HospitalInspections.org

Based on medical record review, document review, patient and staff interview, the hospital's governing body failed to be responsible for the conduct of the hospital in that they failed to ensure the hospital adequately responded to and thoroughly investigated a misread lab sample and ensured the patient involved was fully informed of the misdiagnosis (Refer to A-0049). The governing body also failed to ensure the hospital promoted and protected the rights of a patient by failing to keep her fully informed of her diagnosis, a misread lab, and her surgical procedure (Refer to A-0115 and A-0131). Finally, the governing body failed to ensure that the Medical Staff Committee appointed a qualified Pathologist to a position by not ensuring that she met the special qualifications listed on the application for privileges (Refer to A-0338 and A-0341).


These deficient practices placed all patients receiving services at this hospital at risk for receiving care that does not meet acceptable quality and standards.

Based on record review, document review, patient and staff interview, the hospital's medical staff failed to ensure the quality of care provided to one of eleven patients sampled (Patient #1) in that the surgeon and other hospital staff failed to inform the patient of a misread lab specimen that revealed she did not ever have cancer; failed to inform the patient during her hospitalization that she did not have cancer and that her appendix had been removed during surgery; failed to update patient #1's medical record to remove the diagnosis of cancer, and failed to completely and thoroughly investigate the incident.


Findings Include:


Interview on 7/26/16 between 4:15 PM and 5:30 PM with the Chief Medical Officer revealed, the ex-Risk Manager Staff P and I were aware of patient #1's final diagnosis not being the same as the FNA (fine needle aspiration-a thin needle is inserted into an area of abnormal-appearing tissue or body fluid. As with other types of biopsies, the sample collected during fine needle aspiration can help make a diagnosis or rule out conditions such as cancer) before patient #1 left the hospital. Staff P and I did the initial investigation. The investigation showed a female patient that was profoundly symptomatic and had many studies of her pancreas (CT (computerized tomography) and MRI (magnetic resonance imaging) completed. There were concerns about the patient having acute/chronic pancreatitis (inflammation of the pancreas which can cause abdominal pain, nausea, vomiting, fatigue, and headache).

An endoscope (an instrument used to examine the interior of a hollow organ or cavity) was used to get FNA samples of the pancreas which were reviewed by 2 clinical pathologists (Pathologist Staff G and Pathologist Staff K) and they both agreed on the diagnosis (neuroendocrine tumor of the pancreas-cancerous).

The surgeon determined to take her to surgery based on the findings of the endoscopic procedure, the lab samples, and other radiological exams.

Surgeon Staff F told me he informed the patient about the gland being diseased and not cancerous. The patient was aware of the diagnosis (that she does not have cancer).

Follow up from previous interview on 8/4/2016 at 9:20 AM with the Chief Medical Officer: I did not speak directly to the patient. I was told by Surgeon Staff F that he informed the patient that the FNA results showed that she had cancer, but after the pancreas was tested the results were that there was no cancer. I don't know if anyone sat down and said in exact terms "the initial test was inaccurate" but she knew the FNA results and the final results. Risk Manager Staff P did not speak to the patient to my knowledge. Risk Manager Staff P is no longer employed by the facility and unable to be contacted.

Patient # 1 interviewed on 8/8/16 at 12:00 PM indicated that she was not told that she didn't have cancer while she was in the hospital. Surgeon Staff F did tell her on 9/17/2016 at my follow up appointment "good news, no cancer. It was pancreatitis". I know that date because it was the date that I was told I didn't have cancer. That was the first time I had heard about pancreatitis. At none of my follow up visits, no one ever said there might have been a misread, misdiagnosis, or an error in the lab tests.

- Pathology report signed on 8/6/2015 by Pathologist Staff G and reviewed on 7/25/2016 at 4:35 PM revealed:

Cytology # 15-1315
Pancreatic neuroendocrine neoplasm (primary cancer of the pancreas)
Pathologist Staff K agrees with the above diagnosis is documented in the comments section of the document.

Cytology # 15-1316
Pathology report signed on 8/6/2015 by Pathologist Staff G and reviewed on 7/25/2016 at 4:45 PM revealed:
A diagnosis of Pancreatic neuroendocrine tumor
Pathologist Staff K agrees with the above diagnosis is documented in the comments section of the document.

Cytology # 15-1317
Pathology report signed on 8/6/2015 by Pathologist Staff G and reviewed on 7/25/2016 at 4:45 PM revealed:
Diagnosis is Rare atypical cells (not always an indication of cancer, can be a result of inflammation or infection) present.

