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Based on observation, interview, and record review, it was determined that the Critical Access Hospital (CAH) failed to ensure the physical environment of the operating suite was constructed to ensure the safety of patients with the respect to ventilation, ceilings, and direction of flow of instruments for sterilization. Refer to C0221: Construction.

Based on observation, interview, and record review, it was determined that the Critical Access Hospital (CAH) failed to construct the operating rooms, ceilings, and central sterile in the operative suite to ensure safety of patients.

Findings include:

Review of the "Guidelines for Perioperative Practice". (2016). Association of periOperative Registered Nurses (AORN), Denver, CO. p. 679-680, Sterilization and Disinfection, Flexible Endoscopes. revealed the following:
I.c.: "The endoscopy processing room should be designed to facilitate a unidirectional workflow from the decontamination room to the clean workroom and then to clean storage in a separate location."

Observation on 10/8/19 at approximately 11:00 a.m. revealed Staff B (Central Sterile Technologist) removing a cystoscope from the scope processor in the scope clean workroom that was located between Operating Room (OR) 1, currently used for sterile storage, and OR 2. There were only two ways to enter the room, through a door in OR1 or a door in OR2.

Interview on 10/8/19 at approximately 11:00 a.m. with Staff B confirmed that the room between OR1 and OR2 is used for clean scope workroom and revealed that endoscopes and cystoscopes are decontaminated in the decontamination room, then are brought in a hard covered plastic container across the hallway through the central sterile storage in OR 1 to the scope clean workroom to be sterilized.


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Review of the Guidelines for Design and Construction of Hospitals The Facility Guidelines Institute (FGI) 2018 edition. Published by The Facility Guidelines Institute 9750 Fall Ridge Trail St. Louis, MO 63127 revealed the following:

Operations and Maintenance (O&M) Procedures.
1.1 Operating Rooms
a. Each OR should be tested for positive pressure semi-annually or on an effective preventative maintenance schedule.

Review on 10/9/19 of the facility's balance reports for the operating rooms titled "Certified Pressure Map And Air Change Report", dated 5/2/19, under "report summary remarks" revealed the following: "The area is served by RTU-2 [Roof Top Unit]. The controls for RTU-2 are non-functional. RTU-2 static pressure does not control to set-point and the controls are locked out the ATC [Automatic Temperature Control] contractor". Further review of the balance reports showed the prior balance test was dated 11/30/16. There was no documentation that balance testing has been done in 2017 or 2018.

Review of the Guidelines for Design and Construction of Hospitals The Facility Guidelines Institute (FGI) 2018 edition. Published by The Facility Guidelines Institute 9750 Fall Ridge Trail St. Louis, MO 63127 revealed the following:

2.1-7.2.3.3 Ceilings
(2) Semi-restricted areas
(a) ceiling finishes in semi-restricted areas shall be:
(i) Smooth and without crevices
(ii) Scrubbable
(iii) Non-absorptive
(iv) Non-perforated
(v) Capable of withstanding cleaning with chemicals
(b) Where a lay-in ceiling is provided, it shall be gasketed or each ceiling tile shall weigh at least one pound per square foot.
(c) Use of perforated, regular, serrated, or highly textured tiles shall not be permitted in semirestricted areas.

Observation on 10/8/19 while touring the surgical suite with Staff I (Preoperative Nurse Manager) revealed the facility does not have the correct ceiling tiles in the semi-restricted areas. These tiles appeared non-weighted with perforated marking throughout each tile making them unable to be cleaned.

Interview on 10/8/19 at approximately 11:00 a.m. with Staff I confirmed that the tiles in the semi-restricted areas were non-weighted and perforated.

Review of the Guidelines for Design and Construction of Hospitals The Facility Guidelines Institute (FGI) 2018 edition. Published by The Facility Guidelines Institute 9750 Fall Ridge Trail St. Louis, MO 63127 revealed the following:

4. Compliance
4.1 Compliance Requirements
4.1.2.2.1 Heating, Ventilation, and Air-conditioning System Alterations. Alterations to mechanical systems serving the building heating, cooling or ventilating needs shall comply with the requirements of Section 6, "Systems and Equipment,"applicable to those specific portions of the building and its systems that are being altered. Any new mechanical equipment installed in conjunction with the alteration as a direct replacement of existing mechanical equipment shall comply with the provisions of Sections
4.1.2.2.2 Space Alterations. Alterations to space listed in Table 6.4 shall comply with the requirements of Sections 6.7, 7, 8, and 9, applicable to those specific portions of the building and its systems that are being altered....
6.7 Air distribution Systems
6.7.1 General....Where space pressure relationships are required, the air distribution system design shall maintain them, taking into account recommended maximum filter loading, heating-season lower airflow operation, and cooling-season higher airflow operation...

Review of the maintenance records revealed that the filters in the operating rooms at the time the HVAC (Heating, Ventilation, and Air Conditioning) units were balanced on 5/2/19 were HEPA (High-efficiency particulate air) filter rated at 99.97% efficient. Maintenance records also revealed that on 8/2/19 these filters were switched out and replaced with HEPA filter that were rated at 95% efficient. Since the changing of the filters the facility has failed to re-balance the system.

