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Based on observations, record review and interview, it was determined that the Governing Body failed to ensure the facility followed their Bylaws in order to evaluate the total hospital operation through a program of Quality Assurance and Risk Management.


The Governing Body's failure to effectively monitor implementation of policies governing the Critical Access Hospital's (CAH) total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment had the potential to place all patients receiving services at the CAH at risk for potential harm.


Findings include:

Refer to tag C-0241 and cross reference tag C-0320.

Based on observations, record review and interview, the Governing Body failed to ensure they followed the facility Bylaws in order to evaluate the total hospital operation through a program of Quality Assurance and Risk Management.


Findings include:


Based on observations on 5/23/16 at 8:50 a.m. and on 5/24/16 at 9:20 a.m. and 10:05 a.m. revealed the following:
-Sterilized single wrapped instruments in the ED did not have internal chemical integrators.
-The facility had two methods of dating instruments, which made it difficult to know when an item was out of date.
-Hinged instruments were not processed in the open position.
-Basins were stored with dried water marks indicating they had not been dried properly and could be contaminated.
-Test strips used to check the concentration of the disinfecting solution for the endoscopes were being used and had expired on 8/2011 and had not been dated when opened.
-The Sterile Processing Suite was being cross-contaminated by not identifying each specific room for its function as a clean or dirty area.
-The Sterile Processing Suite was not being monitored for temperature and relative humidity.
-Biological Indicators (BI)were not being initialed and dated, were not being used with the same lot numbers for the test and control BIs, and were being used pasted their expiration dates.
-Rapid Readout cards were not filled out completely with documentation of the lot numbers for the test and control BIs.
-Autoclave tape was being used inside instrument packs instead of Chemical integrators. The autoclave tape had quit being made in 2007.
-Bowie-Dick tests were not being done daily when the autoclave was being used to ensure air was being removed from the autoclave during the sterilization cycle.


Interviews on 5/24/16 at 9:20 a.m. and 10:05 a.m. with RN E, who was in charge of Sterile Processing and the Endoscopy Department revealed she had not identified how to establish the different areas required for a Sterile Processing Unit. RN E was using expired testing strips for high disinfection solutions and expired Biological Indicator (BI) controls were being used. She did not know that the test and control BI had to be from the same lot number. She did not know she needed to document the lot numbers on the Rapid Read Out cards. RN E did not understand the need to use Chemical Integrators inside instrument sets. She did not know what a Bowie-Dick test was and that it needed to be used before a load was run in the autoclave. She did not know hinged instruments needed to be processed in the open position. She did not know the temperature and relative humidity needed to be monitored and logged in the Sterile Processing unit.


Record review of the facility's Governing Body Bylaws (not dated) under II.10 revealed the following:
"It shall be the duty of this District Board to analyze and evaluate the total hospital operation and to inquire into cases of major performance deficiencies and proper patient care thru a program of Quality Assurance, Risk Management and Corporate compliance.
11.10.1 Provide for adequate personnel
11.10.2 Approve and review a plan of monitoring deviations from desired standards of performance ...
11.10.5 Identify the Board's need for information and arrange for timely supply of this information.
11.10.6 Provide for independent review of performance reports.


Record review of the Governing Body meeting minutes for 1/26/15 to 3/28/16 revealed only one documentation on 10/26/15 in executive session that a QI/RM report was presented. There was no documentation of staffing needs.


Record review of the Medical Staff Bylaws revised on 5/2011 revealed the following:
"Article XI - Quality Improvement/Risk Management
11.1 Purpose
11.1.1 To monitor and evaluate the quality and appropriateness of patient care and the clinical performance of all individuals with clinical privileges ...
11.2 Authority ...
11.2.2 The Governing Board shall be overall responsible and delegates authority and accountability for the operation of the quality improvement/risk management program ...
11.3 Scope..
11.3.2 All departments are monitored by the Medical Staff to assure quality and appropriateness of patient care ...
11.7.5 Quality Improvement/Risk Management Committee
A. Purpose:
1. To improve quality of patient care delivered by the (Hospital) with the prevention or reduction of injuries to patients and employees ....
C. Meeting requirements:
1. The committee shall meet as necessary, but not less than quarterly.


Record review of the Medical Staff Meeting Minutes for January, March, and April 2016 revealed no documentation that any QA (Quality Assurance) information including Infection Control was presented at the meetings. From 10/14/15 to 3/9/16 there was a notation "Continue with staffing issues" with "No action" in the Action/Follow-up section or for three months listed the same employee as coming back full time.


