Mana Family Medicine South

Summary Statement of Deficiencies 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: Through review of laboratory policy and procedure, observation and interview it was determined that the laboratory failed to label one of three specimen collection containers with patient name or unique patient identifier. Findings follow: A) During a tour of the laboratory on 10/20/22 at 4:00 p.m. three urine specimen containers were observed in the laboratory testing area; one labeled with the patient's first and last name only. B) Review of the laboratory policy and procedure revealed that "a properly labeled specimen must have 2 forms of identification, the patient name and birthdate, the patient ID or the accession number". . C) In an interview on 10/20/22 at 4:30 p.m. , the laboratory staff members (#10 and #2 on the CMS 209 form) confirmed that the specimens identified above had been analyzed and lacked proper patient identification on the containers as required by policy and procedure. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if 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 -- applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature of one of two rooms in which supplies with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 10/20/22 at 01:15 p.m. two rooms containing items with a temperature storage requirement (the main laboratory and storage room) separated by a closable door, were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for only the main laboratory was presented. C) During a tour of the laboratory on 10/20/22 at 03:40 p.m., six boxes of Sofia2 Flu/SARS (lot# 708095 expiration date 2023-08-02 storage temperature requirement of 15 degrees C. to 30 degrees C.) and 200 BD Serum Separator blood collection tubes (lot# 2017186 expiration date 2023-01-31 with a storage temperature requirement of 4 degrees C. to 25 degrees C. ) were observed in the separate storage room. D) Upon request, the laboratory could not present the temperature records for the storage room in which the supplies identified above were stored,. E) In an interview on 10/20/22 at 3:50 p.m. the laboratory staff members (#10 and #2 on the CMS 209 form) confirmed that the daily temperature of the room in which the supplies identified above were stored had not been monitored and recorded.. D5783

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation, lack of documentation and interview it was determined that the laboratory failed to document room temperature in one of three rooms surveyed in which supplies with storage temperature requirements were located. Findings follow: A) During a tour of the laboratory on 11/18/20 at approximately 11:00 AM, the surveyor observed three boxes of Quidel Sofia SARS Ag tests, lot # 706237 expiration date 2021-09-02 with a storage temperature requirement of 15 degrees C. to 30 degrees C. in a separate Covid-19 testing room separated from the laboratory by a closable door. B) Upon request the laboratory was unable to provide documentation of temperature records for the room identified above. C) In an interview on 11/18/20 at approximately 11:00 AM, the laboratory staff member identified as number eight on the CMS 209 form confirmed that the laboratory failed to measure and document temperature in the room identified above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observation, and confirmed by interview with laboratory staff it was determined that 36 of 36 EDTA blood collection vials that had exceeded their date of expiration was present and available for usein the outpatient phlebotomy area. Findings follow: A) During a tour of the laboratory on 11/18/20 at approximately 11: 00 AM 36 of 36 Vacuette EDTA blood collection vials, lot # B190785 expiration date 11-10-2020 were observed in the phlebotomy supply storage bin in the outpatient phlebotomy area . B) In an interview on 11/18/20 at approximately 11:00 AM, the laboratory staff member, identified as number eight on the CMS 209 form, confirmed that the items identified above had expired and were available for use. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation, lack of documentation, and interview it was determined that the laboratory failed to monitor and document room temperature in one of two rooms in which laboratory supplies with storage temperature requirements were stored. Findings follow: A. During a tour of the laboratory on 4/5/18 at approximately 1100 AM, 70 ea. 5.0 ml BD SST vacutainers lot# 7321646 expiration date 2019-11-30, 56 ea. 4.0 ml BD EDTA blood collection tubes lot # 7339691 and expiration date of 2019-04-30, 15 ea. 8.5 ml BD SST blood collection tubes lot # 7160782 with an expiration date of 2018-5-31 all with a storage temperature of 4degrees C. to 25 degrees C. were observed in a separate phlebotomy room isolated from the laboratory by a closable door. B. Upon request, the laboratory was unable to provide documentation of temperature meansurements of the phlebotomy room. C. In an interview on 4/5/18 at approximately 11:30 AM, the testing personnel identified as number 1 on the CMS 209 form confirmed that supplies with storage temperature requirements were in the separate phlebotomy room and room temperature was not monitored and documented. 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 --