HospitalInspections.org

At the time of the revisit on 07/06 and 07/2011, the hospital had not archived conditional compliance with the condition of participation 42 CFR 485.627.

Based on review of governing body meeting minutes and hospital documents and interviews with hospital staff, the hospital does not ensure the organizational structure of the hospital is effective in providing quality health care in a safe environment. The governing body failed to monitor, evaluate and ensure the services of the hospital. Refer to ID Prefix Tag C-241 for details and findings.

At the time of the revisit on 07/06 and 7/2011, this deficiency was not corrected.

Based on record review and interviews with hospital staff, the governing body does not ensure that policies governing the CAH"s total operation are implemented and ensure quality health care is provided in a safe environment.

Findings:
1. The governing body does not ensure that surgical procedures are performed in a safe manner. Refer to Tag 0320

2. The governing body does not ensure the hospital has an effective quality assurance program implemented to evaluate the quality and appropriateness of the diagnosis and treatment furnished. There was no evidence of the hospital monitored, collected data, or analyzed patient care. Refer to Tags 0337, 0338, 0342 and 0343

3. The governing body did not ensure the hospital had developed an active ongoing infection control program that reviewed and evaluated practices in the hospital, with corrective actions taken when needed, to ensure a sanitary environment and avoid sources and transmission of infections for patients and personnel. Refer to Tag 0278.

4. The governing body failed to assure that the nutritional needs of inpatients are met in accordance with recognized dietary practices. Refer to Tag 0279

5. The governing body failed to have documentation showing all the personnel operating the diagnostic x-ray equipment are qualified and trained, and the radiology department has oversight by the Medical Staff and Governing Body. Refer to Tag 0283

At the time of the revisit on 07/06 and 07/2011, this deficiency was not corrected.

Based on surveyors observations, review of the infection control documents, hospital meeting minutes and policies and procedures, and interviews with staff, the hospital failed to develop and maintain an active on-going infection control program for ensuring a sanitary environment, and identifying and preventing infections and communicable diseases

Findings:

Since the survey on 05/24/2011, the hospital has had one infection control meeting, 06/08/2011.
1. Although the policies and procedures and Infection Control Plan (Plan) had approval dates for 06/08/2011 through 06/15/2011, the plan and policies were not specific to the hospital. The original Plan, provided to the surveyors on the morning of 07/06/2011 had approval signatures by the Infection Control Committee (ICC) and the Governing Body. It was a prepackaged generic manual that was designed for hospitals with wide-range, specialized services and would need to sample high risk areas.
a. The Plan and policies said the program would track and trend nosocomial infections in Special Care Units, infections in neonates, postpartum infections, and ventilator related pneumonias.
i. The hospital is a 25-bed critical access hospital. It does not have specialized units, offer post-partum and neonatal care on a routine basis. Staff C and M told the surveyors the hospital does not routinely have patients on ventilators.
ii. The hospital is responsible to track all infections, monitor cultures and antibiotic usage to ensure the organism is sensitive to the medication prescribed, and notify the physician if the organism is resistant to the medication. Then to report that data for analysis to the ICC.
b. The Plan and policies did not specify how often the ICC would meet to review and analyze infection control surveillances, concerns and data.
c. The Plan did not reference on what current nationally recognized infection control guidelines it was based, such as CDC (Centers for Disease Control and Prevention), APIC (Association for Professionals in Infection Control and Epidemiology), SHEA (the Society for Healthcare Epidemiology of America), or AORN (the Association of periOperative Registered Nurses).

