee with soap and water. Staff N removed the non-sterile gloves and put on another pair but did not wash her hands with soap and water or use hand sanitizer before putting on another pair of gloves.

3. During an interview on 11/14/13 at 9:10 AM, Staff V, LPN, stated that during a dressing change if the dressing is not soiled she would not have to wash her hands after removing the old dressing and gloves. Staff V stated that since the dressing was not soiled it would not require her to wash her hands with soap and water or use hand sanitizer after removal of gloves.

4. During an interview on 11/14/13, at 9:20 AM, Staff W, LPN, stated that during a dressing change she would not remove her gloves to re-dress a wound after using a cleanser on the wound.

5. During an interview on 11/14/13 at 10:55 AM, Staff J, Registered Nurse (RN), ICP stated:
- All staff received hand hygiene training/education at hire and yearly and she expected staff to follow the facility's policy and procedures.
- Staff did not have to change gloves after cleansing a wound or before putting on a dressing after cleansing the wound.
- She does not monitor dietary, housekeeping, or operating room staff for infection control issues.

6. Observation on 11/13/13 at 9:18 AM showed white fuzz and broken surface material at the corners of the shoulder area of a mattress located on the single table in the procedure room.
7. During an interview on 11/14/13 at 10:50 AM, Staff P, Director of Operating Room, stated that the hospital does not have a specific policy on checking padded surfaces in a surgical environment. She stated that surgical staff assigned in the room check the integrity of mattresses and equipment throughout the day, each time it is cleaned and prepared for the next process.
8. Record review of the facility policy titled, "Aseptic Technique" dated 03/25/09, last reviewed 06/30/10, showed:
- All personnel working within the operating room environment must have a basic knowledge and appreciation of aseptic technique and contamination control.
- The Surgical Department will adhere to the Infection Control Committee and Quality Improvement Committee policies for infection control.
- Maintaining Contamination Control includes enforcing controlled traffic flow patterns into and out of the OR Suites and the Surgical Department and all persons who enter the Surgical Department (including Pre and Post-Operative Areas) are in correct surgical attire.

9. During observation of the surgical facilities on 11/13/13 at 9:15 AM, Staff P, OR Director, stated that the surveyors did not need to dress out (change into surgical attire which includes surgical top and pants, hair cover, and shoe covers) to tour Surgery because she had not had it terminally cleaned (includes removing all detachable objects in the room, cleaning lighting and air duct surfaces in the ceiling, and cleaning everything downward to the floor) and it was okay for us to come through. The surveyors were standing in the semi-restricted area of the department. When asked what she would do if she had an emergency case come in she stated that the facility did not do emergency cases, they are transferred so the surveyors did not need to change. The surveyors changed into surgical attire to tour Surgery.

10. During an interview on 11/14/13 at 10:55 AM, Staff J, RN, ICP, stated that she had no participation in the IC policies or surveillance of IC practice for the Surgery Department.

11. During an interview on 11/14/13 at approximately 11:45 AM, Staff D, RN, Employee Health Nurse, stated that she no longer tracks employees, volunteers, or contracted staff illnesses in an infection control log because the previous administrator instructed her to stop tracking call ins.


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Based on observation, interview and record review the facility failed to ensure the approved diet manual was current and that nursing staff knew how to access the diet manual for reference information. The facility census was eight.

Findings included:

1. Review of the facility's policy titled "Diet Manual," reviewed 11/07/13 showed that the facility policy was to have a current diet manual and the diet manual was available for use by ... nursing staff.

2. During an interview on 11/13/13 at 8:50 AM, Staff M, Director of Dietary stated that the approved facility diet manual was the Iowa Simplified Diet Manual, 10th edition dated 2007 (six years old) and that a copy was located in the nurse's station.

3. Observation on 11/13/13 at approximately 9:30 AM, in the nurse's station showed Staff M searched for the diet manual and found it in a cabinet.

4. During an interview on 11/13/13 at 9:40 AM, Staff N, Licensed Practical Nurse (LPN) stated that she did not know where the facility diet manual was located.

5. During an interview on 11/14/13 at 8:35 AM Staff H, Registered Nurse (RN) stated that:
- He was the Charge Nurse.
- He had been employed in the facility for six years.
- He did not know where the facility diet manual was kept.

