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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES, was out of compliance.

A-0395 A registered nurse must supervise and evaluate the nursing care for each patient. Based on interviews and document review, the facility failed to ensure STAT (immediate) labs used for diagnostic results critical to the care of the patient were completed and reviewed in 3 of 5 medical records reviewed in which the physician placed an order for STAT laboratory tests (Patient #2, 5 and 6). In addition, nursing staff failed to monitor, evaluate and report findings of low oxygen saturations for patients whose supplemental oxygen was titrated in 3 of 4 medical records reviewed for patients who required supplemental oxygen (Patient #2, #4 and #7).

A-0405 Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care as specified under §482.12(c), and accepted standards of practice. Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. Based on document review and interviews, the facility failed to ensure medications, specifically pain medications and medications designated as time-sensitive, were administered according to the provider's orders and facility policy in four of four medication administration records reviewed (Patients #1, #2, #3, and #4). In addition, the facility failed to ensure staff performed pain reassessments according to facility policy after administering scheduled pain medications in two of seven inpatient medical records reviewed (Patients #2, #3).

Based on interviews and document review, the facility failed to ensure STAT (immediate) labs were completed and reviewed in 3 of 5 medical records reviewed in which the physician placed an order for STAT laboratory tests (Patient #2, 5 and 6). In addition, nursing staff failed to monitor, evaluate and report findings of low oxygen saturations for patients whose supplemental oxygen was titrated in 3 of 4 medical records reviewed for patients who required supplemental oxygen (Patient #2, #4 and #7).

Findings include:

Facility policies:

The Critical Test Results policy read, the need for timely communication of test results and diagnostic procedures to the responsible care giver to direct treatments and care of the patient. It is the responsibility of the CNO to guarantee compliance with the policy. The nurse must immediately report these results to the physician, the date and time will be documented in the medical record. The physician will confirm the noted value back to the nurse. The nurse will record the physician notification with the date, time and result reported to the physician. Regardless of a normal or critical result this procedure is also followed for immediate labs or "STAT" Laboratory values ordered by the physician.

The Provider Lab Ordering Guide read, the physicians who order STAT labs for diagnostic care, when a STAT lab is ordered, a label will immediately print for the nurse to collect the STAT lab. Once the STAT lab sample is collected the courier is notified to pick up the sample, the guide states that the result will be available in four hours from this notification. STAT labs are available seven days a week.

The Lab Services Policy read, the hospital has laboratory services available directly, through a combination of direct and contractual services. The scope and complexity of the hospital laboratory service must be adequate to meet the needs of its patients.

The Oxygen Therapy policy read, physicians may prescribe maintenance of a specific oxygen saturation (SpO2) level during rest and activity (e.g. "maintain SpO2 >_%).

The Assessment, Reassessment policy read, reassessments are performed by each discipline according to the patients' vital signs, status or condition in accordance with the professional's scope of practice. Reassessment is ongoing and occurs to determine the response to and effectiveness of certain care, treatment and services received. When there is a significant change in the patient's condition a full reassessment is performed. Such as but not limited to: significant changes in the patient's vital signs, to determine response to a certain treatment.

The Respiratory Assessment, Re-Assessment, Documentation, and Response Time policy read, assessment and reassessment will be performed on all patients who are receiving respiratory care procedures before and after each treatment or with any change of respiratory status, appropriate to patient need.

1. The facility failed to ensure nursing staff followed the process for STAT labs.

A. Leadership Interviews

1. On 8/13/20 at 3:14 p.m., Chief Nursing Officer (CNO) #9 was interviewed. CNO #9 stated nurses were expected to draw STAT labs within one hour after the order was placed. CNO #9 stated lab results were expected to be received within four hours after the nurse contacted the lab courier to be picked up for processing. CNO #9 stated the delayed lab results for STAT Troponins noted for Patients #5 and #6 were concerning.

2. On 8/18/20 at 10:31 a.m., Director of Quality (Director) #18 was interviewed. Director #18 stated according to a representative from the contracted lab, the results would be reported to the facility within four hours after the facility contacted the lab to notify the sample needed to picked up for processing. Director #18 stated the facility had a responsibility to ensure STAT lab results were received in order to meet their standard of care. She stated the STAT lab tests conducted for Patients #5 and #6 did not meet those standards.

B. Document Review

1. Document review revealed a STAT comprehensive metabolic panel (CMP, an electrolyte lab which measures 14 different substances in the blood) was ordered for Patient #2 and the blood sample was sent to the lab for processing, but the results were never received by the facility. The nursing staff did not follow up and contact the lab for results. Patient #2 was transferred to the hospital, where she was found to have electrolyte imbalances, specifically low potassium and experienced a cardiac event.

a. Patient #2's medical record was reviewed. Review of the Physician Orders revealed a STAT CBC (complete blood count) and a STAT CMP were ordered on 1/17/20 at 10:27 a.m. The order details read, it was collected on 1/17/20 at 11:26 a.m., and sent by Registered Nurse (RN) #5 for processing.

i. The provider Progress Note read, Patient #2 was started on 20 milligrams (mg) of Lasix (a diuretic medication used to treat fluid retention and swelling) on 1/15/20. The physician documented the plan was to increase the Lasix to 40 mg the once lab results were reviewed. The provider also documented Patient #2 had diarrhea.

ii.. Nursing assessments entered on 1/17/20 at 12:03 a.m. and 3:15 a.m. documented Patient #2 exhibited vomiting. A nursing assessment entered on the same day at 8:17 a.m. documented Patient #2 had liquid watery stool.

iii. A document faxed from the lab dated 1/20/20 at 5:06 p.m. read, the blood sample for Patient #2 had not been processed as it was not received. This document from the lab was sent to the facility three days after the STAT order was placed.

