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Based on interview, review of medical personnel files, review of Kentucky Administrative Regulation (KAR) 902 KAR 20:016, and review of the facility's policy, it was determined the facility failed to ensure its employees received a preemployment medical examination for three (3) of three (3) sampled employees hired after 08/31/18, Employee #2, #7, and #8. Also, three (3) of three (3) sampled employees who had been employed for at least three (3) years did not receive a periodic triennial (every three years) medical examination (Employee #1, #9, and #10).

The findings include:

Review of 902 KAR 20:016 titled, "Hospitals: Operations and Services," effective 08/31/18, revealed in Section 3 (9) (d) for personnel, the hospital shall have an employee health program for the mutual protection of employees and patients, including provisions for preemployment medical examination and follow-up medical examination no less than every three (3) years thereafter for staff who serve patients.

Review of the facility's policy titled, "Employee Screening: New Hire and Ongoing," policy #IC 13-2, revised 07/2019, revealed upon hire all employees completed a health screen which was reviewed by the Director of Quality Management (DQM) or his/her designee. The health screen consisted of a questionnaire on medical history, tuberculosis risk assessment, latex allergy screening tool, color blind test, tuberculin skin test, vaccination history, and urine drug screen. There was no indication a medical examination by a physician or physician extender was required. Further review revealed post-employment the employee was expected to report any illness where a communicable disease might be suspected, take an annual influenza vaccination, and take an annual tuberculosis risk assessment questionnaire and/or tuberculin skin test. There was no indication a follow-up medical examination was required at least every three (3) years.

1. Review of Employee #2's, a Respiratory Therapist, medical file revealed he had a date-of-hire (DOH) of 12/17/18. He had no evidence of a preemployment medical examination in his file.

2. Review of Employee #7's, a Speech-Language-Pathologist, medical file revealed she had a DOH of 02/25/19. She had no evidence of a preemployment medical examination in her file.

3. Review of Employee #8's, the Rehabilitation Therapy Manager, medical file revealed she had a DOH of 08/19/19. She had no evidence of a preemployment medical examination in her file.

4. Review of Employee #1's, a Respiratory Therapist, medical file revealed she had a DOH of 09/04/15. She had no evidence of a follow-up three (3) year medical examination in her file.

5. Review of Employee #9's, an Occupational Therapist, medical file revealed she had a DOH of 06/24/16. She had no evidence of a follow-up three (3) year medical examination in her file.

6. Review of Employee #10's, a Physical Therapy Assistant, medical file revealed she had a DOH of 07/11/16. She had no evidence of a follow-up three (3) year medical examination in her file.

Interview with the DQM, on 08/29/19 at 2:55 PM, revealed he was unaware of the changes in the KAR that took effect on 08/31/19 with the language change to medical exam and the follow-up medical exam to be done every three (3) years. The DQM stated he believed the health screening done at preemployment, ongoing monitoring of employees for communicable diseases, and the annual influenza vaccination and TB evaluation were adequate to ensure mutual protection of employees and staff against any communicable disease.

Based on observation, interview, medical record review, review of the manufacturer's product instructions, and review of the facility's policies, it was determined the facility failed to ensure a clean and sanitary environment for patient care to prevent and control infections.

1. The facility failed to ensure Registered Nurses (RN) followed the manufacturer's product instructions for maintaining the microbiological safety of ready to hang or open tube feedings for two (2) of three (3) sampled patients with tube feedings (Patient #2 and #4).

2. The facility also failed to ensure RN's followed appropriate standard precautions, hand hygiene, and contact isolation precautions when performing patient care for two (2) of twenty-four (24) sampled active patients (Patient #6 and #8).

The findings include:

1. Review of the facility's policy titled, "Clinical Services Policy and Procedure: Gastric/Duodenal Tube," revised 01/01/19, revealed there were no instructions or guidance for staff on the required label information for tube feedings. The section "Guidelines for Maintaining Continuous Enteral Feedings" revealed enteral tube feeding bags and tubing would be changed every twenty-four (24) hours. Also, a feeding bag would be filled with no more than a four (4) hour supply of formula at a time. Nurses were responsible for hanging or refilling the formula.

