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Based upon observation, record review, and interview, the governing body failed to

A. Ensure a sanitary environment to prevent infections;

Refer to Tag A-747

B. Ensure the physical environment was maintained to provide a safe environment for patients;

Refer to Tag A-700

C. Ensure surgical services was following acceptable standards of practice to ensure the health and safety of patients;

Refer to Tag A-940

D. Ensure the hospital maintained an effective, ongoing, quality assessment and performance improvement (QAPI) program;

Refer to Tag A-263

E. Ensure Outpatient services were organized and integrated with inpatient services;

Refer to Tag A-1076

F. Ensure the hospital conducted appropriate discharge planning activities for all inpatients;

Refer to Tag A-799

G. Ensure the hospital had an effective and active utilization review program for the review of the necessity of admissions, extended stays, and professional services, as well as the appropriateness of the facility for the admission.

Refer to Tag A-652

Based upon observation, record reviews, and interviews, the facility failed to:

A. Ensure patients received care in an environment that promoted safety, infection control, and security. The facility failed to provide a sanitary environment to prevent infections in the hospital setting.. The facility also failed to ensure the infection control officer had developed and implemented infection control policies and procedures to investigate, report, prevent, and control infections within the hospital.

Refer to Tag A-0747

B. Follow their own policy to ensure 24 of 24 (#1-#24) patients reviewed were informed of the patient's rights. The facility also failed to ensure Medicare patients received "An Important Message From Medicare" information.

Refer to Tag A-0117

C. Ensure 24 of 24 (#1-#24) patients reviewed were provided written information concerning their rights to make decisions concerning their medical care including their right to accept or refuse medical care and their right to formulate an advance directive.

Refer to Tag A-132

Based on records review and interviews the facility and/or Governing Board failed to

A. incorporate the contracted services into the Quality Program, (Laboratory Services, Therapy services and Linen and Laundry Services). The Materials Management, Plant Operations, Dietary, Housekeeping, Medical Records, Nursing, Radiology, Respiratory, Pharmacy, and Surgery departments were not reporting outcomes to the Quality Program.

A. Refer to Tag A0265

B. to measure, analyze, and track quality indicators from the following departments, Materials Management, Plant Operations, Housekeeping, Surgery, and contracted services Therapy services, Laboratory services, and Linen/Laundry services.

B. Refer to Tag A0267

C. collect data, from the following departments, Materials Management, Plant Operations, Housekeeping, Surgery, and contracted services Therapy, Laboratory, and Linen/Laundry services.

C. Refer to Tag A0273

D. identify opportunities for improvement and changes to improve the quality of patient care in the facility.

D. Refer to Tag A0276

E. choose a performance improvement project.

E. Refer to Tag A0297

F. set expectations related to data information concerning safety and quality of care, treatment and services.

F. Refer to Tag A0309

Based upon records review and interviews, the facility failed to have an effective and active utilization review program for the review of the necessity of admissions, extended stays, and professional services, as well as the appropriateness of the facility for the admission.

Review of policy #2.29 titled "Utilization Review Plan", last reviewed 4/8/11, revealed a comprehensive 19 page utilization review plan that included the purpose of the plan, responsibilities, authority and duties for the utilization review plan, composition of the committee, as well as well as a document titled "Medicare State Operations Manual" with the regulatory references and interpretive guidelines.

Request was made for meeting minutes of the utilization committee, and any reviews or reports related to the activities of the utilization review committee but none were retrieved or offered.

Review of Medical Staff Bylaws, Article X-Committees and Functions, Section 4-Utilization Management Committee revealed the following: A. Composition. The Utilization Management Committee is a standing committee of the medical staff and shall consist of the Physician Advisor, one physician of the active staff, the Administrator or designee, the Director of Nurses or designee, the Utilization Management coordinator, and representatives from Health Information management and discharge planning. The committee shall: 1. Comply with applicable requirements of the Utilization Management plan approved by the medical staff and governing board. 2. Require documentation that Utilization Management is applied regardless of payment source. 3. Require that focused reviews be emphasized. 4. Determine whether under utilization and when appropriate, over-utilization of practices impact adversely on the quality of patient care and recommend the appropriate action to be taken. Meetings. The Utilization Management Committee shall meet as often as necessary to accomplish its functions, but at least six times per year.

An interview was conducted with Staff #6 on 8/18/11 at 2:00 PM. Staff #6 reported the Utilization Review was not presently being done. Staff reported that she does the Case Management part and calls insurance companies to get approvals and referrals and talks with the patient's physician about length of stay. Staff #6 further reported she would guess the Chief of Staff was the Physician Advisor and she was not sure who else was supposed to be on the committee but the committee had not met since she began doing the Case Management 3 months ago.

Based on records review, observations, and interviews the facility failed to
A. maintain a clean and safety environment for the patients,
B. ensures regular maintenance of the facility's equipments was being performed.
C. conducted and reports to QAPI the twelve required fire drills for the year 2010.

Findings were:
1. The surveyors observed during a tour of the Surgical Department on 8/15/2011 and a follow up tour 8/19/2011:

A. The entrance to the surgical suite was cluttered with a mop bucket containing dirty water and mop, a linen hamper containing dirty linens, a trash bag filled with trash sitting on the floor and a trash can containing trash with out a liner . A broken piece of radiology equipment (portable X-ray machine) was sitting in the entrance to the surgical suite.

B. In the surgical suite, the floors appeared dirty, discolored and covered with stains. The operating suite was cluttered with a stretcher, operating room table pushed off to the side, several small tables, an anesthesia machine, an endoscopy cart with two scopes hanging open to the environment along with a second endoscopy cart with scopes hanging open to the environment, a cart with linen on top of it uncovered and open to the environment. There was a linen hamper with dirty linen left from the last surgical case performed on 8/12/2011.

2. During the tour of the Emergency Department on 8/15/2011 and five days later on 8/19/2011, the surveyors observed an unlabeled container in the sink. The container was covered with a cloudy residue and the bottom was stained dark brown. The container was once semi-transparent. The container contained surgical instruments. In the same sink were two coffee cups and three containers of cleaning agents (Betasept, a container labeled bleach, and a container of bed sanitizer). This was the only sink in the patient care area of the emergency room on the trauma side. The contents (instruments) remained in the container for five days. The Emergency Room staff was observed eating food at the Nurses' Station desk. There was a portable (supplemental) air conditioner set up in the emergency room with a flexible pipe that was vented through the ceiling. A ceiling tile was pushed to the side and the flexible pipe was held in place with silk tape.

3. Observed during the course of the survey (8/15 thru 8/19) the Soiled Utility Room wall and sink were discolored with stains. There were puddles of hardened green gel soap on the counter and on the front of the sink. Three infusion pumps sat on the counter for five days. A used commode chair remained in this soiled utility room for five days. On the floor of soiled utility room was a bag labeled spill kit. The floor was discolored with stains.

4. On tour of the facility's Clean Utility Room, the surveyors observed an air conditioner unit in the ceiling with the cover removed (due to a water leak from a rusted drip pan). The drip pan had been removed and the facility's staff had zip-tied a patient bath basin suspended from the ceiling to the unit to catch the leaking water. Suction tubing was taped to a hole in the bottom of the basin. The tubing ran to the wall and was taped down the wall into a trash can. The trash can was approximately 1/3 full of standing water. Sitting on the floor next to the trash can was an isolation set up (a container used to hold the personal protective equipment for use in patient rooms). On a follow up tour of the clean utility room on 8/16/2011, the basin had been removed and the air conditioner cover placed on the unit. The basin and tubing was in the trash can with the standing water still present. This remained in the clean utility room for five days.

5. During the duration of the survey, it was observed that the floors throughout the facility were discolored with stains and that pieces of tile were chipped and missing from the floors.

6. During a tour on 8/15/2011 at 2:30 PM, the patients' Handicap Bathroom access was blocked by a housekeeping cart. To enter the bathroom, a patient would have to pass a barrel of dirty linen and a barrel of trash. In the entrance to patient handicap bathroom, it was observed that the housekeeping department filled their mop buckets here. The dispenser for the cleansing agent for mopping floors was located next to the door at the entrance to patient handicap bathroom. The entrance hall to the bathroom was soiled and stained.

7. Observed on tour 8/15/2011 in patient's room (115), the air conditioner unit was full of dust, dirt, and lint. The bathroom shower had brown stains down the walls. The base of the commode had black build-up with the appearance of mildew. Observed on 8/18/2011, a patient had been assigned to room 115 with no evidence of changes to the condition of the room.

8. Observed while on tour of the medical floor on 8/17/2011 at 10:30 the privacy curtains in one of the patient rooms was stained.

9. Observed on tour of the Dietary department on 8/16/2011 at 10:30, a rusty table where the pots and pans are stored. Over the garbage disposal area, the hot water runs continuously. The dietary staff reported a valve is broken and the hot water has been running continuous over the garbage disposal for one year.

10. During an interview with staff #13 and #16 the question was asked, "How often are the privacy curtains taken down and sent to the laundry?" Staff #13 and #16 responded that the curtains were not sent to the laundry. The last time the curtains were washed, staff #4 took the curtains home and cleaned them.

11. During an interview, staff #10 confirmed that staff #4 took the ER privacy curtains home and laundered them and then returned them to the hospital. During the Exit Conference, Staff #4 confirmed she took the privacy curtains home and laundered them and then returned them to the hospital.

12. Interview with staff #1 and #3 on 8/19/2011 at 3:00 PM confirmed the cleanliness and safety of the facility has not been addressed at this facility.

13. Review of routine and preventive maintenance records revealed only (11) pieces of equipment had been checked on 7/24/2011. The SPBS, Inc is a biomedical repair and maintenance company that services hospital equipment. According to the SPBS, Inc medical equipment service inventory equipment list report for the facility and printed on 12/7/2010, the facility has 311 pieces of equipment. Record review revealed a signed contract dated 3/17/2011 between staff # 44 and the facility for equipment checks.
Interview with staff #3 on 8/19/2011 at 3:00 PM confirmed QAPI (Quality Assurance performance Improvement) program for assuring the facility equipment and patient care equipment was in compliance has not been done.

14. Review of Fire Drill Critiques revealed evidence of drills conducted on nine dates in 2010, and three dates in 2011. In 2010, 7 of 9 fire drills were on the day shift and two fire drills on the night shift. In 2011, 2 of 3 fire drills were on the day shift and one fire drill on the night shift. During an interview with staff #3 on 8/16/2011 at 11:00 am in the office of the Materials management, staff #3 stated that the drill critiques reviewed represented the total drills conducted by the facility.

The condition and practices found pose an Immediate jeopardy to patient's health and safety.

Based on records review, interviews, and observations, the facility failed to:

A. provide a sanitary environment to ensure patient's health and safety

Findings were:
1. During a tour of the Surgical Department on 8/15/2011 and a follow up tour 8/19/2011, the surveyors observed that the entrance to the surgical suite was cluttered with a mop bucket containing dirty water and mop, a linen hamper containing dirty linens, a trash bag filled with trash sitting on the floor and a trash can containing trash with out a liner . A broken piece of radiology equipment (portable X-ray machine) was sitting in the entrance to the surgical suite.

2. In the surgical suite, the surveyors observed that the floors appeared dirty, discolored and covered with stains. The operating suite was cluttered with a stretcher, the operating room table was pushed off to the side, several small tables, an anesthesia machine, an endoscopy cart with two scopes hanging open to the environment along with a second endoscopy cart with scopes hanging open to the environment, a cart with linen on top of it uncovered and open to the environment. There was a rolling cart with a large of Cidex pan stored on top. Stored on the second shelf under the Cidex were open packages of patient supplies. There was a linen hamper with dirty linen left from the last surgical case performed on 8/12/2011.

3. Interview with staff #18 on 8/19/2011 at 9:00 AM during the tour, confirmed the clutter in the surgical suite and that the linen, trash, mop bucket and stained floors had been there since the last surgical case performed on 8/12/2011.

