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Based on record review and interviews with hospital staff the governing body does not ensure that all services provided by the hospital are provided in a safe manner.

Findings:

1. The governing body failed to ensure surgical services are provided in accordance with acceptable standards of practice and in a safe manner. Refer to Tags - 0940, 0941, 0942, 0944, and 0945.

2. The governing body failed to ensure the hospital had an ongoing, hospital-wide, data-driven quality assessment and performance improvement ( QAPI) program. Refer to Tag - 0263.

3. The governing body failed to ensure the hospital maintains an active ongoing infection control/prevention program to prevent, control, and investigate infections and communicable diseases minimize infections and communicable diseases in patients and staff. Refer to Tag - 0474.

4. The governing body failed to ensure all physicians performing surgical procedures have privileges granted for the procedures that they perform. Refer to Tag - 0945.

5. The governing body failed to ensure nursing staff are trained, qualified, and competent to care for the patients to whom they are assigned. Refer to Tag - 0397.

6. The governing body failed to ensure the hospital maintained an effective functioning grievance process and that all grievances were recognized, investigated, resolved and a written response was sent to the individual filing the grievance. Refer to Tag - 0118.

7. The governing body failed to ensure the hospital kept complete retrievable medical records. Refer to Tag - 0940, Finding #8, and Tag - 0959.

Based on record review and interviews with hospital staff, the hospital does not ensure that an ongoing, hospital-wide, data-driven quality assessment and performance improvement ( QAPI) program is maintained. Review of governing body and medical staff meeting minutes from January to September 2011 did not have evidence of QAPI reports. Three of seven medical staff meeting minutes documented "no report" for QAPI. Four of seven medical staff meeting minutes had minimal information concerning quality care. Governing Body meeting minutes did not have any documentation of QAPI activities.

Findings:

1. Medical Staff meeting minutes reviewed did not have any attachments with indicators from the hospital's services.

2. January 18, 2011 Medical Staff meeting minutes only documented injury report and monthly infection control. No data was attached.

3. April 19, 2011 Medical Staff meeting minutes documented the following; Scorecard presented for review; (Staff name) (ER) is waiting on ER stats; Discussed Dr. (name) will chair the QA activities and report to Medical Executive. No attachments or other information was in the meeting minutes.

4. May 17, 2011 Medical Staff meeting minutes documented the following; Reviewed and discussed chart review and deficiency report; Requested to have an investor's meeting in June and for (staff name) to do CPSI training at this meeting.

5. July 19, 2011 Reviewed and discussed deficiency report. No documentation was attached.

6. Medical Staff bylaws state in Section 8.10 Quality Improvement Committee
The Medical Executive Committee shall be the Quality Improvement Committee. Subcommittee appointments assigned by the President may be responsible for focused reviews.

7. There was no evidence of QAPI indicators from all hospital services and departments.

8. Hospital staff stated on 10/13/11 during the exit conference that they did not have a functioning QAPI program.

9. The Performance Improvement Committee is also, according to the hospital's grievance policy, to be involved in the grievance process.

Based on interviews with staff and review of hospital documentation, the hospital failed to maintain an active ongoing infection control program to provide a sanitary environment to avoid transmission of infections and communicable diseases.

Findings:

1. The facility did not ensure that an active ongoing infection control program was being utilized to monitor, track, and control infections and communicable diseases in all hospital units, in order to provide a sanitary environment to patients and employees. On 10/13/2011, Staff U , the person identified as responsible for infection control, told the surveyors that she maintains an infection control log. After further interview and document review the infection control log was incomplete due to the omission of data that is required per hospital licensure.

2. Staff U told the surveyors that no one monitored the use of the hospital disinfectant on different patient units and surgery, to ensure the disinfectant was applied appropriately and according to manufacture's guidelines. Review of meeting minutes containing infection control did not contain evidence the hospital's infection control program chose the disinfectants or were responsible for selection of the disinfectants, or that the disinfectants were approved by the governing board to ensure effective cleaning and to provide a safe and sanitary environment for patients and employees.

