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670 STONELEIGH AVENUE

CARMEL, NY 10512

MEDICAL STAFF

Tag No.: A0045

Based on medical record review, document review and interview, in four (4) of six (6) medical records reviewed, it was determined the governing body, in accordance with State regulation, failed to appoint Labor and Delivery Nurses as Qualified Medical Personnel/Practitioner (QMP) to evaluate pregnant patients for labor. (Patients #s 1, 2, 3 and 4).

These findings may have placed these patients and their unborn babies at risk for potential harm.

Findings include:

Review of the facility's policy titled "Labor Evaluation," last reviewed 2/2019, states: the purpose of the policy is "patients will be referred to the Birthing Center by their provider for evaluation of labor. Patients may be evaluated in the Labor and Delivery area by a Labor and Delivery nurse."

Review of the facility bylaws revealed Labor and Delivery Nurses were not designated as qualified medical personnel. These nurses were conducting evaluation of pregnant patients in labor.

Review of Medical Record for Patient #1 revealed: this is a pregnant patient who presented to the facility Labor and Delivery area on 4/12/19 at 6:00 PM, with a complaint of headache and to rule out labor. A nurse examined the patient and discharged the patient home at 8:05 PM that night.
The patient returned to the facility on 4/21/19 at 12:36 PM, to rule out labor. The nursing staff examined and assessed the patient and the nurse discharged the patient at 1:49 PM that day.

Review of Medical Record for Patient #2 revealed: this thirty-three year old pregnant patient presented to the facility on 2/5/19 at approximately 3:30 PM, referred by her physician because the patient had an elevated blood pressure in his office that day. The nursing staff assessed the patient and performed fetal heart rate monitoring. The patient was discharged home at 5:34 PM with a diagnosis of fatigue in pregnancy and pelvic pain, and she was given instructions for preeclampsia and to follow-up with a cardiologist the next day.

Similar finding was noted for Patient # 3, a pregnant patient who presented to the facility with abdominal pain, and Patient #4 who presented to the facility on 4/4/19 with a complaint of contractions. Both patients were examined by the Labor and Delivery Nurse.

These findings were shared with Staff A, the Director of Quality on 6/21/19 at approximately 3:00 PM.

PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES

Tag No.: A0122

Based on document review and staff interview, it was determined the facility did not follow its policy for response to patient complaints and grievances. This finding was evident in seven (7) of 11 grievances files reviewed.

Findings Include:

Review of hospital policy, titled "Patient Complaints/Grievance," last revised 5/18, states: "the patient will be contacted via telephone, email or in person within 24-72 hours of receipt of their concern/complaints to inform the patient that an investigation and follow up will be made."

Review of Grievance # 1 identified, a patient complained of not receiving a Magnetic Resonance Imaging test during his visit in the emergency department . The grievance was received on 4/25/19 and the facility wrote a handwritten note on 4/30/19, that they spoke with the patient. The patient received a final letter on 5/29/19. The patient did not receive an email or a phone call within the 24-72-hour timeframe, as per policy.

Grievance #2 identified, the facility received a patient grievance on 3/25/19. The facility notified the patient on 4/4/19. The patient did not receive a phone call or a email within the 24-72 hours, as per policy.

Grievance #3 identified, the facility received the grievance on 5/10/19. There was no documented evidence that the patient received an email or phone call within the 24-72 hours as per policy. The final letter was sent out on 5/29/19.

Similar findings were identified in Grievance #5 6, 7, 8.

These findings were shared Staff C, Director of Patient Relations, on 6/20/19 at 2:40 PM.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on document review and interview, the facility failed to maintain an effective Quality Assessment and Performance Improvement (QAPI) Program, to ensure that data collected was analyzed to identify opportunities for improvement in health outcomes, patient safety and quality of care.

Findings include:

Review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes from June 2018 to May 2019, showed that the data collected for Mortality and Incidents were not analyzed to identify and develop opportunities for improvement.

Example: The mortality ratio showed that for the 3rd and 4th Quarter of 2018 & 1st Quarter 2019, the hospital was not meeting their target of 0.63%. The mortality rate for the 1st Quarter of 2019 was 0.79% which was higher than that the two previous quarters.

The QAPI meeting minutes showed no documented evidence that the data was discussed and evaluated, to determine the reason they were not able to meet their target and develop corrective actions.

During interview on 6/21/19 at 2:00 PM, Staff W, the Director of Risk Management, confirmed the findings.


