Summit Medical Group Dba Summit Health

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for Urine Chemistry tests in the calendar year 2022. The TP confirmed on 11/17/2022 at 10:40 am the laboratory was not enrolled in PT for Urine Chemistry tests. 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 the survey review of Quality Control (QC) records, Manufactures Package Directions (MPD) and interview with the Testing Personnel (TP) the laboratory failed to retain the assayed control values from the MPD for MAS UA Controls from 10/3 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 -- /21 to the date of survey. The TP confirmed on 11/17/22 at 11:00 am that Assayed Control values from the MPD were not retained. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain work records for Urine Chemistry PT event in the calendar year 2021 performed with the American Proficiency Institute. The TP confirmed on 11/17/22 at 11:45 am that all PT work records were not retained. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor review of Manufactures Package Inserts, observation of the Quality Control material, and interview with the Testing Personnel (TP), the laboratory failed to put open and expiration dates on Urine chemistry control material run on the Clinitek Advantus Urine Chemistry Analyzer on the date of survey. The TP confirmed on 11/17/22 at 12:00 pm the laboratory failed to put open and expiration dates on the control material. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of Quality Control Verification (QCV) records and interview with -- 2 of 6 -- the Testing Personnel (TP), the laboratory failed to verify QC material before use for Urine Chemistry tests performed on the Clinitek Advantus Urine Chemistry Analyzer from 10/03/19 to the date of survey. The TP confirmed 1/17/22 at 11:15 am that QC material was not verified before putting in use. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyors observation of controls in use and interview with the Testin Personnel (TP), the laboratory failed to follow Manufacturers Specifications (MS) for controls at the time of the survey. The finding includes: 1. Controls in use did not have an open or expiration date documented as per MS. 2. The LD confirmed on 8/9 /18 at 1:15 pm that MS were not followed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with Testing Personnel (TP) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 10/03/19 to the date of survey. The finding includes: 1. The laboratory failed to have a procedure to verify new lots of controls before they were put in use. 2. The TP confirmed on 11/17/22 at 10:45 am that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) Work Records (WR), Electronic Medical Record (EMR) and interview with the Testing Personnel (TP) the laboratory failed to ensure test results were reported accurately into the EMR on 11/17/2022. The finding includes: 1. A review of ten EMR entries revealed one patient had results as follows: a) Blood results of "Negative" on the WR but the FR had "Moderate+2". b) Protein results of "Trace" on the WR but the FR had "Negative". c) Ketones results of "Trace" on the WR by the FR had "Negative" 2. The TP confirmed on 11/17/22 at 11: 30 am that the laboratory did not ensure test results were accurately recorded in the EMR. 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 surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP) the laboratory failed to ensure that the FR included the address of the laboratory where testing was performed from 10/03/19 to the date of survey. The TP confirmed on 11/17/22 at 10:00 am that the FR did not have the address of the laboratory where testing was performed. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to establish a procedure for verifying manually entered results from 10/03/19 to the date of survey. The TP confirmed on 11 /17/22 at 10:30 am that the laboratory did not have the procedure mentioned above. 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. -- 4 of 6 -- This CONDITION is not met as evidenced by: Based on surveyor review of the Laboratory records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to provide overall management and direction to the laboratory from 10/25/22 to the date of survey. The findings include: 1. The LD failed to ensure that PT samples were tested . Cross refer D6016 2. The LD failed to ensure a Quality Control program was established and maintained. Cross refer D6020. 3. The LD failed to establish a QA plan. Cross refer D6021. 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; This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PT samples were tested for Urine Chemistry (UC) tests in the calendar year 2022. The TP confirmed on 11/17/22 at 9:45 am that the LD did not ensure PT UC samples were tested. 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 review of Quality Control (QC) records, Procedure manual (PM), Quality Control Manufactures package insert (MPI) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that the QC program was maintained for laboratory services provided from 10/03/19 to the date of the survey. The TP confirmed on 8/18/22 at 11:30 am the LD did not ensure a QC plan was maintained. . 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 -- 5 of 6 -- 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: Based on a lack of a Quality Assurance (QA) plan and interview with the Testing Personnel (TP), the Laboratory Director failed to establish a QA plan from 10/03/19 to the date of the survey. The TP confirmed on 11/17/22 at 11:00 am that a QA plan had not been established. -- 6 of 6 --

