Lovelace Regional Hospital - Roswell

Summary Statement of Deficiencies D0000 During a proficiency desk review on 05/04/2020, the laboratory was found out of compliance with the following condition: 42 CFR Part 493.803 Proficiency Testing, Successful Participation D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; This STANDARD is not met as evidenced by: Based on the review of shipping calendars from the proficiency agency websites, emails from laboratory representatives, proficiency test reports from the Centers for Medicare & Medicaid Services (CMS) proficiency database, the laboratory failed to notify the New Mexico Department of Health of the intent to enroll with a new proficiency testing agency for the calendar year 2020. Findings are: A. Review of the Centers for Medicare & Medicaid CASPER report 155, Proficiency Test scores dated 05/01/2020, revealed the laboratory enrolled in proficiency testing with 2 different agencies, AAB and CAP for 2020 using the same CLIA number. The laboratory received a score of 0% for all analytes from AAB and 100% from CAP. B. Review of the shipping calendar for both proficiency agencies and emails from the laboratory revealed: 1. AAB samples for the 1st event of 2020 were shipped on 02/04/2020. 2. CAP samples for the 1st event of 2020 The Coagulation module, including Fibrinogen, was shipped on 01/27/2020. The Aqueous Blood Gas module was shipped on 02/24/2020. 3. On 02/12/2020, the laboratory sent an application for the new laboratory operator via email to the New Mexico Department of Health but did not include notification of the change to a new proficiency testing agency. D2016 SUCCESSFUL PARTICIPATION Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on reports from the Centers for Medicare & Medicaid Services (CMS) proficiency database, the laboratory failed to successfully participate in proficiency testing for PCO2 and Fibrinogen. Findings are: A. Review of the Centers for Medicare & Medicaid CASPER Report 155, Proficiency Test scores dated 05/01 /2020, revealed the laboratory failed 2 of 3 test events for the analyte PCO2. See D2096 2nd event 2019 = 60% 1st event 2020 = 0% B. Review of the Centers for Medicare & Medicaid CASPER Report 155, Proficiency Test scores dated 05/01/2020 revealed the laboratory failed 2 out of 3 test events for the analyte Fibrinogen. See D2130 2nd event 2019 = 40% 1st event 2020 = 0% D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of reports from the Centers for Medicare & Medicaid Services (CMS) proficiency database, the laboratory failed to receive passing scores for the analyte PCO2 for 2 of 3 test events in 2019 and 2020. Findings are: Review of the Centers for Medicare & Medicaid CASPER Report 155, Proficiency Test scores dated 05/01/2020 revealed: The laboratory failed 2 of 3 test events for the analyte PCO2 with the proficiency testing agency AAB. 2nd event 2019 = 60% 1st event 2020 = 0% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of proficiency test reports from the Centers for Medicare & Medicaid Services (CMS) proficiency database, the laboratory failed to successfully participate in proficiency for the analyte PCO2 for 2 of 3 test events in 2019 and 2020. Findings are: A. Review of the Centers for Medicare & Medicaid CASPER Report 155, Proficiency Test scores dated 05/01/2020 revealed: The laboratory failed 2 of 3 test events for the analyte PCO2 with the proficiency testing agency AAB. 2nd event 2019 = 60% 1st event 2020 = 0% B. Review of the Centers for Medicare & Medicaid CASPER Report 157 Excused Nonparticipation Report dated 04/27/2020, revealed no record that the laboratory had requested excused nonparticipation status for the 1st event of 2020 from the proficiency agency AAB. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of reports from the Centers for Medicare & Medicaid Services (CMS) proficiency database, the laboratory failed to receive passing scores for the analyte Fibrinogen for 2 of 3 test events in 2019 and 2020. Findings are: Review of the Centers for Medicare & Medicaid CASPER Report 155, Proficiency Test Scores dated 05/01/2020, revealed the laboratory failed 2 of 3 test events for the analyte Fibrinogen with the proficiency testing agency AAB. 2nd event 2019 = 40% 1st event 2020 = 0% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of reports from the Centers for Medicare & Medicaid Services (CMS) proficiency database, the laboratory failed to successfully participate in proficiency testing for the analyte Fibrinogen for 2 of 3 test events in 2019 and 2020. Findings are: A. Review of the Centers for Medicare & Medicaid CASPER Report 155, Proficiency Test Scores dated 05/01/2020, revealed the laboratory failed 2 of 3 test events for the analyte Fibrinogen with the proficiency testing agency AAB. 2nd event 2019 = 40% 1st event 2020 = 0% B. Review of the Centers for Medicare & Medicaid CASPER Report 157 Excused Nonparticipation Report dated 04/27/2020, revealed no record that the laboratory had requested excused nonparticipation status for the 1st event of 2020 from the proficiency agency AAB. -- 3 of 3 --

Summary Statement of Deficiencies D0000 During a complaint survey completed on 12/13/19 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following condition: 42 CFR Part 493.1441 Laboratory Director, High Complexity D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on the review of transfusion records, nursing notes, electronic medical records, laboratory policy, nursing blood administration policy, and interviews with laboratory staff, the laboratory failed to ensure nursing staff reported all possible transfusion reactions to the laboratory for 1(BB #5) of 6(BB #1-BB#6) patient medical records reviewed from October and November 2019. This deficient practice could result in delayed identification and treatment of transfusion reactions. Findings are: A. Review of the medical record for BB (Blood Bank Patient) #5. had no documentation the laboratory was notified of a possible transfusion reaction 1. Consent signed 10/08/19 at 6:17 (am/pm not documented). 2. The Transfusion Record for PRBC(Packed Red Blood Cells) Unit W041519025216 indicated the transfusion started on 10/08/19 at 13: 17 pm. The transfusion was completed on 10/08/19 at 15:15 pm. The section, "Evidence of possible transfusion reaction?" was marked "No." 3. The Transfusion Record for PRBC Unit W041519020383 indicated the transfusion started on 10/08/19 at 15:45 pm. The transfusion was completed on 10/08/19 at 17:56 pm. The section, "Evidence of possible transfusion reaction?" was marked "No." 4. Nursing note dated 10/08/19 at 05:08 pm (2 hours and 23 minutes after 2nd transfusion started) indicated "Arrived into room, pt c/o feeling chills and pain in there (sic) right arm. Blood Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- product stopped. Temp checked to be 97.8. Dr [name of provider] on unit, reported incident to him, made aware of vital signs and pt complaint. Dr [name of provider] order to restart blood and offer hydralazine for anxiety. Blood resumed, pt refused hydralazine at this time. Upon further assessment, pt states she has been having chills off and on since early yesterday." B. Review of the Laboratory Blood Bank Policy, Crossmatch and Transfusion, dated 02/28/19, indicated: "All suspected adverse reactions to transfusions are to be investigated when the situation arises, whether or not the ordering physician requests it. THIS IS A STAT PROCEDURE. (see Transfusion. Reaction policy)" C. Review of the Laboratory Blood Bank Policy, Transfusion Reactions, dated 02/28/19 indicated the following: 1. "All personnel involved in the administration of blood products must be able to recognize a suspected reaction so that the transfusion can be stopped, diagnosis established, and appropriate therapy initiated promptly. All nursing personnel must have annual transfusion reaction, blood administration, and recipient identification training. All transfusion reactions, whether immediate or delayed, will be resulted the same and have medical director involvement in the type of reaction identified and treatment of the transfusion reaction. The physician ordering the transfusion will receive the transfusion reaction report. The pathologist will also give direction to the transfusion service whether more transfusions may take place or not." Procedure -"1. In the event a transfusion reaction is suspected, the transfusing nurse should immediately stop the transfusion and notify the physician. 