HospitalInspections.org

Based on observation and staff interviews, the facility staff failed to ensure that patient care supplies were maintained to ensure an acceptable level of quality and safety in three (Emergency Room, Medical/Surgical floor, and Surgery/Sterile Processing) of three patient care areas of the facility. Findings include:

1. On 3/11/14, the Medical/Surgical floor medication room was observed at 8:00 a.m. The surveyor identified three Becton-Dickinson BBL culture swabs with the manufacturer's expiration date of 11/13. The outdated culture swabs were the only culture swabs available in the medication room.

2. On 3/11/14, the emergency department was observed at 10:15 a.m. The following expired/unusable supplies were available for use in these specific areas;
-Eye room:
- four Scrub Care chlorhexidine surgical scrub brushes with the manufacturer's expiration date of 2/13.
- one open box of sterile sponges. The box was not labeled with the date when the box was opened.
- four PDI brand Povidone-Iodine single swabsticks with the manufacturer's expiration date of 12/13.
- four 1/32 ounce foil packs of Polysporin ointment with the manufacturer's expiration date of 12/13.
- five 1/32 ounce foil packs of Double Antibiotic ointment with the manufacturer's expiration date of 9/12.

-Cardiac Room:
- seven 10 ml, red top Vacutainer blood collection tubes with the manufacturer's expiration date of 11/13.
- twenty-nine Gastroccult occult blood test cards with the manufacturer's expiration date of 9/13.
- two #15 sterile disposable scalpels with the manufacturer's expiration dates of 6/13 (1) and 10/13 (1).

The presence of expiration dates on the individual items was confirmed by staff member D, the nurse manager.

3. On 3/12/14, the surgical suites and the central sterilization areas were observed at 1:15 p.m. The following expired/unusable supplies were available for use in these specific areas;
-Operating Room #2:
- two 20 gauge, 3 inch spinal needles with the manufacturer's expiration date of 12/12.
- two 10 ml, Red top Vacutainer blood collection tubes with the manufacturer's expiration date of 8/12.
- two 7 ml, purple top Vacutainer blood collection tubes with the manufacturer's expiration date of 6/13.
- one Ambu brand pediatric CO2 detector with the manufacturer's expiration date of 2/13.
- one NeoStat brand end-tidal CO2 detector with the manufacturer's expiration date of 11/8/13.
- one Argyle brand premi [premature] feeding tube with the manufacturer's expiration date of 5/12.

-Central Sterilization area:
- two open, partially used, 16 ounce bottles of Hydrogen Peroxide with the manufacturer's expiration dates of 1/2009 and 8/1998.

-Operating Room #1:
- two Becton-Dickinson 20 gauge, 3 inch spinal needles with the manufacturer's expiration date of 12/12.
- three Becton-Dickinson 25 gauge, 3 1/2 inch Whitacre needles with the manufacturer's expiration date of 3/13.
- nineteen Hemoccult fecal occult blood test cards with the manufacturer's expiration date of 8/12.
- one open bottle of Hemoccult fecal occult blood test developer with the manufacturer's expiration date of 9/12.

The presence of expiration dates on the individual items was confirmed by staff member E, the Operating Room nurse manager. Staff member E stated that the operating room staff were responsible for checking supplies for outdates monthly.

Based on observation and staff interviews, the facility staff failed to ensure that food was handled and stored according to established dietary practices¹, staff followed appropriate hygiene practices during food preparation², and that the kitchen area was secured according to established dietary principles in the facility kitchen. Findings include:

a. On 3/10/14 at 2:00 p.m., the initial tour of the kitchen was completed with the staff member U, the dietary manager (DM). The following concerns were observed in the refrigerator:
-one half gallon container of milk with the expiration date of 3/10/14, which was still being served to patients;
two soup containers that were not dated when opened;
two containers of lemon pudding being served were dated 2/28/14;
one container of whipped topping being served was dated 2/28/14;
employees' personal food items were stored in the refrigerator utilized for patient food, and the door of the employee bathroom in the kitchen was observed to be open during the initial tour and during the food preparation observations.

At this time the DM stated that all food was to be discarded 7 days after the date it was opened. She stated, "The pudding and whipped topping should have been thrown out."

b. Observation of food preparation activities;

On 3/11/14 at 11:15 a.m., the following was observed:
-The dietary staffs' hair was not contained by a hair net.
-The maintenance manager entered the kitchen during food preparation activities and did not have his hair or moustache restrained.
-An unauthorized individual with a moustache entered the kitchen. The moustache was not restrained.

