Centra Specialty Hospital

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Centra Specialty Hospital on September 7, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of procedures, manufacturer's package insert, instrument 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 -- calibration verification records, lack of documentation, and an interview, the laboratory failed to follow their policy to perform calibration verification for the Abbott EG7+ reagent cartridge blood gas analytes Hydrogen Ion Concentration (pH), Carbon Dioxide Partial Pressure (PCO2), Bicarbonate (HCO3), and Oxygen Partial Pressure (PO2) on the iSTAT analyzer every six months in calendar year 2021. Findings include: 1. Review of the laboratory's procedures revealed iSTAT calibration verification protocol as: "Calibration verification or the analytical measurement range will be performed every six months." 2. Review of the Abbott iSTAT EG7+ cartridge package insert revealed instructions: "Calibration verification is the procedure intended to verify the accuracy of results over the entire measurement range of at test and may be required by your regulatory agency." 3. Review of the laboratory's calibration verification records during the timeframe of January 2021 to the date of the survey on 09/07/22, revealed calibration verification records for the Abbott iSTAT EG7+ blood gas reagent cartridge tests as performed once on 09/07/21. The inspector requested to review additional documentation of the every six month calibration verification for the twenty-one month review timeframe outlined above. No other records were available. 4. An exit interview with the Lead Respiratory Therapist, Medical Laboratory Technician (MLT) Supervisor, Director of Quality Assurance, and Director of Lynchburg General Hospital (LGH) Lab on 09/07/22 at approximately 1:30 PM confirmed the above findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of the facility's Centers for Medicare and Medicaid Services Application for Certification (CMS 116) form, a randomly selected patient's electronic medical record (EMR) blood gas report, and interviews, the laboratory failed to correctly identify their address as the performing laboratory as reviewed on the blood gas panel on September 7, 2022. Findings include: 1. Review of the facilities CMS 116 form revealed a laboratory name and facility physical location address as: Centra Specialty Hospital 3300 Rivermont Avenue Lynchburg, Virginia 24503 2. The inspector randomly selected patient accession #1012332 from the laboratory's test logs dated 09/03/22 for review. The printed blood gas report from the laboratory's Cerner EMR revealed a testing location of: LGH Lab, Lynchburg General Hospital 1901 Tate Springs Road Lynchburg, Virginia 24501 The inspector noted that the printed blood gas report outlined above stated "this test was performed at LGH Lab, Lynchburg General Hospital, 1901 Tate Springs Road" and inquired regarding the lab name and address error. The Lead Respiratory Therapist stated on 09/07/22 at approximately 12:30 PM, "I had not noticed that the performing lab was not correct." The Medical Laboratory Technician (MLT) Supervisor stated simultaneously: "We will have to reach out to the IT department to get this fixed. We had an upgrade in the iSTAT Rals downloader this year and it is possible that our IT department may not -- 2 of 3 -- have updated all test sites appropriately." 3. An exit interview with the Lead Respiratory Therapist, MLT Supervisor, Director of Quality Assurance, and Director of Lynchburg General Hospital (LGH) Lab on 09/07/22 at approximately 1:30 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the Centra Specialty Hospital on December 7, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory was conducted on November 12, 2020 with off-site record review of documentation on December 3, 2020 and a follow-up phone conference on December 4, 2020. The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F.R. 493-1250 Condition: Analytic Systems. Specific deficiencies cited are as follows: 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 the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), policy and procedures (P&P), lack of documentation, and an interview, the laboratory failed to establish a written policy for the competency assessments for individuals performing the job duties of technical consultant at the date of survey on December 7, 2020. Findings include: 1. Review of the CMS-209 Form revealed three (3) technical consultants. See attached Personnel Code Sheet. 2. Review of the P&P revealed the lack of documentation of an established written policy for competency assessments for the technical consultant. The surveyor requested the document and it was not available for review. 3. An interview with the primary testing personnel and technical consultant B at approximately 10:45 AM on December 7, 2020 confirmed the findings. 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 -- D5400 ANALYTIC SYSTEMS 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: Based on the review of the laboratory's performance verification records, Abbott i- STAT System Performance Verification Protocol, daily patient test logs, and interviews, the laboratory failed to: 1. verify the performance specifications for the i- STAT test system in the environment in which testing was performed (Refer to D5421 A), and 2. verify the performance specifications for the EG7+ Blood Gas cartridge (Refer to D5421 B). 