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to ensure that Testing Personnel (TP) who performed Urinalysis Tests participated in the American Proficiency Institute PT events in the calendar years 2018 and 2019. The finding includes: 1. A review of all PT event revealed that two out of five TP performed PT events in 2018 and 2019. 2. The OM confirmed on 10/3/19 at 1:30 pm that PT events were not rotated between TP. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material in use and interview with the Office Manager (OM) the laboratory failed to label the control material used for Urinalysis testing with an open and new expiration date after 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 -- opening at the time of survey. The findings include: 1) There was no open and expiration date written on the QC material. 2) The OM confirmed on 10/3/19 at 111: 00 am controls were not labeled. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records, Manufacture's Package Insert (MPI) and interview with the Office Manager (OM), the laboratory failed to document QC verification for Urinalisys testing performed on the Clinitek Advantis analyzer from August 2017 on the date of survey. The finding includes: 1. The work records for QC verification did not differentiate between old and new lot numbers being tested. 4. The OM confirmed on 10/3/2019 at 12:00 pm that QC verification was not properly documented before putting new QC in use. 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 surveyor review of the Final Report (FR) and interview with the Office Manager (OM), the laboratory failed to have the address of the laboratory where the Urinalysis tests were performed from August 2017 to the date of survey. The OM confirmed on 10/3/19 at 11:30 am the address of the laboratory was not on the FR. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of -- 2 of 3 -- 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to maintain Urinalysis work records and attestation statement for 1-2018 PT event with American Proficiency Institute at the time of survey. The TP # 5 listed on CMS form 209 confirmed on 5/23/18 at 10:15 am that all PT records were not maintained. 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: 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 -- Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA correctly on six out of six TP in 2017. The findings include: 1. The laboratory did not document what records were reviewed and how CA was assessed. 2. The TP # 5 listed on CMS form 209 confirmed on 5/23/18 at 11:00 am that CA was not performed correctly. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Testing Personnel (TP), the laboartory did not follow their scanning policy from October 2017 to the date of survey. The finding includes: 1. The laboratory had a policy to scan patient results into the Eletronic Medical Records (EMR) but patient results were not scanned in EMR from October 2017. 2. The TP # 5 listed on CMS form 209 confirmed on 5/23/18 at 11:00 am that scanning policy was not followed. 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 lack of Performance Specifications (PS) records and interview with the Testing Personnel (TP), the laboratory failed to verify PS for Urinalysis tests performed on the Clinitek Advantus analyzer from August 2017 to the date of survey. The TP # 5 listed on CMS form 209 confirmed on 5/23/18 at 11:15 am that the PS were not performed. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the -- 2 of 5 -- laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to verify that the assayed QC materials were within the acceptable ranges before they were put into use for analytes performed on the Clinitek Advantus analyzer from August 2017 to the date of survey. The finding includes: 1. The laboratory changed lots every quarter. 2. The laboratory ran and reported around 400 patient samples a month. 3. The TP #5 listed on CMS form 209 confirmed on 5/23/18 at 11:00 am that the laboratory did not verify QC materials for Urinalysis analytes. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on the surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to establish a written policy for new QC lot verification used for Urinalysis tests performed on the Clinitek Advantus analyzer from August 2017 to the date of the survey. The TP # 5 confirmed on 5/23/18 at 11:30 am the laboratory did not establish written policies for new QC lot verification. 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 surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to have correct name of the laboratory where the Urinalysis tests were performed from August 2017 to the date of survey. The TP # 5 listed on CMS form 209 confirmed on 5/23/18 at 11:30 am that correct name of the laboratory was not on the FR. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT -- 3 of 5 -- CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to have a procedure to verify manually entered results into electronic medical records for accuracy from August 2017 to the date of survey. The TP # 5 listed on CMS form 209 confirmed on 5/23/18 at 10:15 am that the laboratory did not have the procedure mention above. 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 surveyor review of the Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the required elements from August 2017 to the date of the survey. The TP # 5 listed on the CMS form 209 confirmed on 5/23/18 at 11:00 am that a CA procedure was not established. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Testing -- 4 of 5 -- Personnel (TP), the Laboratory Director (LD) did not specify in detail the duties and responsibilities of TP engaged in the performance of preanalytic, analytic and post analytic phases for Urinalysis tests from August 2017 to the date of survey. The TP # 5 listed on CMS form 209 confirmed on5/23/18 at 11:15 am that the LD did not specify the duties and responsibilities of TP. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to ensure Competency Assessment (CA) was evaluated by a qualified individual in 2017. The finding includes: 1. CA on six out of six TP was performed by the License Practice Nurse who had an Associate Degree. 2. The TP # 5 listed on CMS form 209 confirmed on 5 /23/18 at 10:40 am that the TC did not ensure that a qualified personnel performed CA. -- 5 of 5 --