There was no evidence in the medical record the results for the STAT CMP were received or reviewed by facility staff, which according to CNO #9's interview, the staff should have reviewed the results four hours after the lab was sent. Additionally, there was no evidence in the medical record nursing staff pursued the missing STAT lab results, or recognized and reported to the physician the lab had not been processed, which was in contrast to the policy, which read the provider should immediately be notified of all STAT lab results.

b. The facility provided documentation of an Acute Care Transfer (ACT) reported on 1/19/20 which reviewed Patient #2's transfer to the hospital. The review determined the STAT CMP results were not received by the facility. When Patient #2 was transferred to the hospital the lab results at the hospital showed the patient had a potassium of 2.7 mmol/L. According to the medical record the normal range for potassium levels in the blood is 3.5 to 5.2 mmol/L.

2. Document review and interviews revealed delays in receipt and review of results for STAT Troponin (a cardiac enzyme/protein released by the heart that could be a sign of a heart attack) lab tests for Patient #5 and #6.

a. Review of Patient #5's medical record was completed. On 8/5/20 at 1:33 p.m., the physician placed an order for a STAT Troponin lab because the patient exhibited chest pain. The Lab Results section of the medical record revealed the lab results were received on 8/6/20 at 8:09 a.m. which was 19 hours after it was ordered STAT.

b. A review of Patient #6's medical record review was completed. On 7/8/20 at 9:52 a.m., the physician placed an order for a STAT Troponin lab. The RN collected the sample for the STAT lab on 7/8/20 at 12:35 p.m., which was two hours and 43 minutes after the order was placed. The results were received on 7/8/20 at 19:06 p.m., which was six and a half hours after the lab was drawn and nine hours and 45 minutes after it was ordered.

C. Interviews for Patient #2

a. On 8/12/20 at 2:10 p.m., RN #5 was interviewed. RN #5 stated the nursing supervisors were responsible to follow up on STAT lab results.

RN #5 stated it was important to monitor potassium levels because potassium was an important electrolyte which could directly affect the heart. RN #5 stated a diuretic, such as Lasix, decreased blood potassium levels. She stated electrolytes were affected by increased doses of diuretics. RN #5 stated vomiting and diarrhea could be a sign of dehydration and an electrolyte imbalance.

RN #5 reviewed the medical record for Patient #2. RN #5 stated because the STAT lab was drawn at 11:28 a.m., the results were expected prior to the end of her shift at 7:00 p.m. the same day. RN #5 stated she oriented a new nurse on the day she collected the STAT lab for Patient #2, and was busy so she did not ensure the results for the lab were received. RN #5 stated the process for collecting and getting results of labs was challenging for staff, and stated she had expressed this concern to facility leadership. She stated there had been no changes to improve the process for collecting and getting results for STAT labs.

b. On 8/17/20 at 2:13 p.m., RN #8 was interviewed. RN #8 stated nurses were expected to collect the sample for a STAT lab within one hour of the order being placed. RN #8 stated STAT lab orders were considered a priority for the nurse to complete. RN #8 stated if the primary nurse could not collect the STAT lab within the hour, the primary nurse would request assistance to do so from another nurse or the nurse supervisor to ensure it was completed.

c. On 8/13/20 at 12:33 p.m., Nurse Supervisor (Supervisor) #6 was interviewed. Supervisor #6 stated when a STAT lab test was ordered, the nursing supervisor was responsible to verify the order was placed correctly and assist with the STAT lab draw if the primary RN was unable to draw the lab within one hour. She stated nursing staff was responsible for contacting the courier to pick up the STAT labs to be taken for processing and results should be received within four hours after the nurse contacted the courier.

Supervisor #6 stated STAT lab results were faxed to the nurse's station or critical results were called to the facility directly. She stated the nursing supervisor was responsible to follow up with the doctor for any new patient care orders. She stated nursing supervisors were notified by nursing staff of STAT labs ordered during their work shift and should follow up if lab results were not received. She stated if a STAT lab result was not received by the end of her work shift, this information should be passed in report to the nursing supervisor on the next shift, who would then be responsible to follow up on those results.

Supervisor #6 stated labs were a nursing responsibility and were important to monitor changes in the patients' condition. She stated labs directed the needs of the patients.

d. On 8/12/20 at 1:47 p.m., Medical Director (Director) #4 was interviewed. Director #4 stated after he placed an order for a lab, the nurse was responsible to draw the sample. He stated if there was a critical test result, the lab called the facility to notify them. He stated if the labs were not critical, the results would appear in the Electronic Health Record (EHR). He stated for STAT labs, the results would be faxed to the facility within four hours and he would then review the results with nursing staff.

Director #4 stated metabolic panels such as CMP, provided information regarding renal function and electrolytes. He stated the results of a CMP would be used to guide patient treatment, including changes to medications or dietary changes. Director #4 stated electrolyte labs included information about sodium and potassium levels. He stated the values were important because low or high sodium could cause weakness, seizures, and lethargy. He stated both sodium and potassium could affect cardiac function.

Director #4 stated medications such as diuretics could cause electrolyte imbalances. He stated CMP were obtained in order to monitor a patient's electrolyte response to a diuretic. Director #9 stated albumin (a protein which would be measured in a CMP) is also monitored because if a patient's albumin was low the diuretic was less likely to be effective.