Based on interview and policy review the facility failed to ensure patient care policies were reviewed on an annual basis. This deficient practice had the potential to affect all patients receiving care at the facility. The facility census was eight.
Findings included:
1. Record review of Patient Care Policies showed:
- A facility policy titled, "Swing Bed: Care Plans" dated 09/17/09, last revised 08/19/02 and last reviewed 05/26/11;
- A facility policy titled, "Handwashing" dated 02/24/11, last revised 02/22/06 and last reviewed 02/25/07;
- A facility policy titled, "Personal Protective Equipment" dated 02/11/11, last revised 05/17/06 and last reviewed 02/25/07;
- A facility policy titled, "Dress Code for Operating Room (OR)/Central Supply (C/S) Staff" dated 04/13/09, last revised 08/30/02 and last reviewed 6/30/10;
- A facility policy titled, "Handling and Storage of Sterile Supplies" dated 04/24/09, last revised 09/08/01 and last reviewed 07/07/10;
- A facility policy titled, "Sterilization Procedure" dated 06/17/09, last revised 01/23/98 and last reviewed 07/02/08.

2. During an interview on 11/14/13 at 9:00 AM, Staff A, RN, Chief Nursing Officer (CNO), stated that:
- Policies were reviewed and changed as they came up;
- If she read where something had changed or found new information when questions came up then she made changes;
- Review and revision of policies and procedures was generally a nursing process and in the past the weekend nursing supervisor had assisted with policy review and updates;
- There could be an informal physician review;
- When she made changes to the policies they were taken to the medical staff for approval.

Based on interview and record review the facility staff failed to ensure all physician's orders were dated and signed in five (#3, #7, #15, #16, #18) of five patient medical records reviewed. The facility census was eight.

Findings included:

1. Record review of the facility policy titled, "Physician Chart Completion (Delinquent Chart Report) reviewed 10/24/13, showed the following direction:
- The Medical Staff is required to ... sign all orders ... as outlined by Federal and State regulations.
- All orders need to be signed within rules according to Medical Staff bylaws but no longer than 48 hours of giving the order.
- It is the responsibility of the Medical Staff to complete their records adequately and in a timely manner.

2. Record review of the facility's Medical Staff Bylaws adopted 05/21/12 directed physicians to date and sign all orders written in a patient medical record.

3. Record review of current Patient #3's physician's orders showed an order on 11/07/13 without a dated signature of the physician.

4. Record review of current Patient #7's physician's orders showed a telephone order on 11/12/13 without a dated signature of the physician.

5. Record review of discharged Patient #15's physician's orders showed a verbal order on 09/14/13 without a dated signature of the physician.

6. Record review of discharged Patient #16's physician's orders showed three verbal orders on 10/18/13 and 10/19/13 without dated signatures of the physician.

7. Record review of discharged Patient #18's physician's orders showed six verbal orders on 09/23/13 and 09/26/13 without dated signatures of the physician.

8. During an interview on 11/13/13 at 1:00 PM Staff C, Director of Health Information Management (HIM), reviewed the discharged patient medical records for Patients #15, #16 and #18 and confirmed the physicians failed to date and sign the orders within the appropriate time frame.

Based on policy review, observation, interview and record review the facility failed to:
-Ensure Surgical Services were performed in a safe manner in accordance with applicable Federal and State laws, regulations and guidelines governing surgical services as well as standards and recommendations promoted by the Association of periOperative (the time extending from the start of hospitalization for surgery to the time of discharge) Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI).
-Ensure current policies and scope of services for surgical services;
-Maintain an accurate Operating Room Register for two patients (#30 and #31); and
-Ensure current standard of practice for patient safety in Surgical Services which included:
- Informed consent and History and physical prior to surgery for five (#23, #24, #25, #27, and #28) of five patient's medical records reviewed;
- Safety Practices for the Prevention of Wrong-Patient, Wrong Site, Wrong Procedure and rescue of patients in crisis;
- Sterilization and disinfection procedures; and
- Ensure Aseptic surveillance (oversight of sterile supplies and equipment to ensure a state of being free from disease-causing contamination) and practice.

The severity and cumulative effect of these deficient practices resulted in the facility's overall non-compliance with the requirements found at CFR 485.639 Condition of Participation: Surgical Services.

The facility performs an average of 13 surgical cases per month and 168 annually. These deficient practices put the safety of all patients receiving surgical care at risk. The facility census was eight.

Findings included:

1. Review of the Missouri State Statutes 19 CSR 30.20.140 showed approved written policies and procedures shall define and describe the scope and conduct of surgical services. These shall be reviewed annually and revised as necessary.

