HospitalInspections.org

Based on record review and interview, it was determined that the Governing Body failed to ensure there was an ongoing, effective Quality Assurance Program and that one practicing Physician (Dr. DD) and two practicing Allied Health Professionals (APRN (Advanced Practice Registered Nurse) GG and PA (Physician Assistant) KK) were credentialed.


Findings include:

Quality Assurance Program:

There was no documentation the Medical Staff or Governing Body Meeting minutes to show they had participated in the Quality Assurance Program for one year, from 1/22/15 to 1/28/16.

Record review of the Medical Staff Meeting minutes and the Governing Body meeting minutes revealed no documentation of any information from the Quality Assurance Program was presented.

Record review of the facility's Medical Staff Bylaws and Governing Body Bylaws revealed they were responsible for ensuring review, evaluation and oversight of the Quality Assurance Program to ensure the quality and appropriateness of care and services provided.

Interview on 2/18/16 at 3:50 p.m. with QA/Risk Manager E, she stated she had only had two Quality Assurance meetings and was in the process of identifying what needed to be in the Performance Improvement Plan. She said at this point she did not have a Performance Improvement Plan for each department with written plans, how date was to be collected, bench marks, etc.


Credentialing


Dr. DD had not been credentialed for over two years, APRN (Advanced Practice Registered Nurse) GG was 26 days overdue for re-appointment and PA (Physician Assistant) KK was three months 25 days overdue for re-appointment.

Interview on 2/19/16 at 3:15 p.m. with HIM (Health Information Manager) B, she said the facility had an outside agency who provided their credentialing services. She said prior HIM MM failed to get Dr. DD credentialed when the outside agency sent a letter dated 8/7/13 noting they had sent re-appointment packets on 6/7/13 and 7/15/13 with no response. This letter was their third and final notice. She said she got an email from the outside agency on 10/20/15 at 12:43 p.m. asking if APRN GG and PA KK were still employed by the facility. On 10/20/15 at 1:05 p.m. she replied they were still employed. She said the outside agency then dropped the ball and did not send re-application packets to either one. She said she probably needed to have a system where she was alerted wot when re-appointments were due.

Refer to tag 241 for further information.

Based on record review and interview, the Governing Body failed to ensure there was an ongoing, effective Quality Assurance Program and that one practicing Physician (Dr. DD) and two practicing Allied Health Professionals (APRN (Advanced Practice Registered Nurse) GG and PA (Physician Assistant) KK) were credentialed.


Findings include:


Quality Assurance


Record review of the Medical Staff Meeting minutes from 4/28/15 to 11/24/15 revealed no documentation that any information from the Quality Assurance Program was presented.


Record review of the Governing Body meeting minutes from 1/22/15 to 1/28/16 revealed no documentation that any information from the Quality Assurance Program was presented.


Interview on 2/18/16 at 3:50 p.m. with QA/Risk Manager E, she stated she had only had two Quality Assurance meetings and was in the process of identifying what needed to be in the Performance Improvement Plan. She said at this point she did not have a Performance Improvement Plan for each department with written plans, how date was to be collected, bench marks, etc.


Record review of the Medical Staff Bylaws revised April 2009 revealed one function was to be a member of the Quality/Risk Management Committee with duties of assuring the review and evaluation of the quality and appropriateness of patient care and clinical performance of all individuals with clinical privileges and of identifying areas of risk in the clinical aspects of patient care and safety.


Record review of the Governing Body Bylaws approved 8/28/97 revealed " Article III, Section 8. Quality of Care Responsibility. The Board of Trustees (Governing Body) ...will provide oversight to allow all patients with the same health problem to receive the same level of care through the facility ' s quality improvement effort as described in the Hospital Quality Improvement Plan. The (Governing Body) shall require the Medical Staff and hospital departments, including contracted services, to provide a periodic report in accordance with the ..Hospital Quality Improvement Plan regarding the quality and appropriateness of care and services provided. "



Credentialing

Record review of the facility's Physician and Allied Staff Credentials revealed the following:


Dr. DD - his last application was dated 9/19/11. His last Re-appointment letter with privileges was dated 2/2/12. He would have been due re-appointment by 2/2/14. Dr. DD was two years overdue for re-appointment.


