Amc Laboratory

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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: 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 -- Based on a desk review of proficiency testing records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Routine Chemistry for the Total Bilirubin, blood analyte. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Centers for Medicare and Medicaid (CMS) form 0155D and American Association of Bioanalysts (AAB) 2021 (3rd Event) and 2022 (1st Event) records, it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Routine Chemistry for the Total Bilirubin, blood analyte. Two consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155D report revealed the following results: Routine Chemistry 2021-3rd Event the laboratory received an unsatisfactory score of 0% for Total Bilirubin. Routine Chemistry 2022-1st Event the laboratory received an unsatisfactory score of 60% for Total Bilirubin. 2. Review of proficiency test records from the American Association of Bioanalysts (AAB) for 2021 and 2022 confirmed the laboratory received the following results: AAB Routine Chemistry 2021 - Total Bilirubin analyte - 3rd Event laboratory received an unsatisfactory score of 0% for the analyte. The Laboratory received an "Off Cycle" score of 20% for the 3rd event in 2021 on January 13, 2022. AAB Routine Chemistry 2022 - Total Bilirubin analyte - 1st Event laboratory received an unsatisfactory score of 60%. 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D2016 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 -- 2 of 3 -- 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 a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 During a recertification survey completed on 01/13/2021 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following conditions: 42 CFR Part 493.1250 Analytic Systems 42 CFR Part 493.1403 Laboratory Director, Moderate Complexity 42 CFR Part 493.1441 Laboratory Director, High Complexity 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 review of quality control records, General Quality Assessment Policy, plate detail reports printed with every run and with every tray/plate, email confirmation, interviews with laboratory staff, the laboratory failed to maintain copies of the hematology quality control package inserts (manufacturer instructions) for the quality control materials used for CBC (Complete Blood Count) testing performed on the Abbott Emerald Analyzer and Quality assessment records for the TheraTest system. Findings are: A. Review of the quality control records revealed the laboratory had the instructions for the quality control material used for the new hematology analyzer, the Sysmex XN-330. According to the validation records, the new analyzer was put into use on 10/29/2020. There were no quality control instructions for the previous hematology analyzer, the Cell Dyne Emerald. B. During interview on 01/12/2021 at 11:18 am, the Technical Consultant stated the laboratory staff were requesting copies of the quality control package inserts for 2020 from the manufacturer of the Cell Dyne quality control materials because they could not find the originals. 43577 C. Review of the General Quality Assessment Policy revealed the lab failed to follow a written policy in regards to record retention of Quality Control data. 1. Written policy states Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- that quality control data and patient test results (including instrument printouts) are to be kept at least 2 years. 2. Quality assessment records are to be kept at least 2 years. D. Review of the two plate detail reports from runs, for EL-RF/3 (test used for the detection and measurement of rheumatoid factor in human serum and used as an aid to the diagnosis of Rheumatoid Arthritis) assay, performed on 7/21/2020 and 9/23 /2020 and printed from the TERIS 6.1 Software (TheraTest ELISA Reader Information System, version 6.1) revealed that the QC form (Checklist) for subsequent plates, in the same run, had not been filled out. The QC form must be completed to document that QC was acceptable for the entire run, and must be signed and dated by qualified testing person. These QC forms were not retained and were shredded by the laboratory Technical Supervisor. The Technical Supervisor also serves as the General Supervisor and Testing Person. E. During interview on 01/12 /2021 at 2:52 pm, via speaker phone during the survey in the presence of the Technical Supervisor, the TheraTest Technical Specialist stated that a single and separate QC form (Checklist) is generated from the TERIS Software for every 96 well plate that is read by the Biotek ElX800 Plate Reader. He stated that these QC forms (checklist) must be filled out for every plate read and the performing tech is to accept or reject the run, based on the values, which should fall within a range listed on the data sheets provided with each test kit/lot number. When asked if the QC analysis process was in the procedure and if it was being trained in the field, the TheraTest Technical Specialist stated, "Yes it is." During the same interview, the Technical Supervisor was asked if she was assessing the QC in the same manner as stated by the Technical Specialist, for every single, individual plate. The Technical Supervisor confirmed that she only keeps the first QC form (Checklist) for the first plate and not the subsequent QC forms that print if the run consists of more than one plate. She also stated that she was not trained to fill out, accepting or rejecting, each subsequent QC form for each of the plates on the run. F. Email from the Technical Supervisor sent 01 /25/21 at 7:53 pm confirmed that she is shredding all the subsequent QC forms when the run consists of more than one 96 well plate. Her response in the email read "When I print off the QC/Calibration page this is the only page I keep a hard copy of and I shred the rest because everything is saved on 3 different locations: my computer, jump drive, and TheraTest." She also wrote that she only keeps the hard copy of the plate details and the one QC/Calibration page for every run and that she can easily reprint the subsequent QC pages if needed. 