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Based on interviews and record reviews, the facility failed to meet the Condition of Participation (CoP) for Patient Rights by failing to protect and promote each patient's rights as evidenced by the following:

A. The facility failed to include the patient's legal decision makers in the formation or updating of treatment regiment. See Tag 130

B. The facility failed to ensure that patient's legal decision makers had informed consent prior to procedures. See Tag 131

C. The facility failed to provide care in a safe setting. See Tag 144

Based on interviews and record reviews, the facility failed to adequately involve legal decision makers (patient's representative) in participation of care planning for 1 (P1) out of 14 patients. This failed practice can lead to inconsistent goals and expectations of care, mistrust of care providers, and disruption to therapeutic working relationships.

The findings are:

A. On 03/08/2021 at 9:00 am, interview with P1's legal decision maker verified that P1 has had a gastric tube (G-tube, feeding tube that is inserted into the stomach to provide supplemental nutrition) since 2019. Legal decision maker reported that after surgical procedure on 1/12/2021 at the facility, P1 was experiencing discomfort with tube feedings (process of administering supplemental nutrition via gastric tube) and that the abdomen was swelling when feeds were given. During the stay at the facility, P1's legal decision maker noticed that P1 had increase in labored breathing (irregular breathing pattern indicative of distress) and pain with feeds. Legal decision maker requested that the medical team seek consultation with a stomach specialist on 1/13/2021, with no answer from team. P1's condition continued to deteriorate with him needing to be intubated (insertion of a breathing tube and placement on a ventilator) and sent to Intensive Care. P1's legal decision maker continued to request for specialist involvement with no answer till 1/25/2021 when a stomach specialist was consulted, and it was determined that the G-tube has to be changed because the feedings were not going into the stomach but were building in the abdomen and chest and filling the lungs.


B. Record review of P1's Multidisciplinary Summary Forms from 01/12/2021-01/26/2021 revealed:

1. On 01/12/2021 at 7:36 pm, patient noted to be very tachycardic (rapid heart rate) and tachypneic (raid breathing). Patient placed on oxygen and respiratory therapy (healthcare professional responsible for care of patient's breathing and respiratory system) suctioned airway with lots of chest congestion.

2. On 01/13/2021 at 5:17 am, patient had an episode of tachypnea (rapid breathing) and tachycardia (fast heart rate) and patient's oxygen saturation (measurement of oxygen in blood stream) was in the 70's (low). Patient's supplemental oxygen decreased.

3. On 01/14/2021 at 7:27 am, patient exhibited supraclavicular retractions (inward movement of the skin about the chest, associated with respiratory distress). No documentation of MD (medical doctor) notification of change in status. Note states "one feed [tube feed] was given, mom stated that would be it for the night since his feed was held (stopped)due to respiratory distress at end of the day shift."

4. On 01/14/2021 at 6:22 pm, patient noted to have increased work of breathing, tachycardia, and tachypnea requiring increased supplemental oxygen.

5. On 01/15/2021 at 6:44 am, patient's increased supplemental oxygen and feeds were held.

6. On 01/17/2021 at 5:21 am, patient noted to have intermittent labored work of breathing (sporadic irregular breathing pattern that is indicative of distress).

7. On 01/17/2021 at 5:32 pm, patient noted to be tachycardic and tachypneic with no improvement in retractions even after increased suctioning and administration of oxygen. Note states "Feeds held for majority of the shift due to further respiratory distress when feeds resumed"

8. On 01/18/2021 at 6:00 pm, P1 noted to be intubated and on ventilator. G-tube feedings held.

9. On 01/20/2021 at 5:45 am, note stated "GT (G-tube) vented (opening the vent on the G-tube to allow draining of stomach content, during shift large amount of gastric content (matter and materials taken out of the stomach)emptied.

10. On 01/20/2021 at 5:52 pm, P1's tube feeds restarted.

11. On 01/26/2021 at 7:44 am, P1 extubated (discontinuation of intubation and ventilator support). Respiratory therapist notes that P1 appears to be refluxing feeds orally (movement of liquids from the stomach into the esophagus and mouth).


C.Record Review of P1's Progress Note-Pediatric Inpatient from 01/13/2021-01/26/2021 revealed:

1. On 01/13/2021, noted that on 01/12/2021 P1 was evaluated by Pediatric Intensive Care Unit for respiratory distress and restarted on home pulmonary medications (medications for the treatment of lung based diseases). Despite these efforts, P1 noted to have tachycardia, tachypnea, and increased work of breathing.

