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Tag No.: A0431
Based on interview, record review and observation, the hospital failed to meet the requirements of the Condition of Participation for Medical Records as evidenced by:
1. Failing to ensure the organization of the medical record service was appropriate to the scope and complexity of the services provided as evidenced by failing to ensure the medical records department was under the supervision of a qualified individual to ensure for the prompt completion, filing, and retrieval of medical records. (See Findings A0432)
2. Failing to ensure medical records were accurately written and/or promptly completed. This deficient practice is evidenced by a) failing to ensure accurate times were documented relative to the administration of medications for 18 (#1- #18) of 18 records reviewed for accurate timing of entries and b) failing to ensure medical records were completed within 30 days of a patients discharge for 3 (#3, #5, #6) of 4 discharge records reviewed out of a total sample of 22 patients. (See Findings A0438)
3. Failing to ensure all patients' medical records were protected from water and fire damage as evidenced by patients' medical records being stored on open shelving. (See Findings A441)
Tag No.: A0085
Based on record review and interview, the hospital failed to maintain a complete and accurate list of all contracted services.
Findings:
A review was made with S4Chief Nursing Officer of a list of contracted services dated 2/2012 that was presented by the hospital as a current list. S4Chief Nursing Officer said the hospital's generator contract was not included on the list, the pharmacy contract listed was a previous pharmacy no longer valid, the blood bank sources was not all inclusive, and a laboratory listed was no longer in use.
In an interview on 5/24/16 at 10:00 a.m. with S4Chief Nursing Officer, she verified the hospital's current contracted services list was not accurate or complete.
Tag No.: A0144
Based on interview and observations, the hospital failed to provide care in a safe setting. This deficient practice is evidenced by failing to provide a functioning emergency call system or a reliable alternate method for a patient to promptly request staff assistance.
Findings:
In an interview on 5/25/16 at 8:15 a.m. with S5DON, she said the call system had not been functional for two to three weeks due to a lightning strike. S5DON said the light above the patient's door would still light up if the call button was pushed, but the audible alarm at the nurse's station did not work. S5DON said a staff member was assigned to sit in the hallway looking for call lights above the room doors at all times.
In an observation on 5/24/16 at 3:00 p.m., there was no staff member present in the patient's hallway observing for activated call lights.
Observations on 5/25/16 at 7:50 a.m., 8:00 a.m. and 8:10 a.m. revealed no staff member was in the patient's hallway observing for activated call lights.
In an observation on 5/25/16 at 8:10 a.m., a surveyor pushed the call bell in room 114. The light above the door was lit but there was no audible signal in the nurse's station. No staff member was observing for lights in the hallway and the light above the door was not noticed for greater than 3 minutes.
In an observation on 5/25/16 at 9:00 a.m., S11Ward Clerk was responsible for watching the call lights above the patient's doors. She was observed focusing on her smartphone for greater than 5 minutes.
Tag No.: A0273
Based upon record review and interview, the hospital failed to ensure the Quality Assurance (QA) Program consistently tracked quality indicators related to processes of care, hospital services and operations. This was evidenced by the failure to review contracted services, medication errors, and adverse patient events for the year 2016.
Findings:
Review of the Governing Board Meeting Minutes and Medical Staff Meeting Minutes for 2015 revealed quality indicators for therapy, nursing, infection control, housekeeping, dietary, respiratory, pharmacy, medical records, social services and outpatient services were evaluated with the resulting data reviewed during the meetings. Continued review of the Governing Board Meeting Minutes dated 1/24/16 and 5/12/16 revealed Sub-Committee Reports, Pharmacy and Performance Improvement reports were reviewed. When the reports were requested from S4Chief Nursing Officer on 05/24/16 at 9:00 a.m., she replied that she had not typed the reports and only raw data for 2016 was available for review.
