Muhammed I Khokar Md

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted at Muhammed I Khokar MD on July 19, 2022, by the West Virginia Office of Laboratory Services. The laboratory proficiency testing evaluations with the Medical Laboratory Evaluation (MLE) were reviewed and evaluated with the laboratory CMS 0153D Unsuccessful PT Report for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are cited below. 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 Medical Laboratory Evaluation (MLE) proficiency testing 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 -- (PT) records and the CLIA 155D Individual Laboratory Profile report for Muhammed I Khokar MD, the laboratory failed to successfully participate in a program appoved by CMS for 6 analytes in the specialty of Hematology (#0760) for 2 of 2 events in 2022. Findings: 1. Hematology (#0760) 1st event 2022- 0% Failure to Participate: 0% scores for analytes Cell ID/WBC Diff (#0765), RBC (#0775), HCT (#0785), HGB (#0795), WBC (#0805), Platelets (#0815) 2. Hematology (#0760) 2nd event 2022- 0% Failure to Participate: 0% scores for analytes Cell ID/WBC Diff (#0765), RBC (#0775), HCT (#0785), HGB (#0795), WBC (#0805), Platelets (#0815) D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) evaluations and the CASPER 155D report, the laboratory failed to participate in 2 of 2 PT events for 2022 in Hematology. Findings: 1. Hematology (#0760) 2022 Event 1- 0% 2022 Event 2 - 0% D2131 HEMATOLOGY CFR(s): 493.851(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 review of the CASPER 155D Report and the Medical Laboratory Evaluation (MLE) proficiency testing (PT) evaluations the laboratory failed to achieve a satisfactory performance for the speciality of Hematology in 2 of 2 consecutive 2022 testing events. Findings: 1. Review of CASPER 155D Report identified the following for the specialty #0760 Hematology: 1st event 2022- 0% 2nd event 2022- 0% 2. Review of MLE PT evaluations for the laboratory confirmed the unsuccessful performance of 0% for Hematology in 2 of 2 testing events of 2022. 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 review of the laboratory proficiency testing (PT) records from Medical Laboratory Evaluation (MLE) evaluations and CMS reports, the laboratory director failed to: 1) ensure successful participation for the specialty of Hematology for the regulated analytes on the laboratory test menu. Refer to D2016 2) ensure and monitor -- 2 of 3 -- process to return results to the PT Provider before the deadline. Refer to D2127 and D2131. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from CMS and Medical Laboratory Evaluation (MLE), the laboratory director failed to assure compliance with the regulation requiring successful participation in PT for the analytes Cell ID /WBC Diff, RBC, HCT, HGB, WBC, and Platelets in 2 of 2 testing events in 2022. Findings: 1. Hematology (#0760) 1st event 2022- 0% Failure to Participate: 0% scores for analytes Cell ID/WBC Diff (#0765), RBC (#0775), HCT (#0785), HGB (#0795), WBC (#0805), Platelets (#0815) 2. Hematology (#0760) 2nd event 2022- 0% Failure to Participate: 0% scores for analytes Cell ID/WBC Diff (#0765), RBC (#0775), HCT (#0785), HGB (#0795), WBC (#0805), Platelets (#0815) -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Muhammed I Khokar MD on March 29, 2022, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. 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 the laboratory failed to document a passing background check on the Act Diff 2 Hematology analyzer for 25 of 33 days reviewed (January 2022 thru the date of survey). Findings: 1. Review of background checks from January 2022 thru date of survey identified 25 of 33 days with a failing parameter documented and patient testing conducted. 2. An interview with the laboratory director, on 3/29/22 at approximately 10:45 AM, confirmed the findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on policies and procedures (P&P), record review, and interview the laboratory failed to ensure the Hematology quality control (QC) met the established criteria of acceptability for 22 of 33 days reviewed on the Act Diff 2. Findings: 1. Review of P&P identified a "Quality Control Procedure" allowing patient specimens to be ran if two of the three QC levels are within the acceptable ranges. 2. Review of QC records from January 2022 thru date of survey identified 22 of 33 days that unacceptable QC values were accepted for two or more levels and patient testing conducted. 2. An interview with the laboratory director, 3/29/22 at approximately 11:30 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Muhammad I Khokar MD on February 27, 2020 by the West Virginia Office of Laboratory Services. The facility was surveyed to assess compliance with regulations under the Federal Clinical Laboratory Improvement Amendments (CLIA) 42 CFR 493. Specific deficiencies cited are explained below. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and an interview with the laboratory director, the testing personnel (TP) and/or laboratory director (LD) failed to sign the attestation statements for 2 of 3 MLE PT testing events in 2019. Findings: 1. A review of MLE PT records for 2019 identified 2 of 3 testing events that lacked the attestation signatures of the TP and/or LD. a. The 2019 MLE-M2 testing event had an attestation statement that lacked the signature of the TP and the LD. b. The 2019 MLE-M3 testing event had an attestation statement that was signed by the LD, but lacked the signature of the TP. 2. During an interview with the LD, on 2/27/2020 at approximately 12:00, the LD stated that attestation forms had not been handled properly for the 2 testing events of 2019, but would ensure all parties signed in the future. D2128 HEMATOLOGY CFR(s): 493.851(e) 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 -- (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 a review of the laboratory Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and an interview with the laboratory director (LD), the laboratory failed to perform and document remedial action for unacceptable analyte scores in 2 of 3 testing events of 2019. Findings: 1. A review of 2019 MLE PT records identified 2 unsuccessful analyte scores for the MLE-M2 testing event. a. Specimen HD-7 had a result of 0.6 for monocytes and the acceptable range was 7.0- 16.4. b. Specimen HD-7 had a result of 1.5 for granulocytes and the acceptable range was 25.6-34.9. 2. A review of 2019 MLE PT records identified 2 unsuccessful analyte scores for the MLE-M3 testing event. a. Specimen HD-13 had a result of 0.4 for monocytes and the acceptable range was 2.5-7.8. b. Specimen HD-13 had a result of 4.8 for granulocytes and the acceptable range was 60.3-68.7. 3. It was observed thru record review of the 2019 MLE-M2 and MLE-M3 PT events by the state surveyor that no documentation of remedial action regarding the unacceptable analyte scores could be located. 4. During an interview with the LD, on 2/27/2020 at approximately 12:00, the LD stated there was no documented investigation of the unacceptable analyte scores for the MLE-M2 and MLE-M3 PT events. 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 a review of testing personnel 1 (TP1) competency records, TP1 employee files, laboratory job descriptions, and an interview with the technical consultant (TC), the laboratory failed to establish and follow written policies and procedures (P&P) assessing testing personnel competency and problem solving for each testing platform. Findings: 1. A review of TP1 competency records identified 1 documented competency for TP1 dated 02/12/2020. The laboratory TP competency form did not include evidence of problem solving. 2. A review of TP1 employee files identified the hire date of TP1 documented as 4/24/2019. 3. A review of "Laboratory Policy & Procedure Subject: Job Descriptions" stated that employee competency was to be assessed semi-annually the first year of testing and annually thereafter by the Technical Consultant (TC). 4. During an interview with the TC, on 2/27/2020 at approximately 12:00 PM, the TC stated that the 2/12/2020 competency on TP1 was the only documented competency performed on TP1. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) -- 2 of 8 -- 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 a review of laboratory written policies and procedures (P & P), calibration records for the ACTDiff2 analyzer, and an interview with testing personnel 1 (TP1) and the laboratory director (LD), the laboratory failed to perform and document calibration on the hematology ACTDiff2 analyzer in accordance with established laboratory processes. Findings: 1. A review of written P&Ps in the M.I Khokar MD Laboratory Policy and Procedure manual identified the QA Program P&P as stating "The Beckman Coulter ActDiff2 is to be calibrated every 6 months and calibrator is set on auto delivery. Calibration will be performed as needed if technical failure noted and if indicated." 2. A review of calibration records for the ActDiff2 from January 2018 thru February 2020 identiifed calibration as performed and documented on the following dates: 01/05/2018, 08/31/2018, 02/01/2019, and 02/24/2020. There is no documentation of calibration being performed at the required 6 month interval after the 02/01/2019 calibration. 3. During an interview with TP1, on 02/27/2020 at approximately 10:00 AM, the state inspector asked if the calibration records reviewed were the only calibrations performed on the ACTDiff2 analyzer and TP1 stated that the calibration done 02/24/2020 was the only one she performed and documented. TP was hired 04/24/2019. 4. During an interview with the LD, on 02/27/2020 at approximately 12:00 PM, the LD stated that the calibrators for the ACTDiff2 analyzer were on autodelivery and he was not aware the calibrations had not been performed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for -- 3 of 8 -- verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of laboratory calibration records, patient testing logs, and quality control (QC) records for the ACTDiff2 hematology analyzer and an interview with testing personnel 1 (TP1), the laboratory failed to satisfy the calibration verification requirement, and did not meet the criteria for hematology analyzer exception. Findings: 1. A review of calibration records for the ACTDiff2 from January 2018 thru February 2020 identified a failure to perform and document calibration every 6 months as required by the manufacturer instructions and the written policy and procedures. Refer to D5437. 