Record review of the facility's Policy and Procedure for Risk Management Plan (not dated) revealed the following:
"The Risk Management committee shall have the following duties:
a. shall meet as necessary, but not less than quarterly ...
h. shall submit a report to the Governing Board.


During an interview on 5/25/16 at 1:00 p.m. with QA/Risk Manager (RM) E and DON (Director of Nursing) C, they said they gave information to the Administrator, but did not know why it was not being presented to the Governing Board. QA/RM E said she was told not to give information for the Medical Staff Meeting because it could then become "discoverable." She said she did give a QA/Risk Management (RM) report for the 4th Quarter 2015 at the June 2016 board meeting. DON C said she has been giving information about nursing staffing problems to the Administrator and did not know why it was not being presented at the Board meetings. The DON said that because they were a small hospital and because they were having problems finding nursing staff in the area, some staff had to wear many hats. She said she worked shifts in order to get coverage, and used agency staffing at night. She said QA/RM E was in charge of Sterile Processing, Endoscopy, Infection Control Preventionist and QA/RM. She said QA/RM E had also retired, but came back part-time to help out.


During an interview on 5/25/16 at 3:40 p.m. with Administrator A, he was asked why information from Infection Control committee, QA/RM, and Nursing were not being presented at the Governing Board meetings. He said that he had let that slip. He said they had a QA/RM report at the last Board meeting last Monday night. He asked if reports needed to be given more than quarterly and was informed it was up to the Governing Board and the facility Bylaws as to how often the reports were to be given.

Based on observation, record review, and interview the facility failed to ensure there was a system for identifying and controlling infections as evidenced by:

-Pharmacy medication bags were used multiple times and were worn, discolored and re-taped with labels that were dirty and worn which put them at high risk for cross contamination. There was no system for cleaning the bags or replacing them.

-The kitchen had multiple areas of thick, black build-up of grime on the floors and grease and dirty areas to sight and touch. There was no consistent cleaning of the kitchen and no documentation of when the floors had been cleaned.

-Hand hygiene was not performed during an endoscopy procedure.

-There was thick layers of dust in multiple areas of the hospital.

-Laryngoscope blades were lying loose in Emergency Carts without a way to know they had been given high level of disinfection.


Findings include:


Medication bags

Observation on 5/23/16 at 10:50 a.m. revealed LPN (Licensed Practical Nurse) I was getting medication out of the Nursing Medication cart on the Medical/Surgical unit for Patient #1. The cart was filled with well-worn, discolored zip lock bags. Some of the labels were discolored and dirty. Some of the bags had been taped at the bottom with plastic tape.


Interview at this time with LPN I, she said that was the way Pharmacy dispensed medications.


Observation on 5/24/16 at 9:00 a.m. revealed a rolling medication cart in the procedure room during an Endoscopy. After the procedure, CRNA (Certified Registered Nurse Anesthetist) O wrapped up the medications he had, including used vials of medications, in a plastic bag and put them on top of the rolling medication cart. Observation of the medications in the drawers of the cart revealed they were all sorted out in plastic zip lock bags that were well worn, discolored, and dingy. Some of the labels were dirty and stained. The cart was taken to the Pharmacy where it was stored.


Observation on 5/24/16 at 1:00 p.m. of the Pharmacy with DON (Director of Nursing) C revealed the bag of medications used by CRNA O were in the top drawer of the rolling medication cart. RN U was working in the Pharmacy.


Interview at this time with RN U, she was asked about the zip lock bags. She agreed they were well worn, dingy and discolored. She said she only worked in the Pharmacy when Pharmacy Nurse B was off. She said she was not sure why they were being used. DON C said she was aware of the bags and felt like they needed to be replaced, but RN B got angry when anyone threw out the bags. She said the bags had been used as long as she had worked at the facility, since 2011, and was not sure why that system was being used.


Interview on 5/25/16 at 4:00 p.m. with RN B, she said the system with using the zip lock bags was being used when she started in 1994. She agreed they needed to be replaced. She said she taped the bags because of a problem with time and replacing all the baggies. She said she would start replacing all the bags.