2. On 01/14/2021, noted that P1 has labored respirations and stomach discomfort. Provider note indicates that Aspiration Pneumonia (lung infection that is due to a relatively large amount of material from the stomach or mouth entering the lungs) is a potential diagnosis. Provider indicates that Gastroenterology (Medical Doctor specialized on treatment of conditions and diseases of the stomach and GI system) was consulted but deferred due to critical illness. Tube feeds were paused.

3. On 01/15/2021, P1's computerized tomography (CT) scan of the chest revealed multifocal (originating in multiple areas of the lung) Pneumonia. Tube feeds were resumed.

4. On 01/16/2021, tube feeds continued as P1 is noted to have increased work of breathing.

5. On 01/17/2021, states "His [P1] feeds held since the 14th on/off due to tachypnea and again on 01/17 after increased discomfort and tachypnea with feeds running" Gastroenterology again deferred due to severity of illness.

6. On 01/18/2021, noted that on 01/17/2021 P1 was transferred to intensive care unit for increasing oxygen requirement and work of breathing. P1 was intubated. Notes that tube feeds are to be held for "concern for patient not tolerating"

7. On 01/19/2021, tube feeds restarted and noted P1 to have abnormal respirations.

8. On 01/20/2021, tube feeds held due to concern for P1 not tolerating them.

9. On 01/21/2021, tube feeds restarted.

10. On 01/24/2021, noted that on 01/23/2021 P1 had 1 episode of emesis (vomiting), G- tube feeds continued.

11. On 01/25/2021, noted that on 01/24/2021, P1 had 3 episodes of emesis feed rate advanced to reach home rate of infusion (speed and volume of feeding introduced into the stomach through the G-tube).

12. On 01/26/2021, noted concern from respiratory therapy that P1 is coughing up feeds and had 1 large-volume episode of emesis. Evaluated by Gastroenterology and recommends converting G-tube to a gastro-jejunal (gastric tube that terminates in a portion of the small intestine, not the stomach allowing for easier absorption of feeds)


D. Record Review of P1's Consult Note-Gastroenterology from 01/26/2021 revealed:

1. Noted that P1 has G-tube feeding intolerance secondary to delayed gastric emptying (slowing down of the stomach's ability to remove food from it)

2. Recommendation to convert from G-tube, to GJ-tube


E. Record Review of P1's Consult Note-Palliative Care (Medical speciality focused on pain and symptom relief) from 02/22/2021 revealed:

1. Indicated that during P1's treatment at the facility they had developed acute respiratory failure (medical emergency where patient has a loss of the ability to breath effectively of support their own oxygen levels) after an aspiration event from his G-tube fed formula. The note continues by reporting that the family has concerns regarding the current feeding tube and have requested to speak to a "specialist" but have not had their requests acknowledged by the treatment team.


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The findings for adequate interpretation are as follows:

A) Interview with Patient #1's legal decision maker revealed that they are Spanish-Speaking and required an interpreter. The complainant states that they aren't being communicated with, they don't understand the need for some of the treatments that have taken place, and also felt "punished" for not knowing English.


B) Record Review of policy on Language Interpreter Services revealed:

1) The patient's primary language and the need for an interpreter will be cited in the patient's chart.

2) If the patient or legal decision-makers cannot understand the contents of notices or documents, the contents will be communicated through a hospital-provided interpreter.

3) The hospital will not use non-qualified interpreters except in unusual circumstances.

4) Circumstances requiring interpreter services include treatments that require permission.

5) Employees who have passed the language-qualifying test administered by the hospital may interpret medical information.

6) The list of qualified employee interpreters is accessible through a link on the facility's intranet.

7) Any Clinical Operations employee may conduct non-medical conversations in a second language only within the scope of their job position. A qualifying test is not required for this, as long as it is non-medical.


C) Record Review of Patient Rights and Responsibilities Notification states:

1) "We may not treat you differently because of your race, creed, age, color, or disability. We must treat you the same no matter your beliefs, home country, gender identity, sexual orientation, religion, or marital status."

2) "We must treat you with dignity and respect. We must also keep you safe and protect you from harm."

3) "We must offer you an interpreter if you do not understand or speak English."

4) "You have the right to know what we think is wrong with you. You also have the right to know your treatment choices. This includes knowing the risks, benefits, and results you may expect."


