HospitalInspections.org

Based on observations, record reviews, and interviews, the hospital failed to meet the requirements for the Condition of Participation for Governing Body as evidenced by:

1) Failing to ensure that a hospital license application was submitted to the state licensing agency when the hospital ownership changed on 10/01/12 and on 11/09/12;

2) Failing to ensure drugs and biological were controlled and distributed according to acceptable standards of practice and consistent with State law.

a) The new owner of the hospital did not apply for a CDS (Controlled and Dangerous Substance) license, and the DEA (Drug Enforcement Agency) license was expired. This resulted in the hospital receiving and dispensing drugs without a license to do so.

b) The hospital did not have a current contract for the pharmaceutical services provided to the hospital. This resulted in medications not being available for administration at the scheduled time for 2 of 3 patients' records reviewed for medication administration from a total of 5 sampled patients (#1, #3);

Based on observations, record reviews, and interviews, the hospital failed to meet the requirements for the Condition of Participation for Nursing Services as evidenced by:

1) Failing to ensure the registered nurse (RN) supervised and evaluated the nursing care of each patient as evidenced by:

a) Failing to ensure that the RN (registered nurse) assigned the nursing care of each patient to nursing personnel in accordance with the specialized qualifications and competence of the nursing staff available. Review of personnel files revealed the hospital failed to orient, train, and assess the competency of:

1) 8 of 9 RNs from a total of 9 employed RNs (RNS4, RNS12, RNS13, RNS15, RNS16, RNS17, RNS19, and RNS25).

2) 7 of 7 LPNs (licensed practical nurses) from a total of 7 employed LPNs (LPNS5, LPNS6, LPNS7, LPNS11, LPNS14, LPNS18, LPNS26).

3) 9 of 9 certified nursing assistants (CNAs) from a total of 9 employed CNAs (CNAS8, CNAS9, CNAS10, CNAS20, CNAS21, CNAS22, CNAS23, CNAS24, CNAS30); (see findings in tag A0397);


2) Failing to ensure that non-employee licensed nurses working in the hospital on 12 of 23 nights reviewed for staffing assignments were supervised and the evaluation of their clinical activities was provided for by the director of the nursing service for 5 of 5 contracted nurses from Company B (RNS31, RNS34, RNS35, RNS36, LPNS37) (see findings in tag A0398);

3) Failing to have a system in place that ensured that the nursing staff's licenses were verified to be valid and current other than by visual inspection of the nursing license. This resulted in:

a) 2 nursing staff not having documented evidence of a nursing license in their personnel files from a total of 16 personnel files reviewed (LPNS7, RNS16) and

b) 7 of 7 LPN (licensed practical nurse) licenses not verified with the Louisiana State Board of Practical Nurse Examiners from a total of 7 LPNs employed at the hospital (LPNS5, LPNS6, LPNS7, LPNS11, LPNS14, LPNS18, LPNS26). (see findings in tag A0394).

Based on record reviews and interviews, the hospital failed to ensure that a hospital license application was submitted to the state licensing agency when the hospital ownership changed on 10/01/12 and on 11/09/12 as required by law. Findings:

In a face-to-face interview on 11/27/12 at 1:20pm, AdministratorS1 (Company E) indicated that she had not submitted a Change of Ownership and an application for licensure to DHH (Department of Health and Hospitals) when she acquired ownership of the hospital. When asked why she had not done so, S1 indicated that it was a "lack of follow-up by her" with the attorneys to ensure that the required paperwork had been completed and sent. AdministratorS1 confirmed that the license displayed in the hall of the hospital was the license obtained by Company C.

Hospital Licensing Law
RS 4):2107. Fees and limitations

B. Each license issued hereunder shall be for a period of one year from date of issuance unless sooner revoked, shall be on a form prescribed by the Department, shall not be transferable or assignable,...

Added by Acts 1961, No. 90, ?1; Amended by Acts 1977, No. 579, ?1, eff. July 15, 1977; Acts 1986, No. 497, ?1, eff. July 2, 1986.

Based on observations, record reviews, and interviews, the hospital failed to ensure that each patient received care in a safe setting as evidenced by having emergency equipment (defibrillator and suction pump) and equipment used for patient care (infusion pumps, feeding pumps, oxygen concentrators, sequential compression device) available for use that had expired performance and safety inspections. Findings:

Observation of the crash cart on 11/27/12 at 11:05am revealed the defibrillator and the suction pump had an inspection sticker that indicated that the next performance and safety check for each was expired (due on 09/12). Further review revealed the batteries in the drawer of the cart to be used in the laryngoscope (used to intubate a patient to assist with breathing during a cardiac arrest) had no date of expiration. These observations were confirmed at the time of observation by Director of Nursing (DON) S2.

Observation of the clean supply room on 11/27/12 at 11:20am revealed the following equipment with expired or absent safety and performance inspections:
1 infusion pump with an expired inspection sticker (due on 09/12);
2 enteral pumps (pump used for tube feeding) with no documented evidence of a performance and safety inspection having been performed;
1 oxygen concentrator with no documented evidence of a performance and safety inspection having been performed and 1 oxygen concentrator with the inspection sticker peeled off and unable to read the date of inspection;
7 sequential compression devices with expired inspection stickers or no evidence of an inspection having been performed;
1 suction pump with an expired inspection sticker (due on 09/12);
1 defibrillator with an expired inspection sticker (due 10/10);
1 nebulizer (used to administer respiratory treatments) with an expired inspection sticker (due on 09/12).

