Family Care Walk-In Clinic Inc

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 a review of the laboratory procedure manual, a review of patient Complete Blood Count with White Blood Cell Differential (CBC w/Diff) results, a lack of documentation, and a staff interview, the laboratory failed to follow the policy for repeating and documenting the resolution of CBC w/Diff results that were flagged by the instrument for one of one patient reviewed that had flagged results after policy implementation on 04/29/24. The findings include: 1. A review of the laboratory's procedure titled "Emerald Cell Dyn Data Flag Review" revealed the following statements: "4. If the instrument printout show "s" by any result the CBC should be repeated. If the "s" is still present, notify the provider for direction. The sample may need to be sent out for confirmation or redrawn. 5. Document on instrument printout or patient data log Flag review action. ( ex. Specimen repeated, sent out, redrawn, resolved, etc." The policy was approved by the lab director on 04/29/24. 2. A review of the CBC w/Diff instrument printout for patient number four completed on 06/01/24 revealed the White Blood Cell Differential portion of the CBC was flagged with 's.' 3. There was no evidence that action was taken for the flagged White Blood Cell differential results. 4. An interview with the laboratory liaison on 07/29/24 at 1:30 p. m. confirmed the survey findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of patient test reports, lack of documentation, and staff interview, the laboratory failed to verify the accuracy of the Mean Platelet Volume (MPV), calculated Mean Corpuscular Hemoglobin (MCH) and the calculated Mean corpuscular hemoglobin concentration (MCHC) analytes in 2021, 2022, and 2023. The findings include: 1. Review of four patient test reports revealed the instrument printout from the Complete Blood Count instrument was scanned into the patient chart as the final report. The reports included reporting for MPV, MCH and MCHC for four of four patients reviewed from 2021, 2022, and 2023 (patient numbers one, two, three and four). 2. There was no documentation of twice a year verification of accuracy MPV, MCH and MCHC in 2021, 2022, and 2023. 3. Interview with the laboratory liaison on 07/17/23 at 12:15 pm revealed the following: The laboratory participates in proficiency testing to verify the accuracy of the MPV, MCH, and MCHC. The laboratory had not submitted any results to the proficiency testing program for the three analytes in 2021, 2022, and 2023. No other type of study had been conducted to verify the accuracy of the analytes. This confirmed the survey findings. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. 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 -- This STANDARD is not met as evidenced by: Based on review of patient test records, lack of documentation and interview with the laboratory liaison, the laboratory failed to ensure there was a provider order for Complete Blood Count with White Blood Cell Differential (CBC w/Diff) for patient number four performed and reported on 03/14/23 (one of four patients reviewed). The findings include: 1. Review of patient number four revealed reporting for CBC w/Diff on 03/14/23. 2. There was no written or electronic provider order/request for testing for the CBC w/Diff. 3. Interview with the laboratory liaison on 07/17/23 at 2:15 pm confirmed that no provider order was placed for the CBC w/Diff for patient number four performed and reported on 03/14/23. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), review of testing personnel records, patient test records and staff interview, testing personnel number six did not qualify as a testing person for moderate complexity patient testing due to lack of documentation of highest level of education. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the FORM CMS-209, review of testing personnel records, patient complete blood count (CBC) test reports, and staff interview, testing person number six failed to have documentation of the highest level of education on the date of the survey (07/17/23) with initial training/competency to perform patient testing beginning 09/08/20. The findings include: 1. Review of the FORM CMS-209 revealed testing person number six listed as performing moderately complex patient testing. 2. Review of testing personnel records revealed the following: There was no documentation of the highest level of education for testing person number six. Testing person number six was signed off to perform moderately complex CBC patient testing beginning 09/08/20. 3. Review of patient number 5 revealed the CBC instrument -- 2 of 3 -- printout was performed/initialed by testing person number six on 06/13/23. 4. Interview with the laboratory liaison on 07/17/23 at 2 pm confirmed that testing person number six did not have evidence of the highest level of education for performing moderately complex patient testing beginning 09/08/20 until the date of the survey on 07/17/23. -- 3 of 3 --

Summary Statement of Deficiencies 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: Citation number one Based on review of the laboratory's quality assessment policy, the laboratory's 2016, 2017, and 2018 proficiency testing attestation statements, and interview with testing personnel number five, the laboratory failed to follow the policy for proficiency testing when it did not rotate proficiency among testing personnel in 2016, 2017, and 2018. The findings include: 1. Review of the laboratory's quality assessment policy under the section titled "PROFICIENCY TESTING" revealed the following statement: "The surveys should be rotated alternately between all testing personnel with each person performing an entire survey." 2. Review of the laboratory's 2016, 2017, and 2018 proficiency testing attestation statements revealed that testing personnel number five had performed five of the last six surveys (2016 event three, 2017 events one, two, and three, and 2018 event one). 3. Interview with testing personnel number five on July 13, 2018 at 12:45 pm confirmed the laboratory failed to follow policy for rotation of proficiency testing when testing personnel number performed five of the last six surveys in 2016, 2017, and 2018. __________________________________________________________________ Citation number two Based on review of the laboratory's proficiency testing performance evaluation report for 2017 event three for hematology, the laboratory's policy for proficiency testing, the proficiency testing records for 2017 event three for hematology and interview with the laboratory liaison, the laboratory failed to follow policy for investigation of proficiency testing failure for 2017 event three. 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 2 -- findings include: 1. Review of the laboratory's proficiency testing performance evaluation report for 2017 event three for hematology revealed a score of 60% for the platelet analyte. 2. Review of the laboratory's policy for proficiency testing revealed the following statement: "For any proficiency testing module with a score of less than 80% a