2. Except for environmental rounds and handwashing, the Plan did not specify the types and frequencies of surveillance activities that would be tracked and analyzed to ensure infection control policies would be followed throughout the hospital. Although the Plan and policies said that all Departments were to participate, it did not specify how or when the departments would participate or give guidance of what would be expected from the different departments. It did not specify/give guidance on how surveillance would be conducted or the frequencies it would be conducted for:
a. Isolation techniques and set-ups,
b. Surgical Services' and Central Supply's practices,
c. Housekeeping and environmental cleaning practices (how will they monitor to ensure approved disinfectants are used according to manufacturer's guidelines),
d. Dietary practices,
e. Respiratory practices

3. The back of the infection control policy and procedure manual contained sections/policies for medical waste, admitting, ancillary services (defined as social services, medical records and administration), dietary, ER (emergency room), engineering, environmental services, lab/blood bank, nursing, pharmacy, radiology, surgery, and central supply.
a. When the manual was shown to two department heads (Staff D and N), they were unaware of the manual and had not been consulted to ensure the policies were applicable or employees were knowledgeable of the policies.
b. Except for handwashing, the policies did not specify/address cleaning of equipment according to manufactures' guidelines, list or give guidance to the approved disinfectants usage, give infection control measures/guidance on frequency of cleaning and replacing disposable and reusable equipment.

4. The hospital uses gel and foam alcohol-based hand sanitizers. The hospital's infection control program has not developed a policy specifying where or when the use of hand sanitizer is appropriate and how it is to be applied.

5. Interviews with Staff C, D and N on 07/06 and 07/2011, revealed different disinfectants were used in different departments. Meeting minutes did not demonstrate the ICC had reviewed or approved the current disinfectants to ensure they were effective and would provide a safe and sanitary environment for patient and staff protection.
a. According to Staff D and E, TB-Cide is the disinfectant currently used in the surgical area. The currently approved surgery policy manual documented a different disinfectant, LPH. Neither staff could tell the surveyors the manufacturer's recommended length of time the disinfectant needed to remain wet of surfaces to be effective. Staff D stated as far as she new no one had monitored the application to ensure it was applied appropriately.
b. Staff N could not tell the surveyors the manufacturer's recommended length of time the disinfectant needed to remain wet of surfaces to be effective. Staff N stated as far as she knew no one had monitored the application to ensure it was applied appropriately.
c. Review of environment surveillance data did not demonstrate anyone had reviewed and monitored the application of disinfectants to ensure they remained wet on surfaces the amount of time specified by the different manufacturers. Staff M stated he had not monitored disinfect applications. He stated another person was responsible for environmental rounds.

6. The infection control logs provided to the surveyors on 07/06/2011 did not contain all of the data required for all listed individuals.
a. At the time of review, three of the six inpatient entries did not contain the patient's admission date.
b. The inpatient entries did not contain the date of onset of suspected infection.
c. When culture results were obtained, the log did not identify if the antibiotic/medication usage was appropriate - whether the organism was sensitive or resistant to the medication and if resistant, when the physician was notified of the results. Meeting minutes did not demonstrate data was analyzed to ensure prescribed medication was effective.
d. The log did not contain entries for employee health. On 07/06/2011, the findings were reviewed with the person identified as responsible for the infection control program, Staff M stated someone else did the log for him.
e. The log did not show tracking of outpatient surgery infections. When Staff M was interviewed, he stated he did not have data for outpatient surgery. He stated he thought the surgery department called patient's the next day, but he did not receive any data. Staff C and D stated on 07/06/2011 that except for the follow-up call the day following surgery, staff relied on the surgeon to notify them if any infections occurred.
f. Staff M stated that Employee Health kept their own log of employee illness. No data was provided to the surveyor for review. Meeting minutes did not reflect anyone reviewed employee illness for correlation with hospital patient infections.

7. Although the meeting minutes documented "sterilization report", the only data attached was review of the biological indicators. No other data was attached. On 07/06/2011, Staff M stated that was all that was reported. On the afternoon of 07/07/2011, Staff D stated that was all she was told she needed to report
a. Staff D does not collect and report data on return to surgeries, failures in aseptic practices, infected surgical cases, disinfection between surgical cases, surgical scrub practices, endoscopic cleaning practices, and use of "flash"/shortened time sterilization.
b. On the morning of 07/07/2011, Staff D and E stated that the autoclave representative had brought in a container for immediate use sterilization. They stated the representative did not bring the manufacturer's guidelines for sterilization, but told them the times for sterilization, exposure and dry, needed. Review of the prevaccuum sterilizer autoclave tape showed sterilization of eye instruments on 06/22/2011 at eight cycles of 4 minutes exposure and dry time of 5 to 7 minutes. On the afternoon of 07/07/2011, Staff D brought the manufacture's guidelines, which she stated she had just received. The manufacturer's guidelines required exposure of 4 minutes between 270 and 274 degrees Fahrenheit and a dry time of 20 minutes in a prevaccuum sterilizer.