APRN (Advanced Practice Registered Nurse) GG - his last Re-appointment letter with privileges was dated 1/23/14. He would have been due for re-appointment on 1/23/16. He was 26 days overdue for re-appointment. He did not have an application on file.


PA (Physician Assistant) KK - his last re-appointment letter with privileges was dated 10/24/13. He would have been due re-appointment on 10/24/15. He was three months and 25 days overdue for re-appointment. He did not have an application on file.


Interview on 2/19/16 at 3:15 p.m. with HIM (Health Information Manager) B, she said the facility had an outside agency who provided their credentialing services. She provided a letter dated 8/7/13 sent by the outside agency to the previous HIM MM noting they had sent the doctor a reappointment packet on 6/7/13 and on 7/15/13 with no response. This letter was their third and final notice. HIM B said apparently nothing was done. She said she would have to contact the outside agency about APRN GG and PA KK. At 3:45 p.m. HIM B said she called the agency about APRN GG and PA KK and found out they had dropped the ball. They missed sending them a re-appointment packet. She said she looked through her e-mails and found that on 10/20/15 at 12:43 p.m. the outside agency attached a list of staff and wanted to know if they were still employed by the facility. HIM B emailed back on 10/20/15 at 1:05 p.m. that they were still practicing at the facility. She said she probably needed to have a system where she was alerted to when re-appointments were due.


Interview on 2/19/16 at 4:15 p.m. with Interim CEO/PA A, she said Dr. DD, APRN GG and PA KK were all still working and being scheduled because they did not know they were not credentialed. She said Dr. DD was the Medical Director for the Emergency Department. She said HIM MM apparently did not do her job in ensuring medical staff and allied health professionals were re-credentialed.

Based on observation, record review and interview, the it was determined that the facility failed to ensure:


-Drugs and biologicals were stored in accordance with accepted professional principles and that multi-dose vials, solutions, and biologicals were dated when opened.


Refer to tag 276



-The facility had an active infection control program that was conducted in accordance with nationally recognized practices or guidelines.
-Multiple areas in the facility had thick layers of dust; Kitchen, Therapy Department, Laboratory and Emergency Department (ED).
-The Laboratory did not have a policy or procedure for disinfecting a rolling supply cart that went from room to room. A biohazard container was altered exposing staff and patients to contaminated blood drawing equipment.
-Staff did not disinfect a Glucometer and caddy with blood sugar testing supplies after patient use.
-Staff did not provide Wound care in a manner to prevent cross contamination.


Refer to tag 278

Based on observation, record review and interview, the facility failed to ensure drugs and biologicals were stored in accordance with accepted professional principles and that multi-dose vials, solutions, and biologicals were dated when opened in the Therapy Department, Pre-Op area, and in the Emergency Department.


Findings include:


Observation on 2/18/16 at 2:00 p.m. with Therapy Office Manager Q of a closet in the Therapy Department revealed a plastic container with the following medications:

-Dexamethasone (steroid that treats inflammation) multidose vial
-Bottle of Lidocaine HCL (hydrochloride) (this medication is used on the skin to stop itching and pain from certain skin conditions (e.g., scrapes, minor burns, eczema, insect bites) or as a local numbing agent before IV starts) topical solution
-Bottle of Barium sulfate (an agent used to assist doctors in identifying structures under X-ray) tablets
The multi-dose vial and bottle of topical solution were used but not dated.
There was an opened bottle of 250 cc irrigating sterile saline that was not dated.


Observation on 2/18/16 at 10:30 a.m. of the Pre-operative area with RN Y revealed the following eye drops used for eye surgery were in a container labeled for a patient were not dated when they were opened:

Phenylephrine HCL (medicine used to constrict the blood vessels and dilate the pupil for eye surgeries)
Polymycin B Sulfate (antibiotic for use in eyes)
Cyclopentolate HCL (medicine that dilates pupils before an eye exam)


Interview at this time with RN Y, she said they keep the medications for the patient when they know the patient will be back for a second surgery. She said the eye drops should have been dated when opened.