Interview on 10/9/19 at 10:30 a.m. with Staff H (Manager Environmental Services) confirmed that the filters were changed out and stated this was done due to the cost difference between the two filters.

Observation on 10/8/19 at 1:00 p.m. while touring the surgical suites revealed that OR #4's two air return were at different pressures in relation to each other. When entering OR #4, the right returns was tested using a paper test by holding a piece of paper against the return to feel if there is a draw. The paper was drawn into the return, then the left return was tested and the paper fell to the floor. This finding was shown to Staff I at time of tour.

Review of the last two balance reports, one dated 11/30/16 and the other dated 5/2/19, (OR #4, Connects to Existing Return #23 and #24) revealed that there are the two returns in OR#4. On 11/30/16, #23's return air was 518 CFM (cubic feet per minute) and #24's return air was 421 CFM. On 5/2/19, #23's return air was 77 CFM and #24's was 404 CFM. This is a significant differential in pressure between return ducts #23 and #24 on 5/2/19, which should be equal to avoid skirting over the surgical field.

Review of the Guidelines for Design and Construction of Hospitals, The Facility Guidelines Institute (FGI) 2018 edition, published by The Facility Guidelines Institute 9750 Fall Ridge Trail St. Louis, MO 63127 revealed the following:

7.4 Surgery Rooms
7.4.1 Operating Rooms (ORs), Operating /Surgical Cystoscopic Rooms, and Caesarean Delivery Rooms.
"These rooms shall be maintained at a positive pressure with respect to all adjoining spaces at all times. A pressure differential shall be maintained at a value of at least +0.01 in . of water (2.5 Pa). Each room shall have individual temperature control..."

Observation on 10/8/19 while touring the surgical suite with Staff I, revealed the facility did not have positive pressure differential monitoring units outside all three OR rooms to monitor pressure to the respective adjoining spaces.

Review on 10/9/19 of the surgery schedule for September 2019 revealed the CAH used the operating rooms for colonscopies as well as orthopedic procedures, such as a total hip replacement on 9/26/19 and gynecologic procedures such as diagnostic laproscopy. The CAH performed 49 procedures during this time period.

Observation on 10/10/19 at 8:45 a.m. in the offsite Charlestown Urgent Care blood collection station revealed the current temperature of Refrigerator 2 was 0.9 degrees Celsius.

Interview on 10/10/19 at 8:45 a.m. with Staff D (Director of Emergency Services) confirmed Refrigerator 2 had not been maintaining the acceptable temperature range. Staff D revealed the Urgent Care Center opened on September 3, 2019.

Review on 10/10/19 of the temperature log from September and October for Refrigerator 2 revealed the acceptable temperature was 2-8 degrees Celsius. Further review of the log revealed the temperature was out of range on 34 of 35 days the temperature had been recorded. There was no temperature recorded on 9/3/19 and 9/4/19.

Review on 10/10/19 of an email sent on 8/30/19 by Staff D to personnel located at Charlestown Urgent Care revealed issues with the laboratory refrigerator that had been identified and needed to be checked.

The facility could not provide documentation at the time of survey that Refrigerator 2 had been taken out of use and/or temperature issue addressed prior to using for patient specimen storage.






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Based on interview, record review, and observations of the facility's kitchen on 10/8/19 and a satellite health care facility on 10/10/19, it was determined that several essential mechanical pieces of equipment failed to be in safe operating conditions.

Findings include:

Observation of the facility's kitchen on 10/8/19 at 9:30 a.m. revealed that the walk-in freezer condenser in the back of the unit was dripping on food product and freezing leaving large amounts of ice buildup on food product. While touring the kitchen on 10/8/19 at 9:45 a.m. the high temperature dish machine was running at 165 degrees Fahrenheit (F) during the rinse cycle. The dish machine was run three more times and all three times the temperatures were the same.

Review on 10/8/19 of the dishwasher temperature logs for October revealed the facility was documenting the temperatures for the dish machine using a low temperature log which has temperatures of 140 degrees F for wash temperature and 120 degrees F for a rinse temperature. Review was extended to the September dishwasher temperature logs and the same practice occurred in September with over 49 entries written by staff showing that the dish machine failed to reach 180 degrees F or greater during the rinse cycle.

Interview on 10/8/19 at 9:30 a.m with Staff E (Director of Food Service) confirmed the above findings and confirmed that the rinse temperature for their high temperature dishwasher should run at 180 degrees or greater. Staff E said they would contact maintenance to repair the dish machine and that they would remove the wrong temperature logs and replaced them with the correct ones for high temperature dishwashing.

Interview on 10/8/19 at 9:50 a.m. with Staff E revealed the ice machines within the kitchen area and the kitchenettes on the units for patient use were maintained by the maintenance department. Interview on 10/8/19 at approximately 10:00 a.m. with Staff F (Bio Medical Engineering) revealed their is no maintenance program at this time for the cleaning/de-liming of the ice units.

