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Based on observation, interview, and record review, it was determined the hospital did not meet the Conditions of Participation (COP) for Patient Rights as evidenced by:

1. Failure to follow its policies and procedures to obtain informed consent (the permission a patient gives a doctor to perform a test or procedure after the doctor has fully explained the risks and benefits of the procedure) prior to the surgical procedures. (Refer to A-131)

2. Failure to ensure 2% (percent) Chlorhexidine Gluconate Cloths (CHG- rapid antiseptic cloths used for preoperative [before surgery] skin preparation) were stored and discarded according to the manufacturers recommendation. (Refer to A-144)

3. Failure to ensure the door to the Operating Room (OR) remained unlocked during surgical procedures. (Refer to A-144)

The cumulative effect of these systemic failures resulted in the hospital's inability to protect and promote the rights and safety all patients going for surgery.

Based on interview and record review, the hospital failed to follow its policies and procedures for four of 37 sampled patients (Patient 1, Patient 10, Patient 12, and Patient 20) when informed consent (the permission a patient gives a doctor to perform a test or procedure after the doctor has fully explained the risks and benefits of the procedure) was not obtained prior to the surgical procedures.

This failure resulted in Patient 1 having the wrong procedure performed and the potential for patients and family members not being informed about the scheduled procedures and had the potential for Patient 10, Patient 12, and Patient 20, to have a wrong surgical procedure.

Findings:

During an interview on 10/8/20, at 11:45 AM, with Registered Nurse (RN) 5, RN 5 stated, he checked and verified orders and noted the informed consent was not completed. RN 5 stated, he called the responsible party to obtain informed consent for Patient 1's surgical procedure (placement of feeding tube). RN 5 stated, "My sense, she [responsible party] had not been informed of the surgical procedure." RN 5 stated he gave Medical Doctor (MD) 3 the telephone number of the responsible party after the procedure was completed.

During an interview on 11/20/20, at 3:25 PM, with Medical Doctor (MD) 3, MD 3 stated he was in the room when RN 5 called FM 1 on 9/20/20, and FM 1 did not ask to speak to him. MD 3 stated, it is his ultimate responsibility to obtain informed consent for the surgical procedure to include explaining to the family the risks, benefits, and alternatives, and he did not obtain the informed consent for the procedure (placing a feeding tube to Patient 1's stomach) performed on Patient 1 on 9/20/20.

During a review of Patient 10's "Gastroenterology (focused on the digestive system and its disorders) lab (GL)" dated 3/26/21, signed by MD 5 at 07:51, the GL indicated, "Procedure: [dated 3/26/21] EGD (Esophagogastroduodenoscopy- procedure in which a thin scope with a light and camera is used to look inside the upper digestive tract), colonoscopy (endoscopic examination of the large bowel and distal part of the small bowel)"

During a concurrent interview and record review, on 3/30/21, at 2:18 PM, with Quality Assurance Nurse (QAN), Patient 10's "History and Physical (H&P)-Gastroenterology" dated 3/26/21, was reviewed. The H&P indicated, MD 5 had not marked in the checkbox for "Informed Consent Documented." QAN verified MD 5 had not indicated in the medical record that an informed consent had been documented.


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During a review of Patient 12's "Medical Record (MR)" the MR indicated, Patient 12 was admitted at the facility on 3/24/21, for a craniotomy (a surgical procedure that removes part of the skull to access the brain underneath) tumor resection (removal of an abnormal growth of tissue) on 3/24/21.

During a concurrent interview and record review, on 3/26/21, at 9:56 AM, with QAN, Patient 12's H&P dated 3/24/21, was reviewed. The H&P did not indicate an informed consent was done before the surgery (craniotomy). QAN verified the findings.

During a review of Patient 20's MR, the MR indicated, Patient 20 was admitted at the facility on 2/1/21, for a cystoscopy (a surgical procedure that allows the doctor to examine the lining of the bladder and the tube that carries the urine out of the body), transrectal ultrasound (a procedure that uses soundwaves to create a video image of the prostate - a male gland located between the bladder and the penis), and prostate biopsy (removal and examination of tissue, cells or fluids from the body) on 2/1/21.

