Urgent Care For Children-Trussville

Summary Statement of Deficiencies 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 the CMS CASPER reports (#153 and #155) and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to successfully participate in Hematology testing for two of three consecutive events (Events #2 and #3 of 2021). The failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored twenty percent (20%) for Event #2 2021 and four percent (4%) for Event #3 2021 for White Blood Cell Differential (Hematology). 2. A review of the API proficiency testing revealed the laboratory scored twenty percent (20%) for White Blood Cell Differential 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 -- [Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils all scored twenty percent (20%)] for 2021 Event #2 and four percent (4%) for White Blood Cell Differential [Basophils, Lymphocytes, Monocytes and Neutrophils all scored zero percent (0%) and Eosinophils scored twenty percent (20%)] for 2021 Event #3. The Eosinophils for 2021 Event #3 scored twenty percent (20%) due to one of the five samples not being graded due to no consensus (the result the laboratory provided did not fall within the expected results). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the CMS CASPER reports (#153 and #155) and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to attain a score of at least eighty percent (80%) White Blood Cell Differential (Hematology) in 2021, Events #2 and # 3. This failure resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored twenty percent (20%) for Event #2 2021 and four percent (4%) for Event #3 2021 for White Blood Cell Differential (Hematology). 2. A review of the API proficiency testing revealed the laboratory scored twenty percent (20%) for White Blood Cell Differential [Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils all scored twenty percent (20%)] for 2021 Event #2 and four percent (4%) for White Blood Cell Differential [Basophils, Lymphocytes, Monocytes and Neutrophils all scored zero percent (0%) and Eosinophils scored twenty percent (20%)] for 2021 Event #3. The Eosinophils for 2021 Event #3 scored twenty percent (20%) due to one of the five samples not being graded due to no consensus (the result the laboratory provided did not fall within the expected results). -- 2 of 2 --

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the technical consultant and laboratory director, the surveyor determined the laboratory director failed to ensure the testing personnel of moderate complexity testing presented with the appropriate educational credentials, prior to performing patient testing (Complete Blood Count testing). This affected 2 of 5 Testing Personnel (TP). The findings include: 1. A review of the personnel records revealed no educational credentials for the following two testing personnel: a) TP #2 (Date of Hire, 9/2020) was listed on the CMS form 209 (Personnel Form) and trained on 10/7/2020 on the OLO (Hematology analyzer). However, the personnel did not have educational documentation or verification on file. b) TP #5 (Date of Hire, 7/2020) was listed on the CMS form 209 as personnel who performs moderate complexity testing (No documentation of training was provided). The laboratory did not provide any documentation of educational credentials. 2. During an interview on 4/20/2021 at 11:25 AM, the technical consultant and laboratory director confirmed the above noted findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the technical consultant and the laboratory director, the surveyor determined the technical consultant failed to semi-annually assess the competency of two testing personnel, who perform Complete Blood Count (CBC) testing (moderate complexity). This affected 2 of 5 testing personnel (TP). The findings include: 1. A review of the personnel records revealed the following personnel without documentation the technical consultant performed a semiannual competency assessment: a) TP #3 (Date of Hire, 9/7/2020; training 9/30/2020); no semiannual competency assessment. b) TP #5 (Date of Hire, 7/2020; no training documentation); no semiannual competency assessment. 2. In an interview on 4/20/2021 at 11:25 AM, the laboratory director stated although all of the personnel, listed on the Personnel Form (CMS 209), were trained on the OLO (Hematology analyzer), only TP #2 and #3 usually used the OLO. The laboratory director also stated any of the personnel could potentially need to run the instrument. The technical consultant (technical consultant since July 2020) confirmed she had not done the semiannual competency assessments for the above noted testing personnel. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the technical consultant and the laboratory director, the surveyor determined the technical consultant failed to assess the competency of Testing Personal (TP) #4 on an annual basis. TP #4 was listed on the Laboratory Personnel Form (CMS #209) as testing personnel who perform moderate complexity testing (Complete Blood Count testing). This affected 1 of 5 testing personnel. The findings include: 1. TP #4, testing personnel who previously qualified at the last survey on January 31, 2019, had documentation of initial training dated 9/10/2018, and an initial competency assessment, dated 10/10/2018. The technical consultant did not perform annual competency assessments in 2019 or 2020 for TP #4. 2. In an interview on 4/20/2021 at 11:25 AM, the technical consultant (technical consultant since July 2020) confirmed the laboratory consultant staff had not done the annual competency assessments for 2019 and 2020 for the above noted testing personnel. The laboratory director was present for the interview. -- 2 of 2 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the laboratory specimen collection policy (faxed to the CLIA office), a review of quality assurance (QA) records, and interviews with Testing Personnel (TP) #1, the facility failed to ensure procedures in use assured positive patient identification. The findings include: 1. During the initial tour of the laboratory and a review of pre-analytic processes with TP #1 on 1/31/2019 at approximately 9:35 AM, the surveyor determined the current practices in use have the potential for misidentification of the patient's test results. TP #1 explained the current procedure of performing a CBC (Complete Blood Count) as follows: (A) Testing Personnel entered the patient's date of birth (as the specimen identifier) in the Hematology analyzer; (B) proceeded to the patient's room to collect the specimen, labeling it with the DOB only, and (C) then returned to the laboratory to run the test; the patient's name was hand- written on the CBC after the results printed out. The laboratory failed to address the potential for misidentification if a second testing personnel also had to perform a CBC before the first testing personnel returned. 2. The laboratory further failed to ensure procedures for pre-analytic processes were available to the testing personnel and the surveyor during the survey. [The surveyor requested these procedures; however, the "Specimen Collection Policy", which specified two unique identifiers should be utilized, was not available for review until it was faxed to the CLIA office on 1/31 /2019 at 4:45 PM.] 3. Refer to D5203. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of the laboratory specimen collection policy (faxed to the CLIA office), a review of quality assurance (QA) records, and interviews with Testing Personnel (TP) #1, the facility failed to ensure procedures in use assured positive patient identification. The findings include: 1. During the entrance interview and tour of the laboratory on 1/31/2019 at approximately 9:35 AM, TP #1 was asked about the pre-analytic processes. TP #1 explained tests are ordered in the e-Clinical electronic medical record, and testing personnel entered the date of birth (DOB) as the patient's identifying number in the Hematology analyzer. Then the testing personnel go to the patient's room, collect the sample, and return to the laboratory to run the CBC (Complete Blood Count). 2. As the interview continued on 1/31/2019, the surveyor asked about the potential for misidentification if a second testing personnel also had to perform a CBC before the first testing personnel returned. [A review of the Form CMS-209 listed eight moderate complexity testing personnel.] TP #1 answered she did not think this could happen because the laboratory does not perform many CBC's yet. When asked how the CBC samples are labeled, TP #1 stated they used the DOB. 3. A review of the "Policy and Procedure" manual revealed information about the waived procedures only. The laboratory also used the Operator's Guide for the Beckman Coulter AcT diff 2 analyzer as their Hematology procedure manual. During an interview on 1/31/2019 at 1:10 PM, the surveyor asked TP #1 if the laboratory had a specimen collection procedure. TP #1 stated, yes, because all testing personnel received a copy of the policy during training. However, the facility did not provide a copy of the policy during the survey. 4. A review of quality assurance (QA) documentation revealed an occurrence where the laboratory's QA reviewer discovered three days in September 2019 when testing personnel failed to enter the correct DOB for the individual patients. The same DOB was used for all patients during the three day period. There was no documentation of the