Review of the raw data revealed for year 2016 new indicators were developed for 1) Therapy equipment to be cleaned after each patient, 2) Inside of van to be cleaned daily and disinfected, 3) Occupational Therapy evaluation initiated/completed within 48 hours of admission, 4) Psychotropic drug consents, 5) Respiratory Therapy evaluation prior to discharge, 6) Nursing review of emergency equipment, 7) Facility acquired pressure sores, 8) Nosocomial and Community acquired rates, and 9) Review of dietary food temperatures. There failed to be documented evidence that indicators were developed for medication errors, adverse patient events, and contracted services.
Tag No.: A0286
Based upon record review and interview, the hospital failed to develop Performance Improvement activities related to tracking adverse patient events.
Findings:
Review of the Governing Board Meeting Minutes and Medical Staff Meeting Minutes for 2015 revealed quality indicators for therapy, nursing, infection control, housekeeping, dietary, respiratory, pharmacy, medical records, social services and outpatient services were evaluated with the resulting data reviewed during the meetings. Continued review of the Governing Board Meeting Minutes dated 1/24/16 and 5/12/16 revealed for Sub-Committee Reports, Pharmacy and Performance Improvement reports were reviewed. When the reports were requested from S4Chief Nursing Officer on 05/24/16 at 9:00 a.m. she replied she had not typed the reports and only raw data for 2016 was available for review.
Review of the raw data revealed for year 2016 new indicators were developed for 1) Therapy equipment to be cleaned after each patient, 2) Inside of van to be cleaned daily and disinfected, 3) Occupational Therapy evaluation initiated/completed within 48 hours of admission, 4) Psychotropic drug consents, 5) Respiratory Therapy evaluation prior to discharge, 6) Nursing review of emergency equipment, 7) Facility acquired pressure sores, 8) Nosocomial and Community acquired rates, and 9) Review of dietary food temperatures. There failed to be evidence that indicators were developed for medication errors, adverse patient events, and contracted services.
Tag No.: A0395
Based on record review and interview, the hospital failed to ensure a registered nurse supervised and evaluated the nursing care for each patient. This deficient practice is evidenced by failing to document assessments or interventions between when a patient was discovered to have an acute injury and when they were transferred to a local hospital for 4 (Patient #3, #15, #16, #17) of 4 patients reviewed for transfers.
Findings:
Patient #3
Review of the medical record for Patient #3 revealed she had been admitted to the hospital on 4/11/16 with a decline in mobility and activities of daily living.
Review of the nurse's notes for Patient #3 revealed after she had been found unresponsive at on 4/14/16 at 5:00 a.m. the nurse obtained Patient #3's blood glucose and vital signs. The ambulance arrived at 5:30 p.m. to transfer Patient #3 to a local hospital. There were no documented assessments or interventions after the initial note at 5:00 a.m.
Patient #15
Review of the medical record for Patient #15 revealed she had been admitted to the hospital on 05/13/16 with diagnoses including stroke and left hemiparesis.
Review of the nurse's notes for Patient #15 dated 05/14/16 at 11:15 a.m. revealed patient was sitting up in therapy with head down, very hard to arouse. The note revealed that the patient was transferred back to her room with eyes opened but confused. Vital signs were 86/52 and pulse was 50 and thready.
The next nurses note was at 11:30 a.m. and stated that the physician was notified and stated to send patient out by ambulance. Ambulance was notified at this time. There was no documented assessment of the patient at this time.
The next nurses note was at 11:45 a.m., stating that the patient left per ambulance. Vital signs at that time were 82/50, pulse 72, unable to obtain oxygen saturation.
There were no documented assessements or interventions after the inital note on 05/14/16 at 11:15 a.m. until the patient left by ambulance at 11:45 a.m. (30 minutes).
Patient #16
Review of the medical record for Patient #16 revealed he had been admitted to the hospital on 5/10/16 for decreased endurance, strength, mobility and ability performing activities of daily living.
Review of the nurse's notes for Patient #16 dated 5/12/16 revealed the following entry:
CNA reported to CRRN that patient's pulse was 129. At 6:30 a.m. an EKG was done and sinus tachycardia was noted. Dr was called at 6:35 and he said send him to the ER.