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 personnel competency policies, CMS (Centers for Medicare & Medicaid Services) Personnel Report Form 209, Designation of Duties, personnel records and interview with the Technical Consultant, the laboratory failed to establish and follow a policy for evaluating the competency of the Technical Consultant, Technical Supervisor and General Supervisor. Findings are: A. Review of the personnel competency policy signed by the Laboratory Director on 09/17/2018 revealed no process for evaluating the competency of the Technical Consultant, Technical Supervisor and General Supervisor by the Laboratory Director. B. Review of the CMS Personnel Report Form 209, dated 01/08/2021, indicated the Technical -- 2 of 12 -- Supervisor was also the laboratory's General Supervisor and the only high complexity testing person. C. Review of the Designation of Duties, signed by the Laboratory Director on 08/15/18, revealed no distinction between the responsibilities of the General Supervisor and the Technical Consultant by the Laboratory Director. D. Review of personnel files revealed no documentation of evaluations for the responsibilities assigned to the Technical Consultant, the Technical Supervisor or General Supervisor. F. During interview on the morning of 01/13/2021, the Technical Consultant confirmed the Laboratory Director did not perform a competency evaluation regarding her responsibilities as a Technical Consultant. 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 observation, review of the Quality Assessment/Assurance Policies, plate detail test reports (a map that shows the location of patient samples, quality control materials, calibrators on the 96-well plate), Quality Control records, QA Manual for Qualigen FastPack System, the Qualigen FastPack TSH (Thyroid Stimulating Hormone) Method Verification Kit documentation, and the Risk Assessment and Quality Control Plan, and interview with the Technical Supervisor, the laboratory failed to meet the condition of Analytic Systems. The laboratory reported performing 960 TSH tests, 1020 ANA (Antinuclear Antibody-test looks for antinuclear antibodies in your blood), 1020 Anti-CCP (cyclic citrullinated peptide antibodies- are a type of antibody called autoantibodies), 1020 RF (Rheumatoid Factor), 1020 Anti-TPO (Thyroid peroxidase antibody), 1020 Anti-thyroglobulin, 1060 TB (Tuberculosis Bacillus) tests in a 12 month period. Findings are: A. The laboratory failed to perform and document the review and approval of all new QC values/material of each new lot prior to use. See D5469 B. The lab failed to label the newly, received testing kits with pertinent information required for proper use, such as true expiration dates and open /in use dates used to retrieve Quality Control results when necessary for troubleshooting purposes. See D5415 C. The laboratory failed to perform and document the Calibration verification every 6 months, as required by the Manufacturer. See D5437 D. The laboratory failed to have an effective quality assurance policy. See D5793 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. -- 3 of 12 -- This STANDARD is not met as evidenced by: Based on direct observation of the laboratory testing area, refrigerator, and storage areas, the laboratory failed to label the laboratory reagents and kits with the received date, reagent expiration date after preparation, and the revised open reagent expiration dates. Findings are: A. During observation on 1/12/2021 at 10:00 am, the surveyor noticed no "receive" dates or "expiration" dates on the outside of the kits or on the opened reagent bottles inside the following kits. 1. A TB Gold Test Kit by Qiagen (used for Tuberculosis Bacillus testing) found on the laboratory desk with no indication of when it had been received in the laboratory or when it was opened and placed into use. Kit Lot# 56603267, Exp date: 10/23/2022. 2. El-ANA Profiles: ANA /9 kit by TheraTest (used for Anti-Nuclear Antibody testing) was found in the refrigerator with no indication of when it had been received in the laboratory or when it was opened and placed into use. Kit Lot# 09204588, Exp date: 06/17/2021. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of QC (Quality Control) records, QA (Quality Assessment) Manual for Qualigen FastPack System, the Qualigen FastPack TSH (Thyroid Stimulating Hormone) Method Verification Kit documentation, and the Risk Assessment and Quality Control Plan, and interview with the Technical Consultant, the laboratory failed to perform and document the calibration verification every 6 months, as required by the manufacturer. Findings are: A. Review of the Quality Control records revealed that the laboratory failed to perform and document the method verification for 2019 and 2020. The last documented performance was 01/10/2018. B. Review of the QA Manual for Qualigen FastPack TSH System indicated that the manufacturer required that the Calibration Verification be performed once every six months. 1. Section labeled "Method Validation", on page 16-3, indicated the following: "Important Note: Calibration Verification (verifying the reportable ranges-Step 1) is performed once every six months. The accuracy and precision portion of method validation (Step 2) is only performed once per analyzer." C. Review of the Qualigen FastPack TSH Method Verification Kit documentation also indicated that the calibration verification and the verification of the reportable range must be performed every six months. 1. TSH Method Verification Kit documentation states "Calibration verification occurs through the testing of three of more levels of calibration materials that include a low, mid, and high value at least every six months. Kit includes materials to meet the requirements for calibration verification and verification of the reportable range." D. Review of the Risk Assessment and Quality Control Plan signed by the Laboratory Director on 08/26/2020, revealed the laboratory failed to follow their written Individualized Quality Control Plan for the calibration verification -- 4 of 12 -- process for the laboratory. 