Orlando Health Medical Group, Inc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 26, 2021 to October 28, 2021. Florida Heart and Vascular Multispecialty Group PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have all testing personnel rotate through performance of proficiency testing (PT) samples for five of five events (2020 2nd, 3rd, 2021 1st, 2nd) for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) PT for the blood gas hemoglobin showed Testing Personnel E performed PT for the 2020 2nd event. Review of the API PT showed Testing Personnel A and Testing Personnel E, each performed a portion of the PT for the 2020 3rd event and 2021 1st, 2nd, and 3rd events. Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 10/26 /2021, listed six Testing Personnel. Review of a copy of the Laboratory Personnel Report with the hire dates added showed Testing Personnel A was hired 11/2018, Testing Personnel B was hired 03/08/2021, Testing Personnel C was hired 04/2020, Testing Personnel D was hired 04/2021, Testing Personnel E was hired 03/2020, and Testing Personnel F was hired 01/27/2020. On 10/26/2021 at 11:13 AM, Testing Personnel A and Testing Personnel E stated they were the only ones who performed the PT. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director failed to sign the attestation form for Proficiency Testing (PT) for one (2020 3rd) of five events (2020 2nd, 3rd, 2021 1st, 2nd) for the specialty of hematology for blood gas hemoglobin. Findings: Review of the American Proficiency Institute (API) PT Attestation Statement noted "Signatures Required - Testing personnel and Laboratory Director must physically sign an attestation statement for PT results, and retain the signed statement (or a copy) for a minimum of 2 years." Review of the API PT attestation statement for the 3rd event in 2020 showed the signature of the Laboratory Director was missing . On 10/26/2021 at 11:53 AM, Testing Personnel A stated the signatures were missing. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory system and correct identified problems. Findings: Cross Reference D5209: Based on record review and staff interview, the laboratory failed to fully document training and competency assessments on six of six (A, B, C, D, E, F) testing personnel in 2020 and 2021. This is a repeat deficiency from the survey on 12/12/19 to 12/13/19. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to fully document training and competency assessments on six of six (A, B, C, D, E, F) testing personnel in 2020 and 2021. This is a repeat deficiency from the survey on 12/12/19 to 12/13 /19. Findings: Review of "The Laboratory Personnel Report" signed and dated by the Laboratory Director on 10/26/2021 showed there were six testing personnel. The laboratory's policy titled "Personnel Training and Competency" noted, "Training and Competency documentation will be done after the 90 day orientation period, at 6 -- 2 of 6 -- months and reevaluation of competency will be performed and documented every year thereafter." Review of a copy of the Laboratory Personnel Report with the hire dates added showed Testing Personnel A was hired 11/2018, Testing Personnel B was hired 03/08/2021, Testing Personnel C was hired 04/2020, Testing Personnel D was hired 04/2021, Testing Personnel E was hired 03/2020, and Testing Personnel F was hired 01/27/2020. Review of the competency evaluation documentation for Testing Personnel A showed there was no annual competency performed in 2020. Review of the competency evaluation documentation for Testing Personnel B showed there was no documentation of training and competency after the 90 days orientation period in 2021. Review of the competency evaluation documentation for Testing Personnel C showed there was no documentation of training and competency after the 90 days orientation period or at six months in 2020. Review of the competency evaluation documentation for Testing Personnel D showed there was no documentation of training and competency after the 90 days orientation period in 2021. Review of the competency evaluation documentation for Testing Personnel E showed there was no documentation of training and competency after the 90 days orientation period or at six months in 2020.. Review of the competency evaluation documentation for Testing Personnel F showed there was no documentation of competency at six months in 2020. On 10/26/19 at 12:03 PM, Testing Personnel E stated competencies in 2020 were not done. On 10/28/21 at 1:05 PM, Testing Personnel A stated there were missing competencies. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document review and evaluation of proficiency testing (PT) for five of five (2020 2nd, 3rd, 2021 1st, 2nd) event performance evaluations for the specialty of hematology for blood gas hemoglobin. Findings: Review of the American Proficiency Institute (API) PT showed the Laboratory Director failed to sign "Proficiency Testing Performance Evaluation" forms for the 2020 2nd and 3rd events, and the 2021 1st and 2nd events. The Laboratory Personnel Report, signed and dated by the Laboratory Director on 10 /26/2021, showed the Laboratory Director was the only Clinical Consultant and Technical Consultant. The Laboratory Director was the only person qualified to sign the PT performance evaluation for this laboratory. On 10/26/2021 at 10:39 AM, Testing Personnel E stated the Laboratory Director had not signed the performance reviews. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other -- 3 of 6 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on December 21, 2020 for Florida Heart & Vascular Center Multispecialty Group PA. Florida Heart & Vascular Center Multispecialty Group, PA is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. D2016 SUCCESSFUL PARTICIPATION 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 review of the laboratory's proficiency testing records for 2020, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers 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 -- for Medicare & Medicaid Services (CMS) 153 and 155 reports, on December 21, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, hemoglobin, for two consecutive proficiency testing events in 2020. 