Permian Cardiology Inc

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on August 5, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of 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 -- Bioanalysts proficiency testing records, the facility failed to achieve successful performance in two of two consecutive testing events for the analyte Cholesterol, resulting in unsuccessful performance. Refer to D2087 and D2096. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts proficiency testing records, the facility failed to attain a score of at least 80 percent in two of two consecutive testing events for the analyte Cholesterol, resulting in unsuccessful performance. 1st event 2021 - Cholesterol - 40 percent 2nd event 2021 - Cholesterol - 0 percent 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts proficiency testing records, the facility failed to achieve satisfactory performance for Cholesterol in two of two consecutive testing events, resulting in unsuccessful performance. 1st event 2021 - Cholesterol - 40 percent 2nd event 2021 - Cholesterol - 0 percent 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Cholesterol in 2021. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Cholesterol in the specialty of Routine Chemistry for 2 of 2 events in 2021. Refer to D2016. -- 3 of 3 --

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 review of proficiency testing records and interview, the laboratory failed to rotate proficiency testing among all testing personnel for the Complete Blood Count (CBC) in 4 of 4 events. Findings follow. 1. Review of the American Association of Bioanalysts (AAB) proficiency testing records from the 1st, 2nd, and 3rd events of 2020 and the 1st event of 2021, showed all CBC testing was performed by testing personnel #1 (also the Laboratory Director). 2. Interview with the Laboratory Director on June 15, 2021 at 1025 hours in the laboratory acknowledged testing personnel #2 began testing CBCs in March 2019. Interview with the Laboratory Director on June 15, 2021 at 1105 confirmed he does all the proficiency testing and testing personnel #2 has not performed any of the proficiency testing. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions and interview, the laboratory failed to ensure the Sysmex XP-300 used to test the Complete Blood Count 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 -- (CBC) was not adversely affected by vibrations from the mechanical rocker. Findings follow. 1. On June 15, 2021 at 0935 hours in the laboratory the surveyor observed the mechanical rocker sitting on top of the Sysmex XP-300. Upon investigation on June 15, 2021 at 1200 hours could physically feel the instrument vibrating from the mechanical rocker, and the vibrations stopped when the mechanical rocker was moved to the counter next to the analyzer. 2. Review of the Sysmex XP-300 Instructions for Use, revision Feb 2013, under Safety Information, 2.2 Installation stated, "Avoid shock and vibrations." 3. Interview with the Laboratory Director on June 15, 2021 at 1200 hours in the laboratory confirmed he could also feel the vibrations on the analyzer coming from the mechanical rocker and rearranged the counter space to make room for the mechanical rocker next to the analyzer. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of accuracy assessments and interview, the laboratory failed to verify the accuracy of microscopic urinalysis for 2 of 2 years reviewed from 2019, 2020, and to date in 2021. Findings follow. 1. Accuracy assessments for microscopic urinalysis were requested on June 16, 2021 at 0930 hours but not provided. 2. Interview with the Laboratory Director on June 16, 2021 at 0930 hours in the laboratory confirmed accuracy assessments for microscopic urinalysis were not performed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, the laboratory's policies and procedures, Sysmex XP-300 specimen test runs, and interview, the laboratory failed to ensure 1 out of 10 Complete Blood Count (CBC) specimens flagged on the Sysmex XP-300 were repeated or sent out to a reference laboratory. Findings follow. A. Review of the Sysmex XP-300 Instructions for Use, revision Feb 2013, under 8.3 Histogram Flags stated, "Various information can be obtained from the histograms. The XP-300 extracts the characteristics of the histogram and displays them as histogram flags... When the histogram flags are displayed, perform analysis again. If afterwards the flags are still displayed, the sample is considered to correspond to one of the following: Flag Probable Sample cause WL Incomplete lysing of red blood cells, presence of nucleated red blood cells, increase of large platelets, platelet aggregation or agglutination, precipitation of fibrin, etc. Correction 1) Centrifuge sample and replace the plasma with equal volume of saline or CELLPACK and repeat analysis. 2) Check smear, etc. B. Review of the laboratory's policy and procedure titled Abnormal Results stated, "The following are used to handle abnormal results or flags: ...1. WL relative frequency of WBC-LD has exceeded the range: repeat or send -- 2 of 4 -- out 2. WU relative frequency of WBC-UD has exceeded the range: repeat or send out 3. T1 discriminator positive cannot be determined: order manual differential 4. T2 discriminator positive cannot be determined: order manual differential 5. F1 relative frequency of T1 has exceeded the range: smear review 6. F2 relative frequency of T1 /T2 has exceeded the range: smear review 7. F3 relative frequency of T2 has exceeded the range: Path review 8. RL relative frequency of RBC-LD has exceeded the range: Path review 9. RU relative frequency of RBC-UD has exceeded the range: Path review 10. DW distribution width cannot be calculated: repeat or send out..." C. Review of the last 10 flagged runs from June 15 & 16, 2021 on the Sysmex XP-300 screen showed one set of results, sample ID# 184159, with the WL flags for White Blood Cell (WBC) and the WBC differential requiring a repeat or send out. D. Interview with the Laboratory Director on June 16, 2021 at 1120 hours in the laboratory acknowledged the results were reported and the specimen was not repeated or sent to the reference laboratory. 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 review of quality control records and interview, the laboratory failed to document reagent generation and lot number changes on the Vitros 350 used for Chemistry testing and the Vitros ECiQ for Endocrinology and Toxicology testing. Findings follow. 1. Review of the monthly quality control records from March 2021 and May 2021 maintained by the Orchards LIS system revealed no documentation of the reagent generation or lot number changes typically found in the comments section on the day of testing where the change occurred. 2. Interview with the Laboratory Director on June 16, 2021 at 1015 confirmed he does not document the generations and added, "but now I will." KEY: LIS = Laboratory Information System D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of competency evaluations and interview, the technical consultant failed to document the performance of individuals performing Complete Blood Counts (CBC) at least semiannually during the first year the individual tested patient specimens for 1 of 2 testing personnel (the Laboratory Director was also testing personnel #1). Findings follow. 1. Competency evaluations were requested on June 15, 2021 at 1025 hours for testing personnel #2, but not provided. 2. Interview with the Laboratory Director on June 15, 2021 at 1025 hours in the laboratory acknowledged testing personnel #2 began testing CBCs in March 2019 and he had not performed semiannual competency evaluations in the first year she tested specimens. -- 3 of 4 -- D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of competency evaluations and interview, the technical consultant failed to document the performance of individuals performing Complete Blood Counts (CBC) at least annually after the first year the individual tested patient specimens for 1 of 2 testing personnel (the Laboratory Director was also testing personnel #1) for 1 of 1 years. Findings follow. 1. Competency evaluations were requested on June 15, 2021 at 1025 hours for testing personnel #2, but not provided. 2. Interview with the Laboratory Director on June 15, 2021 at 1025 hours in the laboratory acknowledged testing personnel #2 began testing CBCs in March 2019 and he had not performed annual competency evaluations. -- 4 of 4 --

