Statcare Urgent And Walk-In Medical Care

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on October 21, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, 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 successfully participate in the CMS approved PT program for two out of three consecutive testing events in the Diagnostic Immunology subspecialty for Syphilis Serology test analyte in 2024; the General Immunology subspecialty for the Anti-HIV (Anti-Human Immunodeficiency Virus Antibody), HBsAg (Hepatitis B Surface Antigen), and Anti-HBc (Anti-Hepatitis B Core Antibody) test analytes in 2024; the Routine Chemistry subspecialty for the ALT (Alanine Aminotransferase) (SGPT) (Serum Glutamic-Pyruvic Transaminase), Albumin, Alk Phos (Alkaline Phosphatase), AST (Aspartate Aminotransferase) (SGOT) (Serum Glutamic- Oxaloacetic Transaminase), Bili (Bilirubin), Total, CA (Calcium), Total, CL (Chloride), Cholesterol, Total, Cholesterol, HDL (High-Density Lipoprotein), Creatinine, Glucose (Non-Waived), Iron, Total, LDH (Lactate Dehydrogenase), Total, MG (Magnesium), K (Potassium), NA (Sodium), Total Protein, Trigl (Triglycerides), BUN (Blood Urea Nitrogen), and Uric Acid test analytes in 2024; as well as the Endocrinology subspecialty for the Free TY (Thyroxine), Triiodothyronine, and TSH (Thyroid Stimulating Hormone) test analytes in 2024, resulting in unsuccessful performance. Refer to D2074, D2084, D2096, and D2107. D2074 SYPHILIS SEROLOGY CFR(s): 493.835(e) 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 CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Diagnostic Immunology subspecialty for the Syphilis Serology test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Syphilis Serology Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% 2. A review of the proficiency testing scores from API (2024) confirmed the above findings. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the General Immunology subspecialty for the Anti-HIV, HBsAg, and Anti-HBc test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: General Immunology Subspecialty: 2024 First Event = 0% 2024 Second Event = 0% Anti-HIV Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% HBsAg Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% Anti-HBc Test Analyte: 2024 First Event = 0% 2024 Second Event = 0% 2. A review of the proficiency testing scores from API (2024) confirmed the above findings. -- 2 of 4 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Routine Chemistry subspecialty for the ALT (SGPT), Albumin, Alk Phos, AST (SGOT), Bili, Total, CA, Total, CL, Cholesterol, Total, Cholesterol, HDL, Creatinine, Glucose (Non-Waived), Iron, Total, LDH, Total, MG, K, NA, Total Protein, Trigl, BUN, and Uric Acid test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Routine Chemistry Subspecialty: 2024 Second Event = 0% 2024 Third Event = 0% ALT (SGPT) Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Albumin Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Alk Phos Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% AST (SGOT) Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Bili, Total Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% CA, Total Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% CL Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Cholesterol, Total Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Cholesterol, HDL Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Creatinine Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Glucose (Non-Waived) Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Iron, Total Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% LDH, Total Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% MG Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% K Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% NA Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Total Protein Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Trigl Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% BUN Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% Uric Acid Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% 2. A review of the proficiency testing scores from API (2024) confirmed the above findings. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Endocrinology subspecialty for the Free TY, Triiodothyronine, and TSH test analytes. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Endocrinology Subspecialty: 2024 Second Event = 0% 2024 Third Event = 0% Free TY Test Analyte: 2024 Second -- 3 of 4 -- Event = 0% 2024 Third Event = 0% Triiodothyronine Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% TSH Test Analyte: 2024 Second Event = 0% 2024 Third Event = 0% 2. A review of the proficiency testing scores from API (2024) confirmed the above findings. 