Mid America Clinical Laboratories

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 document review and interview, the laboratory failed to achieve a passing score of 80% for Cell Identification or WBC (white blood cell) Differential for two consecutive events in 2018 (Events 2&3). Refer to D-2130. 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. 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 -- This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to achieve a passing score of 80% for Cell Identification or WBC (white blood cell) Differential for two consecutive events in 2018 (Events 2&3). Findings Include: 1) Review of CMS-155 report indicated the following failing scores for Cell Identification or WBC Differential: a) Event 2/2018=24% b) Event 3/2018=8% 2) In interview on 12/07/18 at 1:22 pm, SP-1 confirmed the above failing scores for Cell Identification or WBC Differential. -- 2 of 2 --

Summary Statement of Deficiencies 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: A) Based on record review and interview, the laboratory failed to retain quality control records for 9 of 11 patients (PT) 1-8 and PT-11 reviewed for January 2017 to April in 2018 for Hematology testing (CBC-Complete Blood Count). Findings Include: 1) Policy titled, "Quality Control Out-of-Range Procedure," dated 5/7/18, and signed by the laboratory director indicated the following, "...QUALITY CONTROLS The specified controls are run each day that testing is performed..." 2) Medical record review indicated the following patients had CBC testing performed in 2017 and January to April of 2018; Patients (PT) 1-8 and PT-11, without quality control records being retained: PT-1=9/14/17 PT-2=10/24/17 PT-3=11/7/17 PT-4=12/13/17 PT-5=1/1 /718 PT-6=2/13/18 PT-7=3/14/18 PT-8=4/24/18 PT-11=5/24/17 3) In interview on 7 /24/18 at 1:40 pm, SP-1 (staff person #1) confirmed quality control records had not been maintained for January 2017 to April in 2018. B) Based on record review and interview, the laboratory failed to document and retain maintenance records for one of one Hematology analyzer reviewed for January 2017 to April in 2018 for CBC- Complete Blood Count testing. Findings Include: 1) Policy titled, "HEMATOLOGY COMPLETE BLOOD COUNT (CBC)," dated 6/29/18, and signed by the laboratory director indicated the following, "...MAINTENANCE 1. Daily...e. Record on Maintenance Log..." 2) Medical record review indicated the following patients had CBC testing performed in 2017 and January to April of 2018; Patients (PT) 1-8 and PT-11, without maintenance procedures being documented and retained: PT-1=9/14 /17 PT-2=10/24/17 PT-3=11/7/17 PT-4=12/13/17 PT-5=1/1/718 PT-6=2/13/18 PT- 7=3/14/18 PT-8=4/24/18 PT-11=5/24/17 3) In interview on 7/24/18 at 1:42 pm, SP-1 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 -- (staff person #1) confirmed maintenance records had not been documented and retained for January 2017 and to April in 2018. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain a copy(s) of the attestation statement, instrument printouts, and director review for one of three proficiency testing events reviewed (Event 2/2017) for Hematology testing (CBC- Complete Blood Count). Findings Include: 1) Review of Event 2/2017 proficiency testing documentation, indicated none was available for the attestation statement, instrument printouts, and director review. 2) Medical record review indicated Patient #11 (PT-11) had CBC testing performed during Event 2/2017 on 5/24/17. 3) In interview on 7/24/18 at 2:33pm, SP-1 (staff person #1) confirmed the laboratory failed to maintain a copy(s) of the attestation statement, instrument printouts, and director review for Event 2/2017. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain documents for a QA (Quality Assurance) Program for one of one specialty reviewed, Hematology, in 2017. Findings Include: 1) Review of the Quality Assurance (QA) program for general laboratory systems indicated none was available for the year, 2017. 2) In interview on 7/24/18 at 3:02 pm, SP-1 (staff person #1) confirmed there was no QA program for the year, 2017. -- 2 of 2 --