2. Within 10 minutes of stopping the transfusion, the laboratory must be notified so that we may begin to investigate the cause of the reaction." 2. The laboratory Transfusion Reaction policy identified and defined 7 types of transfusion reactions; Hemolytic Transfusion Reaction, Febrile Nonhemolytic Transfusion Reaction, Allergic and Anaphylactic Reactions, Transfusion-Related Acute Lung Injury, Transfusion Associated Circulatory Overload, Transfusion-Associated Sepsis and Delayed Hemolytic Transfusion Reaction. 3. The laboratory Transfusion Reaction policy identified the following as signs and symptoms of transfusion reactions: Fever (increase of 1C or 2F) Chills Rigors (a sudden feeling of cold with shivering accompanied by a rise in temperature, often with copious sweating, especially at the onset or height of a fever) Headache Nausea or vomiting Pain at the infusion site or in chest, abdomen or flanks Dyspnea (difficult or labored breathing) Hypotension (low blood pressure) Hypertension (high blood pressure) Tachycardia (abnormally rapid heart rate.) Renal/Kidney Failure DIC (Disseminated Intravascular Coagulation - A condition where blood clots are excessively formed in the body's blood vessels) Urticaria (hives) Generalized flushing or rash Localized swelling or "angi-oedema" Bronchospasm (respiratory distress, wheezing) Anxiety Cyanosis (a bluish discoloration of the skin resulting from poor circulation or inadequate oxygenation of the blood) Orthopnea (sensation of breathlessness while lying down) Congestive heart failure (a weakness of the heart that leads to a buildup of fluid in the lungs and surrounding body tissues) D. Review of the Nursing Administration Policy, Blood Administration, dated 06/26/19, indicated: 1. Education on blood and blood products is provided in new employee orientation and annually thereafter. 2. [Hospital Laboratory] follows standards of the American Association of Blood Banks (AABB) and the Bureau of Biologics of the U.S. Food & Drug Administration (FDA) in procuring, maintaining, administering and monitoring blood and blood components. 3. Obtain the patient's vital signs including B/P (Blood Pressure), HR(Heart Rate), RR (Respiratory Rate) and temp (temperature) and record prior to initiation of blood component. 4. Monitoring for transfusion reaction a. Observe the patient closely for signs of transfusion reaction during the initial 15 minutes and throughout the transfusion. b. Should the patient demonstrate signs of transfusion reaction, see the table below for nursing/laboratory action(s): 3. Only 2 types of transfusion reactions were clearly identified in the table: Anaphylactic and Febrile. Other signs and -- 2 of 7 -- symptoms were listed but the column containing the type of transfusion reaction was missing. 4. Nursing staff were instructed 3 times "Do not stop the transfusion" if the patient only had a temperature 2 degrees above baseline and/or chills in the Blood Administration Policy. There was no corresponding instruction in the laboratory policy. E. Review of AABB Technical Manual, 19th edition, indicated: "The transfusionist should be knowledgeable about signs and symptoms indicative of an adverse reaction and be able to act quickly...If a transfusion reaction is suspected, the transfusion should be stopped...As soon as possible, the transfusion service should be notified of a suspected transfusion reaction." F. During interview on 12/12/19 at 09:55 am, the Laboratory Supervisor stated: 1. The P-tag or transfusion record is not returned to the laboratory following a transfusion. It is scanned into the medical record. 2. There is no one dedicated to the Blood Bank and no one in the laboratory audits the transfusion records. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on the review of November 2019 Lactic Acid turn-around-time reports, patient medical records, manufacturer instructions, and interview with the Laboratory Manager, the laboratory failed to ensure that specimens were processed within the timeframe required by the manufacturer. 23 of 50 patient samples for lactate (or lactic acid) were received in the laboratory beyond the manufacturer's acceptable timeframe. Findings are: A. The laboratory performed lactate testing on patient samples that did not meet the manufacturer's requirements for specimen collection and handling. 1. Review of the Siemens Dimension Flex manufacturer's instructions for collection and handling of lactate samples indicated that samples must be chilled immediately and spun to separate cells from plasma within 15 minutes of collection. The manufacturer also indicated that the separated plasma may be stored for up to 24 hours if refrigerated or frozen for up to 1 month. B. Review of the patient medical records and turn-around-time report for 3(LA2, LA22, and LA24) of 23 patient samples tested 11 /01/19 to 11/30/19 confirmed that these samples were received by the laboratory more than 10 minutes after collection. There was no documentation that samples were spun and the plasma refrigerated or frozen within 15 minutes of collection. > 60 minutes LA2 - 128 Medical record indicated the sample was collected 11/02/19 at 6:47 pm and received by the laboraory at 08:55 pm. 46 - 60 minutes LA6 - 46 LA22 - 49 Medical record indicated the sample was collected 11/16/19 at 6:21 pm and received by the laboraory at 07:10 pm. 31 - 45 minutes LA26 - 37 16 - 30 minutes LA10 - 22 LA12 - 20 LA21 - 26 LA45 - 19 11 - 15 minutes LA7 - 13 LA8 - 13 LA11 - 11 LA14 - 13 LA24 - 15 Medical record indicated the sample was collected 11/26/19 at 11:50 am and received by the laboraory at 12:05 pm. LA25 - 15 LA29 - 12 LA32 - 14 LA33 - 11 LA44 - 12 LA36 - 11 LA40 - 15 LA41 - 12 LA42 - 14 LA46 - 12 C. During interview on the afternoon of 12/10/19, the Laboratory Manager confirmed this finding. -- 3 of 7 -- D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of transfusion records, nursing notes, electronic medical records, laboratory policy, and hospital policy, the laboratory failed to ensure the transfusion policies for both the laboratory and nursing staff had the same requirements for notification and clearly defined methods for identifying transfusion reactions. Findings are: A. Review of the Laboratory Blood Bank Policy, Transfusion Reactions, dated 02/28/19, indicated the following: 1. Procedure - "1. In the event a transfusion reaction is suspected, the transfusing nurse should immediately stop the transfusion and notify the physician. 2. Within 10 minutes of stopping the transfusion, the laboratory must be notified so that we may begin to investigate the cause of the reaction." a. Nursing staff failed to follow laboratory policy for notification of a transfusion reaction for BB #1 within 10 minutes. 11/09/19 19:30 pm 2 hours 45 minutes after transfusion started. Notified provider at 19:40 pm of a possible transfusion reaction. Dyspnea, chills, hypertension, tachycardia and fever documented on the transfusion record. Laboratory notification occurred at 20:10 pm on 11/09/19, 30 minutes later. 2. The laboratory policy identified and defined 7 types of transfusion reactions; Hemolytic Transfusion Reaction, Febrile Nonhemolytic Transfusion Reaction, Allergic and Anaphylactic Reactions, Transfusion-Related Acute Lung Injury, Transfusion Associated Circulatory Overload, Transfusion-Associated Sepsis and Delayed Hemolytic Transfusion Reaction. B. Review of the Nursing Administration Policy, Blood Administration, dated 06/26/19, indicated: 1. "Should the patient demonstrate signs of transfusion reaction, see the table below for nursing /laboratory action(s):" 2. Only 2 types of transfusion reactions were clearly identified in the table: Anaphylactic and Febrile. Other signs and symptoms were listed but the column containing the type of transfusion reaction was missing from the table. 3. Nursing staff were given the following instructions for Anaphylactic reactions - "1. Stop transfusion immediately. 