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Base on the onsite investigation, completed August 13, 2019, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code Tags K291, 211, 324, 345, 346, 353, 354, 355, 521, 712, 915 and 918.

Based on observations and interviews, the facility failed to maintain a sanitary environment with the lack of infection control processes in the areas of wearing Personal Protective Equipment (PPE) and proper cleaning of endoscopes in 1 of 1 observations.

Findings include:

Facility policies:

The Health Care Worker and Infectious Diseases Personal Protective Equipment policy read, it is the policy to provide PPE and training for the correct procedure for donning gowns, masks and gloves for maximum protection. Standard precautions will be followed at all times along with additional precautions when indicated. Remove gloves, gowns and masks and wash hands thoroughly prior to leaving the room.

The gastrointestinal (GI) Laboratory Dress Code policy read, for cleaning of scopes, a disposable impervious gown will be worn. The gowns will not be worn outside of the GI lab.

The Standard Precautions policy read, standard precautions includes hand hygiene, gloves, masks and gowns. Adherence to hand hygiene techniques including washing hands with soap and water or use of an alcohol-based hand rub, reduces transmission of antimicrobial resistant organisms and overall infection rates. Standard precautions apply to all body fluids, secretions and excretions except sweat whether or not they contain visible blood. Gloves shall be changed between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Gowns should be worn when performing procedures that may be likely to generate splashes or sprays of blood, body fluids, secretions or excretions, wear a gown to protect the skin and to prevent soiling of clothing. Always remove the soiled gown as soon as possible and wash hands.

The Infection Control for GI Laboratory policy read, all scopes should be cleaned per manufacturer's instructions and hospital policy. Personnel maintain the endoscopy equipment as directed and infection control practice. Personnel should have knowledge of infection control measures including equipment, personal protection and patient protection.

The Pre-cleaning and Cleaning of a Endoscope/ Colonoscope policy read, wear proper PPE and fill a basin with sufficient volume of detergent solution to completely immerse the scope. Prepare the detergent solution according to the manufacturer's instructions.

References:

The Pentax instructions for use read, during reprocessing always wear PPE (gowns, gloves, face masks, etc.) to minimize the risk of cross contamination. During the cleaning procedure, prepare a basin of detergent solution according to the manufacturer's instructions for concentration.

The Endozime AW Plus Enzymatic Detergent instructions for use read, add ½ ounce of Endozime AW Plus to one gallon of warm water or four milliliters (ML) of Endozime AW Plus to one liter of water.

1. The facility failed to ensure endoscope (an instrument used to look in the body during an endoscopy) processing staff removed PPE and maintained a sanitary environment when leaving the endoscope processing area.

a. On 7/16/19 at 12:17 p.m., Scope Processing Technician (Tech) #5 was observed exiting the scope processing room and walking through the hallway of the GI Lab pushing a cart with a plastic bin on top while wearing her gown and gloves. Tech #5 was then observed leaving the bin outside a procedure room and then entered back into the scope processing room while still wearing the same gown and gloves.

Surgical Technician (Tech) #7 observed Tech #5 leave the scope processing room wearing her gown and gloves. Tech #7 stated Tech #5 was not supposed to be in the hallway while wearing a gown and gloves.

On 7/16/19 at 12:22 p.m., while Tech #6 was cleaning the endoscope in the scope processing room, Tech #5 was observed donning (putting on) her gown and gloves. Tech #5 then reached over Tech #6 and into the cabinets over the sink, removed a washcloth then left the room while wearing her gown and gloves. At 12:23 p.m., Tech #5 then returned to the scope processing room wearing her gown. Tech #5 then removed her gown and discarded it. At 12:28 p.m., Tech #5 cleaned her hands with alcohol foam and donned another gown and gloves. Tech #5 then left the scope processing room while pushing a cart with a plastic bin on it to the doorway of the GI procedure room. Tech #5 then returned to the scope processing room without wearing the gown or gloves.

b. On 7/17/19 at 1:15 p.m., Tech #5 was interviewed. Tech #5 stated she was training to process scopes and set up procedure rooms. Tech #5 stated PPE was a gown, gloves and a surgical hat. Tech #5 stated PPE was worn to protect staff from spreading germs to each other or to another clean area. Tech #5 stated PPE should be donned when going into the scope processing room and removed when exiting the room. Tech #5 stated she did not don and remove PPE properly during the observation because she was caught up in performing her tasks. Tech #5 stated she was being trained by three different staff members and felt she was being told three different ways of performing her tasks. Tech #5 stated she had not received any new hire infection control training since she returned as a new hire on 3/4/19. Tech #5 stated she did have a competency performance criteria for her trainers to evaluate her performance, but it was not completed and she did not know where it was located.