In a face-to-face interview on 11/27/12 at 11:20am, DONS2 confirmed the above findings. DONS2 indicated that all equipment stored in the clean supply room was available for patient use. During the interview a request was made to obtain a copy of the hospital's policy for equipment performance and safety inspections.

In a face-to-face interview on 11/28/12 at 10:00am, DONS2 indicated that the equipment in the clean supply room should have been labeled not to be used. When asked what the hospital would do if a patient was admitted who required an infusion pump, enteral pump, oxygen concentrator, nebulizer, or sequential compression device, DONS2 indicated that they'd have to call a supply company to have the needed equipment delivered. DONS2 provided no explanation as to how the inspection of the delivered equipment would be accomplished.

As of the time of the exit conference on 11/29/12 at 3:15pm DONS2 had not provided the hospital policy for the performance and safety inspections of patient care equipment.

Based on record reviews and interview, the hospital failed to have a system in place that ensured that the nursing staff's licenses were verified to be valid and current other than by visual inspection of the nursing license. This resulted in

1) 2 licensed nurses not having documented evidence of a nursing license in their personnel files from a total of 16 personnel files reviewed (LPNS7, RNS16). and

2)7 of 7 LPN (licensed practical nurse) licenses not verified with the Louisiana State Board of Practical Nurse Examiners from a total of 7 LPNs employed at the hospital (LPNS5, LPNS6, LPNS7, LPNS11, LPN14, LPN18, LPNS26). Findings:

1) Nursing staff without evidence of nursing license:
Review of RNS16's and LPNS7's personnel file revealed no documented evidence of a current nursing license.

In a face-to-face interview on 11/28/12 at 2:10pm, Director of Human Resources S3 confirmed that the personnel files of RNS16 and LPNS7 did not have a copy of their nursing license or the verification of a nursing license.

Review of the hospital policy titled "Licensure Verification LPN / RN", policy number N 1.015 and contained in the manual presented by Administrator/Owner S1 as the current policies, revealed that the initial verification of the nursing license was to be done at the time of the interview and that the license must be seen. Further review revealed that the license must be verified by personnel at least annually.

2) Verification of LPN licenses:
Review of the personnel files of LPNS5, LPNS6, LPNS7, LPNS11, LPNS14, LPNS18, and LPNS26 revealed no documented evidence that their nursing license had been verified with the Louisiana State Board of Practical Nurse Examiners.

In a face-to-face interview on 11/28/12 at 2:10pm, Director of Human Resources S3 confirmed that no one had verified the LPN nursing licenses with the Louisiana State Board of Practical Nurse Examiners.

Review of the hospital policy titled "Licensure Verification LPN / RN", policy number N 1.015 and contained in the manual presented by Administrator/Owner S1 as the current policies, revealed that nursing license must be seen at the time of the nurse's interview and annually. There was no documented evidence that the policy required that a verification with the respective board of nursing be done to assure that the nursing license was valid and current.

Based on record reviews and interviews, the hospital failed to ensure that the RN (registered nurse) supervised and evaluated the nursing care provided to each patient. The RN failed to assess wounds upon admission and weekly thereafter as required by hospital policy for 2 of 2 in-patients with wounds from a total sample of 5 patients (#1, #3). Findings:

Review of the hospital policy titled "Wound Care Protocol", policy number N 2.066 and contained in the manual presented by AdministratorS1 as the current hospital policies, revealed that a wound care protocol scale assessment was to be performed on admission.

Review of the hospital policy titled "Photographic Method of Wound Measurement", policy number N 2.065 and contained in the manual presented by AdministratorS1 as the current hospital policies, revealed that the hospital policy was to document the presence of a wound and the condition of the surrounding skin on admission and at "regular intervals" thereafter. Further review revealed that this was to be done weekly on Sundays to track improvement or decline of a wound and upon transfer or discharge from the hospital. Further review revealed that a photograph was to be taken at the above mentioned times of pressure ulcers and other wounds that were not progressing to healing.

Patient #1
Review of Patient #1's medical record revealed that she was a 73 year old female admitted on 11/14/12 with diagnoses of Cellulitis, Hypertension, Diabetes Mellitus Type II, Venous Stasis Ulcer, Morbid Obesity, Hyperlipidemia, and a history of Right Hip Replacement. Patient #1 was an inpatient at the time of the survey.

Review of Patient #1's "Admit Nursing Assessment" performed on 11/14/12 at 6:50pm revealed that she had cellulitis with stasis ulcers to bilateral lower extremities. There was no documented evidence of the measurement of the wounds, the presence or absence of drainage, the condition of the wound bed, the surrounding skin color, and the condition of the wound edges and surrounding tissue. There was no documented evidence of a photograph of the wound as required by hospital policy.

Review of Patient #1's medical record revealed no documented evidence of the measurement and description of her wounds until 11/25/12 (11 days after admit). There was no documented evidence of wound assessments on 11/18/12 (Sunday) as required by hospital policy.

Patient #3
Review of Patient #3's medical record revealed that she was a 63 year old female admitted on 11/09/12 with a diagnosis of Debility secondary to Right Lower Extremity Cellulitis and a history of Chronic Obstructive Pulmonary Disease, Gastro-Esophageal Reflux Disease, Osteoarthritis, Peripheral Neuropathy, Hypothyroidism, and Coronary Artery Disease. Patient #3 was an inpatient at the time of the survey.

