HospitalInspections.org

Based on observation and interview the facility did not have the correct signage in the emergency department (ED).

Findings:

Record review of the facility policy, "The scope of service for the emergency department" revised 04/16/2021, stated: The ER has 24/7 medically provider presence. Patients are triaged and medically screened by the ER physician.

Observation on 05/10/2022 at 10:30 a.m. revealed no signage stating a physician or doctor of osteopath may not be available 24/7 to provide care.

Observation and interview on 05/10/2022 @ 1050 revealed information signage in the lobby and in the exam room one (1) and two (2) revealed signage that did not address the EMTALA requirements for individuals utilizing the emergency department.

Interview on 05/11/2022 at 12:30 p.m. with staff nurse (ID #C) who stated we have a physician who is right next door, and all the staff knows, and will call them if necessary.

Based on observation, interview and record review, the facility failed to ensure the crash cart in the department of surgery, had a working defibrillator and items available for use were not expired.

Findings include:

Observation on 5/10/22 at 10:45 AM in the pre-op/PACU revealed one emergency crash cart. The top of the crash cart contained one (1) Quick combo Pacing/ Defibrillation/ECG Electrodes with expiration date of 3/19/22 available for use.
One of the drawers of the crash cart contained two (2) biohazard bags each bag containing three (3) expired vacuettes with expiration dates of 1/23/22, 6/5/21 and 2/10/21.

Record review of the Crash Cart checklist showed the last documented check to be 1/6/2022. There was a notation that in the defibrillator unplugged check box that stated "no battery."

Record review of facility policy titled "Crash Cart Checks," dated 11/2/21 showed the following information:

The crash cart will be checked after each use and once in every 24 hour period.

The checking of emergency supplies is done by a checklist found on a clipboard on the top of the cart. Supplies can be obtained from Central Supply for from the replacement tackle box in pharmacy.

Interview with CNO (ID B) at the time of observation confirmed the above findings and stated that if needed, the staff would obtain the crash cart from the emergency department, not use one.

Based on laboratory policy, surveyor observations, review of laboratory records from 2021 and 2022, and confirmed in interview, the facility failed to document the alarm checks per their policy to test the blood bank freezer for five of five instances and one of five instances for the blood bank refrigerator to ensure the storage of blood bank components.

Findings included:

1. Review of the laboratory policy Blood Bank Quality Plan (revised 7/26/19) under Control of Equipment revealed "the blood bank refrigerator and freezer have an audible alarm system that will activate at a temperature that will allow proper action to be taken before blood or components reach unacceptable temperatures. This alarm can be heard at the nursing station and in the laboratory...the alarm is tested quarterly by lowering and raising the temperature of the sensor in the refrigerator/freezer. A record is kept on the chart recorder and in the maintenance manual."

2. Review of the laboratory records revealed the last quarterly check for the blood bank refrigerator was on 12/31/2021. No documentation was available for review for the March 2022 quarterly check.

3. Surveyor observations on 5/11/2022 at 1400 revealed the blood bank freezer that stored the Fresh Frozen Plasma (FFP) was not connected to an audible alarm system. No alarm checks were performed in 2021 and 2022.

4. Further surveyor observations on 5/11/2022 at 1405 revealed no follow up call from the nursing station regarding the blood bank refrigerator temperature alarm. The laboratory manager (Personnel N) on 5/11/2022 at 1408 hours in the laboratory confirmed that the nursing station should have called if they heard the alarm.

5. A sampling of the units of blood stored in the blood bank refrigerator and freezer observed on 5/11/2022 included the following 10 units:

O positive
W044622236165, exp 6/5/22
W044622288815, exp 6/6/22

O negative
W044622265079, exp 6/9/22
W044622271675, exp 6/8/22

A positive
W044622267919, exp 6/7/22
W044622267912, exp 6/7/22

FFP
W044621436450
W044621443788
W044621388065
W044621382660

6. An interview with the laboratory manager (Personnel N) on 5/11/2022 at 1410 hours confirmed the above findings.

I. Based on review of the laboratory policies, hospital blood transfusion records from 2021 and 2022, and confirmed in interview, the hospital failed to meet the requirements of 42 CFR part 493, subpart K to detect and identify suspected transfusion reactions for four of twenty patient records reviewed.

Findings included:

1. Review of the laboratory policy Blood Transfusion Reaction (revision 6/19/19) under indications revealed "signs and symptoms of a complication in transfusion included:

unexplained change in Blood Pressure
SBP [systolic blood pressure] of >/- 30 mmHg
DBP [diastolic blood pressure] of >/-30 mmHg"

2. Random review of hospital blood transfusion records from 2021 and 2022 revealed the following four of twenty patient transfusion records with a change of SBP greater than 30 mmHg which met the laboratory criteria for a suspected transfusion reaction.