8. The meeting minutes did not demonstrate the handwashing surveillances were evaluated and actions taken to improve the data collection and surveillance. The meeting minutes only recorded, "Handwashing has been conducted in all departments by the ICP." According to the forms, the ICP/ICO (infection control practitioner/officer) did not conduct the surveillance. This was confirmed by Staff M on 07/07/2011. The handwashing surveillance performed was a single incident/observation in the different departments. The observation did not monitor the actual practices and did not identify the discipline reviewed for future comparisons.

At the time of the revisit on 7/6/11 the deficiency was not corrected.

Based on document reviews and interviews, the hospital failed to assure that the nutritional needs of inpatients are met in accordance with recognized dietary practices.

Findings:

1. The hospital uses the services of a consultant dietitian. Staff B told surveyors on 7/6/2011 Staff J was the consultant dietitian. Surveyors were provided consultant dietitian reports which were written by Staff S, a certified dietary manager (CDM) . The reports provided by Staff S were dated June 2011. The dietary organizational chart indicates Staff S is in charge of Staff J the dietitian. Staff J was not available for interview during the survey. On 7/6/11 surveyors were provided a job description for the contract dietitian position. The signature on the job description was for the consultant dietitian previously used by the hospital ( Staff L). Documentation in Pt #1's chart indicates Staff L (the former contract dietitian) provided a nutritional assessment. Documentation in the chart also included diabetic teaching from Staff F. There was no hospital orientation training or competencies in Staff F's personnel file.

2. On 7/6/11 dietary policies documented as reviewed and revised in 6/2011 were provided to surveyors. The nutritional screening policy indicates a "dietary aid" will review the nursing nutrition screen and make appropriate recommendations for the patient's dietary needs.

3. On 7/7/11 Staff H's personnel file was reviewed. There was no documentation of training relating to dietary department policy and procedure. There was no job description. An evaluation dated 10/10 was signed by an administrative assistant. There was no evidence Staff H had orientation, training, and appropriate evaluation to the dietary department.

4. On 7/6/11 Staff B provided surveyors a list of quality monitoring. There was no quality monitoring for dietary included.

Based on review of hospital documents, review of personnel files and interviews with the radiology department manager, the hospital failed to have documentation showing all the personnel operating the diagnostic x-ray equipment are qualified and trained, and the radiology department has oversight by the Medical Staff and Governing Body.

Findings:

1. In an interview on the afternoon of 7/6/11 Staff N stated all of the employees received competency training for specific radiology modalities at the facility. The competencies were not developed in coordination with the radiologist. There was no indication the competencies had been reviewed and approved by the radiologist or the medical staff. Staff N verified this finding with surveyors. In the exit interview Staff R also stated the competencies had not been reviewed and approved through Medical Staff or Governing Body.

2. Personnel files (G,I) provided to surveyors included competencies for specific radiology modalities. Competencies did not have signatures by the reviewing staff members. Staff G's answers differed from Staff I. Staff I's records had check marks by answers with nothing written. Staff I did not have hospital orientation and training.

3. In an interview on the afternoon of 7/6/11 Staff N reviewed mammography information with surveyors. Staff N told surveyors the post procedure follow up letters were reviewed with the radiologist. Staff N stated the information did not go to Governing Body or Medical Staff. On 7/6/11 Staff N also provided documentation regarding a computed tomography (CT) dosing study requested by the contracted physicist. Staff N told surveyors the information was not provided to Medical Staff or Governing Body. Staff N did not know if the Governing Body was aware of the study. Staff N had not been asked to provide any CT or Mammography documentation to the Medical Staff or Governing Body. Staff N stated she routinely spoke to the radiologist about issues with radiology.