3. The infection control program did not include proper monitoring of all areas of the hospital . There was no evidence that information based on infection control activities and prevention measures was continuously analyzed, evaluated, or communicated in the different hospital units and facility departments.
4. There was no evidence shown in meeting minutes that infection control was integrated and reporting to quality assurance and performance improvement (QAPI) or Medical Staff. Medical staff meeting minutes for the dates of 3/22/2011, 4/19/2011, 5/17/2011, 7/19/2011, 8/16/2011, did not contain documentation of infection control reporting. Medical staff bylaws state the infection control committee will meet monthly.
5. The hospital's infection control program did not specify the types and frequencies of surveillance activities. The hospital's infection control program did not monitor to ensure policies and practices developed to provide a sanitary and safe environment and prevent transmission of infectious and communicable diseases were followed. There was no evidence that infection control interventions were implemented based on measures selected for monitoring or based on risk assessments.

6. The hospital's infection control program did not review its sterilization practice in surgery or provide evidence that surveillance activities were conducted in the operating rooms and surgical areas. There was no evidence provided that infection control policies and procedures for surgical services were being implemented in the surgical areas. The director of the operating room (OR) staff J stated on 10/13/2011 that he does not make rounds with the infection control nurse but that he has seen her perform environmental swabs. Through interview staff J confirmed she has not done surveillance activities or monitoring of sterilization processes.

7. On the morning of 10/12/2011 staff told the surveyors that the facility routinely uses "flash" sterilization. Staff stated the reason for routine use of "flash" sterilization was the lack of the time to perform terminal sterilization between cases, physician convenience, and the lack of complete instrument sets for the number of procedures performed. Infection control did not monitor surgery practices or policy regarding immediate sterilization performed in surgery and educate to limit it's use to emergency situations only.

8. Review of staff, allied health, and physician health files did not reveal the infection control program reviewed and developed corrective actions to ensure all had complete immunization histories. One out of one pharmacist, five out of five physicians, and eleven out of fifteen staff members did not have complete immunization histories.

9. Environment of Care Committee meeting minutes did not consistently reflect infection control issues/concerns, surveillances, and practices were monitored, reviewed and analyzed with corrective actions to prevent, identify and manage infections and communicable diseases with measures that result in improvement on an ongoing basis.

Based on surveyors observations, review of facility documents and interviews with facility staff, the facility failed to provide surgical services in accordance with acceptable standards of practice.

Findings:

1. Unsterilized surgical instruments were utilized in a procedure on 9/27/2011. The finding was verified with Staff J, K, and L on the afternoon of 10/13/2011 and Staff M on the morning of 10/14/2011. None of the personnel identified in the occurrence (K,L,O) had orientation and training to specific job responsibilities. Refer to tag 397

2. A policy entitled "Sterilization: Flash. Policy. G. Documentation of cycle information and monitoring results is maintained to provide for tracking of the flashed items to the individual patient. Further the policy states "H. Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method". The procedure then stipulates, IX. Flashing Implants: A. The biological result is read at 1 hour, B. The expiration date is recorded on the OR record as expiring on the same day". In the documentation section XVI. documentation A. Patient sticker on the paper spool of the load for which it was run B. Contents of the load; C. Initials of the person running the load; D. At the conclusion of the cycle, parameters of sterilization (30 psi and 270f) must be verified and noted on the autoclave tape."

On the morning of 10/12/2011 staff told the surveyors that the facility routinely uses "flash" sterilization. Staff stated the reason for routine use of "flash" sterilization was the lack of the time to perform terminal sterilization between cases, physician convenience, and the lack of complete instrument sets for the number of procedures performed. During the period of August 1, 2011 until October 12, 2011 sixteen surgical instrument loads were flashed due to back to back cases and physician request.

On 10/12/11 and 10/13/11 surveyors reviewed the "flash sterilization log" . Documentation by staff in the flash log indicates on 9/12/11 the reason a back set was flashed was for "back to back cases". Staff K told surveyors myringotomy sets were flashed because there was not enough time between cases to process the instruments on a full cycle. In an interview with Staff M surveyors were told the physicians were always in a "hurry" and Staff M always felt rushed. Staff M told surveyors physicians complained about turnover times between cases. Staff M also told surveyors staff were not allowed to open rooms until the physicians were in the operating suite which created a rush to set the cases up and sometimes the wrong fluids or products were pulled.