- Documentation above indicated Pathologist Staff K agreed with the findings in 2 of the 3 Cytology reports (15-1315 and 15-1316). Intradepartmental documents (pink slips) failed to include Pathologist Staff K's signature on one of the two pink slips (15-1315). A concurrent review and signature is required when there is a finding of a new cancer. Only one pink slip (15-1316) was provided by the hospital for review; the other pink slip (15-1315) could not be located.

Pathologist Staff K interviewed on 7/28/16 at 2:00 PM stated, "I did not receive the other two samples (15-1316 and 15-1317) nor was I aware of them. Documentation stating otherwise would be incorrect.

Pathologist Staff G interviewed on 7/27/16 at 9:00 AM, FNA's take some samples out of this entire organ, the journals very well document that there are margins of errors in this type of test. When you have a large organ and you are taking some cells there is a larger possibility of potential error. At least one of the samples were not shown to Pathologist Staff K- the one marked atypical it wouldn't have been required. However, the Fellow (Physician Staff Q) initiates the form (the pink slip), they are supposed to ensure at least two people are on it, the original pathologist, fellow, and the pathologist making the second opinion. I assumed the fellow showed both to Pathologist Staff K. In pathology all around the country they (the pink slips) are not integrated into the medical record, we put it into the report its self in the comments section. Physician Staff Q, Fellow is no longer employed at this hospital and was unable to be contacted.

- Addenda to Patient #1's medical record recorded on 9/18/15 by pathologist Staff G regarding 15-1315 and 15-1316 read: This addendum is done for reporting Cytology-Surgical Pathology correlation. The surgical specimen (S15-22266) was reported as chronic and multifocal pancreatitis. The pancreatitis show reduced acinar cell component (acinar cells produce and transport enzymes that are passed into the duodenum (first part of the small intestine) where they assist in the digestion of food) and prominent nests of neuroendocrine cells (cells that release message molecules (hormones) to the blood)--islet cells (cluster of cells that produce the hormone insulin)(all normal pancreatic cells). The FNA cytology correlates with the surgical specimen (thus indicating a discrepancy with the original FNA diagnosis). Surgeon Staff F was notified of this on 9/4/15 and 9/8/15.

Patient #1's pathology report dated 9/4/2016 revealed the post-surgical pathology results for her pancreas were "Negative for tumor in the entirely submitted pancreatic specimen". The surgical specimens indicated no cancer present in the pancreas. So then, the original FNA specimens 15-1315 and 15-1316 did not show that the patient had a pancreatic neuroendocrine tumor (cancer).

- Even though Chief Medical Officer and the ex-Risk Manager investigated the incident regarding the discrepancy between the FNA specimens and the surgical specimens, they failed to speak to the patient herself (even though they were aware of the issue prior to her discharge) and they failed to investigate potential issues in laboratory proceedings (Pathologist K's claim that she did not perform a concurrent review on specimen 15-1315 and did not sign the pink slip (which cannot be located now).


- Even though Surgeon Staff F was aware that patient #1 did not every have cancer, patient #1's medical record reviewed on 7/25/2016 at 1:00 PM revealed a discharge diagnosis of a primary pancreatic neuroendocrine tumor (a type of cancer in the pancreas). The medical record lacked evidence Surgeon Staff F corrected the discharge diagnosis and removed the inaccurate diagnosis of a pancreatic neuroendocrine tumor from the patient's record.


Surgeon Staff F interviewed on 7/27/2016 at 12:15 PM stated, "Once the information is placed in the electronic medical record it is hard to get it out of there, that's a job for IT (information technologies)". Staff F stated the medical record "is not very important" and indicated they do not base their diagnosis on past History and Physicals.


- Patient #1 further revealed during the interview on August 8, 2016 that during an emergency room visit in 2016 when I went in for blood work the doctor came in and said "Oh, I heard about you, you had an extended Whipple procedure (a major surgical operation involving the removal of the head of the pancreas, the duodenum, including the duodenal papilla (opening of the pancreatic duct into the duodenum) or ampulla of Vater (formed by the union of the pancreatic duct and the common bile duct), the proximal jejunum (part of the small intestine between the duodenum and ileum), gallbladder (the small sac-shaped organ beneath the liver, in which bile is stored after secretion by the liver and before release into the intestine), and often the distal stomach) and had your appendix taken out". I said wow that's funny I didn't know (that she had her appendix removed). When I was at my follow up appointment with Surgeon Staff F I asked him about it and he said "Oh, I must have forgotten to tell you, I had to take that out because they form the same kind of tumors that your pancreas had". At that point I didn't know what was taken out, I was quite shocked about that.