Review of the Incident Reports for June 2018 to May 2019, showed the number of code gray (patient incidents involving the security staff) to be significantly higher than the other incidents.
For example: The number of code grays reported between January 2018 to November 2018 was approximately 50, while the number of "patient injury-potential, behavior-miscellaneous and behavior contraband," was less than 10.

The QAPI minutes showed no documented evidence that the data was analyzed and tracked to determine the safety of the service and to identify areas for improvement.

The "Quality, Performance Improvement, Patient Safety and Experience Plan," for 2019 states: "undesirable patterns or trends will be closely analyzed by the department chairs and quality department representative for causality and opportunities."

The facility did not comply with their data analysis guidelines.

QAPI PERFORMANCE IMPROVEMENT PROJECTS

Tag No.: A0297

Based on document review and staff interview, the facility did not develop performance improvement projects that reflected the facility's scope and complexity of its services.

Findings include:

Review of the facility's Quality and Performance Improvement data for June 2018 to May 2019, showed evidence of two (2) ongoing projects. The two (2) projects; Malnutrition and Emergency Department Turn Around Time (the amount of time it took for patients to be discharged or transferred to the units),were done in 2018 and 2019.

Review of the facility's data for this period showed no documented evidence of any significant issues related to Patient Malnutrition and ER turn around time.

This information was confirmed by Staff A, Director of Quality and Patient Safety at the time of the review.

During an interview on 6/19/19 at 10:50 AM, Staff E, the Clinical Supervisor for Dietary stated that "Malnutrition is a big problem." She later confirmed that this hospital does not "particularly" have a problem with malnutrition.
There was no specific data to identify why this project was chosen and the reason for doing the same projects for the last two (2) consecutive years.

During interview on 6/19/19 at 11:15 AM, Staff F, Business Manager, stated that she was responsible for conducting projects in the emergency department and that it does not have an end date.

MEDICAL STAFF

Tag No.: A0338

Based on medical record review, document review and interview, in four (4) of six (6) medical records reviewed, it was determined the medical staff failed to ensure that: (a) nurses who assess patients for signs of labor are designated Qualified Medical Personnel/Practitioners (QMP) and (b) pregnant patients who presented to the Labor and Delivery Unit with medical complaints and possible complications of labor, are assessed by a medical provider. (Patient #1, #2, #3 and #4).

These findings may have placed these patients and their unborn babies at risk for potential harm.

Findings include:

Pregnant patients who presented to the Labor and Delivery Unit with medical complaints and symptoms of possible labor were assessed by the Labor and Delivery Nurses. There was no documented evidence that the nurses were designated by the hospital to perform assessments of pregnant patients, for signs of labor.

There was no documented evidence that the patients were examined by a qualified medical staff.

See findings at A 347.


The medical staff failed to designate in its bylaws, labor and delivery nurses as Qualified Medical Personnel/Practitioner (QMP) who could assess pregnant patients for labor.

See findings at A 353.

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on medical record review, document review and interview, in four (4) of six (6) medical records reviewed, it was determined the medical staff failed to examine and evaluate pregnant patients who presented to the facility.

These findings may have placed these patients and their unborn babies at risk for potential harm.

Findings include:

Review of medical record for Patient #1 identified the following: This twenty-one year old pregnant patient presented to the facility on 4/12/19 at 6:00 PM with a complaint of headache, and to rule out labor. At 6:15 PM, the patient reported to the nurse that she was having irregular uterine contractions. The nursing assessment at 6:23 PM, documented the patient's vital signs: Temperature 98.4 F (normal range 98.6 F), Heart Rate 82 (normal range 60 - 100 beats per minute) and Blood Pressure (B/P) 112/67 (normal range less than 120/80). The patient reported to the nurse that she had a headache rated at 3, on a scale of 0 to 10. The nursing staff performed a fetal non-stress test along with an external tocodynamometer (toco) (a medical device used to measure the frequency and duration of uterine contractions) reading to detect uterine contractions and documented continuous fetal heart rate monitoring. The last pain assessment was documented at 7:32 PM and was noted to be aching and on and off. A nurse documented at 7:51 PM "report given to CNM (Certified Nurse Midwife), labs, blood pressure tracing reactive and occ contraction." The nursing staff discharged the patient from the facility at 8:05 PM that night with instructions that included signs and symptoms of preeclampsia (a complication of pregnancy) and hypertensive disorder of pregnancy. There was no physician/provider order to discharge the patient from the facility.