1. The section titled "Calibration Verification" on page 5, states that the calibration verification is to be performed every 6 months. E. During interview on 01/13/2021 at 10:30 am, the Technical Consultant was asked about the missing calibration verification documentation for 2019 and 2020 for the Qualigen FastPack TSH System. She stated that CLIA (Clinical Laboratory Improvement Amendments of 1988) no longer required that the calibration verification be performed on the Qualigen. The laboratory failed to provide documentation from the manufacturer stating that the calibration verification did not have to be performed every six months. 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 review of the General Quality Assessment Policy, the plate detail reports (a map that shows the location of patient samples, quality control materials, calibrators on the 96-well plate) and the corresponding Quality Control (QC) forms (checklist), and the interview with the Technical Supervisor, the laboratory failed to perform and document the review and approval of all new QC values/material of each new lot prior to use. Findings are: A. Review of the General Quality Assessment Policy revealed the laboratory is not following written policy in regards to performing QC (quality control) on new shipments and/or lot numbers of new kits received by the laboratory. 1. Section titled "Control Procedures" on page 11 of the General Quality Assessment Policy states: "[Name of Laboratory] Laboratory uses only FDA-cleared test kits and relies on the manufacturer for the consistency of the test kit. However, as a calibration verification, whenever a new lot number for a particular kit is purchased, the Positive and Negative Controls or the 2 levels of Controls from the previous kit (kept refrigerated, with added preservative, and stable for 1 year) are tested on the first run of the new kit, and the Unit results are compared to the expected values (see individual tests Procedure Manuals, Binder #1) for those Controls. The plate details and expected values are placed in Binder #4 (Internal Controls Data)." B. Plate detail reports revealed incomplete identification of new kit lot numbers when performing Quality Control (QC) on new shipments or new lot numbers received in the laboratory. This failure resulted in the Technical Supervisor's inability to show lot-to- lot QC documentation for each new lot or shipment received prior to testing patients. 1. The Technical Supervisor was asked to produce the documentation of the QC performed on the current lot of the EL-RF/3 (test used for the detection and measurement of rheumatoid factor in human serum and used as an aid to the diagnosis of Rheumatoid Arthritis), Lot #03204263. A plate detail report from 09/23/2020 was -- 5 of 12 -- presented and reviewed. The lot number of the current EL-RF/3 kit did not appear anywhere on the plate detail printout. The Technical Supervisor was asked to identify the well/plate location of the new Lot number QC on the plate detail printout. She identified the lot number as "G1" and "G2" on the plate detail report. The QC form (checklist) attached to the detail report, was filled out, reviewed, and marked as "Accept Run". The QC form had no indication of when the current lot number was received, QC performed, and approved for use or that a lot-to-lot QC assessment had been performed. C. During interview on 01/12/2021 at 2:52 pm, via speaker phone during the survey in the presence of the Technical Supervisor, the TheraTest Technical Specialist stated that a single and separate QC form (Checklist) is generated from the TERIS Software (used to analyze and produce the test results) for every 96 well plate that is read by the Biotek ElX800 Plate Reader. He stated that these QC forms (checklist) must be filled out for every plate read and the performing tech is to accept or reject the run, based on the values, which should fall within a range listed on the data sheets provided with each test kit/lot number. When asked if the QC analysis process was in the procedure and if it was being trained in the field, the TheraTest Technical Specialist stated, "Yes it is." During the same interview, the Technical Supervisor was asked if she was assessing the QC in the same manner as stated by the Technical Specialist, for every single, individual plate. The Technical Supervisor confirmed that she only keeps the first QC form (Checklist) for the first plate and not the subsequent QC forms that print if the run consists of more than one plate. She also stated that she was not trained to fill out, accepting or rejecting, each subsequent QC form for each of the plates on the run. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 During a proficiency desk review on 02/21/2019, the laboratory was found out of compliance with the following condition: 42 CFR part 493.803 Successful Participation 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 the review of 2017-2018 proficiency records and results reported to the CMS (Centers for Medicare & Medicaid Services) proficiency testing database, the laboratory failed to successfully participate in proficiency testing for Hematocrit (HCT) and Creatinine Kinase (CK). Findings are: A. Desk review on 02/21/19 of CASPER report 155D, Individual Laboratory Profile, revealed the laboratory received Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- failing scores for: 1. HCT - 3rd event of 2017 (testing period began 10/17/17 and results were due 11/01/17) and the 1st event of 2018 (02/20/18 - 03/15/18). 3rd event 2017 = 60% 1st event 2018 = 0% See D2121, D2128, D2130 2. Creatinine Kinase - 2nd (testing period began 04/24/18 and the results were due 05/10/18) and 3rd events (08/28/18- 09/24/18) of 2018. 2nd event 2018 = 0%. 3rd event 2018 = 0%. See D2089, D2094 B. The laboratory failed to submit CK test results for the 2nd event of 2018. See D2089 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of 2018 proficiency records and results reported to the CMS (Centers for Medicare & Medicaid Services) proficiency testing database, the laboratory failed to obtain a score of 80 % for 2 consecutive test events. Findings are: Desk review on 02/21/19 of CASPER report 155D, Individual Laboratory Profile, revealed the laboratory received failing scores for: Creatinine Kinase - 2nd (testing period began 04/24/18 and the results were due 05/10/18) and 3rd events (08/28/18- 09 /24/18) of 2018. 2nd event 2018 = 0%. 3rd event 2018 = 0%. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the review of 2018 proficiency records and results reported to the CMS (Centers for Medicare & Medicaid Services) proficiency testing database, the laboratory failed to submit Creatinine Kinase results for the 2nd event of 2018. Findings are: A. Desk review on 02/21/19 of CASPER report 155D, Individual Laboratory Profile, revealed the laboratory received failing scores for: Creatinine Kinase - 2nd (testing period began 04/24/18 and the results were due 05/10/18) and 3rd events (08/28/18- 09/24/18) of 2018. 2nd event 2018 = 0%. 3rd event 2018 = 0%. B. Desk review on 03/19/19 of online proficiency reports from American Association of Bioanalysts revealed the laboratory failed to submit test results for the 2nd event of 2018. The 3rd event score indicated the laboratory discontinued testing. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) -- 2 of 4 -- (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the review of 2018 proficiency records and results reported to the CMS (Centers for Medicare & Medicaid Services) proficiency testing database, the laboratory failed to obtain a score of 80 % for 2 consecutive test events and must obtain training and/or technical assistance. Findings are: Desk review on 02/21/19 of CASPER report 155D, Individual Laboratory Profile, revealed the laboratory received failing scores for: Creatinine Kinase - 2nd (testing period began 04/24/18 and the results were due 05/10/18) and 3rd events (08/28/18- 09/24/18) of 2018. 2nd event 2018 = 0%. 3rd event 2018 = 0%. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of 2018 proficiency records and results reported to the CMS (Centers for Medicare & Medicaid Services) proficiency testing database, the laboratory failed to obtain a score of 80 % for 2 consecutive test events resulting in unsuccessful participation in proficiency testing for Creatinine Kinase. Findings are: Desk review on 02/21/19 of CASPER report 155D, Individual Laboratory Profile, revealed the laboratory received failing scores for: Creatinine Kinase - 2nd (testing period began 04/24/18 and the results were due 05/10/18) and 3rd events (08/28/18- 09 /24/18) of 2018. 2nd event 2018 = 0%. 3rd event 2018 = 0%. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of 2017-2018 proficiency records and results reported to the CMS (Centers for Medicare & Medicaid Services) proficiency testing database, the laboratory failed to obtain a score of 80 % for 2 consecutive test events. Findings are: A. Desk review on 02/21/19 of CASPER report 155D, Individual Laboratory Profile, revealed the laboratory received failing scores for: Hematocrit - 3rd event of 2017 (testing period began 10/17/17 and results were due 11/01/17) and the 1st event of 2018 (02/20/18 - 03/15/18). 3rd event 2017 = 60% 1st event 2018 = 0% B. During a desk review on 03/11/19 of the online proficiency test reports from the American -- 3 of 4 -- Association of Bioanalysts (AAB) confirmed the HCT scores reported to CMS on 11 /13/18. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the review of 2017-2018 proficiency records and results reported to the CMS (Centers for Medicare & Medicaid Services) proficiency testing database, the laboratory must obtain training and technical assistance for the Hematocrit proficiency testing failures in 2017-2018. Findings are: A. Desk review on 02/21/18 of CASPER report 155D Individual Laboratory Profile, revealed the laboratory received failing scores for the 3rd event of 2017 and the 1st event of 2018. Hematocrit - 3rd event of 2017 (testing period began 10/17/17 and results were due 11/01/17) and the 1st event of 2018 (02/20/18 - 03/15/18). 3rd event 2017 (10/17/17 - 11/01/17) = 60% 1st event 2018 (02/20/18 - 03/15/18) = 0% B. Review of the reports from the American Association of Bioanalysts (AAB) confirmed the scores reported to CMS on 11/12/18. 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 2017-2018 proficiency records and results reported to the CMS (Centers for Medicare & Medicaid Services) proficiency testing database, the laboratory failed 2 consecutive test events for Hematocrit (HCT) proficiency testing failures in 2017-2018 resulting in unsuccessful participation in proficiency testing. Findings are: A. Desk review on 02/21/18 of CASPER report 155D, Individual Laboratory Profile, revealed the laboratory received failing scores for the 3rd event of 2017 and the 1st event of 2018. Hematocrit - 3rd event of 2017 (testing period began 10/17/17 and results were due 11/01/17) and the 1st event of 2018 (02/20/18 - 03/15 /18). 3rd event 2017 = 60% 1st event 2018 = 0% B. Review of the reports from the American Association (AAB) confirmed the scores reported to CMS on 11/12/18. -- 4 of 4 --

Summary Statement of Deficiencies D0000 During a complaint/addition of specialties survey completed on 06/14/18 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following conditions: 42 CFR part 493.801 Proficiency Testing, Enrollment and Testing of Samples 42 CFR part 493.1403 Laboratory director, moderate complexity 42 CFR part 493.1411 Technical Consultant, moderate complexity 42 CFR part 493.1463 General Supervisor, high complexity 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 the review of proficiency test reports, patient records, quality control records, and interviews with laboratory staff, the laboratory failed to enroll in proficiency testing for regulated analytes performed as part of a Complete Metabolic Profile (CMP) and Basic Metabolic Profile (BMP). 646 patients were tested January through April 2018. Findings are: A. Review of 2018 proficiency test records including the 2018 enrollment form revealed the laboratory failed to enroll and participate in proficiency testing for routine chemistry. The records indicated enrollment and testing for the following regulated analytes: CK (Creatinine incase), Magnesium, and TSH (Thyroid Stimulating Hormone) as part of the Comprehensive Chemistry and Immunochemistry modules. B. Interview with a technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- representative of the proficiency testing agency on 06/15/2018 at 10:13 am revealed the laboratory should have enrolled in the Basic Chemistry module. 1. The Basic Chemistry module included the following regulated analytes: ALT (Alanine Aminotransferase), AST (Asparate Aminotransferase), ALB (Albumin), ALKP (Alkaline Phospatase), CO2 (Bicarbonate), TBili (Total Bilirubin), Ca (Calcium), Chloride, Total Cholesterol, Creatinine, Glucose, Phosphorus, Potassium, Sodium, Total Protein, Triglyceride, BUN (Urea Nitrogen), and UA (Uric Acid). 