During a concurrent interview and record review, on 3/26/21, at 2:18 PM, with QAN, Patient 20's H&P dated 2/1/21, was reviewed. The H&P did not indicate an informed consent was done before the surgery. QAN stated, "It should have been marked and done before the procedure."

During an interview on 3/26/21, at 4:43 PM, with Manger Pre-Op (Mgr) 3, Mgr 3 stated, "The informed consent should be done and documented on the H&P."

During a review of the hospital's policy and procedure (P&P) titled, "CORPORATE MODEL POLICY: CONSENT AND INFORMED CONSENT - CALIFORNIA" dated 5/6/19, the P&P indicated, ". . .F. Treatments/Procedures That Require an Informed Consent: 1. Complex treatments/procedures . . .4. Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient's legal representative with the information that is necessary to allow an "informed decision" to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to performance of the procedure. . .e. The role of the health care facility in the informed consent process is to verify that the proceduralist(s) obtained the patient's informed consent before the proceduralist(s) is/are permitted to perform the procedure/tests/ or than an exception (such as the emergency exception) applies that allows treatment to proceed."

Based on observation, interview, and record review, the hospital failed to:

1. Ensure 2% (percent) Chlorhexidine Gluconate Cloths (CHG- rapid antiseptic cloths used for preoperative [before surgery] skin preparation) were stored and discarded according to the manufacturers recommendation.

2. Ensure door to the Operating Room (OR) remained unlocked during procedures.

These failures had the potential to result in all patients going to surgery to receive care in an unsafe setting.

Findings:

1. During a concurrent observation and interview on 3/26/21, at 11:25 AM, with Manager Med/Surg/Tele (Mgr) 1, in the Clean/Medication Room of the Telemetry Unit (patients who require constant monitoring of cardiac conditions, or had a cardiac procedure or surgery), there were four packs of 2% CHG cloths in the Comfort Warmer (electric heating equipment). The temperature of the Comfort Warmer was 125°(degrees) F (Fahrenheit). The 2% CHG package indicated, "Other Information: avoid excessive heat above 40°C (Celsius) (104°F)." Mgr 1 verified the Comfort Warmer was over 104°F.

During an interview on 3/26/21, at 12:15 PM, with Manager Infection Prevention (Mgr IP), Mgr IP stated, "The Sage [brand name] CHG is a product we got away from a few years ago. Not sure how it got there [surgery area]." Mgr IP stated she would find out the correct temperature the cloths should stay at.

During a concurrent interview and record review on 3/26/21, at 2:22 PM, with Mgr IP, a letter to the facility, from the manufacturer SAGE, dated 3/26/2021 was reviewed. The letter indicated, "This letter is being sent to you in response to your request for information regarding warming the 2% Chlorhexidine Gluconate (CHG) Cloths in a Comfort Personal Cleansing Warmer (Comfort Warmer). Sage Products recommends that the product be stored according to the conditions listed on the package label. The product packaging refers to the storage temperatures during the shelf life of the CHG product." Mgr IP stated, "The cloths can stay in the warmer for 84 hours, and then be discarded. The Sage CHG should not have been inside (the warmer)."

During an interview on 3/26/21, at 3:25 PM, with Mgr 1 and Mgr 2, Mgr 1 stated the 2% CHG cloths are used for central line (procedure when doctors place in a large vein in the neck, chest, or groin) dressing and open heart (surgery of the heart) prep (preparation) the night before and day of surgery. Both Mgr 1 and Mgr 2 stated they have been using the cloths for awhile, but do not remember how long. Mgr 1 and Mgr 2, both stated they were not aware of the 84 hour time limit.

During a review of "SAGE Products SAFETY DATA SHEET" (SDS), dated 3/27/2015, the "SDS" indicated, "Antiseptic Body Cleansing Washcloths, 2% Chlorhexidine gluconate Cloth,
7.2 CONDITIONS FOR SAFE STORAGE, INCLUDING ANY INCOMPATIBILITIES:
Store product flat. Store between 20-25° C (68 - 77°F). Avoid excessive heat above 40°C (104°F)."