Kitchen


Observation on 5/23/16 at 1:05 p.m. with Certified Dietary Manager (CDM) J revealed the following:

-The table under the steamer had a thick build-up of lime scale. The shelves under the table had a layer of dust and grease to touch and sight.

-The floor under the steamer had a thick accumulation of debris and black grime especially in the corners of the frame for the RO (reverse osmosis) unit.

-There was a thick build-up of black grime on the floor under the legs of the stove/oven.

-There was a thick build-up of brown dust and grime under the vegetable sink on the white pipes. There was a thick build-up of black grime in the corners and under the legs of the sink. The legs were rusted.

-The top drawer where scoops were stored had a layer of debris and grime.

-The bottom area of the refrigerator had an accumulation of debris and grime. Nine wire racks inside the refrigerator were rusted.

-The shelf under the steam table on the service line had a layer of grease to touch.

-There was a thick layer of dust under the cold area of the service line.

-The end table of the service line had two shelves underneath that had a layer of dust and grime to touch.

-The cooler at the service line had 14 rusted wire racks and an accumulation of grime on the bottom of the unit toward the back.

-The floor under the dish machine on two walls had a thick layer of grime, debris and lime scale.


Interview at this time with CDM J, she said the staff had a choice of going home or staying to clean. She said most chose to go home. She said she needed to start ensuring they stayed and cleaned the kitchen.


Record review of the facility's Policy and Procedure for General Sanitation of Kitchen dated 1/2004 revealed the following:

"POLICY:
The staff shall maintain the sanitation of the kitchen through compliance with a written, comprehensive cleaning schedule.

PROCEDURE:
1. Cleaning and sanitation tasks for the kitchen will be recorded ...
5. A cleaning schedule will be posted and employees will initial and date tasks when completed..."


Record review of the Dietary Cleaning Schedule dated 4/24-30/16, 5/1-7/16, and 5/15-21 revealed the following areas had no initials to show they had been cleaned during these dates:

Convection oven, walk-in refrigerator floor, storeroom floor, cabinet/drawers or dish machine.

The following had one initial during the above three weeks:

Cafeteria refrigerator unit and the cafeteria steam table.

The following daily cleaning items were initialed as follows for 21 days:

-West reach-in refrig - 10 times
-Cook's reach-in refrig - 4 times
-Combi-steamer - 3 times
-Coffee maker - 10 times
-Work tables - 6 times

There was nothing on the list about cleaning the kitchen floors, or the service line.


Endoscopy Procedure - Hand Hygiene


Observation on 5/24/16 at 8:50 a.m. of an endoscopy procedure revealed RN (Registered Nurse) E and LPN (Licensed Practical Nurse) T put on gloves and removed gloves multiple times during the procedure without performing hand hygiene. There was a pump bottle of sanitizing hand gel on a table behind the surveyor. That was the only bottle of hand gel in the room besides the small bottle of hand gel in the closed cabinet on the left side toward the back of the room by CRNA (Certified Registered Nurse Anesthetist) O. Anesthesia was not observed performing hand hygiene during the procedure. Doctor L performed an EGD (EsophogealGastroDueodenoscopy) with gloves on. After the procedure he removed his gloves, picked up a chart, and left the room without performing hand hygiene. There was no hand gel from the room to the PACU (Post Anesthesia Care Unit).


Observation on 5/24/16 at 9:26 a.m. revealed RN S was in the procedure room recovering the patient after the EGD. She had on a pair of gloves. She touched the vital sign machine, used an ear temperature probe, and then touched pen and paper to write down the readings. She removed the blood pressure cuff, heart monitor leads and helped the patient to a wheelchair. Without removing her gloves and performing hand hygiene, she took the patient to a room on the Medical/Surgical unit.


Record review of the facility's Policy and Procedure for Standard Precautions dated 6/2007 and reviewed on 7/2015 revealed the following:

"1. Hand washing- Hand hygiene will be done:
a. When coming on duty and upon completion of a duty
b. When hands are visibly soiled ...
f. Before and after care of patient or before donning gloves and after removing gloves.
2. Hand sepsis using alcohol based hand rub:
a. Before and after direct contact with patient: when entering room and when leaving the room
b. before preparing medication
c. before donning gloves
d. after removing gloves
e. after contact of object in the immediate vicinity of patients."