Review of Abbott Nutrition Abbott Laboratories product information guides titled, "Glucerna 1.5 Cal," dated 2018, and "Jevity 1.5 Cal," dated 2018, both revealed, under the instruction for ready-to-hang, failure to follow the instructions for use increased the potential for microbial contamination and reduced hang time. For an enteral feeding pump, the guide stated the product could hang for up to forty-eight (48) hours after initial connection when clean technique and only one (1) new set was used, and the hang time was not specified as less than forty-eight (48) hours by the set manufacturer. Otherwise, the product should hang for no more than twenty-four (24) hours.

Review of Abbott Nutrition Abbott Laboratories product information guide titled, "Maintaining Microbiological Safety of Tube-feeding Formulas," dated 2016, revealed to discard open, unused ready-to-hang formula after forty-eight (48) hours. An open system was defined as the formula decanted from the original container into the feeding reservoir. It also revealed there should be an open system hang time of eight (8) to twelve (12) hours with the date and time the product was hung put on the product label.

Observation, on 08/27/19 at 1:40 PM, revealed Patient #2 had an open system tube feeding of Jevity 1.5 at forty (40) milliliters (ml) per hour with a labeled hang date of 08/25/19 at 2:00 AM. Continued observation, on 08/27/19 at 3:40 PM, revealed the open system tube feeding bag had changed. However, the bag was not labeled with date, time, rate, room number or patient identification. Further observations of the open system tube feeding, on 08/28/19 at 8:19 AM and 11:20 AM, revealed the tube feeding bag was not labeled for date, time, rate, room number or patient identification. Continued observation, on 08/28/19 at 3:30 PM, revealed RN #6, after interview, writing Jevity onto Patient #2's intravenous fluid (IV) bag.

Observation, on 08/27/19 at 2:20 PM, revealed RN #1 hanging Patient #4's closed system tube feeding which was not labeled with date and time, name of formula, rate, room number, or patient identification. Continued observation, on 08/27/19 at 3:05 PM, revealed Patient #4's closed system tube feeding label without a date and time, name of formula, rate, room number or patient identification.

Review of Patient #2's medical record revealed he/she was admitted on 08/22/19 with diagnoses including Acute Respiratory Failure, Cerebrovascular Accident (CVA), Pleural Effusion, and Moderate to Severe Protein-Calorie Malnutrition. Review of the admission orders revealed he/she was to receive a continuous tube feeding of Jevity 1.5 at forty (40) ml/hour. Review of the Medication Administration Record (MAR) revealed tube feeding information was not included on it. Further review revealed the 08/27/19 and 08/28/19 nurses notes contained totals for tube feeding twice daily. However, there was no documentation of the time the tube feeding was changed.

Review of Patient #4's medical record revealed he/she was admitted on 07/27/19 with diagnoses including Acute Respiratory Failure, Diabetes, and Encephalopathy. Review of the admission orders revealed he/she was to receive a continuous tube feeding of Glucerna 1.5 at eighty (80) ml/hour. Review of the MAR revealed tube feeding information was not included on it. Further review revealed the 08/27/19 nurses notes contained totals for tube feeding twice daily. However, there was no documentation of the time the tube feeding was changed.

Interview, on 08/27/19 at 3:30 PM, with RN #6, revealed the tube feeding changed every twenty-four (24) hours. She stated the night nurse for Patient #2 had misdated the tube feeding as 08/25/19 at 2:00 AM instead of 08/26/19 at 2:00 AM. RN #6 revealed the tube feeding should be labeled with date time, rate, room number, and patient identification. She stated the IV bag and the tube feeding bag were changed at the same time so one (1) label on the IV bag counted for both.

Interview, on 08/27/19 at 3:40 PM, with RN #1, revealed, for Patient #4, she did not put the information onto the label after she hung the tube feeding. The tube-feeding should have been labeled with date, time, initials, flow rate, and patient name.

Interview, on 08/28/19 at 9:20 AM, with RN #2, revealed Patient #2's open tube feeding bag should be changed every twenty-four (24) hours and the bolus tube feeding for the open system every four (4) hours. She stated she did hang the tube feeding and label the bag and did so correctly with the date of 08/26/19. RN #2 revealed the tube-feeding label should have date, time, patient, and initials. She stated she would immediately remove the tube feeding if this information was not on the label and hang a new tube feeding with a new set.