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: A. Based on the review of the laboratory's performance verification records, Abbott i- STAT System Performance Verification Protocol, and interviews, the laboratory failed to verify the performance specifications for the i-STAT test system in the environment in which testing was performed on 8/28/20. Findings include: 1. Review of the laboratory's Abbott i-STAT test system's (serial number 311008, installed 8/28 /20) performance verification documentation revealed the verification procedures were performed off-site at an affiliated hospital. A phone interview with the primary testing personnel, point of care coordinator and lab director on 12/04/20 at approximately 9:45 AM revealed that the performance verification studies were conducted off-site at an affiliated hospital by the point of care coordinator. The new device was re-located to the testing lab on 8/28/20. 2. The review of the "Abbott i- STAT System Performance Verification Protocol" revised 4/04/20 revealed the following statements: " OVERVIEW- A verification protocol provides an efficient means to collect statistically valid data that can be used to assess the performance of each device and each sensor type found in cartridges containing tests for chemistries, blood gases and hematocrit that will be used for i-STAT testing." "VERIFICATION OF ADDITIONAL NEW OR REPLACEMENT DEVICES- Reportable Range- Test the lowest level, the mid level and the highest level of calibration samples available for each cartridge that will be performed on a new or replacement device. Precision- Each cartridge that will be used with the new or replacement device must be included in the Precision study." 3. An interview with the primary testing personnel and point -- 2 of 3 -- of care coordinator at approximately 11:00 AM on 12/07/20 confirmed that the findings. B. Based on the review of the laboratory's performance verification records, Abbott i-STAT System Performance Verification Protocol, daily patient test logs, and interviews, the laboratory failed to verify the performance specifications for the EG7+ Blood Gas cartridge from 8/28/20 up to 12/01/20 while reporting twenty-seven (27) patients. Findings include: 1. Review of the laboratory's Abbott i-STAT test system's (serial number 311008, installed 8/28/20) performance verification documentation revealed the verification procedures were performed for the CG8+ blood gas cartridge. A phone interview with the primary testing personnel, point of care coordinator and lab director on 12/04/20 at approximately 9:45 AM revealed that the testing lab utilized the EG7+ blood gas cartridge for patient testing and not the CG8+ blood gas cartridge. It was stated, "Both cartridges contain the same analytes, with the CG8+ including glucose and the studies cover the EG7+ blood gas cartridge." 2. An Abbott Point of Care technical specialist stated, "Each individual test cartridge must be verified prior to patient testing" during a phone interview at approximately 9:22 AM on 12/7/20. In addition, the review of the "Abbott i-STAT System Performance Verification Protocol" revised 4/04/20 revealed the following statements: " OVERVIEW- A verification protocol provides an efficient means to collect statistically valid data that can be used to assess the performance of each device and each sensor type found in cartridges containing tests for chemistries, blood gases and hematocrit that will be used for i-STAT testing." "VERIFICATION OF ADDITIONAL NEW OR REPLACEMENT DEVICES- Reportable Range- Test the lowest level, the mid level and the highest level of calibration samples available for each cartridge that will be performed on a new or replacement device. Precision- Each cartridge that will be used with the new or replacement device must be included in the Precision study." 3. A patient query from the RALs laboratory information system (LIS) revealed 27 patients were tested and resulted with the EG7+ blood gas cartridge from 8/28/20 up to 12/01/20. 4. An interview with the primary testing personnel and point of care coordinator at approximately 11:00 AM on 12/07/20 confirmed the findings. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), performance verification records, Abbott i-STAT System Performance Verification Protocol, daily patient test logs, and interviews, the technical consultant (TC) failed to verify the performance specifications of the i-STAT test system in the environment in which testing was performed and for the EG7+ Blood Gas cartridge on 8/28/20. The review of the CMS-209 Form and interview with TC B on 12/07/20 at approximately 10:45 AM revealed TC B is the point of care coordinator for the affiliated hospital system. Refer to D5421 A and B. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Centra Specialty Hospital on January 23, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 the review of policy and procedures (P&P) and interview, the laboratory did not have a P&P for performing competency assessments on testing personnel at the date of the survey on January 23, 2019. Findings include: 1. Review of the available P&P's revealed no policy for performing competency assessments on testing personnel performing patient testing. The inspector requested to review the P&P for competency assessments. The document was not available for review at the date of survey. 