D) Record review of provider progress notes in patient's chart dated 01/16/21:

1) Documentation reflects provider discussion with Patient #1's legal decision-makers regarding medical status of while using Staff #21 as an in-person interpreter. This note states that items discussed include: explaining changes in care, Blood Transfusion needed to correct anemia (low blood count), edema (fluid build-up) & the use of Lasix (medication for edema), antibiotic medication for pneumonia (bacterial infection of the lungs), the need for oxygen and respiratory care, Chest Physiotherapy (physical tapping on the lungs to help remove fluid), steroid use to bring down swelling and open airways.

2) S21 does not appear on the hospital's list of certified interpreters. Certification provides proof that the acting interpreter is qualified as fluent in the language needed, has passed the courses provided by the facility for medical terminology and translation, can adequately explain medical conditions and treatments available in the preferred language of the patient and patient's family, and have passed the language-qualifying test administered by the hospital qualifying them as dual role interpreters.


E) Record Review of meeting summary on 3/11/21 revealed that the facility plans to apologize to the decision-makers for P1 for not properly utilizing a qualified interpreter and lack of communication.


F) Interview on 03/08/21 in P#1 room reflects the following: during a bladder scan prior to our arrival, P#1's legal decision maker hand, wrote that, 1000 milliliters of urine was retained (held in the bladder & needed to be removed by catheter). Staff #20 (S20) stated she relayed that only 200 milliliters were retained, however they admit that they did not use an interpreter and they are not fluent in the legal decision-maker's preferred language.


G) Record Review on 3/11/21 of Patient #13's (P#13) provider note for 1/5/21 revealed: that in discussing the medical need to transfer patient to another facility out of state, reps from patient's insurance were involved in the conversation with facility staff however, there is no indication of whether an interpreter was used to relay conversation to P13's decision-makers. The outcome of this peer to peer discussion was that the patient would be sent to another hospital in a different state instead.


H) Record Review of chart notes 11/10/20 - 01/06/2021 for P13 reveal: no indication of a language barrier identified in the patient's chart. This section of patient's medical record must be filled in to indicate if Interpreter Services are necessary.

Based on interviews & record reviews, this facility has failed to provide adequate interpretation accommodations for the process of informed consent for 2 (P1 & P13) out of 5 selected patients identified a needing specialty services or procedures during treatment. This failed practice is likely to cause misunderstanding about what is being consented to or withheld.

The findings are:

A) Interview with Patient #1's legal decision maker revealed that they are Spanish-Speaking and required an interpreter. The complainant states that they aren't being communicated with, they don't understand the need for some of the treatments that have taken place, and cannot provide true consent for the treatments.


B) Record Review of policy on Language Interpreter Services revealed:

1) The patient's primary language and the need for an interpreter will be cited in the patient's chart.

2) If the patient or legal decision-makers cannot understand the contents of notices or documents, the contents will be communicated through a hospital-provided interpreter.

3) The hospital will not use non-qualified interpreters except in unusual circumstances.

4) Circumstances requiring interpreter services include treatments that require permission.

5) Employees who have passed the language-qualifying test administered by the hospital may interpret medical information.

6) The list of qualified employee interpreters is accessible through a link on the facility's intranet.

7) Any Clinical Operations employee may conduct non-medical conversations in a second language only within the scope of their job position. A qualifying test is not required only if it is non-medical. All medical conversations must take place with an interpreter.


C) Record Review of Patient Rights and Responsibilities Notification states:

1) "We may not treat you differently because of your race, creed, age, color, or disability. We must treat you the same no matter your beliefs, home country, gender identity, sexual orientation, religion, or marital status."

2) "We must treat you with dignity and respect. We must also keep you safe and protect you from harm."

3) "We must offer you an interpreter if you do not understand or speak English."

4) "You have the right to know what we think is wrong with you. You also have the right to know your treatment choices. This includes knowing the risks, benefits, and results you may expect."


D) Record review of provider progress notes in patient's chart dated 01/16/21:

1) Documentation reflects provider discussion with Patient #1's legal decision-makers regarding medical status of while using Staff #21, MD as an in-person interpreter. This note states that items discussed include: explaining changes in care, Blood Transfusion needed to correct anemia (low blood count), edema (fluid build-up) & the use of Lasix (medication for edema), antibiotic medication for pneumonia (bacterial infection of the lungs), the need for oxygen and respiratory care, Chest Physiotherapy (physical tapping on the lungs to help remove fluid), steroid use to bring down swelling and open airways.