-Staff member U, the DM, was preparing food items for lunch. The dietary manager was not observed washing or sanitizing her hands prior to entering the kitchen. A ladle was hanging above the food prep area. The DM used her bare hand to take the ladle from the hook. She grasped the scoop with her fingers. The ladle was then placed in a soup mixture;

-An un-named member of the dietary staff was instructed to make sandwiches for patients. The staff member was not observed washing or sanitizing her hands prior to starting food preparation. The staff member then retrieved a pair of gloves. The kitchen staff member crumpled the gloves up in her bare hands and moved through out the kitchen performing other duties. The kitchen staff member placed the gloves on her hands without washing or sanitizing. She was observed to open lids of condiment containers, retrieve utensils, retrieve the patient menu cards, and open multiple drawers and cupboards. She did not change gloves when moving from one task to the next. During the sandwich assembly, the kitchen staff member wiped the gloves on her apron and continued to assemble the sandwich. All the items used to make the sandwich were then put away. The gloves were removed but the kitchen staff member did not wash or sanitize her hands after the gloves were removed.

-The bathroom door (which was located right next to the prep table), was open during the preparation of the sandwiches. The surveyor observed an un-named staff member enter the bathroom, close the door, and when the staff member left the bathroom, the door was left open.4

-The dietary manager, staff member U, was observed preparing food items for the patients in the hospital. The dietary manger was observed putting gloves on her hands. She was not observed washing or sanitizing her hands prior to putting the gloves on her hands. The dietary manager wiped her hair and forehead with her gloved hands, wiped the gloved hands on her apron, and touched multiple surfaces in the kitchen. The dietary manager retrieved fruit. The fruit was cut into pieces and placed in serving bowls. The dietary manager used her gloved hands to pick up the fruit cups with her fingers in the bowls touching the fruit and grasping the inside of the bowls. She opened the cooler and set the fruit cups on a shelf in the cooler. She did not remove her gloves.

-The dietary manager was observed leaving the kitchen wearing gloves on her hands on two separate occasions during the food preparation activities. Each time the DM re-entered the kitchen, she had only one glove on her left hand. The other glove was crumpled in her right hand. The crumpled glove was placed on her hand and she continued to perform food preparation activities.

c. Kitchen area not secured;

The kitchen was not secured from unauthorized personnel. ³
During the observation of food preparation on 3/11/14 at 11:45 a.m., an unknown male entered the kitchen wearing a soiled baseball hat and he had a mustache. The unidentified man was not stopped or acknowledged by any members of the kitchen staff. The man walked through the area where the food was being prepared, entered the DM's office, and then exited the area through the food prep area of the kitchen. The DM stated that she did not see a man enter the kitchen. The DM stated that the kitchen was not secured at night. She had no means of locking her kitchen to exclude unauthorized visitors or employees.


d. Hand Sanitizer;

Avaguard Foaming Hand Antiseptic 70% Ethyl Alcohol was mounted on the kitchen wall in three separate locations. On 3/11/14 at 11:45 a.m., the dietary manager was asked if she used the hand sanitizer, and she stated that she used the sanitizer. The kitchen manager was unaware that the hand sanitizer mounted was not acceptable for the kitchen. The dietary manager stated that the water at the hand washing sinks in the kitchen did not get hot. The DM stated "washing hands in cold water is not effective." A kitchen staff member stated that the water in the hand sinks was cold. At 4:15 p.m., the DM took the temperatures of the water in two hand sinks. The temperature of the water was 55°F. The DM could not get the water to stay flowing longer than 5 to 7 seconds at a time. The DM took the water temperature for one minute at each sink. On 3/13/14 at 8:00 a.m., the maintenance manager stated that he could not get the water past 55 degrees in the hand sinks. He stated he would turn up the water so that both sinks had hot water.