Review of Patient #3's medical record revealed that photographic wound documentation of a blister to the right medial ankle and a blister to the right dorsal foot was written on 11/09/12 by Director of Nursing (DON) S2. There was no documented evidence of an assessment of the cellulitis to the right lower extremity. Further review revealed the next assessment and photograph of the cellulitis to the right lower extremity was documented on 11/25/12 (16 days since the previous assessment). There was no documented evidence of an assessment of Patient #3's wounds on 11/11/12 and 11/18/12 (Sunday) as required by hospital policy.

In a face-to-face interview on 11/29/12 at 10:45am, DONS2 confirmed that Patient #1's wounds were not assessed and photographed at the time of admit. She further indicated that wounds were to be assessed weekly on Sunday according to the hospital policy. DON S2 confirmed that Patient #1 and Patient #3 were currently inpatients in the hospital.

Based on observations, record reviews, and interviews, the hospital failed to ensure the RN (registered nurse) assigned the nursing care of each patient to nursing personnel in accordance with the specialized qualifications and competence of the nursing staff available. Review of personnel files revealed the hospital failed to orient, train, and assess the competency of:

1) 8 of 9 RNs from a total of 9 employed RNs (RNS4, RNS12, RNS13, RNS15, RNS16, RNS17, RNS19, and RNS25).

2) 7 of 7 LPNs (licensed practical nurses) from a total of 7 employed LPNs (LPNS5, LPNS6, LPNS7, LPNS11, LPNS14, LPNS18, LPNS26).

3) 9 of 9 certified nursing assistants (CNAs) from a total of 9 employed CNAs (CNAS8, CNAS9, CNAS10, CNAS20, CNAS21, CNAS22, CNAS23, CNAS24, CNAS30);

Findings:

Observation on 11/29/12 at 12:10pm revealed CNAS30 was assigned as the CNA for the day shift.

In a face-to-face interview on 11/29/12 at 12:10pm, CNAS30 indicated that he was hired on 11/23/12. He further indicated that his orientation consisted of working with another CNA for 3 hours. CNAS30 indicated the CNA oriented him to some hospital policies, and he was directed to ask the nurse if he had any questions. He further indicated that he did not have any orientation related to patient rights, infection control, and his job duties, and a nurse had never observed him performing his duties to determine if he was competent in his role as a CNA.

Review of RNS4's personnel file revealed that she was hired on 10/22/12. Further review revealed no documented evidence of the presenter who provided orientation on 11/15/12. Further review revealed no documented evidence that an evaluation of competency had been performed for RNS4.

Review of the personnel files of RNS12, RNS13, RNS15, RNS16, RNS17, RNS19, and RNS25 revealed no documented evidence that orientation to the hospital and their job duties had been provided prior to the RNs providing direct patient care. Further review revealed no documented evidence that an evaluation to determine competency had been performed for RNS12, RNS13, RNS15, RNS16, RNS17, RNS19, and RNS25.

Review of the personnel files of LPNS5, LPNS6, LPNS7, LPNS11, LPNS14, LPNS18, and LPNS26 revealed no documented evidence that orientation to the hospital and their job duties had been provided prior to the LPNs providing direct patient care. Further review revealed no documented evidence that an evaluation to determine competency had been performed for LPNS12, LPNS13, LPNS15, LPNS16, LPNS17, LPNS19, and LPNS25.

Review of the personnel files of CNAS8, CNAS9, CNAS10, CNAS20, CNAS21, CNAS22, CNAS23, CNAS24, and CNAS30 revealed no documented evidence that orientation to the hospital and their job duties had been provided prior to the CNAs providing direct patient care. Further review revealed no documented evidence that an evaluation to determine competency had been performed for CNAS8, CNAS9, CNAS10, CNAS20, CNAS21, CNAS22, CNAS23, CNAS24, and CNAS30.

Review of the personnel files of RNS25, LPNS7, and CNAS9, CNAS10, CNAS21, CNAS22, and CNAS23 revealed no documented evidence that they were certified in CPR which was required by hospital policy.

Review of the job descriptions for the RN, LPN, and CNA positions revealed that CPR certification was an educational requirement for each position.

In a face-to-face interview on 11/27/12 at 1:20pm, AdministratorS1 indicated that when she purchased the hospital on 11/09/12, she had to hire staff immediately, because the staff hired previously by Company C and Company D refused to come to work, because Company D failed to meet payroll on 10/19/12 and 11/02/12.

In a face-to-face interview on 11/28/12 at 12:05pm, Director of Human Resources S3 indicated that the employee's signature on the orientation form meant that the employee was informed that orientation will be held 12/03/12. She further indicated that the newly hired employees had not received orientation, training, and an assessment of competency prior to performing direct patient care.

In a face-to-face interview on 11/28/12 at 2:15pm, Director of NursingS2 (DON) indicated that she had not performed competency evaluations on the present nursing staff. When asked how she could determine that the staff was competent, DONS2 indicated that she looked at the years of experience that the staff member had worked. She further indicated that LPNS5 was a new graduate, and she had been orienting with the RN to "beef her skills and documentation". DONS2 indicated that she had no documented evidence of the orientation that had been performed. During the interview DONS2 was informed that review of the nursing staff's personnel files revealed no documented evidence of competency of the staff to provide care to the current patients, DONS2 indicated that she didn't have any comment to offer.

Review of the hospital policy titled "Cardiopulmonary Resuscitation", policy number N 2.049 contained in the policy manual presented by Administrator/Owner S1 as their current policies, revealed that CPR certification was required of all direct care clinical personnel.

