HospitalInspections.org

Based on observation, record review and interview the hospital failed to meet the requirements for the Conditions of Participation as evidenced by:

Failure of the hospital to implement a quality assessment/performance improvement program which measured, analyzed, and tracked quality indicators as evidence by collecting statistical data not related to processes of care, hospital services and operations. This resulted in the hospital's failure to identify system problems related to infection control related to handwashing , environmental cleanliness, disinfection of equipment, and monitoring of patients for possible hospital acquired infections and pharmacy services related to monthly pharmacy inspections, expired medications, destruction of discharged patient medications, storage of medications in appropriate temperatures (See findings at Tag A0267);

Failure of the hospital to ensure participation of the contracted pharmacy services in the Quality Assurance/Performance Improvement program as evidenced by failure to develop indicators in order to evaluate and monitor the safety and quality of care provided. This resulted in the hospital's failure to: 1) determine an accurate medication error rate due to relying on self-reporting of the nursing staff as the only means of data collection; 2) ensure the integrity of medication requiring refrigeration by storing medication in a refrigerator with temperatures above the documented parameters for 30% of the time in a four month period; 3) perform medication cart inspections to ensure expired medications, biologicals and wound cleansers were not available for administration to patients currently in the hospital by storing all medications together (See findings at Tag A0275);

Failure of the hospital to follow their Quality Assurance/Performance Improvement (QA/PI) Plan as evidenced by failure to set priorities for performance improvement activities which focused on high-risk, high-volume or problem-prone areas. This resulted in the monitoring of statistical data not affecting health outcomes or the quality of care (See findings at Tag A0285);

Failure to ensure medical errors were tracked as evidenced by relying on self-reporting as the only means of determining medication errors resulting in a zero percent medication error rate for 2474 medications administered for the four reporting quarters of 2010 (See findings at Tag A0287); and

Failure of the Governing Body failed to ensure the Quality Assessment/Performance Improvement (QA/PI) plan was implemented as evidenced by failure to set priorities for improvement activities and evaluate all improvement actions implemented. This resulted in failure to have a functioning Infection Control Program and failure of the hospital to be provided all of the services agreed to by the contracted Pharmacy (See findings at Tag A0312).

Based on record review and interview the hospital failed to have a process in place to ensure all licenses were current for personnel requiring licenses for 3 of 3 files reviewed (Pharmacist S4, MD S5, MDS6). Findings:

Review of the credentialing file of for MD S5 revealed a Louisiana State Board of Medical of Medical Examiners license with the expiration date of 01/31/11; a Louisiana Board of Pharmacy for Controlled Dangerous Substances (CDS) which expired 06/01/10; and a Controlled Substance/Regulated Chemical Registration Certificate (DEA)with an expiration date of 06/30/10.

Review of the credentialing file of for MD S6 revealed a Louisiana State Board of Medical of Medical Examiners licensure with the expiration date of 04/30/09 and a Controlled Substance/Regulated Chemical Registration Certificate (DEA) with an expiration date of 08/31/09.

Review of the Pharmacy contract folder and the Policy and Procedure Manual revealed no documented evidence of a current license for Pharmacist S4.

In a face to face interview on 04/20/11 at 11:30am Administrator S2 indicated credentialing and licensing was previously performed by an employee who went out on sick leave. Further S2 indicated she was now assuming that duty and already recognized the licensure was not current.

Based on record review and interview the hospital failed to ensure the Governing Body By-Laws included the categories of practitioners eligible for appointment to the Medical Staff. Findings:

Review of the Governing Body By-Laws dated 05/11/09 revealed no documented evidence the categories of practitioners eligible for appointment to the Medical Staff was included.

In a face to face interview on 04/20/11 at 11:30am S2 Administrator verified medical doctors as well as nurse practitioners are on staff at the hospital.

Based on observation, record review and interviews the Governing Body failed to ensure all services were provided as stated in the pharmacy contract as evidenced by no documention the additional services of medication pass and chart audits were performed and the monthly checks of the medication cart, expired drugs, narcotics, stock drugs and discharged patients medications were performed by a pharmacist as stated in the contract. This resulted in inaccurate monthly inspection reports submitted by the pharmacy, expired medications and medications of discharged patients available for administration to currently admitted patients, inaccurate stock lists with no PAR levels causing overstocking of medications, and a zero medication error rate based on nurse self-reporting due to the pharmacy failing to persorm monthly medication passes and chart audits. Findings:

Review of the Pharmacy Contract dated 09/16/09 Article 1. Pharmacy's Responsibilities D. revealed... "Additional services to be provided by an independent pharmacy consultant include monthly medication pass, inspection of medication room and medication carts; inspection of emergency drug storage Hospital or expiration dates; and inspection of controlled medications, chart review...".

Review of the Continuous Performance Improvement Indicator reports for all four quarters of 2010 revealed no documented evidence the performance of contracted services provided in the hospital had been monitored and/or reviewed no less than annually for safety and quality for the Pharmacy. The facility could not submit any collected data for the first quarter of 2011.

Review of the Governing Body Meeting Minutes for the past twelve months (02/10/11, 11/02/10, 08/17/10, 05/12/10, 02/08/10) revealed no documented evidence review of the contracts for Pharmacy Services was performed.

Neither the hospital or the Pharmacist S4 could submit any documentation for the performance of chart checks or medication passes.

Review of the Hospital Inspection Form 04/29/10, 05/27/10, 06/08/10, 07/19/10, 08/27/10, 09/15/10, 10/29/10, 11/26/10, 01/27/11, 02/24/11 and 03/21/11 revealed documentation that expired medications had been removed and discontinued and expired non-narcotic medications were destroyed as needed by the facility.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 verified a pharmacy tech was delegated the duty of performing the monthly inspections and that he (S4) just signed his name to the forms. Further S4 indicated he may need to monitor the pharmacy tech more closely. S4 indicated chart checks and medication passes were not being performed.

