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Tag No.: C0195
Based on record review and interviews with staff, the hospital failed to have an agreement with an outside source for quality assurance to ensure the quality and medical necessity of medical care at the hospital as required.
Findings:
1. The hospital provides/offers emergency services, inpatient internal medicine and endoscopic surgical services.
2. Medical record review, for the purpose of determining physicians' delivery of quality care and medical necessity (peer review) was not being conducted.
3. On the morning of 09/25/2015 Staff O stated the hospital did not have an outside peer review for medical necessity.
Tag No.: C0220
Based on surveyors' observations and interviews with staff, the hospital failed to ensure the hospital was constructed, arranged and maintained in a condition to ensure the adequate care and safety of the patients and staff.
Findings:
A tour of the hospital was conducted on 09/23/2015 between 10:00 a.m. and 12:05 p.m.
Pharmacy Department:
~supplies stored in corrugated boxes on the floor
~clutter observed throughout the drug room
~expired medications stored in unlabeled containers
~commercial floor fan
~temperature in the drug room was warm. During the tour, hospital staff stated the hospital had problems with the air-conditioning system.
Surgery Department :
Supplies and equipment should be removed from external shipping containers and web-edged or corrugated cardboard boxes in the unrestricted areas before transfer into the surgical suite. External shipping containers and web-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry decontaminates into the surgical suite.
The floor, walls, ceiling, and work surfaces should be constructed of non-porous materials that will withstand frequent cleaning and wet conditions.
Separating "clean" and "dirty" areas limits environmental contamination and the potential for bioburden on devices to be sterilized.
~carpeted flooring in the surgical directors office and equipment storage room
~housekeeping cart stored in the sterile corridor
~no separation of "clean " and "dirty" in the central sterile area
~un-packaged surgical instruments stored on a cork board
~acoustic ceiling tile in the central sterile, sterile storage, soiled utility (used to clean endoscopes) and sterile supply rooms
~air-vent in the sterile supply room contained black dust
~supplies stored in corrugated boxes
~solid wood shelving in the equipment room
~clean linen stored on a cart in front of the operating room (OR)
~sterile supplies stored on a metal wire rack in the OR
~exposed wood beneath the wall cabinet in the OR
~missing ceramic tile beneath the cabinet in the OR
~air-vent in the OR with dust and water stains
~loose leaf paper on the walls in the OR
~cracked ceiling tile above the cabinet in the OR
~trash receptacle greater than 32 gallons by the scrub sink for the procedure room
~unfinished wood shelving in the housekeeping room
~cork board hanging on the wall in the procedure room
~no handwashing sink in the soiled utility room
Tag No.: C0278
Based on review of hospital documents and staff interviews, the hospital failed to analyze infection preventionist (IP) surveillance data and concerns.
Findings:
1. On 09/25/2015 between 10:15 a.m. and 11:00 a.m., the Infection Preventionist (IP) was interviewed.
2. A hospital form titled, "Marshall County Medical Center Evaluation of 2014-2015 Infection Control Plan" was reviewed by the surveyors.
~The analysis/summary on the form documented goal was or was not met.
~There was no analysis as to the reason/rationale as to why the goal was/was not met. This was confirmed by the IP.
3. Hospital satff stated sterilization of the surgical instruments occurred at an off-site location. The IP was asked if she had conducted an inspection of the off-site location. She stated, "No."
Tag No.: C0291
Based on review of hospital documents and staff interview, the hospital failed to maintain a list of services provided under arrangement or agreement.
Findings:
On the morning of 09/23/2015, surveyors requested a list of all contracted services including contracted individuals and list of services provided.
An undated list was provided to the surveyors to review. The list was not complete. The list did not contain the physicist, dosimeter reading and the test and balance contract providers.
On 09/25/2015 at 11:25 a.m., Staff O stated the contracted services list provided to the surveyors was current.
The surveyors reviewed the Quality Assessment and Performance Improvement (QAPI) meeting minutes from September 2014 to present. The QAPI meeting minutes did not contain evidence the contracted services were evaluated and analyzed.
Tag No.: C0294
Based on review of hospital documents, personnel files and medical records, and interviews with staff, the hospital failed to ensure nursing staff were trained and evaluated on competency to perform the essential functions of their jobs for five (Staff L, R, W, EE and MM) of nine staff whose personnel files were reviewed.
Findings:
1. On 09/23/2015 at 12:20 p.m., Staff L told the surveyors she was the Interim Operating Room Director. The hospital did not have documentation of skills competencies required for this position for Staff L. The hospital did not have documentation Staff L had competency skills to supervise endoscope processing. Staff L told the surveyors that only Staff R knew how to process endoscopes.
2. The hospital did not have documentation of skill competencies to demonstrate Staff R had knowledge to process endoscopes according to manufacture guidelines and current standards of pactice. See Tag C-320.