- I (Patient #1) knew nothing about the test (FNA) being inaccurate until I got a call out of the blue from Surgeon Staff F (Tuesday August 2, 2016) asking me to sign an affidavit and telling me about the test and a disagreement. I told him to send it over and I read it. I had questions about it because he wanted me to say that I was told in the hospital that I didn't have cancer and that it was pancreatitis.

- The medical record lacked documentation that Surgeon Staff F notified patient #1 of the discrepancy between the FNA sample and the final surgical specimen pathology prior to her discharge. The medical record lacked documentation that Surgeon Staff F notified the patient during her hospitalization that she did not have cancer or that her appendix was removed during the surgery.








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Based on document review, medical record review, patient and staff interview, the Hospital failed to provide adequate information about a patient's health status and diagnosis to allow her to make informed decisions about her plan of care during her hospitalization (refer to A-0131).


This deficient practice placed all patients at risk for not having adequate information to make informed decisions about their healthcare.

Based on record review, document review, patient and staff interview, the hospital failed to promote one of eleven patients sampled (Patient #1) right to make informed decisions regarding her care in that they did not keep her informed of her health status by: failing to disclose a discrepancy between the initial FNA (fine needle aspiration-a thin needle is inserted into an area of abnormal-appearing tissue or body fluid. As with other types of biopsies, the sample collected during fine needle aspiration can help make a diagnosis or rule out conditions such as cancer) diagnosing the patient with a neuroendocrine tumor (cancer) of the pancreas and the final surgical pathology revealing no signs of tumor (cancer); by Surgeon Staff F not informing the patient that she was cancer-free during her hospitalization; and by Surgeon Staff F failing to inform the patient that he removed her appendix during the same surgery.


These deficient practices have the potential for all patient receiving services at the hospital to not be fully informed off their health status and to not be able to participate fully in the planning of their care.


Findings include:


Patient #1 interviewed by telephone on Monday August 8, 2016 revealed in part: I was referred to KU Medical Center in August for an upper GI (ERCP)--endoscopic retrograde cholangiopancreatography a specialized technique used to study the bile ducts, pancreatic duct and gallbladder. Ducts are drainage routes; the drainage channels from the liver are called bile or biliary ducts. The pancreatic duct is the drainage channel from the pancreas) to look at the pancreas. At that time they found 3 lesions on the pancreas. They told me I needed to have those removed. From there, I was referred to Surgeon Staff F and I saw him on August 20, 2015. He drew a picture of the Whipple surgery (a major surgical operation involving the removal of the head of the pancreas, the duodenum, including the duodenal papilla (opening of the pancreatic duct into the duodenum) or ampulla of Vater (formed by the union of the pancreatic duct and the common bile duct), the proximal jejunum (part of the small intestine between the duodenum and ileum), gallbladder (the small sac-shaped organ beneath the liver, in which bile is stored after secretion by the liver and before release into the intestine), and often the distal stomach) that I was going to have and where the tumors were. Then they were going to take out a portion of the stomach, the duodenum and part of the pancreas to remove those tumors and the gallbladder to prevent gallstones in the future. The surgery was scheduled for August 31, 2016 and Surgeon Staff F ordered an MRI (Magnetic Resonance Imaging-noninvasive medical test that physicians use to diagnose and treat medical conditions. MRI uses a powerful magnetic field, radio frequency pulses and a computer to produce detailed pictures of organs, soft tissues, bone and virtually all other internal body structures) on August 27, 2015 and I had surgery on September 1, 2015. I remained in the hospital until September 9, 2015.


I (Patient #1) had a follow up visit on September 17, 2015 and that's when Surgeon Staff F told me "good news, no cancer", it was pancreatitis. "You remember that date". No one ever said there might have been a misread, misdiagnosis, or an error at any of my follow up visits.