Interview, on 08/28/19 at 9:30 AM, with RN #3, revealed he did not hang the tube feeding the night of 08/25/19 because the facility was out of bags for the tube feeding. He further revealed any tube feeding not labeled should be changed immediately with the charge nurse for safety rounds informed.

Interview, on 08/28/19 at 11:20 AM, with RN #7, revealed he was not concerned with a tube feeding bag not being labeled if the bag looked clean, and he would not change it until the regularly scheduled time to change. RN #7 stated tube feeding bags were changed every twenty-four (24) hours, and it was acceptable to label the IV bag and not the tube feeding bag because the one (1) label counted for both the IV and tube feeding bags.

Interview, on 08/28/19 at 1:15 PM, with RN #9, revealed tube feeding bags not labeled should be thrown away with the tubing. The tube feeding label should have the date and time hung, rate, formula, initials, patient's last name and room number. She stated if the information for time and date was not on the label there was potential for bacterial growth if the feeding hung too long.

Interview, on 08/28/19 at 1:27 PM, with the Materials Manager, revealed Abbott, the supplier for supplements and tube feedings, had many of the closed system tube feedings on back order. He further revealed Patient #2 had to use the open system of the tube feeding bag to continue with his/her tube feedings.

Interview, on 08/29/19 at 1:36 PM, with House Supervisor, RN #10, revealed the tube feeding should be changed every twenty-four (24) hours, bag and equipment. She stated the label on the tube feeding should have time, date, rate, room number, patient's last name, and initials. RN #10 revealed if there was no information on the label, the tube feeding must be taken down and changed. She stated it was important to follow guidelines to prevent bacterial growth.

Interview, on 08/29/19 at 2:34 PM, with the Chief Nursing Officer (CNO), revealed tube feedings were changed at midnight daily, every twenty-four (24) hours. The longer the tube feeding hung put the patient at a higher risk for infection. She stated the tube feeding label should have date, time, room number, rate, and patient's name.

Interview, on 08/29/19 at 2:55 PM, with the Director of Quality Management, revealed the policy was to change tube feedings every twenty-four (24) hours, and if the tube feeding was not timed and dated, it should be changed. He stated this was important because there was an increased potential for the tube feeding to grow organisms past twenty-four (24) hours.

2. Review of the facility's policy titled, "Hand Hygiene," policy #IC 4-2, revised 10/2018, revealed effective hand hygiene was considered to be the basis for an effective Infection Control Program. The policy directed staff to perform hand hygiene between patient care activities within the same episode of care, as when moving from high contamination patient care activity to a cleaner activity or moving from a contaminated body site to a less contaminated body site. An example would be moving from perineal care to tracheostomy care. Further review revealed hand hygiene was also required between glove changes, after removing gloves, and after any contact with body fluids, dressings, and patient linen.

Review of the facility's policy #IC 4-5, no title, revised 10/2018, revealed sufficient precautions to control cross-infection in isolation patients included proper hand hygiene, handling of linen, dressings and contaminated instruments, and the use of gowns, masks, and gloves when stipulated. Specific procedures included wearing gowns when soiling would be likely to occur or when contact with the patient or contaminated environmental surfaces would occur and performing hand hygiene with alcohol-based sanitizer upon entering and leaving the room. If hands were visibly soiled or if contact special enteric isolation were in place, then hand washing with soap and water must be completed.

Review of the facility's policy titled, "Determination of Isolation," policy # IC 4-3, revised October 2018, revealed patients with a history of multi-drug resistant organism (MDRO) infection/sepsis/colonization would be placed in contact precautions. Contact isolation required strict enforcement of standard precautions and hand hygiene protocol at all times.

Review of the facility's policy titled, "Standard Precautions," policy # IC 4-4, revised July 2019, revealed the components of standard precautions included hand hygiene and use of personal protective equipment (PPE). Further review revealed hand hygiene was required before and after every patient interaction even when gloves were used. Gloves would be changed after every patient contact, when moving from dirty to clean tasks, and (gloves) would never be washed between patients. Principles of working from clean to dirty must be followed. Hand hygiene must be performed prior to putting on gloves and after removing gloves. In addition, gowns were worn to prevent contamination of clothing and protect the skin of personnel from blood and body fluid exposures. Gowns were also worn by personnel during the care of patients infected with epidemiologically important microorganisms to reduce the opportunity for transmission of pathogens from the patient or items in his/her environment to other patients or environments. Gowns were to be removed and hands sanitized before leaving the patient's environment.