Director #4 stated he saw Patient #2 on the day she transferred from the facility to the hospital, 1/19/20. He stated STAT labs were ordered the previous Friday, 1/17/20 and the results were never received. He stated when Patient #2 transferred to the hospital her potassium was 2.7 which was considered low. Director #4 stated if the blood work had been received, Patient #2's potassium could have been corrected at the facility.

Director #4 stated facility leadership had discussed problems with not receiving laboratory results from the lab in the expected timeframe's. He stated the issue had been discussed in the facility Quality Program meetings one month prior to the survey. Director #4 stated the lab process had been discussed with greater frequency since Patient #2's transfer to the hospital. However the facility was unable to provide evidence of a process change to prevent this issue from reoccurring.

2. The facility failed to ensure nursing staff monitored patients overnight after supplemental oxygen was removed.

The Oxygen Therapy policy read, Physicians may prescribe maintenance of a specific oxygen saturation level.

The Assessment, Reassessment policy read, reassessments are performed according to the patient's vital signs, status or condition. Reassessment is ongoing and occurs to determine the patient's response to treatment.

The Respiratory Assessment, Re-Assessment, Documentation, and Response Time policy read, assessment and reassessment will be performed on all patients who are receiving respiratory care procedures before and after each treatment or with any change of respiratory status, appropriate to patient need.

A. Document Review

1. Review of the medical records for Patients #2 and #4 revealed the patients oxygen saturations were not monitored by the registered nurse overnight after supplemental oxygen was removed. The patients were found the next morning to have low oxygen saturations.

a. According to the History and Physical (H&P) for Patient #2, Patient #2 experienced postoperative hypoxia (a condition in which the body is deprived of adequate oxygen supply) and required 1 liter of oxygen when she admitted to the facility. The provider documented, continue to wean oxygen as able.

i. According to the Physician Orders, on 1/11/20 the physician placed an order for Oxygen Therapy which read, titrate oxygen to maintain oxygen saturations of greater than 92%.

ii. On 1/14/20, a Respiratory Test Result read, Patient #2 had saturations of 97% on 1 liter of oxygen while alert. The patient was trialed without oxygen (room air), at which time Patient #2 fell asleep and her saturations dropped to 86%. The patient resumed 1 liter of oxygen while the patient was asleep and her saturations increased to 90-92%. According to Test Result, the plan was to continue to titrate the patient's oxygen and schedule a nocturnal oximetry (a study in which a pulse oximeter is used to monitor and record oxygen levels in the blood during sleep) closer to the time of discharge.
There was no evidence in the medical record a nocturnal oximetry study was conducted.

iii. On 1/16/20 at 3:00 p.m., a Treatment Note documented Patient #2 was on 2 liters of oxygen with oxygen saturations of 96%. On the same day at 8:08 p.m., a Licensed Practical Nurse (LPN) documented Patient #2's oxygen saturations were 93% on room air. The next assessment of Patient #2's oxygen saturations did not occur until the following morning at 7:15 a.m., when the patient's oxygen saturations were 67%.

There was no documentation in the medical record of when the supplemental oxygen was titrated from 2 liters to room air, or evidence the patient's respiratory function or oxygen saturations were monitored during the night by the registered nurse.

b. Patient #4's medical record was reviewed. According to the H&P completed on 8/5/20, Patient #4 had a history of COPD (chronic obstructive pulmonary disease, a lung disease which causes obstructed airflow from the lungs) and was on 2 liters of oxygen.

i. A Respiratory Therapy Education note was completed on 8/5/20 at 7:55 a.m. The note read, Patient #2 had a history of COPD but was not on home oxygen.

ii. A nursing assessment entered on 8/9/20 at 10:22 a.m., documented Patient #4's oxygen saturations were 84% on room air. The nurse documented one minute later the patient was placed on 1 liter of oxygen and her saturations improved to 92%.

iii. A nursing assessment was entered on the same day at 7:22 p.m., which documented Patient #4 was on 2 liters of oxygen with saturations of 93%. The patient's oxygen saturations were not assessed again until 7:34 a.m. the following day, at which time a RNT documented the patient was on room air (no oxygen) with saturations of 82%. The RN placed the patient on 1 liter of oxygen and the patient's oxygen saturations improved two minutes later to 93%.

There was no documentation in the medical record of the time or reason the supplemental oxygen was removed during the night of 8/9/20, or evidence the patient's oxygen saturations were monitored during the night by the registered nurse.

B. Interviews

1. Interviews revealed nursing staff were expected to monitor patients' respiratory function and oxygenation while weaning patients from oxygen but staff were unable to speak to a consistent process for this.

a. On 8/12/20 at 6:25 a.m., RN #10 was interviewed. RN #10 stated when a patient was on oxygen, he would frequently check the patient's oxygen saturations. He stated if a patient was titrated from oxygen the prior shift, the oncoming shift needed to know the patient's most recent oxygen level prior to the patient being titrated. RN #10 stated it was possible a patient would not require oxygen during the day but still need it at night.

b. On 8/12/20 at 7:00 a.m., RN #15 was interviewed. RN #15 stated when a patient was titrated from oxygen, she would check the patient's oxygen saturations and then document ongoing checks of the patient's saturations. She stated a pulse oximeter monitor (a device used to monitor oxygen saturations) would be used to ensure the patient's saturations remained 90% or greater.

RN #15 stated when a patient was titrated from supplemental oxygen, a nocturnal oximetry test was conducted to determine whether the patient's saturations dropped at night without oxygen. She stated the nursing supervisor communicated the need for the nocturnal oximetry test with the night nurse then the primary nurse was responsible to conduct the test.