Based on observations, record reviews, and interviews, the hospital failed to ensure that non-employee licensed nurses working in the hospital on 12 of 23 nights reviewed for staffing assignments were supervised. The hospital failed to ensure that the evaluation of the clinical activities of non-employee licensed nurses was provided for by the director of the nursing service for 5 of 5 contracted nurses from Company B (RNS31, RNS34, RNS35, RNS36, LPNS37). Findings:

Observation on 11/29/12 at 12:15pm revealed Contract RNS31 (Registered Nurse) with Company B was the RN Charge Nurse on the day shift.

Review of the "Specialty Rehab Roster" presented by Director of Human ResourcesS3 (H.R.) revealed Contract Nurses RNS34, RNS35, RNS36, and LPNS37 from Company B began working at the hospital on 11/07/12.

Review of the staffing assignments provided by Director of NursingS2 revealed contract nurses worked on the night shifts on 11/07/12, 11/08/12, 11/11/12, 11/12/12, 11/13/12, 11/15/12, 11/16/12, 11/18/12, 11/20/12, 11/21/12, 11/23/12, and 11/24/12.

In a face-to-face interview on 11/27/12 at 1:20pm, AdministratorS1 indicated that the hospital used Company B to supplement the nursing staff with contract nurses. She further indicated that the night shift was covered mostly by RNs from Company B. She indicated that she was not aware that a non-employee RN had to be supervised by a hospital-employed RN.

In a face-to-face interview on 11/28/12 at 2:10pm, Director of H.R.S3 indicated that the personnel files of the contract nurses from Company B were on her computer, and she wasn't able to print the files. She further indicated that she and AdministratorS1 (neither one is a nurse) viewed all the information sent by e-mail from Company B, but Director of NursingS2 had not seen the files. Director of HRS3 indicated that the hospital had not yet provided orientation to these nurses who had already provided patient care. She further indicated that a competency evaluation had not been performed by any hospital-employed RN.

In a face-to-face interview on 11/29/12 at 12:15pm, Contract RNS31 with Company B indicated that today was the second shift that she worked at the hospital, and she had first worked on 11/27/12 on the night shift. She further indicated that she had no orientation provided by the hospital prior to her covering the shift on 11/27/12. RNS31 indicated that she came in 30 minutes before the start of the shift, so the nurses could show her where supplies were kept and how to document on the MAR (medication administration record). She further indicated that she was the only RN in the hospital on the night shift.

Based on observation, record reviews, and interviews, the hospital failed to ensure that drugs and biologicals were administered in accordance with the physician orders for 3 of 3 patients whose records were reviewed for medication administration from a total sample of 5 patients (#1, #2, #3). Findings:

Patient #1
Review of Patient #1's medical record revealed that she was a 73 year old female admitted on 11/14/12 with diagnoses of Cellulitis, Hypertension, Diabetes Mellitus Type II, Venous Stasis Ulcer, Morbid Obesity, Hyperlipidemia, and a history of Right Hip Replacement.

Review of Patient #1's physician's admit orders revealed the following medication orders:
Sliding scale Regular Insulin as follows: blood sugar 151 to 173, give 2 units; blood sugar 174 to 203, give 3 units;
Glipizide 5 mg (milligrams) by mouth daily;
Lopressor 25 mg by mouth daily;
Invanz 1 gram IVPB (intravenous piggyback) every 24 hours.

Review of Patient #1's MAR (medication administration record) revealed her blood sugar on 11/19/12 at 8:30pm was 202, and Regular Insulin 4 units was administered rather than 3 units as ordered. Further review revealed Glipizide 5 mg was not administered on 11/16/12 at 7:00am as scheduled as evidenced by the space requiring the nurse's initials being blank. Glipizide was held on 11/26/12 at 7:30am due to the blood sugar being 106. There was no documented evidence of an order with parameters to hold Glipizide, and there was no documented evidence that the physician was notified that the medication was held. Review revealed Lopressor was held on 11/22/12 at 8:00am due to the blood pressure reading of 99/70. Further review revealed no documented evidence that a parameter for when the Lopressor should be held was ordered by the physician. Further review revealed Invanz 1 gm IVPB was not administered on 11/17/12 at 10:00pm as ordered as evidenced by a circle with the nurse's initials on the MAR.

Review of Patient #1's "Medication Reconciliation List" signed by the physician on 11/16/12 at 12:50pm revealed orders for Xanax 1 mg by mouth twice a day and Celebrex 200 mg by mouth daily. Review of Patient #1's MAR (medication administration record) revealed Xanax 1 mg was not administered on 11/23/12 at 8:00am as scheduled, and the 8:00pm dose was administered at 10:00pm. Further review revealed documentation of "not available" was written in the block on the MAR for 11/23/12. Further review revealed Celebrex 200 mg was not administered on 11/22/12 at 8:00am as scheduled as evidenced by "not available" written in the blank for the nurse's initials. There was no documented evidence that Celebrex was administered on 11/16/12 as evidenced by the space on the MAR for the nurse's initials being blank.

In a face-to-face interview on 11/29/12 at 10:45am, Director of NursingS2 (DON) indicated that the pharmacy currently delivered medications once a day about 9:00pm. She further indicated that any medication that was ordered or scheduled that was not kept in stock and not in the patient's medication bin would not be administered until the night shift. She further indicated that the hospital did not have a protocol for parameters for blood pressure to be used to determine when to hold the Lopressor. DONS2 confirmed that the wrong dose of Insulin was administered on 11/19/12 for Patient #1 who was a current inpatient.