2. A review of QC records and laboratory patient testing logs from December 2019 and February 2020, identified 17 of 28 days of patient testing that had no documentation of at least 2 levels of QC being performed daily to meet the automated hematology analyzer exception for calibration verification. Refer to D5441. a. During 10 of 13 days of patient testing in February 2020 only 1 level of hematology QC was documented and performed. b. During 7 of 15 days of patient testing in December 2019 no hematology QC was documented and performed. 3. During an interview with TP1, on 2/27/2020 at approximately 10:20 AM, the TP1 stated that QC records and calibration records reviewed by the state surveyor were the only documentation of QC and calibrations performed on the ACTDiff2 hematology analyzer. 4. During an interview with the LD, on 2/27/2020 at approximatley 12:30, the LD stated the calibration materials were on auto delivery and that QC is reviewed. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon a review of written laboratory policies and procedures (P&P), quality control (QC) records for the ACTDiff2 hematology analyzer, patient testing logs, and an interview with the testing personnel (TP1) and laboratory director (LD), the laboratory failed to perform and document QC at the specified and required frequency. Findings: 1. A review of the quality assessment (QA) policy in the laboratory P&P manual stated 3 levels of QC were to be ran and evaluated for acceptability before patient testing was to begin. 2. A review of QC records and laboratory patient testing logs from December 2019 and February 2020, identified 17 of 28 days of patient testing that had no documentation of at least 2 levels of QC being performed. a. During 10 of 13 days of patient testing in February 2020 only 1 level of hematology QC was documented and performed. b. During 7 of 15 days of patient testing in December 2019 no hematology QC was documented and performed. -- 4 of 8 -- 3. During an interview with TP1, on 2/27/2020 at approximately 11:00 AM, the TP1 stated there were days she only ran one level of QC due to "patients waiting to be seen by the doctor in the morning" and not having a working printer. 4. During an interview with the LD, on 02/27/2020 at approximately 12:30 PM, the LD stated he reviewed QC and will make sure all 3 levels are ran and verified for acceptability each day before patient testing. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon a review of written laboratory policies and procedures (P&P), quality control (QC) records for the ACTDiff2 hematology analyzer, patient testing logs, and an interview with the testing personnel (TP1) and laboratory director (LD), the laboratory failed to perform and document QC at the specified and required frequency. Findings: 1. A review of the quality assessment (QA) policy in the laboratory written P&P stated 3 levels of QC were to be ran and evaluated for acceptability before patient testing was to begin. 2. A review of QC records and laboratory patient testing logs from December 2019 and February 2020, identified 17 of 28 days of patient testing that had no documentation of at least 2 levels of QC being performed. a. During 10 of 13 days of patient testing in February 2020 only 1 level of hematology QC was documented and performed. b. During 7 of 15 days of patient testing in December 2019 no hematology QC was documented and performed. 3. During an interview with TP1, on 2/27/2020 at approximately 11:00 AM, the TP1 stated there were days she only ran one level of QC due to "patients waiting to be seen by the doctor in the morning" and not having a working printer. 4. During an interview with the LD, on 02/27/2020 at approximately 12:30 PM, the LD stated he reviewed QC and will make sure all 3 levels are ran and verified for acceptability each day before patient testing. 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 review of laboratory written policy and procedures (P&P), quality control (QC) records, calibration records, proficiency testing (PT) records, and testing personnel (TP) competency records, the laboratory director (LD) failed to provide overall management and direction of the laboratory. Findings: 1. A review of laboratory QC records for the ACTDiff2 hematology analyzer identified 17 of 28 days of patient testing that had no documentation of at least 2 levels of QC being performed and evaluated for acceptability before patient testing began. Refer to -- 5 of 8 -- D5441 and D5447. 