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 the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On December 21, 2020 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, hemoglobin, as shown below. Event #2, 2020 hemoglobin-40% Event #3, 2020 hemoglobin-20% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On December 21, 2020, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive proficiency testing events for the analyte, hemoglobin, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analyte, hemoglobin, in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on December 21, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2020 Hemglobin-40% Event #3, 2020 Hemglobin-20% -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy of the Oxygen Saturation Percentage (O2 Sat %) in the specialty of Routine Chemistry at least twice annually for 2018 and 2019. Findings: Review of proficiency testing, (PT) records revealed that there was no record of PT performed on O2 Sat %. During an interview on 2/11/19 at 12:25 PM, the Laboratory Consultant stated that the laboratory did not perform PT for O2 Sat %. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory was unable to provide documentation of the validations of the Hemochron Jr Signature Plus analyzer for Activated Clotting Time (ACT) testing, and the Oxicom 2100 analyzer for Oxygen Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Saturation Percentage (O2 Sat %) testing performed in April 2006. Findings: Review of the laboratory's quality control documentation showed the laboratory did not have documentation available at the time of the survey for the validations on the Hemochron Jr Signature Plus analyzer and Oxicom 2100 analyzer performed in April 2006. During an interview on 2/11/2020 at 12:21 PM, the Director of Operations stated the previous Medical Director thought the laboratory opened in April 2006 and that validations for the instruments were saved. -- 2 of 2 --

Summary Statement of Deficiencies D0000 AMENDED 1/22/2020 A recertification survey was conducted on 12/12/19 - 12/13 /19. Florida Heart and Vascular Multispecialty Group PA clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. Based on the survey findings an Immediate Jeopardy situation was identified and the laboratory was notified of the Immediate Jeopardy at 2:30 PM on 12/13/19. The laboratory failed to perform three levels of liquid quality control for the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer weekly. The laboratory failed to perform two levels of liquid quality control for the Hemochron Jr Signature Plus ACT (activated clotting time) analyzer when a new shipment was received and once per 30 calendar days. The laboratory failed to perform calibrations on the Oxicom 2100 pO2 analyzer since its initial calibration. (D5400) The following Conditions were not met: D2000 - 493.801 Enrollment and Testing of Samples D5200 - 493.1230 General Laboratory Systems D5400 - 493.1250 Analytic Systems D6000 - 493.1403 Moderate Complexity Laboratory Director D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to enroll in proficiency testing with an approved proficiency testing (PT) program from the time patient Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- testing started in July 2018 to December 12, 2019 in the specialty of Routine Chemistry. Findings: Review of PT records from the American Proficiency Institute (API) showed that there was no proficiency testing performed on the analyte pO2 (partial pressure of oxygen) from when patient testing started in July 2018 to December 12, 2019. During an interview on 12/12/19 at 9:46 AM, the Laboratory Consultant stated that the laboratory was not enrolled in PT for pO2. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain the documentation showing they ran internal controls on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer and the Hemochron Jr Signature Plus ACT (activated clotting time) analyzer from when patient testing started in July 2018 to December 31, 2018. Findings: 1. Review of the "Hemochron Q/C Log Sheet" showed that records for the internal controls were not available for review from when patient testing started in July 2018 to December 31, 2018. . During an interview on 12/12/19 at 11:00 AM, the Laboratory Consultant stated that the laboratory did not save the 2018 records. 2. Review of the "Oxicom 2100 Daily Check Log" showed that records for the internal controls were not available for review from when patient testing started in July 2018 to December 31, 2018. During an interview on 12/12/19 at 11:00 AM, the Laboratory Consultant stated that the laboratory did not save the 2018 records. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the general laboratory system and correct identified problems. Findings: Cross Reference D5209. Based on record review and staff interview, the laboratory failed to fully document competency assessments on testing personnel in 2018 and 2019. Cross Reference D5291 Based on record review and interview, the laboratory failed to follow their procedures for monitoring, assessing and correcting problems. The laboratory failed to perform any quality assurance reviews. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 -- 2 of 8 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to fully document competency assessments on testing personnel in 2018 and 2019. Findings: Review of "The Laboratory Personnel Report" signed and dated by the Laboratory Director on 12 /12/19 showed that there were 8 testing personnel (A, B, C, D, E, F, G, H). The laboratory had competency evaluation forms for ACT (Activated Clotting Time) competency and pO2 (partial pressure of oxygen) competency. The laboratory policy titled "Personnel Training and Competency" read, "Training and Competency documentation will be done after the 90 day orientation period, at 6 months and a reevaluation of competency will be performed and documented every year thereafter." 1. Review of the competency records showed that there was no ACT or pO2 competency on testing personnel A, B, C, and F for 2018. During an interview on 12 /12/19 at 11:10 AM, the Cath Lab Manager stated that testing personnel A, B, C, D, E, and F started working in 2018 in the lab. During an interview on 12/12/19 at 11:12 AM, the Cath Lab Manager acknowledged that competency assessments were not completed on all the testing personnel. 2. Review of the competency assessment performed in 2018 showed that the competency assessment forms were not signed by the Laboratory Director. During an interview on 12/12/19 at 9:28 AM, the Laboratory Consultant confirmed that the competency assessment performed in 2018 were not signed by the Laboratory Director. 3. Review of the competency records showed that there was no ACT or pO2 competency on testing personnel A, B, C, D, E, F, and G in 2019. During an interview on 12/12/19 at 11:10 AM, the Cath Lab Manager stated that testing personnel G started 9 months ago and testing personnel H started two weeks ago. During an interview on 12/12/19 at 11:12 AM, the Cath Lab Manager acknowledged that competency assessment had not been performed in 2019 for all testing personnel except for Testing Personnel H who was still in training. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow their procedures for monitoring, assessing and correcting identified problems. Findings: Review of the laboratory's procedure titled "Quality Assurance Plan" showed the laboratory had 3 Quality Assurance (QA) forms, "Director's Review of Monthly Clinical Pathology Quality Assessment," "Monthly Quality Assurance Report" and "Monthly QA Report Checklist." There were no QA forms available for review from when patient testing started in July 2018 to December 12, 2019. During an interview on 12/12/19 at 11:30 AM, the Laboratory Consultant stated that the laboratory had not done any QA reviews. D5400 ANALYTIC SYSTEMS -- 3 of 8 -- CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: AMENDED 1/22/2020 Based on record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and correct identified problems. Findings: Cross Reference D5413. Based on record review and interview, the laboratory failed to record the temperature and humidity of the room where testing was performed from when patient testing started in July 2018 to December 12, 2019. Cross Reference D5429. Based on record review and interview, the laboratory failed to document the maintenance performed on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer and the Hemochron Jr Signature Plus ACT (Activated Clotting Time) analyzer from when patient testing started in July 2018 to December 12, 2019. Cross Reference D5447. Based on record review and interview, the laboratory failed to perform quality controls at least once a day that patient specimens were tested on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer and the Hemochron Jr Signature Plus ACT (activated clotting time) analyzer from when patient testing started in July 2018 to December 12, 2019. Cross Reference D5535. Based on record review and interview, the laboratory failed to perform calibrations on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer according to manufacturer's specifications from when patient testing started in July 2018 to December 12, 2019. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to record the temperature and humidity of the room where testing was performed from when patient testing started in July 2018 to December 12, 2019. Findings: Review of the instruction manual for the Oxicom 2100 showed that the operating environment temperature should be between 65-85 degrees Fahrenheit (18.3-29.4 degrees Celsius). No room temperature or humidity logs were available for review. During an interview on 12/12 /19 at 4:05 PM, the Laboratory Consultant acknowledge that the laboratory was not recording the temperature or humidity of the room where the testing was performed. D5429 MAINTENANCE AND FUNCTION CHECKS -- 4 of 8 -- CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the maintenance performed on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer and the Hemochron Jr Signature Plus ACT (Activated Clotting Time) analyzer from when patient testing started in July 2018 to December 12, 2019. Findings: 1. Review of the instruction manual for the Oxicom 2100 showed that section 5 of the manual on maintenance and section 5.1 titled "Maintenance Schedules" noted daily, weekly, quarterly and semiannually maintenance to be performed. There were no records of maintenance performed available for review. During an interview on 12/12/19 at 2:29 PM, the Laboratory Consultant acknowledged the lab had not recorded the maintenance for the Oxicom 2100 analyzer. 2. Review of the instruction manual for the Hemochron Jr Signature Plus showed the routine maintenance to be performed on the analyzer. There were no records of maintenance available for review. During an interview on 12/12/19 at 2:49 PM, the Laboratory Consultant acknowledged the lab had not recorded the maintenance for the Hemochron analyzer. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality controls at least once a day that patient specimens were tested on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer and the Hemochron Jr Signature Plus ACT (activated clotting time) analyzer from when patient testing started in July 2018 to December 12, 2019. Findings: 1. Review of the laboratory's quality control records for the Oxicom 2100 pO2 analyzer showed that no records of external liquid controls were available for review from when patient testing started in July 2018 to December 12, 2019. During an interview on 12/12/19 at 11:30 AM, the Laboratory Consultant stated that the laboratory was not running liquid controls for pO2. 2. Review of the laboratory's quality control records for the Hemochron Jr Signature Plus ACT analyzer showed that no records of external liquid controls were available for review from when patient testing started in July 2018 to December 12, 2019. During an interview on 12/12/19 at 11:30 AM, the Laboratory Consultant stated that the laboratory was not running liquid controls for ACT. D5535 ROUTINE CHEMISTRY CFR(s): 493.1267(a)(d) -- 5 of 8 -- For blood gas analyses, the laboratory must perform the following: (a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform calibrations on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer according to manufacturer's specifications from when patient testing started in July 2018 to December 12, 2019. Findings: Review of the instruction manual for the Oxicom 2100 showed that section 4 provided instructions on performing calibrations on the the analyzer. Section 5 of the manual read, "The calibration should be confirmed twice a year." Review of the laboratory's records showed that the analyzer was calibrated on 4 /16/18. There were no other calibration records available for review. During an interview on 12/12/19 at 9:32 AM, the Laboratory Consultant acknowledged that the laboratory had not performed any other calibrations on the Oxicom 2100 analyzer after 4/16/18. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: AMENDED 1/22/2020 Based on record review and interview, the Laboratory Director failed to provide overall management and direction in the laboratory. Cross Reference D6007 Based on record review and interview, the Laboratory Director failed to ensure that testing systems used in the laboratory provided quality laboratory services for all aspects of testing performance, including analytic phases of testing. Cross Reference D6015 Based on record review and interview, the Laboratory Director failed to ensure that the laboratory was enrolled in an approved proficiency testing (PT) program for all analytes tested in the laboratory. Cross Reference D6021 Based on record review and interview, the Laboratory Directory failed to ensure the quality assessment programs were maintained to assure quality of laboratory services provided from when patient testing started in July 2018 to December 12, 2019. Cross Reference D6030 Based on record review and staff interview, the Laboratory Director failed to ensure that testing personnel were competent and that their competency was maintained. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (E) The laboratory director must-- (E)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of -- 6 of 8 -- testing; This STANDARD is not met as evidenced by: AMENDED 1/22/2020 Based on record review and interview, the Laboratory Director failed to ensure that testing systems used in the laboratory provided quality laboratory services for all aspects of testing performance, including analytic phases of testing. Findings: The Laboratory Director failed to ensure the temperature and humidity of the room where testing was performed was recorded from when patient testing first started in July 2018 to December 12, 2019. (See D5413) The Laboratory Director failed to ensure the maintenance performed on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer and the Hemochron Jr Signature Plus ACT (Activated Clotting Time) analyzer was documented from when patient testing started in July 2018 to December 12, 2019. (See D5429) The Laboratory Director failed to ensure that the laboratory perform quality controls at least once a day that patient specimens were tested on the Oxicom 2100 pO2 (partial pressure of oxygen) analyzer and the Hemochron Jr Signature Plus ACT (activated clotting time) analyzer from when patient testing started in July 2018 to December 12, 2019. (See D5447) The Laboratory Director failed to ensure that the laboratory performed calibrations on the Oxicom 2100 pO2 analyzer according to manufacturer's specifications from when patient testing started in July 2018 to December 12, 2019. (See D5535) D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure that the laboratory was enrolled in an approved proficiency testing (PT) program for all analytes tested in the laboratory. Findings: The Laboratory Director failed to ensure that the laboratory was enrolled in proficiency testing with an approved PT program in the specialty of Routine Chemistry for the analyte pO2 (partial pressure of oxygen) from when patient testing started in July 2018 to December 12, 2019. (See D2000) D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: -- 7 of 8 -- Based on record review and interview, the Laboratory Directory failed to ensure the quality assessment programs were maintained to assure quality of laboratory services provided from when patient testing started in July 2018 to December 12, 2019. Findings: The Laboratory Director failed to ensure procedures were followed for monitoring, assessing and correcting problems. The Laboratory Director failed to ensure the laboratory performed quality assurance reviews. (See D5291) D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director failed to ensure testing personnel were competent and that their competency was maintained. Findings. The Laboratory Director failed to ensure all testing personnel had competency evaluations in 2018 and 2019, and failed to sign the competency evaluations in 2018. (See D5209) -- 8 of 8 --