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Based on interview, record review, and review of facility policy, it was determined the facility failed to maintain a Governing Body that was effectively managing the facility. The facility admitted Patient #1 on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). According to the facility policy, pre-operative laboratory testing, which included a type and screen (lab test completed prior to administration of blood products) was required prior to surgery. However, the required pre-operative laboratory testing was not completed for Patient #1. After Patient #1's surgery was completed surgery staff did not agree with the Surgeon on the patient's estimated blood loss. The surgery staff failed to report the discrepancy/concern per the follow facility policy.

The findings include:

Record review revealed Patient #1 was transferred to medical/surgical floor at 1:58 PM, where the patient's blood pressure was 70/33. Patient #1 was evaluated by his/her surgeon, after post-operative laboratory results indicated his/her hemoglobin had dropped to 6.7 (normal range 11.8-15.3), and the patients hematocrit was now low at 23.8 (normal range 36.9-46.9). The surgeon ordered blood products STAT (immediately) for Patient #1 at 4:21 PM.

However, Patient #1 had not had a pre-operative type and screen for blood and laboratory testing for the type and screen was ordered STAT at 4:25 PM. Laboratory staff failed to collect the STAT ordered type and screen for Patient #1, until approximately 6:00 PM. The results of the type and screen was not completed until 7:18 PM and the blood was not ready for administration to Patient #1 until 7:40 PM. The blood was not started until 9:00 PM on 03/15/2021 and at 9:28 PM, Patient #1 was in hypovolemia and coded (cardiopulmonary arrest); however, the facility was able to revive Patient #1.

On 03/16/2021 at 12:19 AM, Patient #1's blood pressure dropped to 51/14 and his/her pulse had increased to 119. On 03/16/2021, at 12:25 AM, Patient #1's blood pressure was 69/49 and his/her pulse was 111. At 12:45 AM, approximately 25 minutes after the change in the patient's condition occurred, the nurse had a nurse practitioner (NP) paged due to his/her low blood pressure readings. However, the NP never responded and the nurse failed to take any further action to notify anyone of the change in the patient's condition. Patient #1 went into cardiac arrest again at 1:04 AM on 03/16/2021 and subsequently expired at 1:14 AM.

Refer to A0057

Based on interview, record review, and review of facility policy, it was determined the facility failed to ensure the Chief Executive Officer (CEO), appointed by the Governing Body, was effectively managing the facility. The facility admitted Patient #1 on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). According to the facility policy, pre-operative laboratory testing, which included a type and screen (lab test completed prior to administration of blood products) was required prior to surgery. However, the required pre-operative laboratory testing was not completed for Patient #1. After Patient #1's surgery was completed surgery staff did not agree with the Surgeon on the patient's estimated blood loss. The surgery staff failed to report the discrepancy/concern per the follow facility policy. This deficient practice affected one (1) of nine (9) sampled patients (Patient #1).

The findings include:

Review of the policy titled "QMS Manual and Policy with PI Plan" not dated revealed the Community Chief Executive Officer (CEO) was delegated along with Medical Staff and Leadership to establish, implement and maintain ongoing quality and performance improvement. The policy also stated the facility had developed processes to coordinate effective mechanisms through which the quality and appropriateness of patient care services would be systemically monitored and evaluated pursuing opportunities to improve patient care and resolve identified problems.

Review of Patient #1's record indicated he/she was admitted to the facility on 03/15/2021 for a Panniculectomy; however, there was no evidence a pre-operative lab testing and type and screen had been completed as directed by the facility policy.

Interview with Circulating Nurse (CN) #1, on 03/25/2021 at 3:00 PM, revealed she cared for Patient #1 during surgery on 03/15/2021. She stated the Anesthesiologist had ordered Patient #1's pre-operative laboratory tests but staff was not aware of the patient's tests results until after he/she was taken into the operating room. The CN also stated before the patients surgery had started, she suggested to the Surgeon that a type and screen be collected because the patient's hemoglobin and platelets were low. The CN stated the patient was over four-hundred (400) pounds and this was going to be a "major surgery." However, the nurse stated the surgeon informed her that "he was the physician and he'd order labs if he wanted them."

Review of Patient #1's laboratory results, conducted pre-operatively revealed the patients platelets (a blood component that should react to bleeding thereby initiating the blood to clot) were low at 133,000 (normal range 182-369), his/her hemoglobin (a protein in red blood cells that carries oxygen to the organs/tissues and supplies carbon dioxide from organs/tissues back to the lungs) was also low at 10.9 (normal range 11.8-15.3) and Patient #1's hematocrit (volume percentage of red blood cells in the blood) was 37.9 (normal range 36.9-46.9).

Review of Patient #1's anesthesia record dated 03/15/2021 revealed the patient had lost three hundred and fifty (350) cubic centimeters (cc's) of blood during the procedure, and when he/she arrived in PACU (post-anesthesia care unit) at 12:13 PM, the patients blood pressure was 93/47.

Review of Patient #1's Operative Note completed by Surgeon #1 on 03/15/2021 revealed the patient's procedure had been completed with no complications and fifty four and six tenths (54.6) pounds of skin was removed from the patient. The note also indicated Patient #1's estimated blood loss was 350 cc's.

Interview with Certified Registered Nurse Anesthetist (CRNA) #1, on 03/30/2021 at 11:50 AM, and with Circulating Nurse (CN) #1, on 03/25/2021 at 3:00 PM, revealed staff was not aware of Patient #1's laboratory tests results, until after he/she was taken into the operating room. The CN also stated she suggested to the Surgeon before Patient #1's surgery was started, that a type and screen be collected because the patient's hemoglobin and platelets were low, he/she was over four-hundred (400) pounds and this was going to be a "major surgery." However, the surgeon informed the nurse that "he was the physician and he'd order labs if he wanted them." The CRNA and the CN also stated Patient #1 had "a lot of blood loss" during the procedure and when the surgeon stated to staff to document that Patient #1 had lost 350 cc's of blood, during the procedure the CN asked the surgeon "are you sure?" When the nurse questioned the surgeon's estimated blood loss, he informed the nurse "I said its 350 cc's." The CRNA and CN #1 stated Patient #1 had a minimum blood loss of 1,200 cc's during the procedure and the CRNA stated the surgeon changed his "bloody gown twice" during the patient's surgery. However, the blood loss estimated by the surgeon was documented in Patient #1's medical record by all staff as 350 cc's and neither staff member reported their concerns to supervisory staff as required. Both the CRNA and CN stated they were aware that patient unresolved concerns should be reported to management staff.

According to Patient #1's record, he/she was later transferred/arrived on a medical/surgical floor at 1:58 PM, where his/her blood pressure was 70/33. Review of Patient #1's physician orders on 03/15/2021 revealed a post-operative CBC (complete blood count) was ordered at 2:59 PM and review of the results indicated his/her hemoglobin had dropped to 6.7, and Patient #1's hematocrit was now low at 23.8, at approximately 3:35 PM.

Patient #1 was evaluated by his/her surgeon at approximately 4:00 PM on 03/15/2021 and he was notified of his/her abnormal post-operative lab results. As a result, the surgeon ordered two (2) units of blood and two (2) units of fresh frozen plasma (FFP) STAT (immediately) for Patient #1 at 4:21 PM. Interviews with staff indicated, Patient #1 had not had a pre-operative type and screen for blood, so the test was ordered STAT at 4:25 PM.

Interview with Registered Nurse (RN) #3, on 3/24/2021 at 4:25 PM, revealed STAT orders for blood products were received at 4:21 PM on 3/15/2021. However, she realized no type and screen had been done pre-operatively so an order was entered to obtain one, at 4:25 PM on 3/15/2021, which was required before blood products could be administered to the patient. RN #3 stated, an hour after the orders were entered, no one from lab had come to collect Patient #1's blood and she called the lab to inquire about the patients needed labs at approximately 5:30 PM (approximately one hour after the stat orders were entered). However, RN #3 stated Patient #1's labs were not drawn until around 6:00 PM (approximately one hour and a half after the orders were entered).

Review of Physician Assistant (PA) #1's documentation on 03/15/2021 at 6:20 PM, revealed staff had informed her of Patient #1's continued low blood pressure (72/34 at 6:29 PM). According to the documentation, the PA contacted the lab regarding the patients STAT orders for blood products that were ordered approximately two (2) hours prior, and was informed that the "stat Type and Screen had not even" been completed yet. PA #1's documentation revealed the PA informed Patient #1's surgeon of the delay in the administration of blood to the patient and the administration of "pressors" (medication to raise the blood pressure) to Patient #1 was discussed from the PA to the Surgeon. However, the Surgeon informed the PA that "pressors" could cause substantial damage to the surgical site and the patient needed blood products, which were ordered at 4:21 PM. PA #1's documentation indicated another fluid bolus would be administered to Patient #1 "as we await blood products." PA #1 also ordered staff to transfer Patient #1 to the Intensive Care Unit (ICU) on 03/15/2021 at 7:06 PM. According to the PA, she reported the type and screen delay to the surgeon but was not aware that she should have reported unresolved concerns to management or administrative staff.

Further review of Patient #1's record revealed the patients STAT ordered type and screen was not collected until approximately 6:00 PM, and the results was not completed until 7:18 PM, approximately three (3) hours after the test was ordered STAT. Patient #1's record also indicated the blood was not ready for administration until 7:40 PM, more than three (3) hours after the STAT orders were received.

Interview with the Director of Laboratory Services on 03/30/2021 at 11:00 AM revealed emergency lab services were available for facility patients twenty-four (24) hours a day/seven (7) days a week. The Director also stated Patient #1's STAT ordered labs should have been collected and back in the lab, ready for processing within thirty (30) minutes, so results were ready within an hour of the time the orders were received. The Director stated she was always on-call and staff (lab or nurses) could call her for any problems.

However, review of Patient #1's record revealed even though the blood was ready for administration at 7:40 PM, staff failed to initiate administration of Patient #1's first unit of blood until approximately 9:00 PM. Record review also indicated Patient #1 went into cardiac arrest at approximately 9:38 PM, when the first unit of blood was being transfused, and staff were subsequently able to revive the patient.

Further review of Patient #1's record indicated at 12:19 AM on 03/16/2021, Patient #1's blood pressure dropped to 51/14 and his/her pulse had increased to 119; However, staff failed to inform the patient's physician of the change in his/her condition. The record indicated Patient #1's blood pressure continued to be low on 03/16/2021 as follows; at 12:25 AM, his/her blood pressure was 69/49 and the patients pulse was 111; at 12:30 AM, the patient's blood pressure was 60/30 and his/her pulse was 100. The record also revealed at 12:45 AM on 03/16/2021 (approximately 25 minutes after the change in the patient's condition occurred) the RN had NP #1 paged due to the patient's low blood pressure readings. However, the record provided no evidence that the provider responded and no evidence that the RN took any further action to notify the provider of the change in Patient #1's condition.

Further Review of Patient #1's record revealed the patients' condition continued to deteriorate and he/she subsequently had cardiac arrest again at 1:04 AM on 03/16/2021. Patient #1's record indicated he/she was pronounced deceased at 1:14 AM on 3/16/2021.

Interview with RN #5, on 03/25/2021 at 10:30 AM, confirmed he identified a change in Patient #1's condition on 03/16/2021 at approximately 12:35 AM when he was unable to obtain a blood pressure on the patient. He stated he called the operator and had the in-house Nurse Practitioner (NP) #1 paged at approximately 12:45 AM however the NP never responded and acknowledged he never took any further action to inform the NP of Patient #1's change in condition. He stated the patient's condition continued to deteriorate and he/she "coded" again at approximately 1:04 AM on 03/16/2021 and the NP then responded to the overhead page of the "code" in the ICU. RN #5 stated he should have overhead paged the NP when the provider failed to respond when the change in the patient's condition was initially identified.

Interview with the Chief Nursing Officer (CNO) on 04/05/2021 at 2:35 PM revealed surgical staff should have "stopped the line" when the surgeon would not "ok a type and screen" before Patient #1's surgery was initiated and when there was a discrepancy of Estimated Blood Loss (EBL) stated by the surgeon. She stated both issues should have reported immediately to supervisory staff in the Operating Room (OR) so actions could have been taken at that time, which could have potentially ensured a better outcome for Patient #1. The CNO also stated Patient #1's labs should have been obtained STAT as ordered, and the patient's blood products should have been started immediately when nursing staff was notified they were available for administration. The CNO also stated Patient #1's provider should have been notified immediately when a change in condition occurred again on 03/16/2021, when the patient's condition continued to deteriorate. She also stated patients had the right to receive care/treatment in a safe setting, and also stated care should be provided as outlined in the facility policies and per standards of healthcare practices.

