Medstar Med Grp Southern Md Llc/ Cancer Rec Ctr

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on competency testing record review and interview with the technical consultant (TC), the TC did not document the competency review on all testing personnel (TP) in the laboratory. Findings: 1. The laboratory currently has 8 testing personnel listed on the "Laboratory Personnel Report (CLIA)" (CMS-209). 2. Each TP has a sheet where the TC records the dates that each TP was "Shown or Demonstrated," "Date Successfully Performed," "6 month review," and "Annual review." 3. A review of competency assessment records from 2020 to 2022 showed that for 4 of 8 TP, competency assessment records were present for the TP's initial training and 6 month competency assessments. There was no competency assessment documentation present at the time of the survey for annual reviews performed on the dates recorded on each TP's sheet. 4. During an interview on 07/21/2022 at 12:15 PM, the TC stated that the competency assessments had been performed, but confirmed that documentation of these assessments was not present at the time of the survey. 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 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 laboratory procedure manual and record review and interview with the technical consultant (TC), the laboratory did not ensure that the procedure for evaluating internal hematology quality control (QC) accurately reflected the current practice in the laboratory. Findings: 1. The procedure, "Internal CBC Quality Control Using Patient Specimen" states that, "a patient's sample that has been tested in the early morning hours" "will be tested in the late afternoon. The values will be compared with the morning values and the differences must fall within the stated ranges below." 2. During an interview at 1:00 PM, the testing person stated that they "look at" the results of the two runs to determine if the results are acceptable, but that they don't refer to the acceptable ranges listed in the procedure manual; and 3. The laboratory has documentation that the runs were performed, but there is no indication whether the morning and afternoon runs were acceptable. 4. During an interview on 2 /14/20 at 2:00 PM, the TC confirmed that testing personnel were not following the approved procedure for evaluating internal hematology QC for acceptability. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) 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 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant (TC), the laboratory did not ensure that hematology controls were labeled with the date that they expire. Findings: 1. During a tour of the laboratory at 11:00 AM, it was observed that the opened and in use "Sysmex XN-L Check" hematology controls in the laboratory refrigerator were labeled with the date that they were put in to use but were not labeled with the expiration date. 2. During an interview on 2/14/20 at 11:00 AM, the TC stated that the controls expire 15 days after opening and confirmed that the in-use hematology controls were not labeled with the expiration date. -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of laboratory (lab) procedures and interview with the technical consultant on the day of survey, the lab did not have safety data sheets for chemicals used for lab testing and cleaning. The surveyor requested the safety data sheets, but they were not available in the lab. 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 record review and interview with laboratory (lab) staff, the lab written policies for conducting competency checks conducted on testing personnel did not include instructions for documenting each process used to determine competency. Findings: 1. The written procedure did not include instructions to review and observe the recording of patient testing records, preventive maintenance records and quality control records to ensure they are conducted and reported in an accurate and reliable 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 -- manner; 2. The lab did not have instructions to conduct and document staff competency based on practical skills used to problem solve; and 3. this was confirmed during interview with the technical consultant on the day of survey. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory (lab) staff, the hematology labs written quality control policies did not have instructions to monitor quality control results to detect immediate failures as indicated by control results (same analyte) not within range (between 2 and 3 standard deviations) on consecutive days of testing. Findings: 1. The written hematology quality control policy did not instruct staff that quality control failures for an analyte (between 2 and 3 standard deviations) occurring on consecutive days of testing, can indicate a quality control failure and needs investigation and