Observation on 2/18/16 at 1:10 p.m. in the Emergency Department (ED) with interim CEO (Chief Operating Officer) / PA (Physician Assistant) A revealed an opened bottle of blood glucose monitoring strips that were not dated. There was an area on the label for noting the date when the bottle was opened and the date when the strips should be discarded. In the ED refrigerator was a vial of Humulin R (short acting insulin) that was opened but not dated.


Record review of the facility's Policy and Procedure (P&P) for Open Vials revised on 3/11/14 revealed the following:


" MULTIPLE DOSE VIALS (MDV)
-MDVs shall be dated when opened. They will expire 28 days from the date opened with the following exceptions: Suspected or visible contamination occurs, Deterioration is suspected, Particulate matter is present ...



IRRIGATION FLUIDS
-Sterile water or saline for irrigation will receive a 24-hour expiration date ... "



Record review of an online article by Joint Commission Resources of " The Handbook on Storing & Securing Medications " forward by Robert J. Weber, R.Ph., M.S., F.A.S.H.P. revealed the following:

" Assuring the safe storage and security of medications is a fundamental pharmaceutical care process that serves as a foundation for any hospital pharmacy safety program. Examples of proper storage and security of medications include confirming that ...external products are stored separately from medications administered internally; ... "

Based on observation, record review and interview, the facility failed to ensure there was a system for identifying, reporting and investigating infection in the facility as evidenced by:

-The facility did not have an active infection control program that was conducted in accordance with nationally recognized practices or guidelines. Data was not collected for in-house or community infections, there was no active surveillance, no monitoring, analysis or evaluation of any kind in order to assess risk of infections.
-Multiple areas in the facility had thick layers of dust; Kitchen, Therapy Department, Laboratory and Emergency Department (ED).
-The Laboratory did not have a policy or procedure for disinfecting a rolling supply cart that went from room to room. A biohazard container was altered exposing staff and patients to contaminated blood drawing equipment.
-A Glucometer and a caddy with blood sugar testing supplies were not disinfected after patient use.
-Wound care was not provided in a manner to prevent cross contamination.


Findings include:


Record review of the facility's Policy and Procedure for Infection Prevention Program revised on 4/20/15 revealed the following:

" 1. GOALS ...
A. Surveillance of Infections with Implementation of Control Measures and Prevention of Infections
B. Outbreak Investigation..
II. Division of Responsibilities for Infection Prevention Activities

The Director of Infection Control is ultimately responsible for the infection prevention program ...

Infection Prevention Committee
The Infection prevention committee meets on a quarterly basis and provides input and direction for the infection prevention program ...Reports of infections are presented to the committee which recommends actions and control measures when needed ... "


The Reporting Mechanisms for Infection Prevention was Patient infection cases and Employee Infection cases to be monitored by the Infection Preventionist (IP) who completed the appropriate forms summarizing infections and reported to the infection prevention committee and Director of Nursing. Compliance with infection prevention practices was to be monitored and documented by yearly evaluation and by "observation of practices. The Infection Preventionist and appropriate department managers review the compliance monitoring and initiate appropriate actions. "


Record review of the facility's Infection Control Minutes for one year revealed only one meeting on 6/3/2015. Reports were given on staff flu vaccinations for 2014/2015, an Exposure Report of 1 exposure in 2014 and no exposures in 2015 and a summary of Kansas' CAUTI (indwelling catheters) and CLABSI (central line) use days. An environmental issue was the ice machine used on the nursing floor. The ICP RN JJ discussed employee health and that too many urinalysis were being collected without symptoms. There was a two-page table of 2015 Surveillance Plan that included in-house CAUTI and CLABSI infections, positive culture reports, staff flu vaccinations, handwashing, monitoring for patients with MDROs (Multiple Drug Resistant Organisms) and C-Diff (Clostridium Difficile) blood exposures and employee illnesses. There was a table labeled Infection Control Risk Assessment 2015. The next meetings were to be on 9/2/2015 and 12/2/2015.