A post-survey interview with the CEO, on 04/21/2021 at 1:30 PM revealed he was not a member of the Governing Body, however stated he attended the meetings and was responsible for the daily operations of the facility. The CEO also stated he was responsible to ensure care provided to patients in the facility was provided per standards of practice and as outlined in the facility policies and processes for all departments. The CEO stated he was not aware of any concerns related to delays in Laboratory Services, or any "real concerns specific to patient care" from the Nursing Department. He also stated he was not aware of any concerns related to care provided by Surgeon #1 and had not been informed of any concerns related Surgical services provided in the facility. The CEO also stated he was not aware of any concerns related to Patient Rights in the facility, until the concerns were identified related to care and treatment and services provided to Patient #1.

Based on interview, record review and review of the facility policies, it was determined the facility failed to implement facility policies to ensure care was provided in a safe setting for one (1) of nine (9) sampled patients (Patient #1).

The findings include:

The facility admitted Patient #1 on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). According to the facility policy, pre-operative laboratory testing, which included a type and screen (lab test completed prior to administration of blood products) was required prior to surgery. The surgeon had not conducted the required pre-operative laboratory testing. During the pre-anesthesia assessment, the anesthesiologist ordered a Complete Blood Count (CBC) and Basic Metabolic Panel (BMP). Interviews indicated Patient #1 was taken to the operating room, prior to staff acknowledging the results of the testing. When the circulating nurse obtained the patients laboratory results, she noted that Patient #1's hemoglobin and platelets were low, and asked Surgeon #1 if a type and screen was needed due to the abnormal laboratory results and the extent of the patients surgery. However, the surgeon did not want to obtain any further laboratory testing and started the procedure for Patient #1. The surgeon failed to follow facility policy and order the type and screen and the circulating nurse failed to advocate for the patient when the surgeon failed to follow the facility policy.

Interviews indicated after Patient #1's procedure was complete, the Certified Registered Nurse Anesthetist (CRNA), and the Circulating Nurse, did not agree with Surgeon #1's estimated blood loss of 350 cubic centimeter (cc)'s and stated they would have estimated the blood loss to be approximately 1200cc's. However, surgery staff (CRNA and CN) failed to ensure the discrepancies/concerns were reported and addressed as outlined in the Chain of Command Patient Care issue policy.

Record reviews and interviews indicated Patient #1 arrived in PACU (Post Anesthesia Care Unit) at 12:13 PM, with a blood pressure of 93/47, and he/she was later transferred/arrived on a medical/surgical floor at 1:58 PM, where the patient's blood pressure was 70/33. Review of the record also revealed Patient #1 was evaluated by his/her surgeon, after post-operative laboratory results indicated his/her hemoglobin had dropped to 6.7 (normal range 11.8-15.3), and the patients hematocrit was now low at 23.8 (normal range 36.9-46.9). The surgeon ordered blood products STAT (immediately) for Patient #1 at 4:21 PM.

However, Patient #1 had not had a pre-operative type and screen for blood and laboratory testing for the type and screen was ordered STAT at 4:25 PM. Continued interviews and record reviews indicated laboratory staff failed to collect the STAT ordered type and screen for Patient #1, until approximately 6:00 PM, which further delayed blood administration for the patient. The results of the type and screen was not completed until 7:18 PM, approximately two (2) hours after the laboratory test was ordered STAT, and the blood was not ready for administration to Patient #1 until 7:40 PM, which further delayed blood being available for administration to Patient #1. Registered Nurse (RN) #3, Physician Assistant (PA) #1 and the Surgeon were all aware the ordered laboratory tests for type and screen were not completed per the STAT policy and timeframe, yet neither advocated and reported the delay per the chain of command to resolve the problem.

Interviews and record reviews revealed the facility failed to ensure the blood was initiated for Patient #1 until approximately 9:00 PM, and at 9:28 PM, Patient #1 was in hypovolemia and coded (cardiopulmonary arrest); however, the facility was able to revive Patient #1.

Review of Patient #1's record revealed on 03/16/2021 at 12:19 AM, the patient's blood pressure dropped to 51/14 and his/her pulse had increased to 119. However, there was no evidence the physician was notified of the change in the patient's condition and the record indicated the patient's blood pressure continued to be low. On 03/16/2021, at 12:25 AM, Patient #1's blood pressure was 69/49 and his/her pulse was 111, and at 12:45 AM, approximately 25 minutes after the change in the patient's condition occurred, the nurse had a nurse practitioner (NP) paged due to his/her low blood pressure readings. However, the NP never responded and the nurse failed to follow the chain of command policy or take any further action to notify anyone of the change in the patient's condition. Patient #1 went into cardiac arrest again at 1:04 AM on 03/16/2021 and subsequently expired at 1:14 AM.

Refer to A0144.

Based on interview, record review and review of the facility policies, it was determined the facility failed to implement facility policies to ensure care was provided in a safe setting for one (1) of nine (9) sampled patients (Patient #1).

The findings include:

Review of the facility policy titled "Patient Rights and Responsibilities" not dated indicated patients could expect reasonable safety in as far as the hospital practices and facility environment was concerned. The policy also stated the facility was required to provide patients with evaluation and services, as indicated by the urgency of the patient's case.

Review of the facility policy titled "Chain of Command for Patient Care Issues: Escalation Policy" dated 12/28/2015 revealed the facility was committed to providing safe, quality patient care and also stated the healthcare team was obligated to work toward resolution of identified real/potential problems within the system in which patient care could be affected. If the team member was unable to resolve issues independently, the policy stated the team member was obligated to present the issue to successively higher levels of command, in a timely manner, until a satisfactory resolution was achieved for the patient. According to the policy, all staff were responsible to advocate for the patient at all times and were responsible to implement the chain of command procedures to resolve issues when the safety of facility patients became affected or the delivery of patient care could result in an adverse patient outcome. The policy also stated whenever there were questions/concerns regarding patient care, the situation should be discussed with colleagues to ensure the concerns were valid. If concerns were found to be valid, then the concerned staff should address the concerns with the involved provider to clarify the issue/concerns and attempt to resolve the problem. The policy stated if staff continued to have concerns, supervisory staff (charge nurse, nurse manager or house supervisor) should be notified to assess the situation, and if concerns were not resolved at that time, then the Chief Nursing Officer (CNO) or the administrative staff on call, should be notified.

Review of the facility policy titled "Assignment of Nursing Care" not dated, revealed every patient received an assignment of care by the RN. According to the policy, the RN should plan, evaluate, supervise, participate and coordinate the nursing care of each patient.

Review of the facility policy titled "Scope of Services" last revised in February 2020, stated procedures that were essential for immediate patient care were available twenty-four hours/day, seven days a week, on a STAT basis. The policy further indicated all STAT laboratory results should be reported within one hour from the receipt of the orders in the lab.

Review of the facility policy titled "Pre-Operative Testing" dated August, 2018 revealed blood tests, which included a type and screen were required to be completed within four (4) days of the procedure, when a blood loss was expected to occur.

Review of Patient #1's record indicated he/she was admitted to the facility on 03/15/2021 for a Panniculectomy; however, there was no evidence a pre-operative lab testing and type and screen had been completed as directed by the facility policy.

Interview with the Anesthesiologist on 3/24/2021 at 2:07 PM revealed he completed a pre-operative assessment of Patient #1 on 03/15/2021, and ordered a CBC and BMP. The Anesthesiologist stated he was unaware of any "protocol" for any specific pre-operative laboratory tests to be completed at the facility, and stated he ordered laboratory tests that he deemed necessary.

Interview with Circulating Nurse (CN) #1, on 03/25/2021 at 3:00 PM, revealed she cared for Patient #1 during surgery on 03/15/2021. She stated the Anesthesiologist had ordered Patient #1's pre-operative laboratory tests but staff was not aware of the patient's tests results until after he/she was taken into the operating room. The CN also stated before the patient's surgery had started, she suggested to the Surgeon that a type and screen be collected because the patient's hemoglobin and platelets were low. The CN stated the patient was over four-hundred (400) pounds and this was going to be a "major surgery." However, the nurse stated the surgeon informed her that "he was the physician and he'd order labs if he wanted them."

Review of Patient #1's laboratory results, conducted pre-operatively revealed the patient's platelets (a blood component that should react to bleeding thereby initiating the blood to clot) were low at 133,000 (normal range 182-369), his/her hemoglobin (a protein in red blood cells that carries oxygen to the organs/tissues and supplies carbon dioxide from organs/tissues back to the lungs) was also low at 10.9 (normal range 11.8-15.3) and Patient #1's hematocrit (volume percentage of red blood cells in the blood) was 37.9 (normal range 36.9-46.9).

Review of Patient #1's anesthesia record dated 03/15/2021 revealed his/her surgical procedure was started at approximately 9:12 AM on 03/15/2021, and was completed at approximately 12:00 PM. Patient #1's pre-operative blood pressure reading was 169/73 (average normal range 120/80), and according to the record, Phenylephrine (medication to raise the blood pressure) was administered to Patient #1, on three (3) different occasions during the approximate three (3) hour procedure. Review of the anesthesia record also indicated Patient #1 had lost three hundred and fifty (350) cubic centimeters (cc's) of blood during the procedure, and when he/she arrived in PACU (post-anesthesia care unit) at 12:13 PM, the patient's blood pressure was 93/47.

Review of Patient #1's Operative Note completed by Surgeon #1 on 03/15/2021 revealed the patient's procedure had been completed with no complications and fifty four and six tenths (54.6) pounds of skin was removed from the patient. The note also indicated Patient #1's estimated blood loss was 350 cc's.

Interview with Certified Registered Nurse Anesthetist (CRNA) #1, on 03/30/2021 at 11:50 AM, and with Circulating Nurse (CN) #1, on 03/25/2021 at 3:00 PM, revealed staff was not aware of Patient #1's laboratory tests results, until after he/she was taken into the operating room. The CN also stated she suggested to the Surgeon before Patient #1's surgery was started, that a type and screen be collected because the patient's hemoglobin and platelets were low, he/she was over four-hundred (400) pounds and this was going to be a "major surgery." However, the surgeon informed the nurse that "he was the physician and he'd order labs if he wanted them." The CRNA and the CN also stated Patient #1 had "a lot of blood loss" during the procedure and when the surgeon stated to staff to document that Patient #1 had lost 350 cc's of blood during the procedure, the CN asked the surgeon "are you sure?" When the nurse questioned the surgeons estimated blood loss, he informed the nurse "I said its 350 cc's." The CRNA and CN #1 stated Patient #1 had a minimum blood loss of 1,200 cc's during the procedure and the CRNA stated the surgeon changed his "bloody gown twice" during the patient's surgery. However, the blood loss estimated by the surgeon was documented in Patient #1's medical record by all staff as 350 cc's and neither staff member reported their concerns to supervisory staff as required. Both the CRNA and CN stated they were aware that unresolved patient concerns should be reported to management staff.

Interview with Patient #1's daughter, on 03/24/2021 at 7:30 PM, revealed Surgeon #1 called her on 03/15/2021 at approximately 12:00 PM and informed her that the patient had "lost a lot of blood," during surgery. She stated she reminded the surgeon Patient #1 "was anemic" and asked him if he was "going to give" him/her some "blood." The daughter stated the surgeon informed her they were giving the patient some fluids because his/her blood pressure was low, and if that did not work, he reassured her blood would be administered to the patient.

According to Patient #1's record, he/she was later transferred/arrived on a medical/surgical floor at 1:58 PM, where his/her blood pressure was 70/33. Review of nurses notes on 03/15/2021 at 3:01 PM revealed Anesthesia and Patient #1's provider were notified of his/her low blood pressure readings, and orders were received for Albumin (a blood transport protein) 12.5 grams (gms) to be administered in 250 cubic centimeters (cc's), one (1) dose only at 2:17 PM and a 2,000 cc normal saline bolus to be administered at 2:59 PM.

Review of Patient #1's physician orders on 03/15/2021 revealed a post-operative CBC (complete blood count) was ordered at 2:59 PM and review of the results indicated his/her hemoglobin had dropped to 6.7, and Patient #1's hematocrit was now low at 23.8, at approximately 3:35 PM.

Patient #1 was evaluated by his/her surgeon at approximately 4:00 PM on 03/15/2021 and he was notified of his/her abnormal post-operative lab results. As a result, the surgeon ordered two (2) units of blood and two (2) units of fresh frozen plasma (FFP) STAT (immediately) for Patient #1 at 4:21 PM. Interviews with staff indicated, Patient #1 had not had a pre-operative type and screen for blood, so the test was ordered STAT at 4:25 PM.