Further review revealed there were no documented assessments or interventions until the patient was transported to the hospital at 7:15 a.m. (45 minutes later).
Patient #17
Review of the medical record for Patient #17 revealed she had been admitted on 4/19/16 for rehabilitation after a cerebrovascular accident.
Review of the medical record for Patient #17 revealed the following nurse's note dated 4/29/16 at 11:15 p.m.:
Patient yelling out for help. Patient found sitting up on bed spread on floor. Patient saying she was trying to get out of bed to go to the restroom, saying she was going to call after coming from the restroom. Pt assisted up with staff of four. V/S taken B/P 181/86, P77, R24. MD called. New Order for x-ray of hip.
Further review revealed the patient was transferred at 11:45 p.m. (30 minutes later). There was no documentation of an assessment of the patient's hip or pain level and no reassessment of vital signs after 11:15 p.m. There were also no documented interventions after 11:15 p.m.
In an interview on 5/25/16 at 11:00 a.m. with S4Chief Nursing Officer, she verified there should have been documentation of assessments and interventions between when a patient was found to have an acute injury and when they were transferred to a hospital. She also verified the above mentioned patients did not have sufficient documentation of assessments or nursing interventions after they were found to have an acute injury.
Tag No.: A0397
Based on record review and interview, the hospital failed to ensure the skill and competence of all individuals providing direct patient care had been evaluated as evidenced by failing to maintain documented evidence of skills competency evaluations for 3 (S12RN, S13LPN, S14RN) of 3 direct patient care nurses' personnel records reviewed for competency.
Findings:
Review of the personnel files for S12RN, S13LPN and S14RN revealed no documented evidence that an observation of competency in performance of job duties, including management of oxygen tanks, nasal cannulas, venti-masks, non-re-breather masks, hand held nebulizers, inhalers, use of the blood glucose monitoring device, administration of injections, maintenance of PICC lines and trachs had been conducted.
In an interview on 05/25/16 at 11:40 p.m. with S5DON, she revealed that she performs random skills competency checks on random staff. She was unable to provide a list of the competency skills checks that she performs or the random staff she had observed. Further interview at that time with S5DON and S4Chief Nursing Officer confirmed that there was no system in place to ensure that all direct care staff received skills competency check offs by a qualified person. They further confirmed that the direct care staff perform duties such as oxygen administration, breathing treatments, blood glucose monitoring, injections, maintenace of PICC lines and care of patients with a tracheostomy.
Tag No.: A0405
Based on record review and interview, the hospital failed to ensure drugs and biologicals were administered as ordered by the practitioner responsible for the patient's care. This deficient practice is evidenced by failing to ensure a physician's order was complete before transcribing the order onto the MAR and administering the medication for 2 (#7, #8) of 8 (#1-#8) patients reviewed for medication administration.
Findings:
Review of the hospital policy titled Medication Administration revealed in part,
B. A physician's order must include dosage, route, frequency, duration and other required considerations before administration of the medication.
Patient #7
Review of the admission orders for Patient #7 dated 5/12/16 at 12:45 p.m. revealed the following orders:
Nicotine Polacrilex 2mg oral gum- chew 1 gum PRN (no indication ordered).
Boudreaux's Butt paste -apply topically PRN (no indication ordered).
Review of the physician's order for Patient #7 dated 5/16/16 at 2:45 a.m. revealed the following:
Duoneb INH.
Further review revealed there was no route or frequency ordered. Review of the MAR revealed it had been transcribed by S16LPN as Duoneb HHN tx q 6 hours. Further review revealed no clarification of the incomplete order had been obtained by the physician before the medication was transcribed onto the MAR with a frequency.
Patient #8
Review of a physician's order for Patient #8 dated 5/17/16 at 2:05 p.m. revealed an order for Midodrine 5mg Q a.m. and 2 p.m. daily (No route ordered).