Patient #2
Review of Patient #2's medical record revealed that he was a 70 year old male admitted on 11/14/12 with a diagnosis of Debility and was currently an inpatient during the survey.

Review of Patient #2's physician's orders revealed an order on 11/14/12 at 12:15pm for Clonidine 0.1 mg by mouth every 8 hours as needed for systolic blood pressure greater than 180 mm Hg (millimeters of mercury) or diastolic blood pressure greater than or equal to 100 mm Hg and to repeat the blood pressure.

Review of Patient #2's graphic sheet revealed that his blood pressure on 11/15/12 in the morning (no time documented) was 145/100. Review of the MAR and the nurse's notes for 11/15/12 revealed no documented evidence that Clonidine was administered or that the blood pressure was reassessed as ordered.

In a face-to-face interview on 11/29/12 at 11:40am, DONS2 confirmed that Patient #2's (who was a cuurent inpatient) blood pressure was not reassessed and that Clonidine was not administered as ordered for the systolic blood pressure of 100 mm Hg or higher.

Patient #3
Review of Patient #3's medical record revealed that she was a 63 year old female admitted on 11/09/12 with a diagnosis of Debility secondary to Right Lower Extremity Cellulitis and a history of Chronic Obstructive Pulmonary Disease, Gastro-Esophageal Reflux Disease, Osteoarthritis, Peripheral Neuropathy, Hypothyroidism, and Coronary Artery Disease. Patient #3 remained a current inpatient during the survey.

Review of Patient #3's "Medication Reconciliation List" received by verbal order from PhysicianS33 on 11/09/12 at 2:30pm revealed orders for Synthroid 50 mcg (micrograms) by mouth (p.o.) daily, Lipitor 20 mg by mouth daily, Coreg 3.125 mg by mouth daily, Lisinopril 10 mg by mouth daily, and Remeron 30 mg by mouth at bedtime. Review of the "Physician Orders" revealed an order on 11/16/12 at 12:08pm for heparin 5000 units subcutaneously (SQ) twice a day, discontinue Heparin when the INR (International Normalized Ratio) was greater than 2.0, and to increase Coumadin to 5 mg on 11/17/12.

Review of Patient #3's MARs revealed the following medications were documented as not given with "not available" written in the space on the MAR used the nurse's initials who administered the medication:
11/16/12 - Lipitor 20 mg p.o. and Remeron 30 mg p.o. at 8:00pm;
11/17/12 - Synthroid 50 mcg p.o. at 6:00am; Heparin 5000 units SQ at 8:00am (INR was 1.50 on 11/16/12 at 7:57am); Lipitor 20 mg p.o., Coreg 3.125 mg p.o., Remeron 30 mg p.o., and Heparin 5000 units SQ at 8:00pm;
11/18/12 - Synthroid 50 mcg p.o. at 6:00am; Heparin 5000 units SQ at 8:00am; Heparin 5000 units SQ at 8:00pm;
11/19/12 - Synthroid 50 mcg p.o. at 6:00am; Coumadin 5 mg p.o. at 5:00pm; Heparin 5000 units SQ at 8:00am (INR was 1.90 on 11/19/12 at 7:28am); Heparin 5000 units SQ at 8:00pm;
11/20/12 - Heparin 5000 units SQ at 8:00am and 8:00pm;
11/21/12 - Lisinopril 10 mg p.o. at 8:00am; Heparin 5000 units SQ at 8:00am (INR of 2.29 was not received by the lab until 8:05am on 11/21/12 and not reported until 10:01am - 2 hours after Heparin should have been administered).

Observation on 11/29/12 at 1:20pm revealed RNS31 (registered nurse), a contracted nurse with Company B, calling Company A to inquire about their delivery time of medications to the hospital. Further observation revealed RNS31 informing Company A's representative that she (RNS31) needed Flexeril for Patient #1.

In a face-to-face interview on 11/29/12 at 1:20pm, Contract RNS31 indicated that Patient #1 had requested Flexeril (muscle relaxant) prior to her therapy time. She further indicated that Patient #1's last Flexeril was given at 8:00am on 11/28/12.

In a face-to-face interview on 11/29/12 at 1:35pm, Patient #1 indicated that she asked for a Flexeril before her therapy, so she wouldn't have spasms.

In a face-to-face interview on 11/29/12 at 10:45am, Director of NursingS2 (DON) indicated that the medications that were documented as unavailable should have been available for administration to the patients at their scheduled times.

In a face-to-face interview on 11/27/12 at 1:20pm, AdministratorS1 indicated that she purchased the hospital on 11/09/12.

In a face-to-face interview on 11/29/12 at 2:25pm, AdministratorS1 indicated that she had not signed a contract for pharmaceutical services to be provided by Company A since purchasing the hospital on 11/09/12. She further indicated that the prior owner had a contract with Company A for pharmaceutical services. AdministratorS1 indicated that there had been problems with getting medications delivered timely to the hospital. When told that the pharmacy contract did not provide for 24 hours a day, 7 days a week coverage, S1 indicated the contract was the one that was in place when she bought the hospital.

In a telephone interview on 11/29/12 at 3:05pm, PharmacistS32 with Company A indicated that the new owner of the hospital had never contacted them to negotiate a new contract for pharmaceutical services. He further indicated that the contract with the former owners was null and void once the hospital changed ownership. PharmacistS32 indicated that their company delivered once a day, and stat orders were delivered anytime with a contract in place.