4. During a tour of the Scope Processing Room on 8/19/2011 at 9:00 AM with staff#18, he explained the room was not vented and the ventilation system was not working properly due to equipment needing a new filter. The Air Cleans 1000 ventilation system when turned on starts alarming. The instructions on the machine instruct the user to change the filter. When questioned staff #18 why the filter had not been changed, he stated "the filter cost $500 dollars and the facility will not purchase the filter."

5. The surveyors observed in the Processing Room a pan of Cidex OPA (Cidex solution) for high disinfection of the endoscopy scopes. When asked, Staff #18 was unable to provide a log book or documented evidence for changing of the Cidex solution every 14 days as per manufacturer's guidelines. When asked how often you change the Cidex solution, He stated "I change it every 14 days." Staff was then asked "When was the solution changed?" Staff #18 showed the surveyor a piece of tape date of 8/11/2011 that indicated when the Cidex Solution should have been changed. Staff #18 was not able to produce the CIDEX OPA Solution Test Strips that are needed for checking the concentration of ortho-phthalalldehyde in the Cidex solution. There was no log documenting the Cidex was being checked and monitored.

Review of the manufactures recommendation for use of the Cidex revealed "CIDEX OPA Solution may be reused for up to a Maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the Direction for use. Do Not rely solely on day in use. Concentration of this product during its reuse life must be verified by the CIDEX OPA Solution Test Strips prior to each use to determine that the concentration of orto-phthalaidehyde if above the MEC of 3%. The Product must be discarded after 14 days."

"Use CIDEX OPA Solution in a well-ventilated area and in closed containers with tight-fitting lids. If adequate ventilation is not provided by the existing air conditioning system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthalaldehyde from the air."

Staff #18 was interviewed through out the tour of the Surgical Department on 08/19/2011. Staff #18 confirmed there was neither a log being maintained for the monitoring of when the Cidex was changed nor when the Cidex was tested. Staff #18 confirms that the active ingredient ortho-phthalaldehyde in the Cidex solution was not being monitored because the facility would not purchase the required Cidex OPA Solution Test Strips. Staff #18 confirmed the last endoscopy procedure was done on 08/12/2011 and the endoscopy scope was processed in the Cidex solution that expired on 08/11/2011.

6. During a tour of the Emergency Department on 8/15/2011 and five days later on 8/19/2011, the surveyors observed an unlabeled container in the sink. The container was covered with a cloudy residue and the bottom was stained dark brown. The container was once semi-transparent. The container contained surgical instruments. In the same sink were two coffee cups and three containers of cleaning agents (Betasept, a container labeled bleach, and a container of bed sanitizer). This was the only sink in the patient care area of the emergency room on the trauma side. The contents (instruments) remained in the container for five days. The Emergency Room staff was observed eating food at the Nurses' Station desk. There was a portable (supplemental) air conditioner set up in the emergency room with a flexible pipe that was vented through the ceiling. A ceiling tile was pushed to the side and the flexible pipe was held in place with silk tape.

Interview with staff # 8 on 8/15/2011 at 3:00 PM, confirmed all the items in the Emergency Room sink. When questioned about the contents of the container and what the container is used for, staff # 8 stated this is where we put the instruments we have used in the emergency room that need to be sterilized.

7. During a tour of the facility in the Soiled Utility Room near the nurses' station, the surveyors saw two containers of Cidex. The first container was for floor use and the second container was labeled Ultrasound intravaginal probe. Staff #32 was asked how often the Cidex solution was being changed and checked the answer was "I change it every 28 days and check it before I place the intravaginal probe in the Cidex solution."

Review of the Cidex log for changing the solution revealed the solution was being changed every 28 days. This log was kept in the radiology ultrasound room. Hospital staff members using the Cidex did not have knowledge of when the solution was being changed. The containers of Cidex were not labeled with content (Cidex) or expiration date of the solution.

Review of Cidex OPA product insert revealed:
"CIDEX OPA Solution may be reused for up to a Maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the Direction for use. Do not rely solely on day in use. Concentration of this product during its reuse life must be verified by the CIDEX OPA Solution Test Strips prior to each use to determine that the concentration of orto-phthalaldehyde is above the MEC of 3%. The Product must be discarded after 14 days."

Review of the log for checking the concentration of the Cidex revealed it had been checked by Staff #32 for the intravaginal probe container. The log revealed only one other signature and it was from staff #21. The log showed the Cidex concentration to be adequate on all the dates recorded from 6/29/2011 thru 8/16/2011. On day one of the tour (8/15/2011) the Cidex test strips were checked and pulled from the room. The Cidex test strips had expired on 4/2011 and the container was not labeled with when the Cidex test strips were opened. The test strip bottle states that the strips are only good for 90 days once the bottle is opened. Subsequent review of the log (on 8/16/2011) revealed that the solution was tested on that day, though the bottle of test strips was empty and there were no other test strips available in the facility.

In an interview on 8/19/2011 at 10:30 AM, staff #3 confirmed no Cidex test strips were available in the facility.

8. On day three of the survey (8/17/2011), the surveyors saw in the soiled utility room an intubation handle (the handle and light source for the equipment used to visualize the vocal cords when placing a breathing tube in a patient), complete with batteries, soaking in Cidex solution (it is not recommended that these handles be submersed in liquids). The handle was still soaking on 8/19/2011. There was no evidence of Cidex test strips to check the solution.

During a tour of the facility, in the Soiled Utility Room at the nursing station, there was no evidence of any type of ventilation for the Cidex containers. The vent in the ceiling was covered with dust and lint.

Review of Cidex OPA product insert revealed:
"Use CIDEX OPA Solution in a well-ventilated area and in closed containers with tight-fitting lids. If adequate ventilation is not provided by the existing air conditioning system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthalaldehyde from the air."

9. The surveyors observed during the course of the survey (8/15 thru 8/19) that the Soiled Utility Room wall and sink were discolored with stains. There were puddles of hardened green gel soap on the counter and on the front of the sink. Three infusion pumps sat on the counter for five days. A used commode chair remained in this soiled utility room for five days. On the floor of soiled utility room was a bag labeled spill kit. The floor was discolored with stains.

10. During a tour of the facility's Clean Utility Room, the surveyors observed an air conditioner unit in the ceiling with the cover removed (due to a water leak from a rusted drip pan). The drip pan had been removed and the facility's staff had zip-tied a patient bath basin suspended from the ceiling to the unit to catch the leaking water. Suction tubing was taped to a hole in the bottom of the basin. The tubing ran to the wall and was taped down the wall into a trash can. The trash can was approximately 1/3 full of standing water. Sitting on the floor next to the trash can was an isolation set up (a container used to hold the personal protective equipment for use in patient rooms). On a follow up tour of the clean utility room on 8/16/2011, the basin had been removed and the air conditioner cover placed on the unit. The basin and tubing was in the trash can with the standing water still present. This remained in the clean utility room for five days.

On 8/16/201, the surveyors asked staff #331 "how do you know the equipment in the Clean Utility Room is clean?" She responded, "All equipment in this room is clean." Surveyor observed and confirmed by staff #33, that two of the infusion pumps had some type of dried leakage on the front of the pumps.

Interviewed staff #1 on 8/19/2011, confirmed the basin, tubing and trash can with standing water still present in the Clean Utility Room and present for the duration of the survey.

11. During the survey, the surveyors observed that the floors throughout the facility were discolored with stains and that pieces of tile were chipped and missing from the floors.

The surveyor interviewed staff #10, #13, #16, and #34 on 8/17/2011 at 10:30 AM and they confirmed that the floors had not been stripped and waxed since 2007 when the building was sold to the new owner.

12. During a tour on 8/15/2011 at 2:30 PM, the surveyors observed that the patients' Handicap Bathroom access was blocked by a housekeeping cart. To enter the bathroom, a patient would have to pass a barrel of dirty linen and a barrel of trash. In the entrance to patient handicap bathroom, it was observed that the housekeeping department filled their mop buckets here. The dispenser for the cleansing agent for mopping floors was located next to the door at the entrance to patient handicap bathroom. The entrance hall to the bathroom was soiled and stained.

Interview with staff #16 on 8/17/2011 at 10:30 AM confirmed the housekeeping cart, the dirty linen, and the trash are stored in the entrance to the patient handicap bathroom. This is the only patient handicap bathroom in the facility.

13. During a tour on 8/15/2011 in patient ' s room (115), the surveyors observed the air conditioner unit was full of dust, dirt, and lint. The bathroom shower had brown stains down the walls. The base of the commode had black build-up with the appearance of mildew. Observed on 8/18/2011, a patient had been assigned to room 115 with no evidence of changes to the condition of the room.

Interview with staff #16 on 8/17/2011, confirmed the dirty air conditioner, the stains on shower wall, and the build-up at the base of the commode.

14. During a tour on 8/18/2011 at 9:00 AM, the surveyors observed that the patient nutrition refrigerator had brown liquid in the bottom shelf. The refrigerator had frozen milk and juice which had been placed in Styrofoam cups. The cups had frozen and leaked in the refrigerator. There was documentation that the refrigerator temperature had been checked by the ward clerk earlier that morning. Expired milk (boost) dated 7/27/2011 x 4 was found in the refrigerator.

The ward clerk was interviewed on 8/18/2011 at 9:00 AM and confirmed the brown liquid in the bottom of refrigerator, all the milk and juice in Styrofoam cups were half frozen and leaking, and boost had expired.

15. The surveyors observed while on tour of the medical floor on 8/17/2011 at 10:30 that the privacy curtains in one of the patient rooms was stained.

The surveyors asked Staff #13 and #16 "How often are the privacy curtains taken down and sent to the laundry?" Staff #13 and #16 responded that the curtains were not sent to the laundry. The last time the curtains were washed, staff #4 took the curtains home and cleaned them.

During an interview staff #10 confirmed that staff #4 took the ER privacy curtains home and laundered them and then returned them to the hospital.

During the Exit Conference Staff #4 confirmed that she took the privacy curtains home and laundered them and then returned them to the hospital.


B. ensure that the infection control officer had developed and implemented infection control policies and procedures as evidenced by the following findings:

Findings were:
1. Record review of manager's meeting dated from 7/20/2010 thru 7/26/2011 revealed one meeting dated 12/7/2010, Medical Executive meeting dated 12/3/2010, and Governing Board Meeting dated 12/14/2010 discussed the Infection Control Risk Assessment conducted by the infection control nurse. The events with the highest scores would be the indicators for the infection control plan. This is the only time infection control is documented in the last year of meetings.

2. Review of the Medical Staff By-laws Article X Section 6 Committee and Functions revealed

" A. Composition. The Infection Control Committee/Function is a standing committee of the medical staff and will consist of two (2) physicians from the active medical staff, a representative from administration and from nursing services, and the individual(s) responsible for infection control surveillance activities in the hospital. Other individuals, representing the operating room, pharmacy, housekeeping and laundry, engineering and maintenance, central
services, dietetic services, respiratory care services, etc., shall participate as non-voting consultants on an as-needed basis as requested when their area is involved. The Chief of Staff shall select the chairman.

B. Responsibilities, Duties, and Authority. The committee shall prevent, investigate, and control infection in the hospital by
1. maintaining surveillance of hospital infection potentials.
2. developing a system for identifying, reporting, and analyzing the incidence and major causes of hospital acquired infections,
3. developing and implementing, through administration and the medical staff, a preventive and corrective program designed to minimize infection hazards, and to include an employee health program.
4. actively promoting the adequate application of general policies relating to infection control for all areas of the hospital, to include, but not limited to, isolation procedures and techniques, sterilization procedures, the safe disposal of infectious or contaminated wastes, and prevention of cross-infection through equipment use (e.g., anesthesia, respiratory care, physical therapy, etc.).
5. instituting any appropriate control measure or study if there is suspicion of a danger to patients or personnel. When the situation is considered to be urgent, the committee chairman of the committee or the infection control clinician may institute the control measure immediately and will be assisted by hospital personnel in doing so. The Chief of Staff and Administrator shall be notified as soon as any urgent control measure is instituted and shall be consulted prior to the institution of any non-urgent measure. When the issue involves the care of a private patient, the attending practitioner shall be notified as soon as possible; however, when the patient ' s attending practitioner does not consider the measure necessary (e.g., the need to isolate a patient), the decision of the committee chairman or member, following established infection control policy, shall prevail.
6. reviewing and approving, at least every two years, all policies and procedures related to the infection surveillance, prevention, and control activities in all hospital departments/services.
7. determining which cleaning agents will be used in the hospital.
8. determining when environmental cultures are required.