Environment

Observation on 5/23/16 at 8:50 a.m. of the Emergency Department (ED) with Emergency Preparedness Director D and DON (Director of Nursing) C revealed the following:
-Thick layer of dust on the bottom shelf of an ED bed
-There was a layer of dust on the ceiling examination lamp
-The Emergency crash cart had a thick layer of dust on the top and on a side shelf where the suction canister was stored. There was a layer of dust on the rim around the bottom of the cart.
-Three laryngoscope (an instrument for examining the larynx, or for inserting a tube through it) blades and a Magill forceps (used to introduce a tube through the nose to establish an airway) were stored loose in a drawer.


Interview at this time with DON C, she acknowledged the layers of dust. When asked how staff would know if the laryngoscope blades and forceps had been processed, she said they probably needed to be in bags and labeled as having been processed.


Observation on 5/23/16 at 10:10 a.m. of the Lab with Lab Supervisor H revealed dust on the ledges of the refrigerator and on the back splash ledge of the counters.


Interview at this time with Lab Supervisor H, she said housekeeping cleaned the lab except for the machines.


Observation on 5/23/16 at 11:00 a.m. with DON C of the Emergency crash cart on the Medical/Surgical unit revealed a thick layer of dust on the top and on the side shelf where the suction canister was stored. There were three laryngoscope blades and a Magill forceps stored loose in a drawer without indication if they had been processed.


During this time, DON C said there would be laryngoscope blades and a magil forceps stored in the cart the same as what was found in the ED cart. She said she would take them to Sterile Processing to be reprocessed and packaged like she did for the ones in the ED cart.


Observation on 5/24/16 at 9:42 a.m. revealed an Emergency crash cart in the procedure room. There was a layer of dust on the side shelf with the suction canister.


Interview at this time with RN S, she said the cart was the one kept on the Medical/Surgical unit. When told about the dust on the side shelf, she said she would clean that now.


Record review of the facility's Policy and Procedure for General Housekeeping Guidelines revised on 9/16/14 revealed the following:
"Housekeeping staff schedules...All deep cleaning is done Monday thru Friday, maintaining your area each day you work. All high touch areas (sink, toilet seat, bedside table, toilet handle, bed rail, nurse call light, telephone, patient/visitor chair, ...are cleaned daily."


There was nothing in the policy about cleaning general hospital areas such as the ED, Lab and Medical/Surgical non-patient areas.


an instrument for examining the larynx, or for inserting a tube through it.

Based on record review and interview, the facility failed to ensure all entries in the Electronic Medical Record (EMR) were complete, authenticated by signature, dated and timed as evidenced by:

-5 of 5 patient EMRs reviewed (#'s 7, 8, 9, 10, and 16), who had endoscopy procedures, had Surgical Safety Checklists that were not complete, signed, dated or timed.


Findings include:


Record review of 5 patients' EMRs (Electronic Medical Records) who had endoscopy procedures with Surgical Safety Checklists revealed the following:


-Three patients (#'s 7, 8, and 10) had Checklists that were completely filled out but the form did not have the name of the person who entered the information, the date or time. The dates of the patient's procedures were as follows: Patient #7 - 12/22/15, Patient #8 - 1/19/16, and Patient #10 - 4/19/16.


-One patient's (#9) Checklist only had one box checked yes for known allergies. The rest of the information was blank and the form did not have the name of the person who entered the information, the date or time. The date of Patient #9's procedure was 3/1/16.


-One patient's (#16) Checklist only had one box checked that antibiotic therapy was not applicable to be given 60 minutes before the procedure. The form did not have the name of the person who entered the information, the date or time. The date of Patient #16's procedure was 5/24/16.


Interview on 5/25/16 at 11:40 a.m. with Medical Director AA, after printing out the Checklists for the five endoscopy patients, she said she agreed some of the checklists were not complete and all of them needed to be signed by the person who completed them, dated and timed. She said that was one good reason to have the form put in the computer as an electronic form and not one that had to be scanned in. It would automatically have the name of the person completing the form along with the date and time.


Record review of the facility's Policy and Procedure for Record Auditing dated 7/2005 and revised on 8/2014 revealed the following:

"H. Signing of Entries: A. All entries should be signed, dated and timed by the professional documenting in the record. "

Based on observation, record review, and interview the facility failed to ensure instruments used in the ED (Emergency Department) and Endoscopy procedure room were cleaned, disinfected, and sterilized in the Sterile Processing Department according to accepted standards of practice as evidenced by:

-Sterilized single wrapped instruments in the ED did not have internal chemical indicators.

