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Tag No.: C0220
Unable to assess compliance due to on-going construction/renovation.
Original Findings:
Based on observation, record review and staff interview, it was determined the hospital failed to:
a. appropriately modify rooms within the surgical areas according to nationally recognized requirements for these areas. See Tag C-0221;
b. provide housekeeping and preventive maintenance in the surgical areas to ensure the facilities, supplies and equipment were maintained for safety and quality. See Tag C-0222;
c. collect and handle trash in the surgery areas appropriately. See Tag C-0223 and K-75;
d. store and secure drugs and biologicals appropriately. See Tag C-0224;
e. ensure the surgical areas were clean and orderly. See Tag C-0225;
f. maintain proper ventilation, temperature and humidity controls in the surgical areas. See Tag C-0226 and K-67; and
g. the hospital failed to provide an automatic sprinkler system that is installed in accordance with NFPA 13. See Tag C-0231.
See also LSC Tags K-147, K-130, K-106 and K-78.
Tag No.: C0221
Unable to assess compliance due to on-going construction/renovation.
Original Findings:
Based on observation and staff interview, it was determined the hospital inappropriately modified rooms within the surgical department.
Findings:
On 08/05/13 and 08/06/13, the following observations were made of the surgical areas:
~ Rooms within all areas of the surgical department were not properly labeled to designate what they were. Because the rooms were extremely cluttered and improperly used (clean and dirty items stored together, sterile and non-sterile stored together) it was difficult to distinguish "clean" versus "dirty" areas within the department. A few doors were labeled with paper signs.
The functionality of many rooms within the surgery department had been changed from the original design. For example,
~ The identified "recovery room" was not originally designed for that purpose. The area did not have emergency power from the critical care branch. The room had an open hopper in the corner of the room within six feet of the recovery bed.
Because the recovery room had only a single bed, it could not be determined how multiple patients were recovered at the same time. For instance, there were occasions when the operating room register documented 16 or 17 patients received eye surgery in a six hour period. The register showed 12 -15 minute turnover time between patients, indicating that more than one patient had to be "recovered" at the same time.
In addition, there were days when multiple endoscopic procedures were done with minimal turnover time. These patients required a longer recovery period than eye cases. Based on the times documented on the OR register, the patients would have to be recovered during periods of time that overlapped.
The staff did not identify any other "recovery" room in the facility. On a tour of the department, the surveyors noted there was no other space that met the requirements of a recovery room. The staff who accompanied the surveyors on the tour had no information about how the surgical services patient flow was handled.
There was inadequate storage space in the recovery room. Supplies were stored unsecured on open shelves. The recovery room had no patient toilet and hand-washing sink.
~ A janitor's closet, with the hopper still in place, was converted into an endoscope decontamination room. There was not enough space in this room to process the number of scopes used. There was not enough storage space in this room for all the supplies and equipment necessary for endoscope processing. At the time of survey, two wet endoscopes had been stored inside the automated washer. The room had a sink for gross decontamination of the endoscopes, but there was no hand-washing sink for staff.
~ An endoscope storage room/utility room also held a small medication refrigerator. The endoscope cabinet was left open. Two endoscopes were hanging inside it. An unlocked medication refrigerator sat on a table in front of the endoscope cabinet. The placement of the medication refrigerator impeded movement and blocked counter space and other storage in the room.
~ The surgical instrument decontamination room had a single sink where instruments were washed. There was no separate staff hand-washing sink. There was not adequate counter top space to process surgical instruments before and after washing. Unnecessary supplies and equipment were also stored in this room.
~ The sterile supply room in the surgery area was originally designed to be a utility room. The room had a sink and counter top. There was not enough space to accommodate all the department's sterile supplies. For this reason, sterile supplies were found randomly stored in various areas throughout the department.
There was improper storage of non-surgical supplies in the sterile supply room. Multi-use patient care items were improperly stored in this area. An electric razor was stored on the counter next to a plastic basin. Linen was stored on the counter top as well.
The sterile supply room did not meet requirements for airflow, temperature and humidity.
~ The surgery suite and the procedure suite did not have an identified anesthesia work room that contained anesthesia supplies, equipment and medications dedicated to that department. Instead, anesthesia supplies, equipment and medications were stored randomly throughout the suites.
~ A steam sterilizer had been removed from the surgery restricted corridor but the plumbing and the drain remained open and exposed. The surfaces had not been repaired and sealed.
~ The hospital did not replace the steam sterilizer within the surgical suite for use in an emergency when flash sterilization was required. The only steam sterilizer available was outside of the surgery department and was not easily accessible to staff in an emergency.