2. Record review of the Operating Room Policies and Procedures showed the policies to be outdated and not consistent with current AORN standards of practice for care of the surgical patient care:
- A "Review of Manual" signature page with the last dated review on 11/03/09;
- A list of surgical procedures needing a scrubbed physician assistant which included major (surgical procedure that involves anesthesia or respiratory assistance) General Surgery, Urology, Orthopedic and Gynecological (GYN, surgeries of the female anatomy) surgeries dated 09/19/89;
- Surgery policy titled, "Patient and Employee Safety in the Surgical Suite" dated 06/18/09, last revision 06/10/99, and last reviewed 06/30/10;
- Surgery policy titled, "Aseptic technique" dated 03/25/09, last reviewed 06/30/10;
- Surgery policy titled, "Patient Skin Preparation", dated 03/26/09, and reviewed 06/30/10;
- Surgery policy titled, "Pre-operative Routine" dated 03/26/09, and last reviewed 06/30/10;
- Central Supply policy titled, "Handling and Storage of Sterile Supplies" dated 04/24/09, last revised 09/08/01, and last reviewed 07/07/10;
- Central Supply policy titled, "Sterilization Procedure" dated 06/17/09, last revised 01/23/98, and last reviewed 07/07/10.

3. During an interview on 11/13/13 at 9:30 AM, Staff P, Registered Nurse, (RN), Director of Operating Room (OR), Sterile Processing (SP), Outpatient (OP), and Telemedicine, stated that:
- Current surgical cases were minor (surgical procedure that does not involve anesthesia or respiratory assistance) and consisted of Pain Management, Cataracts, minor Orthopedic procedures and Endoscopies (uses a flexible camera going through a small incision or natural body openings to diagnose and treat disease) procedures.
- Patients that required emergency surgery or major surgeries would be transferred.
- She did not have a written scope of services for surgery and the policies in their entirety had been reviewed based on the signature page in the front of the Policies manual.
- OR policies were revised when she became aware of changes in practice.

4. Record review of the facility "Medical Staff Bylaws" dated 05/21/12, showed:
- A complete history and physical examination shall be recorded within twenty-four (24) hours of admission;
- The history, physical examination, provisional diagnosis, EKG (Electrocardiography, measure of the electrical activity of the heart), chest x-ray and required laboratory examinations must be recorded or dictated on the chart before any surgical operation is undertaken;
- If a complete history and physical has been performed within forty-eight (48) hours prior to admission in the office of a physician staff member, a durable, legible copy of this report may be used in the patient's Hospital medical record in lieu of the admission history and report of physical examination. In such instances, all additions to the history and any subsequent changes in the findings must always be recorded. If there were no new findings, this must be stated.
- When a patient is re-admitted within thirty (30) days for the same problem or diagnosis, an interval history and physical examination reflecting the original information is readily available in the previous admission.
- A written, signed, informed surgical consent will be obtained by the surgeon prior to surgery except in those situations wherein the patient's life is in jeopardy.
- No abbreviations are to be used in the surgical permit.
- All clinical entries in the patient's medical record shall be accurately dated and authenticated.
- CRNA (Certified Registered Nurse Anesthetist) must be under the supervision of a physician. May select the anesthetic agent and technique with an appropriate concurrence (the supervising physician is in agreement.)

5. Record review of the facility policy titled, "Pre-operative Routine" dated 03/26/09, and last reviewed 06/30/10, showed:
- Pre-operative routines on elective surgical patients, both inpatient and outpatient, shall be completed prior to the time of the patient's admission to the hospital.
- The physician's history and physical shall be done prior to taking the patient to the OR and within 48 hours of the surgery.
- The physician shall be responsible for obtaining and documenting informed consent for the anticipated surgical procedure and completion of a history and physical examination as defined in the Medical Staff Rules and Regulations.

Record review of the facility policy titled, "Outpatient Surgery Service" dated 03/26/13, and last reviewed 06/30/10, showed:
- A history and physical (H&P) done by the scheduling physician should precede the admission.
- The surgical permit is to be signed after the patient is seen by the physician performing the operation and may be signed prior to admission.
- Each consent and order sheet shall clearly state the surgical site without the use of abbreviations, in at least one prominent place.

6. Record review of Patient #23's surgical chart showed:
- A surgical consent dated 10/28/13, was signed by the patient and witnessed by a nurse. There was no physician signature.
- The consent read: Cataract Extraction with IOL (Intraocular Implant, artificial lens) Lt Eye (left eye.)
- The physician orders dated 10/28/13 showed an entry to sign consent: Cataract removal ___ Eye with IOL. The surgical eye was not designated.
- The anesthesia plan developed by a CRNA was signed by the surgeon but was not dated or timed.

7. Record review of Patient #24's surgical chart showed:
- A surgical consent dated 07/22/13, was signed by the patient and witnessed by a nurse. There was no physician signature.
- The physician orders dated 07/22/13 showed an entry to sign consent: Cataract removal Lt Eye with IOL.
- The consent read: Cataract Extraction with IOL Implant Lt Eye.
- The anesthesia plan developed by a CRNA was signed by the surgeon but was not dated or timed.
- The surgical H&P, completed by the patient's family physician was dated 06/18/13.
- The surgical H&P completed by the Ophthalmologist (specialist in medical and surgical eye problems ) was dated 04/18/13.