- Patient #1's medical record reviewed on 7/25/16 at 1:00 PM read in part: Discharge Summaries by APRN (Advanced Practice Registered Nurse),FNP-C (Certified Family Nurse Practitioner) Staff O dictated on 09/09/15 at 8:14 AM:

9/1/15: Exploratory laparotomy (surgical operation where the abdomen is opened and the abdominal organs examined for injury or disease), intraoperative ultrasound (a procedure that uses ultrasound (high-energy sound waves that are bounced off internal tissues and organs) during surgery. Sonograms (pictures made by ultrasound) of the inside of the body are viewed on a computer to help a surgeon find tumors or other problems during the operation, body pancreatectomy (surgical removal of the body of the pancreas) and pancreaticoduodenectomy (Whipple procedure), open cholecystectomy (removal of the gallbladder), appendectomy (removal of the appendix), reconstruction with pancreaticojejunostomy (the duct and the pancreas are connected to a loop of small intestine), hepaticojejunostomy (connection of the hepatic duct to the jejunem), and gastrojejunostomy (connection of the stomach to the jejunum), omental flap creation, omentopexy and plasty (part of the lining of the abdominal cavity is used to cover or fill a defect, augment arterial or portal venous circulation, absorb effusions (collections of fluids), or increase lymphatic drainage).

Surgical Pathology 9/1/15:
Hilar lymph node #1: There is no evidence of tumor (0/1).
Appendix: Negative for tumor in the entirely submitted specimen.
Pancreas: Localized chronic pancreatitis. Negative for tumor in the entirely submitted specimen.
Lymph nodes: Negative for tumor (0/3).
Hilar lymph node #2: There is no evidence of tumor (0/1).
Gallbladder: No diagnostic abnormalities.
Whipple contents: Pancreas: Multiple foci of chronic pancreatitis. Negative for tumor in the entirely submitted pancreatic.


- Page 1003 of patient #1's medical record contained documentation by Pathologist Staff G written on 9/18/16 that read in part: This addendum is done for reporting Cytology-Surgical Pathology correlation. The surgical specimen was reported as chronic and multifocal pancreatitis (inflammation of the pancreas which can cause abdominal pain, nausea, vomiting, fatigue, and headache). The pancreatitis showed reduced acinar cell component (acinar cells produce and transport enzymes that are passed into the duodenum where they assist in the digestion of food) and prominent nests of neuroendocrine cells (cells that release message molecules (hormones) to the blood)-islet cells (cluster of cells that produce the hormone insulin)-all normal pancreatic cells. The FNA cytology correlates with the surgical specimen (thus indicating a discrepancy with the original FNA diagnosis). Surgeon Staff F was notified of this on 9/4/15 and 9/8/15.

Interview with Surgeon Staff F on 7/29/16 at 12:45 PM, Afterwards she (Pathologist Staff G) came to me and told me the results of the FNA that she had read and diagnosed as a neuroendocrine tumor of the pancreas was inaccurate. First time in 12 years, a pathologist has ever called me. It was within 7-10 days after the surgery. The patient may have been discharged by then. We already knew the final pathology before the call from Pathologist Staff G. The final pathology came back before the patient discharged that showed she did not have cancer; she was told "no cancer" was found in the pancreas. I told her she did not have cancer. I don't know exactly what was said, it was about a year ago.


Patient #1 further revealed during the interview on August 8, 2016 that during an emergency room visit in July 2016 when I went in for blood work the doctor came in and said "Oh, I heard about you, you had an extended Whipple procedure and had your appendix taken out". I said wow that's funny I didn't know. When I was at my follow up appointment with Surgeon Staff F I asked him about it and he said "Oh, I must have forgotten to tell you, I had to take that out because they form the same kind of tumors that your pancreas had". At that point I didn't know what was taken out, I was quite shocked about that.

I (Patient #1) knew nothing about the test (FNA) being inaccurate until I got a call out of the blue from Surgeon Staff F (Tuesday August 2, 2016) asking me to sign an affidavit and telling me about the test and a disagreement. I told him to send it over and I read it. I had questions about it because he wanted me to say that I was told in the hospital that I didn't have cancer and that it was pancreatitis. I didn't say anything to him, but I knew the date that I was told I didn't have cancer. "You remember that date" and so that was 9/17/2015. There was also a statement that in the MRI there were 2 small lesions in the pancreas that was consistent with the endoscopic ultrasound but in that test there were 3 lesions, so that just made me curious because it just didn't seem right.

The medical record lacked documentation that Surgeon Staff F notified patient #1 of the misinterpreted FNA sample even though Pathologist Staff G notified him prior to Patient #1's discharge. The medical record lacked documentation that Surgeon Staff F notified the patient during her hospitalization that she was cancer-free or that he had removed her appendix during the surgery. The medical record continued to indicate that Patient #1 had a primary neuroendocrine tumor to the date of this review 7/25/16 even though the patient did not ever have cancer.


- Patient admission packet reviewed on 8/3/16 in section titled "Patient Rights and Responsibilities" read in part: To receive complete and current information about your diagnosis, treatment and prognosis in terms you can understand.