5/31/2021: Patient #16 Unit W044621278486; 138 SBP (at 15 minutes after transfusion); 193 SBP (at 1 hour after transfusion); change of 55 mmHg

2/15/2022: Patient #17 Unit W044622221226; 132 SBP (at 15 minutes after transfusion); 185 SBP (at 1 hour after transfusion); change of 53 mmHg

4/04/2022: Patient #15 Unit W044622210683; 147 SBP (at 15 minutes after transfusion); 196 SBP (at 1 hour after transfusion); change of 49 mmHg

4/20/2022: Patient #18 Unit W044622210233; 118 SBP (at 15 minutes after transfusion); 152 SBP (at 1 hour after transfusion); change of 34 mmHg

3. Review of the medical records from the above patients revealed no documentation of the change in blood pressure. No transfusion reaction were investigated for the above units transfused.

4. An interview with Personnel C on 5/12/2022 at 1240 hours in the physician's office confirmed the above findings. She acknowledged that the nursing and laboratory policies for transfusion reaction identification were dissimilar and should be updated.

II. Based on review of the laboratory policies, laboratory blood bank records from 2021 and 2022, and confirmed in interview, the hospital failed to meet the requirements of 42 CFR part 493, subpart K to document daily quality control of blood bank reagents for four of twenty days reviewed.

Findings included:

1. Review of the laboratory policy Pretransfusion Testing ABO-Rh-Antibody Screen-Compatibility Testing (revision 10/25/2017) under Quality Control revealed "quality control of all reagents is performed each day of testing and logged in the blood bank quality control log book."

2. Random review of the laboratory blood bank records from 2021 and 2022 revealed the following four of twenty days with no documentation of the daily quality control when transfusion testing were performed.

3/1/2022: transfusion testing for Patient #65
2/16/2022: transfusion testing for Patient #66
2/1/2022: transfusion testing for Patient #67
12/18/2021: transfusion testing for Patient #68

3. An interview with the laboratory manager (Personnel N) on 5/12/2022 at 1340 hours in the laboratory confirmed the above findings. She acknowledged that the quality control is required each day of patient testing.

Based on observation, interview, and record review, the facility failed to ensure the safety of visitors, vendors, and staff. The facility failed to:

adequately mark as a hazard; a very large and deep hole located directly off a sidewalk by the loading dock; and correct this exterior safety hazard.

Findings included:

Record review of facility form titled "Monthly Monitoring Patient Care Equipment, Environment, and Safety Devices," undated, showed a 2-page document that listed multiple elements to be inspected that included "sidewalk areas in good walking condtition."

Observation on 05/11/2022 at 10 AM during a walk of the exterior perimeter of hospital grounds with Staff P, Maintenance Director, showed the following:

-a large, deep hole located at the juncture of 2 sidewalks near the hospital loading dock. The hole was approximately 2 1/2 feet wide and approximately 4 feet deep.

-there was an "H" shaped wooden bracket placed at the edge of the sidewalk next to the large hole. The other sidewalk was unmarked, leaving a large hole exposed. This posed a serious safety hazard to visitors, vendors, and staff. There was no bright yellow "caution tape" or orange "netting "to draw attention to the deep and opened area.

During an interview with Staff P at the time of observation, he said the hole occurred because of some drainage issues related to the downspout drains from the roof. Staff P said that next week , people were coming to fill in the spaces with dirt.

Based on observation, interview and record review, the facility failed to ensure secure storage of medications in the department of surgery.

Findings include:

Observation on 5/10/22 at 10:25 AM in the pre-op/ PACU area revealed one (1) crash cart containing emergency medications that was not locked.

Observation on 5/10/22 at 11:09 AM in OR# 1 revealed the anesthesia cart containing medications unlocked.

Observation on 5/10/22 at 11:16 AM in OR#2 revealed the anesthesia cart containing medications unlocked.

Interview with pharmacy technician (ID EE) at the time of observation stated that all crash carts and anesthesia carts should be locked.

Record review of facility oilicy titled :Security of staff and medications," not dated showed the following information:

5. Any area where medications are stored will be secured.

Based on observation, interview, and record review, the facility failed to ensure outside storage was neat, well-kept and supplies stored per facility policy.

Findings included:

Record review of facility policy titled "Guidelines for Storage of Supplies,"undated, showed:

-Storage must maintain an 18 inch clearance from the ceiling in order to allow for proper function of the fire and safety sprinkler system.

Observation on 05/11/2022 between 10 AM and 10:45 AM showed the following:

Exterior storage closet-lab supplies:

-storage on the shelving that lined 3 walls of the room did not allow for 18 " clearance on the top shelves ; some boxes were stored within 2 to 3 inches from the ceiling.

Interview with Staff P, Maintenance Director , at the time of observation , he stated this storage was not acceptable per policy.

Based on Record review and interview the facility failed to provide surgical services in a manner to ensure the health and safety of patients.

1. The facility failed to ensure that the operating room was supervised by an individual with operating room experience or training;

2. The facility failed to have updated policies and procedures that were in accordance with acceptable standards of practice and nationally recognized professional organizations;

Findings include:

1. Interview with CNO (ID B) on 5/10/22 at 10:16 AM revealed that there was no Operating Room (OR) Director. The position has been vacant for about a year. There are two (2) Registered nurses who work PRN (as needed) and two (2) scrub technicians that are here fill-time.

Record review of personnel file for CNO (ID B) revealed no operating room work experience or training.