In an interview on 5/24/16 at 1:20 p.m. with S4Chief Nursing Officer, she said S16LPN should not have placed medication frequencies onto the MAR if it was not ordered by the physician. She also said incomplete orders should have been clarified by the physician before the order was placed on the MAR.
Tag No.: A0432
Based on record review and interview, the hospital failed to ensure the organization of the medical record service was appropriate to the scope and complexity of the services provided as evidenced by failing to ensure the medical records department was under the supervision of a qualified individual to ensure for the prompt completion, filing, and retrieval of medical records.
Findings:
Interview on 05/23/16 at 1:30 p.m. with S1Administrator revealed that the hospital had a contract with an RHIT (Registered Health Information Technician). S1Administrator further stated that the hospital had an electronic file system since 2014.
Interview on 05/24/16 at 2:00 p.m. by telephone with S2RHIT revealed that she (S2RHIT) was only contracted as a consultant and was not over the hospital's medical records department. S2RHIT reported that she is only onsite every 3 months on a consultant basis.
Review of the RHIT contract dated 02/15/13 revealed S2RHIT was contracted as a consultant.
This surveyor requested from S1Administrator information relative to the number of delinquent medical records 4 times during the survey from 05/23/16 to 05/25/16. The hospital was unable to provide this documentation.
Review of medical records from 05/23/16 to 05/25/16 revealed 3 (#3, #5, and #6) of 4 discharge records reviewed were in-complete in that the discharge summaries were not co-authenticated by the physician.
Interview on 05/24/16 at 3:00 p.m. with S1Administrator revealed that she was unaware that the admitting physician had to sign the document if the PA had already signed.
Review of the hospital policy titled "Delivery of Services: Medical Records", Number 02-01-01, revised May 2015 revealed in part: Completion of Records - Medical records will be completed by 30 days post-discharge. If not, a deficiency notice will be sent to the physician/person whose documentation is delinquent. If not corrected, that person may lose privileges ...every effort is made to complete the medical record. If medical records remain incomplete, a deficiency notice will be sent certified mail to notify the physician or discipline in question of the issue and impending consequences.
Interview on 05/23/16 at 3:30 p.m. with S1Administrator revealed the surveyor received copies of QAPI (Quality Assurance Performance Improvements) reports dated January 2016, February 2016, and March 2016 which documented 100% compliance with completed medical records. S1Administrator also confirmed that there had been no letters sent out to physicians that she was aware of for the past 3 months.
Record review for 3 (#3, #5, and #6) of 4 patients reviewed for completed documentation of the medical record revealed discharge summaries were not authenticated by the physician.
Interview on 05/24/16 at 10:30 a.m. with S1Administrator revealed she was unable to provide surveyor with a documented number of delinquent records during the survey. At 11:00 a.m. on 05/24/16, S1Administrator gave surveyor a document that listed 53 patient records that were missing physician signatures from 01/13/16 to present for physicians orders and/or discharge summary's in the chart. Surveyor asked how the hospital was reporting 100% completion in QAPI for January, February, and March 2016 after viewing a document indicating there were 53 patient records with missing signatures. S1Adminstrator was not able to answer. S1Administrator reported that there had not been any letters sent to physicians regarding completion of any medical records.
Tag No.: A0438
Based on record review and interview, the hospital failed to ensure medical records were accurately written and/or promptly completed. This deficient practice is evidenced by
1) failing to ensure accurate times were documented relative to the administration of medications for 18 (#1- #18) of 18 records reviewed for accurate timing of entries and
2) failing to ensure medical records were completed within 30 days of a patients discharge for 3 (#3, #5, #6) of 4 discharge records reviewed out of a total sample of 22 patients.
Findings:
1. Failing to ensure accurate times were documented relative to the administration of medications for 18 (#1- #18) of 18 records reviewed for accurate timing of entries.