Review of the hospital policy titled "Medications", policy number N 3.001 contained in the policy manual presented by Administrator/Owner S1 as their current policies, revealed, in part, "...19. If medication is ordered, but not present: a. Check other patients' drawers to see if it was placed in wrong drawer b. Call the pharmacy or supervisor to obtain the medication ..." Further review revealed no documented evidence that the policy had been reviewed and approved by the governing body since the hospital's sale on 11/09/12.

Based on observations, record reviews, and interviews, the hospital failed to meet the Condition of Participation for Pharmaceutical Services as evidenced by:

Failing to ensure drugs and biologicals were controlled and distributed according to acceptable standards of practice and consistent with State law.
1) The new owner of the hospital did not apply for a CDS (Controlled and Dangerous Substance) license, and the DEA (Drug Enforcement Agency) license was expired. This resulted in the hospital receiving and dispensing drugs without a license to do so.

2) The hospital did not have a current contract for the pharmaceutical services provided to the hospital. This resulted in medications not being available for administration at the scheduled time for 2 of 3 current inpatients' records reviewed for medication administration from a total of 5 sampled patients (#1, #3) (see findings in tag A0500).

Based on observations, record reviews and interviews, the hospital failed to ensure drugs and biological were controlled and distributed according to acceptable standards of practice and consistent with State law.

1) The new owner of the hospital did not apply for a CDS (Controlled and Dangerous Substance) license, and the DEA (Drug Enforcement Agency) license was expired. This resulted in the hospital receiving and dispensing drugs without a license to do so.

2) The hospital did not have a current contract for the pharmaceutical services provided to the hospital. This resulted in medications not being available for administration at the scheduled time for 2 of 3 current inpatients' records reviewed for medication administration from a total of 5 sampled patients (#1, #3). Findings:

CDS and DEA licenses: 1) Observation on 11/28/12 at 10:10am revealed the hospital's licenses were posted on the wall at the end of the hall leading from the entrance of the hospital. Further observation revealed the hospital's DEA (Drug Enforcement Agency) license had expired on 10/31/12, and the CDS (Controlled and Dangerous Substance) license was current.

In a face-to-face interview on 11/27/12 at 1:20pm, AdministratorS1 indicated that she purchased the hospital on 11/09/12.

In a face-to-face interview on 11/28/12 at 10:05am, AdministratorS1 indicated that she was not aware that the DEA license had expired.

In a face-to-face interview on 11/29/12 at 2:25pm, AdministratorS1 indicated that she didn't know that she had to apply for a CDS license, and that it was not transferable with the sale of the hospital.

Review of the LAC 46:LIII. Chapters 25, 27, and 31, revealed, in part, "...FINAL RULE Department of Health and Hospitals Board of Pharmacy Controlled Dangerous Substances ...
Title 46
PROFESSIONAL AND OCCUPATIONAL STANDARDS
Part LIII. Pharmacists
Subchapter B. Licenses
?2705. Licenses and Exemptions
E. Facilities. The issuance of a CDS license to a facility, and the renewal thereof, shall require the possession of a valid and verifiable license or other credential issued by the department, or its successor.

?2707. Licensing Procedures
D. Maintenance of CDS Licenses
1. A CDS license is valid only for the entity or person to whom it is issued and shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall a license be valid for any premises other than the business location for which it is issued.
2. In order to maintain a CDS license, the applicant shall maintain a federal license required by federal law to engage in the manufacture, distribution, prescribing, or dispensing of controlled substances. ...
5. A facility changing ownership shall notify the board in writing 15 calendar days prior to the transfer of ownership.
a. A change of ownership is evident under the following conditions:
i. sale;
ii. death of a sole proprietor;
iii. the addition or deletion of one or more partners in a partnership;
iv. bankruptcy sale; or
v. a 50 percent, or more, change in ownership of a corporation, limited liability company, or association since the issuance of the original CDS license.
b. The new owner(s) shall submit a properly completed application, with all required attachments and appropriate fee, to the board.
c. Upon the receipt of the new CDS license, the previous licensee shall:
i. notify the board of the transaction, including the identity of the new owner(s); and
ii. surrender his CDS license to the board.
d. A CDS license is not transferable from the original owner to a new owner.
e. A change in ownership may require an inspection by the board or its designee.
AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.
HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2131 (October 2008).
2) Pharmacy contract:
Review of the pharmacy contract developed between the hospital and Company A and presented as the pharmacy contract by AdministratorS1 revealed the contract was effective 02/01/09. Further review revealed Company A agreed to provide continuous service to the hospital during the 5 day work week and to provide emergency pharmacy services 24 hours per day, 7 days a week. There was no documented evidence that the number of deliveries and the times of deliveries by the pharmacy to the hospital had been addressed in the contract.

There was no documented evidence of a pharmacy contract that was developed and became effective as of the change in ownership to AdministratorS1 on 11/09/12.

Patient #1
Review of Patient #1's medical record revealed that she was a 73 year old female admitted on 11/14/12 with diagnoses of Cellulitis, Hypertension, Diabetes Mellitus Type II, Venous Stasis Ulcer, Morbid Obesity, Hyperlipidemia, and a history of Right Hip Replacement. Patient #1 was a current inpatient at the time of the survey.

Review of Patient #1's "Medication Reconciliation List" signed by the physician on 11/16/12 at 12:50pm revealed orders for Xanax 1 mg (milligram) by mouth twice a day and Celebrex 200 mg by mouth daily. Review of Patient #1's MAR (medication administration record) revealed Xanax 1 mg was not administered on 11/23/12 at 8:00am as scheduled, and the 8:00pm dose was administered at 10:00pm. Further review revealed documentation of "not available" was written in the block on the MAR for 11/23/12. Further review revealed Celebrex 200 mg was not administered on 11/22/12 at 8:00am as scheduled as evidenced by "not available" written in the blank for the nurse's initials.

