The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SEMPERVIRENS 720 WOOD ST EUREKA, CA Sept. 12, 2014
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on dietetic services observations and dietary staff interview the hospital failed to ensure maintenance of the physical plant in accordance with food service requirements as evidenced by the lack of an air gap in the kitchens ' 2-compartment sink. Lack of an air gap may risk contamination of equipment in the event of wastewater backflow.

Findings:

During general kitchen observation on 9/9/14 beginning at 10 a.m., it was noted that the 2-compartment sink lacked an air gap. The purpose of an air gap is to provide protection against backflow. The standard of practice ensures an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment, or nonfood equipment and shall be at least twice the diameter of the water supply inlet and may not be less than 1 inch (Food Code, 2013). In a concurrent interview with Dietary Staff Y she stated that in a recent county inspection the hospital was cited for one of the sinks that die not have an air gap; however since they were not cited for the 2-compartment sink an air gap was not installed.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation, interview, and document review, the facility failed to ensure a safe environment when:

1. Glucometer testing supplies were used past the expiration date, recommended by the manufacturer when bottles were open, This failure could have led to the use of a ineffective product and inaccurate results.

2. Defibrillator pads used with the AED (Automated External Defibrillator), located on the emergency cart had an manufacturer expiration date that were expired. This failure could lead to the use of pads that were not safe in an emergency due to degradation of the product.

3. Electrical equipment such as refrigerators, a portable fan and suction machine were not maintained and checked on a routine basis by preventive maintenance staff. This failure could have led to the use of equipment that was unsafe due to electrical malfunction.

Findings:

1. During an observation on 9/9/14, at 11 a.m., Assistant Director of Nursing A displayed the glucometer (blood testing device) and testing solution supplies, in the medication room. Assistant Director of Nursing A explained the use of the three testing solutions to test the accuracy of the blood glucose machine. All three testing solution bottles had been opened and were marked as opened on 6/1/14 with a discard date of 9/1/14 also written on the bottles. Assistant Director of Nursing A stated that the solution should have been discarded three months after opening and that staff tested the glucose machine everyday.

On 9/9/14, review of the "Quality Control log for Glucose Monitors" for September 2014, indicated that there were three control solutions (Level 0, Level 1 and Level 2) where quality checks were done every day. Review of the testing supply manufacturers's instructions indicated to write the date on the bottle when the solution was first opened and discard after 3 months or after the bottle expiration date. Review of the blood glucose monitoring system-Quality Control tests and Equipment Care policy revised 8/7/14 indicated to check the use by dates on the control level bottle and discard if three months past the the written open date.

2. During an observation on 9/8/14, at 2:45 p.m., there was an AED with defibrillator pads attached, in a drawer of the emergency cart. The expiration date on the pads was 6/2014. Assistant Director of Nursing A agreed that the defibrillator pads should be replaced because they were past the expiration date and stated she would have to call the company to find out about replacing them.

On 9/8/14, review of the first aid cart check list indicated the AED was checked on 9/5/14 but no defibrillator pad check was written as being checked. On the bottom of the check sheet was written to write down expiration dates of items and notify the supervisor one week prior to the expiration date.

On 9/11/14, review of the medical supplies policy, last reviewed by the facility on 2/21/13, indicated that supplies should be monitored for expiration dates and removed before the expiration date occurs.

3. During an observation on 9/8/14, at 2:45 p.m., there was a small white refrigerator with an electrical plug that inserted into the wall outlet, located in the treatment/exam room. There was no documentation or sticker that indicated electrical maintenance or monitoring had been done on the refrigerator. There was also a small suction machine with an electrical cord and plug in the drawer of the emergency first aid cart. There was no sticker that indicated that preventive maintenance had been done or that the suction had been checked before it was put in service.

During an observation on 9/9/14, there was a fan in the medication room that was on, and a functioning refrigerator, both had electrical cords that plugged into the wall outlets.

During an interview on 9/11/14 at 1:50 p.m., Staff Services Maintenance Manager B stated he supervised the facility maintenance staff and was not sure if electrical equipment on the nursing unit was checked or tested for safety.

During an interview on 9/11/14 at 2:10 p.m., Facility Maintenance Staff C stated that staff did preventive maintenance and maintained logs for fire extinguishers, lights, air conditioning filters but did not track or maintain mobile medical equipment like the suction machines.

During an interview on 9/11/14 at 2:13 p.m., Facility Maintenance Supervisor D stated that electrical outlets were checked for polarity and tension but they not check the equipment that was supplied by electricity such as refrigerators or suction equipment.

Review of OSHA (Occupational Safety and Health Administration) technical manual section VI Chapter I effective 1/20/99 indicated under hospital safety program that all electrical equipment used in the hospital must be approved for safety by underwriters laboratories (UL) or OSHA-approved body which indicates that electrical cords are determined to be hospital grade.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on dietary staff interview and administrative document review the hospital failed to ensure that performance improvement activities 1) fully evaluated the depth and scope of the department and 2) demonstrated opportunities for improvement. Performance improvement activities that are limited to monitoring of quality indicators that demonstrated hospital compliance resulted in missed opportunities to identify areas of improvement.

Findings:

In an interview on 9/10/14 at 10:30 a.m., with Dietary Staff Y she was asked to describe the performance improvement activities for the dietary department. She stated that her primary focus was patient satisfaction surveys. She provided a blank form that evaluated the taste and temperature of the food. She stated the surveys identified issues regarding the acceptability of the overall menu. She stated that there were items on the menu that were not acceptable to the patients; however since it was on the menu the item would be prepared despite the fact she knew in advance it would not likely be consumed. She also stated that the menu was for " older " people and most of the hospitalized patients were younger and " didn ' t like the kinds of food. " She further stated that while this was identified as an area of concern there were no interventions to adjust the menu

On 9/11/14 beginning at 8 a.m., the departments ' performance improvement projects, which were submitted to the continuous quality improvement committee, were reviewed. It was noted that for the first 2 quarters for 2013, with the exception of 2 outliers of 45 indicators all departmental standards were met. Review of the first quarter for the calendar year 2014 revealed that all of the standards were met with the exception of the satisfaction of patient meals. While the department identified an area of improvement the intervention was to " continue to monitor patient food surveys. " There were no quality improvement interventions develop despite an identified issue. It was also noted that with the exception of monitoring timeliness completion of nutritional screenings, in relationship to hospital policy, there were no performance improvement activities for clinical nutrition care services.
VIOLATION: DIRECTOR OF DIETARY SERVICES Tag No: A0620
Based on food storage observations, dietary staff interview, and dietary document review, the hospital failed to ensure procedures to ensure an effective system to maintain a record of food ingredients. Failure to maintain a system for food labeling may put patients at risk of receiving foods they are allergic to, which in severe instances may result in death.

Findings:

During general food storage observations, in the 2-door freezer, on 9/9/14 beginning at 10 a.m., it was noted there were multiple bags of unlabeled food items, identified by Dietary Staff (DS) X as fish sticks, sausage patties and beef patties. In a concurrent interview with DS X he stated the items were removed from the shipping box because there was not enough freezer space. The surveyor asked how the hospital ensured the ingredient label was maintained, in particular for patients with food allergies. He stated there was no system in place. The ingredient label was posted on the shipping box and once it was discarded there was no way to verify ingredients for products.