4. In an interview on the afternoon of 7/6/11 Staff N told surveyors the radiology department utilized a product to disinfect between procedures called TnT. Staff N told surveyors the disinfectant was sprayed on and sat for a long time. Staff N did not know the kill time for the disinfectant. The product label indicates a ten minute kill time is required. Staff N was not sure the disinfectant was utilized correctly. Infection Control Policies reviewed and revised 6/2011 did not include a review of the product. There was no evidence the product had been approved by Infection Control Committee. Staff N asked to review the Infection Control Policies from 6/2011 pertinent to the Radiology Department. Staff N told surveyors the policies had not been provided to radiology and radiology did not have input in the development.


5. On 07/6/11 surveyors were given Governing Body and Medical Staff Meeting Minutes. Review of minutes did not indicate there was any type of radiology department review. On 07/6/2011 this finding was reviewed with Staff B and no further documents were provided.

At the time of the revisit on 7/6/2011 conditional compliance had not been achieved.

Based on observation, staff interviews, and a review of policies and procedures, the hospital failed to ensure that surgical procedures are performed in a safe manner.

Findings:

1. On 7/6/2011 surveyors reviewed the sterilization log for 6/22/11. Eleven eye cases were performed on 6/22/11. On 7/6/11 surveyors reviewed the sterilization logs and the autoclave tape for 6/22/11. Documentation on the log included loads one through eleven. Only one cycle time was documented as 18 minutes. Staff E provided autoclave tape for the eleven loads. The autoclave tape indicated a variation of cycle and dry times. None of the times on the autoclave tape matched the sterilization log. Staff E told surveyors the flashpack container used to process the instruments was brought by the sales representative for the facility to try before the container was purchased. Staff told surveyors during the trial use on 6/22/11 the sales representative instructed the facility on the sterilize and dry times. In particular, the sales representative told Staff E to increase the dry time according to if there was moisture on the instruments. Staff E told surveyors the facility did not have the manufacturer's guidelines for use with the trial container. Staff E also told surveyors the dry times had to be increased because a small amount of moisture was noted in the bottom of the container with shorter cycles. This information was verified with Staff D in an interview on 7/6/11.

2. Review of the operating room log indicated eleven eye cases were performed on 6/22/2011 from 0831-1355. The times indicated on the operating room log from the end of one case to the beginning of another varied. In an interview with Staff D on the afternoon of 7/6/11, surveyors were told disinfectant cleaners used by the facility required a twenty minute kill time for adequate disinfecting of surfaces. Surveyors asked Staff D based on the times documented in the operating room log for 6/22/11, if adequate disinfection of all surfaces occurred. Staff D reviewed the operating room log for 6/22/2011 with surveyors and indicated the disinfectant would not have been on long enough between cases to adequately disinfect surfaces.

3. On 7/7/11 surveyors reviewed surgical and central sterile policies and procedures. The policy manual provided to surveyors documented a revised, reviewed and approved date of 6/2011.
A. The manuals did not contain policies on appropriate operating room attire, use of flash sterilization, and use of alcohol based hand sanitizers.
B. The policy regarding cleaning and disinfecting indicated a product "LPH" would be used for disinfecting and cleaning between cases. In an interview on 7/7/11 with Staff D the facility uses a product called TBcide. None of the policies and procedures referred to this product. This product was not listed as reviewed and approved through the Infection Control Committee.
C. The central sterile policy entitled "sterilization" referred to Cidex as the chemical agent of choice for cold sterilization. Staff D told surveyors on 7/7/11 Cidex was not used in the facility. The policy also states a "gravity" sterilizer is used for steam sterilization. Staff D and E told surveyors the facility sterilizer was a prevac. The policy also referred to use of Steris System 1 which Staff D and E told surveyors was not being used in the facility.
D. On 7/7/2011 Staff D told surveyors there was no policy for cleaning of endoscopy equipment. On 7/7/11 in the afternoon, surveyors were provided Central Sterile policies and procedures documented as reviewed and revised 6/2011. Included in the polices was "Cleaning procedure for Olympus Gastrointestinal Fiberscopes."


