Bhadresh Nayak Md Plc

Summary Statement of Deficiencies 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 record review and interview with the Technical Consultant, the laboratory failed to follow its policy to assess testing personnel competency for 2 (Testing Personnel #2 and #3) of 3 testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's "Employee Evaluations" policy revealed a section stating, "The Director, Clinical Consultant, Technical Supervisor, Technical Consultant, General Supervisor and Testing Personnel all need an initial evaluation based on Federal Regulatory Responsibilities. At there initial evaluation, a copy of their education must be present to show they have the level of education required to perform the laboratory testing. The Competency Evaluation form, based on Federal Regulatory Responsibilities will be filled-out." 2. A review of the laboratory's "Competency Assessment" form included a section titled "Elements" stating, "1. Direct observation of performance: patient ID, collection, preparation, specimen acceptability, loading instruments. 2. Monitoring results: recording and reporting of results and critical values. 3. Review results: reviewing test results, QC, maintenance and PT records. 4. Maintenance: direct observation of maintenance and function checks. 5. Assessment: test performance of external PT/unknown specimens. 6. Problem Solving: troubleshooting instruments, rejection of samples, QC outliers" 2. A review of the laboratory's personnel competency record revealed the following testing personnel were missing elements of the competency assessment: a. Testing Personnel #2 i. Competency assessment dated 6/6/22 a. Lack of review for reviewing test results, quality control, maintenance, and proficiency testing records. b. Lack of direct observation of maintenance and function checks. c. Lack of test performance 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 -- external proficiency testing/unknown specimens. d. Lack of troubleshooting, rejection of samples, and quality control outliers. ii. Competency assessment dated 12/30/22 a. Lack of direct observation of maintenance and function checks. b. Lack of test performance of external proficiency testing/unknown specimens. b. Testing Personnel #3 i. Competency assessment dated 6/6/22 a. Lack of review for reviewing test results, quality control, maintenance, and proficiency testing records. b. Lack of direct observation of maintenance and function checks. c. Lack of test performance of external proficiency testing/unknown specimens. d. Lack of troubleshooting, rejection of samples, and quality control outliers. ii. Competency assessment dated 12/30/22 a. Lack of review for reviewing test results, quality control, maintenance, and proficiency testing records. b. Lack of test performance of external proficiency testing /unknown specimens. c. Lack of troubleshooting, rejection of samples, and quality control outliers. 3. An interview on 1/5/23 at 1:51 pm with the Technical Consultant confirmed Testing Personnel #2 and #3 had not competency assessments completed according to the laboratory's policy. 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 record review and a lack of documentation, the laboratory failed to ensure testing personnel met the qualification requirements at 493.1423. Findings include: 1. The laboratory failed to ensure testing personnel were qualified. Refer to D6065. **This is a repeat Condition from the 7/19/21 recertification survey** 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 a lack of documentation and record review, the laboratory failed to ensure testing personnel were qualified for 1 (Testing Personnel #3) of 3 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel records revealed a lack of qualification documentation for Testing Personnel #3 listed on the CMS-209 form performing moderate complexity hematology testing. 2. The surveyor requested qualification documentation for -- 2 of 3 -- Testing Personnel #3 showing they were qualified to perform moderate complexity testing on 1/5/23 at 1:51 pm and it was not made available. 3. The laboratory was provided 7 days to supply documentation and it was not made available. **This is a repeat deficiency from the 7/19/21 recertification survey** -- 3 of 3 --