8. Record review of Patient #25's surgical chart showed:
- A surgical consent dated 08/19/13, was signed by the patient and witnessed by a nurse. There was no physician signature.
- The physician orders dated 08/19/13, showed an entry to sign consent: Cataract removal Rt Eye (right eye) with IOL.
- The consent read: Cataract Extraction with IOL Implant Rt Eye.
- The anesthesia plan developed by a CRNA was signed by the surgeon but was not dated or timed.
- The surgical H&P, completed by the patient's family physician was dated 07/18/13.

9. Record review of Patient #27's surgical chart showed:
- A surgical consent dated 08/26/13, was signed by the patient and witnessed by a nurse. There was no physician signature.
- The physician orders dated 08/26/13 showed an entry to sign consent: Cataract removal Lt Eye with IOL.
- The consent read: Cataract Extraction with IOL Implant Lt Eye.
- The anesthesia plan developed by a CRNA was signed by the surgeon but was not dated or timed.
- The surgical H&P, completed by the patient's family physician was dated 07/11/13.

10. Record review of Patient #28's surgical chart showed:
- A surgical consent dated 08/26/13, was signed by the patient and witnessed by a nurse. There was no physician signature.
- The consent initially read: Cataract Extraction with IOL Implant Lt Eye. The abbreviation Lt had been marked through and Right written in.
- The Physician's orders dated 08/26/13 at 8:00 AM showed an order to Sign Consent: Cataract Removal Lt Eye, with Intraocular Lens Implant. The Lt had been marked thru and Rt written.
- The operative record dated 08/26/13 showed:
-Preoperative Diagnosis: Cataract Left eye. Left was marked thru with an error notation and Right eye checked; and
-Operation: Phaco (Phacoemulsification is a cataract surgery in which the eyes internal lens is broken down into tiny liquid particles with an ultrasonic hand piece and sucked out,or aspirated, from the eye) with IOL Left eye. Left was marked thru with an error notation and Right eye checked.
- The anesthesia plan developed by a CRNA was signed by the surgeon but was not dated or timed.
- The surgical H&P, completed by the patient's family physician was dated 07/17/13.

11. During an interview on 11/13/13 at 10:45 AM, Staff P, RN, Director of OR, SP, OP, and Telemedicine, stated that:
- An H&P was required to be completed within one week prior to surgery;
- The original H&P from the first Eye surgery was used for Cataract patients coming back for surgery on the second Eye within one month;
- According to policy an H&P must be done within 48 hours.
- The pre-operative visit and anesthesia assessment was completed the day of surgery by the CRNA. The surgeon was responsible for oversight of the CRNA and signed off on the anesthesia plan prior to surgery.

12. Record review of the facility Operating Room Register showed the operative date recorded for two Patients (#30, #31) of two patients reviewed as 09/18/13. The actual operative date for Patients #30 and #31 was 09/16/13.

13. Review of "AORN Malignant Hyperthermia Guide?line"(MH, a rare life-threatening condition that is usually triggered by exposure to certain drugs used for general anesthesia. In susceptible individuals, these drugs can induce a drastic and uncontrolled increase in skeletal muscle rigidity, which overwhelms the body's capacity to supply oxygen, remove carbon dioxide and eventually lead to circulatory collapse and death if not treated quickly) specific to perioperative care for patients confirmed to have, or who are thought to be susceptible to MH showed:
-The guideline is based on current, available research and incorporates information from the Malignant Hyperthermia Association of the United States (MHAUS) protocol (MHAUS is a nonprofit organization dedicated to assisting in the diagnosis and treatment of MH).
-The MHAUS protocol was developed by a panel of experts based on scientific research and is viewed as the national guideline or standard of care for the MH patient.
- Nurses should be prepared to monitor the patient and treat a MH crisis if they are working in any type of facility or department where MH trig?gering agents are used (OR, labor and delivery, interventional radiology, emergency department). Perioperative nurses and other health care provid?ers should stay up-to-date with new research and treatment recommendations.
-AORN Malignant Hyperthermia Guideline, Table 5, showed the suggested content for a Malignant Hyperthermia (MH) Cart was consistent with the recommendation of MHAUS.