The Hospital reported a census of 605 inpatients. Based on observation, medical record review, and staff interview the Hospital failed to protect and secure confidential patient information in one of eleven laboratories (cytopathology lab) located on the main hospital campus. The failure of the Hospital to protect patient information has the potential to expose medical and personal information to unauthorized individuals.

Findings Include:

- Tour of the Hospital on 8/2/2016 at 3:45 PM in the cytopathology lab revealed current documentation called "Intra-departmental consultation form" also known as a "pink slip" , used for internal quality assurance purposes containing patient identification information that are stored in a binder on the top shelf of an open bookshelf. Additional documentation used for internal quality assurance purposes containing patients' identifying information were observed bound together lying on an open work surface in the cytotechnologist area. Neither room is locked during Hospital business hours. Both rooms can be unoccupied at any given time.

Physician Staff G, Physician Staff H, Physician Staff I, and Cytotechnologist Staff J interviewed on 7/27/2016 revealed a document called "Intra-departmental consultation form" used internally for quality assurance purposes is assigned to cytopathology specimens in the cytology lab and accompanies the specimen through the review process by cytopathology. The hospital staff agreed this document contains patients' identifying information. The completed document is kept in a binder on an open shelf in the cytology lab and is accessible for review at any time by any staff working in the lab.

Policy titled "Rules and Regulations of the Medical Staff " reviewed on 8/2/2016 at 4:45 PM revealed "...All Medical Records, the information contained therein, and any other patient-specific information shall be treated in accordance with all applicable legal and ethical rules related to the confidentiality of patient medical information and shall be released only in accordance with the Hospital's Policies and Procedures governing medical records ..."

Policy titled "Confidentiality, Security, and Integrity of Data" reviewed on 8/3/2016 at 10:00 AM revealed "...Access to individual health information will be granted at the minimum necessary level to insure confidentiality without compromising patient care delivery ...Every user of the Hospital systems must sign the Confidentiality Agreement/Signature Attestation ...Breach of confidentiality, unauthorized disclosure, or breach of Hospital policy regarding system use will result in disciplinary action ..."

Based on staff interview, document, and policy review the Hospital failed to ensure the physician appointed as Pathology Chairman met the special qualifications required for Privileges in Cytopathology (diagnosis of human disease by means of the study of cells obtained from body secretions and fluids, by scraping, washing, or sponging the surface of a lesion, or by the aspiration of a tumor mass or body organ with a fine needle including interpretation of Papanicolaou smears of cells from the female reproductive system) by failing to ensure she had completed an accredited residency in anatomic pathology or anatomic/clinical pathology and American Board of Pathology Boards added certification or met eligibility for added certification in Cytopathology within 6 months of start date (refer to A-0341).



This deficient practice had the potential to allow members of the medical staff the opportunity to provide services they are not qualified for with the potential to cause harm to all patients treated within the hospital.

Based on record review, staff interview, and policy review the Hospital failed to ensure each applicant's suitability for their approved clinical privileges by failing to ensure special qualifications were met for the privileges requested on their application form for 1 of 16 credentialing files reviewed (Pathologist Staff G).

This deficient practice had the potential to allow members of the medical staff the opportunity to provide services they are unqualified for with the potential to cause harm to all patients treated within the hospital.


Findings Include:

- Pathologist Staff G's application for privileges dated 3-24-15 reviewed on 7/28/2016 at 2:30 PM revealed a request for Clinical Pathology Core Privileges, Anatomic Pathology Core Privileges, and Cytopathology (diagnosis of human disease by means of the study of cells obtained from body secretions and fluids, by scraping, washing, or sponging the surface of a lesion, or by the aspiration of a tumor mass or body organ with a fine needle including interpretation of Papanicolaou smears of cells from the female reproductive system). The special qualifications for Cytopathology included "...Criteria: in addition to completion of an accredited residency in anatomic pathology or anatomic/clinical pathology and ABP boards added certification or eligibility for added certification in cytopathology within 6 months of start date ...". Staff G's application revealed they were not board certified in cytopathology.

- A form titled "Criteria-Based Core Privileges: Pathology" completed by Pathologist Staff G on 3/24/16 requested Clinical Pathology Core Privileges and Anatomic Pathology Core Privileges. In addition, Staff G applied for the Special Non-Core Privilege of Cytopathology. Section titled "Recommendation of Clinical Service Chief" signed and dated on 3/31/16 lacked a recommendation of the privileges requested in that there was no indication of what privileges if any he recommended. The form show that the privileges were approved by the Credentials Committee Chair on 5/11/2015, Executive Committee of the Medical Staff Chair on 5/28/2015, and The Board of Directors Representative on 6/9/2015 even though the applicant was not board certified in Cytopathology.

