Ng Medical Group, Pc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 6, 2019. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory 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 -- performance in two consecutive events (1st & 2nd Events of 2019), resulting in the first unsuccessful occurrence for Hematology # 760. Findings include: Refer to D2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (1st & 2nd Events of 2019), resulting in the first unsuccessful occurrence for Hematology # 760. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology # 0760 on Event 1 and Event 2 of 2019 with a score of 0%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed Hematology on Events 1 & 2 of 2019 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (1st & 2nd Events of 2019), resulting in the first unsuccessful occurrence for Hematology # 760. Findings include: Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory -- 2 of 3 -- performance in two consecutive events (1st & 2nd Events of 2019), resulting in the first unsuccessful occurrence for Hematology # 760. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology # 0760 on Event 1 and Event 2 of 2019 with a score of 0%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed Hematology on Events 1 & 2 of 2019 resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 11, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: 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 review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures for assessing testing personnel (TP) competency. Findings include: 1. SOP document review revealed the laboratory failed to establish and follow written policies and procedures for performing TO competencies. 2. An interview with Staff #3 (CMS 209) in the breakroom on 12/11/18 at approximately 12:30 p.m. confirmed there were no competency policies and procedures in the laboratory SOP. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to perform and document maintenance as defined by the manufacturer as required. Findings include: 1. Observation during the laboratory tour on 12/11/18 at approximately 11:30 a.m. revealed the Labcorp centrifuge was last calibrated on 4/9/2015. 2. An interview with the Labcorp representative in the laboratory on 12/11/18 at approximately 11:40 a.m. confirmed the Labcorp centrifuge had not be calibrated with the required frequency since 4/9/2015. 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 testing personnel (TP) document review and staff interview, the laboratory director/technical consultant(LD/TC) failed to provide technical oversight of the laboratory as required. Findings include: Refer to D6054 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 testing personnel (TP) document review and staff interview, the laboratory director/ technical consultant (LD/TC) failed to perform a six-month competency as required. Findings include: 1. TP document review revealed the TC failed to perform a 2018 six-competency for Staff #7 (CMS 209). 2. An interview with Staff #3 (CMS 209) on 12/11/18 in the breakroom at approximately 12:30 p.m. confirmed the LD/TC did not perform the aforementioned TP competency in 2018. 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 testing personnel (TP) document review and staff interview, the technical consultant (TC) failed to perform an annual competency on all TP as required. Findings include: 1. TP document review revealed the TC failed to perform an annual competency on Staff #3 (CMS 209) for 2017 and 2018 thus far. 2. An interview on 12 -- 2 of 3 -- /11/18 with Staff #3 (CMS 209) in the breakroom at approximately 12:30 p.m. confirmed the TC did not perform an annual competency for the aforementioned TP in 2017 and 2018 thus far. This is a repeat deficiency. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the laboratory failed to employ a sufficient number of individuals who meet the qualifications to perform laboratory testing as required. Findings include: Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official 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); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the laboratory failed to employ qualified TP due to lack of education documentation. Findings include: 1. TP document review revealed the laboratory failed to provide a high school diploma for Staff #7 (CMS 209) at the time of survey. 2. An interview with Staff #3 (CMS 209) in the breakroom on 12/11/18 at approximately 12:30 p.m. confirmed the aforementioned lack of education documentation. This is a repeat deficiency. -- 3 of 3 --