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Based on interviews and record reviews the facility's medical staff failed to operate under its own current bylaws that are in accordance with Federal and State laws and regulations.

The findings include:

On 10/27/10 at 12:45 p.m. during an interview with the Medical Director's secretary, the secretary stated that the facility no longer conducted peer reviews. The secretary stated that the contract was cancelled with the physician who was conducting the peer reviews in October 2005.

On 10/27/10 at 1:00 p.m. an interview was conducted with the facility's Medical Director. The Medical Director stated that she was new to this position and, "no physician specific peer reviews were being conducted at the facility; none that I am aware of."

On 10/27/10 at 2:00 p.m. an interview with the Quality Assurance Director was done. This interview revealed that there were no written policies and procedures for physician peer review accept for what was written in the by-laws.

On 10/27/10 a review of the Governing Body's by-laws dated October 12, 2009 was done. The Governing Body by-laws stated:
Florida State Hospital shall provide for peer review of physicians who deliver health care services:

a. The membership of the medical peer review group shall be chosen alphabetically from the list of full-time physicians and psychiatrists. The membership shall consist of seven individuals, consisting four psychiatrists and three physicians. The psychiatrists shall be started with the letter A, working forwards, and the physicians shall be started with the letter Z, working backwards, utilizing a list provided by the Medical Support Staff Office. Membership shall be for a two-year term with half the membership being rotated about every year to maintain some continuity. The chairperson of the group shall be selected by the President of the Professional Clinical Staff.

b. The peer review group shall adopt rules of order for the peer review process.

c. The group shall design a methodology for the fair review of the case with the physician involved.

d. The group shall design mechanisms to identify and avoid any conflict of interest on the part of the peer review group.

e. The group shall arrange for the recording of the agendas and minutes which do not contain confidential material for review by the Division of Medical Quality Assurance of the agency.

f. The group shall review, at least annually, the peer review procedures by the Governing Body of the licensed facility.

g. the group shall make the focus of the peer review process on review of professional practices at the facility to reduce morbidity and mortality and to improve patient care.

Based on observation, staff interview and record review it was determined the facility failed to assess for the use restraints for 2 of 7 sampled patients. (#1,3)

The findings are:

1. Observation of patient # 1 on 10/2/10 at 12:00 noon, 1:00 PM and 10/26/10 at 8:50 AM revealed the use of a Posey vest restraint while sitting in bed with a 1 on 1 aide on duty supervising the patient 24/7.

Review of the record lacked documentation of an assessment for restraint use, no plan of care, no duration for the use of the restraint on the order dated 10/11/10, no least restrictive type used and no alternative prior to the use of the Posey.

Interview with the nurse manager on 10/26/10 at 10:45 AM revealed the patient needs the vest restraint due to falls. Asked if the patient had fallen since admission (9/10/10) and the nurse stated he/she has had no falls. The nurse stated the patient is ambulatory with assist.

Further interview revealed there should have been assessments with a plan of care completed upon admission.

Review of the facility policy indicates upon admission an assessment will be completed with a plan of care by a registered nurse.

2. Observation of patient #3 on 10/25/10 at 12:10 PM, 1:20 PM, 1:30 PM and 10/26/10 at 9:00 AM and 1:20 PM found the patient to have bilateral wrist restraints in place.

Interview with nurse manager on 10/26/10 at 1:25 PM revealed the patient has wrist restraints due to the patient pulling out the naso-gastric tube. Further interview revealed there should have been an assessment which would generate a plan of care for wrist restraints.

Review of the record lacked documentation of an assessment for restraint use, no plan of care, no duration for use of restraint on the order dated 10/23/10, no least restrictive type used and no alternative prior to the use of the Posey.

Review of policy indicated an assessment is completed upon admission with a plan of care implemented.