-The facility had two methods of dating instruments, which made it difficult to know when an item was out of date.

-Hinged instruments were not processed in the open position.

-Basins were stored with dried water marks indicating they had not been dried properly and could be contaminated.

-Test strips used to check the concentration of the disinfecting solution for the endoscopes were being used and had expired on 8/2011 and had not been dated when opened.

-The Sterile Processing Suite was being cross-contaminated by not identifying each specific room for its function as a clean or dirty area.

-The Sterile Processing Suite was not being monitored for temperature and relative humidity.

-Biological Indicators (BI)were not being initialed and dated, were not being used with the same lot numbers for the test and control BIs, and were being used pasted their expiration dates.

-Rapid Readout cards were not filled out completely with documentation of the lot numbers for the test and control BIs.

-Autoclave tape was being used inside instrument packs instead of Chemical indicators. The autoclave tape had quit being made in 2007.

-Bowie-Dick tests were not being done daily when the autoclave was being used to ensure air was being removed from the autoclave during the sterilization cycle.


Findings include:


Observation on 5/23/16 at 8:50 a.m. of the Emergency Department (ED) with Emergency Preparedness Director D and DON (Director of Nursing) C in Exam room 1 revealed multiple packages of single wrapped hinged instruments not in the open position. Half of the packages did not have an internal chemical indicator. Some of the packages were dated with a future date, 6/20/17, 2/25/18, and 5/27/18. Other dates on the packages were 3/3/16, 2/22/16, 6/16/15 and 12/5/15. There was a metal basin in a sterilized paper package dated 4/26/16 with a brownish/yellow wet stain on the back.


Interview at this time with Emergency Preparedness Director D, she was asked if the dates were a processing date or expiration date. She said she did not know. She said RN (Registered Nurse) E did the sterile processing and would be at the facility tomorrow.


Observation on 5/24/16 at 9:20 a.m. with RN (Registered Nurse) E of the cleaning process for the endoscope used in an earlier procedure. The facility used Revital Resert High Level Disinfectant which is hydrogen peroxide to disinfect their endoscopes. RN E was asked to check the strength of the solution being used. She took a test strip out of the bottle and checked the solution.


Record review of the test strip bottle revealed it was not dated when it was opened. The expiration date on the bottle was 8/2011. It had been out of date for approximately 4 ½ years.


There was no manufacturer's insert for the test strips.


Interview at this time with RN E, she said she thought they were good for 90 days.


Further observation at this time revealed there were three separate rooms in the Sterile processing suite. The first room across from the procedure room contained the autoclave and where extra sterile supplies were kept. The second room had a sink and cabinets and the third room was where the scopes were cleaned and disinfected. The scope for the earlier procedure was carried in a closed container through the first and second rooms to be cleaned in the sink in the third room next to the basin with the high level disinfectant.


During an interview with RN E, at this time, she was asked why she did not use the sink in the other room to define a dirty and clean area. She said the way she was processing the scopes was how she was taught by the other person who worked in Sterile Processing. She said they had a pass thru door in the wall in the third room where dirty instruments from other areas were passed to be processed. She said she guessed they could come through the door to the second room and that could be the dirty side. She said she used the second room to wrap instruments. She said she guessed she could move that to the third room and make it the clean area.


Further interview on 5/24/16 at 9:50 a.m. with RN E, she was asked for her temperature and relative humidity (RH) log for the decontamination, sterile processing and storage rooms. She said she did not have one and did not know she needed to keep a record of the temperature and RH in those rooms.


Observation on 5/24/16 at 10:05 a.m. with RN E in the autoclave room revealed an incubator with three biological indicators inside. None of the indicators was dated.


Interview at this time with RN E, she said two of the indicators on one side were tested in the autoclave and the one on the other side was a control. She could not say which test indicator was used with the one control indicator. She was asked for the Rapid Readout card that comes from the test packet from the last time the autoclave was used. The card was dated 5/19/16. It was not filled out completely to show the indicator had been read. She could not say which test indicator was used on that date.


Further observation revealed the 2 test indicators' lot number was 2017-12DF. The control lot number was 2016-04DA. They should have been the same lot number. There was a bag with two more biological control indicators dated 2016-04DA. Those expired on 4/2016. There was a second bag of biological control indicators with lot #2017-08DF. There were no test packets with that lot number. The test packets on hand were dated 2017-12DF.


