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Based on observation, interview, and record review the facility failed to ensure patient medical records were protected from unauthorized access in the medical record department.

This failure created the potential for unauthorized individuals to gain access to patients protected health information.

Findings:

Policy

According to the policy, HIPPA: Physical Safeguards for Protected Health Information, paper records will be stored in a secure location. Access is available only to facility staff as required to perform their job function. Restricted work areas will be supervised by facility staff.

1. The facility failed to ensure patients' medical records were secured from unauthorized individuals.

a) On 10/05/15 at 1:00 p.m., in the Health Information Management (HIM) department, 36 boxes of pharmacy records which included patient names and dates of birth, and 2 boxes of billing records were observed stacked on a rolling shelving system. The Director of Medical Records (Employee #3) stated there was no way to lock the rolling shelving system. The records remained in this location at all times. The main entry door to the HIM department was locked after normal business hours.

b) At 8:50 a.m. on 10/06/15, in an interview with Employee #3, s/he stated that contracted cleaning personnel, plant operations staff, the nursing supervisor, and employees with desks in the area who were not part of the HIM department had a key to enter the HIM department after hours when no HIM department staff was present. Employee #3 stated the contracted cleaning personnel were present in the facility during normal business hours but did not clean the HIM department during normal business hours because "they're trying not to disturb us. They come on Friday's after everyone is gone".

Based on observation, interview, and record review the facility failed to ensure informed consent was obtained for procedures requiring informed consent in 1 of 4 outpatient medical records reviewed (Patient #28).

This failure created the potential that the patient did not fully understand the reason, benefits, and risks, of the procedure to make an informed decision.

Findings:

Policy

The policy, Consents for Treatment 10/1/2011, stated a properly signed Informed Consent is necessary for treatments or procedures which are not routine in nature and which may pose a greater than minimal risk to the patient. The procedural informed consent is obtained in addition to the general consent for treatment form.

1. The facility failed to obtain procedural consents in 1 out of 4 outpatient medical records reviewed.

a) On 10/06/15, review of Patient #28's medical record showed s/he was admitted to the Nuclear Medicine department on 4/22/15 to receive a Lexiscan sestamibi stress test. This was a nuclear scanning test performed to determine how well blood was flowing to the heart muscle and required a radioactive material (Sestamibi) be injected into the patient's blood stream.

There was no procedural consent for the Lexiscan sestamibi stress test in Patient #28's medical record to show that the patient had been advised of the reason, benefit, and risks of the exam.

b) On 10/07/15 at 12:36 p.m., the Regulatory Consultant (Employee #2) stated "there is supposed to be a consent for every procedure. We went to look for the consent and there was not one."

The Fire and Life Safety Validation survey was conducted on November 3 and 4, 2015 on Event ID 6WG321.

The results of the validation survey were discussed with the Adminsitrator and the Maintenance Supervisor during an exit conference conducted on November 4, 2015.
The deficienies cited were K-25, K-27, K-39, K-40, K-46, K-50, K-51, K-62, K-70, K-74, K-77, K-144, K-147, and K-211.

The deficiencies result in the Condition of Participation for Physical Environment (A700) being out of compliance with the Conditions of Participation set forth by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services.

Based on observation, interviews, and document review, the facility failed to ensure glucometer test strips were maintained in accordance with manufacturer's guidelines and in a manner to ensure efficacy.

This failure created the potential for erroneous test results when checking patients' blood sugars.

Findings:

POLICY

According to the procedure Glucose Meter - Nova Statstrip Point of Care, write the discard date on the label of the vials when they are first opened. Discard date for the vial of test strips is 6 months after the date first opened.

REFERENCE

According to the manufacturer's guidelines for Nova StatStrip Glucose Test Strips, once opened, the StatStrip Test Strips are stable when stored as indicated for up to 180 days or until the expiration date, whichever comes first.