Review of the Governing Body By-Laws dated 05/11.09 revealed.... 11. Duties of the Governing Board/Body of Directors include but are not limited to the following: ........Maintains responsibility for services furnished under contracts. The Governing Body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards of contractes services. This includes all contracted services having to submit monthly PI (Performance Improvement) data...".

In a face to face interview on 04/20/11 at 2:30pm S1 Director of Nursing indicated the hospital pays an extra charge for the additional services stated under Article 1. D.. Further S1 indicated he assumed the Pharmacy was providing those services. S1 indicated a meeting was held on 04/04/11 to discuss the problems in the pharmacy.

Review of the minutes for the meeting between Administration and Pharmacy held 04/04/11 revealed no documented evidence the discussion included the services not provided by the Pharmacy as stated in the pharmacy contract. Further review revealed the content of the meeting focused on the monetary losses due to the frequency of the drugs of the inpatients being filled and the wastage caused at discharge.

Based on record review and interview the hospital failed to ensure the contracted service for Pharmacy was provided in a safe and effective manner as evidenced by no documented evidence the Governing Body evaluated the services within the last twelve months. This resulted in: 1) inaccurate monthly facility checks performed by a pharmacy tech instead of the pharmacist as stated in the contract; an unclean medication cart; biologicals, cleansers and creams stored with oral medications; home and medications of discharged patients stored in the medication cart with those of current patients; expired medications in the refrigerator and medication cart available for patient use; 2) overstocking of stock medications and storage of medications not on the stock medication list; and 3) medications stored in a refrigerator above the recommended temperature of 38 degrees Fahrenheit - 42 degrees Fahrenheit for 30 of 108 days in temperatures of 45 - 60 degrees Fahrenheit. Findings:

Review of the Governing Body Meeting Minutes for the past twelve months (02/10/11, 11/02/10, 08/17/10, 05/12/10, 02/08/10) revealed no documented evidence review of the contracts for Pharmacy Services was performed.

1) inaccurate monthly facility checks
Observation on 04/19/11 at 10:15am of the medication cart located in the storage room behind the nursing station revealed the following expired medications found in the medication cart and available for patient use:
Pink Bismuth expiration date 02/11
Biscodyl 5mg tablets expiration date 12/11/10
Promethegan 25mg suppositories (quantity 10) expiration date 12/22/10
Bacteriostatic Water (quantity 15) expiration date 02/11
Novulin R 100 units/mL expired 01/01/11
Humulin R 100 units/mL expired 01/01/11
Tubersol 5 units/0.1mL labeled "To be Refrigerated" found in the right bottom drawer of the medication cart.
Bacteriostatic Water (quantity 2) opened, unlabeled with the expiration date of 02/11 found in the top left drawer of the medication cart
Diphenhist 25mg capsules with the expiration date of 11/22/10
Sterile Water 250 mL vial no date vial had been opened

Observation on 04/19/11 at 10:15am of the medication cart located in the storage room behind the nursing station revealed approximately 61 medications for 26 discharged patients (discharged 10/21/10 through 04/18/11) were stored with stock medications and ordered medications for the four patients currently admitted to the hospital.

Review of the Hospital Inspection Form 04/29/10, 05/27/10, 06/08/10, 07/19/10, 08/27/10, 09/15/10, 10/29/10, 11/26/10, 01/27/11, 02/24/11 and 03/21/11 revealed documentation that expired medications had been removed and discontinued and expired non-narcotic medications were destroyed as needed by the facility.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated the Pharmacy Tech is responsible for checking the medication cart once a month for expired medication and making sure the medication for the discharged patients have been removed from the cart.

Review of Policy Number: P 1.001 issued by the Pharmacist, no date documented, submitted by both the contract pharmacist and the Director of Nursing as the one currently in use, revealed ....Part C. Upon discharge of the patient or for any other reasons for discontinuing of a specific medicine, (such as changing drugs, allergic reactions or other reasons), the drugs are destroyed by the pharmacy".

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 verified a pharmacy tech was delegated the duty of performing the monthly inspections and that he (S4) just signed his name to the forms. Further S4 indicated he may need to monitor the pharmacy tech more closely. S4 indicated chart checks and medication passes were not being performed.

2) overstocking of stock medications and storage of medications not on the stock medication list
The hospital could not provide a list of the stock medications or PAR levels kept in the hospital requested by the survey team at the time of entrance. Assistant Director of Nursing S3 verified the hospital did not have a list of the stock drugs kept in the hospital.

Review of a Stock List was faxed by the contract pharmacy on 04/19/11 at 11:40am. Further review of the list revealed no documented evidence of any PAR levels required to be maintained in the hospital.

Observation of the medication cart on 04/19/11 at 10:15am revealed the stock medications were kept along with the ordered medications of the currently admitted patients. Further review revealed the following drugs stored in the medication cart which were not listed as stock medications on the list provided by the contract pharmacy: Bacteriostatic Water, Biscodyl Suppositories, Tubersol Injections, Naprosyn Sodium, Clearox, Magnesium Citrate, Valium Injections, Juven, Senna S, Proteinex, Zinc, Biscolox Suppositories, and Levemir Injections.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated stock drugs should be checked monthly during the inspection checks. Further S4 indicated the pharmacy and facility need to work together to streamline the stock medication list and to assign PAR level in an effort to decrease the amount of drugs kept in the facility.

3) medications stored in a refrigerator above the recommended temperature
Review of the Refrigerator "Refrigerator Temperature Chart" for revealed the acceptable temperature range for the refrigerator as 35-45 degrees Fahrenheit.

