Rps Shergill, Md Pllc

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of Hematology records, lack of documentation, and TP1 interview, the laboratory failed to ensure personnel competency assessments were performed (refer to D5209), failed to ensure proficiency test (PT) results were reviewed and evaluated (refer to D5211), failed to provide a written procedure for performing Complete Blood Counts (CBCs) (refer to D5401), failed to maintain CBC reagents at an acceptable refrigerated temperature (refer to D5413), and failed to ensure the CBC Quality Controls (QC) was regularly reviewed to detect immediate errors or monitored over time (refer to D5441). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results. 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 the policy entitled 'Quality Assurance Program', lack of documentation, and an interview with TP1, the laboratory failed to follow written 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 -- policies and procedures to assess employee competency for performing complete blood counts (CBCs) on the Sysmex pocH-100i hematology analyzer for one of one testing persons. Findings include: 1. The policy entitled 'Quality Assurance Program' effective 2023, states: a. All new personnel will be properly oriented to the laboratory as according to the Orientation Check List b. All personnel will have a competency evaluation done within the first 30 days of hire, six months after hire, again at the one year date and yearly thereafter. c. Training for all new procedures or new methodologies will be make available to personnel as needed. 2. A request was made to review the orientation check list, training records, and competency assessments for non-waived hematology testing for TP1, hired in June 2024, and documentation could not be provided. 3. On an on-site interview on 8/13/2025 at 11:30 AM, TP1 confirmed there were no documented orientation, training, or competency records. 4. The laboratory reports performing 60 CBCs annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing records, lack of documentation, and an interview with TP1, the laboratory failed to review and evaluate the Proficiency Testing (PT) results obtained from four of four American Proficiency Institute (API) PT events for complete blood counts (CBCs) on the Sysmex pocH-100i hematology analyzer in 2024 and 2025. Findings include: 1. A request was made to review the API PT hematology results and corresponding laboratory PT evaluation and review from the 2024-1, 2024-2, 2024-3, and 2025-1 PT events, and documentation could not be provided. 2. On an on-site interview on 8/13/2025 at 11:30 AM, TP1 confirmed there was no documentation of the PT results, evaluation, or review. 3. The laboratory reports performing 60 CBCs annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 a lack of documentation and an interview with TP 1, the laboratory failed to have a written procedure for performing complete blood counts (CBCs) on the Sysmex pocH-100i hematology analyzer. Findings include: 1. A request was made to review the procedure for CBCs on the Sysmex pocH-100i hematology analyzer, and documentation could not be provided. 2. On an on-site interview on 8/13/2025 at 11: 30 AM, TP1 confirmed there was no documented procedure for performing CBCs on the Sysmex pocH-100i hematology analyzer. 3. The laboratory reports performing 60 CBCs annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 2 of 3 -- CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of temperature logs for June and August 2025, and an interview with TP1, the laboratory failed to initiate

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 an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the testing person, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analytes Cell Identification, Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin, (HGB), White Blood Cell Count (WBC), Platelets, and the specialty Hematology in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. Refer to D2130 and D2131. 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 -- 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 an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the testing person, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analytes Cell Identification, Red Blood Cells (RBC), Hematocrit (HCT), Hemoglobin, (HGB), White Blood Cell Count (WBC), and Platelets in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2023 and 2024 API PT records revealed analyte scores of less than eighty percent for the following Hematology events: a. Cell Identification: 2023-3 = 0%, 2024-1 = 0% b. RBC: 2023-3 = 0%, 2024-1 = 0% c. HCT: 2023-3 = 0%, 2024-1 = 0% d. HGB: 2023-3 = 0%, 2024-1 = 0% e. WBC Count: 2023-3 = 0%, 2024-1 = 0% f. Platelets: 2023-3 = 0%, 2024-1 = 0% 2. In a phone interview with the testing person on 5/9/24 at 11:45 AM, it was confirmed that the laboratory was unsuccessful in the PT events listed above. 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 an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the testing person, it was determined the laboratory failed to attain a score of at least eighty (80) percent of overall testing event score for the specialty Hematology in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2023 and 2024 API PT records revealed Hematology scores of less than eighty percent for the following events: a. 2023-3 Hematology = 0% b. 2024-1 Hematology = 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 lack of documentation and an interview with the laboratory director, the laboratory failed to have a written procedure for Complete Blood Count (CBC) on the Sysmex pocH-100i analyzer. Findings include: 1. A request was made to review the procedure for the Complete Blood Count (CBC) on the Sysmex pocH-100 I analyzer and documentation could not be provided. 2. An interview conducted on September 29, 2023 at approximately 11:30 AM with the laboratory director confirmed the laboratory did not have written procedure for CBCs. 3. The laboratory reports performing approximately 300 CBCs annually. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 a lack of documentation and an interview with the laboratory director, the laboratory failed to verify the performance specifications for accuracy, precision, reportable range, and reference range for the Complete Blood Count (CBC) on the Sysmex pocH-100i analyzer received in January 2023 prior to reporting patient test results. Findings include: 1. A request was made to review the verification of performance specifications for the Complete Blood Count (CBC) on the Sysmex pocH-100i analyzer received in January 2023, and documentation could not be provided. 2. The laboratory started testing patients on March 10, 2023. 3. An interview conducted on September 29, 2023 at approximately 11:30 AM with the laboratory director confirmed the laboratory did not have the verification studies for accuracy, precision, reportable range and reference range for the CBCs on the Sysmex pocH-100i. 4. The laboratory reports performing approximately 300 CBCs annually. -- 2 of 2 --