~ The identified pre-op room had no patient toilet and hand-washing sink.
~ A closet had been converted into a staff kitchen that opened directly into the semi-restricted hallway within the surgical area. There was no door to separate the "kitchen" from the semi-restricted corridor. Microwave cooking was allowed in this room.
~ Staff stated the interior semi-restricted corridor to the surgery suite was used as a tornado shelter for all staff, visitors and patients who may be in the hospital during a weather emergency.
The staff were asked if this surgical hallway was the only interior safe area. The staff stated there were interior corridors, other than the surgical suite, that could be used as a tornado shelter.
~ The women's dressing room in the surgical area was carpeted and could not be adequately cleaned and sanitized on a daily basis.
~ Papers were taped on the walls throughout the pre-op, surgery, recovery, decontamination and sterile processing areas.
Staff that accompanied the surveyors on a tour of the surgical areas made no comment regarding the findings.
Tag No.: C0222
Unable to assess compliance due to on-going construction/renovation.
Original Findings:
Based on observation, record review and staff interview, it was determined the hospital failed to provide housekeeping and preventive maintenance in the surgical areas to ensure the facilities, supplies and equipment were maintained for safety and quality.
Findings:
On 08/05/13 and 08/06/13, a tour of the surgical and related areas was conducted.
1. The surgical light over the OR table area in the procedure room did not work.
2. A nurse call system in the procedure suite did not work.
3. There was an exposed pipe and an open hole in the floor in the restricted corridor of the surgery suite.
3. Throughout the surgical areas walls, floors, and ceiling tiles were in disrepair. Baseboards were missing or broken. Peeling wallpaper and exposed sheet-rock was found on some walls within the procedure suite. Wall paint was chipped. Wood doors were gouged and scratched. Because of the types and condition of the walls, floors, doors and ceiling tiles, regular dusting, disinfection and deep cleaning could not be adequately carried out.
Water stains were found on ceiling tiles. Ceiling tiles were misshapen in some places and were no longer in proper position.
Cabinets and drawers could not be opened or closed correctly. Old wood surfaces on the cabinets and drawers were marred, chipped, cracked or had peeling varnish. None of the wood surfaces could be adequately sanitized.
4. Some walls within the restricted and semi-restricted surgical areas had textured wallpaper that could not be cleaned or sanitized as necessary.
5. There was no documentation of preventive maintenance for the steam sterilizer and no records of repair. There was no record of preventive maintenance and repair for the sonic instrument washer or the automated endoscope cleaner. The plant manager stated he was not aware that all surgical equipment needed to be on a regular maintenance schedule.
6. The sonic surgical instrument washer was not installed correctly. Staff had to attach a hose from the instrument sink faucet to the washer to fill it. Likewise, a waste water hose was draped back into the instrument sink to drain. The automated washer sat on a steel cart over unfinished flooring that could not be cleaned and disinfected. There was a large hole in the wall under the washer that went completely through the sheet rock.
7. The instrument decontamination sink was rusted and had evidence of mineral build-up. The counter tops, walls and surfaces in the decontamination area were dirty, grimy, and cluttered. Surfaces were chipped, marred and broken and could not be sanitized.
8. In the instrument processing room, cleaning chemicals were stored on a shelf over personal protective equipment and other supplies. Clean supplies items were stored on the counter top and not within closed cabinets in the decontamination room. These items were exposed to splashing from dirty water when instruments were being washed.
9. Drawers and cabinets did not close properly in the decontamination room. Baseboards were missing and there were gouges in the walls. The area had no evidence it had ever been terminally cleaned. The area was cluttered and disorganized.
10. A multi-drawer rolling cabinet in the recovery room was marred, chipped and had plastic trim broken off. The surfaces could not be sanitized.
11. The findings were discussed with the administrator. She stated she did not know why staff had not reported the needed repairs to maintenance.
Tag No.: C0223
Unable to assess compliance due to on-going construction/renovation.
Original Findings:
Based on observation and interview, it was determined the hospital failed to collect and handle trash in the surgery area appropriately. Findings:
On 08/05/13, a large, industrial size gray garbage can was observed stored in the semi-restricted hallway in the surgical area. The can held trash from the surgical area and food waste. The trash can did not have a cover and had not been emptied in four or more days.
The staff stated the trash can had always been there and no one knew there was anything wrong with it.
Tag No.: C0224
Unable to assess compliance due to on-going construction/renovation.
Original Findings:
Based on observation, record review and staff interview, it was determined the hospital failed to store and secure drugs and biologicals appropriately. Findings:
On 08/05/13 and 08/06/13, observations were made of the surgical areas.