Review of the policy titled "Care of the Equipment on the Unit" submitted by the Nursing Department, no date of implementation, revision or review revealed .... "Unit Refrigerator: D. Temperature should be maintained between 35-45 degrees F".

Review of the policies and procedures submitted by the pharmacy revealed no documented evidence of any parameters for the temperature of the medication refrigerator.

Review of the temperature log for the refrigerator located in the room behind the nurses' station and containing patient medications from 01/01/11 through 04/18/11 revealed of the 108 days which should have been monitored 4 days were missed; 31 days the temperature was recorded > than 45 degrees Fahrenheit and 63 days with the temperature recorded at 45 degrees Fahrenheit and 10 days the temperature was below 45 degrees Fahrenheit. Further review revealed no documented evidence the temperature had been verified or any corrective action taken.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated the temperature of the refrigerator should be maintained between 38 degrees Fahrenheit and 42 degrees Fahrenheit. Further S4 indicated he was not aware of the elevated temperatures of the medication refrigerator since the monthly review form only monitored the temperature log "being complete and up to date". S4 indicated the log should be reviewed for temperature as well.

Review of the policy titled "Care of Equipment on the Unit" no date of implementation, review or revision and submitted as the one currently in use by the hospital revealed.... 2. A. Will be checked daily at night and the temperature (between 35-45 degrees) will be recorded on the form on front of the refrigerator". Further review revealed no documented evidence instructing the staff on the corrective action to be taken if the temperatures were outside of the acceptable range.

Based on interview the hospital failed to conduct a performance improvement project. Findings:

In a face to face interview on 04/20/11 at 3:00pm Administrator S2 and Director of Nursing S1 verified the hospital had not conducted a performance improvement project within the last 12 months.

Based on record review and interview the hospital failed to ensure the pharmacist was responsible for developing, supervising and coordinating all activities of pharmacy services as evidenced by failing to: 1) ensure all approved medication and pharmacy policies and procedures were reviewed annually; 2) participate in the Pharmacy & Therapeutics Committee or QA/PI activities; 3) monitor the storage of medication related to medication stored in refrigerators; 4) ensure expired medications and medications of discharged patients were not available for patient use; 5) develop and maintain controls on Stock medication with PAR levels resulting in overstocking of medications on the Stock drug list as well as miscellaneous drugs which were mot on the stock drug list; 6) perform monthly medication passes and chart audits; and 7) perform and submit to the hospital accurate monthly pharmacy inspections. Findings:

1) failing to ensure all approved medication and pharmacy policies and procedures were reviewed annually
Review of the policy and procedure manual developed for the hospital by Contract pharmacy "a" revealed no documented evidenced the policies were reviewed and/or revised since 2009.

In face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated the manual was developed in 2009 and had not been reviewed since that time.

2) participate in the Pharmacy & Therapeutics Committee or QA/PI activities;
The hospital could not submit any minutes from Pharmacy & Therapeutics Committee meetings.

Review of the Continuous Performance Improvement Indicator report submitted to the Governing Body revealed the following information:
First Quarter of 2010 - Medication Error Rate revealed a 0% error rate.
Second Quarter of 2010 - Medication Error Rate revealed a 0% error rate.
Third Quarter of 2010 - Medication Error Rate revealed a 0% error rate.
Fourth Quarter of 2010 -Medication Error Rate revealed a 0% error rate.
The facility could not submit any collected data for the first quarter of 2011.

In a face to face interview on 04/20/11 at 3:00pm Administrator S2 indicated chart audits were not performed concerning medication administration. Further S2 indicated the medication error rate is calculated based solely on self-reporting by the nursing staff.

In face to face interview on 04/19/11 at 1:45pm Pharmacist S4 verified he (S4) did not participate in Pharmacy & Therapeutics Committee activities or Quality Assessment/Performance Improvement. Further S4 verified monthly medication passes or chart audits were performed as stated in the pharmacy policy and procedure.

Review of the Pharmacy Contract dated 09/16/09 Article 1. Pharmacy's Responsibilities D. revealed... "Additional services to be provided by an independent pharmacy consultant include monthly medication pass, inspection of medication room and medication carts; inspection of emergency drug storage Hospital or expiration dates; and inspection of controlled medications, chart review...".

3) monitor the storage of medication related to medication stored in refrigerators
Review of the Refrigerator "Refrigerator Temperature Chart" for revealed the acceptable temperature range for the refrigerator as 35-45 degrees Fahrenheit.

Review of the policy titled "Care of the Equipment on the Unit" submitted by the Nursing Department, no date of implementation, revision or review revealed .... "Unit Refrigerator: D. Temperature should be maintained between 35-45 degrees F".

Review of Policy Number P 1.003 titled Medications and Pharmaceutical Preparations " no date of implementation, revision or review and submitted by the hospital as the one presently in use, revealed ....D. Ordering and Maintaining drugs and Pharmaceutical Preparations: 2. The pharmacist is to maintain and inspect from time to time the biological refrigerator in the hospital pharmacy and/or elsewhere assuring that the temperature range of the biological refrigerator is 38-42 degrees " .

Review of the temperature log for the refrigerator located in the room behind the nurses' station and containing patient medications from 01/01/11 through 04/18/11 revealed of the 108 days which should have been monitored 4 days were missed; 31 days the temperature was recorded > than 45 degrees Fahrenheit and 63 days with the temperature recorded at 45 degrees Fahrenheit and 10 days the temperature was below 45 degrees Fahrenheit. Further review revealed no documented evidence the temperature had been verified or any corrective action taken.