2) S21 does not appear on the hospital's list of certified interpreters. Certification provides proof that the acting interpreter is qualified as fluent in the language needed, has attended the courses provided by the hospital for medical terminology and translation, can adequately explain medical conditions and treatments available in the preferred language of the patient and patient's family, and have passed the language-qualifying test administered by the hospital qualifying them as dual role interpreters.

E) Interview on 03/08/21 of P1's decision-maker and S20 reflect the following: P#1's legal decision maker hand-wrote that during a bladder scan in the morning prior to our arrival, 1000 milliliters of urine were retained (held in the bladder & needed to be removed by catheter). Staff #20 (S20) states she relayed that only 200 milliliters were retained, however they admit that they did not use an interpreter and they are not fluent in the legal decision-maker's preferred language.


F) Record Review on 3/11/21 of Patient #13's (P13) provider note for 1/5/21 revealed that in discussing the medical need to transfer patient to another facility out of state, reps from patient's insurance were involved in the conversation with facility staff however, there is no indication of whether an interpreter was used to relay conversation to P13's decision-makers. The outcome of this peer to peer discussion was that the patient would be sent to another hospital in a different state instead.

G) Record Review of P13's chart notes 11/10/20 - 01/06/2021 reveal no indication of a language barrier identified for education. A preferred language should be noted in all patient's medical charts to indicate if an interpreter will be required.

Based on interviews and record reviews, the facility failed to provide care in a safe setting for 1 (P1) out of 14 patients. This failed practice is likely to lead to increased length of stay, direct and indirect harm, and high chance of mortality.

The findings are:

A. On 03/08/2021 at 9:45 am, interview with P1's legal decision maker revealed that on 02/19/2021 P1 had a right lower extremity X-Ray. During the procedure, the decision maker explained that they were removed from the room by the radiology technician, even though they usually remain in P1's room for the X-Ray while wearing a lead vest. Decision maker stated how they watched from outside the room as P1's leg was manipulated (contorted or positioned) by the radiology technician and that P1 was exhibiting non-verbal signs of extreme pain. After the X-Ray was complete, P1 continued to have pain in the right leg and the decision maker requested imaging of it. Imaging did not occur until 02/21/2021 which revealed a fracture (break).


B. Record Review of P1's Multidisciplinary Summary Form from 2/19/2021-02/22/2021 revealed:

1. On 02/19/2021 at 6:39 pm, note reports that patient was in pain throughout shift even after being administered morphine (pain relief medication) three times.

2. On 02/20/2021 at 6:46 am, note stated "pts [P1] parents expressed concern of pt having pain in right leg, abdomen, and overall discomfort. Pts parents expressed concerns about day team not paying attention to them and not truly listening to what they were saying away well as not truly getting down to the root of his problems " Note also indicates that P1 was uncomfortable and hard to calm most of the night. No documentation of providers notified of concerns.

3. On 02/20/2021 at 7:53 pm, note reported that P1 appears very uncomfortable when being repositioned and that parents are concerned about continued pain.

4. On 02/21/2021 at 6:30 am, note reflected that P1 had severe pain and needed morphine.

5. On 02/21/2021 at 6:14 pm, note stated "Xray was taken today of right knee due to increased swelling. Xray showed a fracture and parents were very distraught and were telling staff that when an xray was taken yesterday on the 19th, that "the person taking the Xray was not gentle with their son" and "was moving his legs with the top of the hip abductor pillow (cushioned wedge placed between the legs of a patient to maintain proper positioning and prevent dislocation of the hip joint.) still belted in on the top while moving his legs outwards". The parents were requesting a incident report be placed and would like a copy as soon as possible."

6. On 02/22/2021 at 6:21am, note stated "mother stated she is frustrated with lack of communication and lack of attention by providers. Frustrated with the femur (thigh bone) fracture. She stated she doesn't feel she is being taken seriously or listened to." Note indicated P1 is uncomfortable, moaning, making incomprehensible (not understandable) sounds, and grimacing (frown or non verbal indication of discomfort).


C. Record Review of P1's Progress Note-Pediatric Inpatient from 02/19/2021-02/23/2021

1. On 02/19/2021, note stated "She [P1's mother] is concerned that his [P1] legs look like they are different heights. Under musculoskeletal (concerning of muscles, bones, ligaments, tendons, and nerves) assessment it indicates that right leg is shorter than the left. Hip X-ray ordered because of this finding.