3. On 09/23/2015 at 11:15 a.m., emergency department (ED) Staff KK identified Staff W as the Nurse Manager. The hospital did not have documentation of skills competencies required for this position for Staff W. Staff W's personnel file did not contain a job description for ED Nurse Manager, or orientation and competencies for the ED. On 09/23/2015 at 2:45 p.m., Staff JJ confirmed Staff W's personnel file did not contain the information.
~ On 09/24/2015 at 9:00 a.m., Staff W stated she had just recently accepted the position and stated she had not previously been orientated to the ED.
4. On 09/23/2015, at 12:45, Staff L and R told the surveyors that Staff EE worked in the surgery unit. On 09/25/2015 at 10:40 a.m., the surveyors observed Staff EE working in surgery area with post-operative Patient #28.
~ The personnel file for Staff EE did not contain evidence Staff EE was orientated and trained to work in the surgery unit.
5. On the morning of 09/23/2015, the surveyors observed Staff MM providing nursing care to patients. Staff JJ told the surveyors that Staff MM was an agency nursing aide. She stated the only competency the hospital had was the documents supplied from the agency. The hospital did not provide evidence the hospital had orientated and verified the nursing competency for Staff MM.
Tag No.: C0307
Based on review of medical records and policies and procedures, and interviews with hospital staff, the hospital failed to ensure that all entries in the medical records were authenticated with:
a. Signature of the individual who responsible for the entry; and
b. Title of each individual.
This occurred in 3 (# 9, 15 and 17) of 7 medical records reviewed.
Findings:
Electronic medical records EMR were reviewed on the afternoon of 09/25/2015.
Review of the EMR documented generic NR1 and NR2 designations were used to document in the EMR by agency staff, such as the licensed practical nurse (LPN) and the certified nurse aide (CNA). This was confirmed by hospital staff during medical record review.
Electronic medical records (EMR) # 9, 15 and 17 documented, "NR1 or NR2" on the medication administration form.
The EMR had documented entries with no identified authors or correct title of the author.
Tag No.: C0320
Based on review of hospital documents, surveyors' observations and interviews with hospital staff, the critical access hospital (CAH) failed to provide surgical services in a safe manner that conformed to nation standards of practice. The hospital failed to:
a. define and keep current the scope of services;
b. provide supervision of surgical services by an experienced registered nurse;
c. ensure operating room (OR) staff were trained in acceptable standards of practice with endoscope reprocessing.
d. ensure patient care equipment was inspected, maintained, and tested as required/indicated per manufacturer ' s guidelines.
e. develop and implement policies and procedures based on recognized national standards and manufacture guidelines for endoscopes;
f. conform to standards of practice for the high level disinfection of endoscopes;
g. make available a current roster of each practitioner's surgical privileges and ensure they were located in the surgery department and where scheduling of cases were performed. See Tag C-321; and
h. surgical care was provided in a clean and safe environment. See also Tags C-220, and Life Safety Code survey K Tags.
Findings:
1. On 09/23, 24, and 25/2015, the surveyors conducted a survey of the hospital's surgical services. The administrative staff were asked to provide policies and procedures and other documents related to the provision of surgical services.
~ There was no documentation of a written scope of surgical services currently provided by the hospital.
2. On 09/23/2015 at 12:20 p.m., Staff L told the surveyors she was responsible for supervision of surgical services. The hospital did not have documentation of skills competencies required for this position for Staff L. The hospital did not have documentation Staff L had competency skills to supervise endoscope processing.
~ On 09/23/2015 at when the surveyors asked Staff L about endoscope processing, she stated only Staff R knew how to reprocess endoscopes scopes.
3. On 09/25/2015 at 10:15 a.m. surveyors observed different kinds of endoscopes. Surveyors observed Staff R reprocessing an endoscope. Staff R submerged the endoscope in the water before performing leak test.
4. On 9/25/2015 at 10:15 a.m. Staff R told surveyors that she always submerged the endoscope in water before performing leak testing. Staff R told surveyors that she had limited knowledge on the cleaning processes of Endoscopic Retrograde Cholangiopancreatography (ERCP) endoscopes. Staff R told surveyors that she is the only staff member that currently processed endoscopes in the CAH.
5. Surveyors asked Staff R what she would do if there was a leak in the endoscope. Staff R told surveyors that she would take it out of the water without disinfecting the scope and give the endoscope to the manager to ship back to the manufacturer.
6. On 09/25/2015 at 11:00 a.m. Staff R told surveyors that endoscopes were rarely sent for inspection and or repair.
7. On 09/25/2015 at 2:00 p.m. surveyors requested and reviewed the endoscope maintenance log. The last documented endoscope preventative maintenance was 2013.
8. On 09/25/2015 at 7:00 p.m. surveyors reviewed manufacturer's guidelines for Olympus endoscopes (which were the endoscopes used at the CAH). The manufacturer's guidelines documented regular preventative maintenance was to be done yearly.
