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Based on observations, record reviews, and interviews, the hospital failed to meet the requirements of the Condition of Participation for Patient Rights as evidenced by failing to ensure that each patient had the right to receive care in a safe setting. The hospital failed to ensure:

1) Patient observations by staff were conducted as ordered by the physician for 1 of 1 patient who was found unresponsive by staff (Patient #10);

2) CPR was performed on a patient who was found unresponsive for 1 of 1 death record reviewed; and

3) Patients rooms did not have safety risks for 20 of 20 patient rooms. (See Findings Tag A-144)

Based on record reviews, interviews and observations, the hospital failed to ensure each patient had the right to receive care in a safe setting as evidenced by:

1) Failing to ensure patient observations by staff were conducted as ordered by the physician for 1 of 1 patient who was found unresponsive by staff (Patient #10);
2) Failing to perform CPR on a patient who was found unresponsive for 1 of 1 death record reviewed; and
3) Failing to ensure patients rooms did not have safety risks for 20 of 20 patient rooms.
Findings:

1) Failing to ensure patient observations by staff were conducted as ordered by the physician (Patient #10) and
2) Failing to perform CPR on a patient who was found unresponsive (Patient #10):

Review of the Hospital policy titled, Close Observation/1:1 Supervison, Policy Number PC-4, revealed in part the following: Level I: Close Observation, check patient every 15 minutes. Document close observation procedures in the medical record to include patient's behavior and status, level of observation and frequency of staff contact and patient's response. The Close Observation Documentation Form will be completed for the duration of the close observation period and become a part of the patient's permanent medical record.

Review of the Hospital policy titled, Death of a Patient, Policy Number PC-12, revealed in part the following: In the event that a patient death is suspected, the staff member finding the patient will determine if the patient has a DNR status order. If the patient does not have DNR status order, staff will activate EMS, begin basic life support protocols, notify the attending physician and notify next of kin.


Review of the medical record for Patient #10 revealed an admit date of 07/08/16 with diagnoses of bipolar disorder and mania. The physician ordered Level I close observations, check patient every 15 minutes. There was documented evidence in the record that the patient was a full code, and not on a DNR status.

Review of the patient's nurses progress notes dated 07/22/16 at 8:45 a.m. revealed the nurse was called to the patient's room. "Pt (patient) found unresponsive, no pulse, no breath sounds, pupils fixed and dilated, skin cool to touch. Pt had evacuated bladder and bowel. Dr notified, time of death 0845, cause of death-myocardial infarction."

Review of the record revealed there was no documented evidence of close observations of the patient every 15 minutes from 07/22/16 at 6:45 a.m. until the patient was found unresponsive on 07/22/17 at 8:45 a.m. (2 hours). Further review of the record revealed no documented evidence that CPR/basic life support was initiated on the patient when she was found unresponsive.

On 04/26/17 at 11:00 a.m., interview with S1Administrator and S2DON confirmed that they were unable to provide any documented evidence that the patient had been observed from 07/22/16 at 6:45 a.m. until she was found unresponsive on 07/22/16 at 8:45 a.m. They further confrmed that there was no evidence in the record that CPR had been initated on the patient when found unresponsive. When S2DON was asked why CPR was not initiated, she had no response but stated that the patient was a full code and basic life support should have been started.


3) Failing to ensure patients rooms did not have safety risks for 20 of 20 patient rooms:

Observations on 04/24/17 beginning at 9:30 a.m. of the patients' rooms revealed a total of 20 single occupancy rooms. The following safety risks were identified:
a) All beds had metal frames and supports which presented a ligature risk.
b) All windows opened to the outside and there was no secured covering on the outside of the windows to prevent contraband from entering hospital. Screws/braces attached to the windows were not tamper-resistant and could easily be removed.
c) All bathrooms had sinks with protruding faucets and exposed pipes that posed a ligature risk.
d) All bedroom and bathroom doors had 3 hinges spread apart enough to present a ligature risk.
e) All door handles were attached in a way that presented a ligature risk.
f) The majority of rooms had a loose covering on the air-conditioning/heating unit that could present an electrocution risk with the exposed wires.

On 04/26/17 at 9:30 a.m., S1Administrator and S2DON observed the above environmental concerns and confirmed that they were safety risks to the patients.

