Union Medical Care Pllc

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 a surveyor's review of the manufacturer's package inserts for the Genzyme OSOM Rapid Strep A, Alere Influenza A&B and an interview with the laboratory testing person, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls for waived testing from January 10, 2019 through June 5, 2019. FINDINGS: 1. The laboratory testing person confirmed on June 5, 2019 at approximately 9:30 AM, the surveyor's findings that the required external positive and negative quality controls (QC) were not performed for the Rapid Strep A and for the Influenza A&B kits with each new kit opened from January 10, 2019 through the June 5, 2019. 2. The testing person confirmed the laboratory performs the QC and records the following: testing person initials, date performed and acceptable on each test kit box. However, once the kit is used it is discarded, therefore, there is no record that QC was performed. a. The laboratory did not have a patient log sheet for tests performed, the test order and result are recorded directly into the patient's electronic medical record (EMR). b. The surveyor could not determine the number of test kits used and patients tested from January 10, 2019 through June 5, 2019 since the kit boxes were discarded. c. The current OSOM Rapid Strep A test kit in use (lot # 191127 exp. 8/31/20) had the testing person's initials, and date performed. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 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 laboratory testing person, the laboratory failed to enroll in Health and Human Services (HHS) approved PT program for the specialty Bacteriology/throat cultures and Hematology automated Complete Blood Count (CBC). FINDINGS: 1. The laboratory testing person confirmed on June 5, 2019 at approximately 10:00 AM that the laboratory did not enroll in an approved PT program for Bacteriology/throat cultures and for Hematology automated CBC. 2. The laboratory did not have a patient log sheet for CBC and throat cultures performed, the test order and results are recorded directly into the EMR. The surveyor used the annual total test volume recorded on the Center for Medicaid & Medicare Services (CMS) 116 form as follows: a. Bacteriology/throat culture 50 patients tested from January 10, 2019 through June 5, 2019. b. Hematology /CBC 20 patients tested from January 20, 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 surveyor's review of the laboratory's available quality control records and an interview with the laboratory testing person, the laboratory failed to have complete quality control (QC) records available for the Diatron 3CP Abacus hematology analyzer (S/N #380085); the lot numbers for the 0.04 bacitracin disc and Select Strep Agar (SSA) used for Bacteriology/throat cultures. FINDINGS: 1. The laboratory testing person confirmed on June 5, 2019 at approximately 9:45 AM, that the manufacturer's control assay information sheets for hematology control material and QC records for lot to lot verification were not available from January 17, 2019 through June 5, 2019. a. The laboratory did not retain copies of previous control material assay sheets from January 17, 2019 through June 5, 2019. The surveyor could not determine the number of control material lots used for Hematology/CBC testing. 2. The surveyor could not determine the number of 0.04 bacitracin disc and Select Strep Agar (SSA) used for Bacteriology/throat culture. 3. The surveyor used the annual total test volume recorded on the CMS 116 form as follows: a. Bacteriology /throat culture 50 patients tested from January 10, 2019 through June 5, 2019. b. Hematology/CBC 20 patients tested from January 20, 2019 through June 5, 2019. D5002 BACTERIOLOGY CFR(s): 493.1201 -- 2 of 10 -- 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: Based on lack of procedures for Bacteriology testing, no QC records and an interview with the laboratory testing person, the laboratory failed to met the requirements for Bacteriology/throat culture testing. Refer to: D5209, D5291 D5403, D5471 and D5477. 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 the lack of procedures for Hematology, no QC records and an interview with the laboratory testing person, the laboratory failed to have met the requirements for Hematology testing. Refer to: D5209, D5291, D5403, D5407, D5421 and D5441 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 policies and procedures and an interview with the laboratory testing person, the laboratory failed to establish written policies and procedures to assess the competency of the laboratory testing personnel that perform both Bacteriology/throat cultures and Hematology/CBC testing. FINDINGS: The laboratory testing person confirmed on June 5, 2019 at approximately 10:00 AM, 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, Hematology 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 and function checks. 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 -- 3 of 10 -- 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 laboratory testing person, the laboratory failed to establish written policies and procedures to assess, monitor and identify problems and issues in the general laboratory system for both Bacteriology/throat cultures and Hematology testing. FINDINGS: The laboratory testing person confirmed on June 5, 2019 at approximately 10:00 AM, 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 & calibration 9. routine laboratory maintenance & equipment function checks 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 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)