Interview with Registered Nurse (RN) #3, on 3/24/2021 at 4:25 PM, revealed she admitted Patient #1 to the medical floor on 03/15/2021 at approximately 1:50 PM, and the patient was lethargic/pale in color, and his/her blood pressure was low at 70/33. RN #3 stated the surgeon evaluated Patient #1 at the bedside at approximately 4:00 PM and was notified of the abnormal post-operative labs. The RN stated STAT orders for blood products were received at 4:21 PM on 3/15/2021. However, she realized no type and screen had been completed pre-operatively so an order was entered to obtain one, at 4:25 PM on 3/15/2021, which was required before blood products could be administered to the patient. RN #3 stated, an hour after the orders were entered, no one from lab had come to collect Patient #1's blood and she called the lab to inquire about the patient's needed labs at approximately 5:30 PM (approximately one hour after the stat orders were entered). However, RN #3 stated Patient #1's labs were not drawn until around 6:00 PM (approximately one and a half hours after the orders were entered). Per the RN, she knew to report patient concerns to the provider/physician but did not know she should have reported unresolved patient concerns to management staff.

Review of PA #1's documentation on 03/15/2021 at 6:20 PM, revealed staff had informed her of Patient #1's continued low blood pressure (72/34 at 6:29 PM). According to the documentation, the PA contacted the lab regarding the patient's STAT orders for blood products that were ordered approximately two (2) hours prior, and was informed that the "stat Type and Screen had not even" been completed yet. PA #1's documentation revealed the PA informed Patient #1's surgeon of the delay in the administration of blood to the patient and the administration of "pressors" (medication to raise the blood pressure) to Patient #1 was discussed from the PA to the Surgeon. However, the Surgeon informed the PA that "pressors" could cause substantial damage to the surgical site and the patient needed blood products, which were ordered at 4:21 PM. PA #1's documentation indicated another fluid bolus would be administered to Patient #1 "as we await blood products." PA #1 also ordered staff to transfer Patient #1 to the Intensive Care Unit (ICU) on 03/15/2021 at 7:06 PM. According to the PA, she reported the type and screen delay to the surgeon but was not aware that she should a have reported unresolved concerns to management or administrative staff.

Further review of Patient #1's record revealed the patients STAT ordered type and screen was not collected until approximately 6:00 PM, and the results were not completed until 7:18 PM, approximately three (3) hours after the test was ordered STAT. Patient #1's record also indicated the blood was not ready for administration until 7:40 PM, more than three (3) hours after the STAT orders were received.

However, review of Patient #1's record revealed even though the blood was ready for administration at 7:40 PM, staff failed to initiate administration of Patient #1's first unit of blood until approximately 9:00 PM. Record review also indicated Patient #1 went into cardiac arrest at approximately 9:38 PM, when the first unit of blood was being transfused, and staff were subsequently able to revive the patient.

Interview with RN #5, on 03/25/2021 at 10:30 AM, revealed he admitted Patient #1 to the ICU on 03/15/2021 at approximately 8:15 PM, and also stated the patient was pale and "you could tell" he/she was "anemic" (a decreased amount of red blood cells or hemoglobin in the blood). RN #5 stated he obtained the patient's first unit of blood from the laboratory and subsequently started the first unit of blood at approximately 9:00 PM. The RN stated Patient #1 went into cardiac arrest at approximately 9:38 PM; however, stated he/she showed no signs/symptoms of an adverse blood reaction. The RN also stated NP #1 was at the bedside after the patient went into cardiac arrest and the nurse was ordered to rapidly infuse the remaining blood in the first unit. The second unit of blood was retrieved from the lab and was also rapidly infused which was initiated at approximately 10:00 PM. RN #5 also stated Patient #1's first unit of STAT ordered FFP's were initiated at approximately 10:30 PM and both units had been transfused at approximately 11:00 PM on 03/15/2021.

Further review of Patient #1's record indicated at 12:19 AM on 03/16/2021, Patient #1's blood pressure dropped to 51/14 and his/her pulse had increased to 119; However, staff failed to inform the patient's physician of the change in his/her condition. The record indicated Patient #1's blood pressure continued to be low on 03/16/2021 as follows; at 12:25 AM, his/her blood pressure was 69/49 and the patients pulse was 111; at 12:30 AM, the patient's blood pressure was 60/30 and his/her pulse was 100. The record also revealed at 12:45 AM on 03/16/2021 (approximately 25 minutes after the change in the patient's condition occurred) the RN had NP #1 paged due to the patient's low blood pressure readings. However, the record provided no evidence that the provider responded and no evidence that the RN took any further action to notify the provider of the change in Patient #1's condition.

Further Review of Patient #1's record revealed the patients' condition continued to deteriorate and he/she subsequently had cardiac arrest again at 1:04 AM on 03/16/2021. Patient #1's record indicated he/she was pronounced deceased at 1:14 AM on 3/16/2021.

Continued interview with RN #5, on 03/25/2021 at 10:30 AM, confirmed he identified a change in Patient #1's condition on 03/16/2021 at approximately 12:35 AM when he was unable to obtain a blood pressure on the patient. He stated he called the operator and had the in-house Nurse Practitioner (NP) #1 paged at approximately 12:45 AM; however, the NP never responded and acknowledged he never took any further action to inform the NP of Patient #1's change in condition. He stated the patient's condition continued to deteriorate and he/she "coded" again at approximately 1:04 AM on 03/16/2021 and the NP then responded to the overhead page of the "code" in the ICU. RN #5 stated he should have overhead paged (audio announcement heard throughout the facility) the NP when the provider failed to respond when the change in the patients' condition was initially identified.

Interview with NP #1, on 03/26/2021 at 12:25 PM, revealed the first time he saw Patient #1, on 03/15/2021 he/she was "a code blue" and stated the patient was pale in color and was in "hypovolemic shock." The NP also stated the nurse should have notified him immediately when the second change in the patient's condition occurred. The NP stated anytime a patient's blood pressure was low, he should be notified and also stated he did not recall receiving a notification related to the change in Patient #1's condition, prior to the patients second "code". However, NP #1 stated he could have been paged overhead and would have immediately responded to the change in Patient #1's condition.

Interview with the Director of Laboratory Services on 03/30/2021 at 11:00 AM revealed emergency lab services were available for facility patients twenty-four (24) hours a day/seven (7) days a week. The Director also stated Patient #1's STAT ordered labs should have been collected and back in the lab, ready for processing within thirty (30) minutes, so results were ready within an hour of the time that the orders were received. The Director stated she was always on-call and staff (lab or nurses) could call her for any problems.

Interview with the Chief Nursing Officer (CNO) on 04/05/2021 at 2:35 PM revealed surgical staff should have "stopped the line" when the surgeon would not "ok a type and screen" before Patient #1's surgery was initiated and when there was a discrepancy of estimated blood loss (EBL) stated by the surgeon. She stated both issues should have been reported immediately to supervisory staff in the Operating Room (OR) so actions could have been taken at that time, which could have potentially ensured a better outcome for Patient #1. The CNO also stated Patient #1's labs should have been obtained STAT as ordered, and the patient's blood products should have been started immediately when nursing staff was notified they were available for administration. The CNO also stated Patient #1's provider should have been notified immediately when a change in condition occurred again on 03/16/2021, when the patient's condition continued to deteriorate. She also stated patients had the right to receive care/treatment in a safe setting, and also stated care should be provided as outlined in the facility policies and per standards of healthcare practices.

Interview with the Surgeon on 03/31/2021 at 8:20 AM revealed Patient #1 was evaluated at a larger hospital for a Panniculectomy and the physicians there declined to perform the patient's surgery and wanted the patient to "lose weight first." However, he felt he could do the surgery because the surgery would be "life changing" for Patient #1. He stated his biggest concern pre-operatively for Patient #1 was his/her low vitamin levels, which would affect wound healing. The surgeon acknowledged Patient #1 had a diagnoses of Anemia and his/her hemoglobin and platelets were low pre-operatively; however, stated that was not a concern. The Surgeon stated he did not recall anyone suggesting a type/screen pre-operatively for Patient #1. However, Surgeon #1 stated "hind sight is 20/20" and "retrospectively" he should have ordered a type and screen pre-operatively for Patient #1 because it "took a lot of time for the patient to get blood products post-operatively." The surgeon stated he was unaware of the policy for pre-surgery labs. He stated that he ordered labs that he saw necessary. The surgeon also stated Patient #1 "lost 350 cc's of blood for sure" during the procedure and he did not recall anyone questioning the estimated blood loss in the operating room for Patient #1. He stated he should have ordered emergency release blood to be administered to Patient #1 due to the delays in his/her blood getting drawn for a type and screen, and blood being available to the patient, and the patient's continued low pressure readings post-operatively. He stated he had not reported the delay in laboratory staff obtaining the patient's type and screen STAT to anyone, and expected staff to implement his orders as they were written. He stated he was not aware of the need to report unresolved patient concerns to administrative/management staff. However, stated he could not say if receiving the blood products in a timely manner would have changed the outcome for Patient #1. Surgeon #1 stated Patient #1 had the right to receive care in a safe setting, and also stated facility policies as well as standards of practice should have been followed/implemented when care was provided to Patient #1.

Interview with the Chief of Surgery on 03/29/2021 at 2:03 PM revealed pre-operative laboratory tests, to include type/screens should have been obtained for Patient #1. He also stated he would have cancelled Patient #1's surgery, if he would have been aware of his/her pre-operative abnormal laboratory results. He also stated staff should have reported any identified discrepancies with Patient #1's estimated blood loss immediately to the OR supervisor so the patient's case could have been investigated. The Chief of Surgery, stated its standard of practice for surgeons to be aware of and be monitoring blood loss amounts when surgeries are conducted. He also stated if blood loss was a concern for Patient #1 during the procedure, labs should have been ordered from the OR to check what the patient's status was, so if Patient #1 needed blood, it could have been replenished at that time.

Interview with the Medical Chief of Staff on 03/30/2021 at 4:30 PM revealed he also conducted surgical procedures at the facility and stated Patient #1's procedure should not have been conducted at the facility. He stated if Patient #1 had been "turned down" at a bigger facility, he would have told the patient that he/she was too high risk and he/she could die. He also stated Patient #1 wouldn't have necessarily had to have a pre-operative type/screen; however stated staff should have reported the discrepancy in the surgeon's EBL to supervisory staff immediately because if a patient loses 1,000 cc's or more, during a procedure "we should think about giving blood and FFP's." He also stated if a patient loses 1,000 cc's or more during a procedure, a STAT hemoglobin should have been drawn and took to lab for processing from the OR. The Medical Chief of staff stated waiting four (4) hours after a surgical case was over, to obtain post-operative labs was "too long," especially if the surgeon had informed the patient's family that he/she "had lost a lot of blood" during the procedure. The Medical Chief of Staff also stated physicians should not write STAT orders and "sit there." He also stated it seemed a lot of people were involved in Patient #1's case, however "no one was in charge." The Chief of Staff also stated STAT to him meant labs would be drawn and to the lab in 10-15 minutes. Per the Chief of Staff, Patient #1's labs should have been done "quickly" and emergency release blood as well as "pressors" to raise his/her blood pressure, should have been administered to Patient #1, because his/her clinical status continued to deteriorate. He also stated someone should have identified that the laboratory delays as well as the nursing delays were "killing the patient." He stated Patient #1 had a right to receive care in a safe setting and staff should have followed the facility policies, to assist in ensuring a better outcome for Patient #1.

Based on observation, interview, record review and a review of facility policy it was determined the facility failed to ensure the medical staff was well organized and accountable to the governing body for the quality of the medical care provided to one (1) of nine (9) sampled patients (Patient #1).

The findings include:

Record review revealed the facility admitted Patient #1 on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). According to the facility policy and interview with the Chief of Surgery, pre-operative laboratory testing which included a type/screen was required before every surgery in which blood loss was expected. However, Surgeon #1 failed to complete the pre-operative laboratory testing. During the pre-anesthesia assessment, the Anesthesiologist ordered a Complete Blood Count (CBC) and Basic Metabolic Panel (BMP). Interviews revealed the facility staff transferred Patient #1 to the operating room, before staff acknowledged the results of the laboratory testing. Interviews revealed when the circulating nurse obtained Patient #1's laboratory results, she noted that the patient's hemoglobin and platelets were low, and asked Surgeon #1 if a type/screen was needed due to the abnormal laboratory results and the extent of the patient's surgery. However, the surgeon told the nurse he did not want any further laboratory testing and started the procedure on Patient #1.

Interviews indicated after Patient #1's procedure was complete, the Certified Registered Nurse Anesthetist (CRNA), and the Circulating Nurse, as well as a surgical first assist, did not agree with Surgeon #1's estimated blood loss of 350 cubic centimeter (cc)'s and stated they would have estimated the blood loss to be approximately 1200 cc's. However, staff failed to ensure the discrepancies/concerns were reported and addressed.