2. Discontinue the blood unit and all involved blood tubing. 3. Attach a new bag of normal saline with IV tubing with a rate of TKO. 4. Notify provider. 5. Check all identifying names and numbers on the patient's wristband, unit and paperwork for discrepancies. 6. Record and monitor patient's vital signs. 7. Administer oxygen 2L/min/NC as indicated. 8. Begin a transfusion reaction investigation." 4. Nursing staff were instructed 3 times in the chart "Do not stop the transfusion" if the patient only had a temperature 2 degrees above baseline and/or chills in the Blood Administration Policy. There was no corresponding instruction in the laboratory policy. C. Review of transfusion records for 6 Blood Bank Patients (BB #1-BB #6) patients in October and November 2019 revealed no documentation the laboratory was notified of a possible transfusion reaction for BB #5. The patient initially reported chills and pain at the infusion site but later reported the chills had -- 4 of 7 -- been ongoing. See D3025 D. Review of the Laboratory Blood Bank policies and the Nursing Blood Administration policy revealed no specific criteria for evaluating the following signs and symptoms associated with transfusion reactions that may already be present in the patient prior to transfusion: Chills Rigors (a sudden feeling of cold with shivering accompanied by a rise in temperature, often with copious sweating, especially at the onset or height of a fever) Headache Dyspnea (difficult or labored breathing) Hypotension (low blood pressure) Hypertension (high blood pressure) Tachycardia (abnormally rapid heart rate) Urticaria (hives) Generalized flushing or rash Bronchospasm (respiratory distress, wheezing) Anxiety 1. Review of transfusion records for 6 Blood Bank Patients (BB #1-BB #6) patients in October and November 2019 revealed 1 patient, BB #1, had signs of increased respiratory rate prior to transfusion of 2 units of PRBC on 11/09/19. 2. Unit W04151928752, transfusion started at 13:40 pm. The pre-transfusion RR (respiratory rate) at 13:35 pm was 22 breaths per minute, flagged as abnormal in the electronic medical record. At 15:00 pm, the patient's RR dropped to 19 and subsequent measurements ranged 20-24 until 19:40 pm when a possible transfusion reaction was identified during the transfusion of Unit W041519029352. The RR had increased to 37 breaths per minute by 19:30 pm. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 The following deficiencies were cited during a recertification survey completed on 08 /24/2018 for the federal requirements of 42 CFR Part 493 for Laboratories. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of quality control records, laboratory policies manufacturer's instructions, and interviews with laboratory staff, the laboratory failed to perform an external positive and negative control each day of patient testing for the ROM Plus test kit. 446 patients, ROM1 - ROM466 were tested 10/10/2016 - 05/22/2018. Findings are: A. Review of laboratory quality control policy and the manufacturer's instructions revealed the following: 1. The laboratory had updated the (IQCP) Individual Quality Control Plan on 05/22/2018, replacing the name of the previous kit (Amnisure) used for testing vaginal fluid for the presence of amniotic fluid in pregnant women with the new kit, ROM Plus. 2. The laboratory's ROM Plus quality control policy revised on 10/04/2017 indicated the performance of an external positive and a negative control for each new lot or shipment of test kits. Internal or procedural controls were documented with each patient tested. 3. Review of the manufacturer's quality control instructions from the manufacturer's website dated 04/21/2014 indicated that the external quality controls should be performed "every 30 days, or for every new lot number or shipment received, whichever comes first." B. During interview on 08/21/2018 on 08:30 am, the laboratory manager stated that the ROM Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Plus kit was already in use by the laboratory when she began working for the laboratory in October 2017. 