C. Meetings. The Infection Control Committee shall meet as often as necessary to accomplish its functions, but at least four (4) times per year. The practitioner findings, after any required peer review, will be placed in the practitioner's file."

3. Record review of infection control log revealed the infection control log consisted of patient name, type of infection, date, antibiotic started, and if cultures were done. These items were recorded in a spiral notebook. No evidence of monitoring or tracking of incidents related to infections or communicable diseases.

Interview of staff #6 on 8/18/2011 at 2:00 PM confirmed that the infection log was incomplete and did not have any notations about employee health issues.

4. Review of personnel files revealed no training or education on infection control for the facility staff.

5. Interview with staff #5 and #6 on 8/22/201, confirmed infection control meetings have not met as required by the Medical Staff By-laws. Record review of Manger Meeting minutes dated July 2010 thru July 2011 reveled no evidence of infection control problems being addressed in these meetings. Interview of staff #5 on 8/19/2011 at 3:00 PM confirmed infection problems have not been addressed in the QAPI nor has staff been in-serviced.


The condition found at this facility and the practices observed pose Immediate Jeopardy to patient's health and safety.

Based upon records review and interviews, the facility failed to ensure that discharge planning was done for patients requiring it.

Review of the facilities discharge planning policy and procedures revealed that the facility's policy was unclear and failed to contain all the requirements pertaining to discharge planning Review of 5 of 5 inpatient medical records (#3, #7, #9, #14, #16) revealed no documentation of a discharge planning process. Refer to Tag A-800.

Review of the facility's policy # PCS 06-001, titled "Discharge Planning, Interdisciplinary" revealed the following: 1.2 It is the policy of this service to help promote interdisciplinary discharge planning. Social Service will coordinate discharge planning for patients identified and referred in the high-risk or life-threatening categories."

The facility does not offer Social Services. The only screening done of patient's discharge/case management needs was found in the initial nursing assessment in the section titled "Discharge Needs/Case Management". This section contained the following "yes" or "no" questions: "1. Dependent Adult; 2. Pediatric with needs; 3. Physician/Nurse Referral; 4. Home alone and over 75; 5. Caregiver, Family Member, Significant other available for support/care; 6. Friends/neighbors available for support/care; 7. non-compliance with medical regime; 8. Diagnosis: New CVA (Cerebral Vascular Accident), Cancer, Fracture, Alzheimer's, Overdose, Alcohol abuse; 9. Did the injury result from a domestic dispute/assault; 10. Do you have any concerns for your safety when you leave the hospital; 11. Do you feel someone has or may take advantage of you financially; 12. Do you feel you have been or may be at risk of physical/sexual assault." This section of the initial nursing assessment did not have a score to determine categories of need as mentioned in the policy that patients in the "high risk or life threatening" categories would receive discharge planning.

Further review of the policy revealed, Section III-Interdisciplinary Planning Team, 3.1 'Will be comprised of health care disciplines to include the nurse and the physician. Other health care disciplines will serve as consultants, such as rehab services, Pharmacist, Social Worker, dietician, and respiratory therapy. 3.3 Content for Team Conference: The team will discuss: Reason for admission, Problems that need to be resolved prior to discharge, and identify which health care discipline will be needed to assist with the problem. Follow-up conference will include outcomes of actions." The policy failed to state how often the Team Conferences would be held or the purpose of the the team meeting. Refer to Tags A-806, A-807, A-818.

The policy did not address a discharge planning evaluation and how and when that was to be done, what to do if the patient, patient's family, or patient's physician requested discharge planning, process for developing and reassessing the patient's discharge plan, counseling or education for patient and family, how a patient would be provided information regarding skilled nursing facilities, home health, hospice, or durable medical equipment. The policy also did not include reassessing the discharge planning process by integration into the QAPI ( Quality Assurance Performance Improvement).Refer to Tag A-843.

Review of medical records #3, #7, #9, #14, #16 revealed no documentation to indicate any discharge planning process was taking place. There was no documentation of discharge planning evaluations. There was no documentation of Interdisciplinary Team Conference or nursing notes related to discharge planning. There were no patient care plans in the medical records. There was a discharge summary/ instruction form in each medical record that was completed at time of discharge with discharge instructions for medication and follow-up appointments. Refer to Tags A-808, A-809, A-811.

An interview was conducted with the Director of Nursing on 8/19/11 at 2:30 PM. The Director of Nurses confirmed that discharge planning was not done by the facility and the Director replied, "I never have known what discharge planning means so no, we're not doing it."

The cumulative effect of the hospitals failure to meet these standards results in the Condition of Discharge Planning not to be met.

Based on record review, observation and interview the facility failed to

A. provide an ongoing process of the QAPI (quality assurance performance improvement) program that measures, analyzes, tracks adverse patient events, infection control, and other aspects of performance improvement for the surgical department.

Findings were:

1. Review of meetings Titled Managers Meetings dated July 20, 2010 thru July 20, 2011 revealed no evidence of routine collection, organization, follow-up, and evaluation of data being processed from the surgical department for quality assurance.

There was no evidence of documentation that any staff member had taken responsibility for collecting, measuring, analyzing , or tracking performance improvement in the surgical department for the facility

2. An interview with Director of Nursing on 8/19/2011 at 3:30 PM confirmed that no QAPI (quality assurance performance improvement) data were collected, measured, analyzed, or tracked in the surgical department for the facility

B. provides a sanitary environment to prevent infections in the surgical setting.

Findings were:
1. During a tour of the Surgical Department on 8/15/2011 and a follow up tour 8/19/2011, the surveyors observed that the entrance to the surgical suite was cluttered with a mop bucket containing dirty water and mop, a linen hamper containing dirty linens, a trash bag filled with trash sitting on the floor and a trash can containing trash with out a liner . A broken piece of radiology equipment (portable X-ray machine) was sitting in the entrance to the surgical suite.

2. In the surgical suite, the floors appeared dirty, discolored and covered with stains. The operating suite was cluttered with a stretcher, the operating room table was pushed off to the side, several small tables, an anesthesia machine, an endoscopy cart with two scopes hanging open to the environment along with a second endoscopy cart with scopes hanging open to the environment, a cart with linen on top of it uncovered and open to the environment. There was a rolling cart with a large of Cidex pan stored on top. Stored on the second shelf under the Cidex were open packages of patient supplies. There was a linen hamper with dirty linen left from the last surgical case performed on 8/12/2011.

During the tour on 8/19/2011 at 9:00 AM, staff #18 confirmed the clutter in the surgical suite and that the linen, trash, mop bucket and stained floors had been there since the last surgical case performed on 8/12/2011.

3. During the tour of the Scope Processing Room on 8/19/2011 at 9:00 AM with staff#18, he explained that the room was not vented and the ventilation system was not working properly due to equipment needing a new filter. The Air Cleans 1000 ventilation system when turned on starts alarming. The instructions on the machine instruct the user to change the filter. When questioned staff #18 why the filter had not been changed, he stated " the filter cost $500 dollars and the facility will not purchase the filter."

4. the surveyors observed in the Processing Room a pan of Cidex OPA (Cidex solution) for high disinfection of the endoscopy scopes. When asked, Staff #18 was unable to provide a log book or documented evidence for changing of the Cidex solution every 14 days as per manufacturer's guidelines. When asked how often you change the Cidex solution, He stated "I change it every 14 days." Staff was then asked "When was the solution changed?" Staff #18 showed the surveyor a piece of tape date of 8/11/2011 that indicated when the Cidex Solution should have been changed. Staff #18 was not able to produce the CIDEX OPA Solution Test Strips that are needed for checking the concentration of ortho-phthalaldehyde in the Cidex solution. There was no log documenting the Cidex was being checked and monitored.

Review of the manufactures recommendation for use of the Cidex revealed "CIDEX OPA Solution may be reused for up to a Maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the Direction for use. Do Not rely solely on day in use. Concentration of this product during its reuse life must be verified by the CIDEX OPA Solution Test Strips prior to each use to determine that the concentration of ortho-phthalaldehyde if above the MEC of 3%. The Product must be discarded after 14 days."

"Use CIDEX OPA Solution in a well-ventilated area and in closed containers with tight-fitting lids. If adequate ventilation is not provided by the existing air conditioning system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthalaldehyde from the air."

5. Staff #18 was interviewed through out the tour of the Surgical Department on 08/19/2011. Staff #18 confirmed there was neither a log being maintained for the monitoring of when the Cidex was changed nor when the Cidex was tested. Staff #18 confirms that the active ingredient ortho-phthalaldehyde in the Cidex solution was not being monitored because the facility would not purchase the required Cidex OPA Solution Test Strips. Staff #18 confirmed the last endoscopy procedure was done on 08/12/2011 and the endoscopy scope was processed in the Cidex solution that expired on 08/11/2011.

6. During the tour on 8/19/2011 at 10:00 AM, the surveyors observed that the endoscopy scopes were hanging from the endoscopy cart in the operating room suite open to the environment. It was observed on the tour a total of 4 scopes hanging open to the environment. An endoscopy and colon scope on the cart closet to the stretcher. The second endoscopy cart was pushed in the corner of the operating suite with an endoscopy and colon scope hanging open to the environment.

During tour, staff #18 was asked if scopes are reprocessed prior to the surgical procedure. Staff #18 stated scopes are cleaned after the procedure and hung back on the endoscopy cart till the next scheduled case. No prior cleaning is done before the case.
Review of operating log/register and interview with Staff #18 revealed scheduled cases for this year have been (2) in January, (1) in February, (1) in March, (3) in April, (2) in July, (2 ) in August.

Interview with Staff #18 confirmed no processing of the scopes prior to the surgical procedure.

Hang Time of Scopes Prior to Reprocessing
Published by: The University of Chicago Press on behalf of The Society for Heath Epidemiology of America
ASGE-SHEA Guideline
Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2011

"American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Healthcare Epidemiology of America (SHEA) collaborated with multiple physician and nursing organizations, infection prevention and control organizations, federal and state agencies, and industry leaders to develop evidence-based guidelines for reprocessing GI endoscopes.

They include endoscope shelf life or " hang time " (the interval of storage after which endoscopes should be reprocessed before use), the role of microbiological surveillance testing of endoscopes after reprocessing, and questions regarding endoscope durability and longevity from the standpoint of infection prevention.

In the interest of utmost caution, Association of perioperative Registered Nurses (AORN) and the Association for Professionals in Infection Control and Epidemiology (APIC) espouse maximal storage intervals without reprocessing of 5 and 7 days, respectively."

C. provides and maintains an environment for sterile processing, continued education for staff on sterilization of supplies, biological testing, and review and revision of sterile processing policies and procedures.

Findings were:

1. Observed on tour of the sterile processing room on 8/19/2011 at 10:00 AM with staff #18 the autoclave last inspection was March 2010.

2. Review of record titled Steam Sterilization Record revealed sterilization log did not include load identification, indicator results, and identification of the contents of the load.


3. Review of personnel record for staff #18 revealed no documentation of education on sterilization of supplies since 2006.

4. Staff #18 was interviewed on 8/19/2011 at 10:30 AM and confirmed that he had not taken any type of education courses on sterilization of supplies and equipment since 2006. Interview with Director of Nurses on 8/19/2011 at 2:00 PM confirmed education courses for sterilization of supplies had not been provided.