c. On 7/17/19 at 11:06 a.m., Tech #6 was interviewed. Tech #6 stated PPE was used to protect staff and patients from the spread of diseases or infections. Tech #6 stated PPE should be donned before any contact with a dirty scope and instruments. Tech #6 stated PPE should be removed after scopes are cleaned and prior to exiting the scope processing room. Tech #6 stated she had seen Tech #5 exit the scope processing room while wearing PPE and stated Tech #5 was not following the correct infection control processes. Tech #6 stated she should have told Tech #5 the correct infection control process of removing the PPE when she observed her exit the scope processing room while wearing PPE. Tech #5 stated she was unsure if Tech #6 was taught the proper use of PPE by her first trainer.

d. On 7/18/19 at 10:23 a.m., an interview with Infection Preventionist RN (RN) #4 was conducted. RN #4 stated PPE was used to protect staff from pathogens being splashed onto them while cleaning endoscopes in the scope processing room. RN #4 stated gowns were considered contaminated and should be removed prior to exiting the scope processing room to prevent the spread of infectious pathogens throughout the facility. RN #4 stated she started educating new employees hired since January of 2019 on hand hygiene and PPE. RN #4 stated she had not performed any hand hygiene training for Tech #5 because she was not technically a new employee. RN #4 stated when Tech #5 was rehired on 3/4/19 and went through the new employee education, Tech #5 was a secretary. RN #4 stated she was unaware Tech #5 was going to be processing endoscopes or working in the procedure area. RN #5 stated when staff changed their role and required additional training the department manager should reach out to her and inform her.

RN #4 provided the competency and education for donning and removing PPE. The competency to remove PPE stated to remove all PPE before exiting patient room and then perform hand hygiene. The education material provided stated the front of the gown and sleeves were considered contaminated.

e. On 7/17/19 at 2:29 p.m., Director of Surgical Services (Director) #8 was interviewed. Director #8 stated the purpose of PPE was to prevent contamination and pathogen exposure to staff. Director #8 stated if staff did not follow PPE protocol, they risked exposing all staff and scopes with cross contamination. Director #3 stated the infection preventionist RN trained staff regarding PPE.

2. The facility failed to ensure staff followed manufacturer's guidelines when diluting enzymatic solution when processing an endoscope (an instrument used to look in the body during an endoscopy).

a. On 7/16/19 at 12:20 p.m., an observation was conducted of an endoscope being processed (cleaned). Surgical Technician (Tech) #6 prepared 60 milliliters (mL) of Endozime AW Plus Enzymatic Detergent and placed it in a sink half full of water. There were no marks on the sink to measure water amount, nor did Tech #6 use a measuring device. Tech #6 stated the enzymatic solution ratio was 4 ml of enzymatic detergent to one liter of water. Tech #6 used the enzymatic solution ratio to perform all processing steps to clean the endoscope. Once the endoscope was processed, the half sink of water was measured. The water measured 10,595 ml.

The Endozime AW Plus Enzymatic Detergent instructions for use read, add four mL of Endozime AW Plus to one liter of water. According to the amount of water in the sink which was measured after the observation, the amount of enzymatic which should have been added to the water amount should have been 42.4 mL instead of the 60 mL done.

b. On 7/17/19 at 11:06 a.m., Tech #6 was interviewed. Tech #6 stated the enzymatic solution dissolved and broke up proteins on endoscopes to clean them. Tech #6 stated if the enzymatic concentration was not correct it would not function correctly. Tech #6 stated if the solution was over concentrated it could damage the endoscope. Tech #6 stated she was trained to measure the water in the sink with a gray plastic bin when she was taught how to prepare the enzymatic solution, but she did not routinely use the bin as a measuring tool. When asked about the solution ratio which was observed, Tech #6 stated the solution was over concentrated.

c. On 7/18/19 at 10:23 a.m., Infection Preventionist RN (RN) #4 was interviewed. RN #4 stated it was important to follow manufacturer's instructions for use when preparing enzymatic solution to prevent possible pathogen transmission from the endoscopes to patients and to maintain equipment warranties. RN #4 stated if the enzymatic solution was under diluted or over diluted pathogens would not be destroyed. RN #4 stated staff were trained how to prepare enzymatic solution per the manufacturer's guidelines during their unit specific orientation.