2. During an observation on 3/29/21, at 11:04 AM, in OR 2, Patient 5 was moved from the gurney to the OR table by the OR team. At 11:11 AM, Registered Nurse (RN) 4, locked the door to the OR suite. At 11:23 AM, Surgeon Medical Doctor (MD) 6, tried to get into the OR (OR 2), but the door was locked. MD 6 entered OR 2 by going through the Sub-sterile room (accessible from the hallway to the OR, and equipped with a flash sterilizer [steam disinfecting of objects], warming cabinet [warming equipment], countertop, and sink). At 11:43 AM, after the surgical procedure was completed, RN 4 unlocked the door to the OR.

During an interview on 3/29/21, at 11:45 AM, with RN 4 and Risk Management Specialist (RMS), RN 4 stated, "We lock it (door) to keep crowd control down. The doctor knows to go through the sub sterile room." RN 4 was asked how long she had been locking the door, and RN 4 stated "I'm not sure, awhile now." RMS stated she was not aware the OR doors were being locked.

During an observation on 3/29/21, at 11:50 AM, in the OR, with RMS, the other OR suite doors were checked.
The following was noted:
OR 3 - case in progress, door unlocked
OR 4 - case in progress, door unlocked
OR 5 - empty
OR 7 - setting up for case, door unlocked
OR 8 - empty
OR 1 - setting up for case, door unlocked

During an interview on 3/29/21, at 11:55 AM, with Director of Operating Room (DirOR), Mgr 4, RMS, and RN 4 (present), DirOR stated, "That is not our policy (to lock the doors). It may be a practice for some, but the door shouldn't be locked. It can be a safety issue." Mgr 4 stated, "I'm not aware of the doors being locked. I know in room 1 they will (lock the door), but they go around [walk through another walkway]. It's not a policy." When asked about inservice for locking the doors, RMS stated, "No, because it's not policy."

During a concurrent interview and record review, on 3/29/21, at 2:38 PM, with DirOR, the hospital policy and procedure (P&P) "Traffic Control in the Perioperative Areas," dated 7/23/2019, was reviewed. The P&P indicated, "2. a. Once the procedure begins the main door will be locked." The DirOR stated, "I saw that, and I noticed it referenced AORN (Association of periOperative Registered Nurses). AORN indicates door closed, not locked."

During a review of facility document titled Outpatient Surgery, Division of AORN, dated 11/20/17, the Outpatient Surgery article titled "Limit Foot Traffic in Your OR", indicated "Locked doors create safety concerns and impede staff members who have legitimate reasons for disrupting surgery."

During a review of AORN eGuidelines, 2021, the AORN eGuidelines indicated, "Sterile Technique, Recommendation 7. Moving Around a Sterile Field, 7.5. Keep doors to the operative or invasive procedure room closed as much as possible except during the entry and exit of patients, required personnel, and necessary equipment." The Guideline for Sterile Technique was approved by the AORN Guidelines Advisory Board and became effective November 1, 2018.

Based on interview and record review, the hospital failed to follow its policy and procedure on pain management assessment and reassessment for three of 37 sampled patients (Patient 12, Patient 14, and Patient 20) when:

1. Comprehensive pain assessments were not completed for Patient 12 and Patient 20 on admission.

2. Pain reassessment was not completed and documented for Patient 14.

These failures had the potential to result in inadequate pain relief for patients.

Findings:

1. During a concurrent interview and record review, on 3/29/21, at 9:56 AM, with Quality Assurance Nurse (QAN), Patient 12 and Patient 20's Medical Record (MR) were reviewed. QAN was unable to find documented evidence the comprehensive pain assessments were completed on admission for Patient 12 and Patient 20. QAN stated pain assessments should be done on admission.

During an interview on 3/29/21, at 12:05 PM, with Manager Pre-Op (Mgr) 3, Mgr 3 stated, "All patients should have a comprehensive pain assessment on admission and when they get transferred to each unit."

2. During a concurrent interview and record review, on 3/29/21, at 11:28 AM, with QAN, Patient 14's Medication Administration Record (MAR) dated 2/9/21 to 2/13/21, was reviewed. The MAR indicated an order for Norco (medication to relieve pain) 10 milligram (mg- a unit of measurement) PO (by mouth) every six hours PRN (as needed) for pain was documented as administered with no pain reassessment on the following days:

2/10/21 at 5:28 AM, no reassessment documented
2/11/21 at 3:36 PM, no reassessment documented
2/12/21 at 12:29 AM, no reassessment documented
2/13/21 at 8:11 AM, no reassessment documented

QAN stated, "Pain should be reassessed one hour post (after) administration of pain medication."

