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Based on observations, review of policies/procedures, manufacturer's information, and staff interviews, the Critical Access Hospital (CAH) staff failed to ensure the chair and bed alarm sensor pads were used only for 6 months in accordance with the manufacturer's instructions for 6 of 6 AliMed chair alarm sensor pads and 1 of 1 AliMed bed alarm sensor pad. The CAH staff identified a census of 8 patients at the start of the survey.

Failure to ensure staff followed the manufacturer's instructions for use of chair alarm sensor pads could potentially result in the chair alarm sensor pads to malfunction and cause the alarm not to sound and place patients at risk for injury and harm.

Findings include:

1. Review of CAH policies/procedures revealed the lack of a policy/procedure that addressed the use of chair alarm sensor pads for only six months in accordance with the manufacturer's instructions.

2. Observations on 1/25/16 at 1:15 PM with Staff I, Assistant Chief Nursing Officer (ACNO), revealed 5 AliMed chair alarm sensor pads and 1 AliMed bed alarm sensor pad stored in the supply room. 5 of 5 AliMed chair alarm sensor pads and 1 of 1 AliMed bed alarm sensor pad had manufacturer's instructions on the chair and bed alarm pad as follows, "Setup Instructions. . . Record expiration date here (six months from initial use date). . . Caution. . . We recommend that the use of this product does not exceed six months. . . " 5 of 5 AliMed chair alarm sensor pads and 1 of 1 AliMed bed alarm sensor pad lacked a date for initial use of the chair and bed alarm sensor pads.

Observations on 1/25/16 at 2:50 PM with Staff K, Registered Nurse (RN), revealed 1 of 1 AliMed chair alarm sensor pad in Patient # 2's room. 1 of 1 AliMed chair alarm sensor pad in Patient #2's room had manufacturer's instructions on the chair and bed alarm pad as follows, "Setup Instructions. . . Record expiration date here (six months from initial use date). . . Caution. . . We recommend that the use of this product does not exceed six months. . . " The AliMed chair alarm sensor pad lacked a date for initial use of the chair and bed alarm sensor pads.

3. During an interview on 1/25/16 at 1:30 PM, Staff I, when asked for a policy on chair alarms, reported the lack of a policy/procedure to date the chair alarm sensor pads when put into use in accordance with the manufacturer's instructions as use for only six months and acknowledged the chair and bed alarm sensor pads lacked a date for initial use of the chair and bed alarm sensor pads. Staff I stated the chair and bed alarm sensor pads were purchased in January or February 2014.

Based on review of policies, meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to ensure the required group of professionals, including a physician and a mid-level provider reviewed all patient care policies for 19 of 19 patient care departments. (Anesthesia, Dietary, Emergency Room, Nursing, Radiology, Surgery, Cardiac Rehabilitation, Laboratory, Radiology, Sleep Study, Infusion, Health Information Management, Infection Control, Pharmacy, Ambulance, Social Work/Case Management, Physical Therapy, Occupational Therapy, and Speech Therapy)

Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in failure to address and develop policies for changing patient care needs not addressed in the CAH policies and/or opportunities to update the policies as needed.

Findings include:

1. Review of the undated CAH policy/procedure titled "Policy/Procedure Development (P/P)", revealed in part ". . . All new and/or revised policies will be created using the appropriate template, reviewed and approved by Administration, Midlevel Provider, and Physician prior to implementation. All policies will be reviewed annually using a predetermined schedule. . . ."

2. Review of the Medical Staff Meeting Minutes for July 14, 2015 revealed in part ". . . Annual Policy and Procedure Review: The following policies/manuals were available for review: Anesthesia, Blood Bank Agreement, Dietary, Diet Manual, ER, QI Plan, Medical Staff Bylaws and Rules and Regulations, Medical Staff UR/QI Policy, Med/Surg Nursing, Organ Procurement Policy, Patient Rights Policy, Radiology, Surgery, Transfer Policy and Visitor Policy. All policies/manuals were approved by the Medical Staff. . . ."

Review of Professional Advisory Committee (PAC) Meeting Minutes dated January 28, 2015 revealed lack of documentation of annual review of all patient care policies. The minutes contained documentation of approval of new or revised policies, not all patient care policies.