RN #15 stated if a patient's oxygen saturations dropped during the night, the patient could experience headaches, shortness of breath, or the inability to breathe. She stated oxygenation was vital to the patient for healing and circulation.

c. On 8/13/20 at 6:45 a.m., LPN #11 was interviewed. LPN #11 stated if a patient's oxygen was titrated to room air, she would check the patient's oxygen saturations immediately and then every two hours during the night when she rounded. She stated patients who needed supplemental oxygen could quickly desaturate and could die or incur brain damage if their oxygen saturations were low enough.

d. On 8/13/20 at 12:32 p.m., Nursing Supervisor (Supervisor) #6 was interviewed. Supervisor #6 stated when a patient's oxygen was titrated staff would closely monitor the patient every four hours for at least the first 24 hours without oxygen. This was in contrast to LPN #11's interview which she stated she would monitor oxygen saturations every two hours during titration. Supervisor #6 stated she would not expect a patient to be titrated from oxygen overnight because most patients' oxygen needs increased at night, and a patient who did not need oxygen during the day might still need it at night.

e. On 8/12/20 at 9:48 a.m., Respiratory Therapist (RT) #17 was interviewed. RT #17 stated nurses and techs monitored a patient's oxygen through their work shift, including if the patient was not on oxygen. RT #17 stated when a patient's oxygen was titrated, staff would assess the patient's oxygen saturation immediately using the pulse oximeter and reassess fifteen to thirty minutes later. This was in contrast to LPN #11 and Supervisor #6's interviews regarding when staff would monitor a patient's oxygen saturation while titrating oxygen. RT #17 stated if a patient had been recently weaned from oxygen, it was possible the patient could need oxygen again two hours later and it was important to monitor the patient's oxygenation.

RT #17 stated the white communication board in the patient's room was used to communicate a patient's oxygen status to other staff caring for the patient. RT #17 stated staff would write on the board if a patient's supplemental oxygen was being titrated if staff encountered a challenge when titrating a patient's oxygen. RT #17 stated this was done to ensure communication occurred with nursing staff when a patient was being titrated from oxygen.

i. On 8/1/20 at 10:15 a.m., an observation was conducted of Patient #4's room. During the observation, CNO #9 stated the white communication board was used by nursing staff to ensure information about the patient was updated. He stated the board was a primary means for staff of different disciplines to communicate and stated it was updated each morning during the nursing report conducted at shift-change.

Observation revealed Patient #4's whiteboard read, Oxygen 1-2L (liters). Patient #4 stated she had not been on supplemental oxygen for several days. Patient #4 was not on supplemental oxygen during the time the observation was conducted.

C. Leadership Interviews

1. Interviews with facility leadership revealed the facility did not ensure a protocol was in place for titrating supplemental oxygen.

a. On 8/13/20 at 9:16 a.m., the Director of Quality (Director) #18 was interviewed. Director #18 provided a document entitled "Oxygen Protocol," which included guidelines for titration of supplemental oxygen. Director #18 stated when the physician placed an order for the oxygen protocol, the order would include a reference text for the nursing staff to review. She stated this was the protocol staff were expected to follow for titration of oxygen.

In an interview conducted on 8/13/20 at 11:04 a.m., Director #18 stated she was aware of the event during which Patient #2 was not monitored overnight when supplemental oxygen was removed and was found to have low oxygen saturations the following day. She stated there had been no changes made to facility processes as a result of the event.

b. On 8/13/20 at 3:13 p.m., the Chief Nursing Officer (CNO) #9 was interviewed. CNO #9 stated the "Oxygen Protocol" document provided to surveyors by Director #18 was not a protocol nursing staff were aware of. CNO #9 had not seen the Oxygen Protocol prior to the survey. He stated there was no policy in place which specifically provided guidance on how to titrate supplemental oxygen.

3. The facility failed to ensure nursing staff, specifically the rehabilitation nursing technicians (RNT) who assessed vital signs, reported findings of oxygen saturation levels below the parameters specified by the physician to the nurse on duty.

The Oxygen Therapy policy read, physicians may prescribe a specific oxygen saturation level to be maintained.

The Assessment, Reassessment policy read, reassessments are performed according to the patient's vital signs or condition to determine the effectiveness of certain treatment. When there is a significant change in the patient's condition, such as a significant change in the patient's vital signs, a full reassessment is performed.

The Respiratory Assessment, Re-Assessment, Documentation, and Response Time policy read, assessment and reassessment will be performed on all patients who are receiving respiratory care procedures with any change of respiratory status.

A. Document Review

1. Review of the medical records for Patients #4 and #7 revealed nursing staff responsible to assess the patients' vital signs and oxygenation did not communicate findings of low oxygen saturations to the primary RN.

a. The medical record for Patient #4 was reviewed. On 8/4/20, the physician placed an order for Oxygen Therapy which read, titrate oxygen to maintain oxygen saturations of greater than 90%.

i. Review of the medical record revealed the RNT documented on two occasions Patient #4's oxygen saturations were below 90%.

On 8/12/20 at 12:18 a.m., the RNT documented the patient's SPO2 was 88%. The RNT did not document whether the patient was receiving supplemental oxygen or was on room air at the time of the assessment.

On 8/12/20 at 7:48 p.m., the RNT documented the patient's SPO2 was 89% on room air.

There was no documentation in the medical record the low oxygen saturations were reported to the primary RN, and no evidence the patient's saturations were subsequently re-evaluated.

b. The medical record for Patient #7 was reviewed. On 6/9/20, the physician placed an order for oxygen therapy which read, titrate oxygen to maintain oxygen saturations of greater than 92%.