Based upon record review and interviews, the hospital failed to ensure adverse patient events were investigated. This was evidenced by the failure to investigate the adverse event with Patient #10 who on 07/22/17 was found unresponsive and pulseless.
Findings:

Review of the medical record for Patient #10 revealed the patient was admitted on 07/08/16 with diagnoses of bipolar disorder and mania. According to the nursing notes dated 07/22/17 and timed 8:45 a.m., documentation revealed "Pt. (patient) found unresponsive, no pulse, no breath sounds, pupils fixed and dilated, skin cool to touch. Pt. had evacuated bowel and bladder. Dr. notified, time of death 0845, cause of death-myocardial infarction." Further review of the medical record revealed the patient was not on a DNR (Do Not Resusitate) status.

Review of the close observation 15 minute checks dated 07/22/16 revealed from 6:45 a.m. to 8:45 a.m.,when the patient was found to be unresponsive and pulseless, there failed to be documentation the patient was monitored. There failed to be documented evidence CPR/basic life support was initiated when the patient was found in cardiac arrest.

Review of the Quality Assurance (QA) data revealed there failed to be documented evidence the adverse event for Patient #10 was reviewed through the QA program.

On 4/26/17 at 11:00 a.m., interview with S1Administrator and S2DON revealed when asked if the adverse advent with Patient #10 was investigated, they replied it was; however, the administrative staff could produce no documentation of the investigation.

Based on record review and staff interview, the hospital failed to ensure the registered nurse supervised and evaluated the nursing care for each patient as evidenced by failing to perform CPR for a patient who was a full code and found unresponsive for 1 of 1 death records reviewed (Patient #10).
Findings:

Review of the Hospital policy titled, Death of a Patient, Policy Number PC-12, revealed in part the following: In the event that a patient death is suspected, the staff member finding the patient will determine if the patient has a DNR status order. If the patient does not have DNR status order, staff will activate EMS, begin basic life support protocols, notify the attending physician and notify next of kin.

Review of the patient's record revealed an admit date of 07/08/16 with diagnoses including bipolar disorder and mania. The physician ordered Level I close observations, observe patient every 15 minutes.

Review of the patient's nurses progress notes dated 07/22/16 at 8:45 a.m. revealed the nurse was called to the patient's room. "Pt found unresponsive, no pulse, no breath sounds, pupils fixed and dilated, skin cool to touch. Pt had evacuated bladder and bowel. Dr notified, time of death 0845, cause of death-myocardial infarction."

Further review of the record revealed there was no documented evidence of close observations every 15 minutes from 07/22/16 at 6:45 a.m. until the patient was found unresponsive on 07/22/17 at 8:45 a.m. Further review of the record revealed no documented evidence that CPR/basic life support was initiated on the patient when she was found unresponsive.

On 04/26/17 at 11:00 a.m., interview with S1Administrator and S2DON confirmed that there was no evidence in the record that CPR had been initiated on the patient when found unresponsive. When S2DON was asked why CPR was not initiated, she had no response but stated that the patient was a full code and basic life support should have been started.

Based on record review and interview, the hospital failed to ensure that the discharge summary was written by the qualified practitioner responsible for the care of the patient for 2 of 2 discharge records reviewed (Patient #10, #14). Findings:

Review of the medical records for patients #10 and #14 revealed the discharge summaries were scribed by S8LPN/Case Manager and later signed by the responsible physician.

On 04/26/17 at 10:00 a.m., an interview with S8LPN/Case Manager confirmed she writes the discharge summary for all patients and the physician signs it later. She confirmed that the physician is not with her at the time she writes the summary and it is not dictated by the physician. She stated she gets the information from the record and team meetings.

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

1. Failing to have a pharmacist who was responsible for developing, supervising and coordinating all activities of the pharmacy services as evidenced by not having a contract with a pharmacist who was responsible for the overall administration of the pharmacy services. (See Findings A-0492)

2. Failing to ensure all medication orders (except in emergency situations) were reviewed by a pharmacist before the first dose was dispensed (review for therapeutic appropriateness, duplication of a medication regimen, appropriateness of the drug and route, appropriateness of the dose and frequency, possible medication interactions, patient allergies and sensitivities, variations in criteria for use, and other contraindications). (See Findings A-500)

Based on record review and interview, the hospital failed to have a pharmacist who was responsible for developing, supervising and coordinating all activities of the pharmacy services as evidenced by not having a contract with a pharmacist who was responsible for the overall administration of the pharmacy services.
Findings:

On 04/24/17 at 3:15 p.m., interview with S2DON revealed that the director of the hospital's pharmacy services was S3Pharmacist. S2DON revealed that S3Pharmacist also works for the pharmacy that fills all medications for the patients in the hospital.