During a review of the hospital's policy and procedure (P&P) titled, "Pain Management Assessment and Reassessment", dated 12/3/19, the P&P indicated, "A. All patients presenting to the hospital will have a pain assessment. B. Comprehensive Assessment 3. A comprehensive pain assessment should include, to the extent relevant, intensity, site(s), quality, radiation, and onset. . .C. Pain Reassessment 1. A pain reassessment shall be performed within one hour after pain intervention. . .I. Documentation: Pain assessments, reassessments, and pain intensity levels are documented in the medical record."

Based on observation, interview, and record review, it was determined the hospital did not meet the Conditions of Participation (COP) for Surgical Services as evidenced by:

1. Hospital failed to complete Preoperative (before surgery) Procedure Check List (PPC - a checklist that is required to be asked and assessed as part of safe care before going to surgery) prior to surgical procedures for four of 37 sampled patients. (Refer to A-951)

2. Hospital failed to verify PPC lists were completed prior to surgical procedures for six of 37 sampled patients. (Refer to A-951)

3. Hospital to complete patient History and Physical's (H&P) prior to the surgical procedures for six of 37 sampled patients. (Refer to A-952)

The cumulative effect of these systemic practices resulted in Patient 1 receiving unintended surgical procedure (placement of feeding tube) and expired after 17 days and potential to affect other patients.

Based on observation, interview, and record review, the hospital failed to follow its policies and procedures for seven of 37 sampled patients (Patient 1, Patient 5, Patient 6, Patient 9, Patient 10, Patient 28 and Patient 33) when:

1. The hospital failed to complete a Preoperative (before surgery) Procedure Check List (PPC- a checklist that is required to be asked and assessed as part of safe care before going to surgery) prior to the surgical procedure (placement of feeding tube) for Patient 1.

2. The hospital failed to verify PPC lists were completed prior to surgical procedures for Patient 9, Patient 10, Patient 33, Patient 5, and Patient 6, Patient 28.

These failures resulted in Patient 1 receiving a surgical procedure not intended for Patient 1 and had the potential for Patient 9, 10, 33, 5, 6, and 28, to have wrong surgical procedure.

Findings:

1. During a concurrent interview and record review, on 10/8/20, at 11:41 AM, with the Director of Operating Room (DirOR), Patient 1's clinical record was reviewed. DirOR stated the bedside nurse should initiate a PPC. The DirOR stated Registered Nurse (RN) 5 did not complete a PPC prior to Patient 1's surgical procedure performed on 9/20/20. DirOR verified Patient 1's medical record did not include a PPC for the 9/20/20 surgical procedure.

During an interview on 10/8/20, at 11:45 AM, with Registered Nurse (RN) 5, RN 5 stated, before a procedure begins, he reviews orders, labs (laboratory), and verifies a completed informed consent for the procedure is in the medical record. RN 5 stated the bedside nurse initiates the PPC. RN 5 stated, he was the nurse who assisted with Patient 1's procedure on 9/20/20. He stated, before the procedure "I don't believe it [PPC] was done and I don't remember checking on it [PPC]." RN 5 stated the PPC is a system in place to double check and verify the correct patient, orders, labs, and surgical consent, H&P [History and Physical - method by which doctors gather information about a patient's past and present medical condition in order to make informed clinical decisions], etc. are complete and correct before beginning a surgical procedure.

During an interview on 10/8/20, at 12:59 PM, with RN 7, RN 7 stated she was taking care of Patient 1 starting at 7 AM, on 9/20/20. She received report in the morning of 9/20/20, and in the report; there had been no mention of a scheduled procedure for Patient 1. RN 7 stated, when she returned from break, she saw RN 1 and another staff member with equipment outside the Patient 1's room. RN 7 stated, she had not completed a PPC, since she was not informed Patient 1 had been scheduled for a surgical procedure on 9/20/20.