2. According to AORN (Perioperative Standards and Recommended Practices-2010) "documentation of cycle information and monitoring results should be maintained in a log to provide tracking of the flashed item(s) to the individual. IV.i.1. Sterilization records should include information on each load, including the items processed; the patient receiving the item(s); the cycle parameters used (temperature, duration of cycle); the date and time the cycle is run; the operator information; and the reason for flash sterilization."

During a tour of the operating room on 10/12/2011, Staff G, Chief Nursing Officer, told surveyors sterilizers 4 and 5 were only used for flashing. Later Staff J told surveyors sterilizers 4 and 5 were used for flashing and to run regular loads. Surveyors reviewed sterilization logs for sterilizers #1, #2, #3, #4, and #5.

Sterilizer tapes indicate the number of loads completed for each day. Upon review of the sterilization logs surveyors found many sterilization loads were not documented on the log. Sterilizer tapes which coincide with the loads could not be found.
Sterilizer #4: 8/25/11 loads 1 and 5 were documented with sterilizer tapes. Loads 2,3, and 4 could not be found. Sterilizer #4 9/12/11 included tapes for load #3. No load documentation was found for loads #1 and #2 loads. Sterilizer #4 9/22/11 included tapes for loads #1 and #6. No load documentation was found for #2,3,4, and 5.
Sterilizer #5 8/16/11 included tapes for load #4. No load documentation could be found for loads 1,2, and 3. Sterilizer #5 10/6/11 included tapes for load #3. There was no load documentation for loads 1 and 2.
These findings were confirmed with Staff J on the afternoon of 10/13/11. The facility failed to provide lot and load identification for surgical instruments and implants.

3. According to the policy "implant device tracking" a written record will be kept of all implanted devices that will include: A. Implant Date; B. Expiration Date; C. Patient Name; D. Patient Social Security number; E. Implant location; G. Manufacturer; H. Model. Stipulated in "procedure, I. The implant log will be maintained by the clinical coordinator at the OR Control Desk. II. The circulating nurse will obtain and document the required information for each case. III. Stickers with device manufacturer information will be placed on the patient's medical record. IV . Implants used at this facility include but are not limited to plates, screws, rods, ear tubes, inner ear prostheses, synthetic bone and other spinal fusion/stabilization devices, pain management devices and dural grafts.

Another policy "Vendor access to surgery and Vendor Statement of Accounts" stipulates: II. New Products, Consignment or Implants: A. Any vendor bringing consignment items/products/instruments or implants must see the Surgical Services Manager or Materials Manager at the completion of the surgery case requiring such products to provide a comprehensive list of pricing for all items used. Further in the policy, C.; Instrumentation brought in by vendors must be checked in to Sterile supply and decontamination prior to the day of surgery to allow for necessary sterilization measures. All instruments that are brought in for a loan by vendors are required to be inventoried with the SPD Team Leader before the set is sterilized. The sterilization guidelines are required for any instrument or set that is brought into the hospital. D. Flash sterilization will not be used. Full cycle sterilization will be used on all instruments for all patients. E. Sets requiring sterilization must be delivered at least 48 hours before the scheduled case.

The policy "lot load monitoring" stipulates: Purpose: "to establish traceability of the contents of each sterilized in the event of a sterilizer failure or malfunction. Policy: I. All materials sterilized shall be lot or load monitored. II. A method of record keeping for the purpose of product recall, which would be indicated if an unsatisfactory test result is received, malfunction of a sterilizer is suspected, or any similar occurrence will be maintained on a daily basis in the SPD monitor log. Procedure: I. All supplies sterilized shall be labeled with a load or lot control number before the sterilization process."

According to AORN Perioperative Standards and Practice Recommendations -2010, pg 422, "Recommendation III, Borrowed or consigned (i.e., loaner) instruments should be examined, cleaned, and sterilized by the receiving health care organization before use, according to manufacturers' written instructions." Further the recommendation stipulates, When loaner instruments are received, all moving parts, tips, box locks, ratchets, screws, and cutting edges should be examined for defects and to ensure proper working order. Instruments consigned may not have been adequately decontaminated. Conditions during storage and transport are not known. The quality of any previous processing has not been verified, and sterile storage conditions have not been maintained during transport. Further on page 423, loaner instruments should be logged in and inventoried with the receiving facility before use."