1. The laboratory manager was unable to locate a copy of the IQCP and correlating studies in use prior to 05/22/2018 for the ROM Plus kit. 2. Review of records for another test system revealed the laboratory had performed a correlation study between the current test kit and the previous kit on an unknown date. However, there were no records indicating the laboratory had completed the study and the new test system was approved by the laboratory director. C. Review of the patient test and quality control records revealed the laboratory started using the new test kit on 10/04/2016. The laboratory failed to perform an external positive and negative control on the following patient test days: October 2016 The external controls were performed on 10/04/2016, 10/10/2016 and 10/28/2016. 10/10/2016 - 2 patients, ROM1 and ROM2 10/11/2016 - 4 patients, ROM3 - ROM6 10/12/2016 - 1 patient, ROM7 10/14/2016 - 1 patient, ROM8 10/17/2016 - 1 patient, ROM9 10/19/2016 - 2 patients, ROM10 and ROM11 10/23/2016 - 1 patient, ROM12 10/25/2016 - 2 patients, ROM13 and ROM14 10/26/2016 - 1 patient, ROM15 10/27/2016 - 1 patient, ROM16 10/28/2016 - 1 patient, ROM17 10/28/2016 - 2 patients ROM18 and ROM19 10/30/2016 - 1 patient, ROM20 10/31/2016 - 1 patient ROM21 November 2016 There was no documentation of external controls in November 2016. 11/02/2016 - 1 patient, ROM22 11/03/2016 - 2 patients, ROM23 and ROM24 11/06/2016 - 1 patient, ROM25 11/08/2016 - 1 patient, ROM26 11/11/2016 - 1 patient, ROM27 11/12/2016 - 1 patient, ROM28 11/13/2016 - 2 patients, ROM29 and ROM30 11/14/2016 - 3 patients, ROM31 - ROM33 11/15/2016 - 1 patient, ROM34 11/16/2016 - 1 patient, ROM35 11/17/2016 - 1 patient, ROM36 11/19/2016 - 1 patient, ROM37 11/20/2016 - 2 patients, ROM38 and ROM39 11/21/2016 - 1 patient, ROM40 11/25/2016 - 1 patient, ROM41 December 2016 The external controls were performed on 12/28 /2016. 12/02/2016 - 3 patients, ROM41-ROM44 12/03/2016 - 1 patient, ROM45 12/04 /2016 - 1 patient, ROM46 12/06/2016 - 4 patients, ROM47-ROM50 12/07/2016 - 1 patient, ROM51 12/09/2016 - 1 patient, ROM52 12/11/2016 - 1 patient, ROM53 12/16 /2016 - 1 patient, ROM54 12/20/2016 - 1 patient, ROM55 12/22/2016 - 1 patient, ROM56 12/23/2016 - 1 patient, ROM57 12/26/2016 - 2 patients, ROM58 and ROM59 12/27/2016 - 2 patients, ROM60 and ROM61 12/28/2016 - 3 patients, ROM62- ROM64 12/29/2016 - 2 patients, ROM65 and ROM66 12/31/2016 - 1 patient, ROM67 January 2017 The external controls were performed on 01/12/2017. 01/02/2017 - 2 patients, ROM68 and ROM69 01/03/2017 - 1 patient, ROM70 01/04/2017 - 2 patients, ROM71 and ROM72 01/05/2017 - 1 patient, ROM73 01/06/2017 - 1 patient, ROM74 01/07/2017 - 1 patient, ROM75 01/09/2017 - 2 patients, ROM76 and ROM77 01/10/2017 - 1 patient, ROM78 01/11/2017 - 1 patient, ROM79 01/14/2017 - 1 patient, ROM80 01/16/2017 - 1 patient, ROM81 01/17/2017 - 1 patient, ROM82 01/18 /2017 - 2 patients, ROM83 and ROM84 01/19/2017 - 1 patient, ROM85 01/20/2017 - 2 patients, ROM86 and ROM87 01/21/2017 - 1 patient, ROM88 01/22/2017 - 1 patient, ROM89 01/23/2017 - 2 patients, ROM90 and ROM91 01/26/2017 - 2 patients, ROM92 and ROM93 01/27/2017 - 1 patient, ROM94 01/31/2017 - 4 patients, ROM95-ROM98 February 2017 The external controls were performed on 02 /04/2017. 02/05/2017 - 1 patient, ROM99 02/08/2017 - 4 patients, ROM100-ROM103 02/09/2017 - 1 patient, ROM104 02/10/2017 - 3 patients, ROM105-ROM107 02/13 /2017 - 1 patient, ROM108 02/14/2017 - 1 patient, ROM109 02/20/2017 - 1 patient, ROM110 02/23/2017 - 1 patient, ROM111 02/25/2017 - 1 patient, ROM112 02/28 /2017 - 2 patients, ROM113-ROM114 March 2017 There was no documentation of external controls in March 2017. 03/01/2017 - 4 patients, ROM115-ROM118 03/02 /2017 - 2 patients, ROM119 and ROM120 03/03/2017 - 2 patients, ROM121 and ROM122 03/04/2017 - 1 patient, ROM123 03/06/2017 - 2 patients, ROM124 and ROM125 03/10/2017 - 1 patient, ROM126 03/11/2017 - 1 patient, ROM127 03/12 /2017 - 1 patient, ROM128 03/16/2017 - 1 patient, ROM129 03/17/2017 - 1 patient, -- 2 of 5 -- ROM130 03/20/2017 - 1 patient, ROM131 03/22/2017 - 1 patient, ROM132 03/23 /2017 - 1 patient, ROM133 03/24/2017 - 4 patients, ROM134-ROM137 03/26/2017 - 1 patient, ROM138 April 2017 There was no documentation of external controls in April 2017. 