Review of record titled Steam Sterilization Record revealed biological readings were not being read within the 48 hour incubation time period and following hospital policy.

5. Review of policy titled Biological Monitoring (spores) SPD#12B revealed:
"4.12 A final determination of sterility can be made after 48 hours of incubation.
4.21 Document finding in the log book. If SPD (Sterile Processing Department) staffs are not available to read spore testing at 48 hours, it will be read and documented early the next morning."

Review of the manufactures recommendation for use of 3M Attest Biological Monitoring System Technical Product Profile revealed "When examining the processed indicator at regular intervals such as 8, 12, 18, 24 and 48 hours, also examine the control indicator for a color change toward yellow (evidence of bacterial growth). Record results and discard indicators in accordance with your healthcare facility's policy. The Attest (Trademark) monitoring system provides separate color coded vials for steam indicators. This one spore per vial system provides the user with the best assurance of sterility. If both indicator organisms are on the same spore strip (e.g., as in a two spores per vial system), a positive growth control could be obtained if incorrect incubation conditions existed (e.g., incubator not functioning, or vials inadvertently incubated at wrong temperature). If the test biological indicator came from a cycle with a sterilization process failure, a false positive control and false negative test would result."
Incubation
Attest (Trademark) System for SteamAttest (Trademark) Indicator Cap Color Incubation time
1261P Blue 24 hours
1262P Brown 48 hours

Observed on tour 8/19/2011 at 10:00 with Staff #18 the biological test had been in the incubator since 8/14/2011.

staff #18 was interviewed on 8/19/2011 at 10:00 and confirmed confirmed that the biological test placed in the incubator on 8/14/2011 was still present on the 8/19/2011 and the autoclave inspection label read March 2010.

6. Review of record titled Sterile Processing Department policy and procedure manual revealed the last review and revision was 6/15/2005.

7. Review of record titled Temperature and Humidity Reading revealed the last recording of temperature and humidity in the surgical suites was May 20, 2009, and was not read daily as per the policy for Temperature and Humidity Control in the SPD (Sterile Processing Department Manual.)

Review of policy titled Temperature and Humidity Control in the SPD (Sterile Processing Department) revealed
"I. PURPOSE: Provide guidelines for humidity and temperature control in the SPD and
Sterile Storage Area.
II. POLICY: To ensure the bacterial count will be at a minimal the Relative Humidity of
the air in the SPD and Sterile Storage should be maintained between 30- 60% with the temperature maintained within the following temperature ranges:
Decontamination- 60 to 65 degree F
Sterilization room- - 75 to 85 degree F
Sterile storage - up to 75 degree F
III. PROCEDURE: The temperature and humidity will be documented on the daily SPD
and Sterile Storage Area Log. If found to be out of range, the OR Supervisor and/or Plant Operations Supervisor will be notified. Corrections and actions taken will be documented on the SPD or Sterile Storage Area Log. Temperature and Humidity outside the recommended ranges will also be reported to the infection control nurse and sterile items will be considered unsterile."

Staff #5 was interviewed on 8/16/2011 at 11:00 AM and confirmed that the Sterile Processing Department policy and procedure manual had not been reviewed and revised since 6/15/2005. Temperature and Humidity had not been recorded since May 20, 2009.

D. provide operating room supervision for the surgical Department.

Findings were:

1. Review of records revealed one part-time registered nurse and one scrub technician for the surgical department.

2. Review personnel file for Staff #23 revealed the job description for a RN Circulator signed 6/4/2009. Staff #23 only works part-time.

Staff #5 was interviewed on 8/15/2011 at 3:00, and confirmed that the surgical department consist of one part-time registered nurse and one scrub technician. The Director of Nursing (#5) stated "I do not know anything about the Surgery Department."

E. ensure the surgical department policy and procedure manual had been approved by the medical executive committee and the governing board.

Findings were:

1. Review of record titled Endoscopy policy and procedure manual revealed the last revision and review was 6/4/2009.

2. Review of the surgical department policy and procedure manual revealed no signature page for approval of the policies. There was no evidence the medical executive committee or governing board had approved the surgical department policy and procedure manual.

Interview with staff # 4 and # 5 on 8/22/2011 at 1:30 PM confirmed the surgical department policy and procedure manual had not been revised or reviewed. The administrator was unaware that policy and procedures required approval by the medical executive committee and the governing board.

F. have working equipment in the operating room suites while surgical cases were being performed.

Findings were:

During a tour of the surgical suite on 8/19/2011 at 9:00 AM, the surveyors observed that the cardiac monitor had a sign on it posted broken 7/20/2011. Surgical cases were performed on 7/21/2011, 8/11/2011, and 8/12/2011.

Interview on 8/19/2011 at 9:00 AM with Staff #18, confirmed the cardiac monitor had been broken since 7/20/2011.

G. ensure the surgical department had a complete and up-to-date register.

1. Review of record titled "OR, ANES, PACU AND UNITS DATE " (operating room log/register) revealed missing components of the operating room register. Review of register dates August 5, 2010 thru July 14, 2011 found no evidence of name of surgeon, name of personnel (scrub and circulating), type of anesthesia used and name of person administering it, Pre and post -op diagnosis, and age.

Interview on 8/19/2011 at 9:00 AM with Staff #18, confirmed the operating room log/register is incomplete.

2. Record review of log/register revealed missing names of patients receiving surgical procedures. Patient #23 had procedure on 7/21/2011, #24 had procedure on 8/11/2011, and #25 had procedure on 8/12/2011.

Interview on 8/19/2011 at 11:30 AM with Staff #39, confirmed patient #23, #24, and #25 had surgical procedures performed.

H. ensure the operative report was complete on two of two surgical records.

Findings were:

Review of operate records #23 and #24 revealed no entries of time and date of surgery, assistants in performing the procedure, description of findings, and name of surgical procedure performed. The operative reports were signed and dated, but not timed.

The condition and the practices found in the Surgical Department pose an Immediate jeopardy to patient's health and safety.

Based upon records review and interview, the facility failed to ensure outpatient services were organized as a department of the hospital.

The facility failed to establish policies and procedures to assure integration of outpatient services with inpatient services. Refer to Tag A-1077

The facility also failed to ensure that an individual was was responsible to direct the overall operation of the outpatient services. Refer to Tag A-1079.

Based upon record review and interview, (A) the Governing Body failed to identify the categories of physician and non-physician candidates eligible for granting of clinical privileges. The Governing Board also failed to identify the types of practice prerogatives and terms and conditions that may be granted to qualified Allied Health Professionals (AHPs). (B) The Governing Body also failed to ensure that 4 of 4 (#28, #29, #37, #38) AHPs had a designated supervising physician and the degree of supervision established for the AHP. (C) The Governing Body failed to ensure that patients are under the care of a physician based on review of 5 of 25 ( #3, #7, #9, #16, #22 ) medical records which showed that an AHP was the health care provider working independently to provide health care services to patients.

(A) Review of the Governing Body Bylaws, "Article IV-Organization of the Medical Staff" revealed the following: "The Governing Board shall organize the physicians and other practitioners granted privileges at the Hospital into a medical Staff under Medical Staff Bylaws approved by the Governing Board." Review of "Article V-Medical Staff Appointments, Section 1-Governing Board Authority" revealed the following: "The Governing Board shall have authority and responsibility for all appointments and reappointments of Medical Staff members and assignment of clinical privileges in accordance with the Medical Staff Bylaws, Rules and Regulations." Further review of the bylaws revealed no categories of candidates eligible for appointment to the medical staff or granting of privileges.

Review of the Medical Staff Bylaws, Article V-Categories of the Medical Staff, Section 6-Allied Health Professionals, B. Categories of Allied Health Professionals (AHP) Eligible for Practice Prerogatives revealed the following: The governing board shall, at least once each medical staff year, review and designate the categories of AHPs eligible to apply for practice prerogatives in this hospital. The governing board shall also identify the types of practice prerogatives and terms and conditions that may be granted to qualified AHPs in each category." Further review of medical staff bylaws revealed no categories were identified of AHPs eligible to practice in the facility, no evidence of the governing board reviewing or designating the types of practice prerogatives and terms and conditions that may be granted to qualified AHPs.

(B)Further review of the Medical Staff Bylaws, Article V, Section 6, D-2 revealed the following: "Each AHP who is granted practice prerogatives shall designate a supervising physician on the medical staff, if appropriate, for purposes of supervision and reporting. Evidence of such supervision shall be included in the AHP's application for practice prerogatives. The degree of supervision required, whether direct or remote, shall be clearly established for each AHP".

Review of the credentialing files for AHPs #28, #29, #37, and #38 revealed no documentation of a supervising physician, no supervisory agreement between the AHP and the Supervising Physician, and no determination of the degree of supervision required.

An interview was conducted with the Director Of Medical Staff Services on 8/22/11 @ 11:00 am. The Director reported that she knew the AHPs had a supervising physician but there was no written agreement for physician supervision. The Director also reported there was no specification of what the AHP or the Physician was responsible for in an agreement.

(C) Review of the Medical Staff Bylaws, Article V, Section 6, A revealed the following: Allied Health Professionals are health care providers who may work independently or dependently to provide health care services to patients. All Allied Health Professionals working at this hospital must be under the supervision of a member of the medical staff.

Review of patient medical records revealed the following:

Patient #3 was admitted on 1/3/11 with a cough and generalized weakness. Patient was seen in the Emergency Room by Staff #28 who was a Physician Assistant (PA). Staff #28 wrote admitting orders to admit to Staff #27 who was a Medical Doctor (MD). However, Staff #28 wrote the History and Physical, Physician Progress Notes, wrote physician's orders, and wrote the discharge summary. Staff #27 signed a telephone order that he had given, but wrote no other orders, progress notes, and did not co-sign any documents done by the AHP (#28).

Patient #7 was admitted on 2/7/11 with complaints of nausea, vomiting, and right flank pain. The patient was 28 weeks pregnant. Admission orders were written by MD (Staff #41) to MD (Staff #42) services. All other orders were written by (Staff #37) who was a Family Nurse Practitioner (FNP). The History and Physical and Discharge Summary were completed by Staff #37. MD (Staff #41) did not provide care to the patient, wrote no orders or progress notes, and did not co-sign any documents done by Staff #37.

Patient #9 was admitted on 3/9/11 with an allergic reaction to Tylenol PM. Patient was seen in the emergency room by MD (Staff #42) and admitted the patient to the service of MD (Staff #27). PA (Staff#28) dictated a short stay summary and wrote discharge orders. There was no progress notes written by PA(Staff #28) or MD (Staff #27). Staff #28 wrote discharge orders but there was no evidence that Staff #27 provided supervision during this admission.

Patient #16 was admitted on 5/25/11 with 3rd degree burns over 10% of her body. Patient was seen in the emergency room by MD (Staff #41), was admitted to the services of MD (Staff #43) but was provided care by Nurse Practitioner (Staff #37). Staff #41 wrote admitting orders but staff #37 completed the history and physical and all other orders to direct the patient's care. There was no documentation of supervision from any MD. and there was no orders, progress notes, or any other documentation by Staff #43, who was the admitting physician.

Patient #22 was seen in the emergency room on 7/30/11 with complaints of mouth and throat pain and fever. Patient was seen by PA (Staff # 29) in the emergency room and discharged home with a diagnosis of pharyngitis. There was no evidence of physician supervision documented in the medical record.

Based upon record review and interview, the Governing Board failed to approve medical staff bylaws, rules and regulations.

Review of the Governing Board bylaws, "Article VI-Medical Staff Bylaws" revealed the following, "The Medical Staff shall be regulated by Medical Staff Bylaws, Rules and Regulations which set forth its organization and government and which, when warranted, shall be reviewed and revised by the Medical Staff. the period between reviews shall not exceed two (2) years. The Medical Staff may recommend to the Governing Board the adoption of proposed Bylaws, Rules and Regulations and amendments thereto, and such changes shall become effective when approved by the Governing Board.

