Bringing transparency to federal inspections
Tag No.: C1018
.
Based on observation, document review and interview, the Critical Access Hospital failed to ensure that physicians properly executed Informed Consents for procedures by not timing the forms for 7 of 7 (Patient #1001, #1002, #1003, #1004, #1005, #1006, and #1007).
Failure to ensure that informed consents are properly executed creates a risk for lack of understanding to what and when a patient consented to a procedure.
Findings included:
1. Review of the hospital's document titled "Rules & Regulations of the Medical Staff Prosser Public Hospital District DBA Prosser Memorial Hospital," dated 02/26/19, showed that all clinical entries in the patient's medical record shall be dated, timed and signed. A medical record shall not be permanently filed until it is completed by the responsible provider, except by order of the Medical Executive Committee.
2. Surveyor #10 reviewed records for 7 patients (Patients #1001, #1002, #1003, #1004, #1005, #1006, and #1007). The review showed that the records did not have a time recorded on the informed consent by the following physicians: Urologist, (Staff 1005), Podiatrist (Staff #1006), General Surgeon (Staff #1007), Orthopedist (Staff #1008), and Ear, Nose and Throat Physician (Staff #1009).
3.On 06/16/21 at 8:30 AM, Surveyor #10 reviewed the electronic medical records with a Registered Nurse (Staff #1010). During the review Surveyor #10 interviewed Staff #1010 about the missing times on the informed consents. Staff #1010 verified that the time on the forms had not been recorded by the physician (Staff #1006, #1007, #1008, and #1009) for 4 patients (Patient #1001, #1002, #1003, and #1004).
4. On 06/17/21 at 1:45 PM, Surveyor #10 reviewed the electronic medical records with the Clinic Manager of the Prosser Memorial Hospital Specialty Clinic (Staff #1004). During the review Surveyor #10 interviewed Staff #1004 about the missing times on the informed consents. Staff #1004 verified that the time on the forms had not been recorded by the physician (Staff #1005) for 3 patients ( Patient #1005, #1006, and #1007).
.
Tag No.: C1200
.
Based on observation, interview, and document review, the critical access hospital failed to develop and implement an effective infection prevention and control program that ensured that flexible endoscopes were appropriately reprocessed according to manufacturer's instructions for use, failed to ensure that staff were fit tested for N95 respirators and did not store them for reuse, and failed to ensure that environmental surfaces were maintained to ensure they were cleanable.
Failure to develop and implement an effective infection prevention and control program puts patients, staff, and visitors at risk of illness of communicable diseases.
Findings included:
1. The hospital failed to ensure staff properly reprocessed instruments for patient care that required high-level disinfection.
Cross Reference: Tag C-1206
2. The hospital failed to ensure that staff were fit tested for N95 respirators that were used for respiratory protection.
Cross Reference: Tag C-1206
3. The hospital failed to ensure that staff did not store N95 masks for reuse while in conventional use capacity.
Cross Reference: Tag C-1206
4. The hospital failed to ensure that environmental surfaces were maintained to ensure they were cleanable.
Cross Reference: Tag C-1208
Due to the scope and severity of deficiencies cited under §42 CFR 485.640, the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs was NOT MET.
.
Tag No.: C1206
.
Item #1 - Endoscope Reprocessing
Based on observation, interview, and document review, the hospital failed to ensure that flexible endoscopes were reprocessed according to manufacturer's instructions for use (IFUs).
Failure to reprocess endoscopes according to manufacturer's IFUs places patients at risk for infection, serious complications or harm from infections, or death.
Findings included:
1. Review of the manufacturer's IFUs for the Olympus CYF-VHR cystoscope showed the following:
a. Fill a clean, large basin with water when performing the leakage test. Immerse the endoscope when performing the leakage test, angulate the bending section, and perform for 30 seconds to confirm that no bubbles emerge.
b. Manual cleaning of the endoscope:
i. Fill a basin with detergent solution and immerse the endoscope to perform the manual cleaning steps.
ii. Brush the channel, keeping the endoscope immersed during the brushing step.
iii. Flush the instrument channel with 30 mL of detergent solution, repeating two additional times.
iv. Following cleaning, immerse the endoscope in a basin of water and flush the instrument channel with 30 mL of water three times.
v. Following the rinsing steps, flush the channel with 30 mL of air three times.
c. Manual disinfection of the endoscope:
i. Fill a large basin with disinfection solution and immerse the endoscope in the solution for the manual disinfection.
ii. Flush the instrument channel with 30 mL of disinfectant solution.
iii. Ensure the endoscope is completely immersed in disinfection solution according to manufacturer's IFUs for disinfection time.
iv. Following disinfection, remove the endoscope from the basin and flush the instrument channel with 30 mL of air.
v. Immerse the endoscope in a basin of water, wipe down the exterior surfaces, and flush the instrument channel with water three times.
vi. After rinsing, flush the instrument channel with 30 mL of air three times.
d. Do not coil the endoscope in a diameter of less than 10 cm when storing the endoscope.
2. Record review of the policy provided for the urology clinic endoscope cleaning process showed that the document was for the ENT clinic. The document was titled, "Flexible Endoscope Cleaning Process for ENT Clinic," no policy number, no date. Review showed that the Olympus CYF-VHR endoscope was not included in the cleaning instructions for this policy.