Review of the medication Administration Record for Patient #3 revealed a medication listed as Humalog 100 units/milliliter per accu check before meals and at hour of sleep per sliding scale. Further review revealed a blood glucose of 228 had been obtained and insulin had been given but there was no time of administration recorded. The time of administration of the insulin was in a range listed between 5:00 a.m. and 7:00 a.m.
In an interview on 5/24/16 at 9:11 a.m. with S4Chief Nursing Officer, she verified there was no documentation of the exact time a medication was administered on the MAR. She said the MAR listed a 2 hour window for medication administration and initials would populate within the window after the medications were administered. She verified accurate times of administration were not listed for medications that may have been time dependent such as insulin or medications requiring levels for dosing. S4Chief Nursing Officer said, "The system is flawed."
In an interview on 5/24/16 at 4:00 p.m. with S15LPN, she said the electronic MAR did not actually document the time a medication was administered. She said there was a two hour window on the MAR for a medication to be administered and even if the medication was administered four hours late, the nurse's initials would show up on the documentation as the medication having been administered between the 2 hour window. S15LPN said for instance, if a medication had a two hour window of 8:00 a.m. until 10:00 a.m. and that medication was administered at 4:00 p.m., once the nurse clicked the computer to document the medication had been given it would place the nurse's initials in the slot between 8:00 a.m. and 10:00 a.m. S15LPN said the next nurse giving a medication would not be able to look at the MAR and realize the medication had been administered late.
2. Failing to ensure medical records were completed within 30 days of a patients discharge.
Review of the hospital's Bylaws of the Medical Staff 00-06-01, Article VI: Corrective Action, Section 5: Automatic Suspension, revised May 2015 revealed in part: Automatic suspension shall be triggered if one of the following happens: d.) Failure to complete a patient's medical chart, including history & physical and/or discharge summary within 30 days of discharge.
A review of the hospital policy titled, "Delivery of Services: Medical Records", 02-01-01, revised May 2015 revealed in part: Completion of Medical Records, All medical records must be completed within 30 days of discharge.
Patient #3: Review of Patient #3's medical record on 05/24/16 revealed an admission date of 04/11/16 and a discharge date of 04/14/16. The discharge summary dated 04/15/16 was electronically signed by the S10PA (Physician's Assistant) and not the physician.
Patient #5:Review of Patient #5's medical record on 05/24/16 revealed an admission date of 03/01/16 and a discharge date of 03/14/16. The discharge summary dated 03/17/16 was electronically signed by the S10PA (Physician's Assistant) and not the physician. Patient #6:Review of Patient #6's medical record on 05/24/16 revealed an admission date of 12/07/15 and a discharge date of 12/09/15. The discharge summary dated 12/14/15 was electronically signed by the S10PA (Physician's Assistant) and not the physician.Interview on 05/24/16 at 3:00 p.m. with S1Administrator revealed that she was unaware that the admitting physician had to sign the discharge summary if the document was already signed by the PA.
30364
Tag No.: A0441
Based on observation and interview, the hospital failed to ensure all patients' medical records were protected from water and fire damage as evidenced by patients' medical records being stored on open shelving.
Findings:
Interview on 05/23/16 at 1:30 p.m. with S1Administrator revealed that the hospital had no medical records onsite and that the hospital had been on an electronic file system since 2014.
Observation on 05/25/16 at 9:50 a.m. revealed a locked room that contained 4 open metal units with 7 shelves each, 2 open metal units with 6 shelves each, and 1 open metal unit with 3 shelves containing folders of patient records dating from 2004 to 2009. All paper folders containing patient records were exposed to the sprinkler system suspended from the ceiling.
Interview on 05/25/16 at 9:50 a.m. with S1Administrator stated that she was unaware of the records onsite. Interview with S4CNO (Chief Nursing Officer) at that time stated that these were patient consent forms that were waiting to be scanned into the electronic system and confirmed that the records were not protected from fire or water damage.