4. On 7/7/11 surveyors reviewed Governing Body Meeting Minutes, Quality Assurance Meeting Minutes, Infection Control Meeting Minutes and Quality Assurance documents. There was no review of surgical services where quality of care, incidents related to surgery, or surgical infection control practices were reviewed. Infection Control Meeting minutes documented a review of the biological indicator strips only. There was no documentation the Infection Control Committee was aware of the use of the flash pack, changes in cycle times, and changes to chemicals used in the facility for cleaning and disinfecting. There was no documentation the Infection Control Committee reviewed and approved cleaning and disinfecting agents used throughout the facility. In an interview on 7/7/2011, surveyors were told the infection control policies pertinent to the surgical area had not been presented or reviewed with Staff D the Operating Room Supervisor. Staff D also told surveyors there had been no instruction to provide any quality or infection information to Quality Assurance or Infection Control Committees. Refer to tag 0278.


5. On 07/8/11 surveyors reviewed Staff D, Operating Room Supervisor's personnel records. There was no job description in the personnel record. An evaluation recorded in the file was based on a "staff" nursing position. Documentation in the file did not indicate any training in the operating room other than on the job. There was no documentation indicating Staff D had current education and training as the Operating Room Supervisor. On 7/7/2011 Staff D told surveyors the staff did not have access to outside resources such as Association of Perioperative Nursing (AORN). A skills checklist dated 6/13/2011 was in the personnel file. The skills checklist for Staff D the OR supervisor was the same as Staff E a scrub tech.

At the time of the revisit on 07/06 and 07/2011, this deficiency was not corrected.

Based on record review and interviews with hospital staff, the hospital does not ensure the quality assurance program which has been reactivated after a period of not functioning includes all patient care services and other services affecting patient health and safety. Services such as dietary, radiology, pharmacy, infection control and medication therapy were not included as part of the evaluation of patient care services in the quality assurance program. Implementation of a functioning quality assurance program was not demonstrated by hospital staff during the followup survey.

At the time of the revisit on 07/06 and 07/2011, this deficiency was not corrected.

Based on review of infection control documents, hospital meeting minutes, policies and procedures and personnel files, and interviews with staff, the hospital does not ensure that an effective quality assurance program is implemented and nosocomial infections and medication therapy are evaluated. The hospital failed to develop an active on-going infection control program for ensuring a sanitary environment, and identifying and preventing infections and communicable diseases by designating a person qualified through training and/or experience as the infection control officer (ICO).

Findings:

1. Since the survey on 05/24/2011, the hospital has had one infection control meeting, 06/08/2011.

2. The Plan and policies were not specific to the hospital although the policies and procedures and Infection Control Plan (Plan) had approval dates for 06/08/2011 through 06/15/2011.

3. Except for environmental rounds and handwashing, the Plan did not specify the types and frequencies of surveillance activities that would be tracked and analyzed to ensure infection control policies would be followed throughout the hospital.

4. Two department heads (Staff D and N) were unaware of the policies contained in the infection control manual and were not knowledgeable of the policies and had not been consulted to ensure they were applicable.

5. Meeting minutes did not demonstrate the ICC had reviewed or approved the current disinfectants to ensure they were effective and would provide a safe and sanitary environment for patient and staff protection.

6. The infection control logs provided to the surveyors on 07/06/2011 did not contain all of the required data for all listed individuals.

At the time of the revisit on 07/06 and 07/2011, this deficiency was not corrected.

Based on record review and interviews with hospital staff, the hospital does not ensure that a functioning QA/PI system is implemented so that remedial action can address deficiencies found through the QA/PI program. Review of Governing Body and Medical Staff meeting minutes for 2010 and 2011 and interviews with hospital staff during the survey did not have evidence the newly implemented hospital QA/PI plan has been implemented and that the QA/PI program is fully functional .

At the time of the revisit on 07/06 and 07/2011, this deficiency was not corrected.

Based on record review and interviews with hospital staff the hospital does not ensure that a functioning QA/PI program is implemented in the hospital. The hospital has not documented any remedial action because the new QA/PI plan has not been fully implemented and all services are not participating. This was verified by hospital staff on 07/07/11 and by review of Governing Body and Medical Staff meeting minutes for 2010 and 2011.