Observation on 04/19/11 at 10:15am of the medication refrigerator in the room located behind the nurses ' station revealed a temperature of 50 degrees Fahrenheit. Further observation of the refrigerator revealed the following patient medications stored for use as ordered: 2 100mL 0.9% Normal Saline and Pepcid infusion; 6 Biscolax 10mg; 7 vials of Brovana 15meq; ASA 300 mg suppositories; 1 Biscodyl 10mg suppository; 1 multi-dose vial of Levemir; 1 multi-dose vial of Lantus;
1 multi-dose vial of Humulin R; 2 multi-dose vials of Humalog; and 1 multi-dose vial of Humulin 70/30. Further all medications stored in the refrigerator were verified by RN S3.

Review of the packaging insert for Levemir revealed unused vials of the medication should be stored between 36? to 46?F. Review of the drug inserts for Brovana revealed to protect this medication from light and heat and to store in the sealed protective pouch until ready to use. Refrigerate this medication between 36-46 degrees F (2-8 degrees C). Review of the inserts for Insulin (Lantus, Humulin and Humalog) revealed to maintain temperatures between 36 - 46 degrees Fahrenheit.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated the temperature of the refrigerator should be maintained between 38 degrees Fahrenheit and 42 degrees Fahrenheit. Further S4 indicated he was not aware of the elevated temperatures of the medication refrigerator since the monthly review form only monitored the temperature log "being complete and up to date". S4 indicated the log should be reviewed for temperature as well.

Review of the policy titled "Care of Equipment on the Unit" no date of implementation, review or revision and submitted as the one currently in use by the hospital revealed.... 2. A. Will be checked daily at night and the temperature (between 35-45 degrees) will be recorded on the form on front of the refrigerator". Further review revealed no documented evidence instructing the staff on the corrective action to be taken if the temperatures were outside of the acceptable range.

4) ensure expired medications and medications of discharged patients were not available for patient use
Observation on 04/19/11 at 10:15am of the medication cart located in the storage room behind the nursing station revealed the following expired medications found in the medication cart and available for patient use:
Pink Bismuth expiration date 02/11
Biscodyl 5mg tablets expiration date 12/11/10
Promethegan 25mg suppositories (quantity 10) expiration date 12/22/10
Bacteriostatic Water (quantity 15) expiration date 02/11
Novulin R 100 units/mL expired 01/01/11
Humulin R 100 units/mL expired 01/01/11
Tubersol 5 units/0.1mL labeled "To be Refrigerated" found in the right bottom drawer of the medication cart.
Bacteriostatic Water (quantity 2) opened, unlabeled with the expiration date of 02/11 found in the top left drawer of the medication cart
Diphenhist 25mg capsules with the expiration date of 11/22/10
Sterile Water 250 mL vial no date vial had been opened

Observation on 04/19/11 at 10:15am of the medication cart located in the storage room behind the nursing station revealed approximately 61 medications for 26 discharged patients (discharged 10/21/10 through 04/18/11) were stored with stock medications and ordered medications for the four patients currently admitted to the hospital.

Review of the Hospital Inspection Form 04/29/10, 05/27/10, 06/08/10, 07/19/10, 08/27/10, 09/15/10, 10/29/10, 11/26/10, 01/27/11, 02/24/11 and 03/21/11 revealed documentation that expired medications had been removed and discontinued and expired non-narcotic medications were destroyed as needed by the facility.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated the Pharmacy Tech is responsible for checking the medication cart once a month for expired medication and making sure the medication for the discharged patients have been removed from the cart.

Review of Policy Number: P 1.001 issued by the Pharmacist, no date documented, submitted by both the contract pharmacist and the Director of Nursing as the one currently in use, revealed ....Part C. Upon discharge of the patient or for any other reasons for discontinuing of a specific medicine, (such as changing drugs, allergic reactions or other reasons), the drugs are destroyed by the pharmacy".

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 verified a pharmacy tech was delegated the duty of performing the monthly inspections and that he (S4) just signed his name to the forms. Further S4 indicated he may need to monitor the pharmacy tech more closely. S4 indicated chart checks and medication passes were not being performed.

Review of Policy Number: P 1.002 titled "Duties of Pharmacist" , no date of implementation, review or revision and submitted by the hospital and contract pharmacy as the one currently in use revealed... "Part B. 3. All drug cabinets maintained on the nursing units are to routinely be checked by the pharmacist who shall formulate and enforce a control system for any and all drugs stored in

Review of Policy Number: P 1.002 titled "Duties of Pharmacist" , no date of implementation, review or revision and submitted by the hospital and contract pharmacy as the one currently in use revealed... " Procedure Part A. D. Insure the proper and safe storage and arrangement of drugs in stock as well as filled prescriptions for dispensing to the hospital patients by duly authorized personnel; and shall further maintain and insure proper controls with respect to refrigeration, humidity, protection from overexposure to excessive light and complete maintenance of sanitary conditions in the storage and handling of any and all drugs and/or pharmaceutical preparations".


5) develop and maintain controls on Stock medication with PAR levels resulting in overstocking of medications on the Stock drug list as well as miscellaneous drugs which were mot on the stock drug list
The hospital could not provide a list of the stock medications or PAR levels kept in the hospital requested by the survey team at the time of entrance. Assistant Director of Nursing S3 verified the hospital did not have a list of the stock drugs kept in the hospital.

Review of a Stock List was faxed by the contract pharmacy on 04/19/11 at 11:40am. Further review of the list revealed no documented evidence of any PAR levels required to be maintained in the hospital.