Observation, on 08/27/19 at 2:05 PM, revealed RN #1 washed hands and donned gloves when beginning care for Patient #6. She then removed a soiled dressing, cleaned the heel wound and periwound area, and immediately placed a new dressing on the wound. RN #1, using bed linens, assisted in rolling the patient over to observe a wound on the patient's coccyx. Again, using bed linens, she assisted rolling the patient back so he/she was in a supine position. At that time, RN#1 proceeded to perform tracheostomy care. No glove change or hand hygiene was performed during any patient care. Once the wound care, wound assessment, and tracheostomy care were completed, RN #1 removed her gloves and washed her hands.

Observation, on 08/29/19 at 8:35 AM, revealed RN #8 was performing care for Patient #8 who required contact isolation. RN #8 was wearing a gown with both sleeves ripped out. This gown was supplied by the facility as part of PPE required to be worn by staff when caring for patients under contact isolation. The House Supervisor, RN #10, was also present and reminded RN #8 that she should put on an intact gown and leave the sleeves on. When directed by RN #10, RN #8 did remove her gown, wash her hands, and don a new, intact gown.

Interview, on 08/27/19 at 2:20 PM, with RN #1, revealed she was aware of the policy regarding handwashing and glove change. She stated she was in a hurry when caring for Patient #6. RN #1 stated the risk of cross-contamination was minimal due to the bacteria remaining in the room.

Interview with RN #8, on 08/29/19 at 8:45 AM, revealed she tore the sleeves out of the gown because she was hot and was unable to tolerate the gown when caring for Patient #8. RN #8 stated she should wear an intact gown, but she was going to wear it as she chose. She revealed she usually worked nights but had recently started working days. RN #8 stated her date-of-hire was June 2019 at which time she had received infection control training which included use of PPE.

Interview, on 08/29/19 at 1:35 PM, with the House Supervisor, RN #10, revealed RN #1 should have removed and discarded the dirty heel dressing, removed the dirty gloves, and sanitized her hands. Then, RN #1 should have donned clean gloves to proceed with cleaning the wound, followed by handwashing, donning clean gloves, and applying the new dressing. The supervisor also stated RN #1 should have changed gloves and washed her hands after using bed linens to roll the patient. The house supervisor stated RN #1 should then have washed her hands again prior to donning clean gloves and performing tracheostomy care. The house supervisor revealed in no instance should RN #1 have worn the same gloves to perform wound care, roll the patient, and perform tracheostomy care for the patient. In addition, the supervisor stated RN #1 should have washed her hands between each task and when going from dirty to clean within the same task. The House Supervisor stated RN #8 should not have removed the gown's sleeves. She stated performing handwashing, changing gloves, and wearing gowns were done to prevent the spread of infection.

Interview, on 08/29/19 at 2:41 PM, with the CNO revealed the staff should follow the isolation policy. She stated the isolation signage posted outside patient rooms would guide the staff in choosing appropriate PPE. The CNO revealed everyone was expected to wash their hands going in and out of patient rooms. If indicated by the sign, staff might be directed to wear gowns and gloves. She stated the rooms had a "dirty zone" which indicated the areas where PPE must be worn. Nursing staff were educated upon hire and annually regarding handwashing and donning and doffing of gloves during tasks. These tasks were essential to the infection control process to prevent cross-contamination between patients. The CNO revealed RN # 1 should have washed her hands and changed gloves during the patient care tasks involving wound care, tracheostomy care, and repositioning the patient using bed linens. Further interview with the CNO revealed RN #8 would have received training upon hire outlining proper use of PPE. Therefore, she would have known she should have never compromised the gown's integrity by removing the sleeves.

Interview with the Director of Quality Management, on 08/29/19 at 2:55 PM, revealed RN #1 should have followed handwashing and infection control policy when performing the dressing change, tracheostomy care, and general patient care. In addition, RN #8 should not have removed the sleeves from the gown. The gown was designed to minimize exposure of skin and clothing to infectious bacteria. This concept was key to preventing the spread of infection from patient to patient; patient to staff; and staff to the community.