There is documentation that a Certified Nurse Midwife (CNM) ordered urine tests at 6:48 PM, blood tests at 6:51 PM and Tylenol 650 mg orally for pain which a nurse administered to the patient at 7:30 PM. There is no documented evidence that the patient was assessed by the CNM.
There was no documented evidence that the patient was assessed by a qualified medical personnel and that the patient was assessed for the presenting symptom of an headache.

The patient returned to the facility on 4/21/19 at 12:36 PM to rule out labor. The patient reported to a nurse that she had mild uterine contraction at 12:30 PM and at 1:00 PM. The nurse documented at 12:45 PM that the Temperature was 97.8 F; at 12:51 PM the Heart Rate was 92 and the B/P was 123/68. A nurse performed an external toco to detect uterine contraction at 1:00 PM; a nurse performed a vaginal examination at 1:15 PM, a fetal non-stress test at 1:48 PM, and there was continuous fetal heart rate monitoring. At 1:15 PM, a nurse documented that an obstetrician "inquires of patient status, made aware of rare contraction, no SROM (spontaneous rupture of membranes), no vaginal bleeding". The patient was discharged at 1:49 PM that day. There was no physician/provider order to discharge the patient from the facility.
There was no documented evidence that the patient was evaluated by a qualified medical personnel.


Review of medical record for Patient #2 identified the following: This thirty-three year old patient presented to the facility on 2/5/19 at approximately 3:30 PM, referred by her physician because the patient had an elevated blood pressure in his office that day. The patient was 38 weeks 5 days pregnant with a due date of 2/22/19. The nursing staff performed an external fetal heart rate monitoring at 3:35 PM as the physician ordered. The physician also ordered a blood and lab tests at 3:35 PM at 3:47 PM. Nursing staff performed a fetal non-stress test along with an external tocodynamometer reading for uterine contractions as well as an external ultrasound.
At 3:45 PM the nursing staff documented that the patient's initial B/P was 141/74, (normal range less than 120/80), Temperature 97. 9F (normal range 98.6 F), Heart Rate 117, (normal range 60 - 100 beats per minute) and Respiration was 15 (normal range 12 - 20); patient denied pain. The patient was discharged home at 5:34 PM with a diagnosis of fatigue in pregnancy and pelvic pain. The nurse gave the patient instructions for preeclampsia and to follow-up with a cardiologist the next day. The nurse also instructed the patient to start a 24 hour urine collection that night.

There was no documentation in the medical record that a qualified medical personnel evaluated the patient nor was there an order to discharge the patient home. The physician relied on the nursing staff assessments to treat, diagnose and discharge the patient.


Review of medical record for Patient #3 identified the following: This is twenty-one year old pregnant patient presented to the facility on 3/1/19 at 3:02 AM, with a complaint of abdominal pain. The patient had a previous medical history of miscarriage and Lyme Meningitis (a bacterial infection of the nervous system), with a gestational age of 38 weeks and 3 days and a due date of 3/24/19. A physician ordered a fetal non-stress test at 3:31 AM and an external fetal monitoring at 3:32 AM. The nursing staff conducted an assessment of the patient at 3:02 AM and documented a pain score was 2, review of the patient's skin, psychosocial and activities of daily living. The nurse documented a B/P of 119/70 which was not timed. There were no other vital signs in the medical record. The medical record contained a physician's order to discharge the patient home at 3:32 AM. The nursing staff discharged the patient from the facility at 3:45 AM with instructions that included information for preterm labor.

There was no documentation in the medical record that the patient was assessed by a qualified medical personnel.


A similar finding was noted for Patient #4 who presented to the facility on 4/4/19 with a complaint of contractions and there was no documented evidence that the patient was assessed by a qualified medical personnel.


Review of the facility's policy titled "Labor Evaluation" which was last reviewed 2/2019 states: the purpose of the policy is "patients will be referred to the Birthing Center by their provider for evaluation of labor. Patients may be evaluated in the Labor and Delivery area by a Labor and Delivery nurse."

Review of the facility's rules and regulations and medical staff bylaws identified Labor and Delivery Nurses are not authorized or designated to perform nursing assessment of the patients who are in possible labor.

These findings were shared with Staff A, the Director of Quality on 6/21/19 at approximately 3:00 PM.

MEDICAL STAFF BYLAWS

Tag No.: A0353

Based on medical record review, document review and interview, in four (4) of six (6) medical records reviewed, it was determined the medical staff did not develop bylaws to designate labor and delivery nurses as Qualified Medical Personnel/Practitioner to evaluate pregnant patients for labor. (Patient #1, 2, 3 and 4).