AORN also states p.468, "a formalized program between health care organizations and health care industry representative should be established for the receipt and use of loaner instrumentation...The loaner instrumentation process should include, but not be limited to, requesting loaner instrumentation or implant; receiving loaner items, including a detailed inventory list; obtaining manufacturers written instruction for instrument care, cleaning, assembly, and sterilization; cleaning, decontaminating, and sterilizing borrowed instrumentation by the receiving facility performed in accordance with recommended practices, transporting processed loaner instrumentation to the point of use; returning items to the sterile processing department following the procedure, maintaining historical records of the transactions. Further at X.c.1, all loaner instruments should be considered contaminated and delivered directly to the decontamination area for processing. X.c.6. Implants and instruments should be visually inspected for damage. X.c.9 Implantable devices should be sterilized with a B1 and a Class 5 integrating indicator and documented in accordance with FDA regulations and AORN recommended practices."

In an interview on the afternoon of 10/13/2011 Staff K told surveyors implants were a consignment item and brought in to the operating room through sales representatives. Staff K was identified as the staff member over central sterile. Staff K told surveyors the sales representatives put the trays together and the central sterile staff did not know what was in the trays. Staff K was not sure if implants were in any of the trays central sterile staff sterilized.

In an interview on the afternoon of 10/13/2011 Staff L was identified as a surgical scrub technician and occasionally helps out in the central sterile. Staff L told surveyors implants were brought in to the operating room through sales representatives. Staff L did not know if all implants were brought in by the sales representatives. Staff L did not know if plates and screws were sterilized by the central sterile staff or if they were brought in by the sales representatives. Later Staff L told surveyors the "frag sets" do have plates and screws in them.

In an interview on 10/13/11 Staff J told surveyors implants were sterilized outside the facility and brought in by the sales representatives. Staff J thought implants and instrument sets were brought in twenty four hours ahead of time. Staff J also stated if implants had to be sterilized by the facility he thought they were brought in twenty four hours ahead of time and ultimately it was the circulators responsibility to know if the implant was sterile or not.

5. Review of the implant log for 9/22/11 indicates plates and screws were brought to the facility by a vendor and signed for by Staff Q. The documentation lists the catalog number for the plate and individual screws utilized. There is no other documentation on the log sheet. Patients name is not included and expiration/sterilization of the implant was not documented. Review of the surgeries performed on 9/22/11 indicate patient #6 received implanted plates and screws during a surgery performed 9/22/11. The plates and screws documented in the record matched the plates and screws on the implant log. Documentation of sterilizer tapes for 9/22/11 did not include any plates and screws. Documentation of loads 2,3,4,5 could not be found. Loads#1 and #6 did not include plates and screws. The hospital could not provide documentation the implants had been sterilized and tracked.

Review of the implant log for 8/27/11 indicates cannulated screws were implanted in patient#3. Documentation in the log did not indicate lot/serial numbers or expiration dates. There was no documentation in any of sterilization logs indicating the implants had been sterilized. The hospital could not provide documentation the implants had been sterilized.

Review of the implant log for 10/3/11 indicates rods, screws, and plates were implanted in Pt #6. Expiration date for each of the implants indicated a zero. There was no documentation in any of the sterilization logs indicating the implants had been sterilized.

6. Infection Control Meeting Minutes 2011 do not include any surveillance for the Operating Room. There is no documentation the Infection Control Program reviews and analyzes sterilization practices, hand hygiene, or any infection control practices in the perioperative suite. In an interview 10/13/2011 Staff J stated he observes but does not document any surveillance activities. Staff J told surveyors he did not know the name of the product used to clean with between cases but thought there was a two minute kill time for the product.

7. Review of Quality Assurance Performance Improvement does not include specific indicators designated for Surgical Services. In an interview 10/13/2011 Staff J stated "they" collect data and turn information into Staff G. Review of Quality Assurance Performance Improvement Meeting Minutes 2011 did not include information pertinent to surgical services.