Interview with CNO (ID B ) on 5/12/22 at 12:37 PM she confirmed that the had no OR experience or training. She went on to say that she took on the responsibilities of operating room while there was no director as part of her role as chief nursing officer. She stated that they have conducted interviews but have not found the right candidate for the position.

2. Interview with CNO (ID B ) on 5/11/22 at 11:15 AM she stated that the facility had planned to review and update all surgical services policies but have not yet been able to complete the task.

Cross Reference C-1200 Infection Control


A. The facility failed to ensure operating physicians had current privileges to perform surgeries.

Cross reference C-1142

B. The facility failed to ensure post-anesthesia evaluation included all required elements and was performed before discharge.

Cross reference C-1144

C. The facility failed to ensure that certified registered nurse anesthetist (CRNA) providing patient care were credentialed and appointed privileges.

Cross reference C-1145

D. The facility failed to ensure proper disinfection and sterilization procedures

Cross reference C-1200 Infection control

Based on record review and interview, the facility failed to ensure physicians had been appointed privileges for surgeries performed on patients (ID 55).

Findings include:

Review of medical record for patient (ID 55) showed she had an excision of right breast mass performed on 2/17/22 by physician (ID S).

Review of credentialing file for physician (ID S) showed no breast surgery privileges requested or approved for reappointment period dated 11/24/2020.

Review of Bylaws of the Medical Staff of Rice Medical Center showed he following information:

Article V
Membership

A. No physician, dentist, podiatrist, or psychologist, including those in a medical administrative position by virtue of a contract with the Hospital, shall admit or provide medical or health related services to patients in the Hospital unless he or she is a member of the Medical Staff and has been granted privileges.

Interview with credentialing staff (ID G) on 5/12/22 at 9:30 AM stated that the new delineation of privileges form is now two-sided, it looked like an entire page was overlooked.

Based on interview and record review, the facility failed to ensure post-anesthesia care evaluations were documented to have taken place prior to discharge and contained all required elements in 35 of 35 patient records reviewed (ID#s 29-63).

Record review of CMS requirements §485.639 (b) showed the following information:

The post-anesthesia follow-up report must be written on all inpatients and outpatients prior to discharge from surgery and anesthesia services. The post-anesthesia follow-up report must be documented in the patient's medical record, whether the patient is an inpatient or outpatient of the CAH, and must include at a minimum:

-Cardiopulmonary status;
-Level of consciousness;
-Any follow-up care and/or observations; and
-Any complications occurring during post-anesthesia recovery.

Review of medical records for patients (ID#s 29-63) showed no documented time on the post anesthesia assessment. The post anesthesia assessment consists of two check boxes stating the following:
-Patient without complaint and no apparent post anesthetic sequelae
-See progress note

Interview with staff (ID C) on 5/12/22 at 12:45 PM confirmed the above findings.

Based on interview and record review, the facility failed to ensure Certified Registered Nurse Anesthetists (CRNA) had been granted provides before providing care to patients on 12/28/ 2021 (IDs 59, 60, 61, 62 and 63).

Findings include:

Review of Bylaws of the Medical Staff of Rice Medical Center showed the following information:

5.07 Allied Health Professionals

A. Qualifications: the Allied Health Professionals shall consist of members who:
1. Meet the qualifications for medical staff membership;
2. Have satisfactorily completed their provisional appointment;

B. Prerogatives: Allied health Professionals shall be entitled to:
1. Exercise such clinical privileges as are granted to him/ her pursuant to these Bylaws;

Review of credential file for CRNA (ID V) showed no delineation of privileges or evidence that he had been approved to provide services at the facility.

Record review of the Operating Room (OR log) for 12/28/21 showed CRNA (ID V) to be the practitioner that provided services to patients (IDS 59, 60, 61, 62 and 63).

Interview with administrative staff (ID W) on 5/12/22 at 10:45 AM confirmed the above findings and stated that CRNA (ID V) had not gone through the credentialing process.

Based on observation interview and record review the facility failed to have an effective infection prevention and surveillance program related to surgical services.

1. The facility failed to perform testing to ensure efficacy of the autoclaves;
2. The facility failed to implement an effective process to ensure contaminated endoscopes are not used on patients;
3. The facility failed to ensure high-level disinfection with Cidex OPA was performed correctly;
4. The facility failed to ensure surgical technicians performing sterile processing duties had documented competencies;
5. The facility failed to ensure proper temperature and humidity ranges in the operating room (OR) on days when surgical cases were performed;
6. The facility failed to ensure temperature and humidity was monitored in sterile supply storage rooms;
7. The facility failed to ensure proper storage of laryngoscope blades;
8. The facility failed to ensure multi-dose vials of medications were used according to acceptable standards of practice;
9. The facility failed to ensure proper transportation of contaminated endoscope from procedure room to decontamination area
10. The facility failed to ensure sterile instruments were sterilized in the open position;
11. The facility failed to ensure clean linen was free from contamination in the pre-op/PACU area
12. The facility failed to ensure cardboard boxes from the outside were not in areas containing sterile supplies.