- A form titled "Recommendation and Actions on Appointment and Delineation of Clinical Privileges Initial Appointment/Additional Privilege Request" revealed the Signature of the Clinical Services Chief dated 5/6/15 with the answer "Yes" to the question "There is adequate documentation in the practitioner's credentials file that the practitioner meets all department/service criteria/standards for privileges requested."... D) Privileges: I (Clinical Service Chief) have reviewed the requested clinical privileges and supporting documentation and make the following recommendations(s): Recommend all requested privileges. The Clinical Service Chief recommended all requested privileges for Pathologist Staff G even though their was no documentation in her application showing she met the special qualifications/criteria for clinical privileges in Cytopathology.

- Pathologist Staff G was Recommended for Medical Staff Status as Pathology Chairman with privileges in Anatomic pathology, Clinical pathology, and Cytopathology by the Chief of Clinical Services on 3/31/2015 (5/6/15), Credentials Committee Chair on 5/11/2015, Executive Committee of the Medical Staff Chair on 5/28/2015, and The Board of Directors Representative on 6/9/2015 even though the applicant was not board certified in Cytopathology.

Pathologist Staff N interviewed on 7/28/2016 at 12:00 PM indicated there had been a change in the criteria required to be granted privileges in cytopathology to allow Pathologist Staff G to be able to "sign out" (diagnose) cytopathology cases. The change occurred after Staff G was appointed and granted privileges. Staff N revealed Staff G developed the new criteria herself and presented it at the Credentials Committee meeting on 7/13/2015. The revision was discussed and approved in the Executive Committee of the Medical Staff Meeting on 7/23/2015. The new application form listed the Special Qualifications for Cytopathology to include "...in lieu of added certification in cytopathology, experience as a practicing cytopathologist for at least 10 years in an academic medical center in the US, along with participation in cytopathology specific continuing medical education and teaching cytopathology in an academic medical center ...". Staff N revealed they had previously applied for privileges in Cytopathology and had similar experience as Staff G but were denied because they were not board certified in Cytopathology.

Pathologist Staff L in an email received on 8/2/2016 at 4:13 PM revealed Pathologist Staff G had signed out (diagnosed) 13 cytopathology cases between July 21, 2015 and July 23, 2015 before the criteria change went into effect. Staff L indicated they had two previous hires with similar background that did not have board certification in Cytopathology and they were not allowed to become privileged in Cytopathology. Staff L reported Staff G indicated s/he could modify the criteria to reflect that a person did not have to have the board certification if they had so many years of experience.

Pathologist Staff L interviewed on 8/4/2016 at 12:00 PM confirmed that Pathologist Staff G would not be eligible for board certification in cytopathology at this point. Staff L indicated there is a 4-year residency program for pathology, a 1-year fellowship in Cytopathology and then an exam must be successfully completed. Pathologist Staff G never did a Cytopathology fellowship and that is required for current certification, so again she would not be eligible for the board certification within six months as specified by their privileges application.

- Credentialing Procedures of the Medical Staff reviewed on 8/3/2016 directed "...In connection with all applications affecting Medical Staff membership or clinical privileges, the applicant shall have the burden of producing information for an adequate evaluation of the applicant's qualifications and suitability for the clinical privileges and Medical Staff category requested, resolving any reasonable doubts about such matters, updating any information used during the application process in a timely fashion, and satisfying reasonable requests for additional information about the applicants suitability for the clinical privileges and Medical Staff category requested. The applicant's failure to sustain this burden shall be grounds for denial of the application ..."

The Hospital reported a census of 605 inpatients. Based on observation, medical record review, and staff interview the Hospital failed to protect and secure confidential patient information in one of 11 laboratories located on the main hospital campus (cytopathology lab). The failure of the Hospital to protect patient information has the potential to expose medical and personal information to unauthorized individuals.