14. Review of the Malignant Hyperthermia Association of the United States (MHAUS) "Recommendation for MH" showed therapy should be aimed at prompt treatment of hyperkalemia (condition in which the concentration of the electrolyte potassium in the blood is elevated), administration of Dantrolene, hyperventilation (rapid or deep breathing beyond the normal rate), and cooling to target core temperature 38?C. The recommended Malignant Hyperthermia cart content includes drugs, general equipment, monitoring equipment, nursing supplies, and laboratory testing supplies.
15. Record review of the facility policy titled, "Malignant Hyperthermia: Emergency Management in the OR (Operating Room)" dated 03/25/09, and last reviewed 06/30/10, showed personnel responsibilities in the event a MH situation "Cold Alert" was called in surgery. The policy did not contain a list of supplies and equipment necessary to respond to a "Cold Alert" and the facility did not have a centrally located stock of supplies and equipment.

16. Observation on 11/13/13 at 9:30 AM showed the OR code cart stored in the Outpatient Department did not contain all of the medications or the supplies and equipment necessary to respond to a MH crisis

17. During an interview on 11/13/13 at 9:30 AM, Staff P, RN, Director of OR, SP, OP, and Telemedicine, stated that:
- There was a policy outlining personnel responsibility in the event a MH crisis occurred but it did not itemize necessary supplies.
- She was not aware the facility needed to have supplies and equipment centrally stored and readily available to respond to a MH crisis.
- She had Dantrolene (a muscle relaxant, it is the only specific and effective treatment for malignant hyperthermia) in her office.

18. During an interview on 11/13/13 at 10:45 AM, Staff P, RN, Director of OR, SP, OP, and Telemedicine, stated that:
-The current practice for marking the surgical site was the pre-op staff marked an x over the operative eye of the cataract patients.
-They did not have an a process for official time out. Prior to surgery the nursing staff verified the patient's ID (identity) against their name band and asked the patient to identify themselves.
-The facility did not have policies that addressed Surgical-site marking or Surgical Time-out.

19. Record Review of the AORN position statement for "Preventing Wrong-Patient, Wrong-Site, and Wrong-Procedure Events" showed:
- Multidisciplinary teams that include perioperative RNs, surgeons, anesthesia care providers, risk managers, and other health care professionals should collaboratively develop procedures and protocols to prevent wrong-patient, wrong-site, wrong-procedure events.
- Multidisciplinary team members should implement and monitor standardized processes for the prevention of wrong-patient, wrong-site, wrong-procedure events. Policies for individual health care organizations should clearly delineate the role and responsibility of the physician and other team members in marking and verifying the correct surgical site.
- Surgical team members should complete a preoperative checklist that includes, but is not limited to, pre-procedure verification, site marking, and time-out procedures.

20. Record review of the facility policy titled, "Patient and Employee Safety in the Surgical Suite" dated 06/18/09, and last reviewed 06/10/10, showed the RN always identifies the patient by checking the wristband with the patient's chart and the operating schedule. In addition, the RN verifies communication with the patient.

21. Record review of the multi-society position statement "Immediate-use Steam Sterilization"(IUSS, formerly referred to as flash sterilization in which a shortened process of steam sterilization is used to sterilize surgical instruments) released on 03/22/11 by the Association for the Advancement of Medical Instrumentation (AAMI) and endorsed by AORN and Association for Professionals in Infection Control (APIC) showed:
- "Immediate use" is broadly defined as the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field.
- Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants.
- A sterilized item intended for immediate use is not stored for future use, nor held from one case to another.
- The same critical reprocessing steps (such as cleaning, decontaminating, and transporting sterilized items) must be followed regardless of the specific sterilization cycle employed;
- Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing.

22. Record review of AORN's "Recommended Practices for Sterilization" dated 2013, showed:
- Biological indicators (bacterial spores or germs capable of causing infection or illness known to be resistant to the mode of sterilization being monitored and are grown in a liquid or onto a paper carrier) should be use to monitor sterilizer efficacy (effectiveness.) Efficacy monitoring (biological indicators are run through a sterilization cycle to demonstrate whether the conditions were adequate to achieve sterilization through actual killing of the spore) should be performed at least weekly and preferable daily.
- Each sterilization cycle should be monitored to verify that parameters required for sterilization have been met.
- Documentation of cycle information and monitoring results should be maintained in a log.
- Immediate use steam sterilization records should include information on each load, including:
-The items processed,
-The patient on whom the items were used;
-The type of cycle;
-The cycle parameters used (i.e. temperature, duration of cycle);
-Monitoring results;
-Date and time the cycle was run;
-Operator information (person who initiated the cycle, person who retrieved the item form the sterilizer);
-The reason for the IUSS.

23. Record review of the facility's policy titled, "Biological Control" dated 04/24/09 showed:
-The steam sterilizer shall be tested with live bacterial spores at least weekly, and/or with each load that contains implantable objects.
-The C/S (Central Supply) tech (technician) shall notify the Central Supply Supervisor of any testing interval which exceeds seven (7) days.
-The Central Supply Supervisor is responsible for insuring that C/S technicians are aware of policy requirements.

