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2301 HIGHWAY 71

SPIRIT LAKE, IA 51360

LICENSURE OF PERSONNEL

Tag No.: A0023

Based on review of policies, personnel records, and staff interviews the hospital failed to ensure all staff completed the Adult/Child Abuse Mandatory Reporter training as required by state law.

Failure to ensure 2 of 21 employees completed the Adult/Child Abuse Mandatory Reporter training could potentially result in harm to the patient related to the lack of staff's knowledge for identifying and reporting suspected child and dependent adult abuse at the hospital. (Staff Q, Food Services Supervisor and Staff R, Housekeeper)

Findings include:

1. Review of a policy titled "Staff Education", revised on 8/20/14, revealed the policy failed to include Food Services, Maintenance or Housekeeping the categories of employees required to complete the Adult/Child Abuse Mandatory Reporter training.

2. Review of a document titled, "Iowa Administrative Code 235B" included in part, " ... Information education and training requirements...A person required to report cases of dependent adult abuse pursuant to sections of 235B and 235E ...shall complete two hours of training relating to the identification and reporting of dependent adult abuse within 6 months of initial employment ...The person shall complete at least two hours of additional dependent abuse identification and reporting training every five years ..."
3. Review of the personnel files for Staff Q, Food Services Supervisor, and Staff R, Housekeeper, lacked documented evidence staff completed the Adult/Child Abuse Mandatory Reporter training.

4. During an interview on 9/23/15, at 11:50 AM, Staff P, Vice President of Quality, Inpatient and Community Services, reported only direct patient care staff are required to complete Adult/Child Abuse Mandatory Reporter training, which would not include Housekeeping, Food Services or Maintenance.

INSTITUTIONAL PLAN AND BUDGET

Tag No.: A0074

Based on review of policies, documents, and staff interview, the hospital administrative staff failed to submit the hospital's budget plan for capital expenditures to the state health planning agency as required by the regulation. The hospital administrative staff reported a census of 13 patients.

Failure to ensure the administrative staff submitted the hospital's budget to the state health planning agency could potentially prevent the state health planning agency from reviewing the hospital's capital expenditures.

Findings include:

1. Review of a policy titled "Budget Process:, revised 5/09, revealed the policy failed to address the requirement of the hospital to submit the hospital's budget plan to the state health planning agency.

2. During an interview on 9/22/15 at 1:10 PM, Staff E, Chief Financial Officer (CFO) acknowledged he did not submit the hospital's budget plan to the state health planning agency. Staff E said he had never submitted the hospital's budget plan to the state health planning agency and was unaware he needed to.

PATIENT RIGHTS: NOTICE OF RIGHTS

Tag No.: A0117

Based on review of policy, observations, and staff interview the hospital failed to ensure staff at 2 of 2 off-site clinics informed patients of their patient rights, responsibilities, and visitation rights at the time of the patient registration.

Failure to ensure staff at 2 of 2 offsite clinics informed patients of their patient rights, responsibilities, and visitation rights could potentially result in patient's inability to exercise their rights and responsibility to assist in the provision of the highest possible quality of care. (Spirit Lake Medical Center Clinic and Lakes Regional Healthcare Clinic)

Findings include:

1. Observation on 9/22/15 at 7:25 AM during a tour of the Lakes Regional Healthcare Physical Therapy Clinic showed the patient admission department lacked documented evidence of the hospital's Patient Rights and Responsibilities information provided to patients who received care and services at the clinic. Further observation showed the patient admission waiting area lacked postings of Patient Rights and Responsibilities for patients to review.

2. During an interview at the time of the observation, Staff G, Therapy Technician reported during the patient registration, he provided patients with the "Authorization for Care and Treatment" form and after each patient reviewed it the patient would sign their name prior to receipt of services. Staff G said he was unaware he needed to inform patients of their patient rights and responsibility prior to the patient receiving services at the clinic. Staff G said he was unaware of the hospital's patient rights and responsibilities policy. Staff G agreed the clinic did not have written documents regarding patient rights and responsibilities to give the patients to review and/or postings of patient rights and responsibilities at the clinic.

3. Review of the document titled, "Authorization for Care and Treatment" revealed a section titled, "Patient Rights and Responsibilities" patients acknowledged they have received or were offered a copy of the Patient Rights and Responsibilities information or may appoint a designated representative by instructing Lakes Regional staff verbally or in writing that they have received a copy.