2. Interview with the primary testing personnel and laboratory quality manager at approximately 1:15 PM confirmed the above listed findings. D5400 ANALYTIC SYSTEMS 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 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 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on tour of the lab testing area, review of policy and procedures (P&P), manufacturer operator's guide, quality control (QC) records, and interview, the laboratory failed to: 1) ensure the laboratory director reviewed and signed P&P (Cross Reference D5407); 2) monitor and document room temperatures (Cross Reference D5413); and 3) perform QC every eight (8) hours of patient testing (Cross Reference D5537). D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Base on the review of policy and procedures (P&P) and interview, the laboratory director did not sign and approve the P&P in use at the date of the survey on January 23, 2019. Findings include: 1. The inspector requested to review the P&P in use for the blood gas testing. Review of the P&P revealed the lack of the laboratory director's signature and approval for the following: - Point of Care Testing: I-STAT System V20 POC 7095.D.001, - Point of Care Testing: Quality Assurance V20 POC 7095.B. 001, - CMG: Proficiency Testing Policy V5 CMG.01.15.330, - Respiratory Care: Arterial Blood Sample Collection- CSH V3 CSH.RSP.01.32.02 and, - Respiratory Care: Care Critical Values- CSH V3 CSH.CLIN.RSP.32.09. 2. An interview with the laboratory quality manager and primary testing personnel at approximately 1:15 PM confirmed the above-specified findings. 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 the tour of the lab testing area, review of the manufacturer operator's guide and an interview, the laboratory failed to monitor and document the room temperature for the Abbott i-STAT C3+ and CG4+ blood gas cartridges from May 1, 2018 and up to the date of survey on January 23, 2019. Findings include: 1. Tour of the lab testing area for the Abbott i-STAT hand-held analyzer revealed that the staff store the Abbott i-STAT C3+ and CG4+ blood gas cartridges at room temperature for use. 2. Review of the manufacturer operator's guide, pg. 16, revealed the following statements: "Room Temperature Cartridges: - Verify that all boxes of cartridges at room temperature have been out of the refrigerator less than the time frame indicated on the -- 2 of 6 -- cartridge box. Deliver any expired cartridges to the i-STAT 1 System coordinator. - Verify that room temperature has not exceeded 30 C (86 F). - Document in the i- STAT QC log. Action: If the measured temperature of the room has been continuously below 30 C (86 F) use cartridges as required. Remedial Action: If the measured room temperature has exceeded 30 C (86 F) for any period of time: - Quarantine the cartridges. - Notify the i-STAT 1 System coordinator immediately. - DO NOT USE the cartridges. - Record the out-of-control event in the i-STAT QC Log and the action taken." The inspector requested to review room temperature documentation from May 1, 2018 and up to the date of survey on January 23, 2019. The documentation was not available for review. 3. An interview with the laboratory quality manager and primary testing personnel at approximately 1:15 PM confirmed the above-specified findings. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of quality control (QC) records, and an interview, the laboratory failed to perform QC materials every eight (8) hours of patient testing for the Abbott i- STAT C3+ and CG4+ blood gas cartridges from May 1, 2018 and up to the date of survey on January 23, 2019, in which seventy-six (76) patients were resulted. Findings include: 1. Review of the Abbott i-STAT hand-held analyzer blood gas RALS QC records (serial number 315896) revealed that the laboratory performed Abbott TriControl (level 1-lot number 301100 and level 3-lot number 321100) every 30 days from May 1, 2018 and up to the date of survey on January 23, 2019. Review of the blood gas RALS QC records revealed the following dates that did not have QC performed and patients were resulted: 05/17/2018- Accession number 1429, 05/18 /2018- Accession number 1429, 05/19/2018- Accession number 2238, 05/20/2018- Accession number 1242, 05/21/2018- Accession number 1429, and 2238, 05/24/2018- Accession number 1497, 05/25/2018- Accession number 1429, 05/26/2018- Accession number 1497, 05/30/2018- Accession number 1688, 05/31/2018- Accession number 1688, 06/07/2018- Accession number 1559, 06/08/2018- Accession number 1706, 06/09/2018- Accession number 0478, 06/12/2018- Accession number 1688, 06/13/2018- Accession number 1677, 06/16/2018- Accession number 1706, 06/22/2018- Accession number 2262, 06/26/2018- Accession number 1497, 06/30/2018- Accession number 1497, 07/06/2018- Accession number 0684, 07/08/2018- Accession number 1657, 07/11/2018- Accession number 2328, 07/13/2018- Accession number 1611, 07/14/2018- Accession number 2066, 07/16/2018- Accession number 1998, 07/18/2018- Accession number 1611, 08/02/2018- Accession number 2322, 08/03/2018- Accession number 1519, 08/04/2018- Accession number 1717, 08/06/2018- Accession number 2094, 08/11/2018- Accession