Record review revealed Patient #1 arrived in PACU (post-anesthesia care unit) at 12:13 PM with a blood pressure of 93/47, then was transferred/arrived on a medical/surgical floor at 1:58 PM, where his/her blood pressure was 70/33. Blood products were ordered STAT for Patient #1 at 4:21 PM after standard post-operative laboratory results revealed the patient's hemoglobin had dropped to 6.7 and hematocrit was also low at 23.8. However, since the pre-operative required type and screen had not been ordered for Patient #1, blood administration for the patient was delayed. Both Surgeon #1 and PA#1 were aware of the blood administration delay for Patient #1 but both failed to take any further action to ensure the blood was administered STAT.

The facility initiated blood for Patient #1 at 9 PM. However, the patient coded (cardiopulmonary arrest) at 9:28 PM due to hypovolemic shock. The facility was able to revive the patient; however, he/she coded again at 1:04 AM and was pronounced deceased at 1:14 AM on 03/16/2021.

Refer to A0347.

Based on observation, interview, record review and a review of facility policy it was determined the facility failed to ensure the medical staff was well organized and accountable to the governing body for the quality of the medical care provided to one (1) of nine (9) sampled patients (Patient #1).

The findings include:

Review of the facility policy titled "Medical Staff Bylaws" revised April, 2018 revealed the Chief of Staff was responsible to act in coordination with the Community Chief Executive Officer (CEO) in all matters of medical concern within the hospital. Review of the bylaws also revealed the Chief of Staff was responsible for the enforcement of the Medical Staff Bylaws, Rules and Regulations. The Chief of Staff was also responsible individually or through his/or designee to receive and interpret the policies of the Governing Body for the medical staff and to report to the governing body on the performance and maintenance of quality, with respect to the medical staffs delegated responsibility to provide medical care.

Review of the facility policy titled "Pre-Operative Testing" dated August, 2018 revealed blood tests, which included a type/screen were required to be completed within four (4) days of the procedure, when a blood loss was expected to occur.

The facility admitted Patient #1 on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). According to the facility policy, Surgeon #1 should have ordered pre-operative laboratory testing, which included a type and screen (lab test completed prior to administration of blood products) prior to Patient #1's surgery. However, the surgeon failed to conduct the required pre-operative laboratory testing.

Review of Patient #1's medical record and Interview with the Anesthesiologist on 3/24/2021 at 2:07 PM revealed he completed the patient's pre-operative assessment on 03/15/2021, and ordered a CBC (Complete Blood Count) and BMP (Basic Metablolic Panel). The Anesthesiologist stated he was not aware that the facility policy directed medical staff to ensure a type/screen was completed within four (4) days of a procedure when a blood loss was expected to occur.

Review of Patient #1's pre-operative laboratory results revealed his/her platelets (a blood component that should react to bleeding thereby initiating the blood to clot) were low at 133,000 (normal range 182,000-369,000), and his/her hemoglobin (a protein in red blood cells that carries oxygen to the organs/tissues and supplies carbon dioxide from organs/tissues back to the lungs) was also low at 10.9 (normal range 11.8-15.3).

Interview with Certified Registered Nurse Anesthetist (CRNA) #1, on 03/30/2021 at 11:50 AM, and with Circulating Nurse (CN) #1, on 03/25/2021 at 3:00 PM, revealed staff was not aware of Patient #1's laboratory tests results, until after he/she was taken into the operating room. The CN also suggested to the Surgeon before Patient #1's surgery was started, that a type and screen be collected because the patient's hemoglobin and platelets were low, he/she was over four-hundred (400) pounds and this was going to be a "major surgery." However, the surgeon informed the nurse that "he was the physician and he'd order labs if he wanted them." The CRNA and the CN also stated Patient #1 had "a lot of blood loss" during the procedure and when the surgeon stated to staff to document that Patient #1 had lost 350 cc's of blood, during the procedure the CN asked the surgeon "are you sure?" When the nurse questioned the surgeon's estimated blood loss, he informed the nurse "I said its 350 cc's." The CRNA and CN #1 stated Patient #1 had a minimum blood loss of 1,200 cc's during the procedure and the CRNA stated the surgeon changed his "bloody gown twice" during the patient's surgery. However, record review revealed the blood loss estimated by the surgeon as 350 cc's was documented in Patient #1's medical record, which included his/her anesthesia record completed by the CRNA.

Review of Patient #1's Operative Note completed by Surgeon #1 on 03/15/2021 revealed the patient's procedure had been completed with no complications and fifty four and six tenths (54.6) pounds of skin was removed from the patient. The note also indicated Patient #1's estimated blood loss was 350 cc's.

Record reviews and interviews indicated Patient #1 arrived in PACU (Post Anesthesia Care Unit) at 12:13 PM, with a blood pressure of 93/47, and he/she was later transferred/arrived on a medical/surgical floor at 1:58 PM, where the patient's blood pressure was 70/33. Review of the record also revealed Patient #1 was evaluated by Surgeon #1 after post-operative laboratory results indicated his/her hemoglobin had dropped to 6.7 (normal range 11.8-15.3), and the patients hematocrit was now low at 23.8 (normal range 36.9-46.9). According to Patient #1's record, Surgeon #1 ordered blood products STAT (immediately) for Patient #1 at 4:21 PM.

However, because the Surgeon had failed to order the required pre-operative testing as outlined in the facility policy, a type and screen had to also be ordered STAT at 4:25 PM, which further delayed blood being ready and available for administration to Patient #1.

Further interviews and record reviews indicated laboratory staff failed to collect the STAT ordered type and screen for Patient #1, until approximately 6:00 PM, which also further delayed blood administration for the patient. Continued interviews and record reviews indicated the results of the type and screen was not completed until 7:18 PM, approximately two (2) hours after the laboratory test was ordered STAT, and the blood was not ready for administration to Patient #1 until 7:40 PM. Registered Nurse (RN) #3, Physician Assistant (PA) #1 and the Surgeon were all aware the ordered laboratory tests for type and screen were not completed per the STAT policy and timeframe, yet neither intervened or took any actions to ensure blood or blood products could be administered STAT as ordered.

Review of Physician Assistant (PA) #1's documentation on 03/15/2021 at 6:20 PM, revealed staff informed her of Patient #1's continued low blood pressure (72/34 at 6:29 PM). According to the documentation, the PA contacted the lab regarding the patients STAT orders for blood products which were ordered approximately two (2) hours prior, and was informed that the STAT Type and Screen had not even been completed yet. PA #1's documentation revealed the PA informed Patient #1's surgeon of the delay in the administration of blood to the patient and the administration of "pressors" (medication to raise the blood pressure) to Patient #1 was discussed from the PA to the Surgeon. However, the Surgeon informed the PA that "pressors" could cause substantial damage to the surgical site and the patient needed blood products, which were ordered at 4:21 PM. PA #1's documentation indicated another fluid bolus would be administered to Patient #1 "as we await blood products." PA #1 also ordered staff to transfer Patient #1 to the Intensive Care Unit (ICU) on 03/15/2021 at 7:06 PM. According to the PA during an interview conducted on 03/26/2021 at 3:50 PM, she reported the type and screen delay to the surgeon; however, neither took any further actions to ensure Patient #1's blood was ready and available for administration and the PA was not aware that she should have reported unresolved concerns to management or administrative staff.

Interview with the Surgeon on 03/31/2021 at 8:20 AM revealed Patient #1 was evaluated at a larger hospital for a Panniculectomy and the physicians there declined to perform the patient's surgery and wanted Patient #1 to "lose weight first." However, he felt he could do the surgery because the surgery would be "life changing" for Patient #1. He stated his biggest concern pre-operatively for Patient #1 was his/her low vitamin levels, which would affect wound healing. The surgeon acknowledged Patient #1 had a diagnoses of Anemia and his/her hemoglobin and platelets were low pre-operatively; however, stated that was not a concern. The Surgeon stated he did not recall anyone suggesting a type/screen pre-operatively for Patient #1. However, Surgeon #1 stated "hind sight is 20/20" and "retrospectively" he should have ordered a type and screen pre-operatively for Patient #1 because it "took a lot of time for the patient to get blood products post-operatively." The Surgeon stated he was unaware of the policy for pre-surgery labs and stated that he ordered labs that he saw necessary. The surgeon also stated Patient #1 "lost 350 cc's of blood for sure" during the procedure and he did not recall anyone questioning the estimated blood loss in the operating room for Patient #1. The Surgeon stated he should have ordered emergency release blood to be administered to Patient #1 due to the delays in the blood getting drawn for a type and screen, and blood being available to the patient, and his/her continued low pressure readings post-operatively. He stated he had not reported the delay in laboratory staff obtaining the patient's type and screen STAT to anyone, and expected staff to implement his orders as they were written. He stated he was not aware of the need to report unresolved patient concerns to administrative/management staff. However, stated he could not say if receiving the blood products in a timely manner would have changed the outcome for Patient #1. Surgeon #1 stated facility policies as well as standards of practice should have been followed/implemented when care was provided to Patient #1.

Interview with the Chief of Surgery on 03/29/2021 at 2:03 PM revealed pre-operative laboratory tests, to include type/screens should have been obtained for Patient #1, and also stated he would have canceled Patient #1's surgery, if he would have been aware of his/her pre-operative abnormal laboratory results. He also stated staff should have reported any identified discrepancies with Patient #1's estimated blood loss immediately to the OR supervisor so the patient's case could have been investigated. The Chief of Surgery, stated its standard of practice for surgeons to be aware of and be monitoring blood loss amounts when surgeries are conducted. He also stated if blood loss was a concern for Patient #1 during the procedure, labs should have been ordered from the OR to check what the patient's status was, so if Patient #1 needed blood, it could have been replenished at that time.

Interview with the Medical Chief of Staff on 03/30/2021 at 4:30 PM revealed he also conducted surgical procedures at the facility and stated Patient #1's procedure should not have been conducted at the facility. He stated if Patient #1 had been "turned down" at a bigger facility, he would have told Patient #1 that he/she was too high risk and he/she could die. He also stated staff should have reported the discrepancy in the surgeon's Estimated Blood Loss (EBL) to supervisory staff immediately because if a patient loses 1,000 cc's or more, during a procedure "we should think about giving blood and (Fresh Frozen Plasma) (FFP)." He also stated if a patient loses 1,000 cc's or more during a procedure, a STAT hemoglobin should have been drawn and took to lab for processing from the OR. The Medical Chief of staff stated waiting four (4) hours after a surgical case was over, to obtain post-operative labs was "too long". The Medical Chief of Staff also stated physicians should not write STAT orders and "sit there." He also stated it seemed many people were involved in Patient #1's case; however, "no one was in charge." The Chief of Staff also stated STAT to him meant labs would be drawn and to the lab in 10-15 minutes. Per the Chief of Staff, Patient #1's labs should have been done "quickly" and emergency release blood as well as "pressors" to raise his/her blood pressure, should have been administered to Patient #1, because his/her clinical status continued to deteriorate. He also stated someone should have identified that the laboratory and the nursing delays were "killing the patient." He stated staff should have followed facility policies, to assist in ensuring a better outcome for Patient #1.

A post-survey interview with the CEO, on 04/21/2021 at 1:30 PM revealed he was not a member of the Governing Body; however, stated he attended the meetings and was responsible for the daily operations of the facility. The CEO also stated he was responsible to ensure care patient care provided in the facility was provided per standards of practice and as outlined in the facility policies and processes for all departments. The CEO stated he was not aware of any concerns related to delays in Laboratory Services, or any "real concerns specific to patient care" from the Nursing Department. He also stated he was not aware of any concerns related to care provided by Surgeon #1 and had not been informed of any concerns related Surgical services provided in the facility. The CEO also stated he should be notified of any patient care concerns that occur in the facility. However, he had not been made aware of any concerns related to patient care until the concerns were identified with care/treatment provided to Patient #1.

Based on interview, record review and a review of facility policy, it was determined the facility failed to ensure a Registered Nurse (RN) supervised the nursing care for each patient in accordance with accepted standards of nursing practice and hospital for policy for one (1) of nine (9) sampled patients (Patient #1).

The findings inlcude:

Record review revealed Patient #1 was admitted on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). After the surgical procedure, Patient #1 arrived on the medical/surgical unit of the facility at 1:58 PM on 03/15/2021 with a low blood pressure of 70/33, and review of the patient's record indicated his/her blood pressure continued to be 100/43 or lower. On 03/15/2021 at 4:21 PM, Patient #1's physician ordered two (2) units of blood and two (2) units of fresh frozen plasma (FFP)'s to be administered STAT (immediately), after post-operative laboratory results revealed his/her hemoglobin had dropped to 6.7, and his/her hematocrit was now low at 23.8. Since a type and screen (to check the patient ' s blood type and screen for antibodies in the blood) for blood had not been ordered prior to surgery, the type and screen was ordered STAT at 4:25 PM. According to the patient's record and interviews with staff, blood was not available for administration until 7:40 PM. Patient #1's blood pressure from 7:40 PM to 9:00 PM continued to be low at 80/44 or below. However, the RN failed to ensure blood was initiated for Patient #1 until 9:00 PM; approximately four (4) hours after the STAT orders for blood products were received.

