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Based on document review and interview it was determined for 1 of 1 (Pt#17) patient, requiring the use of restraints in the Emergency Department (ED), the Hospital failed to ensure safety checks were performed every 15 minute and documented in accordance with its policy. This has the potential to affect all patients requiring the use of restraints in the ED.

Findings include:

1. The policy titled "Harmful To Self or Others/Suicide" (effective 10/22/15) was reviewed on 7/18/17 at approximately 4:00 PM. The policy required "Special Instructions: 1. A screening will be conducted during triage to facilitate patient placement in the E.D. See Attachment A... Patient Protection Plan: 9. Patient will be placed in a designated room with an employee assigned to be in constant attendance with the patient. The patient shall be visible by the employee during showering, toileting, and when visitors are present." Attachment A of the policy included screening tools for Infectious Disease, Suicide Risk, and Child Abuse and stated a revision date of 9/2015. A different form, with the same screening tools but a revision date of 6/2017, was noted on patient records. This form stated "*YES = place patient in room with observation capability... institute Patient Protection Plan".

2. An interview was conducted with the Manager of the ED (E#9) on 7/19/17 at approximately 2:00 PM. E#9 stated that when the Patient Protection Plan is instituted, it refers to the "ED Observation Record" with every 15 minute checks and is to be initialed by the staff member completing the observation.

3. Pt #17's record was reviewed on 7/19/17 at approximately 2:00 PM. Patient #17 presented to the Emergency Room on 7/16/17 by local policy with the Chief Complaint of ? patient ingested pills". ED physician documentation stated "I don't want to be here. I don't want to live." ED nursing triage documentation stated "brought to ED via (local police department) - suicidal ideation". The ED Observation Record lacked documentation of every 15 minute observation for 7/17/17 at 1:00 AM. and lacked documentation as to who completed the observations on 7/16/17 at: 9:30 AM, 9:45 AM, 10:00 AM, 10:15 AM, 10:30 AM and 10:45 AM.

4. An interview was conducted with E#9 during the record review. E#9 stated, "observation sheets should have been completed every 15 minutes and the staff member observing the patient should have put their initials."

Based on document review and interview, it was determined for 3 of 11 (MD- Medical Doctor #2 and MD#3) physicians, whom have the ability to order the use of violent and/or non-violent restraints, the Hospital failed to ensure MDs ordering restraint and/or seclusion had a working knowledge of the Hospital's policy. This has the potential to affect all inpatients and Emergency Department patients serviced by the Hospital.

Findings include:

1. The Hospital policies titled "Restraints and/or Seclusion for Violent Behavior", Policy Number 9000-035A and "Restraints for Non-Violent Behaviors", Policy Number 9000-035B, (both effective June 10, 2016) were reviewed on 7/18/17 at approximately 3:00 PM. The policies both stated orders for "restraint and/or seclusion" and for "restraints" "require an order from a physician or Allied Health Professional... with competency in monitoring, assessment, and care of the restrained patient."

2. The physician files were reviewed on 720/17 at approximately 1:40 PM with the Medical Staff Coordinator (E#13) and the Manager Medical Staff Office and Credentialing Support Person from outlying Hospital (E#14). The Chief Executive Officer (E#15, the Chief Medical Officer (E#16), and the Chief Nursing Officer (E#1) were also present. The files lacked documentation the physicians (MD#2 and MD#3) had a working knowledge of the Hospital's restraint and/or seclusion policy and competence in ordering restraints, in accordance with the Hospital's policy.
a. MD#2- Initial appointment 8-16/16/04 and reappointed 1/1/17.
b. MD#3- Initial appointment 10/13/16..

3. An interview was conducted with E#1, E#15, and E#16 on 7/20/17 at approximately 1:50 PM. E#1 stated "We still have a few that have not returned their verifications that they have read our policies (on Restraint/Seclusion)."

Based on document review and interview, it was determined for 1 of 7 (Pt #21) surgical patients, the Hospital failed to ensure documentation was complete and accurate. This has the potential to affect all surgical patients serviced by the Hospital.

Findings include:

1. Pt #21's record was reviewed on 7/20/17 at approximately 12:00 PM. Pt #21 was admitted to the Ambulatory Surgery Area on 7/19/17 with the diagnosis of History of Colon Cancer and underwent a Screening Colonoscopy. Pt #21 had a history of Diabetes Mellitus. The following documentation deficiencies were identified:
a. A standing order protocol titled "Perioperative Glucose Protocol" that was not ordered or signed by the physician.
b. A standing order protocol titled "Outpatient Gastroscopy and Colonoscopy" which lacked the date and time they were initiated and lacked the time the surgeon signed them.
c. On 7/17/17, there was an order for intravenous Lactated Ringers at 60 milliliters per hour. Nursing documentation lacked the rate of the intravenous fluids.
d. A standing order protocol titled "Post Op Anesthesia Orders (Adult)" in which the "Glucose Management" section was blank.