Based on observation, staff interview and record review, the facility failed utilize the Quality Assurance process to evaluate the effectiveness and thoroughness of the infection control process. Infection control practices and policies did not reflect current CDC guidelines in the cleaning of accucheck machines and the cleaning and sterilizing of surgical instruments. There were potential infection control issues with food storage in the Dietetic department. The facility failed to incorporate the Respiratory and Radiology departments into the facility-wide Quality Assurance program. The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality health care in a safe environment and resulted in the condition not being met. Cross-reference to A-267.

Based on observation, staff interview and record review, the facility failed to incorporate all hospital departments, including infection control, radiology and dietetic departments, into the Quality Assurance program. The Quality Assurance program failed to monitor the infection control program. There were no policies on the cleaning and sterilizing of surgical instruments. The policy on the autoclave and the cleaning of glucometers did not reflect current CDC guidelines. The Respiratory and Radiology departments were not incorporated into the facility-wide Quality Assurance Program. The storage of ready-to-eat foods in the Dietetic Department was not in accordance with FDA (Food and Drug Administration) guidelines.

The findings are:

1. During medication observation on 10/25/10 at 1:00 PM on unit 31 which is the acute care unit a licensed practical nurse was observed performing an accu check on patient # 2. The nursed placed the accu check machine on the patient's bed. Afterwards the nurse returned to the medication room and placed the machine on top of the work desk and preceded to prepare insulin for the patient. The nurse left the monitor on top of the desk when she left the medication room to give the injection. Afterwards the nurse did not clean the accu check machine.
Interview with the nurse on 10/25/10 at 1:30 pm stated she doesn't clean the accu check monitor unless she sees blood.

Interview with registered nurse while on tour of the emergency department on 10/25/10 at 12:30 PM revealed the accu-check monitors are used for more than one patient. We clean it with either alcohol or bleach solution after each use. She stated that was the hospital policy. She further stated the manufacture recommends the same for cleaning.

Review of the facility policy indicates to clean with soft cloth with 70% alcohol or 10% (1 part bleach for every 9 parts water) solution and it says the monitor shall be disinfected after it is contaminated with blood.

Review of the facility's policy in unit 31 indicated to clean the monitor with alcohol or 10% bleach solution if blood is visible.

CDC guidelines recommend that monitors not be shared. If they must be shared, it should be cleaned and disinfected after every use per manufacturer's instructions. In this case the manufacturer's instructions are for single use with a comment indicating the device should not be used for multiple use.

Interview with infection control director on 10/27/10 at 11:46 AM indicated she was not aware of changes related to cleaning of glucometers. We are changing our policy as we speak to reflect multiple use of monitors and cleaning per CDC guidelines.

She also stated she does not monitor the use of glucometers and cleaning of surgical equipment within the infection control process.

2. Observation and interview on 10/27/10 at 11:00 AM with manager and staff who are trained to operate the autoclave machine indicated she cleans the dirty equipment with Westadayn solution. She stated she soaks tweezers, scapulas and scissors about 30 minutes with a cap full of Westadayn solution to about a gallon of water. The staff was not sure of the amounts of water to solution ratio. They did not know what the recommended ratio for cleaning should be. Both stated they were trained to do this upon hire years ago. Instructions on the bottle of Westadayn indicated to use 1 oz to 5 gallons of water.

Interview and observation with different staff in the emergency room on 10/27/10 at 11:30 AM indicated they clean with Westadayn solution using a different ratio and soaking for 2-3 hours. They were unsure of the recommended amounts to use.

Further interview with the manager of unit 31 indicated we do not have a policy for disinfecting of instruments. During this interview, the manager stated we use biological test strips while the autoclave is in operation to monitor the temperature.

Observation on 10/27/10 at 1:10 PM revealed the use of chemical indicator strips but not biological indicator spore testing.

Interview at the same time indicated they did not do biological indicator spore testing and don't have a policy for this. Further interview indicated we should have a policy for the use of biological indicator strips.