04/01/2017 - 2 patients, ROM139 and ROM140 04/02/2017 - 3 patients, ROM141-ROM143 04/04/2017 - 1 patient, ROM144 04/05/2017 - 1 patient, ROM145 04/06/2017 - 2 patients, ROM146 and ROM147 04/09/2017 - 2 patients, ROM148 and ROM149 04/11/2017 - 1 patient, ROM150 04/12/2017 - 1 patient, ROM151 04/14 /2017 - 1 patient, ROM152 04/15/2017 - 1 patient, ROM153 04/16/2017 - 1 patient, ROM154 04/17/2017 - 1 patient, ROM155 04/18/2017 - 1 patient, ROM156 04/19 /2017 - 1 patient, ROM157 04/20/2017 - 1 patient, ROM158 04/21/2017 - 2 patients, ROM159 and ROM160 04/25/2017 - 2 patients, ROM161 and ROM162 04/26/2017 - 1 patient, ROM163 04/30/2017 - 1 patient, ROM164 May 2017 The external controls were performed on 05/28/2017. 05/01/2017 - 1 patient, ROM165 05/02/2017 - 3 patients, ROM166-ROM168 05/05/2017 - 1 patient, ROM169 05/07/2017 - 2 patients, ROM170 and ROM171 05/08/2017 - 1 patient, ROM172 05/10/2017 - 1 patient, ROM173 05/11/2017 - 1 patient, ROM174 05/13/2017 - 2 patients, ROM175 and ROM176 05/19/2017 - 3 patients, ROM177-ROM179 05/20/2017 - 1 patient, ROM180 05/21/2017 - 3 patients, ROM181-ROM183 05/22/2017 - 3 patients, ROM184-ROM186 05/23/2017 - 2 patients, ROM187 and ROM188 05/24/2017 - 2 patients, ROM189 and ROM190 05/25/2017 - 1 patient, ROM191 05/30/2017 - 1 patient, ROM192 05/31/2017 - 1 patient, ROM193 June 2017 The external controls were performed on 06/16/2017, 06/19/2017, and 06/21/2017. 06/01/2017 - 2 patients, ROM194 and ROM195 06/02/2017 - 1 patient, ROM196 06/05/2017 - 1 patient, ROM197 06/08/2017 - 3 patients, ROM198-ROM200 06/09/2017 - 2 patients, ROM201 and ROM202 06/11/2017 - 1 patient, ROM203 06/14/2017 - 2 patients, ROM204 and ROM205 06/17/2017 - 1 patient, ROM206 06/18/2017 - 1 patient, ROM207 06/20/2017 - 1 patient, ROM208 06/22/2017 - 2 patients, ROM209 and ROM210 06/23/2017 - 2 patients, ROM211 and ROM212 06/24/2017 - 1 patient, ROM213 06/26/2017 - 1 patient, ROM214 06/27/2017 - 1 patient, ROM215 06/28 /2017 - 1 patient, ROM216 06/30/2017 - 1 patient, ROM217 July 2017 The external controls were performed on 07/06/2017. 07/01/2017 - 1 patient, ROM218 07/08/2017 - 3 patients, ROM219-ROM221 07/09/2017 - 1 patient, ROM222 07/10/2017 - 1 patient, ROM223 07/11/2017 - 1 patient, ROM224 07/18/2017 - 3 patients, ROM225- ROM227 07/19/2017 - 1 patient, ROM228 07/20/2017 - 1 patient, ROM229 07/21 /2017 - 2 patients, ROM230 and ROM231 07/22/2017 - 1 patient, ROM232 07/23 /2017 - 2 patients, ROM233 and ROM234 07/25/2017 - 3 patients, ROM235 and ROM237 07/26/2017 - 1 patient, ROM238 07/27/2017 - 1 patient, ROM239 07/29 /2017 - 1 patient, ROM240 07/31/2017 - 1 patient, ROM241 August 2017 There was no documentation of external controls in August 2017. 08/01/2017 - 2 patients, ROM242 and ROM243 08/03/2017 - 2 patients, ROM244 and ROM245 08/07/2017 - 1 patient, ROM246 08/08/2017 - 2 patients, ROM247 and ROM248 08/09/2017 - 1 patient, ROM249 08/10/2017 - 1 patient, ROM250 08/11/2017 - 4 patients, ROM251- ROM254 08/12/2017 - 2 patients, ROM255 and ROM256 08/13/2017 - 2 patients, ROM257 and ROM258 08/21/2017 - 1 patient, ROM259 08/25/2017 - 1 patient, ROM260 08/29/2017 - 1 patient, ROM261 08/31/2017 - 1 patient, ROM262 September 2017 The external controls were performed on 09/17/2017. 09/02/2017 - 5 patients, ROM263-ROM267 09/04/2017 - 1 patient, ROM268 09/05/2017 - 2 patients, ROM269 and ROM270 09/06/2017 - 1 patient, ROM271 09/10/2017 - 2 patients, ROM272 and ROM273 09/12/2017 - 1 patient, ROM274 09/13/2017 - 1 patient, ROM275 09/14/2017 - 4 patients, ROM276-ROM279 09/15/2017 - 2 patients, ROM280 and ROM281 09/16/2017 - 2 patients, ROM282 and ROM283 09/17/2017 - 2 patients, ROM284 and ROM285 09/19/2017 - 1 patient, ROM286 09/20/2017 - 3 patients, ROM287 - ROM289 09/21/2017 - 2 patients, ROM290 and ROM291 09/22 -- 3 of 5 -- /2017 - 2 patients, ROM292 and ROM294 09/23/2017 - 2 patients, ROM293 and ROM295 09/25/2017 - 2 patients, ROM296 and ROM297 09/26/2017 - 1 patient, ROM298 09/27/2017 - 1 patient, ROM299 09/28/2017 - 1 patient, ROM300 09/29 /2017 - 1 patient, ROM301 09/30/2017 - 1 patient, ROM302 October 2017 The external controls were performed on 10/02/2017. 