Findings include:

Interview with infection preventionist (ID C) on 5/12/22 at 1:08 PM stated that she does track antibiotic usage and surgical site infection information but, she doesn't have much involvement with the operating room. She went on to say that does not perform rounds in the OR and that she never has really went in there.

1. AUTOCLAVE EFFICACY TESTING

Record review of facility surgical services policies showed no policy and procedure for use of autoclaves or routine steam sterilization of surgical instrumentation.

Record review of Centers for Disease Control and Infection Prevention (CDC), Steam Sterilization Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) showed the following information: The basic principle of steam sterilization, as accomplished in an autoclave, is to expose each item to direct steam contact at the required temperature and pressure for the specified time.
The Bowie-Dick test is used to detect air leaks and inadequate air removal and consists of folded 100% cotton surgical towels that are clean and preconditioned. A commercially available Bowie-Dick-type test sheet should be placed in the center of the pack. The test pack should be placed horizontally in the front, bottom section of the sterilizer rack, near the door and over the drain, in an otherwise empty chamber and run at 134°C for 3.5 minutes. The test is used each day the vacuum-type steam sterilizer is used, before the first processed load. If the sterilizer fails the Bowie-Dick test, do not use the sterilizer until it is inspected by the sterilizer maintenance personnel and passes the Bowie-Dick test.
The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus stearothermophilus (formerly Bacillus stearothermophilus).

Observation on 5/10/22 at 12:05 PM in the sterile processing department showed two autoclaves (one (1) gravity and one (1) prevacuum.

Interview with staff (ID R), surgical technician, at the time observation stated that each load in processed in the autoclaves contain a card that changes color when exposed to steam. She went on to say that the load contents are recorded on the back of the card. She also stated that this the only documentation that is kept or documented for each load. When askes if there are biological indicators or bowie-dick tests performed, she stated "No."

Record review of operating room log from 1/6/22-5-5/22 showed six (6) patients that had surgical procedures using instrumentation processed in via autoclave (ID #s 45, 54, 55, 56, 57, and 58).

2.ENDOSCOPE REPROCESSING PROCESS

Record review of Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice: Flexible Endoscopes showed the following information: Perform mechanical processing in accordance with the endoscope manufacturer's IFU and the mechanical processor manufacturer's IFU. Identify flexible endoscopes that are processed and ready for use with a distinct visual cue. A multidisciplinary team that includes infection preventionists, endoscopy and perioperative RNs, endoscopy processing personnel, endoscopists, and other involved personnel should establish a policy to determine the maximum storage time that processed flexible endoscopes are considered safe to use without reprocessing. Personnel with responsibility for processing flexible endoscopes should receive initial and ongoing education and complete competency verification activities related to processing flexible endoscopes.

Record review of facility surgical services policies showed no policy and procedure for use of the automated endoscope reprocessor or designated maximum storage time for reprocessing.

Observation on 5/10/22 at 11:00AM in OR# 1 showed drying cabinet containing six (6) endoscopes. There was no visual indicator to know when the scopes were processed.

Interview with surgical technician (ID# Q) at the time of observation, she stated scopes can sit in the cabinet anywhere from three to six months, to ensure the scopes have not been contaminated, they get reprocessed before use. She went on to say that she does not document when she reprocesses a scope.

Interview with surgical technician (ID R) on 5/10/22 at 11:42 AM stated that the facility followed AORN guidelines.

Record review of the facility scope reprocessing log was not consistent with the facility operating room log. Twenty-four (24) patients had procedures using endoscopes in which it could not be verified how long the scope had been stored, or reprocessed before use (ID#s 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 46, 47, 48, 49, 50, 51, 52, 53,

3. CIDEX OPA HIGH LEVEL DISINFECTION
Observation on 5/11/22 at 12:25PM showed CIDEX® OPA available for use in the decontamination room.

Record review of available for use CIDEX® OPA product label showed the following information:
CIDEX® OPA Solution is a high-level disinfectant for reprocessing reusable heat-sensitive semi-critical medical devices such as endoscopic, respiratory therapy, and anesthesia equipment.
-Effective: achieves high-level disinfection in 12 minutes at 20 °C (68 °F)
-Long-lasting efficacy: reusable for up to 14 days when monitored with CIDEX® OPA Solution Test Strips

Record review of facility CIDEX® OPA disinfection log showed no documented temperature or time submerged documented.

Interview with surgical technician (ID R) on 5/11/22 at 12:30 PM, she stated that CIDEX is not used very often and that it is used for laryngoscope blades. She stated that the temperature of the solution not measured. When askes to see the test strips for the solution she stated they had expired and were thrown away and that there were no more available for use.


4. STAFF COMPETENCIES

Interview with CNO (ID B) on 5/10/22 at 10:15 AM, she stated that the facility employs two surgical technicians (IDs Q and R). She stated that they were responsible for scrubbing in cases as well as performing sterile processing duties and endoscope reprocessing.

Record review of personnel file for surgical technician (ID Q) showed no documented competencies for sterile processing or endoscope reprocessing.

Record review of personnel file for surgical technician (ID R) showed no documented competencies for any job functions.