On 04/25/17 at 9:00 a.m., S1Administrator stated that S3Pharmacist was the director of the hospital's pharmacy services. S1Administrator was asked for the contract between the hospital and S3Pharmacist and she provided a contract titled Dispensing Pharmacy Agreement.

Review of this contract revealed that it was an agreement between the hospital and Pharmacy A. The contract revealed in part that the two parties agreed to the following:
1) The pharmacist responsible for pharmacy services shall be responsible for the general supervision of the facility's pharmaceutical services
2) Fee and payment terms for providing medications to the patient's of the hospital
3) Duties which included dispensing needed medications, removing and destroying expired and discontinued medications, and conducting evaluations of the first dose of any medication
4) Distribution of medications, such as STAT medication orders.
The contract was signed by S1Administrator and the regional director of Pharmacy A.

The contract/agreement did not specifically name S3Pharmacist as the director of pharmacy services for the hospital.

On 04/25/17 at 11:45 a.m., a telephone interview was conducted with S3Pharmacist. When asked if he was the director of pharmacy services for the hospital, he stated no. He further revealed that he worked for Pharmacy A, who provided all medications for the patients at the hospital. When asked what services he provided to the hospital, he stated that he filled all prescriptions for the patients and is available at all times for the hospital staff, should they have questions about medications. S3Pharmacist stated that he did not ever visit the hospital to ensure compliance with overall administration of pharmacy services, but that S4Pharmacy Consultant did monthly pharmacy inspections. S3Pharmacist further stated that he is not informed of medication errors at the hospital and is not involved in the hospital's QA program. S3Pharmacist further stated that he was not aware that he was responsible for all pharmacy services at the hospital.

On 04/25/17 at 1:30 p.m., a telephone interview was conducted with S4Pharmacy Consultant. He revealed that he was not the director of pharmacy services for the hospital, but was just a consultant. When asked his duties, he revealed that he comes to the hospital monthly to perform a pharmacy inspection, which includes observations in the medication room, observations of the nurses administering medications and review of patient medication records. He stated that he submits a monthly report to the hospital of his findings. He further stated that he was not involved in the hospital's QA program or notified of medication errors.

On 04/26/17 at 10:45 a.m., interview with S1Administrator confirmed that the contract titled Dispensing Pharmacy Agreement did not specify that S3Pharmacist was the director of pharmacy services for the hospital. She further stated that she thought that S3Pharmacist was aware that he was the director of pharmacy services.

Based on record review and interview, the hospital failed to ensure all medication orders (except in emergency situations) were reviewed by a pharmacist before the first dose was dispensed (review for therapeutic appropriateness, duplication of a medication regimen, appropriateness of the drug and route, appropriateness of the dose and frequency, possible medication interactions, patient allergies and sensitivities, variations in criteria for use, and other contraindications).
Findings:

Review of the Louisiana Administrative Code, Title 46 Professional and Occupational Standards, Part LIII Pharmacist, Chapter 15 Hospital Pharmacy, Section: 1511: Prescription Drug Orders, Item A. The pharmacist shall review the practitioner's medical order prior to dispensing the initial dose of medication, except in cases of emergency.

Review of the hospital's Dispensing Pharmacy Agreement with Pharmacy A, revealed that a pharmacist would conduct an evaluation of the first dose of any medication and screen the patient's current diagnoses and medication regimen for pertinent information.

On 04/25/17 at 9:40 a.m., S5LPN revealed that the hospital did not have an on-site pharmacy. She indicated when an initial dose of a new medication (that was not an emergent medication) was ordered for a patient, the staff pulled the new medication from the hospital's "night cabinet", which contained the most commonly prescribed medications. She stated that the medication was then administered without prior review by the pharmacist. She stated that the information regarding the new medication order would be faxed to Pharmacy A and would be reviewed by the pharmacist at a later time, after the initial dose had already been administered to the patient.

Further interview with S5LPN at that time revealed that earlier that morning, she had administered the first dose of Cipro (antibiotic) that she had obtained from the "night cabinet" to Patient #2. When asked if she had contacted the pharmacist in order to have first dose review performed prior to administering the Cipro, she stated no.