These findings may have placed these patients and their unborn babies at risk for potential harm.

Findings include:

Review of the facility's policy titled "Labor Evaluation" which was last reviewed 2/2019, states: the purpose of the policy is "patients will be referred to the Birthing Center by their provider for evaluation of labor. Patients may be evaluated in the Labor and Delivery area by a Labor and Delivery nurse."

Review of the facility's rules and regulations and medical staff bylaws revealed there was no evidence that Labor and Delivery Nurses were designated to rule out labor.

During an interview with the Vice President of Medical Affairs on 6/20/19 at approximately 11:30 AM, he acknowledge there was no documentation in the bylaws that the Labor and Delivery Nurses were designated to evaluate labor.

Review of medical record for Patient #1 revealed; this pregnant patient presented to the facility on 4/12/19 at 6:00 PM with a complaint of headache and to rule out labor. A nurse assessed the patient and continuous fetal heart rate monitoring was provided. There is documentation that a Certified Nurse Midwife (CNM) ordered urine tests at, blood tests and Tylenol 650 mg orally for pain. The patient was discharged from the facility at 8:05 PM.

Patient #1 returned to the facility on 4/21/19 at 12:36 PM to rule out labor. The nursing staff examined and assessed the patient and the nurse discharged the patient at 1:49 PM that day.


Review of the medical record for Patient #2 revealed: this thirty-three year old pregnant patient presented to the facility on 2/5/19 at approximately 3:30 PM, referred by her physician because the patient had an elevated blood pressure in his office that day. The nursing staff assessed the patient and the patient was discharged home at 5:34 PM with a diagnosis of fatigue in pregnancy and pelvic pain and she was given instructions for preeclampsia and to follow-up with a cardiologist the next day.


Similar finding was noted for Patient # 3, a pregnant patient, who presented to the facility with abdominal pain, and Patient #4 who presented to the facility on 4/4/19 with a complaint of contractions. The patients were assessed by the Labor and Delivery Nurses, who are not designated Qualified Medical Personnel/Practitioner, to perform assessments of patients for labor.

These findings were shared with Staff A, the Director of Quality on 6/21/19 at approximately 3:00 PM.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation and staff interview, the food service director did not take responsibility for the daily management of the service to ensure that; (a) proper safety practices for handling food are maintained and (b) proper sanitary environment is maintained in the kitchen.


Findings include:

During tour of the main kitchen on 5/17/19 at 11:25 AM, the following observations were made:

Food Safety:
Food items in the reach-in refrigerator on the lunch tray line, were observed not labeled with the name of the food item, day or date the food was prepared, and the day or date the food must be discarded. For example: no labels were observed on fruit cups, coleslaw cups and salad cups.

An uncovered jug of brown liquid was observed on the counter next to the tray line. When Staff A, Food Service/Nutrition Manager, was asked about the liquid, she stated it's ice tea that will be served on the lunch line tray. This posed a risk for bacterial contamination.

Unsanitary Environment:
-A metal rack belonging to the oven, had evidence of dry accumulation of grease, dirt and grime, and was observed on the kitchen floor between the oven and the stove.

-A plastic trash can beneath the handwashing sink in the cook's station had "swivel covers." The trash can have to be pulled out to be used, and the "swivel cover" on the trash can, prevent the staff from placing used paper towels directly into the trash container without touching.

-The vent above the stoves and ovens in the cook's station was laden with dust and grease.

-Pipes around the oven and kettle in the cook's station had dry accumulation of dirt and grease.

-Accumulation of plate covers, spoons, knives and forks which were covered with dirt, dust and grime, was observed on the dirty floor, in an area at the end of the dishwashing machine. This area had evidence of lack of cleaning.

These findings were observed and verified with Staff D, Food Service/Nutrition Manager, who was present during the tour.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observation and staff interview, the facility failed to maintain the condition of the physical plant in such a manner that the safety and well-being of patients are assured.

Findings include:

During a tour of the Behavioral Health Unit on 6/17/2019 between 2:00 PM-3:00 PM, the following were observed:

(a) All patient beds are provided with restraint rings which present looping hazard.
(b) The chairs in the day room presented looping hazard and were not from the furniture type that is approved by the Office of Mental Health (OMH).

These findings were verified by Staff A, Director of Quality and Staff B, Performance Improvement Specialist, at the time of the observation.

The above findings were brought to the attention of facility's administrators during the exit conference on 6/21/2018 at 3:00 PM.