Summary Statement of Deficiencies D0000 As a result of the CLIA recertification inspection, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview of facility personnel, the laboratory failed to document the review for six of six proficiency testing events in Chemistry and Hematology in 2017 and 2018. The findings included: 1. Review of the American Association of Bioanalysts (AAB) proficiency testing records for 2017 and 2018 (three testing events per year) found that the laboratory failed to document the review for six of six (6 of 6) proficiency testing events for Chemistry (3) and Non- Chemistry (3) in 2018. 2. Interview the laboratory director conducted on January 29,2019 at 09:40 AM confirmed that he did not document the review of all Chemistry and Mon-Chemistry testing events in 2018. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 surveyor observations, control instructions for use, review of quality control records, calibration verification records, patient records, quality, and interview with facility personnel, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283. The findings included: Based on surveyor observations, review of laboratory procedures, and interview with facility personnel, the laboratory failed to follow established procedure for spinning urine specimens for urine microscopic analysis at 1800 revolutions per minute (RPM) for 3 of 3 randomly reviewed patient specimens. Refer to D5403. Based on a review of manufacturer's instructions, quality control records, patient test records, and interview of facility personnel, the laboratory failed to ensure that expired quality control material was not used to verify the quality of patient PSA results tested on the Vitros ECI. See D 5415. Based on a review of laboratory procedures, calibration verification records, and interview with facility personnel, the laboratory failed to perform calibration verification procedures at least every 6 months for 3 of 3 analytes (Sodium, Potassium, and Chloride) in 2018. Refer to D5439. Based on review of quality control instructions for use, quality control records, and interview with facility personnel, the laboratory failed to accurately define the acceptability of 2 of 2 lots of control material used to assess test performance on the Vitros 350 chemistry analyzer. Refer to D5469. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)