Summary Statement of Deficiencies D0000 . An unannounced revisit survey was completed on October 7, 2021, as a follow-up to the recertification survey performed on July 19, 2021. During the survey, it was determined the laboratory was not in compliance for the following Condition-Level deficiencies: Analytic Systems, D5400 Moderate Complexity Laboratory Director, D6000 D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure the Laboratory Director and analysts signed proficiency testing attestation statements for 2 (2020 Events 1 and 2) of 3 proficiency testing event documents reviewed. Findings include: 1. A review of the laboratory's "Proficiency Testing" policy revealed a section stating, "Copies of the original PT program report forms, printouts and signed attestation forms will be kept for two years." 2. A review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed a lack of signatures from the Laboratory Director and the analysts performing testing on the attestation statement for the following events: a. 2020 Hematology/Coagulation Event 1 b. 2020 Hematology/Coagulation Event 2 3. An interview on 7/19/21 at 4:22 pm with TP1 confirmed the attestations for the proficiency testing events listed above were not signed by the laboratory director or analysts performing testing. D3037 RETENTION REQUIREMENTS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to retain proficiency testing records for 2 (2020 Event 3 and 2019 Event 2) of 6 events reviewed. Findings include: 1. A review of the laboratory's "Proficiency Testing" policy revealed a section stating, "All Proficiency Testing results and attestation forms will be kept for a minimum of two years." 2. A review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed a lack of documentation for the following testing events: a. 2020 Hematology /Coagulation Event 3 b. 2019 Hematology/Coagulation Event 2 3. An interview on 7 /19/21 at 4:22 pm with TP1 confirmed the records for the proficiency testing events listed above were not available. 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: . The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to ensure a procedure for the performance of Complete Blood Count (CBC) testing was available to testing personnel. Refer to D5401. 2. The laboratory failed to perform background counts prior to testing patient samples. Refer to D5431. 3. The laboratory failed to ensure quality control for Complete Blood Count (CBC) testing met established laboratory requirements. Refer to D5469. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure a procedure for the performance of Complete Blood Count (CBC) testing was available to testing personnel for the current test system in use. Findings include: 1. The surveyor performed a tour of the laboratory on 7/19/21 at 1: 13 pm and observed a Sysmex XN-330 hematology analyzer used in CBC testing. 2. The surveyor requested the procedure for the performance of CBC testing using the -- 2 of 9 -- Sysmex XN-330 hematology analyzer on 7/19/21 at 2:45 pm and it was not made available. 3. An interview on 7/19/21 at 4:16 pm with TP1 confirmed the procedure for the performance of CBC testing using the Sysmex XN-330 hematology analyzer was not available. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to perform background counts prior to testing patient samples for 3 (6 /19/20, 2/3/20, and 1/10/20) of 10 patient testing dates reviewed. Findings include: 1. A review of the laboratory's maintenance documentation revealed a lack of documentation of background counts as part of daily function checks for the following dates: a. 06/19/20, 5 patients had testing completed this day. b. 02/03/20, 32 patients had testing completed this day. c. 01/10/20, 38 patients had testing completed this day. 2. A review of the laboratory's "Equipment Maintenance" policy revealed a section stating, "Maintenance for the Sysmex Analyzer will follow the maintenance print-out that comes with the instrument. All daily, weekly, monthly and as needed maintenance will be performed and documented." 3. An interview on 7/19/21 at 4:10 pm with TP1 confirmed the laboratory did not have documentation of background counts for the dates listed above available. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure quality control for Complete Blood Count (CBC) testing met established laboratory requirements for 2 (6/19/20 and 3/30/20) of 11 testing dates reviewed. Findings include: 1. A review of the laboratory's "CBC Quality Control" policy revealed a section stating, "The controls will be run daily before patient's are run. When running CBC's it is acceptable to run patient's when two out of three controls are within there given ranges. If that parameter is out two days in a row, then troubleshooting procedures must be performed, and patients not run until the problem is fixed. Step-by-step instructions can be found in the Sysmex Operations Manual. The above data will be reviewed by the testing personnel each day of testing -- 3 of 9 -- and reviewed by the Technical Consultant monthly." 2. A review of the laboratory's quality control data revealed the following dates when quality control was not within limits: a. 3/30/20 two of three quality control levels were tested, and both levels failed for the analyte Mean Corpuscular Volume (MCV). The patient testing log showed two patients had testing performed that day. b. 6/19/20 no records of quality control performance were available. The patient testing log showed five patients had testing performed that day. 3. An interview on 7/19/21 at 3:38 pm with TP1 confirmed quality control was not in range for MCV on 3/30/20. 