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Based on observation, documentation review and interview the facility failed to: 1) insure a sanitary surgical environment as cited in 1 of 2 surgical suites, 2) follow facility policy for the sanitary cleaning of the surgical suites and high level chemical disinfection in 3 of 3 policies reviewed, 3) provide adequate documentation of sterilization logs as cited in 3 of 3 days logged, 4) provide acceptable sterilization of surgical instruments between cases as cited in 97 of 97 instrument sets reviewed,


On 11/16/2010 at 10:00 AM during a tour of the surgical department, surgical suite #2 was observed to
have a hole in the lower wall with shards of sheet rock visible.
An interview with a surgical staff member on 11/17/2010 at 3:00 PM confirmed the hole had been discussed but no resolution had been determined. When asked if surgeries had continued in this surgical suite the staff commented "everyday". When asked if a work order to repair the wall had been submitted the staff member commented he didn't know.
An interview with the administrator on 11/17/2010 at 4:00 PM confirmed he was not aware the hole existed in the surgical suite. The administrator also confirmed environmental rounds had not been done for the surgery department.


During a tour of the building on 11/16/2010 at 10:00 2 bags of dirty linen were observed on the floor in front of the dirty linen cart in the dirty holding room. An interview with the DON during this tour confirmed the linen was supposed to be in the cart.
On 11/17/2010 at 9:00 AM a review of Policy # INFC.05 Housekeeping in the Operating Room and Suite: Item #4 Daily trash and linen disposal. Linen will be placed in the linen cart in the soiled holding room.
Item #6 Operating rooms will be cleaned monthly in addition to daily spot cleaning. An interview on 11/17/2010 at 2:00 PM with surgical staff confirmed the terminal cleaning of the surgery suites occurred quarterly.
Item #8.1 Autoclaves are cleaned quarterly. An interview on 11/17/2010 at 2:30 PM revealed surgical staff were unable produce documentation of an autoclave cleaning schedule.
Further review of surgical cleaning policy #PMSC .06 Glutaraldehyde High Level Disinfection revealed the chemical disinfectant list to be used was Glutaraldehyde. On 11/18/2010 at 2:00 PM an interview with surgical staff revealed Vesphene was the chemical disinfectant being used high level chemical disinfecting..
A review of documentation on 11/17/2010 at 11:00 AM revealed no policy or log was found for temperature, humidity or pressure (which is the industry standard) for the surgery suites. The Director of Nursing confirmed no records were kept for Temperature, humidity or pressure in the surgical suites.


On 11/17/2010 at 4:00 PM A review of the sterilization logs revealed the load and content were identified but the indicator results was not included on the log pages.
When the indicators were asked for they were produced, grouped by week, from manila envelopes kept in boxes.
An interview with the Director of Nurses confirmed the log records for sterilization were incomplete and the indicators were kept separately from the log book.


On 11/17/2010 at 2:30 PM an interview with the scrub tech revealed all eye trays were flashed after the first four (4) were used and most instruments were in fact "flashed". An interview with the Director of Nurses confirmed the instruments trays were "flashed" routinely on "eye"day.
A review of the sterilization records for 10/18/2010 revealed 20 of 20 instrument sets were flashed for 10 minutes or less.
A review of the sterilization records for 10/25/2010 revealed 52 of 52 instruments sets sterilized were flashed for 10 minutes or less. The eye trays were sterilized on a 10 minute cycle with a 1 minute dry time for 36 of 36 eye cases. Foot implants, hand sets and small cannulated instruments were sterilized on a 4 minute sterilization time with a 20 minute dry time for .
A review of sterilization records for 11/8/2010 revealed 25 of 25 instrument sets were flashed sterilized for 10 minutes or less.

Based upon record review and interview, the governing body failed to ensure medical staff were appointed according to the conditions and duration of appointment in the Medical Staff Bylaws.

Review of the document titled "Policies and Procedures Governing Medical Staff" Section 2.5.1 revealed "Initial appointments and reappointments to the Medical Staff shall be made by the Governing Body...". Secition 2.5.2 revealed "Appointments and reappointments to the Medical Staff shall be for a period of two (2) years and shall terminate at the end of the respective medical staff member's rotation.

Review of credentialing files revealed 3 physicians and 4 allied health professionals had been reappointed for 3 year appointments with appointments for dates from 8/1/09 through 3/19/10.

An interview was conducted with the Administrator on 11/17/10 at 2:15 pm in the conference room . The Administrator reported that in 2007, the governing body decided to go to 3 year appointments when it was time for physicians to be reappointed. The Administrator was asked to review the Conditions for reappointment in the Medical Staff policies and the Administrator confirmed that that change had not been made in the Medical Staff policies and the policy indicated appointments were for a period of 2 years.