During a review of hospital's PPC, the PPC included, the nurse should validate the following list prior to a surgical procedure, ". . .Allergy band applied. . . H&P available, H&P interval update, ID (identification) band checked . . .Surgical anesthesia [given for temporary loss of pain for a procedure] consent signed, Surgical/Procedure consent signed, surgical site marked by MD/designee, surgical site verified by patient. . ."

During a review of hospital's policy and procedure (P&P) titled, "Preoperative Procedure Management Policy," revision date 10/1/2020, the P&P indicated, "J. Pre-Op Checklist: 1. Complete the Pre-Procedure and Site Verification Checklist entirely before sending all procedural patients (planned/unplanned/emergent) to procedure. Check off every box. Fill in all appropriate blanks. Ensure it is signed and timed by appropriate staff members."

2. During a review of Patient 9's Intra-Op (Intraoperative - occurring during the operative procedure) Record dated 3/29/21, at 10:12 PM, signed by RN 2, indicated, "Time-in (time the patient is taken in the procedure room) at 3/29/21, at 9:08 AM.

During a concurrent interview and record review, on 3/29/21, at 3:04 PM, with Risk Management Specialist (RMS), Patient 9's PPC dated 3/29/21, at 8:45 AM, was reviewed. The PPC indicated, RN 2 had not reviewed the PPC until 09:30 AM (22 minutes after Patient 9 had entered the operating room). RMS verified the findings.

During a review of Patient 10's Endo (endoscopy-an examination of upper stomach using a camera held on to a flexible tube called endoscope) Intra-Op Record (EIR), dated 3/26/21, at 7:35 AM, the EIR indicated, "Time-in", at 07:28 AM, with RN 5 listed as circulating nurse (nurse who ensures safety of patient during surgical procedures).

During a concurrent interview and record review, on 3/30/21, at 2:18 PM, with Quality Assurance Nurse (QAN), Patient 10's PPC, dated 3/26/21, at 6:32 AM, was reviewed. The PPC indicated, RN 5 had not verified the PPC. QAN verified the findings.

During a review of Patient 33's Intra-Op Record (IR), dated 3/26/21, at 10:45 AM, the IR indicated, "Time-in", at 9:48 AM, with RN 4 as circulating nurse.

During a concurrent interview and record review, on 3/30/21, at 10:15 AM, with Infection Preventionist (IP), Patient 33's PPC, dated 3/26/21, at 6:53 AM, was reviewed. The PPC indicated, RN 6 had not reviewed and verified the PPC checklist was accurate until 10:17 AM. (29 minutes after Patient 33 had entered the operating room)

During an interview on 3/29/21, at 4:03 PM, with Manager Pre-OP (Mgr) 3, Mgr 3 stated, the verification process of the pre-procedure checklist should occur in the preoperative area and before entering the operating room.

During a review of the hospital's policy and procedure (P&P) titled, "UNIVERSAL PROTOCOL PROCEDURE" dated 2/1/18, the P&P indicated, ". . .A. PRE-PROCEDURE VERIFICATION PROCESS Patients undergoing a surgical or invasive procedure will have a Pre-Procedure Verification process. . . 2. Pre-Operative/Pre-Procedure area: a. Pre-procedure Verification Process. 1. The patient shall be involved in the verification process, when possible, which includes the following: a. Verify correct patient using two acceptable patient identifiers per hospital Patient Identification Policy. B. Verify the correct procedure to be performed. C. Verify the correct site for the procedure. 2. The approved checklist includes relevant patient-specific documentation, labeled diagnostic [the identification of an illness] and radiology [imaging technology to diagnose and treat diseases] test results and required blood and equipment needed."


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During an interview on 3/29/21, at 10:25 AM, with RN 3, RN 3 stated, "Patient goes to surgery when the PPC is done by both nurses [Pre-Op and Circulator-circulating nurse who assists everyone during a surgery]."

During an observation on 3/29/21, at 10:33 AM, in the Pre-Op holding area, RN 2 (Circulating Nurse) was at the gurney side talking with Patient 5. The computer was not being used, and there was no visible PPC.

During an interview on 3/29/21, at 10:40 AM, with Mgr 3, Mgr 3 was asked about the Circulating Nurse completing the PPC. Mgr 3 stated, "They [Circulating Nurse] do it when they go back into the surgery room." Mgr 3 was asked when should it be done, and Mgr 3 stated, "Before they [Circulating Nurse] go back into the OR."