During an interview on 2/18/16 at 1:10 p.m. in the Emergency Department, Interim CEO/PA A said the community was having an outbreak of Mononucleosis (Mono) and they had seen patients in the ED recently with Mono.


During an interview on 2/19/16 at 10:40 a.m. with Infection Control Preventionist (ICP) RN JJ, she verified there were no Infection Control meetings the first quarter of 2015 the third quarter, or the fourth quarter. She said she had trouble with the physicians coming to the meetings. The only data she collected was information on infections from the lab. She did not do anything with the information. She was asked if she knew anything about the outbreak of Mono in the community. She said she did not know about the outbreak. She said she watched hand washing/hand hygiene, but did not document her observations. She was asked if she had any data collection or analysis of any data and she said she did not. She said she knew she had a problem with having an effective Infection Control Program.


RN JJ was asked to provide the Infection Control Meeting minutes for 2014. At 1:02 p.m. RN JJ said she could not find any minutes for 2014. She said another person was doing them and told her she could present her information at the Safety Committee Meetings.


Record review of the facility's Safety Committee Meeting Minutes from 1/27/15 to 11/24/15 revealed the following:

3/31/15 - " (RN JJ) is planning an Infection Control Meeting in late April. Date to be announced. "
4/28/15 - RN JJ was in the process of revising the Infection Prevention manual. The Infection Prevention meeting was scheduled for 6/17/15.
8/25/15 - The flu season was coming up and vaccinations would start in October.
10/27/15 - Flu shots were being given in RN JJ's office. RN JJ was starting colon cancer screening for staff over 50 years old and her goal was 80% of eligible staff.
11/24/15 - RN JJ gave a report on who and how many staff had received or declined the vaccination. RN JJ was approved to purchase a Hygiena System Sure Plus Luminometer for Hospitals to check the effectiveness of the housekeeping staff cleaning. RN JJ "shared a report with the Safety Committee with the results of the testing. " There was no report of the findings in the minutes.


Environment

Kitchen:

Observations on 2/17/16 at 12:50 a.m. with Dietary Manager (DM) M of the facility kitchen revealed the following:
- Thick layer of dust on top of refrigerator #2 and on top edge of the doors
-The freezer had a thick layer of dust on the top ledge and the top of the doors
-The circular roll shelves in a corner cabinet had a thick layer of dust and grime
-A black circular rolling ring for the large garbage can in the kitchen had visible dirt and grime
-There was a layer of dust on the multiple electrical tract by the back prep table


Therapy Department:

Observations on 2/17/16 at 2:00 p.m. with Therapy Office Manager Q revealed the following:
-Thick layer of dust on a tan pad under the double wide therapy bed and on the white wood platform the bed was on.
-A single bed had a thick layer of dust on the frame underneath.
-There was a tear in the vinyl covering of a rolling stool.
-A second single bed had a thick layer of dust underneath.
-There was a thick layer of dust on top of a wall cabinet by the second single bed.


Interview at this time with Therapy Office Manager Q, she said housekeeping did the cleaning in the department and should be wiping the high and low areas. She said the therapy staff cleaned the areas used by patients between patient use.



Lab Department

Observations on 2/17/15 at 3:45 p.m. with Lab Director T revealed the following:
-Wire shelving in the blood bank room had a thick layer of dust on the bottom shelf and in the back of the other shelves.
-The top of the refrigerator had a thick layer of dust.
-The top of the blood bank refrigerator had a thick layer of dust.
-The top of the staff lockers in the lab had a thick layer of dust.
-There were multiple cardboard boxes stacked on the floors in the lab area.
-There was a thick layer of dust on top of 4 chemistry refrigerators and a freezer.


Interview at this time with Lab Manager T, she said housekeeping staff cleaned the lab.