9. On 09/23/2015 at 9:00 a.m. surveyors requested the CAH endoscope processing policies and procedures. On 09/25/2015 at 2:00 p.m. Staff B provided a policy titled, "Reprocessing of Flexible Endoscopes" that documented "...connect leak tester ...turn on leak tester and pressurize scope. After scope is pressurized, submerge ..." There was no documented evidence that the policy and procedure for endoscope reprocessing was based on recognized national standards of practice.
10. On 09/25/2015 at 7:00 p.m. surveyors reviewed manufacturer's guidelines for Olympus endoscopes (which were the endoscopes used at the CAH). The manufacturer's guidelines documented, "...Attach the leak test cable to the air source. Check that sufficient air emits from the leak tester ...verify that the air emitted contains no moisture. Attach the leak test cable ...Immerse the entire scope into a basin of water ..."
11. On 09/25/2015 at 7:00 p.m. surveyors reviewed the manufacturer's guidelines documented, "...endoscopes must be cleaned AND high-level disinfected or sterilized prior to shipment ..."
12. On 09/24/2015 at 2:00 p.m. surveyors reviewed 4 (L, R, CC, and EE) OR personnel files. One (Staff R) of 4 OR personnel files contained minimal endoscope processing training and education.
13. The hospital does not have policies and procedures/written process to ensure surgical specimens are managed from procurement to documentation of results being placed on the patient's medical record.
~ On 09/23/2015 at 11:00 a.m., laboratory Staff S told the surveyor that surgical staff delivered surgical specimens to the sent to the pathologist and laboratory staff was only responsible for receipt of the specimen and sending the specimen to the pathologist, surgery staff received the results of the pathologist review. She stated the laboratory staff kept a log of this process.
~ On 09/23/2015 at 12:30 p.m., Staff S stated she received reports from the pathologist and faxed the reports to the physician, but no log was kept to ensure all specimens sent for pathologist review was received and put in the patient's medical record.
14. The endoscope processing room did not have a hand washing sink.
~ On 09/25/2015 at 1013, the surveyor observed Staff L preclean an endoscope. Upon lifting her hands out of the enzyme water, there was a large hole in Staff L's left index finger of her glove. Staff L removed her glove and put on a new glove. She did not perform hand hygiene until she left the decontamination room at the end of the cleaning.
15. The area designated as the central sterile did not have separate dirty and clean processing areas with the appropriate air flow.
16. Staff R told the surveyors that since the last of August 2015, all instruments needing sterilization were sent to another acute care hospital to be processed. Surgery staff and the infection control practitioner had not visited the site to ensure the instruments were process according to recognized standards of practice.
Tag No.: C0321
Based on review of hospital documents and interviews with hospital staff, the hospital failed to ensure a copy of the physicians' current privileges were kept/available in the surgical suite/area.
Findings:
1. The hospital's operating room log documented :
a. Physician V performed procedures of laparoscopy cholecystectomies, colonoscopies and esophageal duodenoscopies; and
b. Physician U performed procedures of colonoscopies and esophagead duodenoscopies.
2. During the tour of the surgical unit on the afternoon of 09/23/2015, the operating room (OR) supervisor told the surveyor that a list of surgical privileges for the physicians were not maintained in the OR area.
Tag No.: C0337
Based on record review and interviews with hospital staff, the hospital does not ensure that the quality assessment and performance improvement (QAPI) program evaluates the hospital's patient care services to ensure patient health and safety.
Findings:
Surveyors requested and reviewed the QAPI meeting minutes from September 2014 to present.
On the morning of 09/25/2015, the hospital's chief quality officer was interviewed.
Review of a document titled, " Organization-wide Quality Assessment and Performance Improvement Program 2015", revised 12/2014, documented, "...The monitoring and analysis process will include at least the following activities:...significant adverse drug reactions,..Pharmacy and Therapeutics Evaluation, medication Variances, significant ADR's and significant medication errors, Organ Procurement...Quality control monitoring in :...Nutrition/Food services...Pharmacy..."
The chief quality officer stated pharmaceutical, organ procurment and dietary services were not evaluated through QAPI.
Tag No.: C0342
Based on hospital documents and record review and interviews with hospital staff, the hospital did not ensure appropriate remedial action is taken to address deficiencies identified through the quality assessment and performance improvement (QAPI) program.
Findings:
Surveyors requested and reviewed the QAPI meeting minutes from September 2014 to present.
On the morning of 09/25/2015, the hospital's chief quality officer was interviewed.
Review of a document titled, " Organization-wide Quality Assessment and Performance Improvement Program 2015", revised 12/2014, documented, "...The data will be organized so those situations in which an analysis of the quality or appropriateness of care is indicated are easily identified..."
There was no analysis of the data collected and no evidence of implementation of corrective action taken. This was confirmed by the chief quality officer.
Tag No.: C0384
Based on a review of personnel files and interviews with hospital staff, the facility failed to ensure that the State nurse aide registry was checked for findings for staff that might have patient contact. In five of five unlicensed personnel files that were reviewed, no evidence of inquiry was documented. On 09/24/2015, Staff JJ told the surveyors that currently the hospital had not done checks with the State nurse aide registry for staff.