1. The facility did not ensure glucometer test strips were used prior to the manufacturer's discard date.

a) On 10/05/15 at 12:52 p.m., a tour of the medical surgical unit revealed 2 opened vials of glucometer test strips with no written date indicating when the test strips were to be discarded.

b) An interview with the Intensive Care Unit (ICU) and Medical Surgical Nurse Manager (Registered Nurse #4, RN) was conducted during the tour. RN #4 stated the glucometer test strips were good for 180 days (which was in accordance with the manufacturer's guidelines). RN #4 further stated that vials should have had a written date indicating when the test strips should have been discarded and that there was no way to know if the strips were expired or not. RN #4 further stated his/her expectation was that whoever opened a glucometer test strip vial was responsible for writing the discard date on the vial.

c) On 10/07/15 at 9:00 a.m., an interview with RN #5 was conducted. RN #5 stated s/he thought the glucometer test strips were good for 3 months once the vial was opened. This was in contrast with the facility's policy. RN #5 further stated the expectation was for staff to write the discard date on the vial once opened.

Based on observation, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of food storage, disinfection of surgical instruments, peripheral intravenous catheter insertion techniques, and cleaning/disinfection of mobile computer workstations.

This failure created the potential for patients to experience illness due to exposure to food borne pathogens if unlabeled food or expired/unsafe food was served to patients. Additionally this failure created the potential for patients to be at risk for health care acquired infections.

FINDINGS:

POLICY

According to policy, Dating System, foods stored in the kitchen shall be dated in a systematic manner to assure food safety. All items should be dated unless container has a manufacture date on it.

According to policy, Decontamination of Instruments and Devices, a neutral pH enzyme pre-soak, prepared in accordance with the manufacture's instructions for use, is used to loosen protein and lipid soils.

According to policy, Intravenous Therapy for the Adult Patient: Peripheral IV Therapy Practice Guideline for Nursing and Allied Health, antiseptic on the insertion site should be allowed to dry before catheter insertion for 30 seconds. Staff should follow Standard Precautions.

According to policy, Hand Hygiene, Antisepsis, and Artificial Fingernails, hands must be washed or sanitized before and after contact with any patient or items in the patient environment.

According to policy, General Infection Prevention Policy, cleaning of patient/resident care equipment and environment is performed to prevent transmission of infection. Unit-based patient care equipment is to be cleaned on a daily basis and when visibly soiled.

REFERENCE

According to the Storage Period for Retaining Food Quality guidelines, herbs and ground spices stored at room temperature should be discarded after 6 months.

According to Prolystica 2X Concentrate Enzymatic Presoak and Cleaner, dilute 1/8 to 1/2 fluid ounce per gallon of warm water.

1. The facility failed to ensure food was identifiable, labeled, and dated with expiration or use by dates. Additionally, the facility failed to ensure food was discarded after the expiration date or use by date.

a) On 10/05/15 at 2:25 p.m., a tour of the kitchen was conducted with Registered Nurse (RN) #4 and the Food Services Supervisor (Employee #6). During the tour, inspection of the Cafe refrigerator and freezer revealed the following items were not dated or labeled with an expiration date and/or use by date: 1 bag of lettuce, 4 cheese slices wrapped in plastic wrap, 1 container of raw shelled eggs, 1 container of ham, 4 loaves of bread, 3 bags of bagels, 1 bag of frozen French Fries, 1 plastic bag with frozen corn dogs, 2 bags of frozen chicken tenders, 2 frozen fish filets in a plastic bag, and 2 bags of frozen hamburger patties.

Inspection of the main kitchen's 3 refrigerators revealed the following items were not dated or labeled with an expiration date and/or use by date: 1 gallon container of green beans, a 4 quart container of carrots, a 4 quart container of white gravy, 1 clear plastic container that contained a red liquid, 1 container that contained a purple liquid, 8 large bags of green lettuce (3 bags with brown leaves), 2 bags of cauliflower, 3 bags of broccoli, 5 natural mild cheddar cheese slices (no manufacture's expiration date), molded yellow cheese slices wrapped in plastic wrap, 1 open plastic bag of sausage links (in uncovered plastic bin), 1 large opened package of bacon slices, 2 covered pans of raw biscuit dough, 1 covered pan of white shredded meat, 1 Styrofoam container of cooked bacon, and 12 burritos in a covered silver pan.