8. The facility's medical records are a combination of electronic medical records and scanned documents. On 10/12 and 10/13/2011 surveyors requested several times multiple complete closed medical records. On both 10/12/2011 and 10/13/2011 all records requested did not have intraoperative documentation. In an interview on 10/12/2011 Staff Z (Information technology) told surveyors the intraoperative record was unavailable because the nursing staff had not unlocked it. Staff Z told surveyors the lock feature was required while the patient was in the hospital so the next department the patient was seen in could document in the correct flowsheet. Staff Z did not know why the records had not been unlocked. 10/13/2011 Staff J told surveyors he was aware of the issue and attempts to resolve caused issues with billing. Staff J was not aware if the problem occurred only after discharge. The facility did not have policies and procedures developed and approved through medical staff and governing body related to the computer documentation. There was no evidence the Governing Body had been apprised and action had been taken to correct the problem. The facility could not provide complete medical records timely.

9. Review of the facility tissue specimen log did not include a specimen from an emergency case, patient #2. The facility failed to log and track tissue as required by policy and standards of practice.

Based on review of hospital documents and interviews with staff, the hospital failed to ensure that all grievances/complaints not resolved at the time of the complaint by staff present are included in the hospital's grievance process. One complaint/grievance documented in the variance/occurrence log and two grievances in a pending file were not on the grievance log reviewed during the investigation and were not included in the hospital's grievance process.

Findings:

1. One grievance which was entered into the variance/occurrence log was not included in the grievance process because the grievance coordinator was not notified and the appropriate complaint form was not filled out by staff. The hospital's grievance coordinator stated at 0945 on 1013 that she had not been given that grievance.

2. Two complaint/grievances in a file labeled pending were not listed on the grievance log. One complain/grievance was dated 06/23/11 and the other was dated 05/23/11. There was no evidence of an investigation and written response within the hospital's grievance policy time frame. The policy states that if after 30 days the investigation is not completed a letter will be sent to the complainant that the hospital is still working to resolve the complaint and the hospital will follow-up with another written response within 60 days. Both complaints were well past the stated time frame.

3. The hospital's grievance coordinator stated at 0945 on 10/13/11 that not all patient complaints were brought to her.

4. The hospital's grievance policy of a complaint does not agree with CMS's definition. The hospital's grievance policy states that if a family/representative complains about the patient care or treatment, then the patient must be contacted to verify that the complainant is their authorized representative. Any person can voice a complaint and the patient does not have to be contacted.

Based on review of hospital documents and medical records, and interviews with hospital staff, the hospital failed to ensure care was provided in a safe setting.

Findings:

1. Unsterilized instruments were used for a surgical procedure on 09/27/2011 for Patient #1. This finding was verified with Staff J, K, and L on the afternoon of 10/13/2011, and with Staff M on 10/14/2011.

2. The hospital's surgical services uses "flash"/immediate sterilization for convenience/"back-to-back" surgical procedures. This occurred 13 of 16 times immediate-use sterilization was utilized between August 1, 2011 and October 12, 2011. (Refer to Tags 0940 and 0749 for specifics). On the afternoon of 10/13/2011, when questioned if other options, like spacing or rearranging the cases, had been reviewed to limit the use of "back-to-back" immediate use sterilization for ENT cases, Staff J told the surveyors the physician would be upset if they altered the schedule.

3. The hospital's surgical services has no method to track and ensure implants obtained from outside sources and used on patients are sterile. Refer to Tag - 0940, Finding #3 for details.

4. Surgical services and infection control do not monitor practices used in the operating room and central sterile to ensure safe practices are utilized. Refer to Tags 0747 and 0940.

Based on review of medical records, hospital documents, and personnel files and interviews with hospital staff the hospital failed to ensure that the nursing care of each patient is assigned to nursing personnel who are trained, qualified, and competent to care for patients with specialized needs. This occurred in 2 out of 2 nursing personnel charts reviewed.

Findings:

1. Two surgical nurses staff O and staff N, did not have current department specific competencies that would evaluate the skill, knowledge, and qualifications of the nurses to care for the complexity and needs of surgical patient.

2. Five out of seven personnel files (L, J, R, K, and X), did not have department specific competencies that would evaluate their qualifications to be assigned to particular patient care areas.

Based on staff interviews and review of hospital records, the hospital failed to ensure the infection control officer maintained a comprehensive system for controlling infections and communicable diseases. The infection control officer did not monitor the surgery department to ensure appropriate measures were taken regarding the sterilization of surgical instruments.

