Bringing transparency to federal inspections
Tag No.: A0046
Based on record review and staff interview, the Governing Body failed to ensure medical staff members were appointed in accordance with the hospital's Medical Staff By-Laws as evidenced by the Governing Body re-appointment of medical staff without delineation of privileges for 5 of 5 (S15Physician, S16Physician, S17Physician, S18Physician, S19APRN)sampled credentialing files reviewed for re-appointments out of a total of 6 credentialing files reviewed (S15Physician, S16Physician, S17Physician, S18Physician, S19APRN, S20CRNA). Findings:
Review of the hospital's Medical Staff Bylaws approved on 06/24/14 and provided as current by S1DON (Director of Nursing), revealed in part the following: 12.1 General Procedures: The Medical Staff through its Credentialing Committees shall investigate and consider each application for appointment or reappointment to the Staff, each request for the modification of Staff membership status, and each request for the granting, renewal or revision of Privileges, and shall adopt an transmit recommendations thereon to the MEC (Medical Executive Committee) which shall be the final authority on granting, renewing, extending, terminating or reducing Medical Staff privileges. The MEC shall be responsible for the final decision as to Medical Staff appointments, which appointments shall become effective upon and are subject to Governing Board approval....12.7 At least 120 days prior to the expiration date of a Practitioner's present Staff appointment, the CEO (Chief Executive Officer) or his/her designee shall provide the Practitioner a reapplication form for use in considering reappointment to the Staff or renewal/revision of Privileges....13.2 Clinical Privileges shall be granted by the Governing Board, based on the recommendations of the MEC...
S15Physician
Review of the credentialing file for S15Physician revealed the physician was an Anesthesiologist and was initially appointed to the Medical Staff on 10/19/05. Review of the file revealed a re-appointment to the Medical Staff by the Governing Body on 05/13/13. There was no documented evidence of any delineation of privileges since 01/05/06.
S16Physician
Review of the credentialing file for S16Physician revealed the physician was a Bariatric Surgeon and was initially appointed to the Medical Staff on 02/06/06. Review of the file revealed a re-appointment to the Medical Staff by the Governing Body on 03/10/14. There was no documented evidence of any delineation of privileges since 09/21/05.
S17Physician
Review of the credentialing file for S17Physician revealed the physician was a Gynecologist and was initially appointed to the Medical Staff on 03/28/06. Review of the file revealed a re-appointment to the Medical Staff by the Governing Body on 11/11/13. There was no documented evidence of any delineation of privileges since 12/20/05.
S18Physician
Review of the credentialing file for S18Physician revealed the physician was an Infectious Disease Specialist and was initially appointed to the Medical Staff on 07/07/09. Review of the file revealed a re-appointment to the Medical Staff by the Governing Body on 02/18/13. There was no documented evidence of any delineation of privileges since 04/13/09.
S19APRN (Advanced Practice Registered Nurse)
Review of the credentialing file for S19APRN revealed the Nurse Practitioner was initially appointed to the Medical Staff on 08/17/06. Review of the file revealed a re-appointment to the Medical Staff by the Governing Body on 03/10/14. There was no documented evidence of any delineation of privileges since 02/22/06.
In an interview on 10/03/14 at 3:00 p.m., S8Medical Staff Manager verified the only delineation of privileges requested and approved by the MEC and Governing Body were on the initial appointments. S8Medical Staff Manager stated privileges were not requested upon re-application and she did not know the physician was required to do so. S8Medical Staff Manager confirmed the above physicians and APRN did not have a delineation of privileges approved by the Governing Body when the re-appointments was approved.