Observation of the medication cart on 04/19/11 at 10:15am revealed the stock medications were kept along with the ordered medications of the currently admitted patients. Further review revealed the following drugs stored in the medication cart which were not listed as stock medications on the list provided by the contract pharmacy: Bacteriostatic Water, Biscodyl Suppositories, Tubersol Injections, Naprosyn Sodium, Clearox, Magnesium Citrate, Valium Injections, Juven, Senna S, Proteinex, Zinc, Biscolox Suppositories, and Levemir Injections.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated stock drugs should be checked monthly during the inspection checks. Further S4 indicated the pharmacy and facility need to work together to streamline the stock medication list and to assign PAR level in an effort to decrease the amount of drugs kept in the facility.

6) perform monthly medication passes and chart audits;
The hospital could not submit any documented evidence monthly medication passes and chart audits were performed by the pharmacy as stated in the signed Pharmacy contract dated 09/16/09.

Review of the Pharmacy Contract dated 09/16/09 Article 1. Pharmacy's Responsibilities D. revealed... "Additional services to be provided by an independent pharmacy consultant include monthly medication pass, inspection of medication room and medication carts; inspection of emergency drug storage Hospital or expiration dates; and inspection of controlled medications, chart review...".

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 verified his company was not performing any medication passes or chart reviews. When asked why medication passes and chart reviews are important, S4 replied both are helpful in identifying medication variances.

7) perform and submit to the hospital accurate monthly pharmacy inspections
Observation on 04/19/11 at 10:15am of the medication cart located in the storage room behind the nursing station revealed the following expired medications found in the medication cart and available for patient use:
Pink Bismuth expiration date 02/11
Biscodyl 25mg tablets expiration date 12/11/10
Promethegan 25mg suppositories (quantity 10) expiration date 12/22/10
Bacteriostatic Water (quantity 15) expiration date 02/11
Novulin R 100 units/mL expired 01/01/11
Humulin R 100 units/mL expired 01/01/11
Tubersol 5 units/0.1mL labeled "To be Refrigerated" found in the right bottom drawer of the medication cart.
Bacteriostatic Water (quantity 2) opened, unlabeled with the expiration date of 02/11 found in the top left drawer of the medication cart
Diphenhist 25mg capsules with the expiration date of 11/22/10
Sterile Water 250 mL vial no date vial had been opened

Observation on 04/19/11 at 10:15am of the medication cart located in the storage room behind the nursing station revealed approximately 61 medications for 26 discharged patients (discharged 10/21/10 through 04/18/11) were stored with stock medications and ordered medications for the four patients currently admitted to the hospital.

Review of the Hospital Inspection Form 04/29/10, 05/27/10, 06/08/10, 07/19/10, 08/27/10, 09/15/10, 10/29/10, 11/26/10, 01/27/11, 02/24/11 and 03/21/11 revealed documentation that expired medications had been removed and discontinued and expired non-narcotic medications were destroyed as needed by the facility. Further review revealed documentation that a crash cart inspection was performed; however through observation of the survey team and verification of RN S1 Director of Nursing on 04/19/11 at 10:30am, the hospital does not have a crash cart.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated the Pharmacy Tech is responsible for checking the medication cart once a month for expired medication and making sure the medication for the discharged patients have been removed from the cart.

Review of Policy Number: P 1.001 issued by the Pharmacist, no date documented, submitted by both the contract pharmacist and the Director of Nursing as the one currently in use, revealed ....Part C. Upon discharge of the patient or for any other reasons for discontinuing of a specific medicine, (such as changing drugs, allergic reactions or other reasons), the drugs are destroyed by the pharmacy".

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 verified a pharmacy tech was delegated the duty of performing the monthly inspections and that he (S4) just signed his name to the forms. Further S4 indicated he may need to monitor the pharmacy tech more closely. S4 indicated chart checks and medication passes were not being performed.

Based on observation, record review and interview the hospital failed to follow their policy and procedure for expired drugs or medications for discharged patients. This resulted in 10 expired medications and 61 medications of discharged patients being stored in the medication cart with the current admitted patients medications and available for possible patient use. Findings:

Observation on 04/19/11 at 10:15am of the medication cart located in the storage room behind the nursing station revealed the following expired medications found in the medication cart and available for patient use:
Pink Bismuth expiration date 02/11
Biscodyl 5mg tablets expiration date 12/11/10
Promethegan 25mg suppositories (quantity 10) expiration date 12/22/10
Bacteriostatic Water (quantity 15) expiration date 02/11
Novulin R 100 units/mL expired 01/01/11
Humulin R 100 units/mL expired 01/01/11
Tubersol 5 units/0.1mL labeled "To be Refrigerated" found in the right bottom drawer of the medication cart.
Bacteriostatic Water (quantity 2) opened, unlabeled with the expiration date of 02/11 found in the top left drawer of the medication cart
Diphenhist 25mg capsules with the expiration date of 11/22/10
Sterile Water 250 mL vial no date vial had been opened

Observation on 04/19/11 at 10:15am of the medication cart located in the storage room behind the nursing station revealed approximately 61 medications for 26 discharged patients (discharged 10/21/10 through 04/18/11) were stored with stock medications and ordered medications for the four patients currently admitted to the hospital.

Review of the Hospital Inspection Form 04/29/10, 05/27/10, 06/08/10, 07/19/10, 08/27/10, 09/15/10, 10/29/10, 11/26/10, 01/27/11, 02/24/11 and 03/21/11 revealed documentation that expired medications had been removed and discontinued and expired non-narcotic medications were destroyed as needed by the facility.

In a face to face interview on 04/19/11 at 10:15am RN 3 Assistant Director of Nursing indicated it was the responsibility of the night nurse to check the medication cart for expired drugs and removing the medications of the discharged patients and locking them in the Assistant Director of Nursing's office.

In a face to face interview on 04/19/11 at 1:45pm Pharmacist S4 indicated the Pharmacy Tech is responsible for checking the medication cart once a month for expired medication and making sure the medication for the discharged patients have been removed from the cart.