3. During an interview on 1/28/16 at 9:05 AM, Staff J, Chief Nursing Officer (CNO), stated the process of annual policy review started at the department level. Staff J acknowledged the actual policies do not go to the Medical Staff Meeting or PAC Meetings for physician/mid-level approval, only new or revised policies go for approval.

Based on observations, review of policies/procedures, manufacturer's information, and staff interviews, the Critical Access Hospital (CAH) staff failed to ensure single patient use chair and bed alarm sensor pads were used for only one patient in accordance with the manufacturer's instructions for 6 of 6 AliMed chair alarm sensor pads and 1 of 1 AliMed bed alarm sensor pad. The CAH identified a census of 8 patients at the start of the survey.

Failure to ensure single use chair and bed alarm sensor pads were used for only one patient could potentially allow patients to be exposed to infectious disease and cause severe illness to the patient.

Findings include:

1. Review of CAH policy/procedure titled "Disposable vs Non-disposable Items", dated 11/10/00, revealed in part, "Any item designated in writing with the description 'disposable' or 'single use only' is intended for a single use only and then discarded as trash when finished with use. . . These items are never reprocessed for use again. . . ."

2. Observations on 1/25/16 at 1:15 PM with Staff I, Assistant Chief Nursing Officer (ACNO), revealed 5 AliMed chair alarm sensor pads and 1 AliMed bed alarm sensor pad stored in the supply room. 5 of 5 AliMed chair alarm sensor pads and 1 of 1 AliMed bed alarm sensor pad had manufacturer's instructions on the chair and bed alarm pad as follows, "Caution. . . Sensor pad is intended to be used for individual patients only. . . Care and Maintenance. . . Sensor pad is for single patient use only. . . "

Observations on 1/25/16 at 2:50 PM with Staff K, Registered Nurse (RN), revealed 1 of 1 AliMed chair alarm sensor pad in Patient # 2's room. 1 of 1 AliMed chair alarm sensor pad in Patient #2's room had manufacturer's instructions on the chair and bed alarm pad as follows, "Caution. . . Sensor pad is intended to be used for individual patients only. . . Care and Maintenance. . . Sensor pad is for single patient use only. . . "

3. During tour of the store room, Staff I stated chair and bed alarm sensor pads were kept in the supply room after they had been cleaned/disinfected following patient use and would be ready for the next patient that needed a chair or bed alarm.

4. During an interview on 1/25/16 at 1:30 PM, Staff I acknowledged they did not know 6 of 6 AliMed chair alarm sensor pads and 1 of 1 AliMed bed alarm sensor pads had manufacturer's instructions on the chair and bed alarm sensor pads for single patient use only and reported the chair and bed alarm sensor pads were disinfected and reused on multiple patients.

During an interview on 1/25/16 at 2:50 PM, Staff K stated staff use the chair and bed alarm sensor pads for more than one patient. Staff K stated staff use disinfectant wipes to clean the chair and bed alarm sensor pads after patient use and then store in the supply room and reused on more than one patient.



22898


Based on observation, review of CAH (Critical Access Hospital) policy, and staff interview the CAH failed to follow the surgical dress code by allowing 1 of 1 surgical scrub technicians (Staff B) to wear finger nail polish while assisting surgeon (Staff E, General Surgeon) during surgical cases. The CAH surgical department reported Staff B assisting Staff E with 298 cases from 1/1-12/31/15.

Failure to adhere to the surgical dress code, wearing nail polish, in the surgery department could potentially result in surgical site infections and added medical expenses to the patient if the nail polish chipped and was found in the surgical wound delaying the post surgical recovery.

Findings include:

Observation on 1/26/16 at 10:20 AM, during the tour of the surgery department revealed Staff B, Surgical Scrub Technician wearing a black-brown colored nail polish. Staff B was assisting Staff E, General Surgeon. Staff B is Staff E's personal surgical scrub technician and assists with all cases performed by Staff E.

Review of policy titled Surgical Attire, reviewed 7/24/15 reads in part..."Neither artificial nails, nor polished nails shall be worn within the semi-restricted and restricted areas of the operating room."

Interview on 1/26/16 at 10:30 AM, with Staff A, Surgery Nurse Manager, acknowledged Staff B wearing nail polish in the operating room. Staff A stated "Nail polish is not acceptable in the operating room".

