Convenientmd Urgent Care - Dover

Summary Statement of Deficiencies 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 record review and staff interview, one of five new testing personnel failed to meet educational qualification requirements for performing moderately complex hematology testing in 2021 and 2022. 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 record review and staff interview, one of five new testing personnel failed to 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 -- meet educational qualification requirements for performing moderately complex hematology testing in 2021 and 2022. Findings include: 1. Review on 11/29/2022 of personnel records revealed one (TP1) of five new testing personnel records failed to include documentation of educational qualifications. Further review revealed TP1 performed complete blood counts starting in January of 2021. 2. Interview on 11/29 /2022 at 9:30 a.m. with the Practice Manager confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and staff interview, the current procedures for hematology testing was not signed and dated for approval by the current laboratory director. Findings include: 1) Review on 9/25, 2018 of all procedures for complete blood cell count (CBC) testing revealed the current laboratory director had not signed and dated them for approval. 2) Interview on 9/25/2018 at 2:30 p.m. with the director of quality assurance and compliance confirmed the CBC procedures were not signed and dated for approval by the current laboratory director. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, results of hematology control materials failed to meet the laboratory's criteria for acceptability prior to reporting patient hematology test results in 2018. Findings include: 1) Review on 9/25/2018 of the laboratory's procedure titled "Hematology Quality Control Guidelines" revised 3/25 /2016, revealed three levels (low, normal and high) of controls for complete blood count (CBC) testing must be performed every day and all three levels must be within 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 -- each level's acceptable ranges. Control levels with results not within acceptable ranges are to be repeated and further troubleshooting needed if still out of range. If, after troubleshooting, control results are still out of acceptable range then the analyzer is to be taken out of service and no patient specimens are to be tested. 2) Review on 9/25 /2018 of CBC control records from 2/23/2018 through 9/25/2018 revealed on 6/23 /2018, 8/25/2018 and 9/10/2018 the high control failed to meet acceptable criteria and was not resolved. 3) Review on 9/25/2018 of patient records from June 2018, August 2018 and September 2018 revealed one patient CBC test had been assayed on 6/23 /2018, one patient CBC test had been assayed on 8/25/2018, and one patient CBC tests had been assayed on 9/10/2018. 4) Interview on 9/25/2018 at 2:30 p.m. with the director of quality assurance and compliance confirmed the above findings. -- 2 of 2 --