5. TEMPERATURE AND HUMIDITY IN THE OPERATING ROOM

Record review of facility policy titled Humidity Control in the Operating Room, dated 2/9/00 showed the following information:
A humidity reading of 45 to 65% will be acceptable in the operating room. A drop in humidity to 20% is still sufficient for control of lent factors, as long as there are at least 13.6 complete revolutions of air exchange every hour during surgery. This meets the criteria at present time.

No flammable or explosive anesthetics are used in the operating room.
Humidity and temperature readings are not required but continue to be spot checked by maintenance at regular intervals.

If any problems and temperature or humidity are identified, the maintenance department is notified immediately for corrective action.

Appropriate environmental control aids in the prevention of surgical wound infections. Temperature in the OR our should be maintained between 68°- 75°F. A minimum humidity of 50% will be sufficient to reduce bacterial growth and suppress static electricity.

Record review of AORN eGuidelines 2022 showed the following information: The recommended temperature range in an operating room is between 68°F and 75°F. The recommended humidity range in an operating room is 20% to 60%.

Record review of the OR Temperature and Humidity Log Sheet showed the following information: Acceptable Humidity Range 45%-65%, Acceptable Temperature Range 68°-75°F

Recorded temperature on 3/3/22 for OR#2 showed 67.1°F and Humidity 65%
Record review of OR log showed six (6) patients had procedures in OR#2 on 3/3/22 (ID#s 29, 30, 31, 32, 33 and 34).

Recorded temperature on 3/22/22 in OR#2 showed 78°F and Humidity 39%
Record review of OR log showed five (5) patients had procedures in OR#2 on 3/22/22 (ID#s 35, 36, 37, 38 and 39).

Recorded temperature on 4/7/22 in OR#2 showed 64°F and Humidity 26%
Record review of OR log showed five (5) patients had procedures in OR#2 on 4/7/22 (ID#s 40, 41, 42, 43 and 44).

Recorded temperature on 4/21/22 in OR#1 showed 64.3°F and Humidity 68%
Record review of the OR log showed one (1) patient had a procedure in OR#1 on 4/21/22 (ID# 45)

Recorded temperature on 4/26/22 in OR#1 showed 65.6°F and Humidity 60%
Record review of the OR log showed three (3) patients had procedures in OR#1 on 4/26/22 (ID# 46, 47 and 48)

Recorded temperature on 5/5/22 in OR#2 showed 67.4F and Humidity 54%
Record review of the OR log showed five (5) patients had procedures in OR#2 on 5/5/22 (ID# 49, 50, 51, 52 and 53)

Recorded temperature on 5/5/22 in OR#1 showed 62.8°F and Humidity 66%
Record review of the OR log showed one (1) patient had a procedure in OR#1 on 5/5/22 (ID# 54)


6. TEMPERATURE AND HUMIDITY OF STERILE SUPPLIES

Record review of the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) showed the following information: The sterile storage area should be a limited access area with a controlled temperature (may be as high as 75°F) and relative humidity (30-60% in all works areas except sterile storage, where the relative humidity should not exceed 70%).

Observation on 5/10/22 at 11:42 AM in the sterile supply/ instrument room showed no thermometer or hygrometer.

Interview with surgical technician (ID R) at the time of observation stated that temperature and humidity is not measured in the sterile supply areas.


7. LARYNGOSCOPE BLADE STORAGE

Review of Association of periOperative Registered Nurses (AORN) eGuidelines 2022 showed the following information: Package and store reusable laryngoscope blades and handles that have been high-level disinfected or sterilized in a manner that prevents contamination and identifies them as ready for use.

Observation on 5/10/22 at 10:17 AM in the pre-op/PACU on top of the crash cart showed seven (7) unpackaged laryngoscope blades available for use.

Observation on 5/10/22 at 110:09 AM in OR#1 in the anesthesia cart showed one (1) packaged laryngoscope blade and eight (8) unpackaged laryngoscope blades and three (3) in the pediatric anesthesia cart available for use.

Observation on 5/10/33 at 11:16 AM in OR#2 in the anesthesia cart showed three (3) unpackaged laryngoscope blades available for use.

Interview with surgical technician (ID R) at the time of observation when asked by the surveyor how do you determine if the laryngoscope blades are used (dirty) or clean, she stated that if they are in the drawer, they are clean.

The facility had no policy for cleaning, disinfecting, and packaging of laryngoscope blades.

8. MULTI-DOSE MEDICATION

Record review of facility policy titled "Multiple Dose Vial," not dated showed the following information:

1. The medical personnel that open the vial shall write the beyond use date, time, and their initials on the container.

3. Opened vial will be utilized for 28 days after opening date unless there is evidence of contamination or use of non-aseptic technique.

Review of Centers for Disease Control and Prevention (CDC) guidelines for multi dose vials states the following: Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should only be kept and accessed in a dedicated clean medication preparation area (e.g., nurses' station), away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single patient use only. Examples of immediate patient treatment areas include operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays.