Interview at this time with RN E, she said she did not know the test indicators had to be used with the control indicators with the same lot number. She reached into the box with the current test packets and pulled out a bag of controls with the lot number 2017-12DF. She could not say why she had a bag full of control indicators without any test packets to go with them. She was asked for all the Rapid Readout cards she had in the room.


Record review of the Rapid Readout cards from 9/2/15 to 4/26/16 revealed there was a section on the card to write the lot number for the test indicator and the control indicator. None of the sections had been filled in.

Further interview at this time with RN E, she was informed of the instruments found in the ED (Emergency Department) that did not have a chemical indicator inside, that were not processed in the open position and the different dating system. She said the old process was to date with the expiration date. Now they only put the processing date since the sterility was good as long as the package was not compromised. She said she did not know the hinged instruments needed to be processed open. She said she used chemical indicators in the single packages and did not know why some did not have them. She said they must have been older packages or someone else did the processing. She said she used a piece of autoclave tape inside sterile instrument sets. She showed a roll of tape labeled 3M Comply 1201 Internal Steam Indicator. When she was informed autoclave tape only showed something had been processed, but could not indicate time, temperature, and pressure like a chemical indicator, she said it was used before and that was how she was taught two years ago.


Observation at this time revealed the facility had an AMSCO General Purpose autoclave with a circular graph readout that noted time and temperature. RN E was asked for the manufacturer's booklet on the autoclave and for the Bowie Dick tests. She said she did not know what a Bowie Dick test was and the autoclave was so old she did not know if they had the manufacturer's booklet.


Further observation at this time revealed three basins stored in a closed metal cabinet with other sterile supplies. All three basin paper packages had brownish/yellow water stains. When RN E was informed that the water stains meant the package was not sterile, that it had been put up wet and not dried properly in the autoclave, she said she may have put too many instruments in the autoclave at one time and that was why they had not dried properly.


RN E was asked for the facility's Policy and Procedures for Sterile Processing.


Phone interview on 5/24/16 at 11:00 a.m. with a representative from 3M revealed they quit making Comply 1201 autoclave tape in 2007. She verified that autoclave tape was only used to show something had been processed. It was not to be used inside instrument packs to show sterility.


On 5/25/16 at 10:45 a.m., DON C was asked for the facility's Policy and Procedure (P&P) for Sterile Processing. The facility did not have a P&P for Temperature and Humidity monitoring in Sterile Processing. The facility did not have the manufacturer's operation manual for the steam autoclave. DON C said they would get a copy from the autoclave manufacturer.


Record review of an online copy of the Operator Manual for Amsco Small and Medium Steam Sterilizers dated 4/15/09 revealed the following under Control Measures For Verifying Sterilization Process 3.4.2:
"Testing for Prevacuum Efficiency
Run a ...(Bowie Dick test) cycle daily before processing any loads. The first prevacuum cycle of each day should be used to test the adequacy of air removal from the chamber and load, so that steam can penetrate the load."


Record Review of the CDC (Centers for Disease Control and Prevention) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 revealed the following:
"Steam Sterilization Overview...The Bowie-Dick test is used to detect air leaks and inadequate air removal...A commercially available Bowie-Dick-type test sheet should be placed in the center of the pack...The test is used each day the vacuum-type steam sterilizer is used, before the first processed load. Air that is not removed from the chamber will interfere with steam contact."


"Physical Facilities. The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items .... The American Institute of Architects 959 recommends negative pressure and no fewer than six air exchanges per hour in the decontamination area (AAMI--Association for the Advancement of Medical Instrumentation recommends 10 air changes per hour) and 10 air changes per hour with positive pressure in the sterilizer equipment room. The packaging area is for inspecting, assembling, and packaging clean, but not sterile, material. The sterile storage area should be a limited access area with a controlled temperature (may be as high as 75 [degrees] F [Fahrenheit]) and relative humidity (30-60% in all works areas except sterile storage, where the relative humidity should not exceed 70%)..."


"Packaging. Once items are cleaned, dried, and inspected...should be arranged in instrument trays/baskets according to the guidelines provided by the AAMI and other professional organizations...These guidelines state that hinged instruments should be opened."


"Storage .... Although some hospitals continue to date every sterilized product and use the time-related shelf-life practice, many hospitals have switched to an event-related shelf-life practice. This later practice recognizes that the product should remain sterile until some event causes the item to become contaminated (e.g., tear in packaging, packaging becomes wet ...Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces..."