The minimum standard or practice would be to ensure the label information such as the common name of the food, the source for each major food allergen as well as other identifying information such as the name and place of the manufacturer was maintained, all of which would be on the original shipping label (Food Code, 2013).
VIOLATION: QUALIFIED DIETITIAN Tag No: A0621
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, and Registered Dietitian interview, the hospital failed to ensure patients received comprehensive nutritional care as evidenced by lack of a complete nutrition assessment for inpatients (Patient 500) with a mental health and medically related diagnosis.

Findings:

Patient 500 was admitted on [DATE], with mental health diagnosis which included schizoaffective disorder (a condition in which a person experiences a combination of schizophrenia symptoms - such as hallucinations or delusions, Mayo Clinic 2014). Patient 500 also had medical diagnosis which included diabetes, high blood pressure and low sodium levels in the blood (Hyponatremia). Current diet order dated 9/10/14 was a regular, high sodium diet. Blood glucose results dated 4/28/14 - 9/5/14 revealed values ranging from 198-220 milligrams/deciliter (mg/dl - a metric unit of measure), normal 90-110 mg/dl.

Admission nutrition screening dated 1/17/14 completed by the Registered Nurse noted the patient was 6 feet 6 inches tall and weighed 196 pounds which was his normal weight. Completion of the screening by the Registered Dietitian (RD) dated 1/17/14 noted estimated caloric needs of 2237-2675. There was also a recommendation to maintain blood glucose levels between 120-180 milligrams per deciliter (a metric unit of measure). A follow up screening dated 2/27/14 noted the patient was now on a regular diet due to poor acceptance of a no concentrated sweets diet. The screening also noted Patient 500 was now at a high nutritional risk experiencing a 10 pound weight increase in the previous week. The screening failed to assess potential causes of the weight gain. There was no comprehensive nutritional assessment despite an identified need or a change in status to a high nutritional risk. The screening did recommend second portions be limited to vegetables and the promotion of an exercise program. Review of hospital document titled "Master Treatment Plan" updated 7/22/14 failed to provide identification or implementation of a nutrition care plan. There was no medical care plan developed to support nutrition recommendations.

A follow up weekly screening dated 2/14/14 noted an additional 10 pound weight increase, a total of 20 pounds in 2 weeks. It was also noted there were 27 nutritional screenings completed from 1/17 - 9/8/14, all of which were completed via fax machine. There were no nutritional screenings or assessments completed which involved patient input.

Review of nutritional care provided to Patient 500 revealed with the exception of weekly nutrition screening there were no comprehensive nutrition assessments despite a nutritionally related medical diagnosis. Review of 23 weekly nutritional screenings from 2/24/14 - 9/8/14 revealed despite identification of nutritionally related issues such as hyponatremia, diabetes and continuous multiple weight fluctuations there were no compressive nutritional assessments completed.

In an interview on 9/10/14 beginning at 2 p.m., with Dietary Staff (DS) Y she stated the primary RD came to the facility weekly or bi-weekly depending on the need. She stated her time spent at the facility was primarily related foodservice support and training of dietary staff. She stated that to her knowledge the nutrition screening documents were completed by faxing the nutrition screening forms to the RD. She stated the RD worked directly with patients only when the physician specifically requested a consultation.

In an interview on 9/11/14 at 9:25 a.m., with RD V she explained she was the relief dietitian and was called to provide services when the primary RD was unavailable. She stated she has been covering for her during the previous week. RD V explained the hospital system was to fax a nutrition screening at the time of admission and weekly thereafter. Based on the information that was provided the RD had a limited role as she would comment on the information that was provided; however she would not consider the screening form as a comprehensive nutrition assessment, rather would be "a very limited assessment." She further stated that based on the screening the RD did not develop a nutrition care plan. RD V also stated that if nutritional recommendations were made the physician may or may not implement; however as the RD she would not follow up with the hospital. RD V further stated she had never had any direct contact with patients and to her knowledge the primary RD did not routinely interview patients. The surveyor asked whether or not medication or laboratory data were provided as part of the nutrition screening fax. She replied that on occasion laboratory data was included; however medication data was not. Review of hospital policy and procedure manual updated 5/26/11 revealed that with the exception of nutritional screening there was no procedure developed to ensure that patients received comprehensive nutrition assessment services.

A nutritional analysis would consist of multiple components including but not limited to collecting, integrating, and analyzing nutrition-related data such as food-drug interactions, cultural, religious and ethnic food preferences, age related nutrition issues and the need for diet counseling. The Registered Dietitian would also evaluate patient ' s nutritional status and the extent of any malnutrition. The data gathered would provide the objective basis for recommendations and evaluation of care. A comprehensive nutrition assessment would include a chart review and patient interview (Fine, University of Illinois, Chicago). Hospital document titled "Dietary Consultant" dated 11/17/08 noted that the "Consultant will provide ...patient nutritional assessment, patient care planning ..."
VIOLATION: DIETS Tag No: A0630
Based on food distribution observations, dietary staff interview, and medical record review, the hospital failed to ensure the physician ordered diet for 1 patient (Patient 500) was accurately clarified. Failure to clarify physician ordered diets may result in compromising the patients' medical status.

Findings:

During meal distribution on 9/9/14 at 12 p.m., it was noted that Patient 500 had a physician ordered "high sodium, regular" diet. It was noted that Dietary Staff X added an unmeasured amount of salt to the soup.

In an interview on 9/9/13 at 1 p.m., with Dietary Staff Y she was asked to describe how the physician ordered diet was met. She stated that nursing staff instructed her to add " a little " extra salt to 1 item in the meal. The surveyor asked if the hospital had specific parameters for a high sodium diet. She stated that they did not. She also acknowledged that the physicians ' order did not offer specific parameters.

In an interview on 9/11/14 at 8:25 a.m., with Registered Dietitian V she acknowledged she was aware of the diet order. She further stated that the hospital did not have any parameters for this physician order and also acknowledged that this order should have been clarified with the physician. Review of the hospital diet manual dated 2012 confirmed that there was no high sodium diet as part of the approved hospital diet manual.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation interview and record review, the governing body failed to ensure:

1. The hospital maintained a hospital-wide quality assessment and performance improvement (QAPI) program and training programs which addressed infection control problem required for an effective infection control program. (Cross Reference A-0747, A0749, and A0756).











2. The hospital failed to ensure the contracted confidential shredding services, for the provision of the destruction of personal health information (PHI) were provided in a safe and effective manner. The hospital did not implement a quality assessment and performance program (QAPI), to ensure that services, furnished under contract, were reviewed on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities. This failure resulted in the potential for patients whose medical records containing health information were selected for destruction from 2011 through 9/12/14, to be accessed by unauthorized persons. (Cross Reference A-0084).

3. The hospital failed to maintain a complete list of all contracted services that included delineation of the scope of services provided and the contractor's responsibility to the hospital for the services provided by the Company L service for 1 of 19 contracted services. This failure has the potential to result in ensuring the contracted service responsibilities are delineated as provided. (Cross Reference A-0085).

The cumulative effect of these systemic problems resulted in the hospitals' inability to maintain a governing body with the necessary oversight and accountability to maintain and implement the policies governing the hospital in accordance with accepted professional practice.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on interview, and administrative record review, the hospital failed to ensure the contracted confidential shredding services, for the provision of the destruction of personal health information (PHI) were provided in a safe and effective manner. The hospital did not implement a quality assessment and performance program (QAPI), to ensure that services, furnished under contract, were reviewed on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities. This failure resulted in the potential for patients whose medical records containing health information were selected for destruction from 2011 through 9/12/14, to be accessed by unauthorized persons.