Tag No.: A0283
Based on review of QAPI (Quality Assessment Performance Improvement) records and staff interview, the hospital failed to ensure the QAPI program was an ongoing program that showed measurable improvement in indicators as evidenced by failing to analyze the data collected to improve performance and processes of care and identify opportunities for improvement. Findings:
Review of the hospital policy titled, Performance Improvement, number PI-010, approved 05/08/2006, and reviewed & revised by S1DON (Director of Nursing) on 06/07/2013 revealed in part the following: The Quality Improvement Department in collaboration with the Quality Improvement Committee will develop an annual Quality Improvement Plan. The purpose of this plan is to provide guidance and structure for performance improvement activities affecting all departments and service units by: establishing performance improvement goals, setting priorities, describing methods of measurement and analysis, assigning responsibilities for performance improvement activities, working to resolve problems and address needs identified through performance improvement activities....
Review of the 2014 PI (Performance Improvement) Dashboard revealed indicators for Medical Staff Documentation, Anesthesia Services, and Infection Control were below the identified goals. Review of the QAPI records revealed only the PI Dashboard and there was no documented evidence of any corrective action plans or identified opportunities for improvement.
In an interview on 10/03/14 at 4:00 p.m., S1DON (Director of Nursing) stated she was responsible for the hospital's QAPI program. S1DON stated they, "Just track and trend." S1DON stated they had not done any corrective action plans and the QAPI program had not identified any opportunities for improvement. She stated the hospital has tracked the "same indicators for years."
Tag No.: A0297
Based on interview, the hospital failed to ensure that it conducted performance improvement projects as part of its quality assessment and performance improvement program. The hospital could provide no documented evidence of a completed performance improvement project that it had conducted as well as an ongoing project.
Findings:
Review of the hospital policy titled, Performance Improvement, number PI-010, approved 05/08/2006, and reviewed & revised by S1DON (Director of Nursing) on 06/07/2013 revealed no documented evidence of any provisions for selecting and conducting performance improvement projects.
In an interview on 10/03/14 at 4:00 p.m., S1DON stated she was responsible for the QAPI program and confirmed that the hospital had not conducted any performance improvement projects and did not have an ongoing project in place at the present time.
Tag No.: A0308
Based on record reviews and interview, the governing body failed to ensure that the hospital's QAPI (Quality Assessment Performance Improvement) program reflected the hospital's organization and services as evidenced by not having all hospital departments and services including those services furnished under contract involved in the QAPI Plan.
Findings:
Review of the hospital policy titled, Performance Improvement, number PI-010, approved 05/08/2006, and reviewed & revised by S1DON (Director of Nursing) on 06/07/2013 revealed in part the following: The hospital's Quality Improvement efforts include the entire organization and involve staff at all levels and from every department....
Review of the 2014 PI (Performance Improvement) Dashboard revealed no documented evidence that the hospital departments of housekeeping, respiratory, pain management department, post-anesthesia care unit, and intensive care unit were included in the QAPI program. Further review of the QAPI documents revealed the contracted services of dialysis, physical therapy, PICC (Peripherally Inserted Central Catheter) line insertions, TPN (Total Parenteral Nutrition) services, Laundry/Linen, and biohazard waste disposal were not included in the QAPI program.
In an interview on 10/03/14 at 4:00 p.m., S1DON (Director of Nursing) stated she was responsible for the QAPI program and confirmed that the above departments and services were not included in the QAPI program. S1DON confirmed there were no quality indicators related to the above services or departments.
Tag No.: A0309
Based on record review and staff interview, the governing body failed to ensure an annual Quality Improvement Plan was developed and implemented, failed to ensure performance efforts addressed priorities for improved quality of care and all actions were evaluated, and failed to determine the number of improvement projects to conduct annually. Findings:
Review of the hospital policy titled, Performance Improvement, number PI-010, approved 05/08/2006, and reviewed & revised by S1DON (Director of Nursing) on 06/07/2013 revealed in part the following: The Quality Improvement Department in collaboration with the Quality Improvement Committee will develop an annual Quality Improvement Plan. The purpose of this plan is to provide guidance and structure for performance improvement activities affecting all departments and service units by: establishing performance improvement goals, setting priorities, describing methods of measurement and analysis, assigning responsibilities for performance improvement activities, working to resolve problems and address needs identified through performance improvement activities....