Interview on 1/26/16 at 12:10 PM, with Staff B revealed he/she was wearing nail polish of a black-brown color. Staff B acknowledged wearing nail polish in the operating room for some time. Staff B was presented the policy titled Surgical Attire and read aloud the section cited above regarding nail polish. Staff B lacked a comment.

Interview on 1/27/16 at 2:00 PM, with Staff G, RN Infection Preventions, lacked awareness of Staff B wearing nail polish in the operating room. Staff G stated, "It is against hospital policy to wear artificial nails or polish in the operating room".





30076


II. Based on observations, policy review and staff interviews, the Critical Access Hospital (CAH) Dietary Department failed to use sanitary practices during food handling and patient meal service. The administrative staff identified a census of 8 patients. The Dietary Manager reported dietary staff provided an average of 18 patient meals daily.

Failure to maintain sanitary practices during meal service and food handling could potentially result in contamination of the patient's food leading to foodborne illness.

Findings include:

1. Observation during food preparation and meal service on 1/25/16, from 11:28 AM to 12:20 PM, revealed Staff Q, Dietary Manager, assigned as the cook for noon patient meal preparation. Staff Q touched multiple surfaces, including but not limited to refrigerator/freezer handles, microwave, steamer handle, convection oven, bread wrapper and fryer basket and failed to wash hands prior to donning gloves. Staff Q prepared a bacon, lettuce, tomato sandwich for a patient and handled ready to eat food, including tomato slices, lettuce leaf and toast, with the contaminated gloves.

3. Observation during food preparation and meal service on 1/25/16, from 11:28 AM to 12:20 PM, revealed Staff Q, Staff R and Staff S, Cooks, and Staff T, Dietary Tech, lifted the garbage can lid with their hand and failed to wash their hands before returning to food preparation activities.

2. Observation during food preparation and meal service on 1/26/16, from 11:15 AM to 12:25 PM, revealed the following concerns:

a. Staff U, Cook, lifted the garbage can lid with her hand on 5 occasions and failed to wash her hands before returning to food preparation activities.

b. Staff R lifted the garbage can lid with her hand on 2 occasions and failed to wash her hands before returning to food preparation activities.

c. Staff Q touched multiple surfaces, including but not limited to refrigerator/freezer handles, convection oven, and fryer basket and failed to wash hands prior to donning gloves. She handled the bread package, drawer handle and refrigerator handle with her gloved hands. Staff Q prepared a tuna salad sandwich for a patient and handled the bread with the contaminated gloves.

4. During an interview on 1/27/16, at 8:45 AM, Staff Q acknowledged a concern for cross-contamination when dietary staff touched the garbage can lid with a hand and then failed to wash their hands. Staff Q acknowledged a concern for cross-contamination with ready to eat food. She confirmed hands should be washed prior to donning gloves, when working with ready to eat food, to avoid potential contamination when donning them and confirmed the gloves would be considered contaminated if other surfaces were touched.

5. Review of a Dietary Department policy titled, "Hand Washing", reviewed 10/22/14, revealed in part "... Hands shall be washed ... after hand contact with unclean equipment ... "

6. Review of a Dietary Department policy titled, "Employee Health and Personal Hygiene", reviewed 10/22/14, revealed in part "... Wash hands any other time an unsanitary task has been performed.

7. The Food Code, published by the Food and Drug Administration and considered a standard of practice for the food service industry, in both the 2005 and 2013 editions, requires food employees wash their hands immediately before engaging in food preparation including working with exposed food, clean equipment and utensils and after engaging in other activities that contaminate them to prevent cross contamination. The Food Code also requires gloves to be used for only one task, such as working with ready-to-eat food and for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation and hands must be washed before donning gloves when working with food.

III. Based on document review, policy review and staff interviews the Critical Access Hospital (CAH) hospital failed to follow their system to identify and prevent transmission of infections and communicable diseases for employees and volunteers. Problems were identified for 3 of 3 volunteers (Staff W, X and Y) selected for review. The CAH identified 45 volunteers.

Failure to identify infections and communicable diseases could potentially result in causing harm to patients through exposure and transmission of communicable diseases.

Findings include:

1. Review of an employee health policy titled, "Post Offer Physical Examination and EHS Requirements", revised 4/22/15 included in part "...a health assessment is required every four years. Employees, volunteers (Hospital and Hospice) and contracted personnel will be required to make an appointment with employee health for completion of the assessment ..."