"Monitoring. The sterilization procedure should be monitored routinely by using a combination of mechanical, chemical, and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items ...
Chemical indicators are convenient, are inexpensive, and indicate that the item has been exposed to the sterilization process ... Chemical indicators should be used in conjunction with biological indicators ...Preferably, a chemical indicator also should be placed on the inside of each pack to verify sterilant penetration ...
Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process ...because they measure the sterilization process directly by using the most resistant microorganisms ... and not by merely testing the physical and chemical conditions necessary for sterilization."


Record review of an online question and answer article by OSAP (Organization for Safety, Asepsis and Prevention) no date, revealed the following:

"Weekly biological/live spore testing and chemical integrators, in each package, should be performed. OSAP would like to refer you to the Centers for Disease Control and Prevention's (CDC) Infection control Guidelines for a detailed explanation of both procedures ....
Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic use (at least weekly) of BIs [Biological Indicators) ...
Manufacturer's directions should determine the placement and location of BI in the sterilizer. A control BI, from the same lot as the test indicator and not processed through the sterilizer, should be incubated with the test BI; the control BI should yield positive results for bacterial growth."

Based on record review and interview, the facility failed to ensure 4 of 5 patients (#'s 12, 13, 14, and 15) admitted to the skilled swing bed unit were afforded the right to be informed of and given written information about advanced directives.


Findings include:


Patient #12

Record review of Patient #12's EMR (Electronic Medical Record) revealed she was admitted on 4/21/16 with paraplegia and urinary tract infection. She was discharged home on 4/25/16. There was no information on admission or during her stay that she had been asked if she had an advanced directive or of giving out any information on advanced directive.


Patient #13

Record review of Patient #13's EMR revealed he was admitted on 1/20/16 with a peptic ulcer and inhalation pneumonia. He was discharged back to Long Term Care at a nursing home on 1/26/16. There was no information on admission or during his stay that he had been asked if he had an advanced directive or of giving out any information on advanced directive.


Patient #14

Record review of Patient #14's EMR revealed she was admitted on 3/13/16 with pneumonia and COPD (Chronic Obstructive Pulmonary Disease). She was discharged home on 3/14/16. There was no information on admission or during her stay that she had been asked if she had an advanced directive or of giving out any information on advanced directive.


Patient #15

Record review of Patient #15's EMR revealed she was admitted on 4/30/16 with a splenectomy after a traumatic fall. She was discharged home on 5/2/16. There was no information on admission or during her stay that she had been asked if she had an advanced directive or of giving out any information on advanced directive.


Interview on 5/24/16 at 2:50 p.m. with DON C, she said there was a place in the EMR where the RN admitting the patient could ask the patient if they had an advanced directive. If they did not have one a pamphlet would be given to them. She did not know if there was a place in the EMR to note a pamphlet had been given to the patient except in the Nursing Progress Note. She looked through the four patients' EMR and could not find any documentation about advanced directive or if a pamphlet had been given to them.


Record review of the facility's Policy and Procedure for Patient's Rights to Refuse Treatment and formulate Advanced Directives dated 11/18/09 revealed the following:
"Statement of Purpose: It is the desire and intent of (hospital) to ensure that the patient's rights to...formulate advance directives are honored...A patient who has the capacity to make a health care decision and who withholds consent to treatment or makes an explicit refusal of treatment either directly or through an advance directive, may not be treated against his/her wishes. Advanced directives will be secured utilizing current hospital approved forms and procedures."


The Policy did not outline when, who, or how Advanced Directives were to be obtained.

Based on record review and interview, the facility failed to provide an ongoing program of activities designed to meet the needs and interests of 3 of 5 patients (#'s 12, 13, and 14) admitted to the skilled swing bed unit.


Findings include:


Patient #12

Record review of Patient #12's EMR (Electronic Medical Record) revealed she was admitted on 4/21/16 with paraplegia and urinary tract infection. She was discharged home on 4/25/16. There was no documentation of any activity assessment. There was no documentation that any activities were provided.


Patient #13

Record review of Patient #13's EMR revealed he was admitted on 1/20/16 with a peptic ulcer and inhalation pneumonia. He was discharged back to Long Term Care at a nursing home on 1/26/16. There was no documentation of any activity assessment. There was no documentation that any activities were provided.