Findings:

During an interview on 9/9/14 at 11:25 a.m., Administrative Staff F stated confidential shredding of patient's health information contained in the medical records was provided by a contracted service Company L.
.

During an administrative record review of the Sempervirens Vendor List Nature And Scope of Service, revised 4/30/13, included the list of 19 vendors providing services to the hospital. The vendor list documented the nature and scope of the contracted services provided to the hospital. The vendor list did not contain the name of the contracted service Company L.

During an interview on 9/11/14 at 2:50 p.m., Administrative Staff F stated the Contract Monitoring Report was the report summarizing the quality and performance of the hospital's contracted services. He stated the report did not include a quality and performance assessment of the contracted services provided by Company L.

The hospital's Contract Monitoring Reports dated August 2013 and September 2014, did not provide a quality performance review for the contracted service Company L.
VIOLATION: CONTRACTED SERVICES Tag No: A0085
Based on administrative record review, and interview, the hospital failed to maintain a complete list of all contracted services that included delineation of the scope of services provided and the contractor's responsibility to the hospital for the services provided by Company L for 1 of 19 contracted services. This failure had the potential to result in ensuring the contracted service responsibilities were delineated as provided.

Findings:

During an administrative record review of the Sempervirens Vendor List Nature And Scope of Service, revised 4/30/13, included the list of 19 vendors, the nature and scope of services provided. The list of contracted services does not include services provided by Company L (resource recovery, waste collection and destruction).

During an interview on 9/10/14 at 11:40 a.m., Administrative Staff F stated the hospital did not have a contract with Company L. When asked how long Company L has been providing the service to the hospital he stated "four years."
VIOLATION: PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS Tag No: A0147
Based on observation, interview, and document review, the hospital failed to ensure the chain of custody for patients' medical records whereby the medical records were deemed to be shredded by a contracted service. This failure had the potential to elicit unauthorized disclosure of the health information contained in the medical records.

Findings:

During an observation on 9/9/14, at 11:25 a.m., in the hospital's basement were two medical record storage facilities named Radiology 1 and B Door. Several years of medical records were stored in both rooms. Stored in room Radiology 1 were greater than 1000 medical records and stored in the B Door room were the years 2013 and 2014 greater than 25 medical records.

During an interview with Administrative Staff G and Senior Medical Office Assistant K on 9/9/14, at 11:25 a.m., they stated once the medical record was scanned into the electronic health record system Avatar and verified for completeness, the record was placed in a large black trash bag (similar to a Glad trash bag) to be taken for shredding. Senior Medical Office Assistant K stated the custodial staff picked up the trash bags. Administrative Staff G stated she was not sure who shredded the medical records and where the trash bags were stored while waiting to be shredded.

During an observation and concurrent interview with Facilities Custodian AA and Facilities Custodian BB on 9/9/14, at 3:15 p.m., at the back of the hospital where the dumpsters were stored were 6 dumpsters, three (3) green dumpsters, two (2) gray dumpsters and one (1) red dumpster with a pad lock. Per Facilities Custodian AA and Facilities Custodian BB the red dumpster is the storage for the discarded black trash bags to be shredded. They stated the contracted service providing shredding for the facility was Company L.
They stated the custodians were the only staff with the key to the red dumpster and the key is kept in the custodian's office.
They unlocked the dumpster which was half full of several black trash bags greater than 5 bags waiting for shredding. They stated their supervisor contacts Company L when the bin is full about once a month for pick up.

During an interview, Administrative Staff G on 9/11/14, at 11:15 a.m., stated the hospital's medical records department did not have a tracking system in place once the records were picked up by the custodians, nor did the medical records department have a tracking system in place with Company L to determine if the records were destroyed. She stated once the facility's custodial department picked up the black bags her department was unaware of the location of the medical record.

The facility policy and procedure titled "Destruction of Health Records" last reviewed January 2014, did not indicate a tracking system to ensure the medical records deemed for destruction by the contracted disposal agency were protected from unauthorized disclosures.
VIOLATION: CONTENT OF RECORD - DISCHARGE DIAGNOSIS Tag No: A0469
Based on administrative document review, and interview, the hospital failed to ensure that medical records were completed within 30 (thirty) days following discharge as required by their medical staff bylaws, rules and regulations. This failure has the potential to result in medical records that lack vital patient health care information being available for the patients' continuing care after discharge.

Findings:

During an administrative document review of the Medical Staff Rules and Regulations, last approved 10/8/13, indicated on page 35 number 18, "Completion of medical records and discharge summaries: The Medical Staff acknowledges the importance of timely completion of medical records and discharge summaries in providing quality patient care..." "...and will be out of compliance if not done within thirty (30) days of discharge. Corrections on charts for patients discharged from Sempervirens will be out of compliance if not done within thirty (30) days of discharge."

On 9/10/14 beginning at 11:20 a.m., the Pending Chart Correction Reports Summary (summary of incomplete discharge summaries) and Pending Chart Correction Reports (summary of charts waiting for corrections) of delinquent records (those still incomplete 30 days following discharge) was received and reviewed with Administrative Staff G. These reports listed 29 delinquent records awaiting completion by physicians and staff.

During an interview on 9/10/14, at 11:20 a.m., Administrative Staff G, stated the number of medical records to be corrected greater than 30 days were twenty-eight (28) and the number of discharge summaries in need of the physician signature greater than 30 days was one (1).
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on inspection of six bubble packs containing the controlled substances (medications subject to abuse) lorazepam (an antianxiety agent) and clonazepam (used in psychiatry for its calming effect) located in the Crisis Stabilization Unit (CSU: an outpatient unit of the hospital from which patients could be admitted into the hospital) medication cabinet, the NARCOTIC RECORD (a record used to track the administration/wastage/disposal of each dosage unit) associated with each bubble pack, and staff interview, the hospital failed to ensure staff accurately filled in the correct number printed on two out of six of these bubble packs into the "Prescription Number" space on the NARCOTIC RECORD that corresponded to each of those two bubble packs. Both bubble packs contained lorazepam 2 mg tablets.

Staff had filled the number ( 0391) printed on the label of the bubble pack containing 26 tablets into the "Prescription Number" space on the NARCOTIC RECORD associated with that bubble pack but which documented it contained 30 tablets not 26 tablets. Staff had filled the number ( 0389) printed on the label of the bubble pack containing 30 tablets in the "Prescription Number" space on the NARCOTIC RECORD associated with that bubble pack but which documented it contained 26 tablets not 30 tablets. This could potentially eventually lead to confusion as to which pack was the source of the tablets as documented on the NARCOTIC RECORDS.

Findings:

1. On 9/10/14 at 8:55 a.m. an inspection of the controlled drug supply in the CSU medication cabinet and of the associated NARCOTIC RECORDs indicated that it contained six bubble packs: two for lorazepam 1 mg, three for lorazepam 2 mg, and one for clonazepam 1 mg. The labels on these pack had a "TR" number and "ID" number and a "CSN" number.

The three lorazepam 2 mg bubble packs all had " 58" printed after "TR" on their labels. Each bubble pack had one of the following three numbers printed after "ID" on the bubble pack labels: 0389, 0390, and 0391 (these numbers were in sequence). The bubble pack labeled with "ID" 0391" contained 26 tablets while the bubble pack labeled with "ID" 0389" had 30 tablets in it.