24. Record review of the Biological monitoring log for the OR sterilizer showed Biological monitoring was being done on a random basis and ranged from three to 19 days apart.
- A test was run on 07/08/13 and the next test was run on 07/18/13, 10 days later.
- The next test was run on 07/28/13, 10 days later.
- A test was run on 09/18/13 and the next test was on 10/02/13, 14 days later.
- The next test was run on 10/21/13, 19 days later.

25. Record review of the sterilization logs and Operating room register for cataract surgeries showed the following:
- On 07/22/13 the facility performed eight cataract surgeries; there were two entries on the sterilizer log for flash (IUSS) of cataract instruments. The first notation had a load #5639 and the next entry load was #5653;
- On 09/16/13 the facility performed 13 cataract surgeries; there were two entries on the sterilizer log for flash of cataract instruments. The first notation had a load #5679 and the next entry load was #5692;
- On 10/28/13 the facility performed 10 cataract surgeries; there were two entries on the sterilizer log for flash of cataract instruments. The first notation had a load #3753 and the next entry was load #5764; and
- Review of the log also showed the load number sequence to be incorrect between 10/17/13 and 10/28/13, load numbers went from 5700 series to 3700 series and back to 5700 series.

Further review of the Sterilizer log showed the log contained the following information; date, load number, sterilizer cycle type, Load content, indicator result and staff initials. The log did not contain the patient on whom the instruments were used, the cycle parameters, or the reason for the immediate use sterilization.

26. During an interview on 11/13/13 at 9:30 AM, Staff P, RN, Director of OR, SP, OP, and Telemedicine, stated that:
-Spore testing was run weekly on the OR sterilizer, read in 24 hours and the results placed in the Attest log (Attest is the brand name of biological monitor used).
- She did not know there were gaps in the sequence of tests run or why.
- She was not familiar with AAMI standards for sterilization and was not aware of current AORN recommendations.

27. During an interview on 11/13/13 at 9:30 AM, Staff Q, Licensed Practical Nurse (LPN) and Scrub tech, stated that:
- The facility used a contract service to provide instruments for cataract surgeries. The company brought two sets of cataract instruments that were rotated the day of surgery.
- The cataract instrument sets were flash sterilized prior to the first case of the day and each subsequent case.
- Prior to the first case both sets of instruments were sterilized; one set went into the OR and the second set was placed on a sterile field prepared in the sub-sterile room.
- The second set was a back up set with extra instruments and might or might not be taken into the OR. If it was taken into the OR then it was decontaminated and flashed between cases.

28. Review of the AORN standard "Traffic Patterns in the Perioperative Practice Setting" dated 2012, showed:
- The unrestricted area includes a central control point that is established to monitor the entrance of patients, personnel and materials. Street clothes are permitted in this area.
- The semi-restricted areas include the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink area, and corridors leading to the surgical suite. Traffic in this area is limited to authorized personnel and patients. Personnel are required to wear surgical attire and cover all head and facial hair.
- The restricted area includes ORs, procedures rooms and clean core area (sterile supply storage). Surgical attire and hair coverings are required.

29. Review of the AORN standard "Cleaning in the Surgical Environment", effective 01/01/03, showed the following:
- These recommended practices are adaptable to various practice settings including traditional OR's, Ambulatory surgery units, physician offices, endoscopy suites, and other areas where operative and other invasive procedures may be performed.
- Surgical procedure rooms and scrub/utility areas should be terminally cleaned daily.
- Operating rooms, in which procedures may be performed, regardless of whether they are used, should be terminally cleaned once during each 24-hour period during the regular work week.
- A clean surgical environment will reduce the number of microbial flora (microscopic living organisms (germs) capable of causing infection or illness) present. Terminal cleaning in the surgical practice setting reduces the number of microorganisms, dust, and organic debris (waste from dead or damaged tissue) present in the surgical environment.

30. Record review of the facility policy titled, "Dress Code for Operating Room (OR)/ Central Supply (C/S) Staff", dated 04/13/09 showed:
- Restricted area: those areas beyond the "red line" (red tape placed on the floor to identify traffic stop points in OR department) marked on the floor. Includes C/S sterilizing room, operating room/anteroom and adjacent storage area;
- All staff entering the restricted areas are expected to:
- Wear disposable hair cover
- Wear static free scrub suit
- Wear shoe covers
- Practice good hand washing and/or surgical scrub techniques.
- All staff working in OR and C/S are expected to be aware of and comply with the dress code.