Patient #3
Review of Patient #3's medical record revealed that she was a 63 year old female admitted on 11/09/12 with a diagnosis of Debility secondary to Right Lower Extremity Cellulitis and a history of Chronic Obstructive Pulmonary Disease, Gastro-Esophageal Reflux Disease, Osteoarthritis, Peripheral Neuropathy, Hypothyroidism, and Coronary Artery Disease. Patient #3 was a current inpatient at the time of the survey.

Review of Patient #3's "Medication Reconciliation List" received by verbal order from PhysicianS33 on 11/09/12 at 2:30pm revealed orders for Synthroid 50 mcg (micrograms) by mouth (p.o.) daily, Lipitor 20 mg by mouth daily, Coreg 3.125 mg by mouth daily, Lisinopril 10 mg by mouth daily, and Remeron 30 mg by mouth at bedtime. Review of the "Physician Orders" revealed an order on 11/16/12 at 12:08pm for heparin 5000 units subcutaneously (SQ) twice a day, discontinue Heparin when the INR (International Normalized Ratio) was greater than 2.0, and to increase Coumadin to 5 mg on 11/17/12.

Review of Patient #3's MARs revealed the following medications were documented as not given with "not available" written in the space on the MAR used the nurse's initials who administered the medication:
11/16/12 - Lipitor 20 mg p.o. and Remeron 30 mg p.o. at 8:00pm;
11/17/12 - Synthroid 50 mcg p.o. at 6:00am; Heparin 5000 units SQ at 8:00am (INR was 1.50 on 11/16/12 at 7:57am); Lipitor 20 mg p.o., Coreg 3.125 mg p.o., Remeron 30 mg p.o., and Heparin 5000 units SQ at 8:00pm;
11/18/12 - Synthroid 50 mcg p.o. at 6:00am; Heparin 5000 units SQ at 8:00am; Heparin 5000 units SQ at 8:00pm;
11/19/12 - Synthroid 50 mcg p.o. at 6:00am; Coumadin 5 mg p.o. at 5:00pm; Heparin 5000 units SQ at 8:00am (INR was 1.90 on 11/19/12 at 7:28am); Heparin 5000 units SQ at 8:00pm;
11/20/12 - Heparin 5000 units SQ at 8:00am and 8:00pm;
11/21/12 - Lisinopril 10 mg p.o. at 8:00am; Heparin 5000 units SQ at 8:00am (INR of 2.29 was not received by the lab until 8:05am on 11/21/12 and not reported until 10:01am - 2 hours after Heparin should have been administered).

Observation on 11/29/12 at 1:20pm revealed RNS31 (registered nurse), a contracted nurse with Company B, calling Company A to inquire about their delivery time of medications to the hospital. Further observation revealed RNS31 informing Company A's representative that she (S31) needed Flexeril for Patient #1.

In a face-to-face interview on 11/29/12 at 1:20pm, Contract RNS31 indicated that Patient #1 had requested Flexeril (muscle relaxant) prior to her therapy time. She further indicated that Patient #1's last Flexeril was given at 8:00am on 11/28/12.

In a face-to-face interview on 11/29/12 at 1:35pm, Patient #1 indicated that she asked for a Flexeril before her therapy, so she wouldn't have spasms.

In a face-to-face interview on 11/29/12 at 10:45am, Director of NursingS2 (DON) indicated that the medications that were documented as unavailable should have been available for administration to the patients at their scheduled times.

In a face-to-face interview on 11/27/12 at 1:20pm, AdministratorS1 indicated that she purchased the hospital on 11/09/12.

In a face-to-face interview on 11/29/12 at 2:25pm, AdministratorS1 indicated that she had not signed a contract for pharmaceutical services to be provided by Company A since purchasing the hospital on 11/09/12. She further indicated that the prior owner had a contract with Company A for pharmaceutical services. AdministratorS1 indicated that there had been problems with getting medications delivered timely to the hospital. When told that the pharmacy contract did not provide for 24 hours a day, 7 days a week coverage, S1 indicated the contract was the one that was in place when she bought the hospital.

In a telephone interview on 11/29/12 at 3:05pm, PharmacistS32 with Company A indicated that the new owner of the hospital had never contacted them to negotiate a new contract for pharmaceutical services. He further indicated that the contract with the former owners was null and void once the hospital changed ownership. PharmacistS32 indicated that their company delivered once a day, and stat orders were delivered anytime with a contract in place.

Review of the hospital policy titled "Medications", policy number N 3.001 contained in the policy manual presented by AdministratorS1 as their current policies, revealed, in part, "...19. If medication is ordered, but not present: a. Check other patients' drawers to see if it was placed in wrong drawer b. Call the pharmacy or supervisor to obtain the medication ..." Further review revealed no documented evidence that the policy had been reviewed and approved by the governing body since the hospital's sale on 11/09/12.

Based on observations, record reviews, and interviews, the hospital failed to ensure that drugs and biologicals were kept in a secure and locked area. The hospital had drugs stored in an unlocked cabinet in the unlocked nutrition room that were available to unauthorized individuals. Findings:

Review of the policy titled "Storage Requirements", policy number 2.01 and contained in the manual presented by AdministratorS1 as the current hospital policies, revealed in part, "...1. All drugs and biological shall be kept in a locked, well-illuminated clean medicine cupboard, closet, cabinet or room under proper temperature controls. 2. Accessible only to individuals authorized to administer or dispense drugs..."