Findings Include:

- Tour of the Hospital on 8/2/2016 at 3:45 PM in the cytopathology lab revealed current documentation called "Intra-departmental consultation form", used for internal quality assurance purposes containing patient identification information that are stored in a binder on the top shelf of an open bookshelf. Additional documentation used for internal quality assurance purposes containing patient identifying information were observed bound together lying on an open work surface in the cytotechnologist area. Neither room is locked during Hospital business hours. Both rooms can be unoccupied at any given time

Physician Staff G, Physician Staff H, Physician Staff I, and Cytotechnologist Staff J interviewed on 7/27/2016 revealed a document called "Intra-departmental consultation form" used internally for quality assurance purposes is assigned to cytopathology specimens in the cytology lab and accompanies the specimen through the review process by cytopathology. The hospital staff agreed this document contains patient identifying information. The completed document is kept in a binder on an open shelf in the cytology lab and is accessible for review at any time by any staff working in the lab.

Policy titled "Rules and Regulations of the Medical Staff" reviewed on 8/2/2016 at 4:45 PM revealed "...All Medical Records, the information contained therein, and any other patient-specific information shall be treated in accordance with all applicable legal and ethical rules related to the confidentiality of patient medical information and shall be released only in accordance with the Hospital's Policies and Procedures governing medical records ..."

Policy titled "Confidentiality, Security, and Integrity of Data" reviewed on 8/3/2016 at 10:00 AM revealed "...Access to individual health information will be granted at the minimum necessary level to insure confidentiality without compromising patient care delivery ...Every user of the Hospital systems must sign the Confidentiality Agreement/Signature Attestation ...Breach of confidentiality, unauthorized disclosure, or breach of Hospital policy regarding system use will result in disciplinary action ..."

Based on medical record review, staff interview, and policy review the Hospital failed to ensure the promotion of the patient's continuity of care by ensuring the physician documented accurate information in the medical record for 1 of 11 patient records reviewed (Patient #1).

This deficient practice had the potential for inadequate post-hospitalization follow-up care.

Findings include:


- Patient #1's medical record reviewed on 7/25/2016 at 1:00 PM revealed a discharge diagnosis of a primary pancreatic neuroendocrine tumor (a type of cancer in the pancreas). The medical record lacked evidence Surgeon Staff F corrected the discharge diagnosis and removed the inaccurate diagnosis of a pancreatic neuroendocrine tumor from the patient's record.


Surgeon Staff F interviewed on 7/27/2016 at 12:15 PM stated, "Once the information is placed in the electronic medical record it is hard to get it out of there, that's a job for IT (information technologies)". Staff F stated the medical record "is not very important" and indicated they do not base their diagnosis on past Histories and Physicals.

Rules and Regulations of the medical staff reviewed on 7/27/2016 at 4:40 PM directed "... All Discharge Summaries shall identify the patient, and contain sufficient information to support the diagnosis, justify the treatment, document the course and results of the treatment, and permit adequate continuity of care among health care providers. Discharge Summaries shall also contain instructions given to the patient relating to physical activity, medication, diet and follow-up care..."

Based on medical record review, staff interview and policy review the Hospital failed to ensure the physician accurately completed the discharge summary within thirty days after discharge for one of eleven medical records reviewed (Patient #1).

This deficient practice had the potential for inadequate post-hospitalization follow-up care.

Findings include:


- Patient #1's medical record reviewed on 7/25/2016 at 1:00 PM revealed the patient was admitted on 9/1/2016 and discharge on 9/9/2016 with a discharge diagnosis of a primary pancreatic neuroendocrine tumor (a type of cancer in the pancreas). The medical record lacked evidence Surgeon Staff F corrected the discharge diagnosis and removed the inaccurate diagnosis of a pancreatic neuroendocrine tumor from the patient's record.


Surgeon Staff F interviewed on 7/27/2016 at 12:15 PM stated, "Once the information is placed in the electronic medical record it is hard to get it out of there, that's a job for IT (information technologies) " . Staff F stated the medical record "is not very important" and indicated they do not base their diagnosis on past Histories and Physicals.


Rules and Regulations of the medical staff reviewed on 7/27/2016 at 4:40 PM directed "... All Discharge Summaries shall identify the patient, and contain sufficient information to support the diagnosis, justify the treatment, document the course and results of the treatment, and permit adequate continuity of care among health care providers. Discharge Summaries shall also contain instructions given to the patient relating to physical activity, medication, diet and follow-up care... and ... The patients Attending Physician shall be responsible for the timely preparation and completion of the patient's Medical Record. Following discharge of the patient, the Medical Record will be completed within 30 days ... "

Based on medical record review, staff interview, and policy review the Hospital failed to ensure the physician accurately document the final diagnosis for 1 of 11 patient records reviewed (Patient #1). This deficient practice had the potential for inadequate post-hospitalization follow-up care.