1. Intravenous solution bags were stored in the bottom of the surgical scrub sink. Staff stated it was "probably stored there for use at another time."
2. Medications were stored unsecured in all areas of the surgical department. There were no locking cabinets designated for medications in the procedure area or the surgery area. Medications were stored in random cabinets and drawers throughout the department. Staff were asked how the hospital could manage inventory and ensure all medications were routinely checked for expiration dates. No reply was given.
3. Expired medications and IV solutions were found in various surgical areas.
4. Opened medications were not dated when opened.
5. A medication that was manufactured in a light-protected package was open to the light and left on a counter.
6. Multiple pre-packaged bags of take home eye medications were found in an unlocked cabinet. The staff did not know who accounted for these medications and who checked for expiration dates.
7. Syringes of sterile normal saline for injection and syringes with needles were found in drawers with office supplies in the recovery room.
8. Bags of intravenous solution were stored in a warming cabinet without evidence of monitoring of temperature. The bags were not labeled with an expiration date after they were placed in the warmer.
9. Malignant hyperthermia emergency medications and IV fluids were stored on an open shelf under a medication administration machine. They were not protected from possible splashing when the floor was mopped.
Tag No.: C0231
Unable to assess compliance due to on-going construction/renovation.
Original Findings:
Based on observation and interview with staff, the hospital failed to provide an automatic sprinkler system that is installed in accordance with NFPA 13. Findings:
Refer to LSC survey tags K-52 and K-56.
Tag No.: C0320
Unable to assess compliance due to on-going construction/renovation. On the morning of 09/17/2014, the Surgery Manager, stated the hospital is no longer performing surgical procedures. Surgical procedures will resume once construction/renovation is completed.
Original Findings:
Based on observation, record review and staff interview, it was determined the hospital failed to ensure:
a. perioperative services were supervised by an experienced staff member;
b. policies and procedures were developed and implemented according to nationally recognized standards of practice;
c. history and physical examinations were performed within the required time frame before surgery;
d. informed consent was obtained for all patients prior to surgery;
e. conscious sedation was provided by qualified, trained and deemed competent registered nurses;
f. post-operative care was provided according to acceptable standards of practice;
g. surgical care was provided in a clean and safe environment. See also Tags C-0220, C-0221, C-0222, C-0223, C-0224, C-0225, C-0226, C-0231 and LSC Survey K Tags;
h. sterilization and high level disinfection were provided according to accepted standards of practice. See also Tag C-0278;
i. sterilized materials were handled and stored appropriately. See also Tag C-0278;
j. surgical staff had a current roster listing of each practitioner's surgical privileges, privilege suspension or restrictions. See Tag C-0321;
k. pre-and post anesthesia evaluation was performed for all surgery patients. See Tag C-0322; and
l. the hospital failed to ensure all patients were discharged in the care of a responsible adult. See Tag C-0325.
Findings:
On 08/05/13 and 08/06/13, observations were made of the pre-operative area, the surgical area and the recovery room. Hospital policies and procedures were reviewed. Staff employment and training files were reviewed. Surgical patient records were reviewed.
1. The administrator stated the surgery manager supervised the surgery department, sterile processing and the pre-operative and recovery areas. The personnel file for the surgery manager was reviewed. There was no documentation of prior surgery experience, specific surgery training or certification. There was no documentation of experience and training in the areas of recovery and sterile processing.
There was no job description and no documentation of orientation to the areas the surgery manager supervised. While the file had current generic annual hospital training, there was no documentation of department specific training. There was no evidence of evaluation of job-specific competencies.
There was no documentation the surgery manager was affiliated with any perioperative professional organization, was mentored by an experienced surgery manager or received any relevant continuing education in the areas she supervised.
There was no documentation of the manager had current certification in CPR, PALS, or ACLS certification. There was no documentation of conscious sedation training and competency, although the manager was required to performed all these functions.
None of the other staff members in the perioperative areas had documentation of job descriptions, department specific orientation and training, competency evaluation or on-going continuing education in their areas.
2. The hospital did not have the policies to address:
a. reprocessing scopes before use if unused for more than five days.
b. periodic deep cleaning of all surgical areas. There were no policies for general housekeeping in the pre-op, recovery, decontamination and sterile processing areas.
c. use of the steam sterilizer and automatic endoscope processor.
d. nursing assessment in the recovery room
e. use of Rapicide, the high level disinfectant used in the surgery department, as no product information was available as referenced in the policy
f. department-specific infection control surveillance
g. all decontamination processes
h. instrument care, cleaning, wrapping, packaging and processing
i. aseptic techniques
j. specific surgical procedure protocols
k. involvement of the surgery department in the QAPI process
None of the policies currently used by the hospital had evidence the information contained within was based on nationally recognized standards. Some of the policy information was not applicable or did not match what was actually done in the surgical areas.