4. An interview on 7/19/21 at 4: 03 pm with TP1 confirmed the laboratory did not have documentation of quality control performed on 6/19/20 available. 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 record review and interview with Testing Personnel #1 (TP1), the laboratory failed to verify criteria for acceptability of control materials prior to use for 17 (March 2020 to July 2021) of 24 months reviewed. Findings include: 1. A review of the laboratory's records revealed the most recent verification of criteria for acceptability of control materials was performed on 2/28/20. 2. The surveyor requested the verification for acceptability of control materials for the lot numbers since 2/28/20 on 7/19/21 at 3:30 pm and they were not made available. 3. An interview on 7/19/21 at 3:40 pm with TP1 confirmed the laboratory did not have documentation of verifying the criteria of acceptability of control materials available. 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 record review and interviews, the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The Laboratory Director failed to ensure quality assessment programs were maintained. Refer to D6021. 2. The Laboratory Director failed to ensure all testing personnel received the appropriate training for the performance of -- 4 of 9 -- Complete Blood Count (CBC) testing prior to performing patient testing. Refer to D6029. 3. The Laboratory Director failed to identify the need for remedial training when laboratory personnel did not meet competency requirements. Refer to D6030 A. 4. The Laboratory Director failed to ensure competency assessment procedures were followed and performed at the intervals specified by the laboratory. Refer to D6030 B. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the Laboratory Director failed to ensure quality assessment programs were maintained for 15 (March 2020 to June 2021) of 24 months reviewed. Findings include: 1. A review of the laboratory's "Quality Assurance Program" policy revealed a section stating, "Our laboratory has an ongoing quality assurance program to evaluate the quality of service we provide. The Laboratory Director oversees the implementation of our plan and helps identify and correct problems as they occur. We periodically review our quality assurance plan to minimize the possibility of recurrence of identified problems." 2. A review of the laboratory's quality assessment documentation revealed the last documented assessment was performed on 3/6/20. 3. An interview on 7/19/21 at 4:18 pm with TP1 confirmed the laboratory did not have documented quality assessments for dates after 3/6/20 available. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: . Based on record review and interviews, the Laboratory Director failed to ensure all testing personnel received the appropriate training for the performance of Complete Blood Count (CBC) testing prior to performing patient testing for 3 (Testing Personnel #2-#4) of 4 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's "Personnel Competency Policy/Procedure" revealed a section stating, "Initial training indicating that the testing personnel have demonstrated testing, read the procedure manual, performs quality control, recognize test failures, and follow reporting procedures must be documented. The director is -- 5 of 9 -- responsible for ensuring that the testing personnel have received the appropriate training for the type of testing being performed." 2. An interview on 7/19/21 at 2:55 pm with the Office Manager revealed the following testing personnel had been hired in the last two years: a. Testing Personnel #2 hire date of 10/12/20 b. Testing Personnel #3 hire date of 6/6/20 c. Testing Personnel #4 hire date of 5/6/21 3. A review of the laboratory's personnel records revealed a lack of training documentation for Testing Personnel #2-#4. 4. An interview on 7/19/21 at 2:55 pm with Testing Personnel #1 confirmed documented training for Testing Personnel #2-#4 was not available. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: . A. Based on record review and interview with Testing Personnel #1 (TP1), the Laboratory Director failed to identify the need for remedial training when laboratory personnel did not meet competency requirements for 4 (Testing Personnel #1-#4) 4 of testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's competency assessment documentation revealed Testing Personnel #1-#4 had the "No" boxes checked, showing personnel did not meet competency requirements, during the assessments performed on 7/19/21 for the performance of instrument maintenance and function checks, assessment of test performance through external proficiency testing, and the assessment of problem-solving skills. 