2. The technical representative also stated the owner of the laboratory called the agency on 06 /13/2018 to enroll in the Basic Chemistry module. C. Review of the patient collection logs for January - May 2018 revealed the laboratory collected CMP and BMP samples for testing in the laboratory. 646 patients were tested January - April 2018. 1. January 2018 153 patients, #J1-153, were tested by the laboratory. The test report for patient #J2 was printed to verify testing by the laboratory on 01/02/2018. The report contained results for the following regulated analytes: Glucose, BUN, Creatinine, Sodium, Potassium, Chloride, Calcium, Total Protein, Albumin, Globulin, TBili, ALKP, AST, and ALT. 2. February 2018 175 patients, #F1-175, were tested by the laboratory. The test report for patient #F1 was printed to verify testing by the laboratory on 02/06/2018. The report contained results for the following regulated analytes: Glucose, BUN, Creatinine, Sodium, Potassium, Chloride, Calcium, Total Protein, Albumin, Globulin, TBili, ALKP, AST, and ALT. 3. March 2018 184 patients, #M1-184, were tested by the laboratory. The test report for patient #M1 was printed to verify testing by the laboratory on 03/07/2018. The report contained results for the following regulated analytes: Glucose, BUN, Creatinine, Sodium, Potassium, Chloride, Calcium, Total Protein, Albumin, Globulin, TBili, ALKP, AST, and ALT. 4. April 2018 134 patients, #A1-134, were tested by the laboratory. The test reports for two (2) patients, #A3 & A4, were printed to verify testing by the laboratory in April on 04/04/2018. The reports contained results for the following regulated analytes: Glucose, BUN, Creatinine, Sodium, Potassium, Chloride, Calcium, Total Protein, Albumin, Globulin, TBili, ALKP, AST, and ALT. D. During the exit interview on 06/14/2018 at 11:00 am, the laboratory director indicated he was not aware of this deficient practice. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on the review of proficiency test reports, patient records, quality control records, and interviews with laboratory staff, the laboratory failed have a system to evaluate non-regulated analytes (Bicarbonate and C-Reactive Protein) twice per year. Findings are: A. Review of 2018 proficiency test records revealed the laboratory failed to enroll and participate in proficiency testing for routine chemistry. The records indicated enrollment and testing for the following non-regulated analytes: GGT (Gamma-Glutamyltransferase) and Vitamin D. B. Review of the 2018 enrollment form indicated the laboratory was enrolled in proficiency testing for Comprehensive Chemistry and Immunochemistry. C. Interview with a technical representative of the proficiency testing agency on 06/15/2018 at 10:13 am revealed the laboratory should have enrolled in the Basic Chemistry module which included the CO2 (Bicarbonate). The technical representative also stated the owner of the -- 2 of 11 -- laboratory called the agency on 06/13/2018 to enroll in the Basic Chemistry module. D. There was no evidence that the laboratory used an alternate method to evaluate CO2 and C-Reactive Proteins twice per year. E. Review of the patient collection logs for January - April 2018 revealed the laboratory collected 646 CMP and BMP samples for testing in the laboratory. 1. January 2018 153 patients were tested by the laboratory. The test report for patient CMP #2J was printed from the electronic medical record system (EMR) to verify testing by the laboratory on 01/02/2018. The report contained results for the following non-regulated analytes: CO2 and CRP (C- Reactive Protein). 2. February 2018 175 patients were tested by the laboratory. The test report for patient CMP #1F was printed from the EMR to verify testing by the laboratory on 02/06/2018. The report contained results for the following non- regulated analytes: CO2 and CRP (C-Reactive Protein). 3. March 2018 184 patients were tested by the laboratory. The test report for patient CMP #1M was printed from the EMR to verify testing by the laboratory on 03/07/2018. The report contained results for the following non-regulated analytes: CO2 and CRP (C-Reactive Protein). 4. April 2018 134 patients were tested by the laboratory. The test reports for two (2) patients, CMP #3A & #4A, were printed from the EMR to verify testing by the laboratory in April on 04/04/2018. The reports contained results for the following non- regulated analytes: CO2 and CRP (C-Reactive Protein). F. During the exit interview on 06/14/2018 at 11:00 am, the laboratory director indicated he was not aware of this deficient practice. 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 observation, review of manufacturer instructions, laboratory temperature records and interviews with laboratory staff, the laboratory failed to have a system to monitor the temperature of Refrigerator/Freezer #2 used to store chemistry reagents and samples. Findings are: A. Review of 2018 temperature logs for Refrigerator /Freezer #2 on 06/12/2018 (located near the new Theratest reader) revealed no documentation of temperatures since 05/02/2018. B. Review of the manufacturer's instructions for the use of the Radiance Industrial Company Min-Max Time Stamp thermometer located in Refrigerator/Freezer #2 indicated the sensor should be placed away from the refrigerator wall. C. Observation of the contents of Refrigerator /Freezer #2 on 06/12/2018 at 2:56 pm revealed the laboratory had placed the thermometer sensor on the top rack against the refrigerator wall. D. Observation of the contents of the refrigerator on 06/12/2018 at 3:00 pm and 6/13/2018 at 9:15 am revealed the laboratory stored the following reagents/supplies: 2 boxes Theratest EL- RF/3 IgM, IgG, IgA lot 03182753 expiration date 03/20/2019; received on 04/24 /2018. 