2. Review of an employee health policy titled, "TB Skin Test Converters", revised 4/22/15 included in part "... All employees, auxiliary volunteers and contract personnel shall have a TB assessment annually ..."

3. During an interview on 1/27/16, at 11:25 AM, Staff G, Registered Nurse (RN) Employee Health, acknowledged she lacked documented information to show Staff W, X and Y, Volunteers had a Tuberculosis (TB) test, annual TB assessment or health assessment.

4. During an interview on 1/27/16, at 11:25 AM, Staff J, Chief Nursing Officer, reported she had discovered the lack of documented health requirements, for the CAH volunteers, when she became in charge of them approximately 3 months ago and informed them in December and January, the CAH would begin requiring a health information questionnaire, health assessment and TB test.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) failed to ensure the quality improvement committee monitored and evaluated 5 of 5 contracted patient care services. (Anesthesia, Bone Density, MRI, Nuclear Medicine, and Sleep Study).

Failure to ensure the Quality Improvement Committee monitored and evaluated all the contracted patient care services for quality of care could potentially expose patients to inappropriate and/or substantial care.

Findings include:

1. Review of CAH "Quality Improvement Plan", dated 5/24/2015, revealed in part ". . . The quality program is organization wide. All organized services related to patient care including those furnished by contractors are monitored and evaluated. Each department or service is to proactively address patient care issues related to the population served. Activities shall include: A statement of the problem with data to support the size of the problem; suspected causes of the problem; corrective action taken, follow up and monitoring to determine the effectiveness of actions taken. . . ."

2. Review of the Quality Council Meeting Minutes dated January 27, 2015 to November 25, 2015 and quality reports for 2015 for Anesthesia, Bone Density, MRI, Nuclear Medicine, and Sleep Study revealed the quality reports included data collection only and lacked any corrective actions taken and follow up and monitoring to determine the effectiveness of actions taken. The quality reports for sleep study lacked data from the CAH facility only.

3. During an interview on 1/27/16 at 3:30 PM, Staff H, Director of Quality, confirmed quality reports for contracted services of Anesthesia, Bone Density, MRI, Nuclear Medicine, and Sleep Study included data collection only and lacked any corrective actions taken, follow up and monitoring to determine the effectiveness of actions taken. The quality reports for sleep study lacked data from the CAH facility only.

Based on document review, policy review and staff interviews, the Critical Access Hospital (CAH) failed to ensure 1 of 3 applicable active physicians, 2 of 4 applicable consulting physicians and 2 of 2 teleradiologists selected for review, received outside entity peer review completed by the network hospital, prior to reappointment to the Medical Staff, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the CAH. (Staff E, F, N, O and P). The CAH identified 1 courtesy,1 associate, 5 active and 38 consulting physicians credentialed to provide services to CAH patients.

The CAH administrative staff identified the volume of services by the physicians as follows for the calendar year 2015:

Staff E, D.O. General Surgery - 418 patients
Staff F, M.D, Orthopedics - 69 patients
Staff N, M.D., Teleradiology - 14 reads
Staff O, M.D., Teleradiology - 13 reads
Staff P, M.D., Radiology - 6,100 reads

Failure to ensure all medical staff members receive outside entity peer review affects the CAH's ability to assure physicians provide quality care to their patients.

Findings include:

Review of a medical staff policy titled "Medical Staff QI/Peer Review", dated 12/21/11, revealed in part "... each physician should have one chart pulled at random ... and make those charts available to the external Peer Review ... The results of peer review shall be periodically reported , in aggregate, to ... the Monroe County Hospital Board of Trustees. Results of Peer Review will be considered at the time of re-credentialing by both the Medical Staff and the Board of Trustees ... ensure that these documents are available for review at that time... "

During review of CAH documentation on 1/28/16, beginning at 8:35 AM, Staff H, Director of Quality, acknowledged the CAH failed to obtain external peer review, completed by their network hospital, prior to re-appointment for Staff E, F, N, O and P. Staff H reported the results of the outside entity peer review are reported to the Medical Staff Quality Improvement committee but not included in re-appointment packets presented to the Medical Staff and Governing Body at the time of re-appointment.

During an interview on 1/28/16, at 8:50 AM, Staff V, Director of Radiology reported the contracted radiology groups for Staff N, O and P conducted peer review on their radiologists but confirmed the peer review did not include information specific to CAH patients.