3. On 06/16/21 at 3:30 PM, Surveyor #17 toured a urology clinic that conducts cystoscopy procedures to observe the high-level disinfection process. The surveyor had a medical assistant (Staff #1701) perform a walkthrough of the cleaning processes. The observation and interview showed the following:
a. Staff #1701 did not have a basin to fill with water to perform the leakage test. Staff #1701 indicated that the leak test was performed on the counter of the reprocessing room.
b. Staff #1701 stated that they only cleaned the exterior surface with an enzymatic solution-soaked sponge and dry brushed the instrument channel of the endoscope. Staff #1701 demonstrated how this prcoess would be conducted. Staff #1701 did not have a way to immerse the endoscope in detergent solution or perform the brushing steps in the detergent solution. Staff #1701 stated that they did not perform any flushing with detergent solution, water, or air as specified in the manufacturer's IFUs.
c. Staff #1701 stated that they would then soak the endoscope in a high-level disinfectant solution that was housed in a wall mounted plastic tube system. The staff stated they would not fully immerse the endoscope in the disinfectant solution and would not flush any disinfectant solution through the instrument channel. Staff #1701 stated they would then place the endoscope in another identical tube that contained water and soak for 1 minute. Staff #1701 stated they did not flush the endoscope channel with water or air as required by manufacturer's IFUs.
d. Staff #1701 showed Surveyor #17 how the endoscope was stored. The endoscope was stored in a container and wrapped in a towel. The flexible ends of the endoscope were stored in a manner that did not prevent tight coiling. Surveyor #17 observed portions of the flexible end that were coiled closer than the minimum allowed 10 cm according to manufacturer's IFUs.
4. Record review of endoscope reprocessing training records showed that clinic staff received an in-service from Olympus on endoscope reprocessing on 09/11/20. Staff #1701 did not attend that training but received another training from a physician (Staff #1702) and another medical assistant (Staff #1703) on 10/16/20. The documentation for this training did not contain what elements of the disinfection process were covered.
5. On 06/17/21 at 8:42 AM, Surveyor #17 interviewed the Specialty Clinic Manager (Staff #1704) about the endoscope reprocessing process and staff training at the urology clinic. Staff #1704 stated that Olympus performed competencies when the clinic was brought online. The October staff training occurred when the disinfection process was changed to the wall mounted disinfectant system and this was conducted by the physician (Staff #1701) and a medical assistant (Staff #1703).
Item #2 - N95 mask reuse.
.
Based on observation, interview, and record review, the hospital failed to ensure staff did not reuse N95 masks while in conventional use status.
Failure to ensure that staff are not reusing N95 masks when the facility is in conventional use status risks patient and staff infection from exposure to microorganisms, including COVID-19, from exposure to potentially contaminated personal protective equipment (PPE).
Reference: Centers for Disease Control and Prevention, "Strategies for Optimizing the Supply of N95 Respirators," updated 04/09/21, showed under conventional capacity strategies that extended use of N95 respirators as PPE is a contingency capacity strategy.
Findings included:
1. Record review of an email dated 06/18/21 showed that the hospital notified staff around 10/19/20 that N95 masks did not need to be reused due to having enough PPE on hand. No subsequent documentation from that time was provided.
2. On 06/15/21 at 9:17 AM, Surveyor #17 observed an N95 respirator with a name written on the mask hanging from a hook outside a room of a patient under aerosol contact precautions for COVID-19. The mask was not stored in a manner to prevent contamination and was available for staff use.
3. At the time of the observation, the Quality Director (Staff #1705) confirmed that the mask was labelled with a name and that it should not be stored in such a manner. Staff #1705 stated that the hospital was in conventional capacity for N95 respirator use and that staff should obtain a new mask when needed and discard any previously used mask after use.
Item #3 - Fit Testing
Based on observation, interview, and document review, the hospital failed to confirm N95 fit testing was completed on staff providing care for a COVID-19 patient.
Failure to implement an effective infection prevention program puts patients, staff, and visitors at risk of illness from COVID-19 and other communicable diseases.
Findings included:
1. Record review of the isolation precautions signage titled, "Aerosol Contact Precautions," dated 10/09/20 showed that staff should use an N95 respirator when entering the room for patient care.
2. On 06/15/21, at 10:05 AM, Surveyor #8 and Surveyor #17 observed an occupational therapist (Staff 803) and physical therapist (Staff #804) enter room #9, which was under aerosol contact precautions. Both staff were wearing N95 respirators as required by the patient's precaution status.
3. On 06/17/21, at 1:10 PM, Surveyor #8 conducted a personnel file review with Human Resources Officer (Staff #805) which included confirmation of N95 fit testing. The hospital was unable to provide records confirming fit testing of Staff #803 and Staff #804.
.
Tag No.: C1208
.
Based on observation, document review, and interview, the hospital failed to maintain a clean and sanitary environment by not ensuring environmental surfaces were easily cleanable.
Failure to maintain a clean environment in an operating room puts patients, staff, and visitors at increased risk of exposure to harmful microorganisms.
Findings included:
1. On 06/15/21 between 2:30 PM and 4:00 PM, Surveyor #8 observed the baseboard separated from the wall in operating room (OR) #2. This left an uncleanable gap over 10 ft in length and between 0.25 inch and 0.5 inch in width.
2. On 06/15/21 at 3:30 PM, Surveyor #8 interviewed Director of Surgical Services (Staff #801) and inquired about the separated baseboard. Staff #801 stated she was aware of the separated baseboard and a work order had been submitted.
3. On 06/16/21 at 10:00 AM, Surveyor #8 and Surveyor #17 interviewed Director of Support Services (Staff #802). Staff #802 was asked to produce the work order for the baseboard repair in OR #2. The work order was provided and dated 04/21/21.
.