Observation on 5/10/22 at 11:15 AM in OR#1 anesthesia cart showed:
-One (1) vial of Labetalol Hydrochloride 5mg/mL opened, not labeled
-One (1) vial of Phenylephrine 10mg/mL single-dose vial opened available for use

Observation on 5/10/22 at 11:20 AM in OR#2 anesthesia chart showed:
-One (1) vial of Lidocaine 1% 10mg/mL MDV opened, not labeled
-One (1) vial of Neostigmine Methylsulfate opened, not labeled

Interview with pharmacy technician (ID EE) on 5/10/22 at 11:15 she stated that all multi-dose vials should be labeled with the date opened and that they are then good for 28 days.

9. TRANSPORT OF CONTAMINATED ENDOSCOPES
Record review of facility policy titled "Transportation of Used (Dirty) Endoscopy Scopes," dated 8/13/2012 showed the following information:

Procedure: At the end of all endoscopy procedures the used (dirty) scope will be:
1. Placed on a towel covered cart
2. Covered with a second towel
3. Wheeled to the dirty workroom

Record review of Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice: Flexible Endoscopes showed the following information:
Contaminated endoscopes and accessories must be transported to the decontamination area in a closed container or closed transport cart. The container or cart must be leak proof, puncture resistant, and large enough to contain all contents. The transport cart or container must be labeled with a fluorescent orange or orange-red label containing a biohazard. Biohazard labels must be securely affixed so as to prevent separation from the contents.

Interview with surgical technician (ID# Q) on 5/10/22 at 12:00, she stated that after the pre-cleaning processin the operating room, she wraps the scope in the disposable chuck and carries it to the decontamination room. She stated that they used to transport the scopes in a plastic container but no longer do that.

10. INSTRUMENTATION STERILIZED IN THE CLOSED POSITION

Observation on 5/10/11 at 11:42AM in the OR Sterile Supply showed the following:
-One (1) peel packed sponge stick in the closed position
-One (1) peel packed tenaculum in the closed position
-One (1) peel packed needle driver in the closed position

Record review of Centers for Disease Control and Infection Prevention (CDC), Steam Sterilization Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) showed the following information: hinged instruments should be opened; items with removable parts should be disassembled.

Interview with surgical technician (ID# R) on 5/10/22 at 11:45 AM, she confirmed that the above findings and stated that instruments are to be packaged and sterilized in the open position.


11. UNCOVERED LINEN IN PRE-OP/PACU (POST ANESTHESIA CARE UNIT)

Review of CDC Best practices for linen (and laundry) handling showed the following information:

Sort, package, transport, and store clean linens in a manner that prevents risk of contamination by dust, debris, soiled linens or other soiled items.

Observation on 5/10/22 at 10:11 AM in the pre-op/PACU area showed a rolling cabinet containing exposed linen.

Interview with CNO (ID B) at the time of observation stated that the linen should be covered.

12. CARDBOARD BOXES IN STERILE SUPPLY AREA

Observation on 5/10/22 at 10:53 AM in the sterile supply storage area showed three (3) cardboard boxes on the floor with a piece of paper taped to the front with "TRASH & Saved take home boxes."

Interview with surgical technician (ID Q) on 5/11/22 at 1:15 PM acknowledged that they should not have been in the room and stated that the boxes had been removed.

Based on observation, interview and record review, the facility failed to implement an effective infection control program for preventing and controlling the transmission of infections. The facility failed to :

1. ensure staff utilized appropriate hand hygiene;

2. dispose of contaminated, single-use patient supplies appropriately;

3. store linen in a manner to prevent contamination;

4. package laryngoscope blades to prevent contamination;

5. sterilize hinged instruments in the open position.

Findings included:

1. HAND HYGIENE:

Record review of facility policy titled ""Handwashing" reviewed on 06/10/2020, stated "When going from a dirty site to a clean site, hands shall be washed, or an alcohol hand rub applied between sites.

Observation on 05/12/2022 at 1020 revealed staff (ID#H) did not gel in or out or wash hands between glove changes.

Observation on 05/12/2022 at 1020 revealed staff (ID#H) did not gel in or out or wash hands between glove changes, while cleaning and suturing patient (ID#12)'s wound.

Interview with staff on 05/13/2022 at 12:00 P.M. with staff (ID#H) who verified she did not gel or wash between glove change. She (ID#H) also stated the room did not have the right supplies in the room.

2. CONTAMINATED SINGLE-USE SUPPLIES:

Record review of facility policy "Standard Precautions" reviewed 06/10/2020 stated, single use, disposable items must be disposed of property. Make sure that reusable equipment has been cleansed and reprocessed appropriately prior to use on another patient.

Review of packing of the non-conductive sterile suction tubing by MediChoice stated 'single use only".

Observation on 05/10/2022 at 10:30 a.m. in the clinic room on the crash cart, revealed brown dried material in suction tubing that was connected to the suction machine with a yanker attached.

Observation on 05/10/2022 at 11:50 a.m. revealed used oxygen tubing and connecting tubing found connected to the oxygen and suction canister in the CAT scan room.

Interview on 05/10/2022 at 11:45 a.m. with the Radiology Director (ID#E), who verified the department reuses both the oxygen tubing and suction canister tubing on patients.

Interview on 05/11/2022 at 3:50 p.m. with the Manager of Respiratory therapy (ID# Y), who stated oxygen connecting tubing should be single use.