1 box Theratest El Anti-CCP/2 lot 04182766 expiration date 03/27/2019 received on 04/24/2018. Vitros ECO2, Chloride, Total Bilirubin, Albumin, Alkaline Phosphatase, Alanine Transferase, and Calcium slides. The manufacturer's storage requirement was 2-8 degrees Celsius or colder 17 degrees Celsius. Vitros Immuno -- 3 of 11 -- Wash Vitros ERF (Electrolyte Reference Fluid) The following vials were observed in the door of the refrigerator. The protective seal was removed from each vial but there was no indication when the vials were opened leaving only the stopper. Vitros Cal kit 2 (1) lot 062671 expiration date 05/22/2019 1 vial. Vitros PV II lot A6016 expiration date 10/31/2019 1 vial Vitros Cal Kit 2 (2) lot 02672B1 expiration date 05/22/2019 1 vial Vitros PV I lot W5904 expiration date 06/26/2019 1 vial Vitros Cal Kit 2 (3) lot 02674B1 expiration date 05/22/2019 1 vial Vitros Cal Kit 2 (4) lot 02674B1 expiration date 05/22/2019 1 vial E. Observation of the contents of the freezer on 06 /12/2018 at 3:00 pm and 06/13/2018 at 9:15 am revealed the laboratory stored the following reagents/supplies: Patient serum samples Vitros calibrators for sodium, cholesterol (lot 0839-1348-4943 expiration date 04/01/2019), Creatinine (lot 1507- 1473-5450 expiration date 05/01/2019), Triglyceride, and C-reactive Protein. Vitros CRP PV1 lot L6276 expiration date 11/28/2018, no received date and in a blue bag Vitro CRP PV1 lot L6276 expiration date 11/28/2018, opened on 04/22/2018 at 14:00 pm Vitros calibrator kit lot 0757 expiration date 09/18/2018, received on 03/20/2018 F. During interview on 06/12/2018 at 10:15 am, the laboratory owner stated that Testing Person (TP) #3 had been ill and no patient testing had been performed on the Theratest system. The laboratory owner was not aware that no one was documenting the temperatures and instructed TP #2 to do it. G. During interview on 06/12/2018 at 1: 30 pm TP #1 stated she recorded the temperature of Refrigerator/Freezer #1 on the days she worked but did not monitor Refrigerator/Freezer #2. H. A second review of the Refrigerator/Freezer #2 logs on 06/13/2018 at 5:10 pm revealed no documentation of the freezer or refrigerator temperatures. A third review of the logs on 06/14/18 at 10:43 am revealed documentation of the freezer temperature (-20 degrees Celsius) but none for the refrigerator. 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 review of quality control records and interviews with laboratory personnel and [consulting agency] representative, the laboratory failed to establish acceptable ranges for chemistry quality control materials. Findings are: A. Review of the quality control records indicated the laboratory started patient testing using the Vitros 350 on 12/13/2017. However, there was no evidence of any quality control studies performed for the following lots of quality control materials: Performance Verifier (PV) I lot N5113 expiration date 08/08/2018 PV II lot 3905 expiration date 06 /04/2018 PV I lot W5904 expiration date 06/26/2019 PV II lot A6016 expiration date 10/31/2019 B. Review of quality control printouts in December 2017 and June 2018 -- 4 of 11 -- revealed handwritten documentation by testing personnel of quality control ranges. The preprinted ranges appeared to be normal patient reference ranges. D. During interview on 06/13/2018 at 1:45 pm, Testing Person (TP) #1 stated that she would print copies of the manufacturer's instructions for each lot and use the manufacturer ranges to determine acceptability of the results. She also stated that she did not use the Vitros quality control software in the laboratory she normally works at and could not access the quality control files in the analyzer. E. During interview on 06/13/2018 at 12:00 pm, the former technical consultant stated that neither he nor TP #1 could access the analyzer's quality control files because they had not received training on the software. He further stated "I know everything was done" in reference to the quality control studies. However, he was unable to locate the missing records. F. During interview on 06/14/2018 at 10:07 am, TP #3 also indicated he used the ranges from the manufacturer's instructions to assess the acceptability of the quality control results. G. During interview on 06/14/2018 at 9:00 am, the laboratory owner stated that TP #3 (hired April 2018) had not received training on how to update the quality control ranges on the Vitros 350 and that was why he and TP #1 were writing the ranges on the printouts. H. During interview on 06/14/2018 at 10:17 am, a representative from Vitros stated that it was not the responsibility of the manufacturer to establish quality control ranges for their customers. The representative also stated that the quality control ranges do not print on the report. She confirmed that the ranges printed are the patient reference ranges. I. Review of the manufacturer's instructions indicated that the ranges provided by the manufacturer were "Range of Means" which is defined as a range determined by the means from different analyzers. It is not specific to the analyzer used by the laboratory. The manufacturer stated in the instructions, "Each laboratory should establish its own analyte-specific mean. Each laboratory should evaluate and, if necessary, update the mean after each reagent lot change. The within- lab standard deviation (SD) published on the assay sheet for a given analyte may be used as the laboratory's baseline SD for any slide lot." 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 laboratory history, CMS Personnel Report Form 209, personnel records and interviews with laboratory staff and manufacturer/contractor representative, the laboratory director failed to provide overall management and direction of the laboratory. Findings are: A. Review of laboratory record history indicated the following: On 1/12/12018, the New Mexico Department of Health received a request from [consulting agency] on behalf of the laboratory to update the laboratory director and to add high complexity tests to the test menu. These changes were approved on 04/20/2018 after the [consulting agency] provided documentation showing the laboratory director was no longer directing 5 active non-waived laboratories. B. The laboratory failed to enroll in proficiency testing for regulated analytes performed as part of a Complete Metabolic Profile (CMP) and Basic Metabolic Profile (BMP). See D6015 C. During interview on 06/12/2018 at 11:00 am, the [consulting agency] representative stated the laboratory director also served as the technical supervisor of the laboratory. Review of an unsigned CMS Personnel Report Form 209 faxed by