On 04/25/17 at 11:20 a.m., interview with S6RN revealed that she was not aware of the regulation that stated first dose reviews were to be conducted by a pharmacist prior to patients receiving the initial dose of new medications.

On 04/25/17 at 11:45 a.m., interview with S3Pharmacist, who worked for the pharmacy that dispensed all of the hospital's medications, revealed that first dose reviews are conducted on all initial doses of medications. When asked if he was aware of the initial dose of Cipro that was administered to Patient #2 earlier that morning, he stated no. He further confirmed that a first dose review had not been conducted.

Based on observation, record review and interview, the hospital failed to ensure outdated, mislabeled, or otherwise unusable drugs were not available for patient use as evidenced by 1) having open vials of multi-dose medication available for use that was not dated and/or beyond manufacturers recommendations for use and 2) taping unused narcotics back into the medication blister packs.
Findings:

1) Having open vials of multi-dose medication available for use that was not dated and/or beyond manufacturers recommendations for use.

On 04/24/16 at 2:50 p.m., observation of the medication refrigerator in the medication room revealed all opened multi-dose vials of insulin were not labeled with the first puncture date. These included:
- Novolin 70/30 insulin with expiration date of 12/2016
- Novolin R insulin
- Novolin N insulin
- Novolog insulin
- Humalog insulin
- Humulin N insulin

Interview with S5LPN during the observation revealed that multi-dose vials of insulin should be dated with the first puncture date. She further confirmed the above vials were not labeled.

On 04/24/17 at 3:00 p.m., observation of the medication cart revealed it contained an opened multi-dose vial of Lidocaine Hcl 10mg/mL. The vial was not dated with the first puncture date.

Review of the hospital policy titled "Multiple Dose Vials", policy number MM-9, revealed that multiple use containers of sterile products may be used up to the manufacturer's date of expiration. Exception: Insulin-28 days. Multiple use sterile products not meeting these specifications shall be discarded immediately.

On 04/24/17 at 3:15 p.m., interview with S2DON revealed that S4Pharmacy Consultant comes to the hospital monthly to check for expired and unlabeled medications. She stated that he was just here a few days earlier, on 04/19/17. She confirmed that the above insulin vials were not labeled with the first puncture date.

On 04/25/17 at 1:30 p.m., interview with S4Pharmacy Consultant revealed that he comes to the hospital monthly to perform a pharmacy inspection. When asked if he had observed the unlabeled insulin vials, he stated that he just "spot checks" and did not identify the unlabeled insulin vials.

2) Taping unused narcotics back into the patients' medication blister packs.

On 04/24/17 at 2:50 p.m., observation of the narcotic lock box in the medication cart revealed Patient #4 had a medication blister pack card of Diazepam 2mg. Further observations of the back of the medication card revealed one of the pills had been punched out and halved and then taped back in. At that time, interview with S5LPN revealed that the order had probably changed and the nurse taped the other half of the tablet back in the card.

Further observations of the narcotic lock box at that time revealed that Patient #R1 had a medication blister pack of Diazepam 2mg. Observations of the back of the card revealed that one of the pills had been punched out, halved and then taped back in the card.

On 04/24/17 at 3:15 p.m., interview with S2DON confirmed that narcotics should not be taped back into the medication blister packs, stating that they should be destroyed.

On 04/25/17 at 1:30 p.m., interview with S4Pharmacy Consultant revealed that he comes to the hospital monthly to perform a pharmacy inspection. He stated that his last visit was on 04/19/17. When asked if he had identified the narcotics taped back in the medication cards, he stated no.

Based on record review and interview, the hospital failed to ensure that drug administration errors were documented in the patient's medical record for 3 of 3 patients reviewed for medication errors (Patients #11, 12, 13).
Findings:

Review of the hospital policy titled," Medication Variance and Remediation", Policy Number MM-1, revealed in part: When a medication variance occurs, the person who made the variance or the person who discovered the variance will document the occurrence in the chart.

Review of the hospital's medication variance report provided by S2DON revealed medication errors involving Patient #11 (03/13/17), Patient #12 (05/13/16) and Patient #13 (12/23/16). Further review of the patients' records revealed no documented evidence of an account of the medication error referenced in the variance reports.