2. On 02/20/2021, notes stated "They [P1's parents] are concerned about patient's pain and think there might be something seriously wrong with him that has not been identified. They are frustrated watching their son be so uncomfortable and not knowing what is causing it." Musculoskeletal assessment again stated right leg shorter than the left.

3. On 02/21/2021, note stated "Parents at bedside and are emotional about P1's new fracture. The state that nurses have been gentle with maneuvering P1, but strongly believe the manipulation performed during a pervious xray was very rough."

4. On 02/22/2021, note stated "[P1's parents] Extremely upset about what happened during ankle xray. Mom states that when P1 was taken for his xray, she tried to express concern to rad tech about how she was handling P1. Mom and dad watched the tech move P1's leg in a way they felt ortho (orthopedics, medical specialty related to muscles, bones, ligaments, tendons, and nerves) has told them the leg should NOT be moved. Mom and dad feel very sure that is when distal femur (thigh bone) fracture occurred as there was no swelling, warmth, or tenderness in that location prior to ankle xray."


D. On 03/09/2021 at 10:53am, interview with S8 (registered nurse supervisor) indicated that for pediatric patients that are nonverbal, it would be permissible to have their parent of legal guardian present and in the room during xrays and supplied a lead vest for protection. This is because the parents are the patient's biggest advocates and know what their limits and baseline are.


E. Record Review of P1's Inpatient Provider Progress Note- Pediatric Orthopedics from 02/19/2021-02/22/2021 revealed:

1. On 02/19/2021, note indicated swelling to bilateral lower extremities (both legs).

2. On 02/20/2021, note indicated P1's parents concerned about hip and abdominal pain. Note stated "Mother is requesting radiographs (xray) of P1's right foot and ankle. I don't expect there to show anything but will oblige at this time to alleviate concerns" No updated documentation to reflect results of xray.

3. On 02/21/2021, note stated "patient having more RLE (right lower extremity, leg) pain today with a new knee effusion (swelling). Parents extremely concerned." Provider ordered more xrays, no documentation to reflect results or communication with attending and rest of treatment team.

4. On 02/22/2021, note reflected that in the past 24 hours patient was diagnosed with a right distal femur fracture. No documentation on possible etiology or if this was an expected complication.


F. On 03/09/2021 at 2:03pm, interview with S12 (orthopedic resident physician) confirmed they were the ordering provider for P1's ankle, foot, knee, and femur xrays. Stated that P1's mother expressed concern for right leg pain on 02/20/2021, but that xray was only ordered on 02/21/2021 when swelling was noted. S12 confirmed that when a fracture is identified that the ordering provider is usually notified by radiology. Explained that findings were made aware on the day they were ordered, but that there was no need for an addendum to the charting to update this status as orthopedics is consulting, not the primary care team. When prompted about explaining notification of fracture to other members of the care team, S12 was unable to explain how these findings were shared despite being the primary information receiver. S12 noted that the femur fracture was not an expected complication of the surgical intervention on the right hip. When asked about attending physicians being notified of unexpected changes, S12 stated they did notify their attending and attendings must sign all notes they write. However, attending's signature for notes from 02/19/2021-02/22/2021 were dated for 02/25/2021, reflecting a delay in notification.


G. Record Review of P1's Consult Note-Palliative Care from 02/22/2021 revealed:

1. Note stated, "the family noted that this [femur fracture] as a result of manipulation by a radiology technician. Imaging revealed a significant femur fracture resulting in a fair amount of pain and discomfort."

2.Acknowledgement that pain management has been poor from 02/20/2021-02/22/2021 and that the right distal femur fracture is "very likely the source of uncontrolled serve nociceptive pain (pain originating from stimulation)"


H. Record Review of Facility's Safety Intelligence: Q/R Manager Review Form (adverse event narrator and tracking log) for P1 filed on 02/21/2021 revealed:

1. Event type: complication of care (unexpected, non surgical)

2. Event category: unexpected injury

3. Even detail stated "Family reports to MD (medical doctor) that they believe fracture was cause by movement from foot/ankle X-rays that were obtained on 02/20/2021. Family states that pt's leg was twisted during positioning for X-ray."

4. Note section indicated that xray technician's note from 02/21/2021 stated "pt unable to move for imaging due to condition. Pt is strapped to sponge [abductor pillow] limiting ability to position pt. multiple techniques and angles attempted for imaging."