Findings include:


- Patient #1's medical record reviewed on 7/25/2016 at 1:00 PM revealed a final diagnosis of a primary pancreatic neuroendocrine tumor (a type of cancer in the pancreas). The medical record lacked evidence the patient's final diagnosis had been updated to reflect that the patient did not have a pancreatic neuroendocrine tumor.


Patient #1's surgical pathology report dated 9/1/2016 at 2:12 PM revealed the pancreas samples were negative for malignancies.


Patient #1's pathology report dated 9/4/2016 revealed the post-surgical pathology results for Patient #1's pancreas was "Negative for tumor in the entirely submitted pancreatic specimen" .


Surgeon Staff F interviewed on 7/27/2016 at 12:15 PM stated, "Once the information is placed in the electronic medical record it is hard to get it out of there, that's a job for IT (information technologies)" and did not attempt to change the History and Physical to reflect a correct final diagnosis. Staff F indicated the medical record "is not very important" and indicated they do not base their diagnosis on past Histories and Physicals.


Policy Review on 7/27/2016 at 2:00 PM directed revealed the hospital failed to provide a policy directing staff to document accurately a final diagnosis in patient's medical records.

The Hospital reported an average monthly census of 2290 surgeries. Based on observation, staff interview and policy review, the infection control officer failed to ensure staff inside the surgical area complied with appropriate surgical attire (two unidentified staff in the pre-post operative area and two staff in the surgical suite (Certifed Registered Nurse Anesthetist (CRNA) Staff C and Physician Staff B). This deficient practice has the potential to expose all patients to infectious diseases.

Findings include:

- Tour of the facility on 7/25/2016 at 3:00 PM revealed two unidentified Staff in the preoperative/postoperative area with surgical masks hanging under their chin. Preoperative/Postoperative RN Staff A was present during the observation.

Pre-Postoperative RN Staff A interviewed on 725/2016 at 3:00PM revealed, "The masks should have been removed from their chins after leaving the surgical suite per hospital policy".

Policy titled Surgical Attire reviewed on 7/25/2016 directed "...Masks must be changed between cases and when wet or soiled and must be removed before leaving the semi-restricted area. Masks should either be worn, or removed when not in use. Masks should not be allowed to hang from the neck and on the front of the scrub top ..."


- Surgical Suite observed of on 7/25/2016 at 2:00 PM during a surgical procedure revealed Registered Nurse Anesthetist (CRNA) Staff C and Physician Staff B with hair not completely covered by their bouffant. Staff C was observed to have hair hanging below the bouffant at back and at both sides of their head. Staff B was observed to have hair hanging below the bouffant at back of their head and forehead.

Policy titled Surgical Attire states review on 7/25/2016 at 3:00 PM directed "...The head including all hair, facial hair, sideburns, and neckline must be covered by a disposable surgical hat or hood when in the semi-restricted and restricted areas of the perioperative departments .... All personnel must wear hospital provided disposable head/hair covering ..."

The Hospital reported an average monthly census of 2290 surgeries. There are 32 surgical suites in the main Hospital surgical area. Based on observation, policy review, and staff interview the hospital failed to limit movement into and out of the surgical suite during procedures.

This deficient practice has the potential to expose all patients to surgical site infections.

Findings include:

Observation in the surgical suite 54 on 7/25/2016 at 2:00 PM during the 45 minute surgical procedure of removal of an intrauterine device (IUD), revealed three staff entered and left the surgical suite through the main surgical suite door.

Surgical Registered Nurse (RN) Staff E interviewed on 7/26/2016 at 2:30 PM revealed access to the OR during active surgical procedures "should be limited with specific doors to be used for entrance and exit". S/he revealed staff "are required to use the inner core door when entering and exiting the surgical suite. During joint replacements there is to be no movement into or out of the surgical suite and if an instrument is required that is not in the surgical suite it will be brought to the door for retrieval by the circulating nurse."


- The Hospital has no current policy directing staff to limit movement into and out of the surgical suites. An unpublished policy draft, Traffic Patterns for the Perioperative Departments, directed "...Movement of personnel should be kept to a minimum while invasive and noninvasive procedures are in progress ...Preferred entrance into the surgical suite will be through the cleanest entrance into the room. The number of people present should be minimized during the procedures ..."


- A review of the AORN (Association of periOperative Registered Nurses) recommendations to decrease surgical site infections (SSIs), the researchers concluded that the evidence supports implementing interventions to decrease door openings and traffic in the OR. (AORN.org, 2014)