The medical record revealed nursing staff documented Patient #7's oxygen saturations were below 92% on multiple occasions. Examples included the following:

On 6/15/20 at 8:07 a.m., the RNT documented Patient #7 was on 2 liters of oxygen and her oxygen saturations were 87%. The next assessment of Patient #7's oxygen saturation was performed on the same day at 7:57 p.m., when the RNT documented the patient's saturations were 91%.

On 6/11/20 at 6:29 p.m., the RNT documented Patient #7's oxygen saturation was 90%. The assessment did not specify how many liters of oxygen Patient #7 was receiving.

There was no evidence in the medical record the RNT reported the low oxygen saturation to the primary RN and no evidence Patient #7's oxygen saturations were subsequently re-evaluated.

B. Interviews

1. Interviews revealed the RNT was responsible to report abnormal findings, including findings of low oxygen saturations, to the primary nurse in order to ensure the patient was reassessed.

a. On 8/12/20 at 6:25 a.m., RNT #10 was interviewed. RNT #10 stated any aspect of a patient's condition which was abnormal, including abnormal vital signs, would be communicated to the primary nurse so the patient could be re-evaluated. RNT #10 stated he checked a patient's oxygen saturations when he rounded every two hours.

b. On 8/12/20 at 6:53 a.m., RNT #14 was interviewed. RNT #14 stated he assessed vitals each morning and was responsible to document and report any abnormal findings to the RN. He stated vitals included oxygenation. RNT #14 stated if a patient's oxygen saturations were below 90 %, he would encourage the patient to breathe and report his findings to the nurse.

c. On 8/13/20 at 2:01 p.m. RN #7 was interviewed. RN #7 stated patients on oxygen were monitored by checking their vitals each shift. RN #7 stated she expected the RNT to alert her if a patient's oxygen saturations were below 90%. She stated if she re-checked a patient's oxygen saturations and they remained low, she would alert the physician, place the patient on oxygen and continue to monitor the patient.

d. On 8/13/20 at 12:32 p.m. Supervisor #6 was interviewed. Supervisor #6 stated if a patient was on room air and their oxygen saturation was below 90%, nursing staff would place the patient on oxygen and notify the physician of the change. She stated if oxygen was being titrated, nursing staff would ensure the saturations remained above 90%. Supervisor #6 stated removing or initiating oxygen was not within the nursing technician's scope of practice, and stated the rehab technician would be responsible to alert the registered nurse of any change in respiratory status.

e. On 8/13/20 at 3:13 p.m. CNO #9 was interviewed. CNO #9 stated the RNT would report any oxygen saturation below 90% to the nurse. He stated the physician order might specify different parameters for the oxygen saturations to be maintained.

CNO #9 reviewed Patient #4's medical record. He stated on 8/12/20 at 12:18 a.m., when the RNT documented the patient's oxygen saturations were 88%, there was no re-evaluation of the patient's oxygenation and the RNT did not document how much oxygen the patient required at the time. He stated he would expect the RNT to communicate the low oxygen saturation to the nurse in order to ensure supplemental oxygen was replaced and the patient's oxygen saturations were re-assessed. He stated the same would apply to the oxygen saturation of 89% documented on the same day at 7:48 p.m. He confirmed the physician order specified the saturations should be maintained at 90% or higher.

Based on document review and interviews, the facility failed to ensure medications, specifically pain medications and medications designated as time-sensitive, were administered according to the provider's orders and facility policy in four of four medication administration records reviewed (Patients #1, #2, #3, and #4). In addition, the facility failed to ensure staff performed pain reassessments according to facility policy after administering scheduled pain medications in two of seven inpatient medical records reviewed (Patients #2, #3).

Findings include:

Facility policies:

The Medication Administration policy read, Medications shall be administered pursuant to a valid order within 1 hour before or after the prescribed time, except medications defined as time sensitive or ordered to be administered at a specific time. Time sensitive medications shall be administered within 30 minutes before or after the prescribed time. Time sensitive medications include the following: antibiotics, anticoagulants, anticonvulsants, insulins, Anti-parkinsons.

The Assessment, Re-Assessment policy read, Reassessments are performed by each discipline according to the patients' vital signs, laboratory results, status or condition in accordance with the professional's scope of practice. Reassessments across all disciplines is ongoing and occurs at designated intervals during the patient's stay/ treatment to determine the response to and effectiveness of certain care, treatment and services provided. The scope and intensity of the reassessment are based on the patient's diagnosis, care setting, and patient's response to previous care.

The Pain Management policy read, Pharmacological treatment of pain will be a multi-modal approach, consisting of medications consistent with the type and frequency of pain being treated. Reassessment of interventions provided will be conducted within one hour of completion of the intervention or administration of medication. Should pain interventions be ineffective, alternative actions will be taken and will include notification of the physician and interdisciplinary communication of issues identified.

1. The facility failed to ensure medications designated as time-sensitive were administered according to the provider's orders and facility policy.

According to the Medication Administration policy, time sensitive medications shall be administered within 30 minutes before or after the prescribed time.

a. Patient #1's medical record was reviewed.

i. According to the History and Physical (H&P) completed on 8/27/19, Patient #1 had chronic alcoholic hepatic encephalopathy (the loss of brain function when a damaged liver does not remove toxins from the blood) and received Rifaximin (an antibiotic used to treat hepatic encephalopathy) twice daily for this condition. The provider documented Patient #1 had nociceptive (relating to the perception of pain) pain and received Lyrica (a medication used to treat nerve and muscle pain) for this condition.

ii. Review of the medication orders revealed on 8/27/19 the physician placed an order for Rifaximin 550 milligrams to be administered orally BID (twice a day). A physician order was placed the same day for Lyrica 75 milligrams to be administered orally TID (three times a day). Both of the medication orders included a comment reading "TIME SENSITIVE."

iii. Review of the Medication Administration Record (MAR) between the dates of 8/27/19 and 9/2/19 revealed Rifaximin and Lyrica were not administered according to the physician's order and the Medication Administration policy on multiple occasions. Examples included the following:

On 8/27/19, the doses scheduled for 9:00 p.m. for both Lyrica and Rifaximin were administered at 8:00 p.m.