Further observation at this time revealed a rolling phlebotomy cart with blood draw supplies sitting in the blood draw area. Lab Manager T said it was taken from room to room to draw blood for labs ordered by the physicians. When she was asked if there was any policy or procedure for cleaning the cart from room to room, she said she did not know of any.


A red biohazard hazard box was on the floor next to the blood draw chair. Half of the white top was peeled back, exposing all the used blood draw needles and tubing.
Interview at this time with Lab Manager T, she said they altered the top because they could not fit the blood draw equipment into the small round hole provided.


Record review of the facility's P&P for Needles and Sharps Policy revised 2/11/15 revealed the following:

" POLICY: ...
1. Handling of Sharps and Needles ...
D. Place all sharps and needles immediately after use in a leak-proof container that is appropriately labeled ....
F. Do not place hands into containers whose contents include contaminated sharps, instruments, or waste ...
I. Sharps which are too large to fit into the containers may be placed in contaminated waste containers (biohazard boxes). "



Emergency Department (ED)


Observation on 2/18/16 at 1:10 p.m. revealed a thick layer of dust in the following places:
-in the area under the stretcher beds in rooms 1 and 2
-in the cast room on the overhead surgical light and under the stretcher bed
-In the trauma room on the overhead surgical light


Record review of the facility's P&Ps (Policy and Procedures) for Environmental Services all revised on 11/15/12 revealed ones for cleaning beds, patient rooms, examination and treatment rooms, cleaning the laboratory, and ED. The P&Ps for cleaning patient rooms noted to dust above shoulder height. The other P&Ps did not address cleaning high and low areas.



Glucometer


Observation on 2/17/16 at 11:40 a.m. with interim CEO (Chief Operating Officer) / PA (Physician Assistant) A revealed CNA (Certified Nurse Aide) J was preparing to check Patient #4's blood sugar level before lunch. CNA J brought a caddy into the room with all the needed supplies and put the caddy on the over bed tray table without sanitizing the table. She took out the glucometer and an alcohol wipe. After wiping a finger with the alcohol wipe, CNA #J opened the testing strip bottle and reached in with her contaminated gloved fingers and took out a strip. After getting a reading, she put the glucometer and test strip bottle back in the caddy. She took the caddy out of the room without sanitizing it and put the glucometer from the caddy into the charging unit, without disinfecting it.


During an interview at this time with CEO/PA A at this time, she was informed about what was seen during the observation. She was asked if the facility had considered the use of a supply caddy as a problem with cross contamination since it was not disinfected after leaving the room and the bottle of strips was contaminated. She said she understood the point taken.


Record review of the facility's P&P for Fingerstick Blood Glucose Monitoring revised on 4/11/13 and 2/18/16 revealed the following:
" PROCEDURE: ...
Clean meter with a disinfectant wipe and allow to dry then return meter to docking station .... "



Wound Care


Observation on 2/17/16 at 1:50 p.m. with QA (Quality Assurance)/Risk Manager E revealed RN H was preparing to do a dressing change for Patient #4's blistered heel. RN H removed the old dressing and, with the same gloves on, cleaned the wound and put on the new dressing. With the same contaminated gloves on, she reached into her pocket, took out a black marking pen and dated the dressing. She put the marker back in her pocket without disinfecting the marker.


Interview on 2/18/16 at 9:00 a.m. with RN H, she said she knew she was supposed to take her gloves off and wash her hands when going from the dirty part to the clean part of wound care. She said she thought about it one hour later that she forgot to change her gloves and wash her hands.


Record review of the facility's P&P for Wound Care: Orders Dressing Changes reviewed on 2/10/16 revealed the following:

" PROCEDURE: ...
-Remove soiled dressing and place in a bag at the bedside ...
-Remove gloves and wash hands.
-Put on clean or sterile gloves depending upon status of wound.
-Clean the wound according to the order .... "

Based on observation, interview and record review, the facility failed to ensure surgical services were performed in a safe manner as evidenced by:


-Humidity levels were not kept at the accepted standard of 30-60%
-Air exchanges were not monitored
-The facility had no Policy or Procedure for humidity levels or acceptable air exchanges for the OR (Operating Room) suite.