Findings:

1. On 10/12/11 and 10/13/11 surveyors reviewed the "flash sterilization log" . Documentation by staff in the flash log indicates on 9/12/11 the reason a back set was flashed was for "back to back cases". Staff K told surveyors myringotomy sets were flashed because there was not enough time between cases to process the instruments on a full cycle. In an interview with Staff M surveyors were told the physicians were always in a "hurry" and Staff M always felt rushed. Staff M told surveyors physicians complained about turnover times between cases. Staff M also told surveyors staff were not allowed to open rooms until the physicians were in the operating suite. There was not sufficient time to set the cases up and sometimes the wrong fluids or products were pulled. Interview with the designated infection control person, staff U, and the operating room director, confirmed the "flash sterilization log" is not monitored to obtain information to limit the number of instruments being flashed and to implement adherence to current Centers for Disease Control and Prevention (CDC) guidelines that immediate sterilization should only be performed in emergent situations.

a. During the period of August 1, 2011 until October 12, 2011 sixteen surgical instrument loads were immediately sterilized or "flashed". Thirteen of the sixteen instruments were "flashed" due to " Back to back cases and per doctor request." These findings were not monitored by infection control in conjunction with the operating room (OR) director or manager to investigate and monitor measures that can be taken in order to reduce the potential risk of infection in a surgical patient.

b. During review of autoclave tapes, it was shown that on 8/9/2011 that sterilizer number five and load number two contained one set of thyroid instruments and one ear, nose and throat (ENT) special instruments. These instruments were immediately sterilized or "flashed" due to back to back cases.

2. A policy entitled "Sterilization: Flash. Policy. G. Documentation of cycle information and monitoring results is maintained to provide for tracking of the flashed items to the individual patient. Further the policy states "H. Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method".

3. During an interview with Staff J, he stated that he did not know what disinfectant was utilized for cleaning endoscopes, cleaning the operating rooms between cases and what was used as a terminal clean at the end of the day

4."Flash" sterilization: The Centers for Disease Control (CDC -- from Infection Control and Hospital Epidemiology, "Guideline for Prevention of Surgical Site Infection", April 1999, page 261) and Prevention and the Association of Operating Room Nurses (AORN -- Perioperative Standards and Recommended Practices, pages 578 through 581, 2008 edition) do not recommend the use of "flash" sterilization for the routine sterilization of instruments, reasons of convenience or as an alternative to purchasing additional instrument sets or to save time. "Flash" sterilization, according to current CDC guidelines, should -be limited to the purpose of sterilizing a surgical instrument in an emergency, such as when a needed instrument has been dropped or otherwise become contaminated.

Based on record review and interviews with hospital staff the hospital does not ensure that a log of all infections and communicable diseases is maintained that identifies incidents of infection and communicable diseases in both patients and staff that would enable the hospital to evaluate the data contained in the log to determine whether the infections were either present on admission or health-care associated and to protect both the patients and staff from infections.

Findings:

1. On 10/13/2011 Staff U, the person identified as responsible for infection control, told the surveyors the hospital has an infection control log. The infection control log is not complete with the following information included; identification and location of the patient, the date of admission, onset of infection, the type of infection, the cultures taken, the results when known, any antibiotics administered (and whether the organism is sensitive or resistive to the medication), and the practitioners responsible for care of the patient.

2. At the same time, Staff U stated the hospital did not have an infection control log that tracked employee health.

Based on surveyors observations, review of facility documents and interviews with facility staff, the facility failed to provide surgical services in an organized manner with qualified personnel in accordance with acceptable standards of practice.

Findings:

1. Three (J,K,L) of four operating (J,K,L,M) room personnel identified Staff J as the Director of Perioperative Services. On 10/12/11 surveyors were told Staff J was the Operating Room Supervisor by Staff G, Chief Nursing Officer. A staff directory provided to surveyors indicates Staff J is the Perioperative Services Manager. Staff J's personnel file documentation does not show Staff J is a registered nurse with operating room experience. Staff J's personnel file did not have a job description. In an interview on 10/13/2011 Staff J told surveyors he was in charge of Perioperative Services but shared responsibilities with Staff N. Staff J also told surveyors scheduling was handled by Staff N. Organizational documents provided to surveyors did not include Staff N as the operating room supervisor. Staff N's personnel file does not have a job description. In an interview on 10/13/2011 surveyors were told by Staff J he did not know why a termination of a perioperative staff member occurred and that surveyors would need to speak with Staff G the CNO. Staff J told surveyors he was not part of the termination but heard about it. The facility failed to assure surgical services are organized and directed by qualified personnel..