The associated NARCOTIC RECORD for each bubble pack had the "ID" numbers filled in the "Prescription Number" space as follows:

The NARCOTIC RECORD with " 0391" written into the "Prescription Number" space documented that 30 tablets remained in the associated bubble pack, not 26 tablets as observed above. The NARCOTIC RECORD with " 0389" written into the "Prescription Number" space documented the associated bubble pack contained 26 tablets, not 30 tablets as observed above.

The above observations were verified by interview of Nurse PP at that time.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on observation of a nurse (Nurse P) disposing of medication tablets into a Sharps Container (used to dispose of syringes and needles) in the Inpatient Unit Mediation Room, inspection of the Inpatient Unit Medication Room refrigerator, and inspection of six bubble packs of the controlled substances (medications subject to abuse) lorazepam (an antianxiety agent) and clonazepam (used in psychiatry for its calming effect) located in the Crisis Stabilization Unit (CSU: an outpatient unit of the hospital from which patients could be admitted into the hospital) medication cabinet, review of the NARCOTIC RECORD (a record used to track the administration/wastage/disposal of each dosage unit) associated with each bubble pack, policy and procedure review, and staff interview:

1. The hospital failed to develop a procedure regarding disposal of refused medications and include it in their policy regarding medication disposal so that staff disposed of refused medications per the recommendations of the hazardous waste hauler contracted by the hospital to dispose of hazardous medical waste including medications.

2. The hospital failed to ensure that urine drug screening test reagents and urine pregnancy test reagents were not stored in the Inpatient Unit Medication Room refrigerator next to four boxes of Risperdal Consta (an injectable long acting version of the antipsychotic Risperdal) which was contrary to hospital policy.

3. The hospital failed to ensure a procedure was developed that would direct staff which of three numbers (a "TR" number, an "ID" number, or a "CSN" number) printed on the labels of bubble packs of controlled substances (drugs subject to abuse) stored in the Crisis Stabilization Unit Medication Cabinet would be filled in the "Prescription Number" space located on the NARCOTIC RECORD sheets used by the hospital to track these medications. Each of these three numbers variously appeared on various NARCOTIC RECORD sheets with no consistency as to which number should be used.

As a result hazardous medical waste was potentially mishandled with the potential of the leeching of medication into ground water and controlled medication tracking might be hampered due to different methods of filling out the NARCOTIC RECORD sheets.

Findings:

1. On 9/9/14 at 8:44 a.m. the surveyor observed Nurse P dispose of medications into a Sharps Container located in the Inpatient Unit Medication Room. The surveyor looked into the Sharps Container and noted it contained used syringes and needles. During an interview of Nurse P at that time, she stated that the medications belonged to Patient 400 and she disposed of them because Patient 400 had refused his medications. She stated she would normally dispose of refused medications into the Sharps Container. She verified that is where staff also disposed of used syringes as well as refused medications.

On 9/9/14 at 8:47 a.m. during an interview of Nurse Q in the Inpatient Unit Medication Room, she stated she disposed of refused medications in the Sharps Container as that was where she was told to dispose of them.

On 9/9/14 a review of the Policy and Procedure entitled DISPOSITION OF DRUGS (Effective 12/9/08, Revised 9/1/11) indicated it provided procedures for disposing of expired and discontinued medications after placing them in a "medication biohazard container" which was then placed for pickup "...on the day of Bo-hazard (sic) waste pick up."

On 9/9/14 at 10:23 a.m. during an interview of Nursing Supervisor R in the Inpatient Unit Medication Room, she stated that staff was to put refused medications into the Sharps Container. She stated that the biohazard container for medications for discontinues and expired medications was kept on the third floor. She stated she did not have a procedure to get rid of refused medications.

On 9/11/14 at 12:10 p.m. during a telephone interview of Representative T from Company S she stated her company picked up Sharps Container and non-controlled medications from the hospital and disposed of them. She stated that the Sharps Container was autoclaved and that the non-controlled medications (in the medication biohazard container) were burned. She stated that the staff should not put medications into the Sharps Container as, after autoclaving the Sharps Container to destroy any microorganisms, Company S disposed of the Sharps Container in a land fill. She said medications in the Sharps Container could get into the water supply when buried in a land fill.

2. On 9/9/11 at 11:35 a.m. during an inspection of the refrigerator located in the Inpatient Unit Medication Room the surveyor saw the following test reagents stored in plastic bags next to boxes containing injectable Risperdal Consta :

a. One 5 ml bottle of "Detect abuse Liquid Control Urine - Stat Screen 3X Cutoff" (used to test urine for drugs).

b. One 5 ml bottle of "Detect abuse Liquid Control Urine - Negative (used to test urine for drugs).

c. One 5 ml bottle of "Pregnancy Screen hCG Liquid Control Urine - Positive" (used to test for pregnancy).

d. One 5 ml bottle of "Pregnancy Screen hCG Liquid Control Urine - Negative" (used to test for pregnancy).

On 9/9/14 a review of Policy and Procedure 203.211 entitled LABELING AND STORAGE OF DRUGS (Effective: 12/9/08, no revised or revision date) in the Inpatient Unit Medication Room at the time of the refrigerator inspection indicated it stipulated at Procedure 4 that: "Test agents ... shall be stored separately from stock medication ...."

During an interview of Nursing Supervisor R at that time she stated these were test agents for pregnancy tests and urine "tox" screens (to test for drugs). She stated that storing the test reagents next to the boxes of Risperdal Consta was a violation of the hospital policy.

3. On 9/10/14 at 8:55 a.m. an inspection of the controlled drug supply in the CSU medication cabinet and of the associated NARCOTIC RECORDs indicated that staff inconsistently labeled the Narcotic Records in the space labeled "Prescription Number". The controlled drugs came in bubble packs each labeled to originally contain 30 tablets of the controlled drug in each bubble pack. There were six bubble packs: two for lorazepam 1 mg, three for lorazepam 2 mg, and one for clonazepam 1 mg. The labels on these pack had a "TR" number and "ID" number and a "CSN" number.

The two lorazepam 1 mg bubble packs had " 306" printed after "TR". One pack had " 6975" printed after "ID" and the other had " 6976" printed after "ID" on the bubble pack labels (these numbers were in sequence).

The associated NARCOTIC RECORD for each bubble pack had " 306" filled in in the "Prescription Number" space on the Narcotic Record.

The three lorazepam 2 mg bubble packs all had " 58" printed after "TR" on their labels. Each bubble pack had one of the following three numbers printed after "ID" on the bubble pack labels: 0389, 0390, and 0391 (these numbers were in sequence).

The associated NARCOTIC RECORD for each bubble pack had the "ID" numbers filled in the "Prescription Number" space instead of the "TR" number as was done for the lorazepam 1 mg bubble packs.

The clonazepam bubble pack had " 498" printed after "TR" on the bubble pack label and below that label on the body of the card above the section where the tablets were packaged the following "CSN" number was printed " ".

The associated NARCOTIC RECORD had both the "TR" number and the "CSN" number written in the "Prescription Number" space.

The above observations were verified by interview of Nurse PP at that time.

On 9/10/14 at 10:40 a.m. a review of Policy and Procedure 203.217 entitled CONTROLLED SUBSTANCES (Effective: 12/9/08; Reviewed: 3/28/12) indicated it directed staff to fill in the top of the "Narcotic Record" at Procedure 2.4 but it did not provide any direction to staff as to how to do this. Specifically, it did not direct staff what they were to fill in the "Prescription Number" space.

The above observation was verified by interview of Nurse PP at that time.