While some policies were comprehensive in scope and gave appropriate guidance, there was evidence through surveyor observation that policies were not followed.
The surgical department did not have any nationally recognized reference manuals for surgical services, perioperative nursing, decontamination, high level disinfection and sterile processing.
There were no manufacturer's instruction manuals for the steam sterilizer, the automated endoscope processor or the sonic instrument washer.
3. Three (#32, 33 and #34) of seven patient records reviewed for timely history and physical examinations (H&P) did not have and H&P examination within 30 days of surgery.
4. Four (#32, 33, 34 and #38) of seven patient records reviewed for surgery and anesthesia consents documented the following:
a. The record for patient #32 did not have an informed consent documented in the medical record.
b. The informed consent for patient #33 was not signed by the physician.
c. The informed consent for patient #34 was not signed by the physician. An anesthesia consent form for the patient was not signed by the anesthesia provider.
d. The anesthesia consent form for patient #38 was not signed by the anesthesia provider.
e. Although the informed consent for surgical procedures form required the patients to sign for the acceptance or the declination of blood and/or blood products, the staff did not have the patients sign this portion of the form.
5. Clinical records documented conscious sedation was provided by registered nurses. The nurses' files had no documentation of annual training and competency to provide this level of care. Some of the nurses providing conscious sedation did not have evidence of ACLS certification or of basic ECG interpretation.
6. Patients were recovered in a room not originally designed as a recovery room. The room did not have emergency power from the critical care branch. The room had an open hopper in the corner of the room within six feet of the recovery bed.
Because the recovery room had only a single bed, it could not be determined how multiple patients were recovered at the same time. For instance, there were occasions when the operating room register documented 16 or 17 patients received eye surgery in a six hour period. The register showed 12 -15 minute turnover time between patients, indicating that more than one patient had to be "recovered" at the same time.
In addition, there were days when multiple endoscopic procedures were done with minimal turnover time. These patients required a longer recovery period than eye cases. Based on the times documented on the OR register, the patients would have to be recovered during periods of time that overlapped.
The staff did not identify any other "recovery" room in the facility. On a tour of the department, the surveyors noted there was no other space that met the requirements of a recovery room. The staff who accompanied the surveyors on the tour had no information about how the surgical services patient flow was handled.
~ Seven patient records (#32 - #38) were reviewed for post-anesthesia care. The records contained standing recovery orders that included discharge criteria. All records documented the patients were recovered and discharged within 35-45 minutes post-procedure, irregardless of the patient's age, physical condition or surgical procedure performed.
Patient #37 had a diagnostic laparoscopy that then required an "open" laparotomy. The patient was under general anesthesia for two hours and ten minutes. The clinical record documented the patient was discharged home 45 minutes after surgery.
In all cases, documentation indicated the nursing assessment and the decision to discharge the patient home, was based entirely on an Aldrete score. (The Aldrete score is a criteria used to determined a safe discharge from the recovery area to the next level of nursing care and is not intended to solely determine the patient's condition for safe discharge home.)
For example, the recovery nursing documentation did not include the patient's ability to remain awake for 20 minutes without stimulation, ability to sit, stand or walk, the ability to answer questions appropriately, the ability to take oral fluids, the ability to void and other indicators the patient could return home safely.
None of the records documented the patients received comprehensive assessments at the beginning of the recovery period and then again immediately prior to discharge.
None of the records had documentation of recovery nursing assessments that were relevant to the patient's specific surgical procedure. For example, patients who had an EGD (esophagogastroduodenoscopy) were not assessed for swallowing, bloating, coughing, among others. Colonoscopy patients were not assessed for bloating, abdominal tenderness, the ability to expel gas, etc.
Patient #37 (diagnostic laparoscopy/laparotomy) had no nursing assessment related to the patient's surgical procedure except documentation the patient's dressing was "clean, dry and intact." The document did not specify where the dressing was or what type. There was no documentation of assessment of the patient's abdomen or other body systems.
Other findings related to post-operative care included:
Patient #32: The record had no documentation of the amount of IV fluid the patient received in recovery. There were no discharge vital signs recorded. There was no documentation of the patient's destination at discharge and who the patient left with.
Patient #33: The record had no documentation of who drove the patient home and no documentation of discharge instructions.