Patient #14

Record review of Patient #14's EMR revealed she was admitted on 3/13/16 with pneumonia and COPD (Chronic Obstructive Pulmonary Disease). She was discharged home on 3/14/16. There was no documentation of any activity assessment. There was no documentation that any activities were provided.


Interview on 5/24/16 at 2:50 p.m. with DON C, she said the facility did not have an activity director. She said that since they were connected to a Long Term Care facility, the patients on the skilled unit would be taken over there for activities. When she was informed there were no activity assessments or any documentation that patients were receiving activities, she said she would have to address that. She said she thought she could put an activity assessment in the admission history document. She wondered if she could use one of the three activity persons in the Long Term Care area to help them with activities. When she was asked if Activities were addressed in the Plan of Care meeting she said she was sure it was not addressed.


Record review of the facility's Activities and Recreation Policy and Procedure dated 11/18/9 revealed the following:

"Statement of Purpose: It is the desire and intent of (hospital) to establish an activities program as part of the Swing Bed Program to provide physical and mental stimulation for patients confined to the Hospital.


Policy Interpretation and Implementation: The activities program is designed to provide diversional, therapeutic and recreational activities in a way to promotes (sic) physical, mental and psychosocial stimulation and enhances the patient's quality of life. The selection of activities for an individual patient will be based on the comprehensive assessment of each patient and the periodic reassessment during hospitalization...At a minimum, the activities in the hospital will:
-Be directed by a person who is qualified under applicable law or regulation to do so,
-Reflect the schedules, choices and rights of patients, ...

The Hospital shall maintain space and supplies necessary to support the activities offered by the Hospital..."

Based on record review and interview, the facility failed to ensure 2 of 3 swing bed patients (#'s 14 and 15) discharged home from the skilled unit were provided medically related social services to attain or maintain highest practicable physical well-being.


Findings include:


Patient #14

Record review of Patient #14's EMR (Electronic Medical Record) revealed she was admitted on 3/13/16 with pneumonia and COPD (Chronic Obstructive Pulmonary Disease). She was discharged home on 3/14/16. Record review of the Patient's Discharge Summary revealed her condition was exacerbated because she was not taking her medications. She needed a follow up with the County Health nurse to see if they could check on how she was taking her medications.


Further review of her EMR revealed that on admission history she was assessed as not needing a case manager or social services. There was no plan of care meeting to assess her needs prior to discharge.



Patient #15

Record review of Patient #15's EMR revealed she was admitted on 4/30/16 with a splenectomy after a traumatic fall. She was discharged home on 5/2/16. The only notation in the record was that the patient planned to be discharged home from the hospital. There was no assessment in the admission history of what services might be needed.


Record review of the Patient's Discharge Summary revealed an agent for the Southern Area on aging was contacted to call the patient's son and POA (Power of Attorney) to set up a care assessment at home.


Interview on 5/24/16 at 2:50 p.m. with DON C, she said they had weekly Plan of Care meetings with a multidisciplinary team on Fridays or when the patient and family could attend. The problem was that most patients were there less than 7 days and did not have a care meeting. When she was asked about Discharge Summaries for Patients #14 and #15 addressing community needs, she said the facility would not be able that way to know if the patient received those services. She said they had Social Service Person CC, but she was also the Director of the EMS (Emergency Medical Service).


Record review of the facility's Policy and Procedure for Discharge Plan dated 11/18/09 revealed the following:

"Statement of Purpose: It is the desire and intent of (hospital) to ensure that every patient in the Swing Bed Program has a timely and need driven discharge plan that is realistic and facilitates a sustainable transition to a lesser level of care, including home.

Policy Interpretation and Implementation: Discharge planning shall begin as part of the initial assessment process. The anticipated discharge plan will be part of every multidisciplinary planning meeting with discussion about the anticipated date of discharge and the patient needs at the time of discharge. The discharge Planning Nurse will be responsible for the arrangement of any outside services and supportive devices needed at the time of discharge. The goal will be for the discharge services to be in place so as to not delay discharge once the patient is ready."


Record review of the facility's Policy and Procedure for Multidisciplinary Plan of Care dated 11/8/09 revealed the following:
"The multidisciplinary plan of care is the responsibility of the multidisciplinary team. The initial care plan will be developed within 72 hours of admission and reflect all current needs of the patient and the team-based plan for addressing those need (sic).