Inspection of the main kitchen's 2 freezers revealed the following items were not dated or labeled with an expiration date and/or use by date: 1 opened bag of frozen small potatoes, 1 opened bag of frozen omelets, 12 frozen hot dogs in clear plastic wrap, 1 large bag of frozen fish filets, 1 large opened bag of frozen twice cooked baked potatoes, 1 open bag of frozen Salisbury steaks, 1 bin of frozen cinnamon rolls, 1 opened bag of approximately 40 waffle sticks, approximately 20 veggie lasagna squares individually wrapped in clear plastic wrap, and 1 large opened bag of frozen mixed vegetables. Additionally, in 1 of the 2 freezers, a silver cart was found with an uncovered tray with 2 pieces of exposed frozen fried chicken, 2 exposed frozen twice baked potatoes, 2 Styrofoam bowels of exposed frozen mixed vegetables. Employee #6 stated the uncovered tray contents was for a meal to be served that evening for two patients.

A red sign with white lettering was posted outside each of the refrigerators and freezers that stated "LABEL and DATE ALL FOOD ITEMS".

Additionally, throughout the kitchen the following outdated and expired food items were found: 14 opened containers of ground spices and herbs with printed manufacture dates ranging from 05/22/08 to 02/12/15; 1 deli container of deli macaroni with expiration date 10/02/15, 1 four quart container of sweet potatoes with expiration date 09/30/15, 1 container of parmesan cheese packets with use by date 09/25/15, 1 container of horseradish packets with use by date 09/25/15, 5 packages of tortilla wraps with printed manufacture date of 08/2015, 1 half-pint carton of fat free milk with expiration date 09/26/15, and 1 container of light mayonnaise with a handwritten expiration date of 05/15/15.

During the tour, Employee #6 stated the food in the cafe refrigerator and freezer was transferred from larger packages stored in the main kitchen. Employee #6 was unable to clearly state the process for labeling, dating, and monitoring outdated food stored in the kitchen.

b) On 10/06/15 at 3:38 p.m., an interview was conducted with Employee #6 who stated the kitchen staff should have dated food according to the Storage Periods for Retaining Food Quality and the Refrigerator & Freezer Storage Chart. Employee #6 stated s/he was unsure if the facility had a policy about dating food items. S/he further stated food items should be dated when they arrived at the facility and discarded when expired.

c) On 10/07/15 at 10:58 a.m., an interview was conducted with the Chief Financial Officer (Employee #7) who was responsible for overseeing Employee #6 and Food Services. Employee #7 stated s/he expected kitchen staff to follow the Refrigerator & Freezer Storage Chart and the Storage Periods for Retaining Food Quality guidelines. After review of the observation conducted on 10/05/15, Employee #7 stated all kitchen staff were responsible for checking expiration or use by dates, and were responsible for discarding the outdated food according to these dates. S/he further stated all food should be stored in containers or properly covered, clearly labeled, and dated.

Employee #7 stated although s/he monitored the kitchen for cleanliness, s/he did not monitor the food for outdates.

d) On 10/07/15 at 1:13 p.m., an interview was conducted with the Infection Preventionist (Employee #1) who stated food borne illness could occur when food was expired or not properly stored or covered. Employee #1 stated food was at risk for contamination if exposed. S/he further stated kitchen staff should check expiration dates and ensure all food was properly covered.