During an interview on 9/22/15 at 9:25 AM, the Chief Nursing Officer (CNO) acknowledged the clinic lacked Patient Rights and Responsibilities postings and materials for patients to review prior to receiving services at the therapy clinic. Additionally the CNO acknowledged therapy clinic staff failed to follow hospital policy to educate and inform patients of their patient rights and responsibilities at the time of admission for services at the therapy clinic.

4. Observations during a tour of the Spirit Lake Medical Center Clinic on 9/22/15 beginning at 11:58 AM revealed the clinic lacked postings and/or documents of the hospitals Patient Rights and Responsibilities information for patients to review prior to receiving care and services at the clinic.

5. During an interview at the time of the tour Staff H, Vice President of Clinic Operations acknowledged the clinic lacked Patient Rights and Responsibilities postings and materials for patients to review prior to receiving services at the clinic. Additionally, Staff H acknowledged staff failed to follow hospital policy to educate and inform patients of their rights and responsibilities at the time of admission for services at the clinic.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on review of policy, documents, observation and staff interview the hospital staff failed to ensure the maintenance staff monitored the hot water temperatures at the handwashing sinks in the patient examination rooms and patient restrooms at 1 of 2 off-site clinics. Hot water temperatures were identified at greater than 120 degrees Fahrenheit in 9 of 20 patient examination rooms and 2 of 5 patient restrooms. (Spirit Lake Medical Center Clinic)

Failure to ensure the maintenance staff monitored the hot water temperatures at the handwashing sinks in patient examination rooms and patient restrooms could potentially cause serious scalding burns to patients. (The depth of injury directly related to the temperature and duration of exposure to the water. The length of exposure required for a third degree burn to occur is 15 seconds at 133 degrees, 1 minute at 127 degrees, and 3 minutes at 124 degrees.)

Findings include:

1. Review of hospital policy "Utility - Water Supply" revised 2/13, included in part, "...Hot water temperature shall not exceed 120 degrees Fahrenheit. Daily documentation is part of the boiler log..."

2. Observations on 9/22/15 beginning at 11:20 AM with the Vice President of Clinic Operations showed the temperatures of the hot water flowing from the handwashing sink in 9 of the 20 patient examination rooms were the following:

Room #5: 127.2 degrees
Room #8: 131.0 degrees
Room #12: 131.8 degrees (Pediatric exam room)
Room #17: 126.5 degrees
Room #18: 129.6 degrees (Pediatric exam room)
Room #24: 129.9 degrees
Room #25: 130.0 degrees
Room #26: 128.9 degrees
Room #27: 132.8 degrees

Observations showed the temperatures of the hot water flowing from the handwashing sink in 2 of the 5 patient restrooms read at the following:

restroom in the south hallway: 125.6 degrees
restroom in the laboratory area: 129.2 degrees

3. During an interview on 9/22/15 at 11:25 AM, Staff I, Director of Facilities reported the maintenance department staff did not monitor or document hot water temperatures in the patient examination rooms and/or the patient restrooms in the clinic for the past 10 years. The Director of Facilities agreed the hot water temperatures should not exceed 120 degrees Fahrenheit.

PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS

Tag No.: A0147

Based on review of policy, observation, and staff interview the hospital failed to ensure 1 of 2 off-site clinics had a system in place to ensure staff secured patient's medical records to protect patient's confidential information and limited access to those individuals authorized as having "a need to know".

Failure to ensure 1 of 2 off-site clinics had a system in place to ensure staff secured patients medical records to protect patient's confidential information and limited access to those individuals authorized as having "a need to know" could potentially result in unauthorized use of patient's personal information. (Spirit Lake Medical Center)

Findings include:

1. Review of hospital policy titled "Security and Safeguarding of Health and Hospital Information" revised 3/15, included in part, "...Lakes Regional Healthcare (LRH) will strive to ensure that medical records...will be maintained in secure and restricted areas with access limited to those LRH staff members who have a "need-to-know access" based on either patient care needs and/or position responsibilities..."

2. Review of a document titled, "Patient Rights and Responsibilities" revised 8/14, included in part, "...The patient has the right to expect that all communications and records pertaining to his/her care will be treated as confidential."