Review of "Medical Staff Bylaws, Rules and Regulations, Article X-Committees and Functions, Section 2-Medical Executive Committee, B. Responsibilities, Duties, and Authority" revealed the following: "The Medical Executive Committee shall (#23) serve as the Bylaws, Rules and Regulations Committee and shall (a) cause , through ongoing review, that the bylaws, rules and regulations reflect current practice and an efficient organization of the medical staff to perform its functions; (b) review at least annually the medical staff bylaws, rules and regulations and recommend to the Medical Executive Committee and the governing board any changes deemed necessary for compliance with applicable laws and accreditation requirements.

Further review of the "Adoption of Bylaws" page revealed the Medical Staff bylaws, rules and regulations were adopted by the Medical Staff on 12/3/04 and approved by the Governing Body on 12/08/04. This was the only documentation found that the Medical Staff bylaws, rules and regulations had ever been adopted, reviewed or revised.

Further review revealed that a change of ownership occurred on 12/1/07. There was no documentation that the Governing Body established with the change of ownership had ever approved the Medical Staff Bylaws, Rules and Regulations.

An interview was conducted with the Director of Medical Staff Services on 8/17/11 at 2:00 PM. The Director confirmed the dates on the Adoption of Bylaws page as the only dates noted of review and revision of bylaws, rules and regulations.

Based upon record reviews and interviews, the governing body failed to ensure that the medical staff was accountable to the governing body for patient care services being provided by 4 of 4 (#28, #29, #37, #38)Allied Health Professionals (AHP). AHPs had no documentation of a collaborative agreement with a supervising physician. The governing body failed to ensure the designation of practice prerogatives by which the AHPs could practice in the facility. The Allied Health Professionals were not provided supervision by an attending physician and the governing body failed to ensure practice prerogatives were designated for the AHPs.

REFER TO TAG A-0358

Based upon record reviews and interviews, the governing body failed to ensure contracts for services were for the current entity and were reviewed through the Quality Assurance Performance Improvement (QAPI) program.

Review of the contract notebook revealed 24 contracts that were entered into by the previous hospital corporation that had never been revised or rewritten by the current ownership of the facility. There was no documentation in the contract book or that was made available by the administrator that the contracts with the previous corporation would remain in effect with the current ownership.

Review of the Quality Assurance Performance Improvement reporting information revealed there was no reporting to the QAPI program from the following contracted services: Laboratory, Linen and Laundry, and Therapy Services.

An interview was conducted by the Director of Medical Staff Services on 8/19/11 at 2:00 PM. The Director confirmed that contracts had not been reviewed or rewritten by the current ownership and that the contracts that were entered into by the previous ownership were currently null and void without documentation from the contracted service that the contract with the previous owner would be honored by the current owner.

Based upon records review and interviews, the facility failed to follow their own policy to ensure 24 of 24 (#1-#24) patients reviewed were informed of the patient's rights. The facility also failed to ensure Medicare patients received "An Important Message From Medicare" information.

Review of policy and procedure # PM 1.402 titled "Patient Rights and Responsibilities", 3.0-Procedures revealed the following: "Upon admission, all patients or their representative will be given a copy of the "Patient's Rights and Responsibilities". The "Patient's Rights and Responsibilities" will be explained to the patient upon registration/admission. This explanation will be in a language he/she can reasonably be expected to understand. Documentation of the patient's receipt of the "Patient's Rights and Responsibilities" will be made by the patient and placed in their medical record."

Review of 24 medical records revealed a form titled Conditions of Services that contained a section #9 that contained the following check boxes that the patient has received the Additional Facility Specific Addendum: Patient Rights and Responsibilities; Important Message from Champus; Important Message from Medicare; Authorization to Disclose; and Information regarding Advance Directives. Nineteen (19) of 24 records reviewed revealed no check mark that patient had received information "Patient's Rights and Responsibilities", "Important Message From Medicare" or ".Information regarding Advance Directives."

An interview was conducted with Staff #39 on 8/22/11 at 11:00 am. in the Outpatient Admitting Office. Staff #39 reported the patient was not given "Patient's Rights and Responsibilities" or "The Important Message From Medicare".

An interview was conducted with Staff #40 on 8/22/11 at 11:00 am. in the Emergency Room Registration Area. Staff #40 reported the patient was not given "Patient's Rights and Responsibilities" or "The Important Message From Medicare".

Based upon records review and interviews, the facility failed to ensure that 24 of 24 (#1-#24) patients reviewed were provided written information concerning their rights to make decisions concerning their medical care including their right to accept or refuse medical care and their right to formulate an advance directive.

Review of 24 medical records revealed a form titled Conditions of Services that contained a section #9 that contained the following check boxes that the patient has received the Additional Facility Specific Addendum: Patient Rights and Responsibilities; Important Message from Champus; Important Message from Medicare; Authorization to Disclose; and Information regarding Advance Directives and a check box to indicate if patients have executed an Advance Directive and if they brought a copy. Nineteen (19) of 24 records reviewed revealed no check mark that patient had received "Information regarding Advance Directives."

An interview was conducted with Staff #37 on 8/22/11 at 11:00 am. in the Outpatient Admitting Office. Staff #37 reported the patient was not given information regarding advance directives.

An interview was conducted with Staff #38 on 8/22/11 at 11:00 am. in the Emergency Room Registration Area. Staff #38 reported the patient was not given information regarding advance directives.

Based upon observation, record review, and interview, the facility failed to ensure patients received care in an environment that promoted safety, infection control, and security. The facility failed to provide a sanitary environment to prevent infections in the hospital setting.. The facility also failed to ensure the infection control officer had developed and implemented infection control policies and procedures to investigate, report, prevent, and control infections within the hospital.


Refer to Tag A-0747

Based on records review and interviews, the facility failed to collect data from the following departments: Materials Management, Plant Operations, Housekeeping, Surgery, and contracted services Therapy, Laboratory, and Linen/Laundry services.

Review of the Administrative Policy Manual; Performance Improvement Plan, Policy
# 2.8: 3.4 stated "The Medical Staff, employees and contracted services participate in identifying opportunities for improvement, data, collection, multidisciplinary teams and implanting actions to sustain improvements."

Review of the Administrative Policy Manual; Performance Improvement Plan, Policy
# 2.8: 3.6 Performance Improvement Teams stated "The team members represent the various departments or disciplines involved in the process being improved. The Performance Improvement team is responsible for designing, measuring, assessing, improving, and reassessing to assure sustained improvement. The performance improvement teams are time limited and focused on a particular process and outcome. The teams submit final findings and recommendations to the Performance Improvement Committee."

Review of the Managers Meeting minutes from July 2010 till July 2011 found no evidence the Materials Management, Plant Operations, Housekeeping, Surgery, and the contracted services Laboratory, Therapy , and Linen /Laundry services have data (specific to their department) to report to Performance Improvement Committee.

Interview with the Staff #4 and #5 on 8/19/2011 at 2:30 PM in the survey office confirmed there were no quality data being reported to the Performance Improvement Committee from the Materials Management, Plant Operations, Housekeeping, Surgery, and the contracted services Laboratory, Therapy , and Linen /Laundry services.

Based on records review and interview the facility's quality program failed to choose a performance improvement project.

Review of the Managers Meeting minutes from July 2010 till July 2011 revealed no evidence the Manger Meeting (Performance Improvement Committee) had chosen a facility performance improvement project.

Interview with the Staff #4 and #5 on 8/19/2011 at 2:30 PM in the survey office confirmed there facility had not chosen a facility performance improvement project.

Based on records review and interview the Governing Board failed to set expectations related to data information concerning safety and quality of care, treatment and services.

Review of the Shelby Regional Medical Center Rules and Regulations of the Governing Board Article VIII Governing Board Operational: Section 5. Performance Improvement (P1) showed "The Governing Board shall require the Medical Staff and staffs of the Hospital departments/services to implement and report on the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying opportunities to improve patient care, and for identifying and resolving problems. The Governing Board, through the Hospital Administrator, shall support these activities and mechanisms. The Governing Board shall provide for resources and support systems for the quality assessment and improvement and risk management functions related to patient care and safety. The Governing Board shall consider and, if necessary, act upon the results reported from P1 activities, which activities shall strive to satisfy the following objectives: (i) quality patient care provided by members of the medical and allied professional staffs, employees of the Hospital and all others who provide patient care services at this Hospital, (ii) use of planned and systematic procedures to objectively assess the quality of care provided, (iii) implementation of corrective action when problems or opportunities for improvement are identified, and (iv) the provision of one level of patient care throughout the Hospital."


Review of records found one meeting in the last year titled Governing Board Meeting dated 12/14/2011 revealed the Governing Board had not set any expectations of what the Board wanted to see from the Performance improvement of the facility.

Interview with the Staff #4 on 8/19/2011 at 2:30 PM in the survey office confirmed this was the only Governing Board Meeting held in the last year discussing the quality improvement.

Based upon records review and interview, the governing board failed to approve the medical staff bylaws, rules and regulations.

Review of governing board bylaws Article VI-Medical Staff Bylaws revealed "The Medical Staff shall be regulated by Medical Staff Bylaws, Rules and Regulations which set forth its organization and government and which, when warranted, shall be reviewed and revised by the Medical Staff, or its departments, as appropriate. The period between reviews shall not exceed two (2) years. The Medical Staff may recommend to the Governing Board the adoption of proposed Bylaws, Rules and Regulations and amendments thereto, and such changes shall become effective when approved by the Governing Board."

Review of the Medical Staff Bylaws, Rules and Regulations revealed the Bylaws Rules and Regulations had been adopted by the Medical Staff on 12/03/04 and were approved by the Governing Body on 12/08/04.

Further review revealed the a change of ownership occurred on 12/1/07. There was no documentation that the Governing Body established with the change of ownership had ever approved the Medical Staff Bylaws, Rules and Regulations.

An interview was conducted with the Director of Medical Staff Services on 8/22/11 at 1:00 PM. The Director confirmed the last date documented of approval of Bylaws by the Governing Board was 12/08/04.

Based upon records review, the Medical Staff failed to follow medical staff bylaws that required the history and physical be done by the attending practitioner. Review of 4 of 25 (#3, #7, #9, #16) medical records revealed that the history and physical examinations were done by Allied Health Professionals(AHPs). The Allied Health Professionals were not provided supervision by an attending physician and the governing body failed to ensure practice prerogatives were designated for the AHPs.

Review of the Medical Staff Rules and Regulations, Section B.-Medical Records #1 revealed the following: "The attending practitioner shall be responsible for the preparation of a complete and legible medical record for each patient. This record shall include identification date; complaint; personal history; family history; history of present illness; physical examination; special reports such as consultations, clinical laboratory and radiological services and other; provisional diagnosis; medical or surgical treatment; operative reports, pathological findings; progress notes; final diagnosis; condition on discharge; summary or discharge note and autopsy reports when performed."

Review of the Governing Body Bylaws revealed that "the governing board shall, at least once each medical staff year, review and designate the categories of AHPs eligible to apply for practice prerogatives in this hospital. The governing board shall also identify the types of practice prerogatives and terms and conditions that may be granted to qualified AHPs in each category." Further review of medical staff bylaws revealed no categories were identified of AHPs eligible to practice in the facility, no evidence of the governing board reviewing or designating the types of practice prerogatives and terms and conditions that may be granted to qualified AHPs.

Patient #3 was admitted on 1/3/11 with a cough and generalized weakness. Patient was seen in the Emergency Room by Staff #28 who was a Physician Assistant (PA). Staff #28 wrote admitting orders to admit to Staff #27 who was a Medical Doctor (MD). However, Staff #28 wrote the History and Physical, Physician Progress Notes, wrote physician's orders, and wrote the discharge summary. Staff #27 signed a telephone order that he had given, but wrote no other orders, progress notes, and did not co-sign any documents done by the AHP (#28).