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 CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory director (LD) failed to provide overall management and direction of the laboratory services. Refer to D2016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API PT 2024-1, 2024-2, and 2024- 3 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2074, D2084, D2096, and 2107. -- 4 of 4 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the package inserts for the Seksui OSOM Rapid Strep A (RST); Bio-sign Influenza A & B; Henry Schein One Step for Infectious Mononucleosis & Urine Pregnancy; Uri Spec 11 Way analyzer & urine test strips; Chembio HIV ; and the Medline Urine test strips; lack of Quality Control (QC) records; direct observation of test kits in exam room #1; and an interview with the technical consultant (TC), the laboratory failed to follow the manufacturer's QC test kit requirements from June 7, 2021, though the survey date. FINDINGS: 1. The manufacturer's requirements for Seksui OSOM Rapid Strep A (RST); Bio-sign Influenza A & B; Henry Schein One Step for Infectious Mononucleosis; Uri Spec 11 Way analyzer & urine test strips; Chembio HIV ; and the Medline Urine test strips required that QC materials included with the test kits be utilized for each new lot and/or shipment. Also, the Uri Spec 11 Way analyzer & urine test strips and Medline Urine test strips required performance of an external commercial control for each new vial of test strips, prior to use for patient testing. It was noted that the Henry Schein One Step Urine Pregnancy manufacturer's requirements did not require performance of an external control prior to patient testing. a. The laboratory failed to document lot numbers and expiration dates for test kits received and utilized. It was therefore not possible to determine the number of test kits received and utilized from June 7, 2021, through the survey date. b. The surveyor was permitted less than five minutes in exam room one to observe and review test kit inventory due to high patient volume. Also due to high patient volume, the surveyor was unable to visit the three additional exam rooms to observe and review test kit inventory. c. The surveyor was unable to determine the patient 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 -- volume and number of waived test kits utilized as the respective tests were performed and results documented by the Clinical Medical Assistant (CMA) personnel in the Electronic Medical Record (EMR) from June 7, 2021, through the survey date. 2. The TC confirmed on July 28, 2023, at approximately 9:30 A.M. that the providers ordered the tests in the EMR and the CMA personnel performed and documented the results. a. TC confirmed lack of documentation for kit lot numbers and expiration dates. No QC records were available at the time of the survey. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the review of QC and validation records for the Beckman DHX 560 hematology analyzer as well as an interview with the TC, the laboratory failed to retain control material assay sheets for QC controls performed from June 7, 2021, to the prior lot in use. FINDINGS: 1. The laboratory performed three levels of Beckman DHX hematology analyzer controls each day of testing. However, the testing personnel did not retain control material assay sheets for QC controls performed from June 7, 2021, to the prior lot in use. a. It was noted that the laboratory did retain a copy of the control assay sheet for current QC lot in use, #3523150, expiration date 9 /2023. b. It was noted that the laboratory did retain a copy of the calibrator assay sheet for the validation study performed on June 7, 2021, lot # 4921138800. 2. The TC confirmed on July 28, 2023, at approximately 10:00 A.M. that the laboratory testing personnel were not aware that it was required for the control and calibration assay sheets to be retained. 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 the lack of training records and an interview with the TC, the laboratory director (LD) failed to follow the established competency evaluation policy regarding the training, six-month, and annual performance evaluations for CMA personnel. FINDINGS: 1. There was no documentation of training, six-month, and annual competency evaluations for the CMA personnel who performed QC and laboratory testing utilizing the Seksui OSOM Rapid Strep A (RST); Bio-sign Influenza A & B; Henry Schein One Step for Infectious Mononucleosis & Urine Pregnancy; Uri Spec 11 Way analyzer & urine test strips; Chembio HIV ; and Medline Urine test strips. 2. The TC confirmed on July 28, 2023, at approximately 9:30 A.M. that the LD failed to comply with the established competency evaluation policy regarding the training, six- month, and annual performance evaluations for CMA personnel. a. It was not possible to determine the identity of CMA personnel who performed QC and laboratory testing as CMA personnel frequently rotated among other office locations. Refer to D6029. -- 2 of 8 -- D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on reviews of the Quality Assessment (QA ) policy, QA records for 2021, 2022, and 2023, TC's duties and responsibilities, the laboratory's standard operating procedure manual (SOP), and an interview with the TC, the laboratory failed to follow established QA policies, address errors, take remedial action, and resolve errors as they occurred from June 7, 2021, through the survey date: FINDINGS: 1. The laboratory QA policies included instructions for a quarterly review of the following General Laboratory Systems: Preanalytic, Analytic, and Preanalytic Systems. 2. Review of quarterly QA records and documents for 2021, 2022, and 2023 confirmed lack of