On 8/31/19, the dose scheduled for 9:00 p.m. for Rifaximin was not administered until 10:36 p.m.

On 8/30/19, only two of the three ordered doses of Lyrica were administered. The medication was scheduled to be administered three times a day, however it was only administered at 8:25 a.m. and 8:53 p.m.

On 9/1/19, the doses scheduled for 9:00 a.m. for both Lyrica and Rifaximin were not administered until 11:08 a.m.

The medication was not administered within 30 minutes before or after the scheduled time as specified in the facility policy.

b. Patient #4's medical record was reviewed.

i. According to the H&P completed on 8/5/20, Patient #1 had a history of DVT (deep vein thrombosis, a blood clot in the deep veins of the body) and received Heparin (an anticoagulant medication) to prevent a DVT while in the hospital.

ii. According to the medication orders, on 8/4/20, the physician placed an order for Heparin 5000 milligrams to be administered subcutaneously (as an injection administered under the skin) every 12 hours. The order included a comment reading "TIME SENSITIVE."

iii. Review of the MAR between the dates of 8/5/20 and 8/13/20 revealed Heparin was not administered according to the physician's order and facility policy on multiple occasions. According to the physician order the Heparin was scheduled to be administered every 12 hours. Examples included the following:

On 8/5/20 Heparin was administered at 8:46 p.m. The next dose was scheduled for 8:46 a.m. the following day, however it was not administered until at 9:53 a.m., which was 37 minutes outside of the administration window specified in the facility's policy.

On 8/6/20 Heparin was administered at 9:34 p.m. The next dose was scheduled for 9:34 a.m. the following day, however it was administered at 8:21 a.m., which was 43 minutes outside of the administration window.

On 8/8/20 Heparin was administered at 9:27 a.m. The next dose was scheduled at 9:27 p.m., however it was administered at 8:23 p.m., which was 34 minutes outside of the 30 minute administration window.
The medication was not administered according to the policy which stated time sensitive medications should be administered within 30 minutes before or after a dose was scheduled. The physician order designated Heparin as a time sensitive medication.

c. Interviews revealed nursing staff lacked knowledge of the policy specifying how time-sensitive medications were administered and how to identify a medication designated as time-sensitive.

i. On 8/17/20 at 10:22 a.m., RN #2 was interviewed. RN #2 stated if a medication was ordered to be administered BID, the schedule for administration was 9:00 a.m. and 9:00 p.m. She stated most medications could be given one hour before or after the scheduled dose, and stated the window for medication administration was important to allow a patient's body to metabolize the medication.

RN #2 stated she was not aware of a policy regarding administration of time sensitive medications and did not know time sensitive medications should be administered within 30 minutes before or after the prescribed time

RN #2 stated it was important to give certain medications on time because there were risks to the patient if the medication was not given according to schedule. She stated Lyrica was an example of a medication which needed to be given strictly according to the scheduled times because Lyrica affected the patient's nerves and could affect the patient's awareness.

RN #2 stated a nurse may not be aware a medication was time-sensitive because the electronic MAR did not alert the nurse when a medication needed to be given within 30 minutes.

ii. On 8/17/20 at 11:04 a.m., RN #1 was interviewed. RN #1 stated time sensitive medications needed to be administered thirty minutes after the nurse removed the medication from the Pyxis (an automated medication dispensing system). to maintain the active level of the medication in the patient's blood. She stated if the medication was given too early or too late, the levels of the medication in the patient's blood could be altered.

iii. On 8/13/20 at 3:13 p.m., Chief Nursing Officer (CNO) #9 was interviewed. CNO #9 stated the window to administer time sensitive medications was 30 minutes before or after the scheduled dose. He stated medications ordered BID were scheduled for 9:00 a.m. and 9:00 p.m. CNO #9 did not know when the third dose for a medication ordered TID would be administered.

CNO #9 stated nurses were not always aware if a medication was designated as time sensitive in the physician orders. He stated if the nurse did not look at the order in the Electronic Health Record (EHR) in a particular way, the time sensitive designation would not be visible to the nurse. He stated if a nurse did not see this designation or did not regularly administer the medication, the nurse would not know the medication needed to be given within 30 minutes of the scheduled dose.

2. The facility failed to ensure scheduled pain medications were administered according to the provider's orders and facility policy.

According to the Medication Administration policy, medications shall be administered within 1 hour before or after the prescribed time.

a. Patient #2's medical record was reviewed.

i. According to the History and Physician (H&P) completed on 1/12/20, Patient #2 had undergone a spinal fusion (a surgical technique which joins two or more vertebrae) and laminectomy (a surgical procedure which removes a portion of the vertebral bone) six days prior to admission to the facility. The provider documented Patient #2 had a long history of pain in her lower back, buttocks and legs.

ii. Review of the medication orders revealed on 1/13/20 the physician placed an order for hydromorphone (Dilaudid, a controlled narcotic medication used to treat moderate to severe pain) 6 milligrams to be administered orally every 4 hours. Subsequent orders were placed on 1/15/20 for 4 milligrams and on 1/17/20 for 2 milligrams, with the same specified frequency of every four hours.

iii. Review of the MAR between the dates of 1/11/20 and 1/19/20 revealed Dilaudid was not administered according to the physician's orders and the Medication Administration policy on multiple occasions. Examples included the following:

On 1/16/20 Dilaudid was administered at 7:01 p.m. The next dose was scheduled for 11:01 p.m., however Registered Nurse (RN) #1 administered the medication at 12:53 a.m., which was one hour and 52 minutes after the scheduled dose was due.