3. LINEN:

Review of CDC Best practices for linen (and laundry) handling showed the following information:

Sort, package, transport, and store clean linens in a manner that prevents risk of contamination by dust, debris, soiled linens or other soiled items.

Observation of supplies and equipment on 05/10/2022 at 1050 in the emergency department (ED) and exam rooms revealed the following:

a. Uncovered linen was found on the shelf of the supply room in the ED.

4. Laryngoscope packaging:

b. One (1) laryngoscope blade were found uncovered on the crash cart in exam room #1 of the ED.

Three (3) laryngoscopes blades were found uncovered on the crash cart in the clinic area.

5. HINGED-INSTRUMENTS STERILIZED IN THE CLOSED POSITION :

c. The sterilized equipment, that was in the supply closet in the ED room revealed all the needle holders were closed:

One (1) Mayo Hegar Needle Holder, closed, dated 12/07/2022
One (1) Webster Needle Driver, closed, dated 12/12/2021
One (1) Mayo Hegar Needle Holder, closed, dated 12/7/2021
One (1) Heaney Needle driver, closed, dated 12/07/2021
Two (2) Small Crilewood Needle driver, dated 12/06/2021
Three (3) Sponge stick, dated 12/09/2022
One (1) Ryder Needle holder, dated, 12/07/2021

Interview with staff (ID#C) on 05/10/2022 at 11:15 a.m. verified the findings.


23032


Based on observation, interview and record review, the facility failed to implement an effective infection control program for preventing and controlling the transmission of infections. The facility failed to:

1. ensure the kitchen freezer temperature was maintained at at 0 degrees to -10 F.

2. provide effective training of kitchen staff regarding monitoring of proper dish machine temperature and sanitizer concentration.

3. ensure expired food was not available for patient meal preparation.

4. make certain food was stored properly- including labeling and dating per policy.

5. ensure linen was stored in a manner to prevent contamination.

Findings included:

1. KITCHEN FREEZER TEMPERATURE:

Review FDA guidelines , 2019, for proper food storage, the ideal temperature for commercial freezers is at or below 0 degrees Fahrenheit. This keeps food completely safe for consumption by preventing bacteria from growing at the frigid temperature.

Observation in the kitchen on 05/10/2022 at 10:20 AM showed a walk-in refrigerator and freezer. There were external thermometers built into the wall above the door: one for the walk-in refrigerator; one for the walk-in freezer.

Interview at the time of observation with Staff L , dietary director, she said currently the freezer thermometer read: five (5) degrees Fahrenheit (F). Staff L was asked what was the required freezer temperature. She answered 0 degrees to -10 degrees. She went on to say the freezer had been like this for several years. Staff L said that it usually reads 5 to 7 degrees. A repair had been attempted a long time ago.

Staff L was asked if she had checked the temperature of the freezer using a thermometer placed inside the freezer. She said yes, and the results were the same.

The food in the freezer appeared frozen.

Record review of the May 2022 walk-in freezer log showed the freezer temperature was recorded at 6 AM and again at 1 PM. The freezer temperatures listed were all either 5 or 6 degrees.

The walk-in freezer and walk-in refrigerator logs did not show acceptable temperature ranges or direction to staff for actions to take if temperatures were out-of-range.

2. STAFF TRAINING: MONITORING OF PROPER DISH MACHINE TEMPERATURE AND SANITIZER CONCENTRATION:

Observation in the kitchen on 05/10/2022 at 10:54 AM showed an "Auto-Chlor Commercial Dishwasher." Review of this dishwasher's manufacturer's plate and instructions [mounted directly on the front of the machine] showed:

a. "Maintaining Proper Water Temperature": hold Fill Button (B) until temperature gauge shows water temperature is 125 degrees F ; press Start button (D) allow cycle to complete. Check water temperature throughout cycle.

b. "Sanitizer Check Procedures:" check product level in container and confirm that YELLOW stopper tube is in position; cycle dishwasher and visually verify the sanitizer is dispensing properly; with dry hands, dip the test strip in the rinse water solution; compare strip with chart on vial -Minimum 50 to 100 PPM [parts per million] is required.

Interview at this same time with Staff- FF, food service worker, when asked about checking the dish washer sanitizer, she said she looked to make sure it was dripping down where it should be. She was asked if she checked anything else about the sanitizer ? Staff FF said "no." Staff- FF failed to say anything about testing the dish machine sanitizer with test strips for proper concentration.

During an interview on 5/12/2022 at 2:30 PM in the kitchen with Staff-GG, she said she checked the dish machine temperature "now & then." Staff -GG did not know to check the sanitizer. She was shown the May 2022 "Daily Temperature Check-Dishwasher Log." She was asked what "PPM" meant and said she did not know.

Record review of the May 2022 "Daily Temperature Check-Dishwasher Log" showed May 1-10, 2022 daily temperature logged at 120 degrees every day. The required manufacturer's temperature is 125 degrees. "100 PPM " was recorded each day, although both food service staff interviewed did not understand the use of sanitizer test strips.