Interview with infection control director on 10/27/10 at 11:46 AM revealed she was not aware that biological spore testing in conjunction with chemical indicator strips (often referred to as biological indicator strips) was not being used, but would correct this. She also stated she does not monitor the use of the autoclave machine.

Further interview with the manager of unit 31 on 10/27/10 at 2:15 PM revealed the autoclave machine is used 1-2 x week and this has ceased until the facility receives the needed equipment for biological indicator spore testing, make policy changes and train staff. He also stated we are preparing a policy for cleaning instruments indicating the recommend solution ratio and will train staff.

Review of the facility policy for use of autoclave indicates to place biological indicator test strips on packs or trays prepared for autoclaving per manufactures's instruction. The policy did not include the use of biological indicator spore testing.

Review of CDC guidelines for sterilization of instruments indicates to use both a chemical and biological indicator to verify effectiveness.

Interview with the manager on 10/27/10 at 2:15 PM on unit 31 indicated the use of a temperature indicator. Observation of the strip indicates for Steam Sterilization only does not verify or confirm sterility but indicates that temperatures have been reached to achieve sterility.

Interview with the Quality Assurance director on 10/27/10 at 9:45 AM revealed the facility has indicators that they monitor regularly and when the need arises. All departments monitor these and turn in their data to be processed. If changes are needed then we do an investigation and work to resolve the issues. All this is given to QA for reporting to the Board of Directors. The monitoring of glucometers and the use of autoclave was not part of the monitoring. At 2:15 PM the director indicated unit manager of unit 31 is making a new policy for the use of glucometers and the use of the autoclave and cleaning of surgical instruments.


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3. On 10/25/10 a tour of the Dietetic Department was conducted. Uncooked thawing chicken was observed dripping onto containers of ready-to-eat hard-boiled eggs. On 10/27/10 uncooked frozen egg product was observed dripping on containers of ready-to-eat hard-boiled eggs.

A review of the 2009 Food and Drug Administration (FDA) Food Code was conducted. The Food Code stated that cross-contamination must be prevented by properly storing ready-to-eat food away from raw animal foods and soiled equipment and utensils. Under
3-302.13, the Food Code stated that raw or undercooked eggs ....are particularly hazardous because the virulent organism Salmonella Enteritidis may be present in raw shell eggs.


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4. A tour of the Respiratory Department located in Unit 31, accompanied by the Unit Director, was conducted on 10/27/10 at 9:40am. In interview conducted with the Respiratory Director it was revealed the Respiratory Department does not collect data pertinent to respiratory services provided for inclusion in the facility's Quality Assurance Performance Improvement program.

5. A tour of the Radiology Department located in Unit 31, accompanied by the Unit Director, was conducted on 10/27/10 at approximately 10:00am. In interview conducted with the Unit Director, it was revealed the Radiology Department does not collect data pertinent to radiological services provided for inclusion in the facility's Quality Assurance Performance Improvement (QAPI) program.

Review on 10/27/10 of facility's current QAPI indicators did not reveal inclusion of respiratory services or radiological services.

Interview conducted with the facility's Quality Assurance Performance Improvement program director on 10/27/10 at approximately 3:00pm confirmed the Respiratory Department and Radiology Department do not have performance indicators that are included in the facility's program.

Based on observation, record review and staff interview it was determined the facility failed to ensure a registered nurse (RN) assessed 2 of 7 sampled patients for the use of Foley catheter and wounds. (#2, 3 ).

The findings are:

1. Observation of patient #2 on 10/25/10 at 12:10 PM, 1:30 PM, 10/26/10 at 9:00 AM, 9:30 AM and 11:50 AM found the patient in bed without heel protectors.

Interview with an aide on 10/26/10 at 10:30 am who was providing one on one supervision and who works with the patient on another unit stated the patient has a history of wounds to heels and wears heel protectors at home.