2. The facility staff responsible for the disinfection of surgical instruments failed to follow manufacturer's instructions for use of enzymatic detergent in the pre-cleaning of surgical instruments.

a) On 10/06/15 at 10:47 a.m., Employees #8 and #9 were observed pre-cleaning surgical instruments. The surgical instruments were submerged in a metal bowl filled with water diluted with 1 ounce of the enzymatic detergent. Both Employee #8 and Employee #9 stated 1 ounce of the enzymatic detergent was diluted with 4 quarts of water. This was in contrast to the manufacturer's instructions for use. Furthermore, there were no measurement devices used for the water, or markings in the bowl observed.

Employee #9 stated there were no lines in the metal bowls to indicate 4 quarts. S/he further stated the amount of water used to fill the bowl may not be accurate.

b) On 10/06/15 at 11:53 a.m., an interview was conducted with the Peri-Operative Nurse Manager (Employee #10), who stated the enzymatic detergent used for pre-cleaning should be diluted per the manufacturer's instructions for use. S/he stated staff should not be estimating the amount of water used for dilution.

c) On 10/07/015 at 1:13 p.m., an interview was conducted with Employee #1 (Infection Preventionist) who stated facility staff should follow the manufacturer's instructions for dilution of the enzymatic detergent used to pre-clean contaminated surgical instruments.

3. Facility staff did not follow standard precautions and standard infection control practices when inserting a peripheral intravenous (IV) catheter.

a) On 10/07/15 at 8:53 a.m., RN #11 was observed inserting a IV catheter into Patient #27's forearm without using gloves. RN #11 cleaned the skin with the pre-packaged skin prep, and then waved his/her hand above the patient's skin in a fanning motion. RN #11 did not allow the skin preparation to air dry according to policy. RN #11 proceeded to insert the IV catheter into the patient's forearm, then with his/her left hand, grabbed the IV fluids tubing, removed the protective cap with his/her teeth, then connected the tubing to the IV catheter.

b) On 10/07/15 at 9:57 a.m., an interview was conducted with RN #10 who stated facility staff were expected to wear gloves when inserting an IV. S/he further stated the skin preparation used to clean patients' skin prior to an IV placement, should be allowed to dry without waving hands back and forth. S/he stated staff should not be removing safety caps with their teeth.

c) On 10/07/15 at 10:05 a.m., an interview was conducted with RN #11 who stated per facility policy, gloves should be worn when inserting an IV catheter. After review of the observation conducted at 8:53 a.m., RN #11 stated s/he should have placed gloves on prior to IV insertion. When asked about using his/her teeth to remove the protective cap off the IV tubing, RN #11 stated s/he was unsure if it was right or wrong to use his/her teeth.

d) On 10/07/15 at 1:13 p.m., an interview was conducted with Employee #1 who stated gloves were considered standard precautions. Employee #1 stated gloves should be worn when placing an IV catheter and staff should not remove any cap with their teeth.

4. RN staff did not perform hand hygiene prior to transporting a Workstation on Wheels (WOWs) between patient rooms. Additionally, RN staff did not disinfect the contaminated WOW to prevent an increased risk for infection.

a) On 10/06/15 at 9:11 a.m., RN #12 was observed administering medications with a WOW in patient room 211. RN #12 exited the room with his/her WOW without performing hand hygiene. RN #12 did not disinfect the WOW when s/he exited the room or prior to leaving the WOW outside the door of patient room 208. Furthermore, RN #12 did not perform hand hygiene prior to entering patient room 208.

b) On 10/05/15 at 1:21 p.m., an interview was conducted with RN #13 who stated the WOWs were disinfected once a shift with disinfectant wipes (this was in contrast to facility policy). RN #13 further stated if a patient was on isolation precautions, a WOW would be dedicated to that patient.

c) On 10/07/15 at 1:13 p.m., an interview was conducted with the Employee #1 who stated WOWs were disinfected weekly (this was in contrast to facility policy), and as needed. Employee #1 stated staff were expected to perform hand hygiene prior to leaving a patient's room, and before touching the WOWs. S/he further stated if staff did not perform hand hygiene as expected; WOWs would then be considered contaminated. After review of the observation conducted on 10/06/15, Employee #1 stated s/he could not ensure the WOW was not contaminated.