10/01/2017 - 1 patient, ROM303 10 /07/2017 - 1 patient, ROM304 10/08/2017 - 1 patient, ROM305 10/09/2017 - 2 patients, ROM306 and ROM307 10/11/2017 - 2 patients, ROM308 and ROM309 10 /15/2017 - 2 patients, ROM310 and ROM311 10/16/2017 - 2 patients, ROM312 and ROM313 10/19/2017 - 3 patients, ROM314-ROM316 10/20/2017 - 1 patient, ROM317 10/21/2017 - 1 patient, ROM318 10/23/2017 - 1 patient, ROM319 10/24 /2017 - 2 patients, ROM320 and ROM321 10/29/2017 - 1 patient, ROM322 November 2017 The external controls were performed on 11/10/2017. 11/01/2017 - 1 patient, ROM323 11/04/2017 - 2 patients, ROM324 and ROM325 11/06/2017 - 1 patient, ROM326 11/11/2017 - 3 patients, ROM327-ROM329 11/14/2017 - 2 patients, ROM330 and ROM331 11/15/2017 - 1 patient, ROM332 11/17/2017 - 1 patient, ROM333 11/20/2017 - 1 patient, ROM334 11/23/2017 - 1 patient, ROM335 11/28 /2017 - 1 patient, ROM336 11/29/2017 - 3 patients, ROM337-ROM339 11/30/2017 - 1 patient, ROM340 December 2017 The external controls were performed on 12/16 /2017. 12/01/2017 - 2 patients, ROM341 and ROM342 12/04/2017 - 1 patient, ROM343 12/14/2017 - 3 patients, ROM344-ROM346 12/17/2017 - 1 patient, ROM347 12/19/2017 - 2 patients, ROM348 and ROM349 12/20/2017 - 1 patient, ROM350 12/24/2017 - 2 patients, ROM351 and ROM352 12/25/2017 - 1 patient, ROM353 12/26/2017 - 1 patient, ROM354 12/30/2017 - 1 patient, ROM355 12/31 /2017 - 1 patient, ROM356 January 2018 The external controls were performed on 01 /24/2018. 01/02/2018 - 1 patient, ROM357 01/04/2018 - 2 patients, ROM358 and ROM359 01/05/2018 - 2 patients, ROM360 and ROM361 01/07/2018 - 1 patient, ROM362 01/15/2018 - 1 patient, ROM363 01/17/2018 - 1 patient, ROM364 01/18 /2018 - 1 patient, ROM365 01/19/2018 - 1 patient, ROM366 01/23/2018 - 1 patient, ROM367 01/25/2018 - 1 patient, ROM368 01/26/2018 - 1 patient, ROM369 01/27 /2018 - 2 patients, ROM370 and ROM371 01/30/2018 - 2 patients, ROM372 and ROM373 February 2018 The external controls were performed on 02/22/2018. 02/01 /2018 - 1 patient, ROM374 02/03/2018 - 1 patient, ROM375 02/07/2018 - 2 patients, ROM376 and ROM377 02/08/2018 - 1 patient, ROM378 02/09/2018 - 1 patient, ROM379 02/10/2018 - 2 patients, ROM380 and ROM381 02/15/2018 - 1 patient, ROM382 02/17/2018 - 2 patients, ROM383 and ROM384 02/19/2018 - 1 patient, ROM385 02/20/2018 - 3 patients, ROM386-ROM388 02/23/2018 - 1 patient, ROM389 02/25/2018 - 1 patient, ROM390 02/27/2018 - 2 patients, ROM391 and ROM392 March 2018 The external controls were performed on 03/20/2018. 03/03 /2018 - 2 patients, ROM393 and ROM394 03/04/2018 - 1 patient, ROM395 03/05 /2018 - 2 patients, ROM396 and ROM397 03/10/2018 - 2 patients, ROM398 and ROM399 03/11/2018 - 1 patient, ROM400 03/12/2018 - 2 patients, ROM401 and ROM402 03/16/2018 - 1 patient, ROM403 03/17/2018 - 2 patients, ROM404 and ROM405 03/18/2018 - 1 patient, ROM406 03/21/2018 - 2 patients, ROM407- ROM408 03/23/2018 - 1 patient, ROM409 03/25/2018 - 1 patient, ROM410 03/28 /2018 - 4 patients, ROM411-ROM414 03/30/2018 - 1 patient, ROM415 April 2018 The external controls were performed on 0420/2018. 04/04/2018 - 1 patient, ROM416 04/06/2018 - 2 patients, ROM417 and ROM418 04/10/2018 - 2 patients, ROM419 and ROM420 04/11/2018 - 1 patients, ROM421 04/15/2018 - 1 patient, ROM422 04 /16/2018 - 2 patients, ROM423 and ROM424 04/17/2018 - 1 patient, ROM425 04/18 /2018 - 1 patient, ROM426 04/23/2018 - 1 patient, ROM427 04/24/2018 - 1 patient, ROM428 04/29/2018 - 1 patient, ROM429 04/30/2018 - 1 patient, ROM430 May 2018 The external controls were performed on 05/25/2018. 05/02/2018 - 1 patient, ROM431 05/04/2018 - 1 patient, ROM432 05/07/2018 - 1 patient, ROM433 05/10 -- 4 of 5 -- /2018 - 1 patient, ROM434 05/11/2018 - 1 patient, ROM435 05/12/2018 - 4 patients, ROM436-ROM439 05/13/2018 - 1 patient, ROM440 05/19/2018 - 2 patients, ROM441 and ROM442 05/20/2018 - 1 patient, ROM443 05/21/2018 - 1 patient, ROM444 05/22/2018 - 2 patients, ROM445 and ROM446 -- 5 of 5 --