On 9/10/14 at 2:43 p.m. during an interview of the Director of Nurses she reviewed Policy and Procedure 203.217 and stated that Procedure 2.4 was general and lacked detail. She stated that a decision would have to be made as to what number would be placed into the "Prescription Number" space on the NARCOTIC RECORD.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on inspection of two out of two opened vials of insulin (used to lower high blood sugar levels seen in diabetic patients) stored in the Inpatient Unit Medication Room refrigerator, and staff interview, the hospital failed to ensure that hospital policy reflected when one of those vials (Lantus: a long acting insulin) should be removed from active stock and discarded. The manufacturer has documented on the product label that an open vial of Lantus Insulin is good for 28 days after opening while the hospital policy was to use such vials up to 30 days. While the vial was still in date at the time of the survey, there was potential for it to be available for use two days after it should have been removed from active stock.

Findings:

On 9/9/14 at 11:35 a.m. an inspection of the Inpatient Unit Medication Room Refrigerator indicated it contained two open vials of insulin one of which was an open vial of Lantus Insulin with "8-16-14" handwritten on the side of the vial. The manufacturer's labeling on the vial documented "Use within 28 days after initial use."

During an interview of Nursing Supervisor R at that time she stated the hand written date on the vial was the date of opening and that insulin vials were good for 30 days after opening. After review of the manufacturer's documentation on the vial of Lantus Insulin, Nursing Supervisor R stated staff could potentially use the vials for two days longer than they should.
VIOLATION: FOOD AND DIETETIC SERVICES Tag No: A0618
Based on food production observations, dietary staff interview, dietary document and medical record review, the hospital failed to ensure the development of comprehensive systems to ensure the nutritional needs of inpatients were met as evidenced by:

*1. Lack of an effective system to ensure the ingredients of food products were maintained (Cross Reference A620);
*2. Lack of comprehensive nutrition assessment for inpatients (Cross Reference A 621);
*3. Lack of clarification of physician ordered diets (Cross Reference A 630);
*4. Lack of inclusion for contracted dietary staff in the hospitals' employee health screening program (Cross Reference A749); and
*5. Lack of development of performance improvement interventions for an identified menu planning issue (Cross Reference A265);
*6. Lack of performance improvement activities related to the scope of clinical nutrition care services (Cross Reference A265).

The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff in a manner to ensure that the nutrition needs of the patients were met in accordance with practitioners' orders and current standards of practice.
VIOLATION: INFECTION CONTROL Tag No: A0747
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, staff interview and record review, the hospital failed to ensure that a infection control program was implemented to provide the prevention, transmission and investigation of infectious disease process when:

1. (a). The infection control hospital appointed infection control preventionist (Assistant Director of Nursing Staff A) did not receive continuous training in hospital infection control methods, which could lead to the facility's failure to control and prevent infections. (Cross Reference A-0748).

1. (b). There were no specific procedures for the cleaning and monitoring of the use of mops, dilution, use of disinfectants and maintaining equipment so that it could be cleaned according to nationally recognized standards. These failures could lead to the facility's inability to control the spread of infection. (Cross Reference A-0748).

1. (c). Hospital staff were not trained in policies and infection control prevention measures which could lead to the facility's failure to control the prevention and the spread of infections. (Cross Reference A-0748).

1. (d). Policies and procedures were not developed for respiratory infections and[DIAGNOSES REDACTED]icile infection (highly contagious intestinal disease) according to current nationally recognized standards, which could lead to the facility's failure to control the spread of infection. (Cross Reference A-0748).

2. Two contracted workers and one closed patient record out of 8 closed records reviewed, lacked TB ([DIAGNOSES REDACTED]- contagious respiratory disease) documented health screening per facility policy. The facility failed to ensure infection control monitoring was done for employee vaccines such as flu, hepatitis, TB and respiratory fit testing of N 95 mask (fit testing ensured proper respiratory mask (N95) protection for staff against respiratory diseases). These failures could have caused the spread of infection between staff and patients. (Cross Reference A-0749).

3. The facility failed to ensure there was a hospital infection control plan which was reviewed yearly and addressed the demographic area, surveillance of infections and education of staff. This had the potential to decrease the facilities ability to deal with infections in the community and plan for hospital's needs to address area specific infectious outbreaks. (Cross Reference A-0749).

4. Infection control meeting notes lacked patient and staff identified infection control problems with interventions and goals. There were no infection control quality assurance projects or monitoring discussed in quality control meetings in 2013 and 2014. This decreased the facility's ability to address infections and provide solutions to prevent infections. (Cross Reference A-0756).

The cumulative effect of these systemic problems resulted in the hospitals' inability to maintain an effective infection control program, in accordance with accepted professional standards of practice.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
Based on observation, staff interview and record review, the facility failed to ensure:

1. ( a). One licensed staff member (Assistant Director of Nursing A), who was the hospital appointed infection control preventionist, had continuous education training in hospital infection control methods which could lead to the facility's failure to control and prevent infections.

1. (b). There were specific procedures and monitoring for patient room cleaning, use of mops, dilution of disinfectant and ensuring patient equipment used was cleanable and sanitary which could lead to the facility's failure to control the spread of infection.

1. (c). All hospital staff were trained in policies and infection control prevention measures which could lead to the facility's failure to control the prevention and the spread of infections.

1. (d). Policies and procedures were developed and implemented for respiratory infections and C (Clostridium) difficile infection (highly contagious intestinal bacterial disease) which could lead to the facility's failure to control the spread of infection.

Findings:

1. (a). During an interview on 9/10/14 at 9:40 a.m., Assistant Director of Nursing A stated that she worked at the facility as a infection control nurse for 5 years and learned about infection control prevention in nursing school and work experience, but she did not have a specific infection control training course. The Assistant Director of Nursing A stated that she had pulled up information on the CDC (Centers for Disease Control) web site and utilized her work experience to guide her.

On 9/10/14 at 2 p.m., review of Assistant Director of Nursing A's personal file with Employee Services Staff W, did not indicate there was infection control training certificates or courses in her file. During an interview at this time, Employee Services Staff W agreed that there was no infection control continuing education or training in her file.

On 9/11/14, review of the undated job description for the infection control practitioner from the Infection Control Manual of policies and procedures indicated that the infection control practitioner should keep informed of new developments in epidemiology by attending whenever possible, educational conferences, seminars, workshops and review current literature.

On 9/11/14 Review of the APIC (Association of professionals in Infection Control) 2014 Infection Control and Epidemiology (studies of health care diseases) chapter 2- guidelines for Competency and Certification Of Infection Preventionists indicated that Professional development of the infection preventionist remains an essential component of practice, increased focus on patient safety, as well as more intensive public reporting and regulatory requirements, places increasing emphasis on developing and maintaining the skills of the infection preventionist. Professional development is essential to keeping the infection preventionist up to date with the latest knowledge, skills and strategies for preventing infections.

1. (b). During an observation and interview on 9/9/14 at 9:10 a.m., there was a housekeeping closet with a "Re-Juv Nal" disinfectant cleaner solution mixer mounted on the wall. It had hoses attached which allowed it to be emptied into a bucket or spray bottle, Housekeeping/Custodial Supervisor E stated that when they cleaned a room the disinfectant had to set 10 minutes on a surface and sometimes they did not have enough time to wait. Housekeeping/Custodial Supervisor E stated that he had been working at the facility for 9 years and had never seen where the mixed disinfectant was checked for concentration except by looking at it to make sure it was the right color of pink.