2. A review of the competency assessment for Testing Personnel #2 performed on 9/23/19 had the "No" boxes checked showing a failure to demonstrate competency for the performance of instrument maintenance and function checks, assessment of test performance through external proficiency testing, and the assessment of problem- solving skills. 3. A review of the laboratory's competency assessment documentation showed additional "No" boxes checked for Testing Personnel #1-#4 competency assessments performed on 7/19/21, and the competency assessment for Testing Personnel #2 performed on 9/23/19 in the following categories: a. A category titled "Reagents" containing, "Storage", "Stability", "Preparation", and "Disposal". b. A category titled "Quality Control" containing, "Materials", "Frequency", "Documentation", and "

Summary Statement of Deficiencies 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the analyte: Platelets. Findings include: Review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the analyte: Platelets. Refer to D2123 and D2130. D2123 HEMATOLOGY CFR(s): 493.851(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to participate in proficiency testing for the analyte: Platelets for 1 (3rd event of 2020) of 2 testing events reviewed. Findings include: 1. A record review of the American Proficiency Institute (API) proficiency testing records revealed final reports were not submitted to API for the 3rd event of 2020. 2. A record review of the CMS database revealed the laboratory failed to participate for one out of two consecutive PT events for the analyte: Platelets. Platelets PT Event Score 2nd event 2020 60% 3rd event 2020 0% 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte: Platelets for 2 (2nd and 3rd events of 2020) of 2 consecutive testing events reviewed. Findings include: 1. A record review of the American Proficiency Institute (API) proficiency testing records revealed final reports were not submitted to API for the 3rd event of 2020. 2. A record review of the CMS database revealed the laboratory failed to acheive satisfactory performance for two consecutive PT events: Platelets PT Event Score 2nd event 2020 60% 3rd event 2020 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 record review of the CMS database and the American Association of Bioanalysis (AAB) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the specialty of chemistry. Findings include: Review of the CMS database and the AAB proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the specialty of chemistry. Refer to D2089 and D2097. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 record review of the CMS database and the American Association of Bioanalysis (AAB) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing event for the specialty of chemistry for 2 (2020 events 2 and 3) of 2 consecutive testing events resulting in a score of 0. Findings include: 1. A review of the CMS database and the AAB proficiency testing reports revealed unsatisfactory performance, resulting in a score of 0 for two consecutive proficiency testing events for routine chemistry: Routine Chemistry PT event Score 2nd event 2020 0% 3rd event 2020 0% D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for 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 record review of the CMS database and the American Association of Bioanalysis (AAB) proficiency testing reports, it was determined the laboratory failed to achieve an overall testing event score of satisfactory performance in routine chemistry for 2 (2020 events 2 and 3) of 2 consecutive testing events. Findings include: 1. A review of the CMS database and the AAB proficiency testing reports revealed unsatisfactory performance for two consecutive proficiency testing events for routine chemistry: Routine Chemistry PT event Score 2nd event 2020 0% 3rd event 2020 0% -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Technical Supervisor #1 (TC1), the laboratory testing personnel failed to wear gloves while performing patient testing for 2 of 2 surveyor observations. Findings include: 1. An observation by the surveyor on 6/27/19 at 11:45 am exposed one testing personnel performing a CBC (Complete Blood Count) in the laboratory without wearing gloves. 2. An observation by the surveyor on 6/27/19 at 11:47 am exposed a second testing personnel performing a CBC in the the laboratory without wearing gloves. 3. A review of the "Laboratory Safety Policies" revealed a section titled, "Universal Precautions." It states, "gloves should be worn when touching laboratory specimens and tissues." 4. An interview on 6/27/19 at 12:13 pm with TC1 confirmed testing personnel had not been wearing gloves while performing CBC testing in the laboratory. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the 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 -- laboratory failed to retain calibration verification data for 1 (5/14/19) of 4 calibration verification testing events. Findings include: 1. A record review of chemistry calibration verification data revealed a lack of documentation for the 5/14/19 testing event. The laboratory did not provide this information when requested by the surveyor on 6/27/19 at 9:48 am. The following chemistry assays lacked documentation: a. Alkaline Phosphatase b. Alanine Transaminase c. Aspartate Transaminase d. Total Cholesterol e. Creatinine f. High Density Lipoprotein g. Glucose h. Triglycerides i. Low Density Lipoprotein j. Blood Urea Nitrogen k. Hemoglobin A1C 2. An interview on 6/27/19 at 9:55 am with TC1 confirmed calibration verification data for the 5/14 /19 testing event was not retained by the laboratory. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #3 (TP3), the laboratory failed to retain copies of original CBC (Complete Blood Count) reports for 5 (patients #0913932, #0620845, #0313302, #0717266, and #0506672) of 5 patient charts audited. Findings include: 1. An audit of patient charts revealed the following patients had "CBC w/ diff, platelet count, in house" ordered: a. #0913932 b. #0620845 c. #0313302 d. #0717266 e. #0506672 2. An observation on 6/27/19 at 11:45 am was made by the surveyor of testing personnel performing a CBC and obtaining a printed copy from the analyzer. 3. When requested on 6/27/19 at 11:59 am, the laboratory did not produce the original analyzer printed reports for the patients #0913932, #0620845, #0313302, #0717266, and #0506672. 4. An interview on 6/27/19 at 11:59 am with TP3 revealed the original CBC report printouts from the analyzer were not available. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Technical Consultant #1 (TC1), the laboratory failed to label patient specimens with date of collection for 34 of 34 specimens observed. Findings include: 1. An observation by the surveyor on 6/27 /19 at 12:13 pm exposed a rack of 34 specimens near the centrifuge without a date of collection on the 34 specimens present. 2. A review of the laboratory's "Specimen Rejection Criteria" policy revealed a section stating, "specimen must be properly labeled with patient name and date." 3. An interview on 6/27/19 at 12:13 pm with TC1 confirmed 34 specimens in the rack near the centrifuge had not been labeled with the date. -- 2 of 4 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation, and interview with Technical Consultant #1 (TC1), the laboratory failed to label chemistry reagents (glucose and cholesterol buffers) with preparation and expiration dates for the current lots in use. Findings include: 1. On 6 /27/19 at 9:02 am, during a tour of the laboratory, the surveyor observed the glucose and cholesterol buffers in use. There was a lack of documentation on the secondary reagent bottles with the preparation and expiration dates when the reagents were put into use. 3. An interview on 6/27/19 at 9:02 am with TC1 confirmed preparation and expiration dates were missing from secondary reagent bottles for glucose and cholesterol buffers. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to perform and document annual centrifuge function checks for 2 (June 2017- June 2018 and June 2018- June 2019) of 2 years. Findings include: 1. A review of the "Equipment Maintenance" procedure revealed "the centrifuge rpm's will be checked once per year with a digital tachometer." 2. A record review revealed a lack of documentation of annual RPM (rotations per minute)checks for the Horizon model 643E Centrifuge and the Horizon miniE centrifuge. Documentation was not made available when requested on 6/27/19 at 11:26 am. 3. An interview on 6/27/19 at 11:26 am with the TC confirmed the laboratory had not performed and documented annual centrifuge function checks for 2 of 2 years. D5781

Summary Statement of Deficiencies 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 CMS database and review of the American Association of Bioanalysts (AAB) graded proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the hematology analyte: white blood cell (WBC). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory hematology performance for the following analyte: WBC for two consecutive testing events. Refer to D2130. D2130 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 review of the CMS database and review of the American Association of Bioanalysts graded proficiency testing reports, the laboratory failed to achieve satisfactory performance for the hematology analyte white blood cell (WBC) in two consecutive testing events. Findings include: Unsatisfactory performance for two consecutive PT events constituting unsuccessful performance for the hematology analyte WBC: White Blood Cell PT Event Score 2nd event 2018 60% 1st event 2018 60% -- 2 of 2 --