Review of Policy Number: P 1.001 issued by the Pharmacist, no date documented, submitted by both the contract pharmacist and the Director of Nursing as the one currently in use, revealed ....Part C. Upon discharge of the patient or for any other reasons for discontinuing of a specific medicine, (such as changing drugs, allergic reactions or other reasons), the drugs are destroyed by the pharmacy".

Review of the policy titled "Medication Administration" no date of implementation, revision or review documented and submitted by the hospital as the one currently in use, revealed...5. The night shift nurse will remove any medication that has been discontinued during that day and placed in the locked medication room".

Review of Policy Number: P 1.004 issued by the Pharmacist, no date documented, submitted by both the contract pharmacist and the Director of Nursing as the one currently in use, revealed.... c. All outdated medications, drugs, injectable's, and/or biologicals are to be continuously checked and all outdated drug products are to be discarded prior to the date of expiration".

Based on record review and interview the hospital failed to designate in writing a qualified individual as the Infection Control Officer as evidenced by the Assistant Director of Nursing and the IC Officer positions combined resulting in the failure to implement an infection control program which included handwashing surveillance, tracking and trending of infections, cleaning of all equipment used for nursing care according to the manufacturer's recommendations and annual TB testing for all staff providing patient care. Findings:

Review of the personnel file of RN S3 revealed no documented evidence of any experience or training in infection control practices.

Review of the Governing Body Meeting Minutes for the past twelve months (02/10/11, 11/02/10, 08/17/10, 05/12/10, 02/08/10) revealed no documented evidence RN S3 was designated in writing by the Governing body as the Infection Control Officer.

In a face to face interview on 04/20/11 at 3:00pm RN S3 Assistant Director of Nursing, Staff Nurse and Infection Control Officer indicated she was not trained in infection control and had no previous experience in infection. Further S3 verified she was not performing handwashing surveillance, tracking and trending of infections, ensuring all equipment used for nursing care was being cleaned according to the manufacturer's recommendations or that annual TB testing was being performed.

Based on observations, record review and interview the hospital failed to implement a system for identifying, reporting, investigating and controlling infections which included: 1) handwashing surveillance resulting in observations of non-compliance in handwashing when providing patient care; 2) tracking and trending of all patients with abnormal lab results, open wounds, elevated temperature and/or ordered antibiotic therapy resulting in the hospital's inability to determine an accurate nosocomial rate; 3) cleaning of equipment used in patient care according to manufacturer's recommendations resulting in an unclean medication cart, pill crusher, and glucometer; 4) compliance of all staff in annual tuberculin testing for 7 of 7 personnel records reviewed; and 5) participation in the quality assessment/performance improvement process. This resulted in the hospital's inability to determine an accurate infection rate. Findings:

1) handwashing surveillance
Observation on 04/19/11 at 11:15am revealed Infection Control Officer and Assistant Director of Nursing RN S3 and only nurse on duty for the 6a-6p shift) preparing to administer pain medication. Further observation revealed S3 did not wash her hands with soap and water or use hand sanitizer before taking the medication out of the blister pack by pushing the pill out into her hand and then placing it into the paper pill cup.

Observation on 04/20/11 at 7:45am revealed Infection Control Officer and Assistant Director of Nursing RN S3 and only nurse on duty for the 6a-6p shift) preparing to administer medications. Further observation revealed S3 did not wash her hands with soap and water or use hand sanitizer before taking the medication out of the blister pack by pushing the pill out into her hand and then placing it into the paper pill cup. S3 then repeated the same technique to obtain the Loratab medication (which needed to be obtained from the locked narcotic box located within the medication cart) from the blister pack and placed in the paper cup. At no time did she sanitize her hands.

The hospital could submit no documented evidence handwashing surveillance was performed.

Observation on 04/19/11 at 9:00am revealed Infection Control Officer and Assistant Director of Nursing RN S3 and only nurse on duty for the 6a-6p shift) preparing to administer medication. Further observation revealed S3 did not wash her hands with soap and water or use hand sanitizer after slicking her hands in her jacket before taking the medication out of the blister pack by pushing the pill out into her hand and then placing it into the paper pill cup.

In a face to face interview on 04/20/11 at 8:40am Infection Control/Assistant Director of Nursing/Staff RN S3 indicated she washed her hand before she opened the blister pack.

Review of the policy titled "Medication Administration", no date implemented, reviewed or revised, revealed no documented evidence concerning the procedure for handwashing when administering medication.

Review of the Infection Control Policy, no date of implementation, revision or review, revealed.... "Handwashing... 3. Wash hands between tasks and procedures on the same patient to prevent cross contamination when necessary".

2) tracking and trending of all patients with abnormal lab results, open wounds, elevated temperature and/or ordered antibiotic therapy
The hospital could not produce any documented evidence patients were being trended for possible infections.

In a face to face interview on 04/20/11 at 2:00pm the Infection Control Officer and Assistant Director of Nursing RN S3 indicated the hospital admitted many patients from the nursing homes who had Urinary Tract Infections (UTI) and decubitus ulcers; however she did not monitor these patients for the type of organisms causing the infections. Further S3 indicated she did not track antibiotics ordered for inpatients for the reason, type of infection or the identified organism(s).

3) cleaning of equipment used in patient care according to manufacturer's recommendations; Observation of the medication cart on 04/19/11 at 10:15am revealed the inside of all of the drawers contained loose debris, dust and sticky empty plastic bags. The third drawer on the right side of the medication cart contained a sticky substance residue.

In a face to face interview on 04/19/11 at 10:30am designated Infection Control Nurse, Assistant Director of Nursing and 6a-6p staff nurse S3 indicated it was the responsibility of the nurses to make sure the medication cart was kept clean.