Review of the hospitals QAPI records revealed no documented evidence of an annual Quality Improvement Plan. There was no documented evidence of any corrective action plans. There was no documented evidence of specific performance indicators approved by the governing body. There was no documented evidence of any performance improvement projects.
Review of the Governing Body minutes revealed the last documented reporting to the Governing Body regarding QAPI was November, 2013. There was no documented evidence the Governing Body had approved the Performance Improvement Plan since 05/08/06.
In an interview on 10/03/14 at 4:00 p.m., S1DON stated she was responsible for the hospital's QAPI program and stated the QAPI committee consisted of S25Medical Director, S2CEO (Chief Executive Officer), S3CFO (Chief Financial Officer), and the department managers. S1DON verified the Performance Improvement Policy included a provision for an annual Quality Improvement Plan, but stated the hospital did not have one. S1DON stated the QAPI program had not identified any opportunities for improvement and they had used the same indicators for years. She stated they did not have any corrective action plans and were only tracking and trending the data collected. S1DON verified the last documented QAPI report to the governing body was in November 2013. S1DON verified they had not identified any performance improvement projects.
Tag No.: A0749
Based on observation, record review and interview the hospital failed to ensure the infection control officer developed a system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personal as evidenced by:
1) Immediate Use Steam Sterilization (IUSS) being used for non-emergency use:
a) in the place of having enough surgical instruments for surgical cases scheduled on the same day, and
b) in place of having surgeons or instrument company representatives provide instruments for sterilization prior to the day of use to ensure enough time to complete the required sterilization process,
and;
2) observations in the operating rooms (ORs) that included privacy blinds within each OR with dust on them, 2 ventilation intake duct covers in each OR (#1, #2, #3, #4, #5, #6) with an accumulation of dust, torn/cracked armboards and patient safety straps(OR #5 and OR
3) failing to ensure all medical staff had annual TB (Tuberculosis) screening for 2 (S17Physician and S19APRN) of 6 (S15Physician, S16Physician, S17Physician, S18Physician, S19APRN, S20CRNA) sampled credentialing files reviewed; and
4) failing to ensure the hospital's policy & procedure for isolation and contact precautions included provisions for Clostridium difficile (C.diff).
Findings:
1) Immediate Use Steam Sterilization (IUSS) used for non-emergency use:
Review of hospital Policy No. IC-070, titled, "Medical Device Cleaning, Disinfecting, and Sterilization", approved 9/19/05, last review 7/22/14, provided by S1DON as current, revealed the following, in part: ...10. Flash sterilization should be used for emergency sterilization of clean, unwrapped instruments and porous items only.
a. Flash sterilization should be used for emergency sterilization of clean, unwrapped items in a gravity displacement sterilizer with recommended minimum exposure times and temperatures ...
b. Flash sterilization should be used only when time does not permit sterilization by the preferred wrapped procedure...
An observation of the surgical services area, made 10/1/14 at 3:45 p.m. with S1DON and S7RN Surgery Manager, revealed 3 autoclave machines, each with a log hanging on the side titled, "Flash Autoclave Log". Autoclave #1 was located in the central core at one end of the surgical suites, near the central sterilization room. Autoclave #2 was located more centrally in the sterile core, and Autoclave #3 was located near the opposite end of the surgical suites, in a large room containing an endoscopic reprocessing machine.
Review of logs for Autoclaves #1, #2, and #3 provided for the requested last month, revealed the following, (excluding the Biological test cycles):
Autoclave #1 (9/02/14 -9/30/14): Of 15 instrument loads/cycles processed, the following reasons were documented:
"Dirty"- 3, " Need back"-9, "Contaminated"-2, no reason documented-1
Autoclave #2 (8/22/14- 10/2/14): Of 38 loads, the following reasons were documented:
"Need back"-25, "Dropped"-1, "Hole" or "Hole in wrapper"-3, "Need for case"-1, "Unsterile" or "Unsterile from rep"-4, "Short cycle"-1, No documented reason- 3.