Tag No.: A0468
Based on record review and interview, the hospital failed to ensure all patient records included documentation of the discharge summaries authenticated by the physician for 3 (Patient #3, #5, #6) of 4 patient records reviewed for discharge summaries out of a total sample of 22 patients.
Findings:
Review of the hospital's Bylaws of the Medical Staff 00-06-01, Article VI: Corrective Action, Section 5: Automatic Suspension, revised May 2015 revealed in part: Automatic suspension shall be triggered if one of the following happens: d.) Failure to complete a patient's medical chart, including history & physical and/or discharge summary within 30 days of discharge.
A review of the hospital policy titled, "Delivery of Services: Medical Records", 02-01-01, revised May 2015 revealed in part: Completion of Medical Records, All medical records must be completed within 30 days of discharge.
Patient #3:Review of Patient #3's medical record on 05/24/16 revealed an admission date of 04/11/16 and a discharge date of 04/14/16. The discharge summary dated 04/15/16 was electronically signed by the S10PA (Physician's Assistant) and not the physician.
Patient #5:Review of Patient #5's medical record on 05/24/16 revealed an admission date of 03/01/16 and a discharge date of 03/14/16. The discharge summary dated 03/17/16 was electronically signed by the S10PA (Physician's Assistant) and not the physician. Patient #6:Review of Patient #6's medical record on 05/24/16 revealed an admission date of 12/07/15 and a discharge date of 12/09/15. The discharge summary dated 12/14/15 was electronically signed by the S10PA (Physician's Assistant) and not the physician.Interview on 05/24/16 at 3:00 p.m. with S1Administrator revealed that she was unaware that the admitting physician had to sign the discharge summary if the document was already signed by the PA.
Tag No.: A0490
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 consulting 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)
3. Failing to ensure outdated, mislabeled, or otherwise unusable drugs were not available for patient use as evidenced by (a) having open vials of multi-dose medication available for use that was not dated and/or beyond manufacturers recommendations for use and by having discharged patients' medications available for use, (b) marking through the label of discharged patients medications and placing them in the night stock box for use on all patients and (c) taping unused narcotics back into the medication blister packs. (See Findings A-505)
4. Failing to ensure errors in medication administration were documented in the medical record (See Findings A-508)
Tag No.: A0492
Based on record review and interview, the hospital failed to have a consulting 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 05/23/16 at 2:50 p.m., when S5DON was asked the name of the director of the hospital's pharmacy services, she stated that it was either S6Pharmacist or S7Pharmacist. S5DON revealed that S6Pharmacist works for the pharmacy that fills all medications for the patients in the hospital and she is always available to answer any questions the hospital staff may have. She stated that S7Pharmacist comes to the hospital quarterly to destroy medications.
On 05/23/16 at 4:00 p.m., when S3Coorporate Compliance Officer was asked the name of the director of the hospital's pharmacy services, she stated that she thought it was S7Pharmacist. At that time, she looked through the hospital's contract book and was unable to locate a contract between the hospital and S7Pharmacist.
On 05/24/16 at 7:50 a.m., interview with S5DON revealed that she was unable to provide evidence of a written contract between the hospital and a pharmacist who was responsible for pharmacy services in the hospital.
On 05/24/16 at 9:30 a.m., S1Administrator presented a contract to the survey team. She stated that the contract was between the hospital and Pharmacy A, who provides all patient medications at the hospital. S1Administrator further stated that the contract did not specifically name S6Pharmacist as the director of pharmacy services for the hospital, but she was the pharmacist responsible.
The contract revealed it was an agreement between the hospital and the local pharmacy, Pharmacy A. The contract revealed in part that the two parties agreed to the following:
1) a licensed pharmacist shall be designated by Pharmacy A as primary pharmacist to service the hospital inpatients in accordance with pharmacy standards and practices.
2) Pharmacy A shall dispense medications in a timely and routine manner from the time of the physician orders.
3) Process for obtaining medications......