Based on staff interview, review of personnel records and review of policy and procedure the facility failed to perform annual Performance Appraisals on 8 of 11 personnel records and annual Competence Evaluations on 10 of 11 personnel records reviewed.

Review of policy " Performance Appraisals, " Policy # HRJI.09 revealed the following:
Performance Appraisals will be conducted by the employee ' s Supervisor at appropriate interim periods (such as when disciplinary action has been taken relative to performance), annually, and on an as needed basis. The employee shall self- evaluate and complete the applicable job specific, procedure specific and/or the age-specific competency checklist prior to the employee ' s annual evaluation. The preceptor shall evaluate and complete the applicable job specific, procedure specific and/or the age-specific competency checklist prior to the employee ' s annual evaluation.

On review of personnel records #1, #5, #6, #7, #8, #11, #12, #13 did not have annual Performance Appraisals.

On review personnel records1, #4, #5, #6, #7, #8, #10, #11, #12, #13 did not have annual competence evaluations.

In an interview with Director of Nurses (DON) at 3:00pm,11/17/2010 in the Administrative Conference Room the DON confirmed the annual Performance Appraisals in 8 of 11 personnel records reviewed and Annual Competence Evaluations in 10 of 11 personnel records reviewed were not done.

Based on staff interviews, review of personnel records and policy and procedure the facility failed to ensure proper orientation for 2 of 2 assigned pharmacy staff.

Review of the policy, " Orientation and Basic Performance for Pharmacy Support Personnel, " Policy # PHAR.17, revealed the following: " Pharmacy Support Personnel shall be oriented to the following by the Consulting Pharmacist and show competency:
1. To order medications through the facilities drug wholesaler, manufacturer or another pharmacy. 2. To distribute medications throughout the facility. 3. Competency to maintain all inventory records of meds used in the pharmacy. 4. Competency to maintain all pharmacy records and files. 5. Competency to maintain Drug Enforcement Administration(DEA) Controlled Substances records. 6. Competency to supply educational material and drugs information to staff. 7. Competency to function as an Registered Nurse (RN) " .

Review of Personal Records of staff #4 and # 5 revealed the form " Pharmacy Orientation and Basic Performance Records " was done by an RN preceptor and not the Consulting Pharmacist.

Interview with the Director of Nurses, 11/17/10 at 11:00 am in the Administration Conference Room confirmed the form " Pharmacy Orientation and Basic Performance Records " was not done by the consulting Pharmacist.

Based on staff interview, observation and review of policy and procedure, the facility failed to date and initial multi-dose vials and bottles.
Review of the Pharmacy standards of practices, " The United States Pharmacopeia, Chapter 797 " , revealed Multiple-dose containers (e.g., vials) are formulated for removal of portions on multiple occasions because they contain antimicrobial preservatives. The beyond-use date after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days (see Antimicrobial Effectiveness Testing <51>), unless otherwise specified by the manufacturer.
Review of policy, " Guidelines for Distribution of Various Drug Forms, " Policy # PHAR_ revealed the following: Injectables - Single dose vials are discarded after use. A partial use vial returned to Pharmacy will be destroyed. Multi-dose vials may be re-used if certain that that vial is not contaminated. The vial will be dated and initialed. It will be discarded after 30 days. A multi-dose vial, which is found opened and undated, will be discarded. Removal from glass ampoule will be done with a filter needle.

Based on observation at 2:00pm, 11/16/2010 of the Emergency Room a one liter bottle of sterile water was found open and being stored with no label of date opened or initials of the person that opened the bottle as required by policy and procedure.

Based on observation while touring Pre-op/PACU one 8 ounce open bottle of Mylanta approximately half full and one 4 ounce open bottle of lidocaine solution approximately three quarters full was found being stored with no label of date opened or initials of the person that opened the bottle as required by policy and procedure.

In an interview with Director of Nurses (DON) while on tour of the Emergency Room (ER) and the Pre-op/PACU areas at 2:10 PM on 11/16/10 the DON confirmed the sterile water, Mylanta and lidocaine solution was not dated or signed as required by policy and procedure.

Based on staff interviews, observation and policy and procedure review the facility failed to ensure 2 of 3 Emergency Crash Carts were properly secured with breakaway locks.

Review of the policy, " Safety of Patients and Personnel, " Policy # PHAR.07, revealed "All medication storage areas will be locked when not in attendance. Crash carts & Hyperthermia carts are to be secured with breakaway locks to insure credibility of contents " .

