Summary:
Summary Statement of Deficiencies D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's policies and procedures, test orders, complaint document review, and interviews with the Laboratory Services Manager (LSM), and Support Staff Manger (SSM), the laboratory failed to meet the applicable preanalytic system(s) requirements. Finding Includes: 1. The laboratory failed to establish and follow policies and procedures for test requests. (Refer to D5305) 2. The laboratory failed to establish and follow policies and procedures for specimen submission and handling. (Refer to D5311) 3. The laboratory failed to establish and follow policies and procedures for preanalytic quality assessment. (Refer to D5393) D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on record review, an interview with the Laboratory Services Manager (LSM), and an electronic mail (email), the laboratory failed to ensure test requisitions included the time of specimen collection, when appropriate. This deficient practice had the potential to affect all patients tested under three of three specialties which include Microbiology, Chemistry, and Hematology from 01/03/2020 through 04/04 /2022. Findings Include: 1. Review of a urinalysis report log titled "ODH-GHLab_UA Statistics-02_14_22" received 04/05/2022 at 11:48 AM via email found seven out of 36 specimens were received and analyzed with the same collection and receipt times. 2. Review of the "Laboratory General Checklist" provided during the complaint investigation found the following statement: "GEN.40750 Requisition Elements 7. Date of specimen collection, and if appropriate, time of collection." 3. The inspector requested documentation of collection times for the identified seven out of 36 specimens that indicated the same collection and laboratory receipt times from the LSM. The LSM was unable to provide the requested information. The interview occurred 04/04/2022 at 9:40 AM. 4. A follow-up email received 04/05/2022 at 11:48 AM from the LSM stated if there were no collection times written on the requisition or specimen containers, the specimen collection time defaults to the time the specimen was received in the laboratory. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on document review, an interview with the Laboratory Service Manager (LSM), and an electronic mail (email), the laboratory failed to establish and follow a written procedure for the transport conditions of specimens. This deficient practice had the potential to affect all patient specimens transported from off-site laboratories and tested in three of three specialties which include Microbiology, Chemistry, and Hematology from 01/03/2020 through 04/04/2022. Findings Include: ITEM 1 1. Review of the laboratory's policy and procedure manual titled, "Genesis Healthcare System Departmental Policy & Procedure Guide", did not find any mention of a policy and procedure for the conditions and handling of specimens during transport. 2. The inspector requested a policy and procedure for specimens transported to the laboratory from an offsite location which includes specimen transport conditions, from the LSM. The LSM verified there was no policy and procedure which included the specimen transport conditions and was unable to provide the requested -- 2 of 6 -- information. The interview occurred on 04/04/2022 at 11:45 AM. 3. A follow-up email received from the LSM on 04/13/2022 at 4:00 PM stated there was no criteria established for specimen transport from offsite locations. ITEM 2 Based on document review, an electronic mail (email), and an interview with the Laboratory Service Manager (LSM), the laboratory failed to establish and follow a written procedure for specimen acceptability and rejection. This deficient practice had the potential to affect all patients tested in six of six specialties which include Microbiology, Diagnostic Immunology, Chemistry, Hematology, Immunohematology, and Pathology from 01/03 /2020 through 04/04/2022. Findings were as follows: 1. Review of the laboratory's policy and procedure manual titled, "Genesis Healthcare System Departmental Policy & Procedure Guide", did not find any mention of specimen acceptability and rejection. 2. The inspector requested a policy and procedure for acceptability and rejection of specimens from the LSM via email 04/11/2022 at 12:14 PM. The LSM provided the policy and procedure titled, "Specimen Integrity Guidelines", via email on 04/13/2022 at 4:00 PM. 3. Review of the laboratory's policy and procedure titled, "Specimen Integrity Guidelines", provided via email on 04/13/2022 at 4:00 PM, found the following statement: "PURPOSE: To provide guidelines for the management of "sub-optimal" laboratory specimens with regard to hemolysis, icterus, and lipemia. Procedure will define the mechanism that will be used to notify the requesting physician of the sample condition." 4. The LSM was unable to provide a policy and procedure for acceptability and rejection of specimens, that included all variables to specimen acceptability and rejection, such as labeling, tube type, quantity of specimen, broken or leaking containers, transport and storage temperature requirements other than with regard to hemolysis, icterus, and lipemia. . D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of