Record review indicated an admission to the acute care hospital on 10/13/10. In the front of the chart was a pressure ulcer flow sheet from the patient ' s home (another unit on campus). The flow sheet indicated the patient to have a 0.5 x 0.5 centimeter blister to right heel which had decreased from stage II 2 x 2 cm. The last measurement was dated 6/2/10 at 0.5 x 0.5 cm with treatment to use heel protectors. No other measurements were documented.

Review of the home unit's plan of care indicated at risk for skin breakdown related to Diabetes Mellitus, Chronic Venous Insufficiency, dry skin and history of dermatitis and indicated to apply heel protectors as ordered to prevent skin breakdown.

Observation of patient's heels on 10/16/10 at 10:30 am noted dry scaly heels. The left heel revealed a black area which according to the nurse was approximately 1 x 0.5 cm.

Interview with the wound nurse at the same time indicated they are getting heel protectors for the patient. Surveyor asked why they didn't send the patient's heel protectors with patient from his/her home on admission 10/13/10 and the nurse ' s response was we can get some here.

Further record review lacked documentation of skin assessment upon admission and weekly.
Interview with unit staff manager on 10/26/10 at 10:45 AM indicated that their should have been skin assessments completed upon admission and the wounds measured and photos taken weekly.

Review of the facility policy indicated upon admission a skin assessment will be completed within 24 hours by a registered nurse with weekly measurements completed and photos taken.

2. Observation of patient #3 on 10/25/10 at 12:10 PM, 1:20 pm, 1:30 pm and 10/26/10 at 9:00 AM and 1:20 PM found the patient with a Foley catheter.

Interview with the nurse manager on 10/26/10 at 1:25 PM indicated the patient had a catheter due to the use of a diuretic and because it was inserted in the emergency room.

Further interview indicated we should do an assessment upon admission for the use of the catheter.

Review of nurse progress notes on admission indicated a Foley catheter. The record lacked documentation of an assessment for the use of a Foley catheter.

Review of policy indicated an assessment is completed upon admission by a registered nurse.

Based on observation, record review and staff interview it was determined the facility failed to develop a plan of care for 2 of 7 sampled patients. (#2, 3 ).

The findings are:

1.Observation of patient #2 on 10/25/10 at 12:10 PM, 1:30 PM, 10/26/10 at 9:00 AM, 9:30 AM and 11:50 AM found the patient in bed without heel protectors.

Interview with an aide on 10/26/10 at 10:30 am who was providing one on one supervision and who works with the patient on another unit stated the patient has a history of wounds to heels and wears heel protectors at home.

Record review indicated an admission to the acute care hospital on 10/13/10. In the front of the chart was a pressure ulcer flow sheet from the patient ' s home (another unit on campus). The flow sheet indicated the patient to have a 0.5 x 0.5 centimeter blister to right heel which had decreased from stage II 2 x 2 cm. The last measurement was dated 6/2/10 at 0.5 x 0.5 cm with treatment to use heel protectors. No other measurements are documented.

Review of the home unit ' s plan of care indicated at risk for skin breakdown related to Diabetes Mellitus, Chronic Venous Insufficiency, dry skin and history of dermatitis and indicated to apply heel protectors as ordered to prevent skin breakdown.

Observation of patient ' s heels on 10/16/10 at 10:30 am noted dry scaly heels. The left heel revealed a black area which according to the nurse was approximately 1 x 0.5 cm.

Interview with the wound nurse at the same time indicated they are getting heel protectors for the patient. Surveyor asked why they didn't send the patient's heel protectors with patient from his/her home on admission 10/13/10 and the nurse ' s response was we can get some here.
Further record review lacked documentation of a care plan.

Interview with unit staff manager on 10/26/10 at 10:45 AM indicated that their should have a plan of care completed upon admission and the wounds measured and photos taken weekly.

Review of the facility policy indicated upon admission an assessment and a skin assessment will be completed within 24 hours by a registered nurse with a plan of care.