the [consulting agency] representative on 06/12/2018 at 01:19 pm -- 5 of 11 -- indicated no Technical Consultant for the laboratory, only technical supervisor, high complexity. D. Review of laboratory records revealed no documentation that the laboratory director had visited the laboratory in-person. During interview on 06/12 /2018 at 1:45 pm, the laboratory owner (former laboratory director) stated the laboratory director had planned on being present for the inspection. E. Review of the laboratory director's contract (1 page) dated December 21, 2017 revealed no requirement for the director to perform site visits other than during inspections (certification). There was also no documentation of specific duties and responsibilities of the laboratory director in this document. F. Review of laboratory policies revealed the new laboratory director had not reviewed and approved the policies and procedures for moderate complexity testing. See D6031 G. There was no documentation of the highest level of education for 2 (TP #1 and TP#3) of 4 testing personnel, performing non-waived testing. See D6028 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 the review of proficiency test reports, patient records, quality control records, and interviews with laboratory staff, the laboratory director failed to ensure the laboratory was enrolled in proficiency testing for regulated analytes. Findings are: The laboratory failed to enroll in proficiency testing for regulated analytes performed as part of a Complete Metabolic Profile (CMP) and Basic Metabolic Profile (BMP). See D2000 D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on the review of personnel records and interviews with laboratory staff, the laboratory director failed to ensure that documentation of the highest level of education was maintained in the laboratory for 2 (TP #1 and TP #3) of 4 testing personnel. Findings are: A. Review of personnel records revealed no documentation of the education of Testing Person #1, a temporary employee performing moderate complexity testing on the Vitros 350 chemistry analyzer. 1. During interview on 06/12 -- 6 of 11 -- /2018 at 1:30 pm, Testing Person #1 stated the laboratory owner had not requested a copy of her college diploma or transcript since she began working for the laboratory in May 2018. 2. During interview on 06/12/2018 at 1:45 pm, the laboratory owner confirmed that she did not have a copy of a transcript or diploma on file for Testing Person #1. The laboratory owner provided a copy on the following morning, 06/13 /2018. B. Review of personnel records revealed no documentation of the education of TP #3. The laboratory owner contacted TP#3 for this information during the survey on 06/12/2018. A representative from [consulting agency], was able to fax a copy of TP#3's education to the laboratory on the same day. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on the review of laboratory policies, laboratory history and interview with the laboratory director, the laboratory director failed to review and approve the laboratory policies and procedures. Findings are: A. Review of laboratory record history indicated the following: On 1/12/12018, the New Mexico Department of Health received a request from [consulting agency] on behalf of the laboratory to change the laboratory director and to add high complexity tests to the test menu. These changes were approved on 04/20/2018 after the [consulting agency] provided documentation showing the laboratory director was no longer directing 5 active non-waived laboratories. B. Review of laboratory policies for moderate complexity testing revealed no documentation that the laboratory had reviewed and approved the test methods. C. During interview on 06/14/2018 at 2:55 pm, the laboratory director confirmed this finding. 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 facility history records, CMS Personnel Report Form 209, electronic text messages and interviews with laboratory staff and [consulting agency] the laboratory failed to have qualified technical consultant that provided technical oversight of the laboratory. Findings are: A. On 4/27/2018, the former technical consultant notified the New Mexico Department of Health via text message that he was no longer the technical consultant for the laboratory. 1. During interview on 06/12 /2018 at 11:00 am, the [consulting agency] representative stated the laboratory director also served as the technical supervisor of the laboratory. 2. Review of the CMS Personnel Report Form 209 completed by the [consulting agency] representative -- 7 of 11 -- on 06/12/2018 at 01:19 pm indicated no Technical Consultant for the laboratory, only technical supervisor, high complexity. B. The technical consultant failed to establish and maintain documentation of chemistry quality control ranges for the Vitros 350 chemistry analyzer. See D6042 C. Based on the review of facility history records, CMS Personnel Report Form 209, laboratory personnel records and interview with laboratory staff, the technical consultant failed to perform and document competency evaluations for 2 (TP #2 and TP #4) of 4 testing personnel. See D6046 D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on the review of quality control records and interviews with laboratory personnel and [consulting agency] representative, the technical consultant failed to establish and maintain documentation of chemistry quality control ranges for the Vitros 350 chemistry analyzer. Findings are: There was no documentation of laboratory established ranges for chemistry quality control materials. See D5469 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 the review of facility history records, CMS Personnel Report Form 209, laboratory personnel records and interview with laboratory staff, the technical consultant failed to perform and document competency evaluations for 2 (TP #2 and TP #4) of 4 testing personnel. Findings are: A. Review of personnel records revealed no documentation of competency evaluations for 2 (TP #2, #4) #of 4 testing personnel. 1. TP #2 was trained on the Cell Dyne 1700 Hematology analyzer in December 2014. 