During a concurrent interview and record review, on 3/29/21, at 10:46 AM, with Mgr 3, the PPC for Patient 5 was reviewed. Mgr 3 stated there is a section for the OR nurse (Circulating Nurse) to mark that she has reviewed the information. Mgr 3 stated, "It's not marked."

During a concurrent interview and record review, on 3/30/21, at 8:56 AM, with QAN, Patient 5's PPC dated 3/26/21, was reviewed. The PPC dated 3/26/21, indicated, RN 2 had not verified the PPC. QAN verified the findings.

During a concurrent interview and record review, on 3/29/21, at 3:55 PM, with QAN, Patient 6's PPC dated 3/26/21, at 8:44 AM, was reviewed. The PPC indicated, RN 9 had not verified the PPC. QAN verified the findings.


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During a review of Patient 28's PPC, dated 2/24/21, the PPC indicated it was not verified.

During an interview on 3/30/21, at 2:40 PM, with RN 8, RN 8 stated she was the one who filled out the PPC but the PPC was not verified. RN 8 reviewed Patient 28's PPC and stated, "I am not sure what happened. The PPC should be verified prior to surgery."

During an interview on 3/30/21, at 2:42 PM, with DirOR, DirOR verified the finding and stated, "That [PPC] was missed."

During a review of the hospital's policy and procedure (P&P), titled "Preoperative Procedure Management Policy" dated 10/1/20, the P&P indicated, "J. Pre-OP Checklist: 1. Complete the Pre-Procedure and Site Verification Checklist entirely before sending all procedural patients (planned/unplanned/emergent) to procedure. Check off every box. Fill in all appropriate blanks. Ensure it is signed and timed by appropriate staff members."

Based on interview and record review, the hospital failed to complete the History and Physical (H&P - important reference document that provides information about a patients history and examination findings) for six of 37 sampled patients, (Patient 1, Patient 10, Patient 12, Patient 18, Patient 20, and Patient 28) prior to the surgical procedure. This failure had the potential to result in increased risk in adverse health outcome of the surgical procedure for these patients.

Findings:

During a review of Patient 1's "The Endo (Endoscopy-an examination of upper stomach using a camera held on to a flexible tube called endoscope) Intra-Op (Intraoperative - occurring during the operative procedure) Record," dated 9/20/20, at 2:47 PM, indicated, "Time-in (time the patient is taken in the procedure room) 9/20/20 at 1340 (1:40 PM). . .Procedure EGD (Esophagogastroduodenoscopy -endoscopic procedure that allows your doctor to examine your esophagus (throat), stomach and small intestine) with PEG (percutaneous endoscopic gastrostomy, a procedure in which a flexible feeding tube is placed through the abdominal wall and into the stomach) Placement. . ."

During a review of Patient 1's "History and Physical (H&P)- Gastroenterology (focused on the digestive system and its disorders)" dated 9/20/20 at 1:42 PM, the H&P indicated, the H&P was signed by Medical Doctor (MD) 3 at 1:42 PM (2 minutes after Patient 1 had been in the room to begin the surgery).

During a concurrent interview and record review, on 11/20/20, at 3:40 PM, with MD 3, Patient 1's H&P was reviewed. MD 3 stated it was the expectation to review a patient's medical record, which included reviewing the progress notes and lab (laboratory) work. It was also his responsibility to update and complete the H&P and ensure the medical record contained the completed H&P prior to beginning a surgical procedure. MD 3 stated, he did not dictate a consultation H&P for Patient 1 before the surgical procedure on 9/20/20. MD 3 verified Patient 1's H&P was not completed prior to the surgical procedure.

During a concurrent interview and record review, on 11/24/20, at 2:10 PM, with RN 5, RN 5 reviewed the hospital's Preoperative (before surgery) Procedure Check List (PPC- a checklist that is required to be asked and assessed as part of safe care before going to surgery) for Endoscopy procedures. RN 5 stated, the process of the perioperative checklist was to review if the H&P was completed and in the patients chart prior to beginning the surgical procedure. RN 5 stated, on the day of Patient 1's procedure (9/20/20) he did not confirm if the H&P was completed or in the chart prior to the procedure. RN 5 stated, "I can't remember, but I didn't check."

