Cdt Toa Alta

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, General Immunology (Mycoplasma pneumoniae) testing record random review from Januray 5, 2021 to October 31, 2021 and interview with the laboratory supervisor on Noember 10, 2021 at 10:31 AM, it was determined that the laboratory failed to follow the manufacturer's instruction when 26 out of 26 patients specimens were tested and reported for of Mycoplasma pneumoniae from Januray 5 2021; Februrary 17, 2021 and October 16, 2021. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. 2. The manufacturer's instruction establishes to perform the test procedures at room temperature range from 22 to 25 C. 3. On November 10, 2021 at 10:31 AM, review of the Mycoplasma pneumoniae testing records showed that the laboratory did not monitor or document the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from from January 5, 2021; February 17, 2021 and October 16, 2021. 4. The laboratory supervisor confirmed on November 10, 2021 at 10:31 AM, that the laboratory did not monitor or document the room temperature when it processed the patients specimens for Mycoplasma pneumoniae test. 5. The laboratory processed and reported 26 patient samples for Mycoplasma pneumoniae test from January 5, 2021; February 17, 2021 and October 16, 2021. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, Mycoplasma testing records and laboratory supervisor interview by phone on November 10, 2021 at 10:31 AM, it was determined that the laboratory director did not fulfill her responsibilities to ensure that the temperature was recorded each day of patient testing from January 5, 2021; February 17, 2021 and October 16, 2021. Refer D5405. -- 2 of 2 --

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 Proficiency Testing record (year 2019), Creatine Kinase Isoenzyme (CK- MB) testing record review and general supervisor interview on October 9, 2019 at 12: 30 PM, it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for CK-MB test from April 1, 2019 to October 9, 2019 when 96 out of 96 CK-MB patients specimens were processed and reported by the Vitros 350 system. The findings include: 1. On October 9, 2019 at 12:30 PM, the Proficiency Testing record showed that the laboratory did not enroll in an HHS approved Proficiency Testing Program for CK-MB test during the year 2019. 2. The CK-MB testing record showed that the laboratory processed and reported 96 out of 96 patients specimens by the Vitros 350 system from April 1, 2019 to October 9, 2019. 3. The general supervisor confirmed on October 9, 2019 at 12:30 PM that the laboratory did not participate in an HHS approved Proficiency Testing Program for CK-MB from April 1, 2019 to October 9, 2019. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Proficiency Testing record (year 2019), Creatine Kinase Isoenzyme (CK- MB) testing record review and general supervisor interview on October 9, 2019 at 12: 30 PM, it was determined that the laboratory director failed to fulfill her responsibilities to comply with the laboratory Proficiency Testing requirements. Refer to D 6088 (The laboratory director did not enroll the laboratory in an HHS approved Proficiency Testing Program for CK-MB test from April 1, 2019 to October 9, 2019 when 96 out of 96 CK-MB patients specimens were processed and reported by the Vitros 350 system). D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on Proficiency Testing record (year 2019), Creatine Kinase Isoenzyme (CK- MB) testing record review and general supervisor interview on October 9, 2019 at 12: 30 PM, it was determined that the laboratory director did not enroll the laboratory in an HHS approved Proficiency Testing Program for CK-MB test from April 1, 2019 to October 9, 2019. Refer to D 2000. -- 2 of 2 --