According to the record and interviews with staff, at approximately 9:38 PM, Patient #1 coded (cardiopulmonary arrest) due to hypovolemic shock (an emergency condition in which severe blood or other fluid loss makes the heart unable to pump enough blood to the body) and the facility was able to revive the patient. At 10:05 PM, the patient's provider ordered an additional two (2) units of blood. Cryoprecipitate (a frozen blood product) and platelets (blood component whose function is to react to bleeding and initiate a blood clot) were ordered for Patient #1 at 10:15 PM. However, there was no evidence the RN administered the blood and/or blood products to the patient.

Further record review revealed at 12:19 AM on 03/16/2021, Patient #1's blood pressure dropped to 51/14 and the patient's pulse had increased to 119. However, there was no evidence the patient's physician was notified by the RN of the change in the patient's condition. The patient's blood pressure continued to be low, and review of the record indicated At 12:25 AM, Patient #1's blood pressure was 69/49 and pulse was 111; at 12:36 AM, the patient's blood pressure was 97/27 and the pulse was 93. At 12:45 AM, approximately 25 minutes after the change in the patient's condition, the RN had Nurse Practitioner (NP) #1 paged due to the patient's low blood pressure reading. However, there was no evidence that the provider responded and no evidence that the RN took any further action to notify the provider of the change in the patient's condition. At 1:04 AM, Patient #1 coded (cardiopulmonary arrest) for the second time and was pronounced dead at 1:14 AM.

Refer to A0395.

Based on interview, record review and a review of facility policy, it was determined the facility failed to ensure a Registered Nurse (RN) supervised the nursing care for each patient in accordance with accepted standards of nursing practice and hospital for policy for one (1) of nine (9) sampled patients (Patient #1).

The findings include:

Review of the facility policy titled "Assignment of Nursing Care" not dated, revealed every patient received an assignment of care by the RN. The policy also stated the RN should plan, evaluate, supervise, participate and coordinate the nursing care of each patient.

Review of the facility policy titled "Scope of Services" last revised in February 2020, revealed procedures that are essential for immediate patient care were available on a STAT basis, twenty-four hours/day, seven days a week. According to the policy all STAT laboratory results should be reported within one hour from the receipt of the orders in the lab.

Review of the facility policy titled "Chain of Command for Patient Care Issues: Escalation Policy" dated 12/28/2015 revealed the facility was committed to providing safe, quality patient care and also stated the healthcare team was obligated to work toward resolution of identified real and potential problems within the system that could affect patient care. If the healthcare team member was unable to resolve issues independently, the policy stated the team member was obligated to present the issue in a timely manner to successively higher levels of command, until a satisfactory resolution was achieved for the patient. According to the policy, all staff were responsible to advocate for the patient at all times and were responsible to implement the chain of command procedures to resolve issues when the safety of facility patients became affected or the delivery of patient care could result in an adverse patient outcome.

Review of Patient #1's record revealed he/she was admitted to the facility on 03/15/2021 for a Panniculectomy. The patient had diagnoses that included hypertension (high blood pressure). Review of Patient #1's pre-operative laboratory results revealed his/her platelets (a blood component that should react to bleeding thereby initiating the blood to clot) was low at 133,000 (normal range 182-369), his/her hemoglobin (a protein in red blood cells that carries oxygen to the organs/tissues and supplies carbon dioxide from organs/tissues back to the lungs) was low at 10.9 (normal range 11.8-15.3) and his/her hematocrit (volume percentage of red blood cells in the blood) was 37.9 (normal range 36.9-46.9).

Patient #1's record indicated the surgical procedure was started at approximately 9:12 AM and review of the anesthesia record indicated his/her pre-operative blood pressure reading was 169/73 (average normal range 120/80). According to the record, Patient #1's procedure was completed at approximately 12:00 PM, and the record indicated fifty-four and six tenths (54.6) pounds of skin was removed from the patient. The patient arrived in PACU (post-anesthesia care unit) at 12:13 PM, with a blood pressure of 93/47.

Further review of Patient #1's record revealed the patient was later transferred and arrived on a medical/surgical floor at 1:58 PM, where his/her blood pressure was low at 70/33, the patient was lethargic; however, was able to answer staff's questions appropriately. According to the nurse's notes, on 03/15/2021 at 3:01 PM, Anesthesia and Patient #1's provider were notified of the patient's low blood pressure readings. Orders were received for Albumin (a blood transport protein) 12.5 grams (gms) to be administered in 250 cubic centimeters (cc's), one (1) dose only at 2:17 PM and a 2,000 cc normal saline bolus to be administered at 2:59 PM.

Continued review of Patient #1's blood pressure readings after arrival to the medical floor revealed the patient continued to have low blood pressures as follows: 2:20 PM 74/46; 2:44 PM 99/43 and 98/52 at 3:11 PM.

Review of Patient #1's physician orders revealed a CBC (complete blood count) was ordered on 03/15/2021 at 2:59 PM and review of the results at approximately 3:35 PM indicated the patient's hemoglobin had dropped to 6.7, and his/her hematocrit was low at 23.8.

Patient #1's record indicated he/she was evaluated by his/her surgeon at approximately 4:00 PM on 03/15/2021 where he was notified of the patient's abnormal post-operative lab results. Review of the physician orders indicated two (2) units of blood and two (2) units of fresh frozen plasma (FFP) were ordered STAT (immediately) for Patient #1 at 4:21 PM. Further review of Patient #1's orders revealed Patient #1 had not had a type and screen for blood pre-operatively; therefore, a type and screen was ordered STAT at 4:25 PM on 03/15/2021.

Review of Patient #1's blood pressure readings on 03/15/2021 were as follows: at 3:50 PM, 80/36 and at 4:35 PM his/her blood pressure was 100/52.

Further review of Patient #1's record revealed laboratory staff failed to collect the STAT ordered type and screen until approximately 6:00 PM, and continued review of the record revealed the results of Patient #1's type and screen were not completed until 7:18 PM, approximately three (3) hours after the laboratory test was ordered STAT. According to Patient #1's record, the blood was not ready for administration to Patient #1 until 7:40 PM on 03/15/2021, more than three (3) hours after the STAT orders had been received.

Patient #1's record indicated the patient's blood pressure continued to be low and was 92/44 at 5:41 PM on 03/15/2021 and his/her blood pressure was 81/43 at 6:06 PM.

Interview with Registered Nurse (RN) #3, on 3/24/2021 at 4:25 PM, revealed she admitted Patient #1 to the medical floor on 03/15/2021 at approximately 1:50 PM, and the patient was lethargic/pale in color, and his/her blood pressure was low at 70/33. RN #3 stated the surgeon evaluated Patient #1 at the bedside at approximately 4:00 PM and was notified of the abnormal post-operative labs. The RN stated STAT orders for blood products were received at 4:21 PM on 3/15/2021. However, she realized no type and screen had been completed pre-operatively so an order was entered to obtain one, at 4:25 PM on 3/15/2021, which was required before blood products could be administered to the patient. RN #3 stated, an hour after the orders were entered, no one from the lab had come to collect Patient #1's blood and she called the lab to inquire about the patient's needed labs at approximately 5:30 PM (approximately one hour after the stat orders were entered). However, RN #3 stated Patient #1's labs were not drawn until around 6:00 PM (approximately one and a half hours after the orders were entered). RN #3 was never informed any blood products that were available for administration to Patient #1. A follow up interview with the RN was conducted on 03/30/2021 at 2:10 PM she stated was not sure "on the STAT policy" however stated she thought STAT labs were required to be resulted in thirty minutes to one hour. The RN also stated she had not inquired why Patient #1's labs were not obtained until an hour after they had been entered, because "it wasn't her responsibility to call them" and also stated when STAT orders were entered it was the labs responsibility to get them.

Review of Patient #1's provider (Physician Assistant (PA) #1's) documentation revealed on 3/15/2021 at 6:20 PM that she had been informed of Patient #1's continued low blood pressure readings (72/34 at 6:29 PM ). The documentation also indicated the provider had contacted the lab regarding Patient #1's STAT orders for blood products and was informed that the STAT Type and Screen had not even been completed yet, which had been ordered approximately two (2) hours prior. The PA's documentation also indicated she contacted Patient #1's surgeon and informed him the patient's continued low blood pressure and they discussed the administration of "pressors" (medication to raise blood pressure) to the patient; however, the surgeon stated that would cause substantial damage to the surgical site and that Patient #1 needed the previously ordered blood products. PA #1 ordered another 1,000 cc bolus of normal saline fluids to be administered to Patient #1 at 6:30 PM and staff were also ordered to transfer Patient #1, to the Intensive Care Unit (ICU) on 03/15/2021 at 7:06 PM.

Interview with Phlebotomist #1, on 3/30/2021 at 3:10 PM, revealed she was working on 03/15/2021 when Patient #1's STAT orders were received in the lab. She was unable to recall what time she saw the lab orders for Patient #1, however stated she was on the floor drawing labs for other patients between 4 PM-5 PM on 03/15/2021. The Phlebotomist stated she drew patient labs due at 4 PM and 5 PM before returning to the lab and she stated she had trouble drawing Patient #1's blood. However, the Phlebotomist did not communicate the need for assistance to other lab staff. Phlebotomist #1 also stated STAT labs should be drawn and taken back to the lab for processing within thirty (30) minutes of the time they are received.

Interview with RN #4, on 03/24/2021 at 11:15 PM, revealed he cared for Patient #1 on 03/15/2021 for approximately forty-five (45) minutes during the night shift (7 PM-7AM). The RN stated he was informed during report that Patient #1's blood pressure was low and the patient had orders for and needed blood, and also had orders to transfer the patient to the ICU. RN #4 stated Patient #1 was pale and "looked like" he/she "could crash at any time." The RN stated he was informed Patient #1's blood was ready to be administered at 7:40 PM; however, stated the patient's previously ordered bolus of normal saline fluids were infusing. The RN stated his main priority at that time was to get the patient transferred to the ICU because the longer he/she was on the medical floor it would be "bad." He stated the patient was later transferred to ICU after 8 PM on 03/15/2021, and stated he had not retrieved or started the patient's STAT ordered blood.

Review of the Patient #1's record revealed the ordered blood transfusion was not started until 9:00 PM which was over 4 hours after the blood was ordered.

Review of Patient #1's record indicated on 03/15/2021 at approximately 9:28 PM, Patient #1 went into cardiac arrest; however the facility was able to revive the patient.

Further review of Patient #1's record indicated on 03/15/2021 at 10:05 PM, his/her provider ordered two (2) more units of blood to be administered to Patient #1. At 10:15 PM the provider also ordered cryoprecipitate (a frozen blood product) and platelets (blood component whose function is to react to bleeding and initiate a blood clot), for Patient #1. However, there was no evidence in the medical record that the blood and blood products were administered to Patient #1.

Interview with RN #5, on 03/25/2021 at 10:30 AM, revealed he admitted Patient #1 to the ICU on 03/15/2021 at approximately 8:15 PM. He stated the patient was pale and "you could tell" he/she was "anemic" (a decreased amount of red blood cells or hemoglobin in the blood). RN #5 stated he obtained the patient's first unit of blood from the laboratory and subsequently started his/her first unit of blood at approximately 9:00 PM. The RN stated Patient #1 went into cardiac arrest at approximately 9:38 PM; however, the RN stated the patient showed no signs/symptoms of an adverse blood reaction. The RN also stated the patient's provider was at the bedside after he/she went into cardiac arrest and the nurse was ordered to rapidly infuse the remaining blood in the first unit, and the second unit of blood was retrieved from the lab and was also rapidly infused which was initiated at approximately 10:00 PM. RN #5 also stated Patient #1's first unit of STAT ordered FFP's were initiated at approximately 10:30 PM and both units had been transfused at approximately 11:00 PM on 03/15/2021. The RN acknowledged there were also orders to transfuse more blood/blood products to Patient #1; however, he stated he had difficulty reaching family to obtain a consent, which was required for the new blood orders and stated by the time he received consent from the patient's family, Patient #1 "had gotten bad again."

Continued review of Patient #1's record indicated at 12:19 AM on 03/16/2021, Patient #1's blood pressure dropped to 51/14 and his/her pulse had increased to 119. However, there was no evidence the patient's physician was notified of the change in Patient #1's condition. The record also indicated Patient #1's blood pressure continued to be low on 03/16/2021 as follows: at 12:25 AM, his/her blood pressure was 69/49 and the patient's pulse was 111; at 12:30 AM, the patient's blood pressure was 60/30 and his/her pulse was 100. The record also indicated at 12:45 AM on 03/16/2021 (approximately 25 minutes after the change in the patient's condition occurred) the RN had a Nurse Practitioner paged due to the patient's low blood pressure readings. However, there was no evidence in the record to indicate that the provider responded and no evidence that the RN took any further action to notify the provider of the change in Patient #1's condition.