Record review of the facility policy titled, "Aseptic Technique" dated 03/25/09, last reviewed 06/30/10, showed:
- All personnel working within the operating room environment must have a basic knowledge and appreciation of aseptic technique and contamination control.
- The Surgical Department will adhere to the Infection Control Committee and Quality Improvement Committee policies for infection control.
- Sterile linen, packs, basins and such materials are stored in the sterile OR Supply Room.
- Maintaining Contamination Control includes enforcing controlled traffic flow patterns into and out of the OR Suites and the Surgical Department and all persons who enter the Surgical Department (including Pre- and Post-Operative Areas) are in correct surgical attire.

31. During observation of the surgical facilities on 11/13/13 at 9:15 AM, Staff P, Staff P, RN, Director of Operating Room OR, SP, OP, and Telemedicine, , stated that the surveyors did not need to dress out (change into surgical attire which includes surgical top and pants, hair cover, and shoe covers) to tour Surgery because she had not had it terminally cleaned (includes removing all detachable objects in the room, cleaning lighting and air duct surfaces in the ceiling, and cleaning everything downward to the floor) and it was OK for surveyors to come through. The surveyors were standing in the semi-restricted area of the department. When asked what she would do if she had an emergency case come in she stated that the facility did not do emergency cases; they are transferred so surveyors did not need to change. The surveyors changed into surgical attire to conduct the survey of the surgical areas.

32. Record review of AORN "Recommended Practices for Sterilization" showed:
- Sterile packages should be stored under environmentally controlled conditions;
- Sterile storage areas, including racks, shelves, bins, and containers should be kept clean and dry.
- Supplies should be stored in a manner that allows adequate air circulation and ease of cleaning and in a manner that reduces the risk of contamination.

33. Observation on 11/13/13 at 9:30 AM showed the OR Sterile Supply closet with sterile supplies, non-sterile supplies and equipment including surgery table arm boards and positioning aides stored together on wire racks that were overflowing. In one corner of the room there was an enclosed storage cabinet with counter space between the upper and lower cabinets. The counter space contained several layers of sterile supplies stored multiple layers deep and to the bottom of the upper cabinet. The room also contained several pieces of surgical equipment not labeled or covered to indicate they had been cleaned.

34. During an interview on 11/13/13 at 9:30 AM, Staff P, RN, Director of OR, SP, Outpatient OP, and Telemedicine, stated that the Sterile Supply room in the OR was the only storage area for the OR including supplies and equipment. Staff P stated that OR policies were revised when she became aware of changes in practice.

35. During an interview on 11/14/13 at 10:55 AM, Staff J, RN, Infection Control (IC) Director stated that she had no participation in the IC policies or surveillance of IC practice for the Surgery Department.

Based on interview and record review the facility failed to maintain an effective facility-wide Quality Assessment and Performance Improvement (QAPI) Program that included all hospital departments and ensured the Chief Executive Officer (CEO), Medical Staff members and administrative leaders showed accountability for the effectiveness of the QAPI program. The facility failed to ensure the QAPI performance indicators listed in the QAPI Plan were monitored through appropriate data collection and analysis to provide for opportunities of improvement facility-wide.

The severity and cumulative effect of these deficient practices resulted in the facility's overall non-compliance with the requirements found at the Condition of Participation: Periodic Evaluation and Quality Assurance Review. The facility census was eight.

Please refer to C-0337.

Based on interview and policy review, the facility failed to maintain an effective ongoing facility-wide, data-driven Quality Improvement (QI) program throughout the facility. The facility census was eight.

Findings included:

1. Record review of the facility's policy titled, "Harrison County Community Hospital Quality Improvement (QI)/Risk Management (RM) Plan" revised 06/30/08, showed the following direction:
- Activities of QI/RM Program:
- Identify potential problems/concerns in delivery of health care services.
- Objective assessment of cause and scope of each problem.
- Implementation of decisions and plans designed to resolve observed problems.
- Monitor activities designated to ensure desired results have been achieved.
- Assure communication and reporting to Department Heads, Medical Staff, Administrator and Board of Directors.
- Quarterly appraisal of effectiveness of QI/RM Program.
- Types of Review to be Performed:
- Analytical studies of the nature and quality of patient care services and manner of delivery.
- Studies may be either retrospective or concurrent.
- When possible, studies will be focused on potential or established problems in delivery of services.
- Responsibilities:
- Board of Directors/Governing Board
- Ultimately responsible for quality of care within the hospital and overall QI/RM program.
- Establish, maintain and support ongoing QI/RM program.
- Delegates responsibility for the ongoing QI plan to the administrator.
- Committed to provide financial support necessary for the program.
- Assure effective response to findings.
- Assign two Directors to attend the QI/RM program.
- To receive reports from Administration and QI Board member involvement.
- Administrator:
- Responsible for maintaining an effective QI/RM Program.
- Delegates to department heads the responsibility for maintaining QI/RI within their department.
- Problem Identification, Solution, and Follow-Up:
- When a problem is identified, corrective action will be taken at the organizational level where improvement is needed.