d. On 7/17/19 at 2:28 p.m., Director of Surgical Services (Director) #8 was interviewed. Director #8 stated it was important to follow manufacturer's guidelines when preparing enzymatic solution to ensure proper cleaning and remove any bioburden (number of bacteria living on a surface that has not been sterilized) on endoscopes. Director #8 stated if the enzymatic solution was under diluted the solution would not be effective. Director #8 stated if over diluted the solution would create a product build up on the endoscope. Director #8 stated she was unaware staff were not using the gray plastic bins when cleaning endoscopes to ensure the proper water to enzymatic ratio.

Based on observations and interviews the facility failed to ensure point of care testing materials were dated when opened in 2 of 3 observations.

Findings include:

Facility policy:

The Nova Stat Strip Blood Glucose Monitoring policy read, the nursing manager or designee is responsible for monitoring the expiration of both the Nova Stat Strips and quality control solutions. All vials found without a date of opening will be removed from the patient care areas and returned to the laboratory for disposal. Quality controls include calibration and quality control checks. Nova Stat Strips will be labeled with the date upon opening, an expire 180 days post opening or printed expiration date on vial, whichever comes first. Control solutions will be labeled upon opening and expired 90 days post opening or date printed on the vial, whichever comes first.

References:

The Nova Stat Glucose Control Solution manufacturer's instructions read, it is used as a quality control check to ensure the glucose meter and test strips are working properly as a system. Check the date on the control solution vial and do not use the control solution if the expiration date has passed. Once opened, solutions can be stored for three months or until the expiration date printed on the vial, whichever comes first.

The Nova Stat Glucose Test Strips manufacturer's instructions read, the test strips are stable to use for 180 days once opened, or the date printed on the vial, whichever comes first. Do not use the test strips if past the expiration date, this may cause inaccurate results.

1. The facility failed to ensure the control solution bottles and test strips required for glucometer testing and quality control were labeled with the appropriate discard date.

a. On 7/16/19 at 8:30 a.m., a tour of the medication room at the nurse's station was conducted. The observation revealed the test strips used with the glucometer (device used for testing blood glucose levels) and the high and low control solutions were opened without the required discard date labeled on the bottles.

During the observation, Registered Nurse (RN) #1 was interviewed. RN #1 stated the test strips and control bottles should be dated. RN #1 stated the control solutions were good to use for 90 days once opened and the test strips were good to use for 180 days once opened. RN #1 stated since the bottles were not dated, she was unsure of the expiration date.

b. On 7/16/19 at 8:39 a.m., a tour of the nursery was conducted. The observation revealed the test strips used with the glucometer were opened without the required discard date labeled on the bottle.

c. On 7/18/19 at 9:00 a.m., an interview with RN #2 was conducted. RN #2 stated night shift performed quality controls on the glucometer each night using the test strips and control solution. RN #2 stated the control solution bottles should be labeled with a 90 days expiration date when opened. RN #2 stated the test strips should be labeled with a 180 days expiration on the bottle once opened. RN #2 stated if the bottles were not labeled, there was no way to determine if control solutions and test strips were not expired. RN #2 stated if staff used expired control solution or test strips the glucometer would not be properly calibrated and therefore, the blood test results could be inaccurate.

d. On 7/18/19 at 9:15 a.m., A second observation of the medication room at the nurse's station was conducted. The observation revealed two bottles of test strips used with the glucometer were opened. One bottle had a written expiration date of three months, and one bottle had the written expiration date of 6 months. Also observed was a bottle of high and a bottle of low control solutions. The control solution bottles were opened and had a written expiration date of two months on the bottles.

e. An interview with RN Manager (Manager) #3 was conducted during the second observation on 7/18/19 at 9:15 a.m. Manager #3 stated the control solutions should be dated once opened for a three month expiration and the test strips should be dated with a 180 day expiration once opened. Manager #3 stated the bottles should have an expiration date once opened because if used after expiration, the controls would give a false baseline and patient test results would be inaccurate.

Manager #3 was shown the bottles of control solutions incorrectly labeled with a two month expiration and the two bottles of test strips labeled with a three month expiration and a six month expiration date. Manager #3 verified what the expiration dates should read with the manufacturer's instructions. Manager #3 then stated it was clear the staff needed education regarding the expiration dates for the control solution and test strips.