4) Medications are labeled and dispensed in accordance with pharmacy standards and in accordance with the physicians order.
The contract was signed by S1Administrator and the owner of Pharmacy A and dated 01/15/16.
The contract did not designate a specific pharmacist who was responsible for the overall administration of the pharmacy services of the hospital. The contract did not have clearly defined job responsibilities of the pharmacist which included supervision and coordination of all activities of pharmacy services.
On 05/24/16 at 10:05 a.m., telephone interview with S6Pharmacist revealed that she worked for Pharmacy A, who provided all medications for the patients at the hospital. When asked what services she provided to the hospital, she stated that she fills all prescriptions for the patients and is available at all times for the hospital staff, should they have questions about medications. S6Pharmacist stated that she did not ever visit the hospital to ensure compliance with overall administration of pharmacy services. She further stated that she is not informed of medication errors at the hospital, does not perform first dose medication reviews and is not involved in QA or pharmacy committee meetings. S6Pharmacist further stated that she was not aware that she was responsible for all pharmacy services at the hospital.
On 05/24/16 at 1:40 p.m., interview with S1Administrator revealed that she was unsure of all the responsibilities that were required of the director of pharmacy services at the hospital. She further stated that she thought that between S6Pharmacist and S7Pharmacist, they were doing what was required.
Tag No.: A0500
Based on Louisiana Administrative Code, contract review and interview, the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with applicable standards of practice, consistent with state law. This deficient practice was evidenced by failing to ensure all medication orders (except in emergency situations) were reviewed by a pharmacist, before the first dose was dispensed, 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, Professional and Occupational Standards,
Title 46: LIII, Pharmacist, Chapter 15, Hospital Pharmacy, §1511. Revealed in part:
Prescription Drug Orders
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 contract with Contracted Pharmacy A revealed no provisions for
the pharmacist to review medications before the first dose was dispensed and
administered. Review of the hospital's policies and procedures regarding medications
revealed no provisions for a first review of the patient's medications by the pharmacist after
pharmacy hours.
On 05/23/16 at 2:45 p.m., observation of the night stock box with S9LPN revealed a large
plastic bin containing multiple medications. S9LPN reported that if medications are ordered
after pharmacy hours, the staff administers the medication to the patients from the night stock
box, if available. S9LPN confirmed that the pharmacist does not review the patients'
medication prior to the staff administering the medication to the patient.
On 05/23/16 at 3:00 p.m., interview with S5DON revealed that the hospital did not have a policy and procedure developed regarding first dose review of medications by the pharmacist. She further confirmed that the pharmacist was not performing first dose reviews after normal pharmacy hours and was unsure how this would occur.
In an interview on 05/24/16 at 10:05 a.m., S6Pharmacist stated that she worked for the local pharmacy that provided all medications to the patients in the hospital. She further stated that the pharmacy was only open during normal business hours and confirmed that there was no process in place for the pharmacist to conduct a first dose review of medications after pharmacy working hours.
Tag No.: A0505
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 by having discharged patients' medications available for use, 2) marking through the label of discharged patients medications and placing them in the night stock box for use on all patients and 3) 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 and by having discharged patients' medications available for use.
On 05/23/16 at 2:15 p.m., observation of the medication refrigerator in the medication room revealed the following multi-dose vials of insulin:
- Novolin N insulin with handwritten date of 04/13/16 with Patient #3's label on it
- Lantus insulin with handwritten date of 03/24/16 with Patient #R5's label on it
- Lantus insulin with handwritten date of 04/23/16 with Patient #R6's label on it
- Levemir insulin with handwritten date of 02/26/16 with Patient #R7's label on it
- Lantus insulin with handwritten date of 04/11/16 with Patient #R8's label on it
- Lantus insulin with handwritten date of 03/24/16 with Patient #R9's label on it
Interview with S9LPN during the observation revealed that multi-dose vials of insulin should be discarded 7-14 days after the first puncture. Further interview revealed that the above patients were no longer patients in the hospital, but their insulin was available for use.