5. Statement from Pediatric Radiologist: "I don't see significant healing response on the femur fracture 2/21/21, which often takes approximately 14 days to being to manifest radiographically" Statement indicated that fracture most likely occurred within 14 days, during which, P1 was under the care of the facility

Based on record review and interview, the facility failed to follow their blood transfusion policy by not obtaining informed consent for blood products by the ordering licensed provider for 9 (P1, 2, 3, 4, 5, 6, 7, 8, 9) out of 14 (P1-P14) patients sampled. This failed practice has the likelihood of a patient receiving a blood product without being informed of the risk of receiving blood products.

Finding are:

A. Record review of facility's policy "Transfusion of Blood or Blood Products" dated 5/2017 revealed:

1. " The ordering LIP (Licensed Provider) is responsible for obtaining informed consent."

2. " Administration: Ensure informed consent has been obtained."


B. Record review of P1 medical chart revealed:

1. On 9/14/20, a Consent for Surgery for bilateral proximal femur orteotomies (surgery to correct specific deformities of the femur leg bone) was charted, the consent to blood transfusion was filled out and signed. It was certified by S37(Licensed Provider) .

2. On 1/18/21, a Consent for Surgery for central line placement and arterial line placement (tubes placed the vein for access to the patients' blood stream) was charted but the consent to blood transfusion was not filled out. It was certified by S38 (Licensed Provider) .

3. On 1/15/21 at 4:39pm, S53(Licensed Provider) ordered 1-unit of red blood cells to be transfused.

4. On 1/26/21 at 7:00am S56(Licensed Provider) ordered 1-unit of red blood cells to be transfused.


C. Record review of P2 medical chart reveled:

1.On 12/17/20 at 9:53am, S44(Licensed Provider) ordered 3 units red blood cells to be transfused.

2. On 12/18/20, a Consent for Surgery for dilation (action to widen or more open) was charted, the consent to blood transfusion was filled out and signed. It was certified by S34 (Licensed Provider) .

3. On 12/18/20 at 8:00am, S43(Licensed Provider) ordered 2 units red blood cells to be transfused.

4. On 12/18/20 at 7:59am, S43(Licensed Provider) ordered 6 units red blood cells to be transfused.

5. On 12/18/20 at 7:59am, S43(Licensed Provider) ordered 1-unit frozen blood product to be transfused.

6. On 12/19/20 a Consent for Surgery for insertion of Nexplanon (medical device that is placed under the skin to distribute medication) was charted, the consent to blood transfusion was filled out and signed. It was certified by S25(Licensed Provider).

7. On 12/19/20 at 12:58pm S25(Licensed Provider) ordered 1-unit red blood cells to be transfused.


D. Record review of P3 medical chart revealed:

1. On 12/19/20, an Emergency Situation Verification and/or Telephone Consent signed by two physicians was charted.

2. On 12/19/20 at 7:47pm, S19 (Licensed Provider) ordered 1 unit of whole blood and 2 unit of plasma to be transfused.

3. On 12/19/20 at 7:22pm, S41 (Licensed Provider) ordered 3 units of red blood cells and 1-unit frozen blood product to be transfused.

4. On 12/20/20 at 12:16pm, S40 (Licensed Provider) ordered 1 unit of plasma to be transfused.

5. On 12/20/20 at 12:15pm, S40 (Licensed Provider) ordered 1 unit of plasma to be transfused.

6. On 12/21/20, a Consent for Surgery was charted but the type of surgery was not filled out and the consent for blood transfusion was not filled out. It was certified by S20 (Licensed Provider).

7. On 12/22/20, a Consent for Surgery for Peripherally Inserted Central Catheter (PICC - a tube that is placed in the vein for access to the patients' blood stream) was charted but the consent for blood transfusion was not filled out. It was certified by S21 (Licensed Provider).

8. On 12/22/20, a Consent for Surgery for right external drain (a tube that is placed in a area that drains fluid from the body) was charted but the consent for blood transfusion was not filled out. It was certified by S22 (Licensed Provider).

9. On 12/26/20, a Consent for Surgery for tracheostomy (a temporary opening in the neck that allows air to enter the lungs), maxillomandibular fixation (a method used to manage facial trauma) was charted but the consent for blood transfusion was not filled out. It was certified by S23 (Licensed Provider).

10. On 1/5/21, a Consent for Surgery for pericardial window (a procedure to remove extra fluid from around the heart) was charted, the consent for blood transfusion was filled out and signed. It was certified by S24 (Licensed Provider).