3. EXPIRED FOOD:

Observation on 5/10/2022 between 10 :45 AM and 11: 25 AM showed the following expired foods available for patient meal preparation:

a. Walk- in refrigerator: one (1) box green peppers , dated 4/14/2022- several peppers were shriveled and discolored with black areas; one (1) gallon of coleslaw dressing with "opened 10/29/21" written on top of container. Interview at this time with with Staff L, dietary director said the green peppers andd the cole slaw dressing should be discarded.

b. Walk-in freezer: six (6) and 1/2 pound container of frozen strawberries-label read "received 02/21/2020;" twelve (12) pound container of frozen chicken broth with a label that read: "date 11/22/21; use by 11/ (blank) / 21."

c. Stove top: two (2) pieces of cooked fish on a metal tray covered with aluminum foil. When asked how long the fish had been there, Staff L said "too long-should be discarded"

4. FOOD STORAGE : LABELING & DATING:

Record review of facility policy titled " Food Storage and Labeling," undated, showed: food should be labeled as follows:

a. Content: what the food is
b. The date the food was stored
c. Use by date

[*Of note: the facility policy did not detail timeframes for different foods related to "use by" dates.]

Observation on 5/10/2022 between 10 :45 AM and 11: 25 AM showed the following foods not properly labeled and dated:

a. Walk-in refrigerator: one (1) plastic bag of bacon bits- not dated; one (1) zip lock bag of grilled chicken nuggets, dated 4/10/22-"use by" date left blank.

b. Walk-in freezer: two(2) large plastic bags of chicken tenders not labeled with contents or date; two(2) plastic bags of garlic sticks/knots- not labeled / dated; one(1) bag of onion rings not labled or dated; one (1) plastic bin of chopped pecans, dated 11/26/21. Interview at this time with Staff L , she said the nuts were good for about a month.


5. STORAGE OF LINEN :

Review of CDC Best practices for linen (and laundry) handling showed the following information:

Sort, package, transport, and store clean linens in a manner that prevents risk of contamination by dust, debris, soiled linens or other soiled items.

Observation on 05/12/2022 at 2:20 PM across from the kitchen, showed Staff AA, housekeeping staff, inside a room tabled " Linen Closet." Observation inside this room showed:

-one(1) large wire carts with uncovered linen that included multiple bundles of sheets and light-weight blankets. Immediately adjacent to this linen was a cart that contained cleaning supplies. Four(4) opened spray bottles of various cleaning solutions were hung on the side of this cart, in very close proximity to the uncovered linen.

-one (1) wire cart that contained multiple stacks of uncovered towels . Clean mop-heads were stored on the bottom shelf of ths cart.

During an interview on 05/10/2022 at 10:45 AM with Staff -HH , she stated this this room was the storage area for the linen for the hospital.

On 5/12/2022 , Staff C, infeciton Control, was informed of and acknowledged these findings.

Based on observation, interview, and record review, the facility failed to ensure a clean and sanitary environment. The facility failed to:

1. repair a leak in the ice machine in the kitchen;

2. remove contaminated equipment from a respiratory supply storage room.

Findings included:

1. ICE MACHINE LEAK:

Observation in the kitchen on 05/10/2022 at 10:15 AM showed an ice machine with a white sheet located on the floor underneath the front of the mahcine.

During an interview at the time of observation with Staff L, dietary director, she said the ice machine had a leak ; "for about a month." She said it was repaired about six months ago- but needs it again.


2. CONTAMINATED RESPIRATORY SUPPLIES:

Record review of facility form titled "Monthly Monitoring Patient Care Equipment, Environment, and Safety Devices," undated, showed a 2-page document that listed multiple elements to be inspected that included : hallways clear, exits clear, emergency call lights functional, and more. This monthly inspection did not include an inspection of locked storage or unused rooms in the hospital.

Observation during a tour of hosptial on 5/12/2022 at 12:45 PM with Staff-P, maintenance director , showed a room that contained contaminated repiratory equipement, along with an uncovered bedside commode.

There was a wall-mounted " Mist-Gen Tube Accessory Dryer" with clear plastic wrapped aroung the base of the machine, and extending to the floor. It resembled a clear shower curtain. The plastic was dirty and very discolored; stained brownish-yellow color.

During an interview at the time if observation with Staff Y, Respiratory Manager, he said this equipment is no longer used and needs to be removed from this storage area.

Based on interview and record review, the facility failed to involve all departments and services into their Quality Assessment Performance Improvement (QAPI) program. The facility failed to include all contracted services into QAPI.

Findings included:

Record review of facility "Quality Assessment and Performance Improvement Plan," dated January 2022, showed: "Scope: the QAPI plan applies to all hospital departments and services provided, including contracted services."

During an interview on 5/12/2022 at 11:15 AM with Staff-B, CNO , a general discussion was held regarding QAPI: committee structure and quality indicator measurement.

Staff B verified that contracted services included: registered dietitian ; physical therapy; and speech therapy ( not all inclusive).

Record review of "Performance Improvement Committee Meeting" minutes dated 4/07/2021; 10/27/2021; and 03/28/2022 failed to show evidence that registered dietitian; physical therapy; and speech therapy were included in the QAPI plan. There were no established QA indicators or discussion of these contracted services.

Staff B said the facility was in the process of reviewing and upgrading their QAPI program.