Review of the policy titled "Care of Equipment on the Unit", no date of implementation, revision or review, revealed no documented evidence the medication cart was included in the policy as part of the equipment required to be cleaned.

Observation of the medication cart on 04/19/11 at 12:15am revealed a pill-crusher in the
top right drawer. Further review revealed powder residue on the sides which was black in color.

In a face to face interview on 04/19/11 at 10:30am designated Infection Control Nurse, Assistant Director of Nursing and 6a-6p staff nurse S3 was unable to explain how the pill-crusher would be cleaned. Further S3 indicated it was not used for patient use and threw the pill-crusher in the trash can. The surveyor then asked S3 how the Bayer Contour glucometer was cleaned and S3 responded by wiping down the sides with an alcohol wipe. S3 verified the facility was not cleaning the instrument according to the manufacturer's guidelines.

Observation on 04/19/11 at 11:15an Infection Control Officer S3 when demonstrating the use of the glucometer did not wash her hands before using the glucometer.

Review of the Bayer Manufacturer's recommendations for the Contour Glucometer revealed..... "Wash hands and dry them thoroughly before handling to keep the meter and the test strips free of oils and other contaminates. The exterior of the meter can be cleaned using a moist, lint-free tissue with a mild detergent or disinfectant solution such as 1 part bleach mixed with 9 parts water. Wipe dry with wet, lint-free tissue after cleaning".

4) compliance of all staff in annual tuberculin testing for 7 of 7 personnel records reviewed
Review of the personnel files of MD S5, MD S6, CNA S7, CNA S8, CNA S9, RN S1, RN S3 revealed no documented evidence TB testing had been performed within the last 12 months.

In a face to face interview on 04/20/11 at 3:00pm the Administrator S2 indicated the doctors are tested at other hospitals and should be sending the results to the facility. Further S2 indicated the person out on sick leave was the one responsible for obtaining the proof of the TB testing for the physicians. S2 indicated the ADON (Assistant Director of Nursing) is responsible to make sure the nursing staff is provided the TB testing.

5) participation in the quality assessment/performance improvement process
Review of the Continuous Performance Improvement Indicator report submitted to the Governing Body revealed the following information:
First Quarter of 2010 - Nosocomial Infection Rate revealed the finding were left blank; however the recommended actions were to continue ongoing monitoring and reporting.
Second Quarter of 2010 - Nosocomial Infection Rate revealed the finding were left blank; however the recommended actions were to continue ongoing monitoring and reporting.
Third Quarter of 2010 - Nosocomial Infection Rate revealed the word "omit": however the recommended actions were to continue ongoing monitoring and reporting.
Fourth Quarter of 2010 - Nosocomial Infection Rate revealed the word "omit": however the recommended actions were to continue ongoing monitoring and reporting.
The facility could not submit any collected data for the first quarter of 2011.

In a face to face interview on 04/20/11 at 3:00pm Director of Nursing S1 indicated because the facility is small they may have become lax about infection control issues.

Based on interview the hospital failed to ensure the Infection Control Officer maintained a log of incidents related to communicable diseases resulting in patients admitted with infections not being monitored for development of nosocomial (hospital acquired) infections. Findings:

In a face to face interview on 04/20/11 at 2:00pm the Infection Control Officer and Assistant Director of Nursing RN S3 indicated the hospital admitted many patients from the nursing homes who had Urinary Tract Infections (UTI) and decubitus ulcers; however she did not monitor these patients for the type of organisms causing the infections. Further S3 indicated she did not track antibiotics ordered for inpatients for the reason, type of infection or the identified organism(s).

Based on record review and interview the hospital failed to implement a quality assessment/performance improvement program which measured, analyzed, and tracked quality indicators as evidence by collecting statistical data not related to processes of care, hospital services and operations. This resulted in the hospital 's failure to identify system problems related to infection control and pharmacy services. Findings:

Review of the Continuous Performance Improvement Indicator report submitted to the Governing Body revealed the following "Aspects of Care" monitored by the hospital:
Statistical Data (Admits, Discharges, Average Daily Census, Average Length of Stay, Occupancy Rate, Medicare Patient Days, Medicaid Days, Private Pay days, Re-Admits within six months of previous discharge); Radiology (reported number of ordered x-rays on patients); Laboratory (total number of test ordered on patients); Medical Records (History and Physicals compliance rate, Discharge Summaries compliance rate); Risk Management (Total Variances); EOC (Environment of Care)/Safety (omitted in the third quarter); and Total Outcome of Function (omitted in Third Quarter). Further review revealed no documented evidence of indicators involving patient care.

Review of the indicators related to infection control revealed the Nosocomial Infection Rate (omitted in the 3 quarter of 2020) was the only indicator being monitored. After the third quart of 2010, there was no documented evidence infection control was being monitored by the facility.

Review of the indicators related to Pharmacy revealed the total number of doses dispensed and the medication error rate were the only two documented indicators. Further review revealed the medication error rate was determined by self-reporting by the nursing staff and the hospital could not submit any medication variances; therefore the QA/PI report concluded the medication error rate to be zero for the entire year of 2010.
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Based on record review and interview the hospital failed to ensure participation of the contracted pharmacy services in the Quality Assurance/Performance Improvement program as evidenced by failure to develop indicators in order to evaluate and monitor the safety and quality of care provided. This resulted in the hospital's failure to: 1) determine an accurate medication error rate due to relying on self-reporting of the nursing staff as the only means of data collection; 2) ensure the integrity of medication requiring refrigeration by storing medication in a refrigerator with temperatures above the documented parameters for 30% of the time in a four month period; 3) perform medication cart inspections to ensure expired medications, biologicals and wound cleansers were not available for administration to patients currently in the hosptial by storing all medications together. Findings:

Review of the Continuous Performance Improvement Indicator reports for all four quarters of 2010 revealed no documented evidence the performance of contracted services provided in the hospital had been monitored and/or reviewed no less than annually for safety and quality for the following: Laboratory, Radiology, or Pharmacy. The facility could not submit any collected data for the first quarter of 2011.