Autoclave #3 (8-11-14 - 10/1/14): Of 16 instrument loads, the following reasons were documented:
"Need back"-7, "Brought in"-3, " Dropped"-1, "Not sterile" or "unsterile, rep instrument"-3, "hole in blue wrap"-1, No documented reason-1.
In an interview 10/1/14 at 3:30 p.m. S12Instrument Technician explained the number of sterilization cycles using Immediate Use Steam Sterilization (IUSS, previously known as flash sterilization), known as "flash sterilization" by the facility. S12Instrument Technician explained that many times the surgical procedures are scheduled such that the instruments would be needed for another case scheduled, following the one in which the instruments were just used. He further explained that some items, such as a specific drill handle, might be the only one owned by the hospital, and needed for a procedure scheduled from right after one in which it had been used. The instrument technician reported that some surgeons brought their own set of instruments into surgery, but would not deliver them until the day of the scheduled surgery, so the instruments were processed using the "flash cycles" for "time" reasons. S12Instrument Technician reported that often Instrument (company) representatives would bring in instruments and equipment for the surgeons to use, but would not have the instruments and equipment delivered for processing until the day of the scheduled surgery, so again they were pushed for time in order to have the instruments and equipment sterilized and ready for the scheduled time of the procedure. The instrument technician reported surgeries were often scheduled in succession, with the same instruments needed, so they would be processed in the flash autoclave between cases. S7RN Surgery Manager, present for the interview, confirmed S12Instrument Technician's reports and added that if the surgical technicians thought there might be a thinning area or hole in the sterile instrument paper wrap upon opening for a surgery, they would run the instruments through IUSS. When asked when and why the IUSS should be used, S7RN Surgery Manager reported IUSS should be used when something was contaminated such as being dropped, or if instruments were needed immediately, as in an emergency. When asked if using IUSS instead of having enough instruments for scheduled surgical cases was an acceptable standard of care, she agreed it was not. She also agreed that if the Instrument representatives and surgeons bringing instruments into the hospital for use on patients were required to have the instruments to the surgical department the day before the scheduled surgery, there would be time to process the instruments using a regular sterilization cycle, wrapped. S7RN Surgery Manager and S12Instrument Technician both verified instruments not in the surgical department early enough before scheduled surgeries to be processed through a regular sterilization cycle and process, and cases scheduled too close together for the amount of instruments on hand did not constitute an emergency.
In an interview 10/3/14 at 3:00 p.m. S5RN verified that she was the manager of the Pain Management department. S5RN reported that she was aware that instruments used in the Pain Management Department were processed using flash sterilization (IUSS) in the Surgery Department. She reported 8-16 procedures per day were performed in the pain management department. The RN reported the hospital presently owned 2 sets of short probes and 2 sets of long probes (Rhizotomy needle/ probes). S5RN further reported that the Rhizotomy needle/probes were processed (using IUSS) because of the number of procedures scheduled and a limited amount of instruments.
2) observations in the operating rooms (ORs) that included privacy blinds within each OR with dust on them, 2 ventilation intake duct covers in each OR (#1, #2, #3, #4, #5, #6) with an accumulation of dust, torn/cracked armboards and patient safety straps(OR #5 and OR #6), B/P cuffs not cleaned and disinfected (OR #6), laryngoscope handle lying on soiled top of anesthesia cart (OR # 4), suction tubing through an empty syringe barrel and taped to anesthesia cart, and partial pieces of tape and adhesive residue on equipment (ORs #4, #5, #6).