On 1/14/20, Dilaudid was administered at 5:45 p.m. The next dose was scheduled for 9:45 p.m., however the medication was given at 8:04 p.m., which was one hour and 41 minutes before the next scheduled dose was due.

On 1/13/20 Dilaudid was administered at 3:29 p.m. The next dose was scheduled for 7:29 p.m., however the medication was not administered until 9:49 p.m., which was two hours and 20 minutes after the next scheduled dose was due.

iv. There was no documentation of the reason the medications were not given within one hour before or after the scheduled time as specified in the facility Medication Administration policy.

v. On 1/19/20, the physician placed an order to transfer Patient #2 to an acute care facility. The order details read, the transfer was unplanned due to uncontrolled pain and worsened pain since surgery. According to a Physician Progress Note completed the same day, the physician documented Patient #2 had 8/10 pain, and the scheduled Dilaudid did not relieve her pain.

b. Patient #3's medical record was reviewed.

i. According to the H&P completed on 5/11/20, Patient #3 had surgery for a femoral shaft (the long part of the thigh bone) fracture three days prior to his admission to the facility.

ii. According to the Medication Orders, on 5/11/20 the physician placed an order for Tramadol (a controlled narcotic medication used to treat moderate to severe pain) 100 milligrams to be administered orally TID (three times a day).

iii. Review of the MAR between the dates of 5/11/20 and 5/17/20 revealed Tramadol was not administered according to the physician's order and facility policy on three occasions.

On 5/13/20, the dose scheduled for 9:00 a.m., was administered at 6:35 a.m., which was two hours and 25 minutes before the scheduled dose was due.

On 5/14/20 the dose scheduled for 9:00 p.m. was administered at 7:01 p.m., which was one hour and 59 minutes before the scheduled dose was due.

On 5/15/20 the dose scheduled for 9:00 a.m. was administered at 6:51 a.m., which was two hours and nine minutes before the scheduled dose was due.

iv. There was no documentation in the medical record of the reason the scheduled doses were administered early.

c. Patient #4's medical record was reviewed.

i. According to a Physician Progress Note completed on 8/12/20, Patient #4 had a broken humerus (a long bone in the arm) and tibia (the shin bone) due to a fall. The physician documented Robaxin (a muscle relaxant used to treat spasms and pain) had been added to the treatment plan to manage spasm pain.

ii. According to the Medication Orders, the physician placed an order on 8/5/20 for Robaxin 750 milligrams to be administered orally every six hours.

iii. Review of the MAR between the dates of 8/5/20 and 8/13/20 revealed Robaxin was not administered according to the physician's order and facility policy on multiple occasions. Examples included the following:

On 8/5/20, the medication was administered at 3:55 p.m., at which time RN #7 documented the scheduled Robaxin was given early due to pain. The next dose was scheduled for 9:55 p.m., however the medication was not given again until 11:33 p.m., which was 1 hour and 38 minutes after the next scheduled dose was due.

On 8/8/20 Robaxin was administered at 11:05 p.m. The next dose was scheduled for 5:05 a.m. the following day, however the medication was not administered until 6:26 a.m., which was 1 hour and 21 minutes after the next scheduled dose was due.

There was no documentation in the medical record of the reason the scheduled doses were administered late.

d. On 8/17/20 at 10:22 a.m., RN #2 was interviewed. RN #2 stated pain medication was used to alleviate symptoms of pain, and could include narcotics. She stated Robaxin was a medication used to supplement narcotic pain medications to help the muscles relax and take more of the pain away. RN #2 stated if Robaxin was scheduled, it was administered in the same manner as other pain medications.

RN #2 stated scheduled medications were given an hour before or after the scheduled time. She stated this hour window applied whether medication was scheduled for every four, six, or eight hours.

e. On 8/17/20 at 11:04 a.m., RN #1 was interviewed. RN #1 stated if a pain medication was not given at the scheduled time, she would document in the patient's chart the medication was not given, with a comment to indicate the reason. RN #1 stated if a pain medication was given at a different time, the next dose would need to be adjusted accordingly.

RN #1 reviewed Patient #2's medical record. She stated on 1/16/20, Patient #2 received Dilaudid at 7:01 p.m., which made the next scheduled dose at 11:00 p.m. She stated she could not remember if she went into Patient #2's room at 11:00 p.m. She stated she did not document the patient's condition at 11:00 p.m., which was the time Dilaudid was scheduled to be administered.

RN #1 stated if a medication was not given at the scheduled time it was important to document in the patient's record because otherwise it would appear the dose was simply disregarded. She stated sometimes when nurses were assigned to care for 9 or 10 patients, nurses sometimes were not able to give medications as scheduled because they had to assist other patients.

RN #1 stated if a patient's pain was not treated, it was detrimental to a patient's ability to rehabilitate because pain limited a patient's movement and participation.

f. On 8/13/20 at 3:13 p.m. CNO #9 was interviewed. CNO #9 stated pain medications should be given as scheduled within the hour window specified in the policy. He stated staff were instructed to administer controlled substances within 30 minutes. He stated if a medication was given two hours before or after the scheduled time, it would be considered outside of the window for administration.