Based on observation and inspection at 1:50 pm, 11/16/2010 of the Medical Floor Crash Cart it was found with a red breakaway lock but the breakaway lock was not properly applied to secure the cart.

Based on observation at 1:55pm, 11/16/2010 of the Emergency Room Crash Cart it was found with a red breakaway lock in place but the lock was not properly applied to secure the cart. The red breakaway locks had a hand written number on the red lock. These locks on the crash carts could easily be tampered with by removing the current lock, writing the same number on the lock and re-locking the crash cart with a new lock.

Review of the pharmacy policy, " Safety of Patient and Personnel " , revealed the policy did not contain a process for which to number the breakaway locks to secure and insure the credibility of the crash carts.

Based on observation 11/16/2010 of the current hand written numbering process used to number the breakaway locks fails to insure credibility of contents. These Crash Carts can be tampered with by removing the current lock, writing the current number on a new breakaway lock and re-securing the Crash Cart with the new lock.

Review of the current numbering procedure reveals the facility fails to have a process to secure and insure the credibility of the crash carts.

During the observational tour on 11/16/2010 at 2:00pm the Administrator, Director of Nurses and Pharmacy staff #5 all confirmed that 2 of 3 were not properly secured and none of these staff could explain how the numbering process of the breakaway locks ensured credibility of crash cart contents.

Based on observation and interview the facility failed to ensure out of date drugs were removed from floor stock and not available for patient use.

Based on observation 1:50 pm, 11/16/2010 expired medications were found on the Medical Floor. Two containers of potassium chloride had expired 05/10. Two containers of Metoprolol (used for lowering blood pressure) had expired 10/10. One container of Naloxone HCL(used for reversing over doses of opioid) had expired 06/10, One container of Procainamide (used for heart arrhythmias) had expired 09/10.

During the observational tour on 11/16/2010 at 2:00pm the Director of Nurses confirmed that all these medications were expired. The Director of Nurses also reported there was no process for ongoing monitoring of stock medications for expired medications.

Based on observation, interview and document review the facility failed to insure dietary staff competency as cited in 1 of 1 dietary staff.


On 11/16/2010 at 10:00 AM during a tour of the dietary department a refrigerator was observed containing food prepared on the premises, with no date of preparation . Staff # was questioned regarding the lack of date on a container of hard boiled eggs, and commented "Oh I know when I put them in here"


A review of the facility dietary manual Item (7) reads: Prepared on the premises ready-to-eat potentially hazardous food, date marking: (A)....ready-to-eat potentially hazardous food prepared and held in the refrigerator for more than 24 hours ....shall be clearly marked at the time of preparation.

Based on policy review and interview the facility failed to revised the dietary policy manual with 5 years as cited in 1 of 1 manuals reviewed.


On 11/16/2010 at 2:00 PM a review of the dietary policy and procedure manual revealed the signature page reflected the last revision was 8/1/2005.

An interview on 11/17/2010 at 10:00 AM with the administrator confirmed the manual had not been undated or reviewed since 8/1/2005

Based on record review and interviews, the facility failed to develop a plan to assure patient and staff safety in response to local disasters. The facility failed to share the disaster plan with the local disaster management authority. The facility failed to follow its policy regarding local disaster management authority input. The facility has never conducted an exercise in conjunction with state and local authorities. The facility failed to follow its policy to conduct two disaster drills each year with staff member participation, evaluation, and critique. The facility failed to conduct a hazard vulnerability analysis annually per policy (hazard vulnerability analysis was completed in 2005 and never updated). The facility failed to conduct monthly environmental safety inspections per policy (conducted on an annual basis).


Findings include:

Review of policy #EMERG.01 titled "Emergency Preparedness Management Plan" revealed the following: 1) the facility will define its role " within a community wide emergency preparedness effort, " 2)The administrator and/or Medical Director shall meet with the local community representative organizations on an annual basis and coordinate the Center ' s plan within the specifications of its defined Scope of Care and services provided, and 3) The plan with applicable appendices shall be submitted annually to the county emergency assessment agency for review and approval.

During an interview with staff #29 (Safety Officer) on 11/17/2010 at 11:10am in the board room, the Safety Officer denied interfacing with local disaster management officials. The Safety Officer stated that if coordination with local authorities was done, the staff #1 (Administrator) was doing it.

During an interview with staff #1 (Administrator) on 11/17/2010 at 11:45am, the Administrator denied interfacing with local disaster management officials regarding the disaster plan. The Administrator stated that the local disaster management officials do not include the facility in disaster planning and vice versa.