During an interview and observation on 9/9/14 at 9:20 a.m., Housekeeping/Custodial Supervisor E stated that staff used the cloth string reusable mops with diluted disinfectant in a bucket, and pointed to a mop hanging in the custodial closet. Housekeeping/Custodial Supervisor E stated that they used one mop for about every three rooms or change the mop and water if the room is really dirty after use.

During an interview on 9/9/14 at 9:50 a.m., Housekeeping/Custodian H stated that he cleaned about 4 patient rooms and then he changed the mops and water.

During an interview on 9/9/14 at 10:40 a.m., Mental Health Worker I stated that he used both the pink "Re-Juv Nal" cleaner as well as the purple container of disinfectant wipes (Sani Wipes) for cleaning surfaces. Mental Health Worker I stated that there was no special time limit for disinfection and he just let the surface dry.

During an observation and interview on 9/9/14 at 11:20 a.m., the treatment/exam room contained an examination bed with a paper sheet on top. On the sides of the bed was visible white foam from cracks and tears in the padding. Assistant Director of Nursing A stated that the facility did recognize it was an infection control problem due to the exposed foam and inability to clean it effectively. Assistant Director of Nursing A stated that the mental health workers wipe it down with the pink disinfectant solution or the disinfectant wipes. The Assistant Director of Nursing A stated that she thought the contact time of the disinfectant wipes was 1 to 5 minutes. The Assistant Director of Nursing A was asked to review the disinfectant wipe instructions on the bottle and she stated that it had to remain visibly wet for 2 minutes to ensure it was effective. The Assistant Director of Nursing A stated that she thought the" Re Juv Nal" solution disinfectant was the same contact time as the disinfectant wipes.

During an interview on 9/9/14 at 11:25 a.m., The Assistant Director of Nursing A stated that they did have patients that had diarrhea at the same time and they ruled out C-difficile. The Assistant Director of Nursing A stated that they used the disinfectant wipes or pink disinfectant solution to clean with then. The Assistant Director of Nursing A stated that sometimes they used concentrated dilute Clorox bleach but didn't know the concentration.

During an interview on 9/9/14 at 11:50 a.m., The Assistant Director of Nursing A stated that she didn't know how often the housekeepers changed their mops when they cleaned as she did not monitor them. The Assistant Director of Nursing A stated that the housekeeping staff left a fresh mop and mop bucket every night when they were not at the facility.

During an interview on 9/10/14 at 9:20 a.m., The Assistant Director of Nursing A stated that she wrote policies and procedures and usually updated them.

During an interview on 9/10/14 at 9:50 a.m., The Assistant Director of Nursing A stated that the facility followed CDC (Centers for Disease Control) guidelines for cleaning products which were non harmful to use. The Assistant Director of Nursing A stated that she was not aware staff had to wait ten minutes for "Re Ju Nal" to set to be effective or was not aware of concentration or monitoring of the premixed "Re Ju Nal" solution. Review of the facility supplied "RE Juv Nal" instructions indicated for cleaning and disinfection, to mix 2 ounces per gallon of water and to allow surfaces to remain wet for 10 minutes. The instructions indicated that effective bactericidal activity occurs at 400 ppm (parts per million) concentration of the product.

On 9/10/14, review of policy titled "INFECTION CONTROL MANUAL" dated 12/13/10 indicated that the hospital would provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The policy indicated that MOP heads shall be removable and washed when needed. Review of the undated" MHB daily Floor Care" policy indicated that it may necessary to change the water and germicide detergent a number of times to ensure a clean floor. If there were urine, feces or biohazard spills, staff were to change immediately. The policy also indicated that mop heads shall be removable and changed daily. The policies were not specific on mop changes during cleaning or bucket cleaning.

Review of the CDC (Centers For Disease Control) 2003 "guidelines for Environmental Infection Control in Health-Care Facilities, indicated that contaminated surfaces can serve as reservoirs of potential pathogens. Bucket solutions become contaminated almost immediately during cleaning and continuation of solution transfers increase the amount of microorganisms to each subsequent surface. Cleaning solutions must be replaced frequently and mops become contaminated when soaking in dirty cleaning solutions. Mop heads must be replaced each time the disinfectant is emptied. Dilute solutions of cleaning solutions, prepared incorrectly are resources for infection especially if stored in dirty buckets.

Review of CDC /HICPAC 2011 guidelines on cleaning and disinfection indicated to use disinfectants according to manufacturer's guidelines.

Review of the Infection Control Practitioner's job description, undated, indicated that job duties included that she was to review disinfection methods practiced in the hospital and make recommendations for changes. The Infection Control Practitioner's job duties included identifying areas needed to be monitored and teaching infection control and isolation policies to all employers on all levels.

Review of Infection Control organization policy # 0205.105, effective 12/13/2010, indicated the infection control officer was to develop and implement policies for the control of infections and do an ongoing review and evaluation of aseptic, isolation and sanitation techniques of employees in the hospital. The infection control officer was to do preventive infection control surveillance related to the inanimate hospital environment. The Infection control officer or practitioner was to do a periodic review of cleaning agents and schedule and approve any major changes in cleaning products and techniques.

1. (c). During an interview on 9/9/14 at 9:20 a.m., Housekeeping/Custodial Supervisor E stated that if a patient had a infectious disease than he would use the same cleaning precautions for everyone and that housekeeping staff were not supposed to know patient's personal information because of privacy concerns. When asked about C-difficile, Housekeeping/Custodian H stated that he was not aware of C-difficile or if there was any special disinfectant used.

During an interview on 9/9/14 at 9:50 am., Housekeeping/Custodian H stated that if there was a "nasty" spill, you can use bleach solution 5% (percent) diluted with water about 1/4 cup cleaner in the spray bottle or a 1:20 dilution (1 part cleaner to 20 parts water for dilution) or 1 gallon of water with 4 ounces of bleach. Housekeeping/Custodian H stated that staff did not tell you if Patients have MRSA (Methicillin-resistant Staphylococcus aureus) or C-difficile. Housekeeping/Custodian H stated that C-difficile was a intestinal infection, but he was never told that by the nurses there and he was not sure what you would clean that with. Housekeeping/Custodian H stated that you have to ask staff for masks and gowns and they don't always tell you about infections.

During an interview on 9/9/14 at 10:40 a.m., Mental Health Worker I stated that he used Sani Wipes (disinfectant wipes) to wipe surfaces and there is no special time limit as the solution evaporates. Mental Health Worker I stated that once they thought they have had C-difficile outbreak as three patients had diarrhea and he thought housekeeping staff were notified by nursing staff as they go behind us and clean the room.

During an interview on 9/9/14 at 11:20 a.m., The Assistant Director of Nursing A stated that there were patients with diarrhea and that Nursing staff normally wrote messages on the housekeeping's board in the custodial closet to alert housekeepers of issues. She stated she did not monitor how housekeeping staff changed their mops, and that she did training only of her own staff and that housekeeping custodial staff received training through their own supervisors who maintained their records.

On 9/10/14, review of the undated job description for the infection control practitioner indicated that the duties of the practitioner included teaching information pertinent to infection control and isolation policies to all employees on all levels including house staff and students, maintain close communication with supervising personal concerning infection problems and epidemiological (disease producing) hazards and assist with developing and conducting educational training for all hospital personal to improve knowledge and practice of infection control and epidemiology (studies of the patterns, causes and effects of health disease conditions).