Patient #7 was admitted on 2/7/11 with complaints of nausea, vomiting, and right flank pain. The patient was 28 weeks pregnant. Admission orders were written by MD (Staff #41) to MD (Staff #42) services. All other orders were written by (Staff #37) who was a Family Nurse Practitioner (FNP). The History and Physical and Discharge Summary were completed by Staff #37. MD (Staff #41) did not provide care to the patient, wrote no orders or progress notes, and did not co-sign any documents done by Staff #37.

Patient #9 was admitted on 3/9/11 with an allergic reaction to Tylenol PM. Patient was seen in the emergency room by MD (Staff #42) and admitted the patient to the service of MD (Staff #27). PA (Staff#28) dictated a short stay summary and wrote discharge orders. There was no progress notes written by PA(Staff #28) or MD (Staff #27). Staff #28 wrote discharge orders but there was no evidence that Staff #27 provided supervision during this admission.

Patient #16 was admitted on 5/25/11 with 3rd degree burns over 10% of her body. Patient was seen in the emergency room by MD (Staff #41), was admitted to the services of MD (Staff #43) but was provided care by Nurse Practitioner (Staff #37). Staff #41 wrote admitting orders but staff #37 completed the history and physical and all other orders to direct the patient's care. There was no documentation of supervision from any MD. and there was no orders, progress notes, or any other documentation by Staff #43, who was the admitting physician.

Based upon records review, the facility failed to ensure that nurses developed a care plan for 5 of 5 (#3, #7, #9, #14, #16) patients.

Review of 5 of 5 (#3, #7, #9, #14, #16) inpatient medical records revealed no nursing care plan in the medical record. The records contained a nursing admission assessment titled "Patient Process Admission Notes" and shift assessments throughout the hospitalization. No evidence of a nursing care plan was found in any of the medical records reviewed.

Based on records review and interview the facility failed to follow their own policy on IV Admixture Services (Quality Control).

Review of policy titled "Shelby Regional Medical Center IV Admixture Services
Pharmacy Policy & Procedure Manual Quality Control
Original Date: December 17, 2004 4.4.11
Approved By: T. Peterson, R.Ph.
Reviewed Date: April 6, 2009
Revised Date: (no date written)
Quality Control: (no information written)
A sterility testing program has been established to assure that sterility of admixtures is maintained. The program shall include procedures for testing the laminar flow hood (see the policy on Infection Control) and for bacterial contamination of the admixtures.

1. Monthly, one sample admixture selected from returns will be tested for sterility.

2. The sample admixtures accompanied by a bacteriology request form will be taken to the
Bacteriology lab where USP sterility tests will be conducted. The laboratory must culture
all samples for seven days in fluid thioglycolate medium.

3. A record of each test and a yearly summary of sterility test results will be kept.

4. The Technician or Pharmacist will be responsible for selecting the sample admixtures and
taking them to Bacteriology as well as for keeping records of the results.

Interview was held with Staff #31 on 8/18/2011 at 2:00 PM in the Pharmacy. Interview revealed the staff member had not performed this procedure on quality control of IV admixture nor had she seen the policy for quality control of IV admixture.

Based on records review and interview, the facility failed to manage the movement of scheduled drugs from the Pharmacy to the Surgical Department.

Review of Pharmacy policies revealed no policy or procedure for dispensing control drugs to the Surgery Department.

Review of the Narcotic records revealed no sign-out log for the controlled drugs leaving the Pharmacy to be dispensed in the surgical department.

During an interview with staff #31, it was confirmed there are two small black bags stocked with Atropine 0.4 mg ampule (1), Demerol 25 mg ampule (4), Versed 2 mg ampule(5), Narcan 0.4 mg ampule (1), and Romazicon MDV (1) for use in the surgical department. One of these bags is picked up by the Surgical Nurse on the day of surgery and kept till surgery is completed. Surgical nurse then brings the bag back to the Pharmacy at end of day. Staff #31 refills the bag and completes the charges for what medication is used out of the bag and locks the bag up in the Narcotic cabinet. No evidence that the narcotics are counted between the pharmacy and the surgical nurse. There was no drug reconciliation of drugs dispensed and drug usage.

Based on observation and interview the facility failed to label multi-dose bottles with time and date opened.

Items found in the Emergency Room Medication Room: (opened, not dated & timed)

Donnatol Elixir x 1
Maalox x 1
Q Tussin x 1
Robitussin x 1
Benadryl Liquid x 1
Prednisone 15 mg 4 oz x 1
Sulfatrim 200 mg 4 oz x 1
Ceftriaxone 250 mg for injection x 1
Betadine Solution Bottles X 3

On the tour of the facility on 8/15/2011 at 3:00 PM with Staff # 5, confirmed the multi-dose bottles were not dated or timed.

Based on record review and interview the laboratory department failed to have

A. policy and procedure manual that has been revised, reviewed, and approved by the medical executive committee or the governing board.

Review of the laboratory policy and procedure manual revealed the manual had not been revised or reviewed since 2/25/2005. The policy is written as Quest Laboratory for a reference laboratory and it was revealed in the contract agreements LabCorp of America is the present reference laboratory.

Review of the title page for the laboratory department policy and procedure manual revealed the signatures dated 2/11/2011 for approval by the department manager and the hospital administrator. There was no evidence the medical executive committee or governing board had approved the laboratory department policy and procedure manual. The Laboratory department manager signature was a previous manger to the present one.

Interview with the staff #1 and # 19 on 8/22/2011 at 2:30 PM confirmed the department manager and the administrator had approved the laboratory department policy and procedure manual. The administrator was unaware that he could not approve the policy and procedure for the laboratory department. The administrator was unaware that policy and procedures required approval by the medical executive committee or the governing board.

B. a Director of the laboratory services current and active on the facility staff.

Review of CLIA certification revealed the Director of the Laboratory is no longer on staff at the facility.

Review of records revealed the facility does not have a pathologist on staff for the Director of laboratory services as of 8/15/2011.

Interview with the staff #19 on 8/18/2011 at 1:30 PM in the laboratory confirmed the Director on the CLIA certification is no longer on the staff at this facility. He confirmed there is no pathologist overseeing the laboratory services.

Based on record review and interview the facility failed to have in place a Look Back policy on a critical blood transfusion.

Review of laboratory policy and procedure manual revealed no documentation of a Look Back policy for a critical blood transfusion.

Look Back Policy
Doc type: Policy DirectiveCompliance with this policy directive is mandatory.Doc No.: PD2007_075Functional Group - Sub Group: Clinical/ Patient Services - Governance and Service DeliveryClinical/ Patient Services - Incident managementPopulation Health - Infection Control
SummaryThe policy is to ensure a consistent, coordinated and timely approach for notification and management of potentially/affected patients when necessary.

Reference: NSW Government News

Interview with the Lab Director on 08/19/2011 at 12:30 in the Laboratory area confirmed there was no Look Back Policy. He reported I do not know what a Look Back policy relates to.

Based on records review and interview the Dietary department policy and procedure manual has not been approved by the medical executive committee or the governing board.

Review of the title page for the dietary department policy and procedure manual revealed the signatures for approval by the department manager, dietitian, and the hospital administrator. There was no evidence the medical executive committee or governing board had approved the dietary department policy and procedure manual.

Interview with the staff #1 and # 4 on 8/22/2011 at 1:30 PM confirmed the department manager and the administrator had approved the dietary department policy and procedure manual. The administrator was unaware that he could not approve the policy and procedure for the dietary department. The administrator was unaware that policy and procedures required approval by the medical executive committee or the governing board.

Based upon records review, observation, and interview the facility failed to maintain a clean and safe environment for the patients and ensure regular maintenance of the
facility's equipments.

During a tour of the Surgical Department on 8/15/2011 and a follow up tour 8/19/2011, the surveyors observed that the entrance to the surgical suite was cluttered with a mop bucket containing dirty water and mop, a linen hamper containing dirty linens, a trash bag filled with trash sitting on the floor and a trash can containing trash with out a liner . A broken piece of radiology equipment (portable X-ray machine) was sitting in the entrance to the surgical suite.

In the surgical suite, the floors appeared dirty, discolored and covered with stains. The operating suite was cluttered with a stretcher, operating room table pushed off to the side, several small tables, an anesthesia machine, an endoscopy cart with two scopes hanging open to the environment along with a second endoscopy cart with scopes hanging open to the environment, a cart with linen on top of it uncovered and open to the environment. There was a linen hamper with dirty linen left from the last surgical case performed on 8/12/2011.

During a tour of the Emergency Department on 8/15/2011 and five days later on 8/19/2011, the surveyors observed an unlabeled container was observed in the sink. The container was covered with a cloudy residue and the bottom was stained dark brown. The container was once semi-transparent. The container contained surgical instruments. In the same sink were two coffee cups and three containers of cleaning agents (Betasept, a container labeled bleach, and a container of bed sanitizer). This was the only sink in the patient care area of the emergency room on the trauma side. The contents (instruments) remained in the container for five days. The Emergency Room staff was observed eating food at the Nurses ' Station desk. There was a portable (supplemental) air conditioner set up in the emergency room with a flexible pipe that was vented through the ceiling. A ceiling tile was pushed to the side and the flexible pipe was held in place with silk tape.

Observed during the course of the survey (8/15 thru 8/19), the Soiled Utility Room wall and sink were discolored with stains. There were puddles of hardened green gel soap on the counter and on the front of the sink. Three infusion pumps sat on the counter for five days. A used commode chair remained in this soiled utility room for five days. On the floor of soiled utility room was a bag labeled spill kit. The floor was discolored with stains.

During a tour of the facility's Clean Utility Room, the surveyors observed an air conditioner unit in the ceiling with the cover removed (due to a water leak from a rusted drip pan). The drip pan had been removed and the facility's staff had zip-tied a patient bath basin suspended from the ceiling to the unit to catch the leaking water. Suction tubing was taped to a hole in the bottom of the basin. The tubing ran to the wall and was taped down the wall into a trash can. The trash can was approximately 1/3 full of standing water. Sitting on the floor next to the trash can was an isolation set up (a container used to hold the personal protective equipment for use in patient rooms). On a follow up tour of the clean utility room on 8/16/2011, the basin had been removed and the air conditioner cover placed on the unit. The basin and tubing was in the trash can with the standing water still present. This remained in the clean utility room for five days.

During a tour of the facility during the survey, it was observed that the floors throughout the facility were discolored with stains and that pieces of tile were chipped and missing from the floors.

Observed on tour 8/15/2011 at 2:30 PM, that the patients' Handicap Bathroom access was blocked by a housekeeping cart. To enter the bathroom, a patient would have to pass a barrel of dirty linen and a barrel of trash. In the entrance to patient handicap bathroom, it was observed that the housekeeping department filled their mop buckets here. The dispenser for the cleansing agent for mopping floors was located next to the door at the entrance to patient handicap bathroom. The entrance hall to the bathroom was soiled and stained.

Observed on tour 8/15/2011 in patient's room (115), the air conditioner unit was full of dust, dirt, and lint. The bathroom shower had brown stains down the walls. The base of the commode had black build-up with the appearance of mildew. Observed on 8/18/2011, a patient had been assigned to room 115 with no evidence of changes to the condition of the room.

Observed while on tour of the medical floor on 8/17/2011 at 10:30 the privacy curtains in one of the patient rooms was stained.

During an interview with staff #13 and #16 the question was asked, "How often are the privacy curtains taken down and sent to the laundry?" Staff #13 and #16 responded that the curtains were not sent to the laundry. The last time the curtains were washed, staff #4 took the curtains home and cleaned them.

During an interview staff #10 confirmed that staff #4 took the ER privacy curtains home and laundered them and then returned them to the hospital.

During the Exit Conference Staff #4 confirmed she took the privacy curtains home and laundered them and then returned them to the hospital.