Based on observation and interviews, the critical access hospital (CAH) failed to ensure that outdated drugs and biologicals are not available for patient use in multiple hospital and outpatient locations on 10/8/19 and 10/9/19.

Findings include:

Observation on 10/8/19 at 9:30 a.m. in the Emergency Department (ED) revealed 1 out of 3 ED rooms observed contained two yellow top serum separator blood specimen tubes which expired 7/31/19.

Observation on 10/8/19 at 1:15 p.m. in the Valley Regional Urgent Care supply room revealed four red top blood specimen tubes which expired 9/30/19.

Interview on 10/8/19 at the time of observations with Staff D (Director of Emergency Services) confirmed the above findings and revealed inventory is checked monthly for expired blood specimen tubes.

Observation offsite on 10/9/19 at 10:35 a.m. of Urology procedure room 2 revealed two pre-filled saline syringes which expired May 2019 and one bandage roll which expired May 2019. Observation in the Urology supply storage room revealed six pre-filled saline syringes which expired May 2019 and two bandage rolls which expired March 2017, four bandage rolls which expired June 2019 and three bandage rolls which expired May 2019.

Interview on 10/9/19 at 10:40 a.m. with Staff K (Licensed Practical Nurse) confirmed the above findings and revealed supplies are checked monthly for expiration dates.

Observation offsite on 10/9/19 at 12:10 p.m. of the medicine cabinet located within Associates in Medicine revealed one EpiPen Jr (epinephrine injection) expired August 2019 and one unpackaged hypodermic syringe and needle ready for use and taped to the inside of the cabinet door. Further observation in the medicine cabinet revealed the hypodermic syringes and needles are provided by the manufacturer in separate sterile packaging.

Interview on 10/9/2019 at 12:15 p.m. with Staff L (Certified Medical Assistant) confirmed the above finding.


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Observation on 10/9/19 at 1:30 p.m. while touring the physical therapy department with Staff G (Director of Rehabilitation Services) revealed that several boxes of sterile acupuncture needles/dry needs were outdated with the expiration date of 8/19. Staff G stated at time of finding that these needles were just ordered not even 3 weeks ago. Staff G removed the boxes and contacted the company at the time of observation and new needles are being delivered.

Based on observation, interview, it was determined that the CAH failed to maintain a sanitary environment in the kitchen and prohibit multiuse of single use saline bags in radiology.

Findings include:

Observation on 10/9/19 at approximately 9:25 a.m. in the computerized tomography (CT) scan room revealed a spiked bag of saline hanging on an intravenous (IV) pole.

Interview on 10/9/19 at approximately 9:25 a.m. with Staff A (Radiology Technologist) revealed that saline was drawn off the saline bag to add to the device that mixes saline with the contrast and then administers by IV to patients for the CT scan procedures. Interview revealed that it is the practice for radiology to draw saline off of one bag for up to two patients.

Interview on 10/9/19 at 10:30 a.m. with Staff O (Pharmacist) confirmed it is not the policy of the CAH to use mutliuse bags of saline for more than one patient.


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Observation on 10/8/19 at 9:40 a.m. in the kitchen revealed that both manual can openers were in the ready to use position and the cutting blade of both can openers were covered with food product. This observation was shown to Staff E (Director of Food Services) at the time of finding, who stated the can openers are cleaned at the end of every day but not in-between usage.

Based on record review and interview, it was determined that the Critical Access Hospital failed to distinctly discharge patients from acute status and then admit to swing bed status in 2 of 8 patients admitted to Swing Bed status in a standard survey sample of 20 patients. (Patient identifiers are #2 and #3).

Findings include:

Patient #2
Review on 10/9/19 of clinical records revealed that Patient #2 was "discharged from Acute to SNF" (Skilled Nursing Facility) on 8/15/19. This order was signed by Staff M, (Physician) at 14:46 and lacked a distinct physician order discharging the patient from acute care and admitting to Swing Bed status. A clear physician order to admit to Swing Bed status was not found. Staff M's next ancillary esigned order for Patient #2 at 14:46 on 8/15/19 states SNF (swing Level Care).

Interview on 10/9/19 with Staff J, (Risk Management) confirmed the absence of a distinct order to discharge patient from acute care and admit the patient to Swing Bed status.

Patient #3
Review on 10/9/19 of clinical records revealed that Patient #3 was "discharged from Acute to SNF"on 9/7/19 at 18:49. This order was esigned by Staff N, (Physician) and lacked a distinct physician order discharging the patient from acute care and admitting to Swing Bed status. A clear physician order to admit to Swing Bed status was not found. Staff N's next ancillary esigned order for Patient #3 at 18:52 on 8/15/19 states SNF.

Interview on 10/9/19 with Staff J, confirmed the absence of a distinct order to discharge patient from acute care and admit the patient to Swing Bed status.