1. (d). During an interview and observation on 9/9/14 at 9:20 a.m., Housekeeping/Custodial Supervisor E stated that if someone has something contagious that they use the same cleaning precautions for everyone. Housekeeping/Custodial Supervisor E stated that as far as C-dificille, he had never heard of it or was aware if there was any special cleaning supplies.

During an interview on 9/9/14 at 10:40 a.m., Mental Health Worker I stated that he remembered that there were three patients who had diarrhea that staff first thought had C-difficile and stated he thought housekeeping and custodial staff were notified as they went behind staff to clean as well.

During an interview on 9/9/14 at 11:25 a.m., The Assistant Director of Nursing A, stated that they did have patients that had diarrhea at the same time and they ruled out C-difficile. The Assistant Director of Nursing A stated that they used the disinfectant wipes or pink disinfectant solution to clean . The Assistant Director of Nursing A stated that sometimes they used diluted Clorox bleach but didn't know the concentration. Assistant Director of Nursing A stated that she knew the C-difficile organism affected the colon or intestinal track and that staff had to wash their hands with soap and water. The Assistant Director of Nursing A stated that with [DIAGNOSIS REDACTED] organism, staff would use the universal precautions, handle everyone the same way and that the patients are isolated from other patients.

During an interview on 9/9/14 at 11:50 a.m the Assistant Director of Nursing A stated that as far as respiratory infection, staff must wear masks, patients are place in a private room and staff and patients are taught to cover their mouths.

During an interview on 9/10/14 at 9:20 a.m., Assistant Director of Nursing A, stated that she wrote policies and procedures and usually updated them. She stated that she did not have a policy on C difficle and cleaning. When patients came down with diarrhea she initiated a C-difficile protocol where she did surveillance and initiated isolation procedures. Assistant Director of Nursing A stated that there was no formal policy or procedure and she knew what to do from her nursing background. Assistant Director of Nursing A stated that she told her staff that things had to be extra clean and to wash their hands. Assistant Director of Nursing A stated that she told the housekeeping/custodial staff to clean but didn't say specifically to use Clorox or bleach. Assistant Director of Nursing A stated that she followed the CDC guidance and pulled up guidelines on their web site and distributed it to "her" staff licensed and mental health workers.

During an interview and review of hospital infection control policies on 9/10/14 at 9:50 a.m., The Assistant Director of Nursing A pointed out the universal precaution policy, isolation body fluid policy and and HINI (Swine flu) and TB (tuberculosis- bacteria causing infectious disease of the lungs) policies. The Assistant Director of Nursing A, stated that for respiratory infections, they had N95 masks which required fit testing. The Assistant Director of Nursing A stated that not all staff have been fit tested and one staff supervisor who went to the training for fit testing has to wear a special respiratory device instead of the masks. She stated that the facility did not have a specific policy concerning fit testing or general respiratory infection policy.

On 9/10/14, review of infection control policies and procedures indicated there were no C-difficile policies. There was a policy for Universal Precautions revised on 9/10/12, which indicated that all patients were potentially infected with blood borne pathogens which was in blood and body fluids. Body fluids was defined as blood, sputum, secretions, urine feces or vomit. The policy indicated under large spills that a contaminated area should be flooded with with a liquid germicide before cleaning with a fresh germicidal chemical or solution. Contact time should be determined by the manufacturer's recommendation or 10 minutes if bleach was used. It was noted that this policy was not specific to C-difficile and did not have the dilution required of the bleach cleaning solution or isolation precautions . There was a Body Substance Isolation policy reviewed by the facility on 8/7/14 which indicated that contaminated patient items should be cleaned with a germicidal agent such as 1:10 dilution of 5.25% "Sodium Hypochlorite" (bleach) or a comparable strength commercial cleaning agent. The policy did not specify what isolation precautions should be put in place.

On 9/10/14, review of infection control polices indicated that there was a undated policy titled "care of patients with confirmed or suspected swine flu (HINI) influenza in the healthcare setting" which had "DRAFT" written on it. The policy indicated to maintain standard droplet precautions for all patient care activities. There were no respiratory precaution or droplet or airborne precaution policies and procedures. There was no policy and procedures for fit testing for proper fit of masks.

The 2007 CDC (Centers for Disease Control) under part III, Precautions to Prevent the Transmission of Infections indicated that standard precautions are used in all healthcare settings and transmission based precautions are used for known infected patients.

Review of the CDC 2011 basic infection control prevention plan for outpatient basic setting indicated under Fundamental principles of infection Prevention that "standard precautions" replaced earlier guidance relating to universal precautions and body substance isolation. Standard precautions include hand Hygiene, use of personal protective equipment(gowns, masks, gloves) depending on the anticipated exposure, respiratory hygiene and cough etiquette, safe injection practices and safe handling of contaminated equipment or surfaces in the patient environment. Transmission-based precautions are intended to supplement standard precautions in patients with known or suspected colonization of infection of highly transmissible or epidemiologically important pathogens. The three categories of transmission based precautions include contact, droplet and Airborne precautions. Contact precautions are used with Clostridium difficile (C difficile), Droplet precautions used with respiratory viruses such as influenza and Airborne Precautions such as TB (tuberculosis, measles or chicken pox)
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on staff interview and record review, the facility failed to ensure:

3. (a). There was an employee infection control monitoring program where flu, hepatitis,TB (tuberculosis-respiratory infection) and respiratory fit testing (a process that ensured proper respiratory mask protection for staff) was monitored, which could lead to an ineffective program in preventing the spread of infectious diseases to patients and staff if problems were not identified.

3. (b). There was TB (tuberculosis- respiratory infection) screening documentation for 2 contracted workers (Registered Dietitians U and V)) and one out of 8 closed medical records (Patient 104) reviewed per facility policy which could expose patients and staff to the spread of a infectious disease.

4. There was a hospital infection control plan which was reviewed yearly and addressed the demographic area, surveillance of infections and education of staff. This had the potential to decrease the facilities ability to deal with infections in the community and plan for hospital's needs to address area specific infectious outbreaks.

Findings:

3. (a). During an interview on 9/9/14 at 10:10 a.m., Housekeeping/Custodial Supervisor E stated that he had been offered a flu shot but had never gotten one, never signed a declination form or received education material about flu shots.

During an interview on 9/9/14 at 11:50 a.m., Assistant Director of Nursing A (Infection Control Preventionist) stated that the housekeeping/ custodial supervisors and other department supervisors maintain health records of their staff if they have had their flu shots, TB or other health tests.

During an interview on 9/10/14 at 9:50 a.m., Assistant Director of Nursing A stated that all employees are offered flu shots, but she did not think they were required to monitor the employees refusal to provide education about the flu if they refuse.

During an interview on 9/10/14 at 9:50 a.m., Assistant Director of Nursing A stated that they have N-95 masks to be used to protect staff for respiratory isolation and stated only one staff had been fit tested to determine if the mask was suitable for their protection.

On 9/11/14, review of facility Policy 0205.120, last reviewed by the facility on 9/10/12, indicated that each month the Infection Control Nurse prepared the monthly Report on Employee health program indicating the number of physical exams done and TB screening, how may staff tested with PPD (skin test to screen for Tuberculosis) and number of chest X-rays done, employee exposure accidents to infectious cases, cases of failing to order isolation for infected cases and assurance that staff are following procedures to protect the patients from ill employees.