Further Review of Patient #1's record revealed the patient's condition continued to deteriorate and he/she subsequently had cardiac arrest again at 1:04 AM on 03/16/2021. Patient #1's record indicated he/she was pronounced deceased at 1:14 AM on 03/16/2021.

Continued interview with RN #5, on 03/25/2021 at 10:30 AM, confirmed he identified a change in Patient #1's condition on 03/16/2021 at approximately 12:35 AM "or so" when he was unable to obtain a blood pressure on the patient. He stated he called the operator and had the in-house Nurse Practitioner (NP) #1 (on-call provider for the patient) paged at approximately 12:45 AM; however, the NP never responded. The RN acknowledged he took no further action to inform the NP of Patient #1's change in condition. He also stated the patient's condition continued to deteriorate and he/she "coded" again at approximately 1:04 AM on 03/16/2021 and the NP then responded to the overhead page of the "code" in the ICU. RN #5 stated he should have paged overhead the NP when the provider failed to respond when the change in the patient's condition was initially identified.

Interview with NP #1, on 03/26/2021 at 12:25 PM, revealed the first time he had saw Patient #1, on 03/15/2021 he/she was "a code blue" and also stated the patient was pale in color and was in "hypovolemic shock." The NP also stated when the second change in the patient's condition occurred, he should have been notified immediately. The NP stated anytime a patient's blood pressure was low, he should be notified and also stated he did not recall receiving a notification related to the change in Patient #1's condition, prior to the patient's second "code". However, NP #1 stated he could have been paged overhead and would have immediately responded to the change in Patient #1's condition.

Interview with the Director of Laboratory Services, on 3/30/2021 at 11:00 AM, revealed emergency lab services was available for facility patients twenty-four (24) hours a day/seven (7) days a week. The Director also stated Patient #1's STAT ordered labs should have been collected and back in the lab, ready for processing within thirty (30) minutes, so results were ready within an hour of the time the orders were received. The Director also stated laboratory personnel was never notified by nursing staff that Patient #1's blood pressure was low, which could have facilitated a more timely lab test collection, and facilitated the blood products being ready for administration to the patient in a more timely manner.

Interview with the Chief Nursing Officer (CNO), on 04/05/2021 at 2:35 PM, revealed nurses were responsible to plan, evaluate, supervise, participate and coordinate the nursing care of their patients in the facility. She stated the RN should have ensured Patient #1's labs were obtained STAT as ordered and should have started the patient's blood products immediately when they were notified they were available for administration. She also stated when the RN was unable to obtain family consent immediately when the second orders for blood products were received, the physician should have been notified then and orders to emergently transfuse the blood should have been obtained, and the blood products should have been administered to the patient. She stated due to Patient #1's unstable clinical condition, nursing staff should have been more proactive in ensuring the patient's labs were obtained STAT. The CNO also stated nurses were expected to inform the patient's provider immediately when a change in condition occurred. The CNO stated when the patient had a change in condition, Patient #1's in-house provider should have been paged overhead again, when an immediate response was not received.

Based on interview, record review and policy review, the facility failed to ensure the protocol for blood transfusion reaction was implemented when a one (1) of nine (9) sampled residents experienced a cardiopulmonary arrest during a blood transfusion.

The findings include:

Review of the facility policy "Transfusion Reaction Workup" dated as reviewed on 10/2013, revealed it was the policy of the facility "that a written plan of action is available to follow in the event that a possible transfusion reaction occurs during or following the transfusion of blood or blood products. A transfusion reaction is defined as an adverse symptom or physician sign which occurs during or following the transfusion of blood or blood products. The necessary first steps in suspecting a reaction fall to the transfusionist, usually the nurse....." The policy listed responsibilities of both nursing and laboratory personnel if a reaction was suspected.

Record review revealed Patient #1 was admitted on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). After the surgical procedure, Patient #1 arrived on the medical/surgical unit of the facility at 1:58 PM on 03/15/2021 with a low blood pressure of 70/33.

Review of Patient #1's physician orders revealed a CBC (complete blood count) was ordered on 03/15/2021 at 2:59 PM and review of the results at approximately 3:35 PM indicated the patient's hemoglobin had dropped to 6.7, and his/her hematocrit was low at 23.8. On 03/15/2021 at 4:21 PM, Patient #1's physician ordered two (2) units of blood and two (2) units of fresh frozen plasma (FFP)'s to be administered STAT (immediately). Since a type and screen (to check the patient's blood type and screen for antibodies in the blood) for blood had not been ordered prior to surgery, the type and screen was ordered STAT at 4:25 PM. According to the patient's record and interviews with staff, blood was not available for administration until 7:40 PM.

Per the record, Patient #1 was transferred to the to the Intensive Care Unit (ICU) on 03/15/2021 at 7:06 PM. Continued review revealed the blood transfusion was not started until 9:00 PM. Further review of Patient #1's record indicated on 03/15/2021 at approximately 9:28 PM, Patient #1 went into cardiac arrest; however the facility was able to revive the patient.

Interview with RN #5, on 03/25/2021 at 10:30 AM, revealed he admitted Patient #1 to the ICU on 03/15/2021 at approximately 8:15 PM. He stated the patient was pale and "you could tell" he/she was "anemic" (a decreased amount of red blood cells or hemoglobin in the blood). RN #5 stated he obtained the patient's first unit of blood from the laboratory and subsequently started his/her first unit of blood at approximately 9:00 PM. The RN stated Patient #1 went into cardiac arrest at approximately 9:38 PM; however, the RN stated the patient showed no signs/symptoms of an adverse blood reaction. The RN also stated the patient's provider was at the bedside after he/she went into cardiac arrest and the nurse was ordered to rapidly infuse the remaining blood in the first unit, and the second unit of blood was retrieved from the lab and was also rapidly infused which was initiated at approximately 10:00 PM. The RN stated no one thought the patient had an adverse blood reaction and therefore, he did not follow the adverse blood reaction protocol.

Interview with Nurse Practioner (NP) #1, on 03/26/2021 at 12:25 PM, revealed the first time he saw Patient #1, on 03/15/2021 he/she was "a code blue" and stated the patient was pale in color and was in "hypovolemic shock."

Interview with the Director of Laboratory Services, on 3/30/2021 at 11:00 AM, revealed she was not aware that Patient #1 experienced a cardiac arrest during a blood transfusion until 03/19/2021. The Director stated by this time, the blood components (tubing, etc.) had been disposed of and they were unable to complete a transfusion reaction workup.

Interview with the Chief Nursing Officer (CNO), on 04/05/2021 at 2:35 PM, revealed nurses were responsible to plan, evaluate, supervise, participate and coordinate the nursing care of their patients in the facility. The DON stated nursing staff should have followed the blood reaction protocol when Patient #1 experienced a cardiac arrest during a blood transfusion.

Based on interview, record review, and review of facility policies, it was determined the facility failed to maintain and have available adequate laboratory services when emergency laboratory services were required to meet the needs of one (1) of nine (9) sampled Patients.

The findings include:

According to facility policy, all laboratory physician orders ordered on a STAT (immediate) basis should be reported within one hour. On 03/15/2021 at 4:21 PM, Patient #1's surgeon ordered STAT blood products for the patient post-operative Panniculectomy (surgery to remove excessive skin from the abdomen). A type and screen (to check the patient ' s blood type and screen for antibodies in the blood) was ordered STAT on 03/15/2021 at 4:45 PM. Laboratory staff failed to collect the STAT ordered blood specimen for a type and screen for Patient #1 until approximately 6:00 PM. Further, the facility did not obtain the patient's blood type and screen laboratory results until 7:18 PM, approximately three (3) hours after the laboratory test was ordered STAT. Subsequently, blood was not ready for administration to Patient #1 until 7:40 PM, approximately three (3) hours and 30 minutes after the blood was ordered STAT for the patient.

According to the bedside provider (Nurse Practitioner #1), Patient #1 was in hypovolemic shock (an emergency condition in which severe blood or other fluid loss makes the heart unable to pump enough blood to the body) and subsequently expired at 1:14 AM on 03/16/2021.

Refer to A0583.

Based on interview, record review, and review of facility policies, it was determined the facility failed to maintain and have available adequate laboratory services when emergency laboratory services were required to meet the needs of one (1) of nine (9) sampled Patients.

The findings include:

Review of the facility policy titled "Scope of Services" last revised in February 2020, revealed procedures that were essential for immediate patient care were available on a STAT basis, twenty-four hours per day/seven days a week. According to the policy, all STAT laboratory results should be reported within one hour from the receipt of the orders in the lab.

Review of Patient #1's record revealed he/she was admitted to the facility on 03/15/2021 for a Panniculectomy. Review of the patient's pre-operative laboratory results revealed his/her hemoglobin (a protein in red blood cells that carries oxygen to the organs/tissues and supplies carbon dioxide from organs/tissues back to the lungs) was low at 10.9 (normal range 11.8-15.3) and his/her hematocrit (volume percentage of red blood cells in the blood) was 37.9 (normal range 36.9-46.9).

Review of Patient #1's physician orders revealed a CBC (complete blood count) was ordered on 03/15/2021 at 2:59 PM. Review of the results of the CBC at approximately 3:35 PM indicated the patient's hemoglobin had dropped to 6.7 (which was called to nursing staff as a critically low level), and his/her hematocrit had dropped to 23.8.

Patient #1's record indicated the surgeon evaluated the patient at approximately 4:00 PM on 03/15/2021. Review of the physician orders indicated two units of blood and two units of fresh frozen plasma were ordered STAT (immediately) for Patient #1 at 4:21 PM. However, further review of the orders revealed staff determined Patient #1 had not had a type and screen for blood pre-operatively, therefore a type and screen was ordered STAT at 4:25 PM.

However, continued review of Patient #1's record revealed laboratory staff did not collect blood from Patient #1 to complete the STAT ordered blood type and screen until approximately 6:00 PM.

Interview with Registered Nurse (RN) #3, on 03/24/2021 at 4:25 PM, revealed she admitted Patient #1 to the medical floor (after the Panniculectomy) at approximately 1:50 PM on 03/15/2021. She stated Patient #1 was lethargic/pale in color, and his/her blood pressure was low at 70/33. RN #3 stated the surgeon evaluated Patient #1 at the bedside at approximately 4:00 PM and was notified of Patient #1's abnormal post-operative labs. She stated STAT orders for blood products were received at 4:21 PM on 03/15/2021. However, she stated she realized no type and screen had been completed pre-operatively so an order was entered to obtain one, at 4:25 PM on 3/15/2021, which was required before blood products could be administered to the patient. RN #3 stated, an hour after the orders were entered, no one from lab had come to collect Patient #1's blood and she called the lab to inquire about the needed labs at approximately 5:30 PM (approximately one hour after the STAT orders were entered). However, RN #3 stated Patient #1's labs were not drawn until around 6:00 PM (approximately one and a half hours after the orders were entered). The RN stated the patient's blood pressure continued to be low, so she informed Physician Assistant (PA) #1 at approximately 6:16 PM. RN #3 also stated she paged the patient's Surgeon at approximately 6:30 PM and informed him of the patient's low blood pressure readings and informed him the blood products were not available for administration. The Surgeon gave instructions to monitor the patient and stated the patient needed the blood products. RN #3 stated she finished her shift and left the facility at approximately 8:00 PM; however, the RN stated the lab never informed her that the blood products were available for administration to Patient #1.

Review of PA #1's provider documentation for Patient #1 revealed on 03/15/2021 at 6:20 PM, she was informed of the patient's continued low blood pressure readings (72/34 at 6:29 PM). Review of the documentation also indicated the PA had contacted the lab regarding the patient's STAT orders for blood products and was informed that the STAT Type and Screen had not even been completed yet, which had been ordered approximately two (2) hours ago. PA #1's documentation also revealed she informed Patient #1's surgeon of the delay in the administration of blood and documented that another two (2) liter bolus (IV fluids) would be administered to Patient #1 "as we await blood products."

Review of Patient #1's physician orders revealed on 03/15/2021 at 6:30 PM, PA #1 ordered another 1,000 cc bolus of normal saline fluids to be administered to Patient #1 and for staff to transfer Patient #1, to the Intensive Care Unit (ICU) on 03/15/2021 at 7:06 PM.

Review of Patient #1's blood type and screen revealed the laboratory test was not completed until 7:18 PM, approximately three (3) hours after the laboratory test was ordered STAT. Patient #1's record also indicated the blood was not ready for administration to Patient #1 until 7:40 PM on 03/15/2021, more than three (3) hours after the STAT orders had been given.