2. TP #4 had no documentation of training or competency in the personnel file. B. During interview on 06/12/208 at 11:17 am, the laboratory owner stated that TP #2 and #4 were 'still testing." The laboratory owner also stated at 2:42 pm that TP #4 started testing after the primary testing person left the laboratory [at the end of April 2018]. C. Review of historical survey records indicated neither TP #2 nor TP #4 were listed as testing personnel during the survey in August 2016. D6100 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(10) The laboratory director must ensure that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under 493.1489(b)(4). -- 8 of 11 -- This STANDARD is not met as evidenced by: Based on the review of laboratory history and CMS Personnel Report Form 209, the laboratory director failed to ensure the laboratory employed a qualified general supervisor. Findings are: A. Review of the CMS Personnel Report Form 209 signed by the laboratory director on 06/12/2018 indicated the laboratory owner was the general supervisor of the laboratory. B. Review of the delegation of authority dated and signed by the laboratory director on May 23, 2018 indicated the laboratory owner was designated as the General Supervisor for "proficiency testing documents." C. There was no documentation, such as previous hands-on laboratory training /experience, provided during the survey to establish the laboratory owner's qualifications as general supervisor of a high complexity laboratory. D. Review of previous surveys and application packets indicated that prior to 04/20/2018 the laboratory owner's only laboratory experience was as director of a moderately complexity laboratory after completing the 20 CME (Continuing Medical Education) courses for moderate complexity laboratory director in 2013. There was no documentation indicating previous laboratory training or experience. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on the review of laboratory history, CMS Personnel Report Form 209 and interviews with laboratory staff and manufacturer/contractor representative, the laboratory failed to employ a qualified general supervisor. Findings are: Review of the CMS Personnel Report Form 209 and Delegation of Responsibilities revealed the laboratory delegated responsibilities of "proficiency testing documents" to an unqualified individual. See D6143 D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) -- 9 of 11 -- Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on the review of laboratory history and CMS Personnel Report Form 209 and interview with staff, the laboratory failed to employ a qualified general supervisor. Findings are: A. Review of the CMS Personnel Report Form 209 signed by the laboratory director on 06/12/2018 indicated the laboratory owner was the general supervisor of the laboratory. B. Review of the delegation of authority dated and signed by the laboratory director on May 23, 2018 indicated the laboratory owner was designated as the General Supervisor for "proficiency testing documents." C. There was no documentation, such as previous hands-on laboratory training/experience, provided during the survey to establish the laboratory owner's qualifications as general supervisor of a high complexity laboratory. D. Review of previous surveys and application packets indicated that prior to 04/20/2018 the laboratory owner's only laboratory experience was as director of a moderately complexity laboratory after completing the 20 CME (Continuing Medical Education) course for moderate complexity laboratory director in 2013. There was no documentation indicating previous laboratory training or experience. E. During interview on 06/12/2018 at 11: 30 am, the laboratory owner confirmed that she was the general supervisor of the -- 10 of 11 -- laboratory. D9999 The CMP includes the following tests: Glucose - energy source for the body; a steady supply must be available for use, and a relatively constant level of glucose must be maintained in the blood. Calcium - one of the most important minerals in the body; it is essential for the proper functioning of muscles, nerves, and the heart and is required in blood clotting and in the formation of bones. Proteins Albumin - a small protein produced in the liver; the major protein in serum Total Protein - measures albumin as well as all other proteins in serum Electrolytes Sodium - vital to normal body processes, including nerve and muscle function Potassium - vital to cell metabolism and muscle function CO2 (carbon dioxide, bicarbonate) - helps to maintain the body's acid-base balance (pH) Chloride - helps to regulate the amount of fluid in the body and maintain the acid-base balance Kidney Tests BUN (blood urea nitrogen) - waste product filtered out of the blood by the kidneys; conditions that affect the kidney have the potential to affect the amount of urea in the blood. Creatinine - waste product produced in the muscles; it is filtered out of the blood by the kidneys so blood levels are a good indication of how well the kidneys are working. Liver Tests ALP (alkaline phosphatase) - enzyme found in the liver and other tissues, bone; elevated levels of ALP in the blood are most commonly caused by liver disease or bone disorders. ALT (alanine amino transferase, also called SGPT) - enzyme found mostly in the cells of the liver and kidney; a useful test for detecting liver damage AST (aspartate amino transferase, also called SGOT) - enzyme found especially in cells in the heart and liver; also a useful test for detecting liver damage Bilirubin - waste product produced by the liver as it breaks down and recycles aged red blood cells The basic metabolic panel (BMP) is a frequently ordered panel of 8 tests that gives a health practitioner important information about the current status of a person's metabolism, including health of the kidneys, blood glucose level, and electrolyte and acid/base balance. Abnormal results, and especially combinations of abnormal results, can indicate a problem that needs to be addressed. The CMP is made up of 14 tests; the basic metabolic panel (BMP) is a subset of those and has 8 tests. It does not include the liver (ALP, ALT, AST, and bilirubin) and protein (albumin and total protein) tests. A healthcare provider may order a CMP rather than a BMP if he or she wants to get a more complete picture of the status of a person's organ function or to check for specific conditions, such as diabetes or liver or kidney disease. -- 11 of 11 --