3. (b). On 9/10/14 beginning at 1:15 p.m., employee health records for 2 dietetic services contractors (Registered Dietitians U and V) were reviewed. In a concurrent interview with Employee Services Staff (ESS) W she stated that the county employees were required to complete a health physical as well as complete or provide verification for the completion of annual tuberculin testing (TB) and/or screening. ESS W also stated to her knowledge the county did not have a written employee health policy that outlined expectations in relationship to employee health. She further stated that contracted employees were not required to provide verification that TB screening was completed. In an interview on 9/11/14 beginning at 1:15 p.m., with RD U she confirmed she was never asked to complete or provide confirmation of TB testing.

Review of hospital document titled " New Hire Checklist " dated 3/13 revealed that new hires to the county were required to complete both a physical and a tuberculosis skin test. Mental Health Branch policy titled " Tuberculosis screening of Employees " dated 12/13/10 noted that all new employees will have a tuberculosis test before employment and annually thereafter. While the hospital had a policy to ensure tuberculosis screening it did not comprehensively include all staff that provided services.

On 9/11/14 review of the Tuberculosis screening of employees policy # 0205.131 last reviewed by the facility on 6/6/13, indicated that all new employees will have a tuberculosis test before employment and turn in the results of the test to employee services before starting the employment process.

On 9/11/14 at 10:30 a.m., review of closed medical records for Patient 104 indicated that there was no TB (tuberculosis screening assessment done) per policy of the facility. During an interview at this time, Administrative Staff J stated that the admission orders did not indicate that it was ordered or that the Patient had had it in the past and the nurses' note did not indicate that the patient was screened for it.

On 9/11/14, review of the facility policy titled "Tuberculosis Screening Of Patients" effective 12/13/10 indicated that all patients must be screened for tuberculosis upon admission. A tuberculosis screening procedure may not be required if there is satisfactory written evidence available that a tuberculosis screening procedure has been completed within 90 days of the day of admission to the facility.

4. On During a review of the Infection control policy and procedure books with the Director of Nursing on 9/11/14 at 2 p.m., stated that the facility was in the middle of updating infection control policies and stated that there was not a facility infection control plan which indicated demographics,surveillance, antibiotic use or education of staff.

Review of APIC 2014 chapter 1 infection prevention and control program indicated under overall structure and function that infrastructure documents outline goals for infection prevention and control programs. These include to protect the healthcare workers, protect patients, visitors and others in the healthcare environment in a cost effective manner. Each institution is unique and its specific needs must be considered when developing or reorganizing an infection prevention and control program. Factors include size, case mix and types of care provided. The principle functions of the infection control program include the following:

1. To obtain and manage critical data and information including surveillance of infections
2. To develop and recommend policies and procedures
3 to intervene directly to prevent infections and interrupt the transmission of infectious diseases
4. To educate and train hospital workers, patients and non medical caregivers.
VIOLATION: LEADERSHIP RESPONSIBILITIES Tag No: A0756
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure:

Infection control meeting notes and Quality Improvement meeting notes contained patient and staff identified infection control problems with interventions and goals. There were no infection control quality assurance projects or monitoring discussed in quality control meetings in 2013 and 2014. This had the potential to lessen the facility's ability to decrease and address infections.

Findings:

During an observation and interview on 9/9/14 at 9:10 a.m., there was a housekeeping closet with a "Re-Juv Nal" disinfectant cleaner solution mixer mounted on the wall. It had hoses attached which allowed it to be emptied into a bucket or spray bottle, Housekeeping/Custodial Supervisor E stated, when they cleaned a room it had to set 10 minutes on a surface and sometimes they did not have enough time to wait. The Housekeeping/Custodial Supervisor E stated, he had been working at the facility for 9 years and had never seen where the mixed disinfectant was checked for concentration except by looking at it to make sure it was the right color of pink.

During an interview and observation on 9/9/14 at 9:20 a.m., Housekeeping/Custodial Supervisor E stated that if someone has something contagious that they use the same cleaning precautions for everyone. The Housekeeping/Custodial Supervisor E stated that as far as[DIAGNOSES REDACTED]icile, he had never heard of it or was aware if there was any special cleaning supplies.

During an interview on 9/9/14 at 9:50 am., Housekeeping/Custodian H stated that if there was a "nasty" spill, you can use bleach solution 5% diluted bleach with water about 1/4 cup in the spray bottle or a 1:20 dilution or 1 gallon of water with 4 ounces of bleach. Housekeeping/Custodian H stated that staff did not tell you if Patients have MRSA (Methicillin-resistant Staphylococcus aureus-a drug resistant infection) or[DIAGNOSES REDACTED]icile. Housekeeping/Custodian H stated,[DIAGNOSES REDACTED]icile was an intestinal infection, but he was never told that by the nurses about it, and he was not sure what you would clean with. Housekeeping/Custodian H stated, you have to ask staff for masks and gowns and they don't always tell you about infections.

During an interview on 9/10/14 at 9 :45 a.m., Assistant Director of Nursing A (Infection Control Preventionist) stated when there were infections she started an infection control sheet on each infection and documented it in their record. Infections and types are tracked and reported in the infection control committee. The Assistant Director of Nursing A stated the housekeeping/custodial supervisors did not attend the infection control committees.

On 9/11/14, review of infection control meeting notes from August 2013-May 2014 discussed infection control reports including potential and actual infections, antibiotic use, nosocomial infection, MRSA reports and numbers. The only action listed from the May 2013 report was to add to the agenda to learn the standards for infection symptom reporting. There were no plans, actions, nor goals addressing patient related or infection control issues of staff. The latest Infection control meeting notes supplied by the facility from May 2014 indicated infection reports were not available. List of attendees did not include the Housekeeping/Custodial Supervisor E.

On 9/11/14, review of the facility Continuous Quality Improvement Committee meeting agenda notes from July 2013, August 2013, [DATE], October 2013, July 2014 and August 2014 did not include any infection control meeting agenda discussions or potential problem identification and plans.

During an interview on 9/11/14 at 10:45 a.m., Administrative Staff F stated, there was no discussion in the Quality minutes about infection control issues.

During an interview on 9/11/14 at 2 p.m., the Director of Nursing stated while reviewing QA minutes for 2013 and 2014, there was no infection control reports and the infection control infection control meeting minutes should be addressed in the Continuous Quality Improvement committee notes.

On 9/11/14, review of the Infection Control Organization And Policies policy # 0205.105, effective 12/13/10, indicated the medical staff and hospital administration authorized the establishment of the infection control program and committee in accordance with establishing criteria and guidelines for facility infection control. Membership included consultative representatives chosen intermittently from Dietetic, Maintenance, housekeeping and the county Public health Department. The committee was responsible for the "ongoing review and evaluation of all aseptic, isolation and sanitation techniques employed in the facility", "written policies and procedures defining specific indications for the isolation of patients", preventive, surveillance and control procedures relating to the inanimate hospital environment" and review of cleaning procedures and products.

On 9/11/14, review of the Infection Reporting policy reviewed 9/10/12, indicated the infection control committee meets quarterly, is responsible to insure the hospital-wide quality assurance program and training programs, address problems identified by the infection Control Practitioner.

On 9/11/14, review of the Continuous Quality Improvement Plan, revised August 2013, indicated the objectives of the Quality improvement plan is to promote safe effective and appropriate care and provide ongoing process to continually improve the facility's service delivery and support system. An annual evaluation of the Continuous Quality Improvement Plan includes information that all departments have been monitored for infection control, physical plant safety and cleanliness.