Patient #34: There was no documentation of the patient's destination at discharge and who the patient left with. There was no documentation of discharge instructions.
Patient #35: There was no documentation of who the patient left with at discharge.
Patient #36: The record had no documentation of the amount of IV fluid the patient received in recovery. There was no documentation of the patient's destination at discharge and who the patient left with.
7. A review of the OR register indicated that when eye cases were scheduled, there were as many as 16-17 cases done in a six hour period. The hospital only had one OR suite available. It was not possible to turnover the OR suite thoroughly (cleaning and preparation) when the records indicated there was only 12-14 minutes in between cases.
At the time of survey, all surgical areas were cluttered and not maintained in a clean or aseptic manner. Housekeeping and general routine maintenance of the areas was not performed. There were no schedules or requirements for cleaning between patients, terminal cleaning at the end of the day and deep cleaning on a routine basis.
Rooms had been modified to change functionality and did not conform to accepted standards for the design and construction of surgical areas.
The location and storage of equipment and supplies did not conform to national standards for the surgical areas.
Temperature, humidity and air exchanges were not monitored and maintained in a manner to prevent the growth and spread of microorganisms.
Department equipment was not routinely maintained or repaired.
Emergency equipment and supplies were not available in all areas where surgery was performed.
Drugs and biologicals were not secured and stored appropriately.
8. Surgical instruments were not cleaned and sterilized appropriately. There were no policies and procedures to guide staff on these processes. There were no equipment manuals and manufacturer's instructions available to staff for the sterilizer and the endoscope processor. There was no documentation that indicated these pieces of equipment were serviced and maintained as required. Adequate records were not kept of sterilization loads and of high-level disinfection cycles.
Staff stated eye sets were routinely processed using the "immediate use cycle." We asked to clarify that they were referring to "flash" sterilization. The tech stated, "No, it's not flash. It is just a shortened cycle."
9. Items for sterilization were not wrapped or packaged appropriately. Not all sterile packages had clear indication they were actually "sterile" because the hospital did not use chemical indicator tape and the inside indicator could not always be seen. Once processed, sterile instruments and supplies were not stored appropriately.
Endoscopes were not stored appropriately. They were not reprocessed when unused for five days.
There was no documentation of staff orientation, training and competency for decontamination processes, high-level disinfection and sterilization.
Tag No.: C0322
Unable to assess compliance due to on-going construction/renovation. On the morning of 09/17/2014, the Surgery Manager, stated the hospital is no longer performing surgical procedures. Surgical procedures will resume once construction/renovation is completed.
Original Findings:
Based on policy and procedure review, record review and staff interview, it was determined the hospital failed to ensure:
a. a qualified practitioner performed a pre-anesthesia risk evaluation; and
b. failed to ensure a qualified practitioner performed an anesthesia recovery evaluation for two (#32 and #38) of seven surgical records reviewed.
Findings:
A hospital policy, titled "Anesthesia Pre-Operative Requirements," documented, "... The ASA [American Society of Anesthesiologists] class assigned will be assigned by the Anesthesia provider, or the surgeon if no anesthesia provider is to be present during a local procedure... All patients who are undergoing operative and/or invasive procedures requiring anesthesia require assessment for clinical stability prior to the procedure..."
A hospital policy, titled "Post-Operative Anesthesia Care," documented, "... A licensed independent practitioner will document in the medical record the discharge of the patient from the PACU [post anesthesia care unit], when the patient's condition is stable and the patient meets the PACU discharge criteria (Aldrete Scoring System). At least one post-anesthetic visit will be recorded, describing the presence or absence of anesthesia related complications... The date and time of each visit will be specified... The attending physician who discharges the patient will be responsible for meeting the same requirements..."
1. The clinical record for patient #32 had no documentation of an anesthesia risk assessment or ASA designation prior to surgery.
2. The clinical record for patient #38 had no documentation of a post-anesthesia risk assessment or ASA score prior to surgery. There was no documentation of a post-anesthesia visit.
Tag No.: C0325
Unable to assess compliance due to on-going construction/renovation. On the morning of 09/17/2014, the Surgery Manager, stated the hospital is no longer performing surgical procedures. Surgical procedures will resume once construction/renovation is completed.
Original Findings:
Based on clinical record review and staff interview, it was determined the hospital failed to ensure all patients were discharged in the company of a responsible adult for five (#32, 33, 34, 35 and #36) of seven surgical records reviewed.
Findings:
The clinical records for patients #32, #33, #34, #35, #36 had no documentation of who the patient left the hospital with.
The administrator stated there were gaps in documentation.