2. Six (J,K,L,M,N,O) of six operating room personnel did not have job descriptions, departmental competencies, and evaluation of skills for the job's each stated they were performing. There is no evidence of a reporting structure provided to surveyors through job descriptions, facility records, staff evaluations and staff interviews.

In a interview on 10/13/2011 Staff K told surveyors Staff J was in charge of surgery but that Staff N was the supervisor she reported to. Staff K also stated she thought Staff N reported to Staff J but did not know for sure. There was no documentation in Staff N's personnel file indicating Staff N was the operating room supervisor in charge of central sterile.
In an interview on 10/13/2011 Staff L told surveyors Staff J was the Director of Perioperative Services but that either Staff J or Staff N will make assignments and write schedules. Staff L told surveyors she reported incidents to Staff N and thought Staff N reported to Staff J.

In an interview on 10/14/11, Staff M (OR registered nurse) told surveyors Staff J was in charge of the operating room. Staff M stated he thought Staff N was "second in command" but he did not report to her.


3. In an interview Staff J told surveyors the facility recently started implanting total joints. During interviews conducted on 10/12/11 and 10/13/11 Three of four personnel interviewed did not know how implants and consignment equipment were cleaned, sterilized, documented, and maintained to insure sterility. Six (J,K,L,M,N,O)of six operating room personnel records did not have evidence of competency and training specific to job responsibilities.

4. The facility failed to integrate surgical services into the Infection Control Program and Quality Assurance Performance Improvement. See tags 0263, 0747.

Based on interviews with staff, review of personnel files and policy and procedures the facility failed to insure the surgical services were supervised by a qualified registered nurse with ongoing education, competency and training in surgical services.

1. On 10/12/11 surveyors were told Staff J was the Operating Room Supervisor. A staff directory provided to surveyors indicates Staff J is the Perioperative Services Manager. In an interview on 10/13/11 Staff K told surveyors Staff J was the Director of Surgery. In a separate interview on 10/13/2011 Staff K told surveyors Staff J was in charge of surgery but that Staff N ( a registered nurse) was the direct supervisor she reported to. Staff K also stated she thought Staff N reported to Staff J but did not know for sure. Later on 10/13/2011 Staff J told surveyors he was in charge of Perioperative Services but Staff N "had nursing". Organizational documents provided to surveyors did not include Staff N as the operating room supervisor. There was no documentation in Staff N's personnel file indicating Staff N was the operating room supervisor.

In an interview on 10/14/11, Staff M (registered nurse) told surveyors Staff J was in charge. Staff M stated he thought Staff N was "second in command" but he did not report to her.

2. On 10/13/2011 surveyors reviewed Staff J's personnel file. Staff J is a surgical scrub technician. Staff J did not have departmental specific orientation, training, and competency. In an interview the afternoon of 10/13/2011 Staff J confirmed these findings.

Based on interviews with staff, review of personnel records, policy and procedures, the facility failed to insure circulating nurses were working in accordance to policy, procedure, and acceptable standards of practice.

Findings:

1. On 10/13/2011 and 10/14/2011 surveyors were told by Staff K, L, and M an incident occurred in which unsterilized surgical instruments were used during a case. Staff K and Staff L indicated Staff O was the circulating nurse for the case. Staff O's personnel file did not include orientation and training as a circulator. There was no documentation Staff O had worked as a circulator in any previous job. Staff O's personnel file indicated Staff O was a new graduate. Staff O's personnel file only included competency for the post anesthesia care unit (PACU).