2. An interview was conducted with the Surgery Staff Nurse (E#22) on 7/20/17 at approximately 12:10 PM. E#22 had reviewed Pt #21's record and stated Standing Orders were to be ordered for implementation, all entries were to be dated, timed, and authenticated, intravenous rates were to be documented, and orders for blood glucose monitoring for patients with Diabetes Mellitus were to be obtained and identified on the Standing Order sets. E#22 stated these were not done on Pt #21's record and should have been.

A. Based on interview and document review, it was determined the Hospital failed to ensure the work surfaces in the ISO (International Standards Organization) Class 5 work areas were cleaned and disinfected as required. This has the potential to affect all inpatients and outpatients receiving Pharmaceutical Services from the Hospital.

Findings include:

1. The policy titled "Sterile Compounding Environments" (effective 5/9/2012) was reviewed on 7/18/17 at approximately 3:30 PM. The policy required on page 4. "1. Surfaces in ISO Class 5 work area. including LAFWs (Laminar Air Flow Workspace)... require regular and thorough cleaning and disinfecting. These areas must be cleaned on a regular basis including but not limited to: a. The beginning of each compounding shift;...".

2. The Pharmacy logs for the "Daily Checklist for IV (intravenous) Admixture Program" were reviewed on 7/18/17 at approximately 2:15 PM. The logs lacked documentation Hood #1 LAFW was cleaned at the beginning of each compounding shift, as required by policy, as follows:
a. On 4/14/17 shift 1 and shift 2
b. On 4/23/17 shift 1 and shift 2
c. On 5/6/17 shift 1 and shift 2
d. On 5/7/17 shift 1 and shift 2
e. On 5/13/17 Shift 1 and Shift 2
f. On 6/4/17 shift 2
g. On 6/29/17 shift 1 and shift 2.

3. An interview was conducted with the Pharmacy Manager (E#4) on 7/18/17 at approximately 2:15 PM. E#4 stated the Pharmacy has two shifts and the compounding area for the LAFW should have been cleaned twice a day at the beginning of each of those shifts.


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B. Based on observation, interview, and document review, it was determined Therapy services failed to follow Pharmacy and manufacturer guidelines for compounding of treatment medication. This has the potential to affect all patients serviced by Therapy services with an approximate average monthly census of 2,123 patients.

Findings include:

1. An observational tour of the main Hospital's Therapy department was conducted on 7/18/17 at approximately 12:50 PM with the Therapy Manager (E#10). A container of open FIRST Hydrocortisone Compounding Gel 6 grams in 24 grams suspension was observed in a locked drawer. The container lacked the date as to when it was compounded (mixed).

2. An interview was conducted with E#10 on 7/18/17 at approximately 1:00 PM. E#10 stated "We should have dated when we mixed it and then it's good for 28 days. We didn't do that."

3. The FIRST Hydrocortisone Compounding manufacturer guidelines, used by the Hospital Pharmacy, were reviewed on 7/21/17. The guidelines stated "The beyond-use date of the compounded product, as dispensed... is not later than 180 days."

4. An interview was conducted with the Pharmacy Manager (E#4) on 7/21/17 at approximately 1:30 PM. E#4 stated "We go by the manufacturer guidelines because this product is specifically for Therapy and it says 180 days (is how long it's good for)... Yes, it (the compounded product) should have been labeled with the date it was compounded."

Based on document review and interview, it was determined the Hospital failed to ensure radiological protective shielding apparel was maintained and safe for use. This has the potential to affect all patients requiring and staff assisting in radiological services.

Findings include:

1. The policy titled "Policy Number 6700-07 Radiation Protection of Patients and Visitors" (effective July 2017- the policy was made a combination of several other policies into one) was reviewed on 7/19/17 at approximately 9:00 AM. The policy stated "D. Lead aprons, full and half... All of these devices are checked on an annual basis by qualified personnel and reported to the Administrative Director of Imaging Services. Any protection found to be inadequate is properly disposed of and documented on annual report. Questions can be directed to physicist."

2. The form titled "Protective Garments Test... Date: June 2017" was reviewed on 7/18/17 at approximately 1:20 PM. The form stated all shielding apparel was "Adequate". The form further stated the presence of "pin holes", "tear(s)", "tiny slit", "weaken spot", "Cracks", and "torn seam" on twenty six of the seventy three protective shielding apparel listed. The form further stated a list of items "Taken out of Commission"; however, the report lacked a reason as to why these items were "Taken out of Commission". The form lacked documentation as to who had reviewed the report, when, and whether the Physicist had reviewed the report to determine whether the apparel integrity was adequate or not.