CNO #9 stated there were several risks associated with medications not being given according to physician orders. He stated the half-life (the time needed for half of a dose of medication to be metabolized and eliminated from the bloodstream) of a medication could affect the patient's treatment or healing. He stated a narcotic medication could increase the patient's risk of bradycardia (low heart rate) or respiratory depression if given early or late.

3. The facility failed to ensure staff performed reassessments of patients' pain according to facility policy after administering scheduled pain medications in order to monitor the effectiveness of the medication.

According to the Pain Management policy, reassessment of interventions provided will be conducted within one hour of completion of the) administration of medication.

a. Patient #2's medical record was reviewed. Review of the medication orders revealed on 1/13/20, the physician placed an order for hydromorphone (Dilaudid, a controlled narcotic medication used to treat moderate to severe pain), which was scheduled to be administered every four hours.

i. Review of the MAR revealed after the physician's order for Dilaudid was changed to a scheduled frequency on 1/13/20, nursing staff did not reassess Patient #2's pain after administering the scheduled doses of Dilaudid. Examples included the following:

On 1/15/20, Dilaudid was administered at 5:58 a.m., for pain 5/10. Three and a half hours later at 9:23 a.m., a physical therapist documented the patient's pain level had increased to 8. Nursing staff did not reassess Patient #2's pain until the next time Dilaudid was administered at 10:07 a.m. for a pain level of 7.

On 1/17/20, Dilaudid was administered at 12:53 a.m., for a pain level of 6. Patient #2's pain was not assessed again until five hours later at 5:59 a.m., at which time her pain level remained 6.

On 1/18/20, Dilaudid was administered at 9:30 a.m., for pain level of 7. Patient #2's pain was not assessed again until four hours later at 1:34 p.m, at which time the patient's pain remained at 7.

ii. On 1/19/20, the physician placed an order to transfer Patient #2 to an acute care facility. The order details read, the transfer was unplanned due to uncontrolled pain and worsened pain since surgery. According to the Physician Progress Note completed the same day, the physician documented Patient #2 had 8/10 pain, and the scheduled Dilaudid did not relieve her pain.

b. Patient #3's medical record was reviewed.

i. According to the Medication Orders, the physician placed an order for Tramadol 100 milligrams to be administered orally TID (three times daily).

ii. Review of the medical record revealed nursing staff did not reassess Patient #3's pain after administering the scheduled doses of Tramadol. Examples included the following:

On 5/16/20, Tramadol was administered at 8:14 p.m., for a pain level of 4. Patient #3's pain was not reassessed until 8:51 a.m., the following day, at which time the patient's pain was a 10.

On 5/15/20 at 7:53 p.m., Registered Nurse (RN) #15 documented the patient's pain level was five. Tramadol was administered at 7:59 p.m. Nursing staff did not reassess the patient's pain until 8:15 a.m., the following day.

On 5/13/20, Tramadol was administered at 1:03 p.m., for a pain level of 6. Nursing staff did not reassess Patient #3's pain until the medication was administered again at 9:01 p.m., at which time the patient's pain level was 7.

c. On 8/11/20 at 3:05 p.m., RN #13 was interviewed. RN #13 stated she would assess a patient's pain when she administered a pain medication, and would reassess the patient's pain one hour later. She stated she would do so to ensure either the patient's pain level went down, or to notify the physician the medication was not effective. RN #13 stated the same reassessment would be conducted whether a pain medication was scheduled or given as needed.

d. On 8/17/20 at 11:04 a.m., RN #1 was interviewed. RN #1 stated after a pain medication was administered, it would take about thirty minutes to become effective. She stated at that time she would reassess a patient's pain and check their pain scale to determine if the medication was effective. She stated if the medication was not effective it could indicate a different issue or a new area of pain which would need to be investigated further.

RN #1 stated a reassessment was conducted after any pain medication was administered, including scheduled pain medications. She stated when she administered Tramadol the reassessment needed to be performed, and stated there was a prompt on the electronic MAR where the reassessment would be documented.

e. On 8/17/20 at 10:22 a.m., RN #2 was interviewed. RN #2 stated when a pain medication was administered, the patient's pain needed to be reassessed to determine whether the medication was effective. She stated she would check on the patient 30 minutes after administering a pain medication and continue to monitor the patient to ensure the medication helped.

RN #2 stated she would reassess a patient's pain after administering either a scheduled or a PRN pain medication. She stated even when a pain medication was scheduled, it may not be effective and the patient could require a different intervention. She stated the pain reassessment was important to ensure the patient did not receive unnecessary medication and to ensure the patient's pain was addressed.

RN #2 stated if a patient's pain was uncontrolled, the patient would be less likely to participate in therapy and the nurse might have to "chase" the pain all day long without effectively treating it.

f. On 8/13/20 at 3:13 p.m., Chief Nursing Officer (CNO) #9 was interviewed. CNO #9 stated the nurse should reassess a patient's pain one hour after administering a pain medication. He stated the reassessment would be conducted for either a scheduled or as-needed pain medication. CNO #9 stated the purpose of the pain reassessment was to ensure the medication was effective and the patient was comfortable.

CNO #9 stated the risk of failure to reassess pain after a pain medication was administered, included over-medicating a patient who might be naive to pain medication, as well as the risk of a patient's pain being uncontrolled and requiring greater amounts of medication.

In a second interview conducted on 8/18/20 at 9:00 a.m., CNO #9 stated pain assessments needed to be performed for Tramadol. CNO #9 reviewed Patient #3's medical record and confirmed based on facility policy the reassessments needed to be performed for the scheduled Tramadol.