Interview with Phlebotomist #1, on 03/30/2021 at 3:10 PM, revealed she was working with three or four other phlebotomists in the facility laboratory when Patient #1's STAT orders were received in the lab on 03/15/2021. She stated phlebotomists were responsible to check the STAT printer, throughout the shift, for STAT orders. She also stated if phlebotomists were not in the lab when STAT orders were received, someone from the lab usually called them and notified them of any STAT orders. Phlebotomist #1 stated she had Patient #1's lab orders with her on 03/15/2021, and was aware of the patient's STAT lab orders, before she left the lab (unable to recall what time) to obtain blood specimens for other facility patients. The Phlebotomist stated she obtained specimens from other patients who had laboratory testing due at 4 PM and 5 PM before returning to the lab with Patient #1's blood specimen for testing. The phlebotomist stated she was also delayed because she had trouble drawing Patient #1's blood and recalled the patient being pale in color. According to the Phlebotomist, she did not communicate the need for assistance to other lab staff even though she was aware that STAT labs should be drawn and taken back to the lab for processing within thirty (30) minutes of the order being received.

Continued review of Patient #1's medical record revealed the facility initiated one unit of packed red bloods cells to the patient on 03/15/2021 at 9:00 PM, approximately four (4) hours and 30 minutes after blood was ordered STAT. Patient #1's medical record further revealed at approximately 9:28 PM, Patient #1 had cardiac arrest; however, the facility was able to revive the patient at that time.

Further review of Patient #1's record and interview with RN #5 on 03/25/2021 at 10:30 AM revealed he admitted Patient #1 to the ICU on 03/15/2021 at approximately 8:15 PM. He stated the patient was pale and "you could tell" he/she was "anemic" (a decreased amount of red blood cells or hemoglobin in the blood). Review of the medical record and continued interview with RN #5 revealed the patient's first unit of blood was obtained from the laboratory and administration started to the patient at approximately 9:00 PM. Record review and interview with the RN indicated Patient #1 went into cardiac arrest at approximately 9:38 PM, while the first unit of blood was transfusing. The RN also stated the patient's provider (NP#1) was at the bedside after the patient went into cardiac arrest and the nurse was ordered to rapidly transfuse the remaining first unit of blood, and to also rapidly transfuse the second unit of blood. Interview and record review revealed staff were able to revive Patient #1 and the second unit of blood was initiated at approximately 10:00 PM on 03/15/2021.

Further review of Patient #1's medical record revealed the patient's condition continued to deteriorate and he/she subsequently had cardiac arrest again at 1:04 AM on 3/16/2021. Patient #1's record indicated he/she was pronounced deceased at 1:14 AM on 3/16/2021.

Interview with NP #1, on 03/26/2021 at 12:25 PM, revealed the first time he saw Patient #1, on 03/15/2021, the patient was "a code blue" (cardiac arrest). He stated Patient #1 was pale in color and was in "hypovolemic shock."

Interview with Patient #1's Surgeon, on 03/31/2021 at 8:20 AM, revealed he had been informed of the delay in blood and/or blood products for Patient #1 on 03/15/2021. He also stated if the blood would have been administered in a timely manner to Patient #1 it would have helped his/her blood pressure and anemia. However, the Surgeon stated he could not say if the patient would have gotten the blood timely, that it would have changed the outcome for Patient #1.

Interview with the Director of Laboratory Services, on 03/30/2021 at 11:00 AM, revealed the facility had emergency lab services available for facility patients twenty-four (24) hours a day/seven (7) days a week. The Director stated she expected STAT laboratory specimens for labs to be collected and back in the lab, ready for processing within thirty (30) minutes. She stated Patient #1's blood should have been drawn and back into the lab ready for processing within thirty (30) minutes from the time the orders were received on 03/15/2021, which would have facilitated timely blood product administration to Patient #1. The Director also stated lab staff not paying enough attention to the STAT printer, as well as a lack of communication from the laboratory and nursing staff, contributed to the delay in obtaining the patient's STAT ordered labs. She stated nursing staff never informed the laboratory department of the patient's declining clinical condition and when nursing staff called to inquire about why the labs had not been drawn, at 5:30 PM on 03/15/2021, laboratory staff did not ask enough "why" questions. She also stated lab personnel that answered the phone when nursing staff inquired about the delay in obtaining the patient's labs, should have paged the phlebotomist to inquire why the labs had not been drawn and relay the message that floor staff had contacted the lab.

Interview with the Chief Nursing Officer (CNO), on 04/05/2021 at 2:35 PM, revealed Patient #1's STAT ordered labs should have been collected and results given within one hour as outlined in the facility policy. She stated due to Patient #1's unstable clinical condition, nursing staff should have been more proactive in ensuring the patient's labs were obtained STAT.

Based on interview, record review and review of the facility policy, it was determined the faciilty failed to ensure offered surgical services were provided in accordance with acceptable standards of practice for one (1) of nine (9) sampled Patients (Patient #1).

The findings include:

Record review revealed Patient #1 was admitted on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). Interviews and review of facility policies/procedures revealed the facility failed to have a protocol for this procedure, and review of the Operating Room (OR) log and interviews with staff revealed the facility had only conducted one (1) other Panniculectomy since 2018.

According to the facility policy and interview with the Chief of Surgery, pre-operative laboratory testing which included a type/screen was required before every surgery in which blood loss was expected. The surgeon had not conducted the required pre-operative laboratory testing; however, during the pre-anesthesia assessment, the anesthesiologist ordered a Complete Blood Count (CBC) and Basic Metabolic Panel (BMP). Interviews indicated Patient #1 was taken to the operating room, before staff acknowledged the results of the testing. Interviews revealed when the circulating nurse obtained Patient #1's laboratory results, she noted that his/her hemoglobin and platelets were low, and asked Surgeon #1 if a type/screen was needed due to the abnormal laboratory results and the extent of the patient's surgery. However, the surgeon did not want to obtain any further laboratory testing and started the procedure for Patient #1.

Interviews indicated after Patient #1's procedure was complete, the Certified Registered Nurse Anesthetist (CRNA), and the Circulating Nurse, as well as a surgical first assist, did not agree with Surgeon #1's estimated blood loss of 350 cubic centimeter (cc)'s and stated they would have estimated the blood loss to be approximately 1200 cc's. However, staff failed to ensure the discrepancies/concerns were reported and addressed as outlined in the facility policy.

Patient #1 record indicated he/she arrived in PACU (post-anesthesia care unit) at 12:13 PM with a blood pressure of 93/47, then was transferred/arrived on a medical/surgical floor at 1:58 PM, where his/her blood pressure was 70/33. Blood products were ordered STAT for Patient #1 at 4:21 PM after standard post-operative laboratory results revealed the patient's hemoglobin had dropped to 6.7 and hematocrit was also low at 23.8. However, since the pre-operative required type and screen had not been ordered for Patient #1, blood administration for the patient was delayed. The facility initiated blood for Patient #1 at 9 PM. However, the patient coded (cardiopulmonary arrest) at 9:28 PM due to hypovolemic shock. The facility was able to revive the patient; however, he/she coded again at 1:04 AM and was pronounced deceased at 1:14 AM on 03/16/2021.

Refer to A0941.

Based on interview, record review and review of the facility policy, it was determined the hospital failed to ensure offered surgical services were provided in accordance with acceptable standards of practice for one (1) of nine (9) sampled Patients (Patient #1). Patient #1 was admitted on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen). Interviews and review of facility policies/procedures revealed the facility failed to have a protocol for this procedure, and review of the Operating Room (OR) log and interviews with staff revealed the facility had only conducted one (1) other Panniculectomy since 2018.

The findings include:

Review of the facility policy titled "Pre-Operative Testing" dated August, 2018 revealed blood tests, which included a type and screen was required to be completed within four (4) days of the procedure, when a blood loss was expected to occur.

Interview with the Risk Manager on 03/23/2021 at 4:15 PM revealed the facility had no protocol/policy for conducting a Panniculectomy. She also stated there should be policies/protocols for all surgical procedures conducted at the facility.

Interview with the Chief of Surgery on 03/29/2021 at 2:03 PM revealed a patient's blood should be typed and screened for a possible blood transfusion prior to any surgical procedure where 100 cc of blood loss was expected or for any procedure that is expected to last for more than one hour.

Review of the facility policy titled "Chain of Command for Patient Care Issues: Escalation Policy" dated 12/28/2015 revealed the facility was committed to providing safe/quality patient care and the healthcare team was obligated to work toward resolution of identified real/potential problems within the system that could affect patient care. If the healthcare team member was unable to resolve issues independently, the policy stated the team member was obligated to present the issue in a timely manner to successively higher levels of command, until a satisfactory resolution was achieved for the patient. The policy also stated all staff were responsible to advocate for the patient at all times and were responsible to implement the chain of command procedures to resolve issues when the safety of facility patients became affected or the delivery of patient care could result in an adverse patient outcome.

Review of Patient #1's record indicated he/she was admitted to the facility on 03/15/2021 for a Panniculectomy. Further review revealed the patient had diagnoses that included Hypertension.

Interview with the Anesthesiologist on 3/24/2021 at 2:07 PM revealed he completed a pre-operative assessment of Patient #1 on 03/15/2021, and ordered a CBC and BMP. The Anesthesiologist stated he was unaware of any "protocol" for any specific pre-operative laboratory tests to be completed at the facility, and stated he ordered laboratory tests that he deemed necessary.

According to review of Patient #1's pre-operative laboratory results, the patient's platelets (a blood component that should react to bleeding thereby initiating the blood to clot) were low at 133,000 (normal range 182-369), his/her hemoglobin (a protein in red blood cells that carries oxygen to the organs/tissues and supplies carbon dioxide from organs/tissues back to the lungs) was also low at 10.9 (normal range 11.8-15.3) and Patient #1's hematocrit (volume percentage of red blood cells in the blood) was 37.9 (normal range 36.9-46.9). However, there was no evidence that a pre-operative type and screen was completed as directed by the facility policy.

Review of Patient #1's anesthesia record dated 03/15/2021 revealed his/her surgical procedure started at approximately 9:12 AM and was completed at approximately 12:00 PM. Patient #1's pre-operative blood pressure reading was 169/73 (average normal range 120/80), and the record also indicated, Phenylephrine (medication to raise the blood pressure) was administered to the patient on three (3) different occasions during the procedure. The anesthesia record also indicated Patient #1 had lost three hundred and fifty (350) cubic centimeters (cc's) of blood during the surgical procedure.

Review of Patient #1's Operative Note completed by Surgeon #1 on 03/15/2021 revealed Patient #1's procedure had been completed with no complications and fifty four and six tenths (54.6) pounds of skin was removed from the patient. The note also indicated Patient #1's estimated blood loss was 350 cc's.

Interview with Circulating Nurse (CN) #1, on 03/25/2021 at 3:00 PM, revealed she cared for Patient #1 during surgery on 03/15/2021. She stated the Anesthesiologist had ordered Patient #1's pre-operative laboratory tests but staff was not aware of the patient's tests results until after he/she was taken into the operating room. The CN also stated before the patient's surgery had started, she suggested to the Surgeon that a type and screen be collected because the patient's hemoglobin and platelets were low. The CN stated the patient was over four-hundred (400) pounds and this was going to be a "major surgery." However, the nurse stated the surgeon informed her that "he was the physician and he'd order labs if he wanted them." According to the CN, Patient #1 had "a lot of blood loss" during the procedure and when the surgeon directed staff to document that Patient #1 had lost 350 cc's of blood during the procedure, she asked the surgeon"are you sure?" When the nurse questioned the estimated blood loss to the surgeon, he informed her "I said its 350 cc's." CN #1 stated she felt Patient #1 had a minimum blood loss of 1,200 cc's during the procedure. The CN stated she had not reported any of her concerns to anyone before or after Patient #1's procedure was completed.

Interview with the CRNA #1, on 03/30/2021 at 11:50 AM, revealed she provided anesthesia services to Patient #1 during the procedure on 03/15/2021. She stated it was the Surgeon's responsibility to determine how much estimated blood loss (EBL) occurred during a surgical procedure; however, when Surgeon #1 stated the blood loss for Patient #1 was three hundred and fifty (350) cc's, "everyone in the room was surprised" and no one believed the blood loss stated by the surgeon was accurate. CRNA #1 also stated the surgeon changed his "bloody gown twice" during Patient #1's procedure and she did not think the amount stated by the surgeon was realistic and felt like one thousand (1,000) or twelve hundred (1,200) cc's of blood loss was "more accurate." However, the CRNA acknowledged that she documented 350 cc's on the anesthesia record as Patient #1's EBL, and stated all documentation related to fluids taken in and all fluids lost during a surgical procedure, "had to match" and whatever the surgeon states as EBL, is what she is required to document. CRNA #1 stated she did not report the concern of the inaccurate EBL stated by Surgeon #1 to anyone, and also stated she had anticipated that the surgeon "would get serial" hemoglobin and hematocrits post-operatively because most surgeons do, especially after a "big surgery."