11. On 1/7/21 at 12:50am, S39 (Licensed Provider) ordered 1 unit of red blood cells to be transfused.


E. Record review of P4 medical chart revealed:

1. On 12/19/20, an Emergency Situation Verification and/or Telephone Consent signed by two physicians was charted.

2. On 12/19/20, at 11:47pm S46 (Licensed Provider) ordered 1-unit of plasma to be transfused.

3. On 12/19/20 at 10:02pm, S46 (Licensed Provider) ordered 1-unit frozen blood product to be transfused.

4. On 12/19/20 at 8:27pm, S47 (Licensed Provider) ordered 1-unit frozen blood product to be transfused.

5. On 12/19/20 at 5:51pm, S19 (Licensed Provider) ordered 1-unit of whole blood and 3 units of red blood cells to be transfused.

6. On 12/19/20 at 5:51pm, S19(Licensed Provider) ordered 2 units of plasma to be transfused.

7. On 12/19/20 at 5:08pm, S48 (Licensed Provider) ordered 3 units of red blood cells to be transfused.

8. On 12/20/20, an Emergency Situation Verification and/or Telephone Consent signed by two physicians was charted.

9. On 12/20/20 at 8:32am, S40 (Licensed Provider) ordered 2 units of platelets to be transfused.

10. On 12/20/20 at 8:31am, S40 (Licensed Provider) ordered 2 units of plasma to be transfused.

11. On 12/20/20 at 2:36am S45 (Licensed Provider) ordered 1-unit of plasma to be transfused.

12. On 12/21/20, a Consent for Surgery for bilateral reduction (to reset a bone or joint) and casting (hard covering to keep the bone or joint in place) was charted but, the consent to blood transfusion was not filled out. It was certified by S26 (Licensed Provider) .


F. Record review of P5 medical chart revealed:

1. On 1/26/21, an Emergency Situation Verification and/or Telephone Consent signed by two physicians was charted.

2. On 1/26/21 at 4:52pm, S50 (Licensed Provider) ordered 2 units of red blood cells and 1-unit whole blood to be transfused.

3. On 1/26/21 at 4:52pm, S50 (Licensed Provider) ordered 2 units of plasma to be transfused.

4. On 1/30/21, a Consent for Surgery for operative exploration (surgery to find a diagnosis for an illness) was charted, the consent for blood transfusion was filled out and signed. It was certified by S29 (Licensed Provider) .


G. Record review of P6 medical chart revealed:

1. On 2/2/21, a Consent for Surgery for total cranial vault (procedure that reshapes the cranial bones) was charted, the consent for blood transfusion was filled out and signed. It was certified by S28 (Licensed Provider).

2. On 3/1/21 at 10:06am, S22 (Licensed Provider) ordered 1-unit of plasma to be transfused.

3. On 3/1/21 at 7:30am, S49 (Licensed Provider) ordered 2 units of red blood cells to be transfused.


H. Record review of P7 medical chart revealed:

1. On 1/19/21, a Consent for Surgery for open repair of Metopic Craniosynostosis (a surgery that repairs a patient's skull) was charted, the consent for blood transfusion was filled out and signed. It was certified by S27 (Licensed Provider).

2. On 2/25/21 at 10:54am, S22(Licensed Provider) ordered 1-unit of plasma to be transfused.

3. On 2/25/21 at 7:42am, S22 (Licensed Provider) ordered 1-unit of red blood cells to be transfused.


I. Record review of P8 medical chart revealed:

1. On 2/21/21, an Emergency Situation Verification and/or Telephone Consent signed by two physicians was charted.

2. On 2/21/21, a Consent for Surgery for laparotomy (abdominal surgery) was charted, the consent for blood transfusion was filled out and signed. It was certified by S36 (Licensed Provider).

3. On 2/21/21 at 8:54am, S58 (Licensed Provider) ordered 1-unit frozen blood product to be transfused.

4. On 2/21/21 at 3:14am, S59 (Licensed Provider) ordered 2 units frozen blood product to be transfused.

5. On 2/21/21 at 2:02am, S59(Licensed Provider) ordered 12 units of red blood cells 25 units of plasma and 6 units of Platelets to be transfused.