3. Observation on 9/22/15 at 10:15 AM, revealed active patient medical records stored on 7 standing cabinets, approximately 600 active patient medical records stored in 3 upright filing cabinets, and approximately 30 active patient medical records stored on a standing bookcase. The patient medical records contained the patient's demographic information and personal medical information.

4. During an interview at the time of the observation Staff H, Vice President of Clinic Operations estimated there were many thousands of patient medical records stored on the 7 standing cabinets. Staff H said environmental services staff cleaned the office after hours and agreed environmental services staff could potentially access patient's confidential information contained in the patient's medical record. The Vice President of Clinic Operations agreed the environmental services staff did not have a "need-to-know access " position in accordance with the policy.

During an interview on 9/22/15 at 12:10 AM, Staff J, Registered Nurse (RN) Clinic Manager agreed the clinic staff failed to follow the hospital's policy to secure the patient medical records to protect the patient's confidential information. The Clinic Manager acknowledged the staff that did not have a "need to know" could potentially access patient medical record information stored on the 7 cabinets, 3 upright filing cabinets and the standing bookcase.

INFECTION CONTROL PROGRAM

Tag No.: A0749

I. Based on review of policy, observation, and staff interview, the hospital failed to ensure staff cleansed the rubber septum on the medication vial before staff inserted the needle from a syringe into the potentially contaminated rubber septum on the medication vial.

The hospital failed to ensure 2 of 3 staff cleansed the rubber septum on the medication vials before staff inserted the needle from a syringe and/or IV (Intravenous) tubing spike into the potentially contaminated rubber septum on the top of the medication vial could potentially result in transmission of bacteria from the rubber septum through administration of medication or IV fluids resulting in severe illness. (Staff A, Certified Registered Nurse Anesthetist (CRNA) and Staff D, Registered Nurse (RN)

Findings include:

1. Observation on 9/22/15 at 9:00 AM revealed Staff A, CRNA removed 1 medication vial labeled, "Propofol" from an anesthesia cart in the operating room (OR). Continuted observation showed CRNA without cleansing the potentially contaminated rubber septum on the top of the medication vial, CRNA inserted the needle attached to a syringe into the potentially contaminated rubber septum. CRNA withdrew medication into the syringe and then administered the medication to Patient #1 in the OR.

2. During an interview on 9/22/15 after Patient #1's procedure, Staff A, CRNA acknowledged he failed to cleanse the rubber septum on the top of the medication vial prior to inserting the needle and withdrawing the medication from the vial. Staff A stated he had no alcohol wipes available in the OR to cleanse the rubber septum on the medication vial at the time of [Patient #1's] procedure.

3. Observation on 9/21/15 at 1:55 P.M. revealed Staff D, RN, on the medical/surgical unit obtained a new vial of Zosyn (antibiotic) and removed the seal from the top of the medication vial. Continued observation showed Staff D without cleansing the rubber septum on the top of the medication vial, inserted the IV spike from the normal saline solution bag into the potentially contaminated rubber septum on the medication vial. RN D mixed together the medication from the vial and normal saline solution to administer to Patient #2.

4. During an interview on 9/23/15 at 2:45 PM, Staff N, Director of Inpatient Services stated staff are expected to cleanse the rubber septum on all medication vials with an alcohol wipe prior to the insertion of needles or IV line spikes. The Director of Inpatient Services reported staff should not assume the top of the medication vial is clean.



30076

II. Based on review of policies, documents, observations, and staff interviews, the hospital Food Services staff failed to maintain sanitary conditions of food preparation equipment and used sanitary practices during food handling and patient meal service. The Food Services Supervisor identified dietary staff provided an average of 858 patient meals monthly.

Failure to ensure staff maintained sanitary conditions of food preparation equipment and used sanitary practices during meal service and food handling could potentially result in contamination of the patient's food resulting in severe illness.

Findings include:

1. Review of a policy titled "Warewashing and the 3-Compartment Sink", reviewed in 6/2015, revealed in part "...The sanitizing solution will contain a quaternary sanitizing agent dispensed according to manufacturer guidelines. The chemical concentration or PPM will be at 200..."

Review of a Food Services/Nursing policy titled "Kitchen Sanitation and Food Service Personnel Hygiene" revised in 6/15 included in part, "...Food Code 2005...will be used as the standard to assure food safety practices..."

