Harrisburg Family Medical Clinic

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 6/26/25 at 10:59am, one (of one) container of Occult Blood Developer (lot 11-15-551622 Consult Diagnostics, expiration date 5/18) was observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 6/26/25 at 10:59am the Technical Consultant confirmed that the item, identified above, had exceeded its expiration date and was available for use in the laboratory. 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 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: Through review of the laboratory's policy and procedure for specimen identification, observation and interview it was determined that the laboratory failed to identify two of four observed urine specimens using unique identifiers. Findings follow: A. Review of the laboratory's policy and procedure for specimen identification revealed that all specimens are to be identified with the patient's first and last names and date of birth. B. During a tour of the laboratory on 2/12/19 at approximately 3:45 PM the surveyor observed one of one urine specimens in the laboratory sink labeled with the patient's first name only, and one of three specimens in plastic bags to be shipped to the referral laboratory labeled with the patient's first and last name only. C. In an interview on 2/12/19 at approximately 03:45 PM, the technical consultant, identified on the CMS 209 form, confirmed that the specimen observed in the sink had been tested and reported and was labeled with the patient's first name only and the specimens to be shipped to the referral laboratory were labeled with the patient's first and last name only. 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 --