Interview with staff #1 and #3 on 8/19/2011 at 3:00 PM confirmed the cleanliness and safety of the facility has not been addressed at this facility.

Observed on tour of the Dietary department on 8/16/2011 at 10:30, a rusty table where the pots and pans are stored. Over the garbage disposal area the hot water runs continuously. The dietary staff reported a valve is broken and the hot water has been running continuous over the garage disposal for one year.

Interview with staff #7 on 8/16/2011 at 10:30 confirmed she had reported the continuous running hot water and the rusty table, but nothing has been done.

Review of routine and preventive maintenance records revealed that only (11) pieces of equipment had been checked on 7/24/2011. The SPBS, Inc is a biomedical repair and maintenance company that services hospital equipment. According to the SPBS, Inc medical equipment service inventory equipment list report for the facility and printed on 12/7/2010, the facility has 311 pieces of equipment. Record review revealed a signed contract dated 3/17/2011 between staff # 44 and the facility for equipment checks.
Interview with staff #3 on 8/19/2011 at 3:00 PM confirmed QAPI (Quality Assurance performance Improvement) program for assuring the facility equipment and patient care equipment was in compliance has not been done.

Review if Fire Drill Critiques revealed evidence of drills conducted on nine dates in 2010, and three dates in 2011. In 2010, 7 of 9 fire drills were on the day shift and two fire drills on the night shift. In 2011, 2 of 3 fire drills were on the day shift and one fire drill on the night shift.

During an interview with staff #3 on 8/16/2011 at 11:00 am in the office of the Materials management, staff #3 stated that the drill critiques reviewed represented the total drills conducted by the facility.

Record review facility disaster plan revealed the plan was not shared the with the local disaster management authority. The facility failed to have a policy regarding local disaster management authority input.

During an interview with staff # 3 (Safety Officer) on 8/16/2011 at 11:00 am in the survey room, the Safety Officer denied interfacing with local disaster management officials.

Based on record review and staff interviews, the facility failed to conduct the required number of fire drills per year in 2010 (9 drills), and 2011 (3 drills).

Findings include:

Review of Fire Drill Critiques revealed evidence of drills conducted on nine dates in 2010, and three dates in 2011. In 2010, 7 of 9 fire drills were on the day shift and two fire drills on the night shift. In 2011, 2 of 3 fire drills were on the day shift and one fire drill on the night shift.

During an interview with staff #3 on 8/16/2011 at 11:00 am in the office of the Materials management, staff #3 stated that the drill critiques reviewed represented the total drills conducted by the facility.

Based on observation and interview the facility failed to maintain a clean and safe environment for the patients.

During a tour of the Surgical Department on 8/15/2011 and a follow up tour 8/19/2011, the surveyors observed that the entrance to the surgical suite was cluttered with a mop bucket containing dirty water and mop, a linen hamper containing dirty linens, a trash bag filled with trash sitting on the floor and a trash can containing trash with out a liner . A broken piece of radiology equipment (portable X-ray machine) was sitting in the entrance to the surgical suite.

In the surgical suite, the surveyors observed that the floors appeared dirty, discolored and covered with stains. The operating suite was cluttered with a stretcher, the operating room table was pushed off to the side, several small tables, an anesthesia machine, an endoscopy cart with two scopes hanging open to the environment along with a second endoscopy cart with scopes hanging open to the environment, a cart with linen on top of it uncovered and open to the environment. There was a linen hamper with dirty linen left from the last surgical case performed on 8/12/2011.

During a tour of the Emergency Department on 8/15/2011 and five days later on 8/19/2011, the surveyors observed an unlabeled container was observed in the sink. The container was covered with a cloudy residue and the bottom was stained dark brown. The container was once semi-transparent. The container contained surgical instruments. In the same sink were two coffee cups and three containers of cleaning agents (Betasept, a container labeled bleach, and a container of bed sanitizer). This was the only sink in the patient care area of the emergency room on the trauma side. The contents (instruments) remained in the container for five days. The Emergency Room staff was observed eating food at the Nurses ' Station desk. There was a portable (supplemental) air conditioner set up in the emergency room with a flexible pipe that was vented through the ceiling. A ceiling tile was pushed to the side and the flexible pipe was held in place with silk tape.

During the course of the survey (8/15 thru 8/19), the surveyors observed that the Soiled Utility Room wall and sink were discolored with stains. There were puddles of hardened green gel soap on the counter and on the front of the sink. Three infusion pumps sat on the counter for five days. A used commode chair remained in this soiled utility room for five days. On the floor of soiled utility room was a bag labeled spill kit. The floor was discolored with stains.

During a tour of the facility's Clean Utility Room, the surveyors observed an air conditioner unit in the ceiling with the cover removed (due to a water leak from a rusted drip pan). The drip pan had been removed and the facility's staff had zip-tied a patient bath basin suspended from the ceiling to the unit to catch the leaking water. Suction tubing was taped to a hole in the bottom of the basin. The tubing ran to the wall and was taped down the wall into a trash can. The trash can was approximately 1/3 full of standing water. Sitting on the floor next to the trash can was an isolation set up (a container used to hold the personal protective equipment for use in patient rooms). On a follow up tour of the clean utility room on 8/16/2011, the basin had been removed and the air conditioner cover placed on the unit. The basin and tubing was in the trash can with the standing water still present. This remained in the clean utility room for five days.

During the survey, it was observed that the floors throughout the facility were discolored with stains and that pieces of tile were chipped and missing from the floors.

During a tour on 8/15/2011 at 2:30 PM, the surveyor's observed that the patients' Handicap Bathroom access was blocked by a housekeeping cart. To enter the bathroom, a patient would have to pass a barrel of dirty linen and a barrel of trash. In the entrance to patient handicap bathroom, it was observed that the housekeeping department filled their mop buckets here. The dispenser for the cleansing agent for mopping floors was located next to the door at the entrance to patient handicap bathroom. The entrance hall to the bathroom was soiled and stained.

Observed on a tour on 8/15/2011 in patient's room (115), the air conditioner unit was full of dust, dirt, and lint. The bathroom shower had brown stains down the walls. The base of the commode had black build-up with the appearance of mildew. Observed on 8/18/2011, a patient had been assigned to room 115 with no evidence of changes to the condition of the room.

Observed while on a tour of the medical floor on 8/17/2011 at 10:30 the privacy curtains in one of the patient rooms was stained.

Observed on a tour of the Dietary department on 8/16/2011 at 10:30, a rusty table where the pots and pans are stored. Over the garbage disposal area the hot water runs continuously. The dietary staff reported a valve is broken and the hot water has been running continuous over the garage disposal for one year.


During an interview with staff #13 and #16 the question was asked, "How often are the privacy curtains taken down and sent to the laundry?" Staff #13 and #16 responded that the curtains were not sent to the laundry. The last time the curtains were washed, staff #4 took the curtains home and cleaned them.

Based on records review, observations, and interviews, the facility failed to ensure that supplies and equipments were stored and maintained within acceptable level of safety and quality.

Findings were:

A. Seventy-five (75) expired items were found in the facility's Surgery Suite area, Crash cart, Emergency Room supply closet, Emergency Room Medication room, and Nurse's Station soiled utility room.

Surgery Suite Area
Bard Polypectomy snares x 2 2007-06
Bipolar Probe x 1 2009-06
Bipolar Probe x 1 2010-02
Ioban x 2 2009-10
Conmed Electrode x 5 2008-11
Marking pens x 3 2011-04
Surgi Stain x 5 2010-10
Conmed Bovie needle x 1 2010-03
C-arm drapes x 2 6/2009

Crash Cart
Introcan Jelco 18g 1 1/4 x 2 2011-06, x 1 2010-11
Introcan Jelco 20g 11/4 x 3 2011-04
Intocan Jelco 24g 3/4 x 1 2010-10, 1010-2, 2009-09

Emergency Room Supply Closet
Vicryl 0 J340-H x 1 box 1/2011
Vicryl 0 J334-H x 1 box 7/2011
Vicryl 0 JJ41G x 1 box 7/2011
Chromic 0 S114H x 1 box 7/2011
Chromic 1 813H x 1 box 1/2011
Silk SA87G x 1 box 1/2010
Silk 684H x 1 box 1/2011
Silk K882H x 1 box 7/2010
Brose low Bags x 7 bags 7/2010 (On 8/15/2011 found Brose low bags in the emergency room patient care area and ask the emergency room personnel to get rid of the bags and on tour 8/19/2011 found the same Brose low bags again in the emergency room supply closet.)

Emergency Room Medication Room
Culture Swabs (Rapid Strep) x 34 7/2011
Lumbar Puncture Trays x 4 3/2011
Thoracentesis Tray x 1 11/2010

Nurses Station Soiled Utility Room
Cidex Plus Test Strips 4/2011

During the tour of the facility on 8/15/2011 thru 8/19/201, staff #10 and #18 confirmed that these items were expired.

B. no regular maintenance and testing of medical devices and equipment were performed at the facility.

Review of routine and preventive maintenance records revealed (11) pieces of equipment had been checked on 7/24/2011. Record review revealed a signed contract dated 3/17/2011 between staff # 44 and the facility to perform equipment checks. The previous contract was with SPBS, Inc., which is a biomedical repair and Maintenance Company that services hospital equipment. According to the SPBS, Inc medical equipment service inventory equipment report for the facility printed on 12/7/2010, the facility has 311 pieces of equipment that requires maintenance checks. Ninety-five (95) pieces of equipment were due to be checked in the months of January, February, and March.
Interview with staff #3 on 8/19/2011 at 3:00 PM confirmed QAPI (Quality Assurance performance Improvement) program for assuring the facility equipment and patient care equipment was in compliance had not been done.

Based on records review and interview the infection control officer failed to keep a infection control log.

Review of infection control log consisted of patient name, type of infection, date, antibiotic started, and if cultures were done. These items were recorded in a spiral notebook. No evidence of monitoring or tracking of incidents related to infections or communicable diseases.

Interview of staff #6 on 8/18/2011 at 2:00 PM confirmed that the infection log was incomplete and did not have any notations about employee health issues.

Based upon records review and interviews, the facility failed to follow its own policy related to the discharge process that includes criteria for identifying patients needing discharge planning. Review of 5 of 5 medical records (#3, #7, #9, #14, #16) revealed inadequate screening to ensure patient's received appropriate discharge planning.

Review of the facility's policy # PCS 06-001, titled "Discharge Planning, Interdisciplinary" revealed the following: 1.2 It is the policy of this service to help promote interdisciplinary discharge planning. Social Service will coordinate discharge planning for patients identified and referred in the high-risk or life-threatening categories. The facility does not offer Social Services. The only screening done of patient's discharge/case management needs was found in the initial nursing assessment in the section titled "Discharge Needs/Case Management". This section contained the following "yes" or "no" questions:
1. Dependent Adult; 2. Pediatric with needs; 3. Physician/Nurse Referral; 4. Home alone and over 75; 5. Caregiver, Family Member, Significant other available for support/care; 6. Friends/neighbors available for support/care; 7. non-compliance with medical regime; 8. Diagnosis: New CVA (Cerebral Vascular Accident), Cancer, Fracture, Alzheimer's, Overdose, Alcohol abuse; 9. Did the injury result from a domestic dispute/assault; 10. Do you have any concerns for your safety when you leave the hospital; 11. Do you feel someone has or may take advantage of you financially; 12. Do you feel you have been or may be at risk of physical/sexual assault." This section of the initial nursing assessment did not have a score to determine categories of need as mentioned in the policy that patients in the "high risk or life threatening" categories would receive discharge planning.

Further review of the policy revealed, Section III-Interdisciplinary Planning Team, 3.1 Will be comprised of health care disciplines to include the nurse and the physician. Other health care disciplines will serve as consultants, such as rehab services, Pharmacist, Social Worker, dietician, and respiratory therapy. 3.3 Content for Team Conference: The team will discuss: Reason for admission, Problems that need to be resolved prior to discharge, and identify which health care discipline will be needed to assist with the problem. Follow-up conference will include outcomes of actions." The policy failed to state how often the Team Conferences would be held or the purpose of the the team meeting.

