Union Medical Urgent Care Pllc/Williamsburg

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 surveyor's review of the manufacturer's package inserts for OSOM Genzyme Infectious Mononucleosis, Meridian Bioscience Immuno Card Influenza A&B, Woodview Rapid Strep A , Arkay Assure Platinum Glucometer and Siemens Clinitek Status & Multistix 10SG urine dipsticks and interview with the practice manager, the laboratory failed to follow the manufacturer's requirements for performing external controls with each new kit for above tests. FINDINGS: 1. The surveyor reviewed the manufacturer's package insert and the quality control (QC ) requirements for the test kits at survey. 2. The practice manager confirmed on June 5, 2019 at approximately 2:30 PM, that the laboratory failed to follow the manufacturer's requirements for external controls and perform the required QC for the following test kits and tests: OSOM Genzyme Infectious Mononucleosis requires positive and negative controls be tested with each new kit. Meridian Bioscience Immuno Card Influenza A&B requires positive and negative controls be tested with each new kit. Woodview Rapid Strep A requires positive and negative controls be tested with each new kit. Arkay Assure Platinum Glucometer & test strips requires normal and high level controls be tested with each new vial of test strips. Siemens Clinitek Status & Multistix 10SG urine dipsticks requires normal and high level controls be tested with each new vial of test strips. 3. The laboratory failed to record the lot numbers and expiration dates for the above test kits and vials of test strips. The surveyor was unable to determine the number of lots used for patient testing from March 1, 2019 through June 5, 2019. 4. Approximately 100 patients were tested and reported for the same time period. 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 -- D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of proficiency testing (PT) records and an interview with the practice manager, the laboratory failed to enroll in Health and Human Services (HHS) approved PT program for the sub-specialty Bacteriology/throat cultures. FINDINGS: 1. The practice manager confirmed on June 5, 2019 at approximately 2:30 PM that the laboratory did not enroll in an HHS approved PT program for Bacteriology/throat cultures. 2. The surveyor used the annual total test volume recorded on the Center for Medicaid & Medicare Services (CMS) 116 form to estimate how many patient specimens were tested. For Bacteriology/throat culture approximately 100 patients were tested from March 1, 2019 through June 5, 2019. 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 lack of bacteriology QC records and an interview with the practice manager, the laboratory failed to have QC records for 0.04 bacitracin disc and Select Strep Agar (SSA) used for Bacteriology/throat cultures. FINDINGS: 1. The practice manager confirmed on June 5, 2019 at approximately 2:45 PM, that the laboratory did not perform QC for each lot and/or shipment of 0.04 bacitracin discs and Select Strep Agar (SSA) used for Bacteriology/throat culture from March 1, 2019 through June 5, 2019. 3. The surveyor used the annual total test volume recorded on the Center for Medicaid & Medicare Services (CMS) 116 form to estimate how many patient specimens were tested. For Bacteriology/throat culture approximately 100 patients were tested from March 1, 2019 through June 5, 2019. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: -- 2 of 8 -- Based on lack of procedures for Bacteriology testing, no QC records and an interview with the practice manager, the laboratory failed to met the requirements for Bacteriology/throat culture testing. Refer to: D3131, D5209, D5291, D5403, D5471 and D5477. 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 competency assessment policies and procedures and an interview with the practice manager, the laboratory failed to establish written policies and procedures to assess the competency of the laboratory testing personnel that perform Bacteriology/throat cultures testing. FINDINGS: The practice manager confirmed on June 5, 2019 at approximately 2:00 PM, that the laboratory did not establish a written competency evaluation policy to include the six criteria to be followed for competency assessment: 1. Observation of routine test performance for waived and Bacteriology testing. 2. Monitor the recording & reporting of test results. 3. Review of test results, worksheets, quality control records, proficiency test results and preventative maintenance records. 4. Direct observation of performance of instrument maintenance. 5. Assessment of test performance through proficiency testing samples or blind testing. 6. Assessment of problem solving skills. 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 the lack of Quality Assessment (QA) policies and procedures and an interview with the practice manager, the laboratory failed to establish written policies and procedures to assess, monitor and identify problems and issues in the general laboratory system for Bacteriology/throat cultures testing. FINDINGS: The laboratory testing person confirmed on June 5, 2019 at approximately 2:45 PM, the laboratory did not establish a written QA policy for general laboratory systems to include the following: 1. patient confidentiality/test requisition/test report 2. patient identification & specimen integrity 3. compliant investigation 4. communication/internal & external 5. personnel competency assessment 6. proficiency testing/comparison testing 7. policy & procedure manual 8. quality control 9. routine laboratory maintenance 10. test records (worksheets, printouts, etc.) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 3 of 8 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)