3. An interview was conducted with the Director of Imaging (E#4) on 7/18/17 at approximately 1:45 PM. The Chief Nursing Officer (E#1) was also present. E#4 stated "I review this report and if I have a question I can ask the Doctor (Physicist). (The Physicist) doesn't actually see the report and it is not taken to the Radiology meetings. I don't put if something is sent for repair on all of them or if I talk to the Radiation Safety Officer. As long as there isn't a 10% decrease in effectiveness, it's ok to use. I don't put why they are taken out of commission. I just put that I took them out of commission." When asked how the 10% decrease is determined, E#4 did not answer.

Based on document review and interview, it was determined the Hospital failed to ensure the dietary staff followed established policies and procedures to maintain a sanitary food service environment. This has the potential to affect all patients, staff, and visitors receiving dietary food services in the hospital.

Findings include:

1. The policy titled "Managing Patient Care Products, Supplies, and Equipment-Ice Machines, Refrigerators, and Microwaves" (effective 8/27/2015) was reviewed on 7/18/17 at approximately 3:00 PM. The policy stated "A. Refrigerators: 2. b. Departments not electronically monitored will use a log to collect the data, note out of range readings, and contact Plant Engineering for out of range results. c. If found to be out of range: a. If refrigerator houses food, notify Dietary Services to determine if food products are safe for consumption."

2. On 7/18/17 at approximately 1:15 PM the Refrigerator/Freezer Temperature Log for the Behavior Health Unit was reviewed. The log required: "Freezer temperatures should be between -10 degrees F (Fahrenheit) and 0 degrees F. The log stated the freezer temperatures out of range, with no contact of dietary or engineering, on the following dates:
a. On 7/2/17, the freezer temperature was 10 degrees.
b. On 7/3/17, the freezer temperature was 8 degrees.
c. On 7/8/17, the freezer temperature was 20 degrees.
d. On 7/15/17, the freezer temperature was 12 degrees.
e. On 7/16/17, the freezer temperature was 16 degrees.
f. On 7/17/17, the freezer temperature was 2 degrees.

3. During and interview with the Manager of Behavior Health (E#6) on 7/18/17 at approximately 1:15 PM, E#6 acknowledged the freezer temperatures were out of range after reviewing the log and stated there was no documentation that dietary or engineering was notified the freezer temperatures were out of range.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Full Survey Due to a Complaint conducted on July 18 - 20, 2017 the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see A710.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of the Full Survey Due to a Complaint conducted on July 18 - 20, 2017, the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags.

A. Based on document review and interview, it was determined for 17 of 17 physicians and 8 or 8 Midlevel providers (4 of 4 Certified Registered Nurse Anesthetists - CRNAs and 4 of 4 Advance Nurse Practitioners- APNs), the Hospital failed to ensure all physicians and Midlevel providers were trained in infection control upon hire, at regular intervals, and as needed. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

Findings include:

1. The Hospital policy titled "Infectious Medical Waste" (effective 2/1/17) was reviewed on 7/21/17 at approximately 9:00 AM. The policy stated "General Information:... All persons required to handle infectious wastes or other potentially infectious materials will be provided with appropriate orientation, equipment, protective barriers, and on-the-job training... Education: All health care employees who either generate, segregate, package, or transport PIMW (potentially infectious material waste) are to receive training in the identification of PIMW and the proper methods of handling this material. Initial training is required at the time of the department specific orientation and refresher training annually through Educational Services."

2. The physician and Midlevel provider files were reviewed on 7/20/17 at approximately 1:40 PM with the Medical Staff Coordinator (E#13) and the Manager Medical Staff Office and Credentialing Support Person from outlying Hospital (E#14). The Chief Executive Officer (E#15, the Chief Medical Officer (E#16), and the Chief Nursing Officer (E#1) were also present. The files lacked documentation the physicians, CRNAs, and APNs had been trained in infection control upon hire, at regular intervals, and as needed.

3. An interview was conducted with E#1, E#15, and E#16 on 7/20/17 at approximately 1:50 PM. E#1 stated "We do not do infection control training for them (physicians and Midlevel providers).

B. Based on observation, document review, and interview, it was determined for 2 of 2 Hydrocollators, the Hospital failed to ensure the Hydrocollator cleaning/disinfection documentation was accurate and temperature monitoring was conducted to assure the prevention of potential cross contamination. This has the potential to affect all patients receiving Hydrocollator therapy services.

Findings include:

1. An observational tour of the inpatient Therapy Department was conducted on 7/ 18/17 at approximately 12:50 PM with the Therapy Manager (E#10). 2 Hydrocollator units were observed in use.
a. A log titled "Cleaning Schedule" was observed with initials noted on certain days. The log lacked documentation as to which Hydrocollator was being cleaned and disinfected.
b. A log titled "Daily Temperature",was observed over each Hydrocollator; however, the Hydrocollators and logs lacked a designation as to which machine went with which log. One log lacked temperatures for two operating days in July and the other log lacked temperatures for four operating days in May and two operating days in July.