Review of the policy titled "Disposal of Expired Non-Control Meds/IV (intravenous)", policy number 2.08 and contained in the manual presented by AdministratorS1 as the current hospital policies, revealed in part, "...Outdated Non-Controlled Drugs and IV's shall be removed from the stock upon expiration and properly disposed of..."

Observation on 11/27/12 at 10:30am revealed the door to the nutrition room was unlocked. Further observation revealed medications were stored in the unlocked cabinets above the sink in the nutrition room. Observation revealed the following medications were stored in the unlocked cabinets in the nutrition room that were accessible to certified nursing assistants:

1 container of Polyethylene glycol 3350 NF Powder for oral solution (Miralax);
2 unopened bottles of Calcium 600 mg (milligrams) with Vitamin D, 250 tablets;
2 unopened bottles of Magnesium with Chelated Zinc, 250 tablets;
1 unopened container of Anti-Diarrheal Loperamide HCL 2 mg, 12 caplets;
1 unopened container of All Day Allergy Relief Cetirizine 10 mgm 14 tablets;
Assured Allergy (Diphenhydramine HCL 25 mg), 36 tablets;
2 boxes of Assured Immediate Acting Mucus Relief Expectorant, 15 tablets;
2 boxes of Assured Ibuprofen, 40 tablets;
2 boxes of Assured Aspirin enteric safety coated tablets 81 mg;
3 bottles (1 pint) Lactulose Solution, 10 g/15 ml (10 grams per 15 milliliters);
1 bottle of Dakin's Solution full strength 50% (per cent) (16 fluid ounces);
1 container of unopened Thick It Regular Strength, 8 ounces;
6 syringes of Arixtra 7.5 mg /0.6 ml;
6 syringes of Arixtra 2.5 mg / 0.5 ml;
9 packs of Lidoderm Lidocaine Patch 5% (700 mg) Lidocaine;
3 tubes of Mupirocin Ointment 2% (22 grams);
2 tubes of Ciclopirox Olamine Cream 0.77% (30 grams);
1 tube of Triple Antibiotic Ointment (Polymyxin B, Bacitracin, Neomycin), 28 grams;
1 tube of Silvasorb Gel Silver Antimicrobial Wound Gel (1.5 fluid ounce);
1 tube Aloe Vesta Antifungal Ointment Miconazole Nitrate 2% (5 ounces);
30 Spiriva HandiHaler (all expired 07/12) with 1 HandiHaler inhalation device;
25 Unit Dose Vials (2.5 ml) of Ipratropium Bromide Inhalation Solution 0.02%, 0.5 mg / vial;
48 sterile unit dose (3 ml) vials of Albuterol Sulfate Inhalation Solution 0.083% (2.5 mg / 3 ml).

In a face-to-face interview on 11/27/12 at 10:55am, Director of NursingS2 (DON) confirmed the above findings and indicated that the cabinet should remain locked at all times. She further indicated the door to the nutrition room should also be locked. DONS2 indicated that the nutrition room was accessible to the nurses and the certified nursing assistants.

Based on interview the hospital failed to ensure that there was a Director of Rehabilitation Services who supervised and ensured that the services provided were administered properly. Findings:

In a face-to-face interview on 11/27/12 at 1:20pm, AdministratorS1 indicated that she did not have any of the therapists designated as the Director of Rehabilitation Services for the hospital.

Based on record reviews and interviews, the hospital failed to ensure that the rehabilitation staff providing services to patients at the hospital had been trained, oriented, and assessed for competency for 1 of 1 Certified Occupational Therapy Assistant's (COTA) personnel file reviewed from a total of 1 COTA on staff (COTAS27) and 1 of 2 Occupational Therapist's (OT) personnel file reviewed from a total of 2 OT on staff (OTS28). Findings:

COTAS27
Review of COTAS27's personnel file revealed that he was hired on 11/08/12. Further review revealed no documented evidence that COTAS27 had been oriented to the hospital and the OT department, and there was no documented evidence that COTAS27 had been assessed for competency prior to providing direct patient care. Further review revealed no documented evidence that COTAS27 was certified in CPR (cardiopulmonary resuscitation).

Review of COTAS27's job description revealed that his educational requirements included CPR certification, orientation to new equipment and procedures, current knowledge of all applicable equipment utilized by the hospital, and orientation to all policies and procedures, the safety manual, and infection control.

Review of COTAS27's personnel file revealed a form with the next scheduled orientation date of 12/03/12 or 12/04/12.

OTS28
Review of OTS28's personnel file revealed that she was hired on 10/31/12. Further review revealed the job description signed by OTS28 was that of a COTA rather than an OT. Further review of the personnel file revealed no documented evidence that S28 had been oriented to the hospital and the OT department, and there was no documented evidence that OTS28 had been assessed for competency prior to providing direct patient care. Further review revealed no documented evidence that OTS28 was certified in CPR.

In a face-to-face interview on 11/28/12 at 12:05pm, Director of Human ResourcesS3 indicated that the employee's signature on the orientation form meant that the employee was informed that orientation will be held 12/03/12. She further indicated that the newly hired employees had not received orientation, training, and an assessment of competency prior to performing direct patient care.

Review of the hospital policy titled "Cardiopulmonary Resuscitation", policy number N 2.049 contained in the policy manual presented by AdministratorS1 as their current policies, revealed that CPR certification was required of all direct care clinical personnel.