On 05/23/16 at 2:30 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 "Pharmacy Medication Procurement", policy number 03-03-02, revealed that all medications will be destroyed within 30 days of opening.
On 05/23/16 at 3:30 p.m., interview with S5DON revealed that the hospital had no policy and procedure related to the use of multi-dose vials of medication but stated that insulin should be not be used more than 28 days after the first puncture date, per manufacturers recommendations. She also confirmed that the above insulin in the medication refrigerator were prescribed for discharged patients and should not have been available for use.
2) Marking through the label of discharged patients medications and placing them in the night stock box for use on all patients.
On 05/23/16 at 2:45 p.m., observation of the night stock box with S9LPN revealed a large plastic bin with multiple medications in it, including blister pack cards and pill bottles. Further observations revealed the label on four of the blister packs had a patient's name marked through with a black marker. The blister packs contained Zofran, Geodon, Bactrim and Cipro.
On 05/23/16 at 3:20 p.m., interview with S5DON revealed that she was the one who marked through the names of discharged patients with a black marker on their blister pack medication cards. She stated that she needed those medications in the night stock box and did not want to waste them. She further revealed that she realized that should not have been done. Further interview with S5DON revealed that the pharmacist had not approved a list of medications to be placed in the stock box and was not aware of what medications were actually in the box.
On 05/24/16 at 2:40 p.m., interview with S4Chief Nursing Officer revealed that the names on discharged patients medication blister packs should not be marked through with a black marker and placed in the night stock box. She further stated they should be sent home with the patient or be destroyed.
3) Taping unused narcotics back into the patients' medication blister packs.
On 05/23/16 at 2:50 p.m., observation of the narcotic lock box in the medication room revealed Patient #13 had a medication blister pack card of Diazepam 5mg. Further observations of the back of the medication card revealed one of the pills had been punched out and then taped back in. At that time, interview with S9LPN revealed that the patient had probably refused the medication and the nurse taped it back in the card.
On 05/24/16 at 3:10 p.m., observation revealed that all discontinued narcotics were stored in a locked cabinet in S5DON's office until destroyed. Observation of the medications in this cabinet revealed Patient #R10 had a medication blister pack labeled Lorezapam 0.5mg. Observation of the back of the medication card revealed one of the pills had been punched out and then taped back in. At that time, interview with S5DON confirmed that narcotics should not be taped back into the medication blister packs, stating that they should be destroyed. The policy for medication destruction was requested at this time from S1Administrator and S5DON. They confirmed that they were unable to locate a policy and procedure for narcotic medication destruction.
Tag No.: A0508
Based on record review and interview, the hospital failed to ensure errors in medication administration were documented in the medical record for 4 of 4 patients (Patient #R1, R2, R3, R4) reviewed for known medication errors out of a sample of 22 patients.
Findings:
Review of the hospital's policy titled "Pharmacy: Medication Errors, Adverse Reactions & Drug Incompatibility", Policy number 03-03-05, revealed when a medication error occurs the physician was to be notified. There were no provisions to record the error in the medical record.
On 05/24/16 at 12:00 p.m., documentation of all medication errors from the past year were requested from S5DON. At that time, she provided medication variance reports for Patient #R1 (med error dated 02/14/16), Patient #R2 (med error dated 02/15/16), Patient #R3 (med error dated 02/27/16) and Patient #R4 (med error dated 02/28/16). She stated that the hospital had no other medication errors for the past year.
On 05/24/16 at 12:45 p.m., S8RN reviewed the records of Patients #R1, R2, R3 and R4 with the surveyor. There was no documented evidence that an entry was made in the records regarding the medication errors. At that time, interview with S8RN revealed that she did not think staff was supposed to document medication errors in the patients' records.
On 05/24/16 at 2:10 p.m., interview with S5DON confirmed that medication errors are not documented in the patient records. She further stated that she was not aware of the regulation that required documentation of medication errors in the patient records.