2. During an interview on 11/13/13 at 10:00 AM, Staff AA, Director of Radiology, stated that she collected and compiled data on differences of interpretation between Emergency Room Physicians and the Radiologist, Patient return patterns for mammograms, and variations in badge reading reports. She stated that she has not been tabulating them on a comprehensive facility-wide scorecard or database that tracks or looks for trends. She stated that she writes up reports on topics such as those listed and submits them to Staff Y, RN, QI/RM coordinator. She stated that, in the past, not all of the information she processed was considered or reviewed by the board.

3. During an interview on 11/14/13 at 10:55 AM, Staff J, Registered Nurse (RN), Infection Control Preventionalist (ICP) stated that she did not know how the Infection Control Program was integrated into the hospital-wide QI program.

4. During an interview on 11/14/13 at 11:25 AM, Staff Y, RN, QI/RM coordinator stated that:
- The facility's QI program was appraised yearly and the board approved the plan.
- She was not responsible for collecting data or doing data analysis and did not know if the facility had any trends.
- She did not know what current QI indicators or projects the facility was currently looking at.

5. During an interview on 11/14/13 at 11:50 AM, Staff A, RN, Chief Nursing Officer (CNO) stated that:
- She was assigned team leader over the facility's QI/RM program after re-organization of the facility took place when the previous administrator retired.
- She was assigned this position on 09/01/13.
- She stated that year after year the facility did the same QI indicators.
- She stated that the facility might have a new QI indicator but may not.
- She was not familiar with data collection or analysis of the data collected.
- She did not know how to correct issues identified or how to monitor to ensure corrective measures is maintained.
- She stated that this time the facility did not have an active QI program.

6. During an interview on 11/14/13 at 12:15 PM, Staff U, Pharmacy Director, stated that he did not know what the facility-wide QI indicator was.

7. During an interview on 11/14/13 at 12:30 PM, Staff I, Laboratory Manager, stated that he did not know what the facility-wide QI project was.



04467

Based on interview, record and policy review, the facility's activity director (AD) failed to include an activity care plan with measurable goals and timetables for two (#7 and #8) out of two current Swing Bed records reviewed. This had the potential to affect all patients admitted to the Swing Bed program. The facility census was eight with five of those in Swing Bed status (Swing Bed, a Medicare program in which a patient can receive acute care then, if needed Skilled Nursing Home care).
Findings included:

1. Record review of the facility's policy titled, "Swing Bed: Care Plans" dated 09/17/09, showed the following information:
- Within 24-hours of admission to the Swing Bed, an interdisciplinary care plan shall be initiated.
- Swing Bed care plans shall be interdisciplinary in scope, with each discipline involved in the patient's care developing its own portion of the plan.
- Goals shall be as expected patient outcomes, with specific, measurable parameters stated.
- Target dates shall be projected for outcome achievement, when feasible.
- Interventions shall be defined, which will aid in goal achievement.
- Care plans shall be kept current through revision and updating, by the respective practitioner for each discipline.
- The Activities Director is responsible for development of the Activity Plan.

Record review of the facility's policy titled, "Swing Bed: Activity Assessment, Implementation, and Documentation" dated 09/10/09 showed the following information:
- To assure timely development of an activity therapy care plan.
- Is responsible for establishing an activity program for each Swing Bed patient.
- Activity therapy will be documented in the medical record and integrated into the patient's plan of care.

2. Record review of Patient #7's medical record showed she admitted to the Swing Bed unit on 11/12/13.

Record review on 11/14/13 of the patient's medical record showed an activities care plan had not been initiated.

3. Record review of Patient #8's medical record showed she admitted to the Swing Bed unit on 11/05/13.

Record review of the patient's medical record as of 11/14/13 showed an activities care plan had not been initiated.

4. During an interview on 10/14/13 at 10:45 AM, Staff X, Physical Therapy Assistant, (PTA)/Occupational Therapy Assistant (OTA), and Manager of Physical Therapy Services stated that an Occupational Therapist (OT) was responsible for Activities for the Swing Bed patients. Staff X stated that the OT completes a patient assessment and documents the assessment and activities in the electronic medical record. Staff X stated the OT does not develop an individual care plan for activities and does not have a schedule of activities.

5. During an interview on 11/14/13 at 10:55 AM, Staff X, stated that:
- The facility did not have a designated area to provide activities for Swing Bed patients.
- Swing Bed patients were not given a monthly calendar with activities offered listed.
- Swing Bed patients did not have activities care plans with measurable goals and timetables included in their medical records.


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