6. On 2/21/21 at 1:58am, S60(Licensed Provider) ordered 14 units of red blood cells to be transfused.

7. On 3/1/21 at 9:55am, S57(Licensed Provider) ordered 1-unit of red blood cells to be transfused.


J. Record review of P9 medical chart revealed:

1. On 2/21/21, a Consent for surgery for irrigation and debridement of right leg (a procedure to clean a wound) was charted, the consent for blood transfusion was filled out and signed. It was certified by S30 (Licensed Provider).

2. On 2/21/21, a Consent for Surgery for exam under anesthesia of perineum (procedure that is in the area between the anus and the genitals in which the patient is not awake) was charted, the consent for blood transfusion was filled out and signed. It was certified by S31 (Licensed Provider).

3. On 2/21/21 at 10:10pm, S54(Licensed Provider) ordered 2 units of red blood cells and 1-unit of whole blood to be transfused.

4. On 2/21/21 at 5:50pm, S55 (Licensed Provider) ordered 3 units of red blood cells to be transfused.

5. On 2/22/21, a Consent for Surgery for angiogram (x-ray procedure of the patients' blood vessels) was charted, the consent for blood transfusion was filled out and signed. It was certified by S32 (Licensed Provider).

6. On 2/22/21, a Consent for Surgery for irrigation and debridement of right hip (a procedure to clean a wound) was charted, the consent for blood transfusion was filled out and signed. It was certified by S33 (Licensed Provider).

7. On 2/22/21 at 3:00am, S53(Licensed Provider) ordered 1-unit of red blood cells to be transfused.

8. On 2/23/21, a Consent for Surgery for vaginoscopy (a procedure to view the vaginal canal) was charted but, the consent for blood transfusion was not filled out. It was certified by S34 (Licensed Provider).

9. On 2/23/21, a Consent for Surgery for irrigation and debridement of right leg (a procedure to clean a wound) was charted but the consent for blood transfusion was not filled out. It was certified by S35 (Licensed Provider).

10. On 2/25/21, a Consent for Surgery for exam under anesthesia (an exam where the patient is not awake) was charted but the consent for blood transfusion was not filled out. It was certified by S34 (Licensed Provider).

11. On 3/1/21, a Consent for Surgery for ankle amputation (Removal the ankle) was charted but, the consent for blood transfusion was not filled out. It was certified by S35 (Licensed Provider) .
12. On 3/1/21 at 11:35pm S52(Licensed Provider) ordered 1-unit of red blood cells to be transfused.

13. On 3/2/21 a Consent for Surgery for a wound wash out (a procedure to clean a wound) was charted but, the consent for blood transfusion was not filled out. It was certified by S36(Licensed Provider).

14. On 3/3/21, a Consent for Surgery for irrigation and debridement (a procedure to clean a wound) was charted but the consent for blood transfusion was not filled out. It was certified by S35 (Licensed Provider).

15. On 3/4/21 at 3:35am, S51(Licensed Provider) ordered 2 units of red blood cells to be transfused.


K. On 3/8/21 at 3:30pm, during interview with S10 (Registered Nurse) confirmed that nursing uses the surgical consent form to verify a consent is signed prior to transfusion of any blood product.

L. On 3/9/21 at 10:23am, during interview with S7 (Registered Nurse) comfirmed, that the Blood transfusion process is:

1. get order from provider to transfuse.

2. ensure type and screen (blood test to determine blood type and antibodies in the blood) and consent are done.

3. blood bank states it's ready.

4. blood collection slip sent.

5. IV, tubing, saline ready.

6. Blood on unit.

7. Blood verified by 2 licensed personnel (Lot number, expire date, patient's Medical Record Number, Date of Birth, name) .

8. Cosigned in chart.

9. Nursing stays in room 1st 15mins.

S7 (Registered Nurse) stated that the surgical consent does include the consent for transfusion and it's good until the patient is discharged. S7 (Registered Nurse) also stated that the Unit educator told them that is the process.


M. On 3/9/21 at 11:24am during interview with S9 (Unit Based Educator) confirmed, the Blood Transfusion process is:

1. Print blood policy.

2. Provider writes order.

3.Type and screen sent to blood bank.

4.Request filled by blood bank.

5.Call blood bank for confirmation.

6.Any staff member sent to receive blood.

7.Prior to retrieval of blood, verify consent for blood transfusion, blood levels, and order.

Consent has to be done by licensed provider, able to use surgical consent. Validates concerns regarding using surgical even after not on the same medical team.


N. On 3/9/21 at 10:53am. during interview with S8 (Registered Nurse Supervisor) confimed, nursig utilizes the surgical consent for blood transfusion.









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