2. An interview was conducted with the E#10 during the tour. E#10 stated "We couldn't really say which one is being cleaned. I just know we clean one on one day and the other on the other day. As for the temperature logs, there should be a temperature for everyday we're open, but again, we don't say which one goes with which machine. Once we take them down for the year, we wouldn't know which one was which."

C. Based on observation and interview, it was determined the Hospital failed to ensure infection control measure to prevent the potential for cross contamination were practiced and maintained throughout the Hospital. This has the potential to affect all patients, staff, and visitors of the Hospital.

Findings include:

1. An observational tour of the pre-operative area was conducted on 7/19/17 at approximately 9:50 AM with the Ambulatory Surgery Coordinator (E#19) A Certified Registered Nurse Anesthetist (E#18) was observed to leave a patient bay with gloves on and carrying the patient chart, exchanged communication with staff, laid chart on desk, removed gloves, and then went and washed hands at a hallway sink.

An interview was conducted with E#19 during the tour. E#19 stated "(E#18) should have removed the gloves and performed hand hygiene before leaving the patient bay."

2. An observation of the discontinuation of a Vascular Access Device in the Chemotherapy Infusion Clinic was conducted on 7/18/17 at approximately 3:00 PM with the Manager of Speciality Clinic/Outpatient Services (E#20). The Registered Nurse (E#21) was observed wearing gloves, flushing the Vascular Access Device, then went across the room and opened a cabinet and retrieved a Band-Aid, then changed gloves and went back to Pt #4 and removed the Vascular Access Device dressing and needle.

An interview was conducted with E#20 at the end of the observation. E#20 stated "(E#21) should have removed the gloves and performed hand hygiene before going to get the Band-Aid out of the cabinet and should have performed hand hygiene before putting on the gloves to remove the dressing and needle."


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D. Based on document review, observation, and interview, it was determined the Hospital failed to ensure the IV (Intravenous) solution was in the unopened package to prevent the potential for cross contamination, in accordance with its Manufacture Guidelines. This has the potential to affect all patients receiving IV therapy.

Findings include:

1. The Baxter Manufacturer Guideline titled "Sodium Chloride Injection, USP in VIAFLEX Plastic Container" was reviewed on 7/20/17 at approximately 10:00 AM. The manufacturer guidelines required "After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion."

2. During an observational tour of the C-section (cesarean section) room on 7/18/17 at approximately 1:00 PM, a bag of 250 ml (milliliters) NaCl (Normal Saline) was observed in the anesthesia cart that was open and out of its original container.

3. An interview was conducted with E#3 (Director of Perioperative Services) on 7/18/17 at approximately 1:00 PM. E#3 confirmed the IV fluids should not be in the cart without the original container.
An interview was conducted with E#8 (Quality and Safety Analyst Coordinator) on 7/19/17 at approximately 11:00 AM. E#8 stated "the Hospital doesn't have a policy for the IV fluids but the follow the manufactures guidelines."

E. Based on document review, observation, and interview, it was determined the Hospital failed to ensure the sharps containers were not overfilled to ensure proper waste disposal for infection prevention, in accordance with the hospital policy. This has the potential to affect all patients receiving care, and staff providing care, in the Hospital.

1. The policy titled "Infectious Medical Waste policy # 6040-011 (effective February 1, 2017) was reviewed on 7/20/17 at approximately 10:10 AM. The policy required... Segregation of Infectious Waste:...sharps container will not be overfilled, but removed and replaced when 3/4's full."

2. During an observational tour of the C-section (cesarean) room on 7/18/17 at approximately 1:00 PM, a sharps container located on the anesthesia cart was full to the top of the sharps container, past the 3/4 full marking on the container.

3. An interview was conducted with E#3 (Director of Perioperative Services) on 7/18/17 at approximately 1:00 PM. E#3 confirmed the sharps container was over filled and should have been emptied.

F. Based on observation, and interview, it was determined the Hospital failed to ensure that all opened containers of food included a date in the Nutrition Department to assure the prevention of spoilage. This has the potential to affect all patients, visitors, and staff who consume food from the Dietary Department.

Findings include:

1. An observational tour was conducted on 7/19/17 at approximately 8:30 AM with the Director of Dietary (E#7). The bakery area included an open container of vanilla icing that lacked a date of when it was opened or an expiration date. Located in the kitchen area was an open bottle of rice wine vinegar and the spice rack included multiple bottles of spices that were opened that lacked a date of when they were opened or an expiration date and/or date to discard.

2. An interview was conducted with E#7 on 7/19/17 during the tour at approximately 8:30 AM. E#7 confirmed the lack of any dates on the opened food containers and that all opened containers of food should have the dates of when they were opened and/or expiration/discard dates.