Further review of Policy #ERMG.01 revealed "Drills will be conducted at least twice a year, a critique of the drills wi1l be performed, and staff personnel will be monitored and evaluated for knowledge and skills for each type of disaster. "



Review of Policy #ERMG.06 titled "Emergency Management Plan:External Disasters" revealed the following: Staff shall participate in external disaster drills twice a year, a critique of the drill will be completed, Staff Personnel will be evaluated for knowledge and response actions Effectiveness of staff response shall be part of the overall Annual Evaluation of the Environment of Care Program to the Board of Managers by the Safety Committee. Annual assessment shall include evaluation for the following: "Access to food and water and basic utility services, maximum volume of patients that the facility will be capable of providing services, access to drugs, and access to additional personnel. "

Review of Emergency Preparedness forms revealed only one completed hurricane drill critique on 06/08/2006.

During an interview with staff #29 (Safety Officer) on 11/17/2010 at 11:10am in the board room, the Safety Officer stated that the facility conducted hurricane drills two times per year. The Safety Officer described these drills as a meeting where the Safety Officer, the Administrator, and one or two others sit around a table and discuss their roles during a hurricane. There is no regular staff involvement and no after action report is conducted. The Safety Officer stated that the facility has not conducted a drill in conjunction with state and local exercises.

During an interview with staff #1 (Administrator) on 11/17/2010 at 11:45am, the Administrator confirmed that the " drills " were conducted as the Safety Officer had described. General staff are not involved in these " drills. " The Administrator stated these drills were conducted with the hurricane scenario twice per year. The Administrator stated that the facility has not conducted a drill in conjunction with state and local exercises.

Review of policy #EMRG.01 titled "Emergency Preparedness Management Plan" revealed: " A Vulnerability Assessment will be conducted on an annual basis. Findings shall be reported to the Governing Body. "

During an interview with staff #29 (Safety Officer) on 11/17/2010 at 11:10am in the board room, the Safety Officer stated the vulnerability analysis was completed in 2005 and had not changed; therefore, it had not been updated.

Review of policy #SFMG.01 titled Safety Management Plan revealed: " The environmental space will be evaluated on a monthly and annual basis for any safety hazards and a checklist will be completed of the review. Any discrepancies will be reported to the Safety Committee. This checklist will be annually reviewed and updated as appropriate to the environment. "

During an interview with staff #29 (Safety Officer) on 11/17/2010 at 11:10am in the board room, the Safety Officer was asked for copies of the monthly safety hazard checklists. The Safety Officer stated that these checklists were done only on an annual basis. The Safety Officer provided the annual checklists, but could not provide monthly reports.

Based on record review and staff interviews, the facility failed to conduct the required number of fire drills per year in 2005 (4 drills), 2006 (1 drill), 2007 (3 drills), 2008 (2 drills), 2009 (4 drills), and 2010 (3 drills).

Findings include:

Review of Fire Drill Critiques revealed evidence of drills conducted on four dates in 2005, one date in 2006, three dates in 2007, two dates in 2008, four dates in 2009, and three dates in 2010. No critique had documentation of time or shift.

Review of policy #LSMP.01 titled "Life Safety Management Plan" and policy #LSMP.02 titled "Fire Drill Procedure" revealed the following: A fire drill will be held at least 12 times each year, one fire drill per shift per quarter shall be conducted and shall include communication of alarms, simulation of evacuation of patients, and other occupants, and the use of fire fighting equipment.

During an interview with staff #29 (Safety Officer) on 11/17/2010 at 11:10am in the board room, the Safety Officer stated that the drill critiques reviewed represented the total drills conducted by the facility. The Safety Officer confirmed that there were no times or shifts noted on any of the critiques. The Safety Officer also confirmed that the facility policies #LSMP.01 and #LSMP.02 require twelve fire drills each year.

Based on observation and interview the facility failed to ensure out of date supplies and supplies with damaged packaging were removed from floor stock and not available for patient use.

Based on observation 2:00pm, 11/16/2010 while touring the Emergency Room the following items were found with expired (exp) dates, one 4-0 Ethilon suture exp 01/10, two 3-0 Ethilon sutures exp 01/10, two 5-0 Ethilon sutures exp 01/10, two 4-0 Prolene sutures exp 01/10, five Vicryl sutures exp 01/10, two pair of sterile Biogel gloves exp 05/10, one Chloroprep solution for sterilizing skin exp 09/10.

Based on observation 2:00PM, 11/16/2010 while touring Pre-op/PACU the following items were found with expired dates, one pair of sterile Protegrity gloves exp 06/10, four packages of Suretrace Electrodes (for monitoring heart rates) exp 05/08, one box of 10 count Cardiac Defibrillator pads exp 05/08, one box of 10 count Cardiac Defibrillator pads exp 09/05, two red top Vacutainers (for drawing blood samples for lab) exp 09/10, one Suction connecting tubing exp 10/09, two Yankauer suction tips exp 10/09. Four packs of sterile latex gloves with no exp dated were obviously old with brown discolored packaging.