Review of the Governing Body Meeting Minutes for the past twelve months (02/10/11, 11/02/10, 08/17/10, 05/12/10, 02/08/10) revealed no documented evidence review of the contracts for Laboratory, Radiology or Pharmacy Services was performed.

Review of the Pharmacy contract dated 09/16/09 with Pharmaceutical Company "a" revealed.... "D. Additional services are provided by an independent pharmacy consultant include monthly medication pass; inspection of medication room and medication carts; inspection of emergency drug storage or expiration dates; and inspections of controlled medications, chart reviews and stocking of automated machines and/or checking of the stocking of medications into the automated dispensing machine as required by state and federal law...".

In a face to face interview on 04/20/11 at 3:15pm Director of Nursing RN S1 indicated he had a meeting with Pharmacist S4 on 04/04/11; however discussion was centered on the waste of medications (which are donated to a local charitable organization) and the cost of this to the hospital. Further S1 indicated he did not monitor the pharmacist to ensure the monthly medication passes, chart checks, inspection of the medication carts, stock medciations and expired drugs had been performed.

Based on record review and interview the hospital failed to ensure the Governing Body determined the frequency and detail of data collection for the Quality Assessment and Performance improvement Program. Findings:

Review of the Governing Body By-Laws dated 05/11/09 revealed no documented evidence the Governing Body had determined the frequency and detail of data collection for the Quality Assessment and Performance Improvement Program.

Review of the Governing Body Meeting Minutes for the past twelve months (02/10/11, 11/02/10, 08/17/10, 05/12/10, 02/08/10) revealed no documented the the frequency and detail of data collection for the Quality Assessment and Performance improvement Program.

In a face to face interview on 04/20/11 at 3:15pm Director of Nursing RM S1 indicated the Quality Assurance/Performance Improvement Plan needs to be reviewed to make sure all components required by the regulations are included.

Based on record review and interview the hospital failed to follow their Quality Assurance/Performance Improvement (QA/PI) Plan as evidenced by failure to set priorities for performance improvement activities which focused on high-risk, high-volume or problem-prone areas. This resulted in the monitoring of statistical data not affecting health outcomes or the quality of care. Findings:

Review of the Continuous Performance Improvement Indicator report submitted to the Governing Body revealed the following "Aspects of Care" monitored by the hospital:
Statistical Data (Admits, Discharges, Average Daily Census, Average Length of Stay, Occupancy Rate, Medicare Patient Days, Medicaid Days, Private Pay days, Re-Admits within six months of previous discharge); Pharmacy (total number of doses dispensed, medication error rate); Radiology (reported number of ordered x-rays on patients); Laboratory (total number of test ordered on patients); Medical Records (History and Physicals compliance rate, Discharge Summaries compliance rate); Risk Management (Total Variances); Nosocomial Infection Rate (omitted in the 3 quarter of 2020); EOC (Environment of Care)/Safety (omitted in the third quarter); and Total Outcome of Function (omitted in Third Quarter). Further review revealed no documented evidence of indicators involving patient care.

Review of the Quality Assurance/Performance Improvement Plan for 2010-2011 submitted as the one currently in use revealed..... VI. The criteria developed to trigger performance improvement activities are those functions, services, and processes, which are a. High risk. b. Problem prone. d. High volume....".

In a face to face interview on 04/20/11 at 3:15pm Director of Nursing S1 indicated the facility used to have a QA/PI program according to their QA/PI Plan; however in the 2004 survey by DHH the survey team explained to him QA was out and CPI (Continuous Performance Improvement) was what was needed and that the hospital was collecting too much data. S1 indicated he changed his indicators and was surveyed again in 2008 for a full survey and the survey team was satisfied the hospital had met the requirements.

Based on record review and interview the hospital failed to ensure medical errors were tracked as evidenced by relying on self-reporting as the only means of determining medication errors resulting in a zero percent medication error rate for 2474 medications administered for the four reporting quarters of 2010. Findings:

Review of the Continuous Performance Improvement Indicator report submitted to the Governing Body revealed the following information:
First Quarter of 2010 - Medication Error Rate revealed a 0% error rate.
Second Quarter of 2010 - Medication Error Rate revealed a 0% error rate.
Third Quarter of 2010 - Medication Error Rate revealed a 0% error rate.
Fourth Quarter of 2010 -Medication Error Rate revealed a 0% error rate.
The facility could not submit any collected data for the first quarter of 2011.

In a face to face interview on 04/20/11 at 3:00pm Administrator S2 indicated chart audits were not performed concerning medication administration. Further S2 indicated the medication error rate is calculated based solely on self-reporting by the nursing staff.

Based on record review and interview the Governing Body failed to ensure the Quality Assessment/Performance Improvement (QA/PI) plan was implemented as evidenced by failure to set priorities for improvement activities and evaluate all improvement actions implemented. This resulted in failure to have a functioning Infection Control Program and failure of the hospital to be provided all of the services agrred to by the contracted Pharmacy. Findings:

In a face to face interview on 04/20/11 at 3:15pm Director of Nursing S1 indicated the facility used to have a QA/PI program according to their QA/PI Plan; however in the 2004 survey by DHH the survey team explained to him QA was out and CPI (Continuous Performance Improvement) was what was needed and that the hospital was collecting too much data. S1 indicated he changed his indicators and was surveyed again in 2008 for a full survey and the survey team was satisfied the hospital had met the requirements.