Family Medicine

Summary Statement of Deficiencies 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 surveyor observation, the laboratory's quality assurance policy, interview with the technical consultant, and interview with the Advanced Practice Registered Nurse (APRN), not designated as a testing personnel and not listed on the CMS 209 form, the laboratory failed to follow policies to ensure positive identification of a patient's specimen. 1. Surveyor observation of one of one capillary sample reveled the capillary sample was unlabeled. 2. The laboratory's quality assurance policy states "inappropriate labeled samples will be rejected and recollected." 3. Interview with the technical consultant on 12/8/2022 at 11:25 AM revealed the sample was not rejected but the sample was tested by the APRN. 4. Interview with the APRN on 12/8/2022 at 11:40 AM confirmed the APRN performed a hematology test on the unlabeled capillary sample. The APRN indicated she forgot to throw the sample away after testing it. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory and interview with the technical consultant, the laboratory failed to properly label twenty of twenty blood samples, six of six urine samples, and one of one capillary sample observed with the patient's first and last name, patient's date of birth, date and time of collection, and the initial's of collector per the laboratory policy. 1. During observation on 12/8/2022 at 11:20 AM, surveyor observed twenty blood samples labeled only with patient's first and last name. 2. During observation on 12/8/2022 at 11:20 AM, surveyor observed three urine samples labeled only with patient's first and last name and three urine samples labeled only with date of collection and patient's first and last name. 3. During observation on 12/8/2022 at 11:20 AM, surveyor observed one capillary sample with no label. 3. The written procedure for specimen labeling stated staff are to label specimens with the patient's first and last name, patient's date of birth, date and time of collection, and the initial's of collector. 4. The technical consultant confirmed during an interview on 12/8/2022 at 11:25 AM the laboratory did not follow its policy for labeling specimens. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on interviews with the Advanced Practice Registered Nurse and interviews with the technical consultant the technical consultant failed to provide technical and scientific oversight and failed to provide training for individuals performing testing. Refer to D6036 and D6045. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of the instrument print out that the hematology instrument generated from testing the unlabeled capillary sample by the Advance Practice Registered Nurse (APRN), interview with the Advanced Practice Registered Nurse (APRN), and interview with the technical consultant revealed the technical consultant failed to provide technical and scientific oversight. 1. Review of the instrument print out that the hematology instrument generated from testing the unlabeled capillary sample revealed an instrument flag of "AG" on the platelet results. 2. Interview with the APRN on 12/8/2022 at 11:40 AM confirmed the the instrument print out that the hematology instrument generated after the unlabeled capillary sample was tested by the APRN had a flag of "AG" on the platelet result. The APRN confirmed the APRN did not know what the "AG" platelet flag result means. 3. Interview with the technical -- 2 of 3 -- consultant on 12/8/2022 at 11:50 AM confirmed there was no training on the "AG" platelet flag. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on interview with the Advance Practice Registered Nurse (APRN), not designated as a testing personnel and not listed on the CMS 209 form, and interview with the technical consultant the technical consultant failed to provide training for the Advanced Practice Registered Nurse (APRN). 1. Interview with the APRN on 12/8 /2022 at 11:40 AM confirmed the APRN performed hematology testing on an unlabeled capillary sample and confirmed the APRN was not trained to perform hematology testing. 2. Interview with the technical consultant on 12/8/2022 at 11:50 AM confirmed the APRN was not on the CMS 209 form and was not trained to perform hematology testing. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation, review of proficiency records, and interviews, the laboratory improperly referred proficiency testing specimens to another laboratory. (Refer to D2013) D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency 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 -- testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on observation, review of 2019 and 2020 proficiency testing (PT) records, and interview with testing personnel (TP) #8 and #11, the laboratory failed to ensure PT specimens for AAFP event 2020-A were not referred to another laboratory. Findings: 1. Observation of the laboratory on September 23, 2020 showed a refrigerator where the facility routinely kept all specimens. The specimens in the refrigerator meant for retrieval by the reference laboratory were placed in bags imprinted with the reference lab's name and logo. 2. Review of PT for 2019 and 2020 showed the laboratory received modules 613 and 639 from AAFP. Module 613 includes auto diff I and module 639 includes complete urinalysis package. 3. On April 9, 2020 the Nebraska CLIA program received a phone call complaint from a reference laboratory reporting that (6) six PT specimens from Family Medicine 28D0454747 were sent to the reference lab without instructions or test requisitions. A digital photograph provided by the complainant showed an AAFP PT 2020-A UA-1 (for urinalysis), an AAFP PT 2020-A SYX-1, SYX-2, SYX-3, SYX-4, and SYX-5 (for complete blood count, auto diff I). 4. Interview on September 23, 2020 at 12:00PM with TP #11 confirmed that the laboratory did refer six PT specimens to a reference laboratory. 5. Interview on September 23, 2020 at 1:00PM with TP #8 revealed PT specimens from AAFP are placed in the same refrigerator as specimens going to the reference laboratory. 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 lack of a procedure for proficiency testing and an interview with the technical consultant, the laboratory failed to have a procedure for proficiency testing. Findings: 1. No procedure for proficiency testing could be presented during the time of survey on 9/23/2020. 2. Interview with the technical consultant on 9/23/2020 at 11: 30AM confirmed the laboratory did not have a procedure for proficiency testing. -- 2 of 2 --