During the observational tour the Director of Nurses (DON) while on tour of the Emergency Room (ER) and the Pre-op/PACU areas at 2:10 PM on 11/16/10 the DON confirmed the observed items were found with expired dates.

Based on record review and interview, the facility failed to designate a qualified infection control officer. The facility failed to follow the job function qualification requirements for the Infection Control Officer. The facility also failed to update its infection control plan on an annual basis. The facility also failed to conduct active surveillance of employee illness.

Findings include:

Review the qualifications section of the job functions description for the Infection Control Officer revealed a requirement of " prior experience in participating as a team member in implementing or coordinating an infection control program. "

During an interview with staff #2 (Infection Control Officer) on 11/17/2010 in the board room, the Infection Control Officer denied having prior experience in participating as a team member in implementing or coordinating an infection control program. The Infection Control Officer denied having any specialized infection control training or certification. The Infection Control Officer also denied having membership in any national, state, or local infection control association.

Review of the Infection Control Plan revealed the following: " There will be an annual review and evaluation of the Infection Control Program and Plan performed by the CQI Committee and presented to the Governing Body. " Review of the Infection Control Manual Face Sheet revealed the Infection Control Plan was approved on 2/07/2007. The current Infection Control Plan was dated 9/09/2009, but was not signed by the Governing Body Chair. There was no evidence of a plan from 2005 until 2/07/2007. There was no plan update in 2008 or 2010.

During an interview with staff #2 (Infection Control Officer) on 11/17/2010 in the board room, the Infection Control Officer stated the 9/09/2009 plan update was the only one able to be found. The Infection Control Officer denied tracking and trending employee illness as a component of the Infection Control Plan.

Based on document review and interview the facility failed to enforce surgical sanitation policies as cited in 3 of 3 policies reviewed.


On 11/17/2010 at 9:00 AM a review of Policy # INFC.05 Housekeeping in the Operating Room and Suite: Item #4 Daily trash and linen disposal. Linen will be placed in the linen cart in the soiled holding room. During a tour of the building on 11/16/2010 at 10:00 2 bags of dirty linen were observed on the floor in front of the dirty linen cart in the dirty holding room. An interview with the DON during this tour confirmed the linen was supposed to be in the cart.

Item #6 Operating rooms will be cleaned monthly in addition to daily spot cleaning. An interview on 11/18/2010 at 2:00 PM with surgical staff confirmed the terminal cleaning of the surgery suites occurred quarterly.

Item #8.1 Autoclaves are cleaned quarterly. An interview on 11/18/2010 at 2:00 PM revealed surgical staff were unable produce documentation of an autoclave cleaning schedule.

Further review of surgical cleaning policy #PMSC .06 Glutaraldehyde High Level Disinfection revealed the chemical disinfectant list to be used was Glutaraldehyde. On 11/18/2010 at 2:00 PM an interview with surgical staff revealed Vesphene was the chemical disinfectant being used to sanitize the Operating Room surfaces and non steam sterilized instruments.

A review of documentation on 11/17/2010 at 11:00 AM revealed no records were found for temperature, humidity or pressure (which is the industry standard) for the surgery suites. The Director of Nursing confirmed no records were kept for Temperature, humidity or pressure in the surgical suites.

Based upon record review and interview, the facility failed to follow their own policy regarding qualified person being physically present in the emergency treatment area at all times.

Review of policy #ADMI.16 titled "Emergency Services Suite" revealed the following: "An RN (Registered Nurse) will be staffed to provide 24 hours/7days a week to respond to individuals presenting to the Emergency Services Suite. This person shall be present in the emergency treatment area at all times."

An observational tour was conducted on 11/16/10 at 10:15 am. Observation of the Emergency Suite revealed a receptionist/clerk sitting at the registration desk. This was the only staff person in the emergency treatment area.

An interview was conducted with the Administrator on 11/16/10 at 10:15 am in the emergency treatment area. The Administrator reported that an RN is scheduled for the emergency treatment area but does not remain there. The Administrator further reported the RN is given non-patient related duties in the surgical suite that would enable her to leave the surgical suite in the event she needed to return to the emergency treatment area.

On 11/17/10 at 4:00 pm. the above stated policy was reviewed with the Administrator. The Administrator confirmed the Emergency Policies had not been reviewed and revised and the policy stated the RN would be present in the emergency treatment area at all times.