¹
MONTANA DEPARTMENT OF HEALTH & HUMAN SERVICES
ADMINISTRATIVE RULES OF MONTANA TITLE 37, CHAPTER 110, SUBCHAPTER 2 FOOD & CONSUMER SAFETY SECTION
37.110.208 FOOD DISPLAY AND SERVICE ....
(6) Date marking and disposition of ready-to-eat potentially hazardous food must be handled in the following manner:
(a) Refrigerated, ready-to-eat, potentially hazardous food prepared and held for more than 24 hours in a food establishment must be clearly marked at the time of preparation to indicate the "sell by" date, "best if used by" date, or the date by which the food must be consumed which is, including the day of preparation:
(i) 7 calendar days or less from the day that the food is prepared, if the food is maintained at 41°F (5°C)or less; or
(ii) 4 calendar days or less from the day the food is prepared, if the food is maintained between 42° and 45°F (5.5° and 7°C).
(b) A container of refrigerated, ready-to-eat, potentially hazardous food prepared and packaged by a food manufacturing establishment must be clearly marked to indicate the date by which the food must be consumed:
(i) 7 calendar days or less after the original container is opened, if the food is maintained at 41°F (5°C) or less; or
(ii) 4 calendar days or less from the day the original container is opened, if the food is maintained between 42°F and 45°F (5.5°C and 7°C)....
(iii) food in unmarked containers or packages, or for which the time expires, is discarded; and
(iv) written procedures are maintained in the food establishment and made available to the regulatory authority upon request to ensure compliance with (7)(a)(i) through (iii) of this rule and ARM 37.110.206 for food that is prepared, cooked, and refrigerated before time is used as a public health control.
37.110.210 FOOD EMPLOYEES (1) ....

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(3) Food employees shall clean their hands in a hand washing facility that conforms to the requirements
37.110.221.
(4) Food employees shall thoroughly wash their hands and the exposed portions of their arms with soap and warm running water after any of the following activities:
(a) immediately before engaging in food preparation, including working with exposed food, clean equipment and utensils and unwrapped single-service and single-use articles;
(b) during food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks;
(c) when switching between working with raw foods and working with ready-to-eat foods;
(d) after handling soiled equipment or utensils;
(e) after coughing, sneezing, using a handkerchief or disposable tissue;
(f) after using the toilet room;
(g) after eating, drinking or using tobacco;
(h) after touching bare human body parts other than clean hands and clean, exposed portions of arms;...
(j) after engaging in other activities that contaminate the hands.
(5) If used, chemical hand sanitizers must:
(a) have active antimicrobial ingredients that are listed as safe and effective for application to human skin as an antiseptic handwash pursuant to the U.S. food and drug administration's regulations for over-the-counter health-care antiseptic drug products; and
(b) have only components that are:
(i) regulated for the intended use as food additives as specified in 21 CFR 178; or
(ii) generally recognized as safe for the intended use in contact with food within the meaning of the federal Food, Drug, and Cosmetic Act, section 201(s); and
(c) be applied only to hands and arms that are cleaned with a cleaning compound in a hand washing facility by thoroughly rubbing together the surfaces of their lathered hands and arms and thoroughly rinsing with clean water;
(d) if a hand sanitizer or a chemical hand sanitizing solution used as a hand dip does not meet the criteria specified in (5)(a) through (c) of this rule, use must be:
(i) followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; ...
(c) use single-use gloves for only one task, such as working with ready-to-eat food or with raw animal food; use them for no other purpose; and discard them when they are damaged or soiled or when interruptions occur in the food operation;
(f) Food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair. The hair restraints must be designed and worn to effectively keep hair from contacting exposed food;

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(8) Persons unnecessary to the food establishment operation may not be allowed in the food preparation, food storage, or warewashing areas, except as allowed by the person in charge if steps are taken to ensure that exposed food, clean equipment, utensils and linens; and unwrapped single-service and single-use articles are protected from contamination.)
37.110.221 HAND WASHING FACILITIES (1) Hand washing facilities must be constructed, installed, and maintained to facilitate cleaning.
(2) Customers are prohibited from entering the food preparation, food service, food storage or utensil washing areas to use hand washing facilities ...
(5) Service sinks and utensil washing sinks may be used as hand washing facilities if properly located, equipped, maintained, and continuously available for hand washing ...
(7) Each hand washing facility must be provided with warm running water by means of a mixing valve or combination faucet. Any self-dispensing, slow-closing, or metering faucet used must be designed to provide a flow of water for at least 15 seconds without the need to reactivate the faucet. ...

4
37.110.220 TOILET FACILITIES (1) Toilet facilities must be provided for food employees and other authorized persons. .....
(7) Toilet rooms must be completely enclosed, and must have tight-fitting, self-closing doors. Such doors may not be left open except during cleaning or maintenance. If vestibules are provided, they must be kept in a clean