Review of medical records #3, #7, #9, #14, #16 revealed no documentation to indicate any discharge planning process was done. There was no documentation of Interdisciplinary Team Conference or nursing notes related to discharge planning. There was a discharge summary/ instruction form in each medical record that was completed at time of discharge with discharge instructions for medication and follow-up appointments.

An interview was conducted with the Director of Nursing on 8/19/11 at 2:30 PM. The Director of Nurses was asked about the process for discharge planning and the director replied, "I never have known what discharge planning means."

Based upon records review and interviews, the facility failed to have a discharge planning process in place that determined who would receive a discharge planning evaluations. Review of 5 of 5 (#3, #7, #9, #14, #16) revealed no criteria to determine who would receive a discharge planning evaluation.

Refer to A-800

Based upon record review and interview, the facility failed to follow their own policy for a discharge coordinator.

Review of the policy and procedure #PCS 06-001 titled Discharge Planning, Interdisciplinary, Section V. Responsibility, revealed 5.3 Discharge Coordinator: The discharge coordinator will coordinate, organize and assess weekly meetings. The discharge planner/social worker will review and assess patient information, identify potential problems and refer/assist with arrangements as needed. The patient, the patient's representative, will be given a copy of home health services in the area for selection.

An interview was conducted with the Director of Nurses on 8/19/11 at 2:30 PM. The Director reported no one was designated as the Discharge Planner. She further reported that Staff #6 took care of case management but no formal discharge planning was being done. The Director further stated, "I never have known what discharge planning means."

Based upon records review and interview, the facility failed to ensure discharge planning evaluations were done for 5 of 5 ( #3, #7, #9, #14, #16) inpatient records reviewed.

Refer to Tag A807

Based upon record review and interview, the facility failed to ensure discharge planning evaluations were done for 5 of 5 ( #3, #7, #9, #14, #16) inpatient records reviewed.

Refer to Tag A 807

Based upon record review of 5 of 5 inpatient medical records (#3, #7, #9, #14, #16), the facility failed to document discharge planning evaluations in the patient's medical record.

Refer to Tag A 807

Based upon record review and interview, the facility failed to ensure a discharge planning process was in place with qualified personnel to ensure a discharge planning evaluation was provided for 5 of 5 (#3, #7, #9, #14, #16) inpatient records reviewed.

Refer To Tag A-807

Based upon records review, the facility failed to reassess the discharge planning process and/or integrate the discharge planning process into the Quality Assurance Performance Improvement (QAPI) program.

Review of the manager's meetings minutes, medical staff meeting minutes, and governing body meeting minutes revealed no evidence of the discharge planning process being reassessed through the QAPI program or any other mechanism for reassessment of discharge plans. Review of discharge planning policy revealed no provision for reassessing the discharge plan.

Based on records review and interview, the facility failed ensure required supervision of the operating room.

Review of records revealed one part-time registered nurse and one scrub technician for the surgical department.

Review personnel file for Staff #23 revealed the job description for a RN Circulator signed 6/4/2009. Staff #23 only works part-time.

Interview with staff #5 on 8/15/2011 at 3:00, confirmed surgical department consist of one part-time registered nurse and one scrub technician. The Director of Nursing (#5) stated "I do not know anything about the Surgery Department."

Based on records review and interviews, the facility failed to ensure that the surgical department policy and procedure manual had been approved by the medical executive committee and the governing board.

Review of record titled Endoscopy policy and procedure manual revealed the last revision and review was 6/4/2009.

Review of the surgical department policy and procedure manual revealed no signature page for approval of the policies. There was no evidence the medical executive committee or governing board had approved the surgical department policy and procedure manual.

Interview with the staff # 4 and # 5 on 8/22/2011 at 1:30 PM confirmed the surgical department policy and procedure manual had not been revised or reviewed. The administrator was unaware that policy and procedures required approval by the medical executive committee and the governing board.

Based on observation and interview the surgical department failed to have working equipment in the operating room suites while surgical cases were being performed.

Observed on tour of the surgical suite on 8/19/2011 at 9:00 AM, the cardiac monitor had a sign on it posted broken 7/20/2011. Surgical cases were performed on 7/21, 8/ 11, and 8/12, 2011.

Interview on 8/19/2011 at 9:00 AM with Staff #18, confirmed the cardiac monitor had been broken since 7/20/2011.

Based on records review and interviews, the surgical department failed to have a complete and up-to-date register.

A. Review of record titled " OR, ANES, PACU AND UNITS DATE " (operating room log/register) revealed missing components of the operating room register. Review of register dates August 5, 2010 thru July 14, 2011 found no evidence of name of surgeon, name of personnel (scrub and circulating), type of anesthesia used and name of person administering it, Pre and post-op diagnosis, and age.

A. Interview on 8/19/2011 at 9:00 AM with Staff #18, confirmed the operating room log/register is incomplete.

B. Record review of log/register revealed missing names of patients receiving surgical procedures. Patient #23 had procedure on 7/21/2011, #24 had procedure on 8/11/2011, and #25 had procedure on 8/12/2011.


B. Interview on 8/19/2011 at 11:30 AM with Staff #39, confirmed patient #23, #24, and #25 had surgical procedures performed.

Based on records review the facility failed to ensure the operative report was complete on two of two surgical records.

Review of operate records #23 and #24 revealed no entries of time and date of surgery, assistants in performing the procedure, description of findings, and name of surgical procedure performed. The operative reports were signed and dated, but not timed.

Based upon record review and interview, the facility failed to ensure outpatient services was an organized service of the facility with policies and procedures and assurance of integration with inpatient services.

Review of outpatient services provided revealed the following services: Surgery, Radiology, Laboratory, and Therapy Services. Radiology, Laboratory, and Surgery were all provided at the hospital while Therapy Services was a contracted service with an off-site program. There were no outpatient policies and procedures to coordinate the care, treatment or services provided to an outpatient. There was no established method of communication between inpatient and outpatient services to ensure continuity of care.

An interview was conducted with the Director of Nurses on 8/15/11 at 1:00 PM. in the Administrator's Office. The Director reported the hospital provides outpatient services but it is not organized as a hospital department. The Director also reported there were no outpatient policies or procedures that establishes the outpatient services as an integrated hospital service.

Based upon record review and interview, the facility failed to ensure an individual was assigned to be the person who directs the entire outpatient services. The facility failed to define the qualifications and competencies required to direct the outpatient services.

An interview was conducted with the Director of Nurses on 8/15/11 at 1:00 PM in the administrator's office. The Director reported the facility does not have an organized outpatient program so there is no person who is responsible for the service. The Director further reported there are no policies and procedures established to coordinate and organize the program.

Review of job descriptions revealed no job description for Director of Outpatient Services. There were no other job descriptions found with a different title for an individual responsible for directing outpatient services.

Based on records review and interviews the facility failed to incorporate the contracted services (Laboratory Services, Therapy services and Linen and Laundry Services) into the QAPI. The Materials Management, Plant Operations, Dietary, Housekeeping, Medical Records, Nursing, Radiology, Respiratory, Pharmacy, and Surgery departments were not reporting outcomes to the Quality Program.

Review of the Administrative Policy Manual; Performance Improvement Plan, Policy # 2.8:
3.4 " The Medical Staff, employees and contracted services participate in identifying opportunities for improvement, data, collection, multidisciplinary teams and implanting actions to sustain improvements."

3.6 Performance Improvement Teams
"The team members represent the various departments or disciplines involved in the process being improved. The Performance Improvement team is responsible for designing, measuring,
assessing, improving, and reassessing to assure sustained improvement. The performance
improvement teams are time limited and focused on a particular process and outcome. The
teams submit final findings and recommendations to the Performance Improvement Committee."

Review of the Managers Meeting minutes from July 2010 till July 2011 found no evidence of these departments reporting quality outcomes, Materials Management, Plant Operations, Dietary, Housekeeping, Medical Records, Nursing, Radiology, Respiratory, Pharmacy, and Surgery , Laboratory, Therapy Services, and Linen /Laundry Services.

Review of the Managers Meeting minutes from July 2010 till July 2011 found no evidence of a active medical staff being a member of the Performance Improvement committee.

Review of the Administrative Policy Manual; Performance Improvement Plan, Policy # 2.8:
3.5 Performance Improvement Committee stated "The Performance Improvement Committee has the responsibility to assure that the principles of performance improvement are utilized throughout the organization. The Performance Improvement Committee shall be a standing committee of the Medical Staff and shall consist of a minimum of one or more active Medical Staff, Administrator/designee and the Director of Nursing/designee. Other individuals from either the medical or hospital staffs may participate, as consultants on an as needed basis The Performance Improvement Committee meets quarterly and performs the following functions:"

Interview with the Staff #4 and #5 on 8/19/2011 at 2:30 PM in the survey office confirmed there were no quality outcomes being reported to the Performance Improvement Committee from the departments.

Based on record review and interview the facility failed to measure, analyze, and track quality indicators from the following departments, Materials Management, Plant Operations, Housekeeping, Surgery, and contracted services Therapy services, Laboratory services, and Linen/Laundry services.

Review of the Administrative Policy Manual; Performance Improvement Plan, Policy
# 2.8: 3.4 stated "The Medical Staff, employees and contracted services participate in identifying opportunities for improvement, data, collection, multidisciplinary teams and implanting actions to sustain improvements."

Review of the Administrative Policy Manual; Performance Improvement Plan, Policy
# 2.8: 3.6 Performance Improvement Teams stated "The team members represent the various departments or disciplines involved in the process being improved. The Performance Improvement team is responsible for designing, measuring, assessing, improving, and reassessing to assure sustained improvement. The performance improvement teams are time limited and focused on a particular process and outcome. The teams submit final findings and recommendations to the Performance Improvement Committee."

Review of the Managers Meeting minutes from July 2010 till July 2011 found no evidence the Materials Management, Plant Operations, Housekeeping, Surgery, and the contracted services Laboratory, Therapy , and Linen /Laundry services have indicators (specific to their department) to report to Performance Improvement Committee.

Interview with the Staff #4 and #5 on 8/19/2011 at 2:30 PM in the survey office confirmed there were no quality indicators being reported to the Performance Improvement Committee from the Materials Management, Plant Operations, Housekeeping, Surgery, and the contracted services Laboratory, Therapy , and Linen /Laundry services.

Based on records review and interviews the members in the Managers Meeting (Performance Improvement Committee) failed to identify opportunities for improvement and changes to improve the quality of patient care in the facility.

Review of records titled Managers Meeting minutes dated 7/20/2010, 10/19/2010, 10/26/2010, 1/17/2011, 2/82011, 2/15/2011, and 5//3/2011 revealed
Topic: Performance Improvement
Under section: recommendation/conclusions it was written "After discussing the issue, the managers recommended for the acceptance for the information."
Under section: action it was written "The managers accepted the information."
Under section: evaluation it was written "No evaluation indicated."
The mangers in the Managers Meeting (Performance Improvement Committee) failed to identify opportunities for improvement and changes to improve the quality of patient care.

Interview with the Staff #4 and #5 on 8/19/2011 at 2:30 PM in the survey office confirmed there were no quality improvements being discussed at the Performance Improvement Committee from the department Managers.

Based on records review and interviews, the administrator , medical staff, Director of Nursing failed to take responsibility to ensure that problems identified in the infection control program were addressed in the hospital-wide QAPI (Quality Assurance Performance Improvement)and staff in-service.

Record review of Manager Meeting minutes dated July 2010 thru July 2011 revealed no evidence of infection control problems being addressed in these meetings.

Interview of staff #5 on 8/19/2011 at 3:00 PM confirmed infection problems have not been addressed in the QAPI nor has staff been in-serviced.