2. Observation of patient #3 on 10/25/10 at 12:10 PM, 1:20 pm, 1:30 pm and 10/26/10 at 9:00 AM and 1:20 PM found the patient with a Foley catheter.

Interview with the nurse manager on 10/26/10 at 1:25 PM indicated the patient had a catheter due to the use of a diuretic and because it was inserted in the emergency room.

Further interview indicated we should do an assessment which would generate a plan of care for the use of the catheter.

Review of nurse progress notes on admission indicated a Foley catheter. The record lacked documentation of a plan of care.

Review of policy indicated an assessment is completed upon admission with a plan of care implemented.

Based on observation and staff interview it was determined the facility failed to maintain equipment for the use of patients.

The findings are:

Observation on 10/25/10 at 12:10 PM and 10/26/10 at 8:50 AM on unit 31 revealed an emergency call light in a shower stall not functioning.

Interview with nurse and aide at the same time was unaware that it was not working. Further interview indicated one patient is independent with showers and is ambulatory and can use the shower room independently. The current census for unit 31 is 9 with a capacity to hold 24 patients.

Interview with the unit 31 manager on 10 27/10 at 10:10 AM indicated we will have it repaired, posted a sign and train staff not to use the shower room without staff present.

Based on observation, staff interview and record review, the facility failed to maintain an effective infection control program. Infection control issues were identified in the cleaning and sterilizing of surgical instruments and accucheck machines, and with food storage in the dietetic department. There were no policies on the cleaning and sterilizing of surgical instruments. The policy on the autoclave and the cleaning of glucometers did not reflect current CDC guidelines. Storage of ready-to-eat foods in the Dietetic Department did not reflect FDA (Food and Drug Administration) guidelines for proper food hygiene. The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality health care in a safe environment and resulted in the condition not being met. Cross-reference A-749.

Based on observation, staff interview and record review it was determined the facility failed to prevent the potential spread of infection by not following the most current CDC guidelines for cleaning of multi-use glucometers for 1 of 2 sampled patients during medication pass on unit 31, (#2).The facility failed to prevent the potential spread of infection by not following the most current CDC guidelines for disinfecting surgical instruments and sterilization of instruments while using the autoclave machine. The facility failed to maintain proper food hygiene in the dietetic department.

The findings are:

1.During medication observation on 10/25/10 at 1:00 PM on unit 31, which is the acute care unit, a licensed practical nurse was observed performing an accu check on patient # 2. The nursed placed the accu check machine on the patients bed. Afterwards the nurse returned to the medication room and placed the machine on top of the work desk and preceded to prepare insulin for the patient. The nurse left the machine on top of the desk when she left the medication room to give the injection. Afterwards the nurse did not clean the accu check machine.

Interview with the nurse on 10/25/10 at 1:30 pm stated she doesn't clean the accu check machine unless she sees blood.

Interview with a registered nurse while on tour of the emergency department stated on 10/25/10 at 12:30 PM indicated that machines were used for more than one patient. We clean it with either alcohol or bleach solution after each use. She stated that was the hospital policy. She further stated the manufacture recommends the same for cleaning.

Review of the facility policy indicated to clean with soft cloth with 70% alcohol or 10% (1 part bleach for every 9 parts water) solution and it said the machine shall be disinfected after it is contaminated with blood.

Review of the facility's policy in unit 31 indicated to clean the monitor with alcohol or 10% bleach solution if blood is visible.

CDC guidelines recommend that monitors not be shared. If they must be shared, it should be cleaned and disinfected after every use per manufacturer's instructions. In this case the the manuals instructions are for single use with a comment indicating the device should not be used for multiple use.

Interview with infection control director on 10/27/10 at 11:46 AM indicated I was not aware of changes related to cleaning of glucometers. We are changing our policy as we speak to reflect multiple use of monitors and cleaning per CDC guidelines.

