Summary:
Summary Statement of Deficiencies D3017 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(a) Arrangement for services. The facility must have a transfusion service agreement reviewed and approved by the responsible party(ies) that govern the procurement, transfer, and availability of blood and blood products. This STANDARD is not met as evidenced by: Based on review and interview, the facility failed to have a transfusion service agreement reviewed and approved by the responsible party(ies) that govern the procurement, transfer, and availability of blood and blood products. Findings include: 1. In a telephone interview at 1:30 PM on 09/10/18, the laboratory director indicated that, occasionally, the laboratory would transport patients while they were being transfused with blood products. 2. There were no written procedures that described the following information: a. Procedures to show which transfusion services were provided directly by this facility and which were provided through agreement. b. Policies for the proper storage and transportation of blood or blood products. c. Procedures to identify possible transfusion reactions. d. Procedures to notify the laboratory of a possible transfusion reactions. 3. In an interview at 1:30 PM on 09/10 /18, the laboratory director confirmed the surveyor's findings. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- Based on review and interview, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299 as specified. 1. Competency assessments that were performed on personnel were not based on the responsibilities of the position the individual held in the laboratory. Testing personnel and technical consultants received the same competency assessments. See D5209 2. The laboratory failed to have a written or electronic test request when it tested patients' specimens and reported test results. See D5301 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 review of Laboratory Personnel Report (CLIA) (Form CMS 209), laboratory policies and procedures manuals, personnel records, and interview with the laboratory director; the laboratory failed to establish and follow written policies and procedure to assess employee and consultant competency. Findings: 1. Review of Form CMS 209 revealed that there were a total 3 Technical Consultants listed on Form CMS 209. 2. Review of laboratory policies and procedures revealed that there were no procedures that described the laboratory's process for assessing the competency of its technical consultants. 3. Review of personnel records revealed that competency assessments were performed on all testing personnel, which included the 3 technical consultants. However, there were no competency assessments, based on the duties and responsibilities of the position of technical consultant, performed on 3 of 3 technical consultants. 4. At 11:30 AM on 08/29/18, the laboratory director confirmed the surveyor's 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. This STANDARD is not met as evidenced by: Based on review of laboratory's procedures manuals, laboratory records, and interview with the laboratory director, the laboratory failed to have a written or electronic request for patient testing from an authorized person. Findings include: 1. Review of laboratory procedures manuals revealed that there were no procedures that described the laboratory's process for how tests were ordered. 2. Review of laboratory records revealed that the patient transport team used a "patient transport" form as it requisition for documenting ordered tests. No test order was available for review. In a section titled, "Transport Medical Director Chart Triggers for review," under a section titled, "POINT OF CARE TESTING ON ADVOCATE TRANSPORT MACHINE," it instructs you to circle either "GLUCOMETER" or " ISTAT". These are not tests. There was no documentation to show that blood gas testing was ordered. 3. At 3:00 PM on 08/29/18, technical consultant # 2 (personnel # 3 on the personnel list) revealed that the laboratory had standing orders as well as verbal orders. Procedures manuals did not indicate which tests were included in the standing order. Also, -- 2 of 10 -- technical consultant # 2 told the surveyor that verbal orders were not followed up with written orders within 30 days. 4. At 3:30 PM on 08/29/18, the laboratory director confirmed the surveyor's findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review and interview, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 as specified. Findings include: 1. Review of laboratory procedures manuals revealed that the laboratory failed to have a comprehensive procedures manual. See D5403 2. The laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer. See D5421 3. Review of laboratory records revealed that there was no documentation to show that the laboratory determined its calibration procedures and control procedures based on the performance specifications verified or established by the laboratory. See D5425 4. Review of the laboratory's Individual Quality Control Plan (IQCP) revealed that results of the data used to develop their IQCP was run by another laboratory, and not this lab. Also, the Risk Assessment lacked one of the 5 essential components (environment) when the labs IQCP was developed. See D5445 5. Review of the Application for CLIA Certification (Form CMS 116) revealed that this laboratory is a mobile laboratory that moves form site to site, performing blood gas testing. However, there were no records to show that at least 1 level of control material was tested to demonstrate that the transport of equipment did not affect patients' test results. See D5539 6. The laboratory did not retain instrument printouts and