Interview with Surgical Assist #1, on 03/26/2021 at 11:30 AM, revealed he assisted with Patient #1's procedure on 03/15/2021. He also stated the patient "bled a lot" and he would estimate the amount of blood the patient lost to be 1,000 cc's. He stated when the surgeon stated the blood loss to be 350 cc's, he knew it was "quite a bit more than that." However stated he had not reported the obvious discrepancies as required.

According to Patient #1's record he/she arrived in PACU on 03/15/2021 at 12:13 PM, where his/her blood pressure was 93/47. Record review also indicated he/she was transferred/arrived on a medical/surgical floor at 1:58 PM, where his/her blood pressure was 70/33. Review of nurses notes at 3:01 PM, revealed Anesthesia and Patient #1's provider were notified of his/her low blood pressure readings, and orders were received for Albumin (a blood transport protein) 12.5 grams (gms) to be administered in 250 cubic centimeters (cc's), one (1) dose only at 2:17 PM and a 2,000 cc normal saline bolus to be administered at 2:59 PM.

Patient #1's blood pressure readings after he/she arrived to the medical floor were as follows; 2:20 PM 74/46, 2:44 PM 99/43 and 98/52 at 3:11 PM.

Patient #1's physician ordered post-operative laboratory tests and review of the results revealed his/her hemoglobin had dropped to 6.7 (normal range 11.8-15.3), and his/her hematocrit was now low at 23.8 (normal range 36.9-46.9). The surgeon evaluated Patient #1 and blood products were ordered STAT (immediately) for the patient at 4:21 PM. However, because the surgeon had failed to order the pre-operative type/screen for blood as outlined in the facility policy, the type and screen was not ordered STAT until 4:25 PM, which further delayed blood being ready for administration to Patient #1.

Record review revealed Patient #1's STAT ordered type/screen was not collected until approximately 6:00 PM, and the results of the type/screen were not completed until 7:18 PM (approximately two hours after the laboratory test was ordered STAT).

Record review revealed Patient #1's blood was not ready for administration until 7:40 PM; however, staff failed to initiate administration of his/her blood until approximately 9:00 PM (approximately four (4) hours after the STAT orders were received) even though, the patient's blood pressure continued to be low 80/44 or below.

Interview with Registered Nurse (RN) #4, on 03/24/2021 at 11:15 PM, revealed he cared for Patient #1 for approximately forty-five (45) minutes on 03/15/2021 during the night shift (7PM-7AM). The RN was informed in report that Patient #1's blood pressure was low and the patient had orders for and needed blood, and also had orders to transfer the patient to the ICU. He stated Patient #1 was pale and "looked like" he/she "could crash at any time." RN #4 also stated he was informed Patient #1's blood was ready to be administered at 7:40 PM. However, the RN stated Patient #1's previously ordered bolus of normal saline fluids were infusing and his main priority at that time was to get the patient transferred to the ICU because the longer he/she was on the medical floor it would be "bad." He stated the patient was later transferred to ICU after 8PM on 03/15/2021, and stated he had not retrieved or started the patient's STAT ordered blood.

Continued record reviews and interviews indicated at approximately 9:38 PM on 03/15/2021, Patient #1 had cardiac arrest due to hypovolemic shock (an emergency condition in which severe blood or other fluid loss makes the heart unable to pump enough blood to the body) and the facility was able to revive Patient #1. The record also indicated at 10:05 PM, Patient #1's provider ordered an additional two (2) units of blood. Cryoprecipitate (a frozen blood product) and platelets (blood component whose function is to react to bleeding and initiate a blood clot) were also ordered for Patient #1 at 10:15 PM on 03/15/2021. At 10:58 PM, Patient #1's provider ordered laboratory testing which included, a repeat complete blood count (CBC), basic metabolic panel (BMP), prothrombin time/partial thromboplastin time (PT/INR and PTT); However, there was no evidence staff administered the blood and/or blood products to the patient, and no evidence that any further post-operative laboratory testing was obtained.

Interview with RN #5 on 03/25/2021 at 10:30 AM revealed he admitted Patient #1 to the ICU on 03/15/2021 at approximately 8:15 PM, and stated Patient #1 was pale and "you could tell" he/she was "anemic" (a decreased amount of red blood cells or hemoglobin in the blood). RN #5 started Patient #1's first unit of blood at approximately 9:00 PM; however, he stated Patient #1 went into cardiac arrest at approximately 9:38 PM and staff were able to revive Patient #1. RN #5 stated the patient showed no signs/symptoms of an adverse blood reaction, and also stated Patient #1's provider was at the bedside after he/she went into cardiac arrest and ordered the RN to rapidly infuse the remaining blood in the first unit. The provider also ordered staff to rapidly infuse the second unit of blood. RN #5 stated Patient #1's first unit of STAT ordered FFP's were initiated at approximately 10:30 PM and both units were transfused at approximately 11:00 PM. RN #5 acknowledged there were also orders to transfuse more blood/blood products to Patient #1; however, he stated he had difficulty reaching obtaining a required consent, and stated by the time he received consent from the patient's family, Patient #1 "had gotten bad again."

Further review revealed on 03/16/2021 at 12:19 AM, Patient #1's blood pressure dropped to 51/14 and his/her pulse had increased to 119. Patient #1's blood pressure continued to be low, and review of the record revealed At 12:25 AM Patient #1's blood pressure was 69/49 and pulse was 111. However, staff failed to inform the physician of the change in the patient's condition, and at 1:04 AM, Patient #1 had cardiac arrest for the second time.

Further interview with RN #5 on 03/25/2021 at 10:30 AM indicated Patient #1 experienced a change in condition on 03/16/2021 at approximately 12:35 AM "or so" when he was unable to obtain a blood pressure on the patient. He stated he called the operator and had the in-house Nurse Practitioner (NP) #1 paged at approximately 12:45 AM; however, the NP never responded and the RN took no further action to inform the NP of Patient #1's change in condition. He also stated Patient #1's condition continued to deteriorate and he/she "coded" again at approximately 1:04 AM on 03/16/2021 and the NP then responded to the overhead page of the "code" in the ICU. RN #5 stated he should have paged overhead the NP when he failed to respond when the change in the patient's condition was initially identified.

According to NP #1, during an interview on 03/26/2021 at 12:25 PM, Patient #1 was in hypovolemic shock (an emergency condition in which severe blood or other fluid loss makes the heart unable to pump enough blood to the body) and subsequently expired at 1:14 AM on 03/16/2021.

Interview with the Operating Room (OR) Director on 03/31/2021 at 12:00 PM revealed Surgeon #1 had privileges to conduct Panniculectomies at the facility. She also stated, to her knowledge, pre-operative lab tests were ordered as the surgeons deemed necessary. The Director stated she had reviewed Patient #1's record and had not identified any concerns other than his/her blood pressure being in the "90's" in the PACU. However, she stated Patient #1 had "just came out of anesthesia and had lost a lot of tissue," and her review indicated, that the patient was stable while he/she was in PACU. The Director stated if staff had identified concerns before, during or after Patient #1's surgery, they should have reported those concerns to her immediately so they could have been addressed at that time.

Interview with the Chief Nursing Officer (CNO) on 04/05/2021 at 2:35 PM revealed surgical staff to should have "stopped the line" and reported to supervisory staff in the OR when the surgeon would not "ok a type and screen" before Patient #1's surgery was initiated. She also stated staff should have also immediately reported the discrepancy of estimated blood loss (EBL) stated by the surgeon, to supervisory staff in the OR so a conclusion and an accurate EBL could have been determined after Patient #1's surgical procedure was complete. The CNO also stated Patient #1's labs should have been obtained STAT as ordered, and the patient's blood products should have been started immediately when they were notified they were available for administration. She also stated when the RN was unable to obtain consent immediately when the second orders for blood products were received, the physician should have been notified and orders to emergently transfuse the blood should have been gotten, and the blood products should have been administered to the patient. The CNO also stated Patient #1's provider should have been notified immediately when a change in condition in his/her condition occurred again on 03/16/2021, when the patient's condition continued to deteriorate.

Interview with the Surgeon, on 03/31/2021 at 8:20 AM, revealed Patient #1 had been evaluated at a larger hospital for a Panniculectomy and the physicians there had wanted the patient to "lose weight first," and declined to do the surgery. However, he stated he felt he could do the surgery because it was going to be "life changing" for the patient. He stated his biggest concern pre-operatively for Patient #1 was his/her low vitamin levels, which would affect wound healing. The surgeon acknowledged Patient #1 had a diagnoses of Anemia and his/her hemoglobin and platelets were also low, pre-operatively and stated that did not concern him at that time, and he did not recall anyone suggesting a type/screen for Patient #1. However, the surgeon stated "hind sight is 20/20" and "retrospectively" he should have ordered a type and screen pre-operatively for Patient #1 because it "took a lot of time for the patient to get blood products post-operatively." The surgeon stated Patient #1 "lost 350 cc's of blood for sure" during the surgical procedure and did not recall anyone questioning the estimated blood loss in the operating room for Patient #1. He also stated he should have ordered emergency release blood to be administered to Patient #1 due to the delays in his/her blood getting drawn for a type and screen, and blood being available to the patient, and the patient's continued low pressure readings post-operatively. However, stated he could not say if receiving the blood products in a timely manner would have changed the outcome for Patient #1.

Interview with the Chief of Surgery on 03/29/2021 at 2:03 PM revealed pre-operative laboratory tests, to include type/screens should have been obtained for Patient #1. The Chief of Surgery stated Patient #1's procedure should have been canceled and should have not been done due to his/her pre-operative laboratory results. He also stated if he would have been aware of Patient #1's pre-operative abnormal laboratory results, he would have canceled the surgery. He also stated a low blood pressure during a surgical procedure was an indication that a greater blood loss, other than what the surgeon had anticipated, was going to occur and the surgeon should have anticipated that the patient would need additional blood volume post-operatively. Per the Chief of Surgery, staff should have immediately reported any identified discrepancies with Patient #1's estimated blood loss immediately to the OR supervisor so the patient's case could have been investigated. He also stated its a standard of practice for surgeons to be aware of and monitor blood loss amounts when surgeries are conducted. Per the Chief of Surgery, if blood loss was a concern for Patient #1 during the procedure, labs should have been ordered from the OR to check the patient's status, so if the patient needed blood it could have been replenished.

Based on interview, record review and review of facility processes, it was determined the facility failed to ensure that an updated history and physical exam was completed for one (1) of nine (9) sampled patients prior to a surgical procedure requiring anesthesia. The facility admitted Patient #1 on 03/15/2021 for a Panniculectomy (surgery to remove excessive skin from the abdomen) and the record indicated his/her surgeon had completed a history and physical (H&P) examination. However, there was no evidence the surgeon addressed Patient #1's abnormal pre-operative laboratory results or included the patient's diagnosis of Chronic Anemia (decrease in the amount of red blood cells or hemoglobin in the blood) in the report, as outlined in the facility policy.

The findings include:

Review of the facility policy for "Medical Affairs" last revised in August, 2016 revealed a pre-operative history and physical examination with diagnoses, and the current medical status of the patient which included any identified areas of concerns should be documented.

Review of Patient #1's record revealed he/she was admitted to the facility on 03/15/2021 for a Panniculectomy. Review of his/her pre-operative laboratory results revealed the patient's hemoglobin (a protein in red blood cells that carries oxygen to the organs/tissues and supplies carbon dioxide from organs/tissues back to the lungs) was low at 10.9 (normal range 11.8-15.3) and his/her hematocrit (volume percentage of red blood cells in the blood) was 37.9 (normal range 36.9-46.9) and Patient #1's platelets (a blood component that should react to bleeding thereby initiating the blood to clot) were low at 133,000 (normal range 182-369).

Review of Patient #1's General Surgery History and Physical (H&P) dated 03/15/2021 revealed the patient had diagnoses which included Morbid Obesity, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Hypertension, Obstructive Sleep Apnea and a history of Throat Cancer. Further review of the H&P provided no evidence the patient's diagnosis of Chronic Anemia or the patient's abnormal pre-operative laboratory tests were addressed.

Interview with Surgeon #1 on 03/31/2021 at 8:20 AM revealed he was aware that Patient #1 had a diagnosis of Chronic Anemia and was also aware that the patient's platelets and hemoglobin were low pre-operatively. Per the surgeon, he wasn't sure why he hadn't documented that information in Patient #1's H&P, but stated that information should have been included in his report.

Interview with the Risk Manager on 03/23/2021 at 4:15 PM revealed physicians were expected to include medical diagnoses and abnormal laboratory results in the patient's H&P examinations, as outlined in the facility policy.

Interview with the Chief of Surgery on 03/29/2021 at 2:03 PM revealed Surgeon #1 should have addressed Patient #1's diagnoses of Chronic Anemia and the patient's abnormal pre-operative laboratory results in the patient's H&P.