On 04/25/17 at 2:00 p.m., S2DON reviewed the records of the above patients and confirmed that there was no mention of the medication errors in their medical records. S2DON further stated that they do not routinely document errors in the patients' medical records.

Based on record review and interview, the hospital failed to appoint a qualified radiologist to supervise radiology services.
Findings:

Review of the hospital's current contract for radiology services revealed no evidence that a radiologist was named as supervisor of the radiology services.

On 04/25/17 at 10:30 a.m., an interview was conducted with S1Administrator. Upon request for evidence of the governing body appointment of a supervisor of radiology services and his/her credentialing files, S1Administrator confirmed that there was no appointed or supervisor of radiology services.

Based upon observations, record review, and interviews, the hospital failed to ensure therapeutic diets were provided to meet the needs of the patients. This was evidenced by the failure to provide patient #1, who was a diabetic, appropriate dietary substitutions for a No Concentrated Sweets (NCS) diet. Findings:

Observations on 04/24/17 at 12:10 p.m. revealed patient #1 was served a piece of meat and two servings of black-eyed peas for lunch. On 04/25/17, at 11:50 a.m. the patient was served a piece of meat and to servings of mixed vegetables. Review of the Daily Diet Sheet revealed the patient's diet was listed as NAS (No Added Sweets), NCS (No Concentrated Sweets), no dairy, no sweets, no bread, no rice, no potatoes.

On 4/25/17 the menus were requested; however, only regular diets were identified. Interview with S7LPN/Dietary Manager on 4/25/17 at 10:30 a.m. revealed when asked about dietary substitutions, her response was the contracted dietary service determined what dietary substitutions were provided to the patients. There failed to be documented evidence the patients diets were monitored to ensure appropriate substitutions were provided.

Based on observation and interview, the hospital failed to maintain a system for controlling infections as evidenced by failing to maintain a sanitary hospital environment.
Findings:

On 04/24/17 at 9:30 a.m., observations revealed the following:

Room e - ants on the panel of the wall above the nightstand.
Room f - mold in the shower floor and sides of wall in room; tears in the coverings on the arms of the wheelchair, exposing the inside porous surfaces; thick buildup of dirt, grime, hair and dark substance along the base moldings around the entire perimeter of the room.
Room g - trash can in bathroom full of soiled disposable underwear; baseboards caked with grime and dirt.
Room h - bathroom baseboards coated with thick brown substance and hair.
Room i - tears and cracks in the covering on the left side arm of the wheelchair, exposing the inside material.
Room j - side of the clothes hamper coated with thick buildup of black substance and grime; baseboards coated with thick buildup of grime and dirt.
Room k - storage room with 2 of 3 wheelchairs having cracks in the covering on the arms; one gerichair with cracks in the covering on the right arm; dead bugs in the windowsills.
Room l - black substance in the floor of the shower and shower chair.
Room m - gerichair in room with drips, spills, brown substance on sides, old food and spills on legs, fabric on both arms torn.
Room n - spider web with spider in window sill; black substance on the bottom of the shower curtain.
Room d - black substance in corners and back of shower; black substance and hairs on the bottom of toilet.
Room o - strong urine odor, thick build-up of dirt and grime on baseboards and in corners of room.
Room a - brown substance in shower chair; wheelchair with left arm missing, right arm covering cracked.

On 04/26/17 at 8:45 a.m., observation of 4 of 4 wheelchairs of patients in the group therapy room revealed torn areas in the arm coverings. Two wheelchairs sitting in the hallway outside the room had tears in the arm coverings. At 10:15 a.m., 5 of 7 wheelchairs of patients in the group therapy room had tears in the arm coverings.

On 04/26/17 at 9:00 a.m., observation of the Soiled Storage Room revealed storage of a bin of dirty laundry, a container of trash and a container of biohazard waste. There were 2 metal shelving units inside the room which contained various cleaning material such as floor cleaners, alcohol wipes, cleaning supplies for patient rooms, insect spray, dusting cloths, mop heads and other assorted maintenance items including tools, tool bags, light bulbs, caulking and exam gloves. An interview with S7Infection Control Nurse at that time confirmed she was aware of the infection control concerns with the storage of these items in the soiled storage area.

On 04/26/17 at 9:30 a.m., observation of the above findings and interview with S1Administrator and S2DON confirmed the need for cleaning of the patient rooms and need for repair or replacement of the torn wheelchair arm coverings.