Findings include:


Interview on 2/17/16 at 8:30 a.m. with QA (Quality Assessment)/Risk Manager E, she said the facility only did surgical procedures once a month. They did endoscopies (a procedure that lets your doctor look inside your body. It uses an instrument called an endoscope that has a tiny camera attached to a long, thin tube. The doctor moves it through a body passageway or opening to see inside an organ) on the third Tuesday and cataracts on the first Thursday. She said they did endoscopies yesterday.


During a tour of the facility's surgery suite on 2/18/16 at 11:34 a.m. with Sterile Processing technician (tech) X and RN Y revealed the humidity was at 28% in Operating Room (OR) 2. They were asked if the Governing Body had approved the humidity to be below 30% and they said they did not know.


Interview at this time with Sterile Processing Tech X, she said the humidity had been low on multiple occasions. She showed the log sheets for February 2016 where she had been documenting the humidity and temperature. She said she had been in contact with Maintenance Director LL and she thought the problem was a broken belt or something. She was not sure why it was not fixed. She said there were two humidifiers she could plug in to get the humidity up. She said she did not document when the humidifiers were used.


Record review of the temperature/humidity logs for February 2016 revealed humidity was documented from 2/1 to 2/18/16 as the following:
-General work area, humidity was at 23%.
-Decontamination room, humidity was at 27%.
-Sterile storage area, humidity was at 24%.
There was no documentation for 4 days from 2/9 to 2/12/16 in any of the areas.


Sterile Processing Tech X and RN Y were asked about air exchanges in the OR. They said they did not know anything about air exchanges. They thought Maintenance Director LL took care of that. RN Y was asked for the facility ' s Policy and Procedure (P&P) for monitoring the temperature, humidity and air exchanges in the operating suite.


The facility did not have a P&P for monitoring the temperature, humidity or air exchanges in the operating suite.


Interview on 2/18/16 at 3:15 p.m. with Maintenance Director LL, he said the humidity in the OR was a problem. He said Sterile Processing Tech. X had told him a while back that the humidity was too low, but she had been out the past 2 weeks and he had not heard from her since. He said the surgery department had two humidifiers. He said they had to use them in the summer to keep the humidity up. He said he did not know why they were not using the humidifiers now to keep the humidity up. He did not know if they had a policy or procedure for when to use the humidifiers.


Maintenance Director LL was asked about air exchanges in the OR. He said he did not know anything about monitoring air exchanges. He said he only knew to change the air filters. He said he had worked at the facility for 8 years. He took over the director position when the previous director passed away about 6 months ago.
Record review of the AORN (Association of perioperative Registered Nurses) Journal dated June 2009 revealed the following:


A relative humidity level that is too low can result in excessive bacteria-carrying dust in the surgical environment or static electricity ...Log should be maintained on humidity, temperature and air exchanges. " The recommended settings were in a table and were as follows for the American Institute of Architects (AIA):
Humidity in all areas: 30 to 60%
Air Exchanges per hour: OR - 15
Decontamination - 10
Prep and packaging - 4


During a tour of the facility's Sterile Processing room at 11:40 a.m. with Sterile Processing Tech X and RN Y revealed there were no Bowie Dick test sheets with the autoclave daily readouts.


Interview at this time with Sterile Processing Tech X, she said she did not keep the readouts. She said she threw them away. She said she was not taught to keep them.


Record review of the facility's P&P for Bowie Dick Test reviewed on 10/25/15 revealed the following:

" POLICY:
The proper functioning of the prevacuum sterilizer shall be tested daily in a separate, special cycle by the use of a Bowie Dick test. The test checks the proper functioning of the vacuum pump by indicating if all air is being removed from the chamber and items before exposure phase of cycle. Satisfactory test results will show a dark brown uniform coloring ....