2. A review of 2018, 2019, and 2020 calibration records for the ACTDiff2 hematology analyzer identified a failure to perform and document calibration every 6 months as required by the manufacturer and the written policies and procedures. Refer to D5437 and D5439. 3. A review of 2019 Medical Laboratory Evaluation (MLE) PT records identified a failure to investigate and document any remedial action for unacceptable analyte scores for 2 of 3 Hematology testing events. Refer to D2128. 4. A review of 2019 MLE PT records identified a failure of both the LD and testing personnel to sign attestation statements for 2 of 3 testing events. Refer to D2009. 5. A review of TP competency records identified a failure to perform and document TP competency in adherence to established P&P of the laboratory. Refer to D5209. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a review of personnel files of testing personnel (TP), patient testing logs, quality control (QC) records, and calibration records,the laboratory director (LD) failed to provide effective administration of the laboratory, which includes documented assessment of employee competency and intitial training, ensuring accurate test performance with adherence to QC requirements, and compliance with the regulations. Findings: 1. Refer to D6000. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 a proficiency testing desk review for the office of Dr. Muhammed Khokar, the laboratory failed to successfully participate in a program approved by CMS for the Hematology analyte of cell identification/WBC differential for the 2nd Event 2018 and 3rd Event 2018. Findings: Medical Laboratory Evaluation (MLE) testing results: 2018 2nd testing event (MLE-M2) Cell Identification/WBC Differential: 0% 2018 3rd testing event (MLE-M3) Cell Identification/WBC Differential: 0% D2130 HEMATOLOGY CFR(s): 493.851(f) 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 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 Medical Laboratory Evaluation (MLE) records and the CLIA 155 Individual Laboratory Profile, the laboratory failed to achieve satisfactory performance in proficiency testing for analyte Cell Identification/WBC Differential in two consecutive testing events. Findings: Medical Laboratory Evaluation (MLE) testing results: 2018 2nd testing event (MLE-M2) Cell Identification/WBC Differential: 0% 2018 3rd testing event (MLE-M3) Cell Identification/WBC Differential: 0% 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 proficiency testing desk review for the office of Dr. Muhammed Khokar, the laboratory director failed to ensure successful participation in a program approved by Centers for Medicare and Medicaid Services (CMS) for the analyte of cell identification/WBC differential (2nd event 2018 and 3rd Event 2018). Findings: Medical Laboratory Evaluation (MLE) testing results: 2018 2nd testing event (MLE- M2) Cell Identification/WBC Differential: 0% 2018 3rd testing event (MLE-M3) Cell Identification/WBC Differential: 0% D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Medical Laboratory Evaluation (MLE) records and the CLIA 155 Individual Laboratory Profile, the laboratory director failed to ensure compliance with the regulation requiring successful participation in PT testing (D2016) for the analyte of cell identification/WBC differential (2nd event 2018 and 3rd Event 2018). Findings: Medical Laboratory Evaluation (MLE) testing results: 2018 2nd testing event (MLE-M2): Cell Identification/WBC Differential: 0% 2018 3rd testing event (MLE-M3): Cell Identification/WBC Differential: 0% -- 2 of 2 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of the laboratory's patient test requisition and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure that the test requisition solicited the date and time of collection for 4 of 4 patient test records reviewed. Record review was from 2/19/18 to 3/1/18. The findings include: 1. Review of the laboratory's patient test requisitions identified a lack of date and time of collection for 4 of 4 test requisitions. 2. On 3/20/18 at approximately 1:00 PM, TP1 confirmed the findings. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time 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 -- of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, Coulter AcT Diff analyzer's patient test printouts and interview with Testing Personnel #1 (TP1), the laboratory did not maintain a record system that included the identity of the personnel who performed the Complete Blood Cell (CBC) counts on the Coulter AcT diff Analyzer for 4 of 4 patient test printouts reviewed. Record review was from 2/19/18 to 3/1/18. The findings include: 1. Review of the laboratory's policy and procedure manual identified a procedure, "Hematology Standard Operating Procedure", which stated "Reporting Results: All results are reviewed and initialed prior to reporting on the chart." 2. Review of 4 of 4 AcT Diff Analyzer instrument printouts for 2/19/18 to 3 /1/18 revealed the laboratory was not identifying the testing personnel who performed the CBC counts on the AcT Diff hematology analyzer. 3. On 3/20/18 at approximately 1:00 PM, TP1 confirmed the findings. -- 2 of 2 --