On 10/01/14 from 3:10 p.m. to 4:30 p.m., the following observations were made and confirmed by S1DON (Director of Nursing) and S7RN Surgery Manager:
Observation of OR rooms #1, #2, #3, #4, #5, and #6 revealed an accumulation of dust on the privacy blinds in each room. 2 ventilation intake vent covers in each room was observed to have an accumulation of dust. S7RN Surgery Manger confirmed the OR rooms had been cleaned and were ready for use.
Observation of OR room #4 also revealed unlabeled, unwrapped, cut pieces of foam. S7RN Surgery Manager stated the foam was for one time use only, but verified there was no way to verify the when the foam was unwrapped or if it had been used more than once. Adhesive tape residue was noted on the arm boards of the surgical table. A laryngoscope handle was observed lying on top of the visible soiled anesthesia cart. S7RN Surgery Manager stated she was unable to verify if the laryngoscope handle was cleaned or not. An empty syringe barrel was observed taped to the top of the anesthesia cart. Suction tubing was observed to be folded into the empty syringe barrel. S7RN Surgery Manager confirmed the syringe barrel taped to the cart was used to hold the suction tubing, and that the tape could not be disinfected.
Observation of OR room #5 revealed an unwrapped, unlabeled, cut piece of foam was taped to the foot board of the surgery table. Multiple areas of tape residue were noted on the back of the footboard. Tape residue was also noted on the metal frame of the surgical table. S7RN Surgery Manager stated the footboard was prepared for the surgery case for the next morning. Another unwrapped, unlabeled, cut piece of foam was observed on an armboard lying on the base of the surgical table approximately 6 inches from the floor. An empty syringe barrel was observed taped to the top of the anesthesia cart. Suction tubing was observed to be folded into the empty syringe barrel. A padded security strap for the OR table had torn and worn areas along both sides.
Observation of OR room #6 revealed a surgical table arm with torn cracked vinyl covering on two ends of the table arm. The blood pressure cuff in the room was observed to have a white cotton substance in the velcro side of the blood pressure cuff. S7RN Surgery Manager stated the white substance was cast padding. S7RN Surgery Manager verified the cuff had not been cleaned. An empty syringe barrel was observed taped to the top of the anesthesia cart. Suction tubing was observed to be folded into the empty syringe barrel. Multiple unwrapped, unlabeled, cut pieces of foam were noted in the room. Two round tubular shaped pillows were observed to have foam wrapped around the pillows and taped to hold them in place.
In an interview 10/1/14 at 4:30 p.m. S7RN Surgery Manager verified observations made from 3:10 p.m. to 4:30 p.m. and agreed that these findings were not consistent with standards of cleaning and disinfecting in the OR.
17091
3) failing to ensure all medical staff had annual TB (Tuberculosis) screening:
S17Physician
Review of the credentialing file for S17Physician revealed no documented evidence of a current TB screening.
S19APRN
Review of the credentialing file for S19APRN revealed a chest X-ray had been done on 03/14/12, but there was no documented evidence of a current TB screening.
In an interview on 10/03/14 at 3:00 p.m. S8Medical Staff Manager reviewed the credentialing files for S17Physician and S19APRN and verified there was no current TB screening on either staff.
4) failing to ensure the hospital's policy & procedure for isolation and contact precautions included provisions for Clostridium difficile (C.diff):
Review of the hospital's Infection Control policies & procedures revealed no documented evidence of any provisions for isolation of C.diff infections. There was no documented evidence of provisions for hand washing or terminal disinfections of patient rooms related to C.diff.
In an interview on 10/02/14 at 4:00 p.m., S4Infection Control Nurse verified the hospital had no policies or procedures to address C.diff infections. S4Infection Control Nurse provided the document she sent to the hospital staff as education on C.diff. Review of the document revealed the document was FAQs (Frequently Asked Questions) about Clostridium difficile and was written for patient information. Review of the FAQs revealed alcohol based hand rub or soap and water hand washing was to be done by health care workers. There was no documented evidence of any guidance for disinfection of patient rooms.