During an interview on 12/2/20, at 3:50 PM, with Regulatory Specialist (RS) 1 and RS 2, RS 1 and RS 2 verified the H&P by MD 3 was not in the medical record prior to Patient 1's surgical procedure on 9/20/20.

During a review of Patient 10's "Gastroenterology lab (GL)" dated 3/26/21, signed by MD 5 at 07:51, the GL indicated, "Procedure: EGD, colonoscopy [exam used to detect changes or abnormalities in the large intestine {colon} and rectum]."

During a concurrent interview and record review, on 3/30/21, at 2:18 PM, with Quality Assurance Nurse (QAN), Patient 10's "History and Physical (H&P)-Gastroenterology," dated 3/26/21, was reviewed. The H&P indicated, MD 5 had marked the checkbox: "I have reviewed the H&P, I have examined the patient and "no change" has occurred in the patient's condition since the H&P was completed. QAN stated, there was no comprehensive history and physical in the chart, and MD 5 would have needed to complete a short form medical history. QAN verified MD 5 had not completed the short form medical history.



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During a record review of Patient 12's Medical Record (MR), the MR indicated Patient 12 was admitted at the facility on 3/24/21, for a craniotomy (a surgical procedure that removes part of the skull to access the brain underneath) tumor resection (removal of an abnormal growth of tissue).

During a concurrent interview and record review on 3/29/21, at 9:56 AM, with QAN, Patient 12's H&P, dated 3/24/21, was reviewed. The H&P did not have the following information:

a. Chief Complaint
b. History of Present Illness
c. Past Medical History
d. Medications
e. Social History
f. Allergies
g. Family History
h. Physical Examination
i. Procedure Plan
j. Pre-Procedure/Pre-Operative Diagnosis

QAN stated, the H&P should be filled out completely prior to surgery.

During a concurrent interview and record review on 3/26/21, at 2:10 PM, with QAN, Patient 18's H&P, dated 2/10/21, was reviewed. The H&P did not indicate the time when it was completed. An electronic signature was signed by the surgeon on 2/17/21, at 1:16 PM (seven days after the surgery). QAN stated, "H&P's should be signed and dated with the correct time and date before the procedure."

During a concurrent interview and record review on 3/26/21, at 2:18 PM, with QAN, Patient 20's H&P was reviewed. The H&P did not indicate the time when it was completed. QAN stated, "H&P's should be dated with the correct time it was done."

During an interview on 3/26/21, at 2:43 PM, with Manager Pre-Op (Mgr) 3, Mgr 3 stated, "H&P examination should be completed prior to surgery. This is part of the [pre-operative] checklist."


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During a review of Patient 28's PPC, dated 2/24/21, the PPC indicated, "Procedure name: Lap Sleeve Gastrectomy [procedure involving removal of the stomach by 75 to 80% (percent) in order to reduce the food consumption] with possible HHR [Hiatal Hernia Repair- a condition that causes part of your stomach to bulge through the hiatus (small opening) in your diaphragm] possible open, ICG [Indocyanine Green Angiography-diagnostic procedure that uses ICG dye to examine the blood flow] angiography [medical imaging technique used to visualize the inside of blood vessels and organs of the body]."

During a concurrent interview on 3/29/21, at 11:58 AM, and record review of Patient 28's clinical records, with Mgr 3, Mgr 3 reviewed the clinical record and stated, "There was no H&P completed prior to the surgery. The H&P was completed after the surgery."

During a review of the hospital's policy and procedure titled, "Medical Record Content", dated 11/13/18, the P&P indicated, "B. History and Physical Examination a. A comprehensive history and physical examination is required to be performed, authenticated and entered into the medical record no more than 30 days prior to, or within 24 hours after, registration or inpatient admission, but prior to surgery or a procedure requiring anesthesia services. . .c. The comprehensive history and physical examination must include the following items: i. Provisional Diagnosis/Chief patient complaint; ii. Details of the present illness or condition. iii. Past medical and surgical history iv. Assessment of the patients social status and psychosocial needs appropriate to patients age; v. A physical examination inventoried by body systems. . .vi. Diagnosis or diagnostic impression vii. Reason(s) for admission or treatment, goal(s) of treatment and treatment plan."