2. On 10/14/2011 surveyors spoke with Staff M. Staff M told surveyors there had been no formal departmental training and that a contract nurse had oriented Staff M to the computer. Staff M had been assigned a conscious sedation case with another nurse (Staff O) assigned to provide conscious sedation. During the case the assigned conscious sedation nurse left the room to"set up" for the next case. Staff M told surveyors this left only Staff M and the physician in the room during the remainder of the case. Staff M told surveyors Staff O left a unlabeled syringe with Staff M stating it was "Romazicon". Staff O told surveyors there was no labeling indicating type of medication, dosing, date of withdrawal or expiration. Staff O told surveyors the hospital did not provide another conscious sedation nurse during the procedure and the patient was receiving conscious sedation medication. Staff M told surveyors the hospital did not train Staff M to provide conscious sedation. Staff M also told surveyors the physician did not want to wait until the conscious sedation nurse returned. Staff M told surveyors Romazicon was routinely used in the endoscopy suite to "reverse" patients. Staff M told surveyors Staff M did not administer the unlabeled syringe and requested to be removed out of the conscious sedation role. Surveyors reviewed Staff M's file. None of the documents in Staff M's file indicated the hospital had provided hospital or departmental orientation and training.

3. On 10/13/2011 surveyors spoke with Staff K. Staff K told surveyors her primary job responsibilities were in central sterile. Staff K told surveyors she also had functioned as a surgical technician. On 10/13/2011 surveyors reviewed Staff K's personnel files. There was no documentation Staff K had been oriented and trained to central sterile or surgery. There was no documentation indicating Staff K had been instructed in the use of the sterilizers. Staff K did not have a job description in the personnel file.

4. On 10/13/2011 surveyors reviewed Staff J's personnel file. Staff J is a surgical scrub technician. Staff J's personnel file did not have departmental specific orientation, training, and competency. In an interview the afternoon of 10/13/2011 Staff J confirmed these findings.

Based on review of physician credential files and governing body and medical staff meeting minutes for 2011, the hospital does not ensure all physicians performing surgical procedures have privileges granted for the procedures that they perform. One (A) of two (A & B) physicians' credential files reviewed who perform surgical procedures did not have evidence of privileges granted for the procedure the physician performed. Physician A performed laparoscopic appendectomies on two different patients in September 2011 the 25th and the 27th. The privileges delineated in the credential file did not include privileges for a laparoscopic appendectomy procedure.

Based on review of the hospital records and interviews with staff, the hospital failed to maintain a complete operating room log.

Findings:

1. On 10/12/2011 surveyors received a notebook labeled "surgical log". The log provided included column headings "patient identification label, date, time of admission, bed slot, time patient discharged, notes". The note field stipulated prompts of "Temp(temperature):___, oral/axill(axillary)/Tymp(tympanic); Ht: (height)___, Wt (weight): ___. Surveyors reviewed a sheet in the log with the dates of 9/23/11 to 9/26/11. No time of discharge was documented for any patients on the log. The log did not include the name of the anesthesia provider, circulating nurse, scrub nurses, procedures performed, time surgery began and ended. The log did not include all of the required elements.

2. On 10/12/2011 surveyors reviewed a list of procedures by provider. The list indicated a surgical procedure was performed on 9/25/2011. Surveyors reviewed the case performed on 9/25/2011 (Patient #2). Patient #2 was not on the surgical log provided to surveyors. Later on 10/12/2011 Staff A told surveyors the post anesthesia care (PACU) log was the surgical log. The PACU log provided did not include all required elements.

3. This finding was reviewed with administration at the exit conference on 10/13/2011. No further documentation was provided.

Based on interviews with staff and review of records the facility failed to provide an operative report which included all the required elements.

Findings:

1. On 10/13/2011 surveyors were told unsterilized instruments were used in Patient #1's surgery. Staff K and L told their supervisor and thought an incident report was filed and the surgeon was notified. Review of Patient #1's medical record including the operative note did not document the breech in sterile technique in the operative note or an addendum. There was no documentation of a breech in sterility recorded in Patient # 1's medical record.

According to the policy "Process for Reporting Accidents, Injuries, Sentinel and High Risk Events, Date Implemented March 2009. Procedure. 13. The following list includes (but is not limited to ) examples of variances considered to be reportable variances: - break in sterile technique not corrected before any patient exposure to potential contamination". The policy also stipulates "6. Objective documentation of the actual variance is recorded in the medical record. DO NOT include reference to completion of a separate variance report." There was no documentation of a break in sterile technique not corrected before any patient exposure to potential contamination.

2. Implant records provided to surveyors 10/13/2011 indicated Patient #4 had a device placed and removed and replaced with the same but shorter type of device during the intraoperative course. The implant record indicates the device originally placed "was not left in". The operative note does not include a placement and removal of the first device. There is no documentation in the nurses notes two devices were utilized during the case.