2. Review of the manufacturer's label, "Swisher Clear Sanitizer", stated in part, "...measure 200-400 ppm, in order to effectively sanitize food contact surfaces..."

3. Review of the document titled, "ServSafe Food Handler Training manual" stated in part, "...wash hands before putting on gloves and when changing to a new pair and should change gloves when they become dirty and before beginning a new task..."

Review of the document titled, "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 gloves should 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.

Further review of the document titled, "The Food Code", published by the Food and Drug Administration, is considered a standard of practice for the food service industry, in both the 2005 and 2013 editions, requires: surfaces such as cutting blocks and boards, that are subject to scratching and scoring, shall be resurfaced if they can no longer be effectively cleaned and sanitized, or discarded if they are not capable of being resurfaced.

4. Observations on 9/21/15 at 1:00 PM in the food preparation area include the following:

a. The surfaces on 11 of 11 cutting boards used for food preparation were stained and worn included:

4 of 4 green cutting boards,

3 of 3 white cutting boards

1 of 1 red plastic cutting board

1 of 1 yellow cutting board

1 of 1 blue cutting board

1 of 1 tan plastic cutting board

During an interview at the time, Staff Q, Food Services Supervisor, acknowledged the cutting board surfaces were stained and worn.

b. Observation near the 3-compartment sink showed a bucket that held sanitizer solution, staff used to sanitize the food preparation counter. The sanitizer solution concentration measured 100 parts per million (ppm).

During an interview Staff Q, Food Services Supervisor acknowledged the sanitizer solution tested below the manufacturer's recommended concentration of 200 ppm. Staff Q reported staff used the sanitizer solution dispensed at the 3-compartment sink to fill the buckets. Staff Q reported staff are required to measure the sanitizer solution concentration of the the 3-compartment sink twice daily and document the results. The Food Services Supervisor reported staff are not required to check the sanitizer concentration in the sanitizer buckets. Staff Q, the Food Services Supervisor reported there is not defined time period in which the staff are required to replace the sanitizer solution to ensure sanitizer solution remained at the effective concentration level.

5. Observation on 9/22/15, at 7:45 AM showed Staff U, Food Service Worker/Cook wiped the food preparation counter with a cloth he removed from a sanitizer solution bucket by the 3-compartment sink. When asked to measure the concentration of the sanitizer solution in the bucket, Staff Q reported the sanitizer solution concentration measured 100 ppm. Staff Q acknowledged the concentration failed to meet the requirement of 200 ppm.

6. Observation on 9/22/15 at 8:15 AM during breakfast meal service, showed Staff Q, Food Services Supervisor entered the kitchen from his office, without sanitizing hands, donned gloves, touched the microwave, a drawer handle, lids for plate/base warmer, ready-to-eat foods including warmed french toast and the strawberry/orange slice garnish.

7. Observation during food preparation and noon meal service on 9/22/15, from 11:10 AM to 12:20 PM, revealed the following:

a. Staff Q, Food Services Supervisor touched a variety of surfaces in the food preparation area. Staff Q without sanitizing hands, donned gloves and proceeded to prepare the patients food order, a cold sandwich. Staff Q with potentially contaminated gloves touched the cold prep table lid handle, Staff Q's pants, Staff Q's forehead on 4 occasions, the saran wrap box, microwave. Continued observation showed Staff Q, with the same potentially contaminated gloves touched each of the ready-to-eat food including bread slices, roast beef slices, pickle spear and the orange slice garnish.

b. Staff S, Food Service Worker/Cook touched a variety of surfaces in the food preparation area. Staff S without sanitizing hands, donned gloves and proceeded to prepare a patient's food order. Staff S, Food Service Worker/Cook with potentially contaminated gloves opened the cold prep table lid, picked up a grilled chicken breast, sliced the chicken breast, placed each piece of chicken breast on a salad, and served the salad to a patient.

8. During an interview on 9/23/15, at 4:00 PM, Staff T, Registered Dietitian, reported staff are expected to follow the requirements of the 2005 Food Code, including proper handwashing and use of disposable gloves with ready-to-eat food handling. The Registered Dietitian agreed dietary staff should not touch multiple surfaces and then handle ready-to-eat food. The Registered Dietitian reported staff are trained on food safety/sanitation using a program titled "ServSafe Food Handler Training". The Registered Dietitian reported Staff Q and Staff S completed the training.