2. Observation and interview on 10/27/10 at 11:00 AM with manager and staff who are trained to operate the autoclave machine indicated she cleans the dirty equipment with Westadayn solution. She stated she soaks tweezers, scapulas and scissors about 30 minutes with a cap full of Westadayn solution to about a gallon of water. The staff was not sure of the amounts of water to solution ratio. They did not know what the recommended ratio for cleaning should be. Both stated they were trained to do this upon hire years ago. Reading the bottle indicated to use 1 oz to 5 gallons of water.

Interview and observation with different staff in the emergency room on 10/27/10 at 11:30 am indicated they clean with Westadayn solution using a different ratio and soaking for 2-3 hours. They were unsure of the recommended amounts to use.

Further interview with the manager of unit 31 indicated we do not have a policy for disinfecting of instruments.

During this the manager stated we use biological test strips while the autoclave is in operation to monitor the temperature.

Observation on 10/27/10 at 1:10 PM indicated use of chemical indicator strips but not biological indicator spore testing.

Interview at the same time indicated they did not do biological indicator spore testing and don't have a policy for this. Further interview indicated we should have a policy for the use of biological indicator strips.

Interview with infection control director on 10/27/10 at 11:46a.m. indicated she was not aware of biological spore testing in conjunction with chemical indicator strips (often referred to as biological indicator strips) not being used but would correct this. She also stated she does not monitor the use of the autoclave machine.

Further interview with the manager of unit 31 on 10/27/10 at 2:15 pm stated the autoclave machine is used 1-2 x week and this has ceased until the we receive the needed equipment for biological indicator spore testing and make make policy changes and train staff. He also stated we are preparing a policy for cleaning instruments indicating the recommend solution ratio and will train staff.

Review of the facility policy for use of autoclave indicates to place biological indicator test strips on packs or trays prepared for autoclaving per manufactures's instruction. The policy did not include the use of biological indicator spore testing.

Review of CDC guidelines for sterilization of instruments are to use both a chemical and biological indicator to verify effectiveness.

Interview with the manager on 10/27/10 at 2:15 pm on unit 31 indicated the use of a temperature indicator. Observation of the strip indicates for Steam Sterilization only does not verify or confirm sterility but indicates that temperatures have been reached to achieve sterility.


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3. On 10/25/10 beginning at approximately 1:30p.m , a kitchen tour was conducted with a dietary supervisor. A walk-in refrigerator, identified by the supervisor as the 'thawing refrigerator' was observed. On the bottom shelf were several large plastic lidded containers of hard boiled eggs, peeled and ready to eat. On the shelf immediately above the eggs were boxes that contained thawing chicken. One of the boxes of chicken was actively dripping down onto the lid of one hard boiled egg container. An interview was conducted with the supervisor during the observation. The supervisor stated that staff are trained to wipe the lids off with sanitizer prior to opening the eggs. The supervisor confirmed that the eggs were hard boiled, peeled and ready to eat.

On 10/27/10 at approximately 9:30a.m., a follow-up observation of the thawing refrigerator was conducted with the supervisor. The meat drippage remained on the lid of the hard-boiled egg container. The hard-boiled egg containers remained on the bottom shelf. Today there was frozen egg product stored above the hard-boiled eggs. One box of egg product was observed dripping on a different hard-boiled egg container. There was a pool of liquid on the lid of the hard-boiled eggs. An interview was conducted with the supervisor during the observation. The supervisor confirmed that the frozen egg product was raw and needed to be cooked. The supervisor stated that the ready-to-eat food (hard-boiled eggs) should be stored above the raw food.

A review of the 2009 Food and Drug Administration (FDA) Food Code was conducted. The Food Code stated that cross-contamination must be prevented by properly storing ready-to-eat food away from raw animal foods and soiled equipment and utensils. Under
3-302.13, the Food Code stated that raw or undercooked eggs ....are particularly hazardous because the virulent organism Salmonella Enteritidis may be present in raw shell eggs.