KEY POINT: ...
Documentation will be kept with that day's sterilizer records for years. (The blank was not filled in). "


Sterile Processing Tech X and RN Y were asked how they processed the eye surgery instruments. Tech X said the surgeon brought in the instruments and trays with a rubber liner that had projections that kept the instruments in place. She said she would put on sterile gloves, get two sterile towels and take the instruments out of the autoclave and take them into the operating rooms. When RN Y was asked if that was the standard of practice, she said she knew the type of container she needed to order to meet standard of practice for sterilizing immediate use items.


Further observations of the sterile supply storage room revealed single packaged hinged instruments were not processed in the open position. Sterile Processing Tech X and RN Y said they did not know they needed to be processed open and asked how that could be done. RN Y was asked for the facility's Policy and Procedure for processing immediate use instruments and processing single wrapped hinged instruments.


Record review of the facility's Policy and Procedure (P&P) for Sterilization of Eye Instruments dated 11/17/15 revealed the following:

" POLICY ...No instruments will be rushed through using just in time sterilization.
PROCEDURE:
-Instruments will be thoroughly cleaned with distilled water and replaced in trays prior to sterilizing.
-Each tray will be placed in the sterilizer with a Quick Read 270 (degree), Temperature Strip 270 (degrees) and a Steam/Biological indicator .....
-At the end of each case, the scrub will hand off all instruments to central supply personnel for a second cleaning with distilled water prior to sterilizing for the next case ... "


There was nothing in the P&P about how the equipment was moved from the sterilizer to the sterile field in the operating room.


Record review of the joint P&P for Immediate-Use Steam Sterilization by AAMI (Association for the Advancement of Medical Instrumentation), AORN (Association of periOperative Room Nurses) and APIC (Association for Professional in Infection Control & Epidemiology) revealed the following:


-Cleaning, decontamination, and rinsing are critical and users must follow and complete all required processing steps regardless of the sterilization exposure parameters being used.
-Aseptic transfer from the sterilizer to the point of use is critical to protect items from contamination ...
-The device manufacturer's written instructions for reprocessing any reusable device must be followed. The cycle parameters required to achieve sterilization are determined by the design of an instrument, the characteristics of the load, the sterilizer capabilities, and the packaging (if used) ....
-Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing. "


Observation on 2/18/16 at 11:40 a.m. with Sterile Processing Tech X and RN Y of the sterile storage area revealed single packaged hinged instruments such as hemostats, ringed forceps, clamps and scissors were not in an open position.


During an interview at this time with both staff, they said they did not know hinged instruments had to be processed opened. They asked how that could be done.


The facility did not have a policy or procedure for processing single hinged instruments in an open position.

Based on record review and interview, it was determined that the facility failed to ensure there was an effective quality assurance (QA) program to evaluate the quality and effectiveness of services provided by the facility.


-There was no on-going monitoring or data collection.
-There was no problem prevention, identification and data analysis to initiate corrective action or to measure improved quality on a continuous basis.
-There were no reports to the Medical Staff Committee or Governing Body.


Refer to tag 336

Based on record review and interview, the facility failed to have an effective quality assurance (QA) program to evaluate the quality and effectiveness of services provided by the facility as evidenced by:


-There was no ongoing monitoring or data collection
-There was no problem prevention, identification and data analysis to initiate corrective action or to measure improved quality on a continuous basis.
-There were no reports to the Medical Staff Committee or Governing Body


Findings include:


Record review of the facility's Policy and Procedure for Quality Improvement Program revised on 1/27/16 revealed the following:

" PROGRAM OBJECTIVE:

To provide a mechanism that objectively and systematically review and evaluate the quality and appropriateness of patient care and/or services and pursues opportunities for improvement through an ongoing process of reviewing, identifying opportunities for performance improvement, and implementing an improvement plan with ongoing evaluation."


The policy was for the Director of each department to be accountable for implementing, coordinating, and evaluating "all ongoing quality assessment programs. Each department was to identify important aspects of patient care, identify performance measures used to monitor the quality and appropriateness of care, "collaborate with other departments and disciplines in design, measurement, assessment and improvement activities" and to evaluate the results.