number 1710, 08/13/2018- Accession number 2820, 08/18/2018- Accession number 2019 and 1848, 08/19/2018- Accession number 1710, 08/22/2018- Accession number 1519, 08/23/2018- Accession number 2226 and 1519, 08/28/2018- Accession number 1808, 09/13/2018- Accession number 4509, 09/14/2018- Accession number 4404, 09/27/2018- Accession number 8200, 09/28/2018- Accession number 1969, 09/29/2018- -- 3 of 6 -- Accession number 1969, 10/04/2018- Accession number 2632, 10/05/2018- Accession number 3024, 10/06/2018- Accession number 9026, 10/08/2018- Accession number 6853, 10/17/2018- Accession number 3024, 10/20/2018- Accession number 6074 and 3024, 10/26/2018- Accession number 2884, 11/02/2018- Accession number 3024, 11/09/2018- Accession number 5896, 11/17/2018- Accession number 6197, 11/29/2018- Accession number 6197, 11/29/2018- Accession number 7661, 11/30/2018- Accession number 7661 and 3183, 12/01/2018- Accession number 7661, 12/03/2018- Accession number 8056, 12/04/2018- Accession number 7661 and 8056, 12/05/2018- Accession number 7661, 12/14/2018- Accession number 2943, 12/15/2018- Accession number 2943, 12/16/2018- Accession number 6317, 12/17/2018- Accession number 5050, 12/18/2018- Accession number 8056 and 6317, 12/31/2018- Accession number 8056, 01/01/2019- Accession number 8056 and 4681, 01/03/2019- Accession number 3929, 01/12/2019- Accession number 3929, 01/13/2019- Accession number 3929, and 01/23/2019- Accession number 8948. A total of 68 days with 76 patients resulted. 2. Interview with the laboratory director, laboratory quality manager and primary TP at approximately 11:30 AM confirmed the above-listed findings. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the tour of the lab testing area, review of manufacturer operator's guide, quality control (QC) records, and interview, the laboratory director failed to: 1) ensure room temperatures for the lab testing area were monitored and documented (Cross Reference D5413); and 2) ensure that QC was performed every eight (8) hours of patient testing (Cross Reference D5537). D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records and interviews, the laboratory director failed to review and approve four (4) of four (4) new TP training and competency assessments -- 4 of 6 -- documentation prior to performing patient testing procedures from May 1, 2018 and up to the date of survey on January 23, 2019. Findings include: 1. Review of CLIA CMS-209 form revealed that TP B, H, M and TP N were new TP (See attached TP Code Sheet). 2. Review of TP records revealed the lack of the laboratory director's signature of review and approval for the following TP: TP B- hired and performing testing May 9, 2018, TP H- hired and performing testing May 15, 2018, TP M- hired and performing testing May 15, 2018, TP N- hired and performing testing May 22, 2018. 3. Interview with the laboratory director, laboratory quality manager and primary TP at approximately 11:30 AM confirmed the above-listed findings. 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 the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records and interview, the laboratory director did not review and approve the semi-annual competency assessments of four (4) of 4 new TP in 2019 and eleven (11) of 11 TP annual competency assessments in 2018. Findings include: 1. Review of the CLIA CMS-209 Form revealed 4 new TP in 2018 and 11 TP performing patient testing in 2018. 2. Review of the TP records revealed the lack of the laboratory director's review and approval of the following competency assessments: TP B- semi-annual on January 22, 2019, TP H- semi-annual on January 9, 2019, TP M- semi-annual on January 9, 2019 and, TP N- semi-annual on January 22, 2019. And TP A- annual on August 17, 2018, TP C- annual on August 17, 2018, TP D- annual on August 21, 2018, TP E- annual on August 17, 2018, TP F- annual on August 21, 2018, TP G- annual on August 17, 2018, TP I- annual on August 17, 2018, TP J- annual on August 17, 2018, TP K- annual on August 17, 2018, TP L- annual on August 17, 2018 and TP P- annual on August 22, 2018. 3. Interview with the laboratory director, laboratory quality manager and primary TP at approximately 11: 30 AM confirmed the above-listed findings. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 -- 5 of 6 -- Form), personnel records, and interview, testing personnel (TP) P did not have the required education elements to qualify and perform the duties of technical consultant at the date of survey on January 23, 2018 (Cross Reference D6034). D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), personnel records, and interview, testing personnel (TP) P did not have the required education elements to qualify and perform the duties of technical consultant at the date of survey on January 23, 2019. Findings include: 1. Review of the CLIA CMS-209 Form revealed that TP P was listed as the technical consultant. (See attached personnel code sheet.) 2. Review of the personnel records revealed that TP P did not possess the required education elements to qualify as technical consultant and TP P had performed and signed the training and competency assessments of fourteen (14) TP (Cross Reference D6029 and D6030). 3. An interview with the laboratory director, TP P and laboratory quality manager at approximately 11:30 AM confirmed the above findings. -- 6 of 6 --