The Department Director was to submit quarterly written reports to the QA Director of evidence assessments and evaluations were ongoing. The QA Director was to submit these findings at the Quality Improvement Committee. Interdisciplinary process improvement teams were to be organized as needed to address specific problems. The Quality Committee will provide oversight for QI activities and will meet at least quarterly.


Guidelines were for ongoing monitoring and data collection through patient chart audits, quality measure data from Inpatient and Outpatient Quality Reporting Programs, patient surveys, process reviews, staff observation, and input from department director. Implementation of corrective action was through staff education, patient and family involvement, and evaluation of system processes.


Record review of the facility's Quality Committee Meeting Minutes for July 14, 2015 revealed under New Business the re-instatement of the Quality Council. A Quality Action Plan was distributed to the council member and the plan was approved with exception of adding the ER (Emergency Room) department. Other discussion was to start inpatient surveys again soon. Review of the QA Plan 2015 revealed the following actions: Patient Satisfaction, Quality Improvement Standard with the goal of maintaining Performance Improvement projects throughout each department, Creating a Culture of Quality and Safety, Quality Council, Safety Committee, Infection Prevention committee, Utilization Review Committee and Improvement of discharge process.


Record review of the October 22, 2015 meeting revealed In-patient satisfaction surveys were to be started November 1, 2015. There was no information about how this survey was to be presented and how data was to be gathered, analyzed or assessed. There was a note Infection Control Preventionist RN JJ gave a report with a copy of dashboard results, but the results were not with the QA Minutes. There was a statement of a data spreadsheet provided from Utilization Review, but it was not with the QA minutes.


Interview on 2/18/16 at 3:50 p.m. with QA/Risk Manager E, she said she took over Risk Management in April 2015 and then took over QA. She said she had been working more on the Risk Management side and just recently started working on QA. She said she had only had two QA meetings because they meet quarterly. She said she was learning what was required for a QA program and started by meeting with three Department Heads each meeting. She said she would continue to have each department head at the meetings and from there they would identify what would be the facility's Performance Improvement Plan. She said at this point she did not have a Performance Improvement Plan for each department with written plans, how data was to be collected, bench marks, etc.


Record review of the facility's Medical Staff Meetings from April 2015 to November 2015 revealed no information presented from Infection Control Committee or QA committee.


Record review of the facility's Governing Body Minutes from January 2015 to January 2016 revealed no information presented from Infection Control Committee or QA committee.

Based on record review and interview, the facility failed to ensure 4 of 5 patients (#1, #2, #5 and #7) in swing beds were provided on-going activities to meet their interests, and their physical, mental, and psychosocial well-being.


Findings include:


Record review of Patient #1's clinical record revealed he was admitted on 2/6/16. The patient had an activity assessment and there was documentation on 2/10/16 that he received an activity.


Record review of Patient #2's clinical record revealed he was admitted on 2/14/16. The patient had an Interdisciplinary (IDT) Care Plan meeting on 2/16/16 with Activities showing a problem of limited activity with an intervention to visit 2 time a week with appropriate activities. The patient had an activity assessment on 2/17/16. There was not documentation to show the patient received any activities.


Record review of Patient #5's clinical record revealed she was admitted on 2/14/16. The patient had an IDT Care Plan meeting on 2/16/16 with nothing documented in the activities section. The Patient's Activities assessment was dated 2/17/16 and noted to still be in progress. There was nothing documented to show the patient received any activities.


Record review of Patient #7's clinical record revealed she was admitted on 2/14/16. The patient had an IDT Care Plan meeting on 2/16/16 with nothing documented in the activities section. The Patient's Activities assessment was dated 2/17/16 and noted to still be in progress. There was nothing documented to show the patient received any activities.


Interview on 2/19/16 at 8:35 a.m. with Pharmacy Tech/Social Service Tech/and Activity Director V V revealed she did the Activity Assessments, the Social Service Assessments and was the Pharmacy Technician. She went into the Electronic Medical Records to show where she documented activities. She was only able to show documentation in Patient #1's record. She said there must be a problem with her documentation being dropped because she knew she documented more activities than just one.